Ufesg is iesg

JFS-C Standard Document(Sector: CI, CII, CIII, CIV/K)
Version 3.1

Guideline
Edition 1.0

Japan Food Safety Management Association
August 20, 2024

Table of Contents
Introduction ............................................................................................................................4
1.1 JFS-C Standard Document .......................................................................................4
1.2 Scope of Application ..................................................................................................4
1.3 Structure of JFS-C standard document ..................................................................5
1.4 JFS-C Standard Document Guideline......................................................................9I Food Safety Management Systems (FSM) ................................................................ 11
FSM 1 Top Management Responsibility ....................................................................... 11
FSM 2 Top Management Commitment and Food Safety Culture ............................13
FSM 3 Management Review ..........................................................................................15
FSM 4 Compliance with food safety laws ....................................................................18
FSM 5 Food Safety Management System and General Requirements ...................19
FSM 6 Food Safety Policy and Goals ............................................................................22
FSM 7 Food Defense .......................................................................................................23
FSM 8 Food Fraud Prevention .......................................................................................25
FSM 9.1 Documentation procedures ...........................................................................28
FSM 9.2 Control and storage of documented information .......................................28
FSM 10 Specification Control of Purchased or Provided Items and Services .......30
FSM 11 Procedures and Instructions ...........................................................................32
FSM 12 Resource Management ....................................................................................33
FSM 13.1 Purchasing ......................................................................................................34
FSM 13.2 Supplier Performance ...................................................................................36
FSM 13.3 Outsourcing ....................................................................................................38
FSM 14.1 Traceability .....................................................................................................40
FSM 14.2 Traceability verification ................................................................................42
FSM 15 Product development .......................................................................................42
FSM 16 Allergen Management ......................................................................................44
FSM 17 Control of Measuring and Monitoring Devices .............................................46
FSM 18.1 Product labeling (B-to-C products) ............................................................48

1

FSM 18.2 Product labeling (B-to-B products, work in progress, semi-finished products) 49
FSM 19.1 Analysis and Testing .....................................................................................50
FSM 19.2 Environmental Monitoring............................................................................52
FSM 20 Internal Audit ....................................................................................................53
FSM 21 Complaint Handling ..........................................................................................56
FSM 22.1 Serious Incident Management ....................................................................58
FSM 22.2 Verification of food incident management manual..................................60
FSM 23.1 Management of product specifications ......................................................61
FSM 23.2 Product Release .............................................................................................62
FSM 24 Identification of nonconformities and control of nonconforming products63
FSM 25 Corrective Action ..............................................................................................64
FSM 26 Change management.......................................................................................65
FSM 27 Utilization of Kaizen suggestions from personnel .......................................67
II Hazard Analysis and Critical Control Point (HACCP) ...........................................68
HACCP Step 1 HACCP team assembly and identification of the scope of application

68

HACCP Step 2 Product Description ..............................................................................69
HACCP Step 3 Identification of Intended Use ............................................................70
HACCP Step 4 Construction of Flow Diagram ............................................................70
HACCP Step 5 On-site Confirmation of Flow Diagram..............................................72
HACCP Step 6 (Principle 1) Hazard Analysis ..............................................................73
HACCP Step 7 (Principle 2) Critical Control Points ....................................................78
HACCP Step 8 (Principle 3) Critical Limits ..................................................................81
HACCP Step 9 (Principle 4) Monitoring System .........................................................82
HACCP Step 10 (Principle 5) Corrective Actions ........................................................83
HACCP Step 11 (Principle 6) Establish HACCP plan validation and verification procedures....................................................................................................................................84
HACCP Step 12 (Principle 7) Documents and Record ..............................................87
III Good Manufacturing Practice (GMP) ......................................................................89
GMP 1 Facility Environment...........................................................................................89
GMP 2 Factory premise environment ..........................................................................892

GMP 3 Design, construction, layout of business site and work and product flow lines
GMP 4.1 Cross-contamination (including allergen cross-contact) and isolation ..96
GMP 4.2 Control of hazards that require enhancement ...........................................97
GMP 5 Personnel Facilities .............................................................................................99
GMP 6.1 Personal hygiene criteria for personnel .....................................................101
GMP 6.2 Personnel workwear .....................................................................................101
GMP 6.3 Health management of personnel..............................................................101
GMP 6.4 Application to subcontractors and visitors ................................................101
GMP 7 Training ..............................................................................................................106
GMP 8 Housekeeping, cleaning, sterilization, and disinfection .............................108
GMP 9 Rework ............................................................................................................... 112
GMP 10 Patrol and inspection of the site .................................................................. 113
GMP 11 Air and water management ......................................................................... 114
GMP 12 Waste Management ....................................................................................... 116
GMP 13 Pest control ..................................................................................................... 118
GMP 14 Acceptance of purchased items ...................................................................121
GMP 15 Transport .........................................................................................................123
GMP 16 Storage.............................................................................................................125
GMP 17 Stock Management ........................................................................................125
GMP 18 Equipment and Tools .....................................................................................127
GMP 19 Maintenance ....................................................................................................1303

92

Introduction
1.1 JFS-C Standard Document
The JFS-C Standard Document (hereinafter referred to as “this Standard Document”) isa standard document developed by the Japan Food Safety Management Association(JFSM) and is intended to assist organizations to establish, operate and improve its
management systems for manufacturing safe food products. In addition, this Standard
Document can also be utilized to have the system of the organization (*1) evaluated byexternal agencies including Certification Bodies. This Standard Document is utilized byorganizations that endeavor to realize a food safety management system applicableworldwide.
(*1) “Organization” refers to a business entity, group or individual to whom therequirements of this Standard Document apply.
1.2 Scope of Application
The Standard Document applies to the following “Food Manufacturing Sectors (CI, CII,
CIII, CIV)” and “Chemical Products (Including Biochemical Products) Manufacturing Sector(K)”.

(See Table 1)*Pet food is included in the following food manufacturing sector (C).
Food manufacturing sector (C)CI: Processing of perishable animal products

CII: Processing of perishable plant products

CIII: Processing of perishable animal and plant products (mixed products)

CIV: Processing of ambient stable products

Manufacturing sector of chemical products (including biochemical products) (K)K: Manufacture of chemical products (including biochemical products)(Production of chemical products (including biochemical products) and cultures used as foodingredients or processing aids in food production)

In addition, chemical products here means a chemical product (including abiochemical product) related to food.

4

Table 1: List of Sectors by GFSI
Code
AI
AII
BI

Sector/Subsector
Farming of Animals for Meat/ Milk/
Eggs/Honey
Farming of Fish and Seafood
Farming of Plants (other than grains
and pulses)

Code

Sector/Subsector

FI

Retail / Wholesale

FII

Food Broker / Agent

H

Provision of Food Safety Services

BII

Farming of Grains and Pulses

G

BIII

Pre-process handling of plant products

I

C0

Animal primary conversion

CI
CII
CIII

JI

products

JII

constructors and equipment

Processing Equipment (for building andequipment users)(mixed products)
Production of feed

Processing Equipment (for building

Hygienic Design of Food Buildings andPerishable animal and plant productsD

Production of Food Packaging

manufacturers)

Processing of perishable plant products

Processing of ambient stable products

ServicesHygienic Design of Food Buildings andProcessing of perishable animal

CIV

Provision of Storage and Distribution

K

Manufacture of chemical products(including biochemical products)(Production of chemical products

E(including biochemical products) andcatering

cultures used as food ingredients orprocessing aids in food production)

Reference: The GFSI Benchmarking Requirements version 2020.1 PART I*Sectors presented by GFSI that are covered by this standard document are framed.

1.3 Structure of JFS-C standard document
The Standards Document consists of three elements, namely, Food Safety Management
Systems (FSM), Hazard Analysis and Critical Control Point (HACCP), and Good
Manufacturing Practice (GMP).
The Standard Document only specifies common requirements for the manufacturingsector, and does not cover individual hygiene requirements for individual product.
Organizations shall use information appropriate for the organization (e.g. laws andregulations on food safety, standards specified by the relevant industry group, “General
Principles of Food Hygiene” by the Codex Alimentarius Commission (*2), specific code of
conduct), in addition to the requirements stipulated in this Standard Document.
The Standard Document is consistent with the benchmark requirement version 2020.1(*3 hereafter, BR 2020.1) published by GFSI in June 2020. On the other hand, since BR
2020.1 adopts ISO22000:2018 (*4) in its scope structure and numbering structure, thisStandard Document has a structure consistent with both the scope structure andnumbering structure.

5

In addition, the Standard Document uses a process approach that incorporates the plando-check-act (PDCA) cycle of ISO22000:2018 and a risk-based approach as a benchmark.
The Standard Document establishes and implements a food safety management system
to ensure the provision of safe food and services while meeting each applicablerequirement and adopts a process approach for improving its effectiveness.
The process approach indicates that each process used for providing food and services
is regarded as a system and is managed as such. In the process approach, the purpose ofeach process is clarified and managed in consideration of process interactions to aid theorganization to effectively and efficiently achieve the intended results.
Risk (*5) in the Standard Document refers to all the factors that may hinder theachievement of the organization's food safety objectives and targets. Risk-based thinking
involves "focusing on what factors may compromise the achievement of goals andobjectives, identifying those factors, clarifying their effects, and considering necessary
measures." By establishing a hypothesis based on risk, executing it, and performing
verification based on the facts that are obtained, it becomes possible to aim to improve
the accuracy of achieving the objectives and goals of the organization.
As shown in Figure 1, in the Standard Document the process approach adopts the conceptof a plan-do-check-act (PDCA) cycle at two levels. The first level involves the FSM
framework. The second level is targeted at the Do process within the food safety
management system. For this reason, communication between the two levels is extremely
important.
(*2) Codex Alimentarius Commission"GENERAL PRINCIPLES OF FOOD HYGIENE," CXC 1-1969, Rev. 2022.

(*3) GFSI "The GFSI Benchmarking Requirements version 2020.1"(*4) The International Organization for Standardization"Food safety management systems - Requirements for any organization in thefood chain" ISO 22000:2018(*5) Unlike the risk defined in ISO22000:2018 (ISO22000:2018 3.39), the term risk isused in the JFS-C Standard Document as something limited more to food safety.

6

PLAN (FSM)
FSM 1
FSM 2
FSM 4
FSM 5

DO (FSM)

Top Management Responsibility
Top Management Commitment and Food
Safety Culture
Compliance with food safety laws
Food Safety Management System andGeneral Requirements

FSM 7

Food defense

FSM 8

Food Fraud Prevention

FSM 11

Procedures and Instructions

FSM 14.1

Traceability

FSM 6

Food Safety Policy and Goals

FSM 15

Product development

FSM 9.1

Documentation procedures

FSM 16

Allergen Management

FSM 9.2
FSM 10Control and storage of documented

Control of Measuring and Monitoring

FSM 17

information
Specification Control of Purchased or Provided
Items and Services

Devices

FSM 19.1

Analysis and Testing
Environmental Monitoring for Food

FSM 12

Resource Management

FSM 19.2

FSM 13.1

Purchasing

FSM 22.1

Serious Incident Management

FSM 13.2

Supplier Performance

FSM 23.2

Product Release

FSM 13.3

Outsourcing

FSM 24

FSM 18.1

Product labeling (B-to-C products)

Manufacturing

Identification of nonconformities andcontrol of nonconforming products
CHECK (FSM) Performance evaluation

Product labeling
FSM 18.2(B-to-B products, work in progress, semi-

FSM 3

Management Review

finished products)
FSM 23.1

Management of product specifications

FSM 14.2

Traceability verification

FSM 26

Change management

FSM 20Internal Audit

FSM 21

Complaint Handling

FSM 22.2

Verification of food incident responsemanualACT (FSM) Improvement

FSM 25
FSM 27

Corrective Action
Utilization of Kaizen suggestions frompersonnel

Figure 1 Conceptual diagram of two PDCA cycles in the JFS-C Standard Document Food Safety Management System7

At the beginning of this chapter, it was noted that the Standard Document consists ofthree elements: Food Safety Management Systems (FSM), Hazard Analysis and CriticalControl Point (HACCP), and Good Manufacturing Practice (GMP). Instead of working
independently, each of these elements influences the other. Each element has an organic
function within this relationship that spirals up while interlocking. Figure 2 shows aconceptual diagram of the three elements. An understanding of this conceptual diagram
will be effective for organizations that use the Standard Document for building andoperating a food safety management system.

Figure 2 Conceptual diagrams of the organic functions of the three elements(FSM, HACCP, GMP)

8

1.4 JFS-C Standard Document Guideline
This guideline provides ideas and specific examples of what organizations should
implement with regard to the JFS-C standard issued by Japan Food Safety Management
Association（JFSM）.
The food safety management system established by each food business organizationdiffers depending on many factors such as industry, business category, business scale,and social background. This guideline is intended to be used as a reference for eachorganization to build a food safety management system suited to their own needs.

Figure 3 Overall view of JFS Standard Document and Certification ProgramThis guideline covers the C standards of the sector (CI to CIV/K) (Figure 3). Assumingthat operators understand the basics of food safety, the guidelines omit detailed
examples and focus on specific interpretations of the requirements.
This guideline consists of "Requirements" and "Concepts and Specific Examples," andprovides interpretations and guidance as reference. These are only one concept, andother concepts and methods may be selected if it can be explained technically andscientifically that the requirements of the JFS standards are met. By using them together
with research data and food safety theory from research institutes and industry
associations that have been published in the past, the technical information and know-

9how possessed by individual industries can also be utilized.
Even when management based on other approaches is adopted, it is required to ensurethat the level of management is equivalent to this guideline. However, if there is any
discrepancy between the requirements of the standard and the contents of this guideline,
the requirements of the standard shall take precedence.
We hope that this guideline will help you understand the JFS standards.

10

［JFS-C Standard Guideline]
JFS-C standard (Sector: CI, CII, CIII, CIV/K)
I Food Safety Management Systems (FSM)
FSM 1 Top Management Responsibility
Requirements
Top management shall establish and operate a clear organizational structure whichunambiguously defines the job functions, responsibilities, directing and reporting
structure and information sharing of at least the personnel whose activities affect foodsafety.
There shall also be evidence that employees are made aware of them.
Top management shall appoint personnel responsible for the operation of theorganization’s food safety management system.
Concepts, specific examples
1. To clarify the organizational structure, the roles of the organizations anddepartments involved in the food safety management system shall be determined,
communicated to employees.
Use an organization chart that includes a communication system for instructions,
reporting, and consultation.
2. In order to clarify the communication system for instructions, reporting, andconsultation, it is easier to manage by using meeting bodies and morning meetings
to determine the activities necessary for food safety. Instructions, reporting, andconsultation are as follows.
1） Instructions: The clarification of tasks and roles by a supervisor, manager, orother person.
2） Reporting: The person who performed the work communicates the facts to asupervisor, manager, or other person.
3） Consultation: Confirmation of appropriateness should be obtained when it is notpossible to determine whether the work is appropriate, or when new activities areundertaken.
3. The following are points to be considered when establishing the organizational
structure:1） The positions and functions included in this standard are included.
2） The Food Safety Officer (see below) receives direct instructions from top
management.
3） Quality assurance and quality control departments can objectively evaluate foodhandling departments such as manufacturing.

114） No double-directed structure in which instructions pertaining to food safety comefrom two different places.
5） It is a simple organization.
4. The term "information sharing" includes communicating information that may affectfood safety to the person or department that needs that information. In particular,
ensure that changes that may require changes to the HACCP plan, such as new
products or changes in production lines, are communicated to the HACCP team.
5. Examples of evidence that employees are informed about the above include, but are
not limited to, meeting minutes, morning meeting records, and communication
notes. It can also be confirmed in communications during internal and external
audits, etc.
6. Determine a Food Safety Officer as "the person responsible for the operation of thefood safety management system. The competencies required of the Food Safety
Officer include the ability to establish, implement, and maintain JFS standards andthe HACCP system. This responsible person may be the leader of the HACCP team(*see HACCP Step 1), but the two need not be the same, and there may be a HACCP
team leader under the direction of the responsible person. This responsible person
can also be more than one person.
1） The food safety Officer should have a good understanding of the food safety
policies in the organization, and knowledge of food safety and knowledge andexperience in the field will help create an effective system.
2） The role of Food Safety Officer includes the following:(1) Sanitation, including daily inspections, will be carried out systematically inaccordance with management's instructions.
(2) In order to prevent the occurrence of food sanitation hazards, give necessary
attention to matters concerning sanitation control and, when necessary, offer
opinions to management.
(3) Prepare documents concerning sanitation control of facilities and products,
etc., and inform and confirm them with food handlers, etc.
7. Items to be referred to in legal provisions related to food safety (this item isapplicable to the extent in Japan):
1） Assign Food Hygiene Supervisor or Food Hygiene Manager who meets thenecessary requirements.
(1) Food Hygiene Supervisor: Appointed in accordance with Article 48 of the Food
Sanitation Law. Target foods are whole milk powder, sweetened milk powder,adjusted milk powder, meat products, fish meat ham, fish meat sausage,
irradiated food, edible oils and fats, margarine, shortening, and additives.
(2) Food Hygiene Manager: Unless Food Hygiene Supervisor is appointed
according to the Food Sanitation Law Enforcement Regulations, each facilities

12that require a business license, and facilities that submit business notifications
shall be placed.
2） Food Hygiene Supervisor or Food Hygiene Manager shall direct hygiene control
while respecting the opinions of Food Safety Officer.
3） Food Safety Officer can also serve as Food Hygiene Supervisor or Food Hygiene
Manager. If Food Hygiene Supervisor or Food Hygiene Manager is appointed
separately, it is important to share information and collaborate with the Food
Hygiene Officer.

FSM 2 Top Management Commitment and Food Safety Culture
Requirements
Top management shall show evidence of its commitment to building, implementing,
maintaining and continually improving its food safety management systems.
This commitment shall include elements of a food safety culture, and this means, at aminimum, communicating with employees, responding to Kaizen suggestions, training
to improve food safety, and assessing the performance of food safety activities. In
addition, these efforts shall be incorporated and implemented in the food safety
management systems of the entire organization.
Concepts, specific examples131. Top management is responsible for the establishment, implementation, andmaintenance of the food safety management system and demonstrates its
commitment to the establishment, implementation, and maintenance of the systemthrough the implementation of the following:1） Develop a food safety policy.
2） Communicate to employees in a timely manner the importance of compliancewith laws, standards, social norms, and rules set by the organization.
3） Review the food safety management system in a timely manner.
4） Provide necessary resources in a timely manner.
5） Ensure that employees are aware of factors that can influence food defense andfood fraud risks. To this end, establish and maintain a system that allows theorganization to constantly obtain the following information.
●All related laws
●Scientific and technological developments●Industry code of practice●Other information on food safety and product quality issues, etc.
6） Engage, direct, and support employees to contribute to food safety effectiveness.
7） Set business goals that support food safety.
8） Provide opportunities and means for all employees involved in food safety toprovide the organization with potential food safety improvements they discover.
(Responding to “Suggestions for improving food safety from employees” listed in“FSM 27.”)9） Other matters necessary for the establishment, implementation and maintenanceof food safety management systems.
2. The following is a reference example of food safety culture elements for top
management to include in their commitments to promote improvement through thefood safety management system. (5 Dimensions)1）Clarify the vision and mission.
Is food safety integrated into your business strategy? (including providing
resources and other support).
Does the company provide direction and objective goals to employees and clearlystate what is expected of them?
Does it provide messaging with leadership to employees?
2）Conduct outreach to the people.
Have the necessary stakeholders been clarified and the governance structure
clarified?
Do you communicate with employees on site? (e.g., by holding meetings)
Is there an organization in place for learning and training?

14

Does the company have an evaluation system (incentives, rewards, recognition,etc.) for actions taken by employees?
3）Consistency.
Is the top management taking the responsibility seriously as the person who isultimately responsible for the company?
Are employees' performances properly evaluated?
Are all processes kept in writing?
4）Adaptability.
Do they demonstrate food safety expectations while understanding the personal
cultural differences of each employees?
Does the company provide prompt feedback on employee offers?
Is the business model appropriately changed to manage risks and solve problems?
5）Recognize hazards and risks.
Does the company provide risk prevention education, such as by providing basic
hazard information?
Are employees involved in activities to prevent near misses?
Are hazards verified when they occur and are risks communicated?
3. Fundamental to a well-functioning food safety management system is theestablishment and maintenance of a positive food safety culture that recognizes theimportance of the actions of all employees involved in providing safe and appropriate
food. Therefore, it is advisable that not only top management but also all employees
make a commitment. Reference examples are as follows.
(Reference case)In order to prevent contamination by foreign matter, we will conduct thoroughvisual checks of the manufacturing process after washing/cleaning and before thestart of manufacturing. etc.

FSM 3 Management Review
Requirements
Top management shall conduct management reviews on a regular basis and record themin an appropriate manner to review all elements of the overall food safety management
system, including HACCP plans for managing food safety hazards and risks.
In the event of changes that have an effect on food safety, top management shall ensurethat the food safety management system remains relevant and effective.

15

Concepts, specific examples
1. Management Review
Management review" means that top management monitors and evaluates theadequacy, appropriateness, and effectiveness of the targets to achieve the set goals,
and points out areas for improvement.
1） The food safety manager takes the lead in collecting and analyzing informationthat enables top management to evaluate the food safety management system ofhis/her organization, and reports (input) to top management on a regular basis.
2） Top management evaluates its own food safety management system and provides
instructions for evaluation and improvement as a result of management review.
3） Input items for management review shall include the following information:(1) Nonconformity and Corrective Action Information(2) Results of process monitoring and measurements(3) Results of audits and reviews(4) Results of supplier management(5) Environment surrounding the organization(6) Results of verifying the implementation of FSM, GMP and HACCP(7) Results of improving and updating the food safety management system
4） In addition, although not explicitly stated in the requirements, input of thefollowing information is also recommended:(1) Follow-up on the results of previous management reviews(2) Serious accidents and recoveries(3) Review of communication activities, including customer feedback5） HACCP plan reviews may be conducted by the HACCP team, the results of which
are reported to top management. HACCP plan review is to review the HACCP planfrom time to time due to information such as new products, line changes, accidents
at other companies, and revisions to legal and regulatory requirements. In
addition, periodic reviews could also be conducted.
6） The results of the management review shall be reflected in the improvement of
the food safety management system. The results of the management review shall
include decisions and actions regarding the following:(1) Any changes to the food safety management system, including resource needs(2) Revision of Food Safety Policy and Goals
2. Verification activities and analysis for management review
1） Verify the implementation of FSM, GMP and HACCP. The verification shall confirm
that the requirements are met after establishing a verification plan including
objectives, methods, frequency, responsibilities, etc., in accordance with theimportance of the subject matter.
For example, the following methods are used for verification:16

(1) Check records (confirm that established procedures were followed and that
there were no problems)(2) Confirmation that work was performed in accordance with procedures (bywitnessing the work, etc.)(3) Confirmation that food safety is ensured as a result of work performed
according to procedures (e.g., confirmation of workmanship)(4) Confirmation of safety through testing of final products, etc.
(5) Confirmation of equipment used for monitoring, etc. (calibration, etc.)(6) Prior to the introduction of a new procedure, etc., confirmation that theobjective can be achieved with that method (validation)(7) See HACCP Step 11 (Principle 6) for verification of the HACCP system.
2） These checks will be performed as appropriate in response to social events,changes within the organization, product or process changes, or new scientificfindings that affect food safety.
3） If a problem is discovered through verification, it may be addressed through themechanisms of FSM 24 and FSM 25. If the product has already been shipped,
action may be required under FSM 22.1.
4） The results of the verification will be analyzed by the food safety manager or otherperson with expertise in the field. The purpose of this analysis is to clarify theoverall performance of the food safety management system and to provide input
to top management for reviewing the system. This analysis can also consider, forexample, the following information:(1) Records of nonconformities, customer complaints, serious accidents, andactions taken to remedy them(2) Results of internal and external audits(3) Review results of safe product manufacturing systems (HACCP plans, GMP
controls, etc.)
5） The results of the analysis shall be recorded in an appropriate form so that they
can be used in management reviews.
3. Updating Food Safety Management System
1） Top management provides direction for the continuous updating of the food safety
management system and ensures that periodic and ad hoc updates of the foodsafety management system are made. This is done through a process of judgment
and decision making by top management during management reviews.
2） The updating of the food safety management system shall be carried out inconsideration of the following:(1) Results of Management Review(2) Results of internal audits (FSM 20)(3) Results of verification activities and analysis of results(4) Changes in internal and external environment

173） The organization shall establish specific methods for updating the food safety
management system, implement them on a regular and ad hoc basis, keep
records, and report to top management.

FSM 4 Compliance with food safety laws
Requirements
When developing a food safety management system, the organization shall develop,
implement and maintain detailed procedures to ensure that all processes and operations
that have an effect on food safety are in compliance with the laws of both the countryof manufacture and the intended country of sale.
In addition, records of implementation shall also be maintained.
Concepts, specific examples
1. The organization shall clarify the food safety laws and regulatory requirements for
its own organization and define the methods of control. The organization shallcomply not only with the laws and regulations of the country of manufacture, butalso with the laws and regulations pertaining to food safety in the country of sale.
When relevant laws and regulations are revised or new laws and regulations areenacted, it is necessary to grasp them in a timely manner, communicate them to theorganization, and change management methods as necessary. The laws andregulatory requirements of the country of sale must also be understood. Evidence ofthe results of the implementation of the control procedures must be retained. An
example of a record of the implementation of the procedures is a list of relevantlaws, regulations, and requirements, and records of their confirmation and updating.
2. Laws, regulations, and regulatory requirements pertaining to food safety to whichreference should be made (this item is applicable to the scope in Japan)
Business operators engaged in manufacturing or processing shall assign a foodhygiene supervisor or food hygiene manager who meets the necessary requirements.
1） Food Hygiene Supervisors: These are appointed in accordance with Article 48 of
the Food Sanitation Law. Target foods are whole milk powder, sweetened milk
powder, adjusted milk powder, meat products, fish meat ham, fish meat sausage,
irradiated food, edible oils and fats, margarine, shortening, and additives.
2） Food Hygiene Manager: A Food Hygiene Manager is appointed for each facility
that is to obtain a business license and each facility that is to submit a businessnotification, except in cases where a Food Hygiene Manager is appointed inaccordance with the provisions of the Enforcement Regulations of the Food
Sanitation Law.

18

FSM 5 Food Safety Management System and General Requirements
Requirements
The organization shall document the elements of the Food Safety Management Systems
and shall establish, implement and maintain them appropriate to the scope of the
products covered by its business activities.
In addition, the Food Safety Management Systems shall be continuously improved byproperly adapting to changes in the surrounding social environment.
Concepts, specific examples
1. This requirement requires that the framework for the entire food safety management
system be clarified. The JFS-C standard uses a process approach, incorporating thePlan-Do-Check-Act ("PDCA") cycle and risk-based approach of ISO 22000:2018, as
the benchmark. The standard document adopts a process approach in establishing,implementing, and improving the effectiveness of a food safety management system
to ensure the provision of safe food and services while meeting the respective
applicable requirements. (See JFS-C Standard Document Ver. 3.1 "1.3 Structure ofthis Standard Document" and this Guideline Document 1.3 Structure of the JFS-C
Standard Document.)
2. In the process approach, it is important to consider the interaction of each process,e.g., how management, control, monitoring, and support processes relate to eachother. Processes should not be considered in isolation, but rather in relation to otherprocesses, otherwise it may be difficult to achieve operational effectiveness, andconsideration should be given to the sequence of processes, the flow of information,and the flow of goods.
3. In

particular,

the

PDCA

(Plan-Do-Check-Act)

cycle,

which

is

based

on

documentation, implementation, and maintenance, needs to be followed, and sincechanges in the social environment can affect views on food safety and hazard factors,
it is necessary to constantly collect and analyze information and reflect it in
improvements to the management system.
4. In establishing a food safety management system, the following items shall beconsidered:
1） Clarify the scope of application of the food safety management system.
The scope of application is determined by considering areas of manufacturing,lines, processes, products, personnel within the organization, subcontracting, etc.
For example, it is possible to establish a management system for only one of thetwo manufacturing lines, as long as the system includes all the series of activities:
design and development of food products, receiving of raw materials, processing,packaging, storage, shipping, and delivery, but it is not possible to set the scopeof application to cover only processing and packaging and exclude the otheractivities.

19

If part of a series of activities is not within the organization's control, such as the
production of food products designed and developed by another company, or if thecustomer arranges for the delivery of the products, the activities may be excluded
from the scope of application. (In-house activities cannot be excluded from thescope of coverage, even if they are conducted at a different business location.)
2） Extract the processes required for a food safety management system.
Organize and clarify the activities and mechanisms required to establish a foodsafety management system based on the JFS-C standard in terms of its functional
units.
3） Establish the sequence and interrelationships of the processes.
Document the results of establishing the sequence and interrelationships of theactivities and mechanisms identified in (2) above. This may be a document
illustrated with figures and tables.
4） Determine the criteria and methods necessary to ensure the efficient operationand control of the process.
These criteria and methods are determined by the competence of the personnel
operating in the organization and the complexity of the work.
5） Evaluate, measure, monitor and analyze the process, as well as implement thenecessary measures to achieve the planned results and continue to improve.
The system is created in which the activities carried out and the information
obtained from inspections and verifications be analyzed and used as input for future
activity plans.
6） Have a system verification procedure to ensure the continued effectiveness of thefood safety management system.
See FSM 3 and FSM 20. For verification of the HACCP plan, see HACCP Step 11(Principle 6).
5. The organization shall prepare the documentation required by the standard andmake it available to employees who need it. The table below lists the documented
information explicitly required by the standard. For information other than these,
each organization shall consider whether documentation of information is necessary
to demonstrate conformity to this standard, and shall create such documentation as
it deems necessary. The "Food Safety Management System" is a systematicpresentation of an organization's activities. Depending on the size and use of theorganization, not all items requiring documentation may be described in the Food
Safety Management System, but they can be managed as separate documents thatcan be referenced.

20

●List of documented information explicitly required by the standard
ClauseContent of documented information

Check

FSM 1

Records that top management has made employees aware of the definedorganizational structure (at least the duties, responsibilities,
instruction/reporting system, and information sharing for employees in chargeof activities that affect food safety).

FSM 3

Management review by top management

FSM 4

Records of implementation of food legal compliance procedures

FSM 5

Elements of the food safety management system that are deemed necessary
by the organization

FSM 6

Food Safety Policy and Goals

FSM 7●Assessment procedures for prioritizing responses to threats to food defense●Food Defense Plan

FSM 8

●Evaluation procedures for assigning predominance to food deception
reduction measures●Food Deception Prevention Plan

FSM 9.1●Information documentation procedure●Records required to prove the implementation of food safety management

FSM 10Specifications of what is being purchased or supplied

FSM 13.2

Supplier evaluation/approval/monitoring records

FSM 13.3

Documents related to the management of outsourced processes

FSM 14.1●Documented procedures for implementing and maintaining product tracing●The following records are required to ensure traceability:
・Identification of all externally procured raw materials (including containers
and packaging materials), products, or services
・Records to identify batches, semi-finished products, work in progress,
refurbished products, reworked products, finished products and packaging
throughout the manufacturing process
・Record of purchasers and shipping destinations for all products supplied・If the procedure has been updated, record it

FSM 14.2

Trace test verification results

FSM 16

Allergen management plan

FSM 17

Records of actions taken if equipment or devices is found to be inaccurate

FSM 21

Management mechanism for handling complaints and utilizing complaint data

FSM 22.1●Food incident management procedure●Record of incidents that have occurred

FSM 22.2

Product recall test verification results

FSM 23.1

Specifications of products (raw materials (including containers and packaging
materials), semi-finished products, work in progress, recycled products,
reworked products, and final products)

FSM 23.2

Product release (shipping) procedures

FSM 24

Procedures for identifying nonconformities that impact food safety and forclearly identifying, managing, disposing of, and reworking resulting
nonconforming products

FSM 25

Procedures for determining and implementing corrective actions whennonconformities impacting food safety occur

21

FSM 26

Procedures to assess, to the extent necessary, the impact of changes that may
impact food safety in advance

HACCP

Documents and records required for HACCP plan

Step 12（Step 12 requires documentation of all documents and records required for(Principle 7)

the HACCP plan.）

GMP 4.1

Necessary control measures/methodological procedures, including isolation,
aimed at preventing contamination and cross-contamination (including crosscontact)

GMP 4.2

Procedures for control measures/methods for hazards that require enhanced
control (as appropriate)

GMP 6.1

Personal hygiene standards for employees, etc.

GMP 6.3

Health management procedures for employees, etc.

GMP 6.4

Documents related to GMP 6.1 and GMP 6.3 applied to contracted businesses
and visitors

GMP 7●Record of education/training implementation●System for re-education (if necessary)

GMP 8Documented procedures for organizing, cleaning, and sanitizing/disinfecting

GMP 9

Records of product rework

GMP 10Business site patrol/inspection results

GMP 11

Monitoring records of air, high pressure gas, and water (including ice andsteam) used in food production

GMP 19Systems for systematically maintaining all equipment and devices important toproduct safety

FSM 6 Food Safety Policy and Goals
Requirements
The organization shall have a clear, concise and documented food safety policy
statement and objectives specifying the extent of the organization’s commitment tomeet the safety needs of its products. Top management shall ensure the organization toestablish measurable objectives consistent with the organization’s food safety policy,
formulate plans to achieve the objectives, monitor the progresses against the objectives,
and to update the objectives as necessary.
Concepts, specific examples
1. The organization shall develop a written food safety policy. This policy provides
direction for the organization's overall activities related to the food safety
management system and includes the following:1） Commitment to providing safe food products and corporate philosophy
2） Management Policy of the Organization
3） Examples of 1)~2) above are shown below.
(1) The organization provides safe and trusted food products to consumers basedon the consumer.
(2) The organization appropriately responds to changes in the surrounding social
environment, complies with laws, regulations, ordinances, fair rules, and social

22

norms, and promotes organizational activities in line with social ethics.
(3) Accept employee suggestions for food safety improvements and makeappropriate use of employee suggestions to improve food safety awarenessthroughout the organization. (FSM 2)
2. This is important to ensure that all employees understand the direction of theactivities and that each is aware of his or her role. Therefore, the food safety policy
and the goals that are aligned with it should be prepared in a language that all
employees can understand.
3. In addition, not only must the document be prepared, but it shall also be disseminatedto all employees. The following are examples of methods of disseminating the
document:
1） It is always taught when training employees.
2） Post it in a place where employees can see it on a regular basis.
3） Employees are told in the morning meeting. etc.
4. The food safety policy is developed by or with the involvement of top management.
Top management" refers to the chief executive officer of the organization, such as
the president or plant manager, but it does not necessarily have to be the highestranking person in charge as long as he or she has overall food safety responsibility
and authority, and there may also be cases where there are multiple people who
qualify as managers.
5. Top management will periodically review the food safety policy for appropriatenessand revise it as necessary.
6. Food safety goals should be measurable. A "judicable goal" should be a concrete
numerical goal that can be measured to determine whether it has been achieved ornot, for example, the number of food safety-related complaints. Even in cases where
it is difficult to quantify, goals that can be evaluated as achieved or not achieved
should be set.
7. In addition to top management establishing the goals, the framework could be suchthat the food safety officer (see FSM 1) or others establish the goals. Progress onfood safety goals shall be monitored and activities reviewed as necessary.
8. It is recommended that the goals for the organization as a whole be broken down
into goals for each department and individual.

FSM 7 Food Defense
Requirements
The organization shall document, implement, and record assessment procedures to
identify potential and overt threats to hazards of intentional food contamination by
persons within or outside the organization and prioritize response to those threats.

23

The organization shall document and implement a food defense plan that specifies theactions that the organization implements to mitigate or exclude the identified fooddefense threat.
This plan must include GMP and be incorporated into the food safety management
system.
The organization shall also establish access controls for areas where food defense
vulnerabilities have been identified.
The organization shall establish and implement procedures for responding to possible
intentional contamination of product.
Concepts, specific examples
1. Food defense means measures to prevent, avoid, and respond to the intentional
contamination of food by persons inside or outside the organization with physical,
chemical, and biological hazards.
2. In the vulnerability assessment of food defense (analyzing threats and identifying
weak points), the risks of intentional food contamination described in 1. are
identified, their magnitude is evaluated, and the defensive measures are formulated
as a food defense plan. Since it is difficult to completely protect against intentional
food contamination because it is a human activity, priorities are determined,
documented, implemented, and recorded by contrasting the contents of eachextracted vulnerability with the management resources that can be invested.
3. Document and implement procedures for conducting vulnerability assessments offacilities.
4. Based on the results of the food defense and facility vulnerability assessment,
document and implement a food defense plan that includes methods, responsibility
and authority, and decision criteria to prevent intentional food contamination,
tampering, etc.
5. The food defense plan includes the following elements:
1） Personnel from each discipline with food defense responsibilities havebeen designated2） Have policies and procedures in place to record and control employees,
contractors, and visitors entering and leaving the facility area
3） Have procedures to ensure the safety of raw materials, utensils, containers andpackaging materials, drugs, and food during storage and distribution.
4） The site shall be physically secured (security)5） Have procedures and carry out in place for dealing with discovered or suspected
intentionally contaminated or deteriorated food, packaging, or equipment
6） Have an effective recall program (see FSM 22.1)
7） Provide necessary education and training to personnel in accordance with thefood defense plan established by the organization

24

6. Access controls implemented for areas where food defense vulnerabilities are
identified are also included in the food defense plan. Access controls can include
guards, ID cards, or systems that limit or record access to authorized personnel.
7. Reference1） In addition to monitoring cameras and lock controls, communication among
employees is a deterrent to food protection.
2） Excessive reliance on hard measures of food defense may instead damage thegood relationship between employees and managers. Thus, for example, anorganization could explain to employees that the monitoring cameras are notinstalled based on suspicion of employees, but so that the company can prove
the actions of employees in the event of a food accident.
3） Food defense is not limited to physical measures of the facility; internal attacks
from interested parties must also be anticipated. Ensuring that there are no shortterm workers or disgruntled or disgruntled workers is particularly useful.
4） A mechanism for examining trends in social cases, cases of other companies inthe same industry, prevention cases, and predictive signs is required.
8. For specific examples of food defense, please refer to the following. (1), (2), and (3)are applicable in Japan.)1） Ministry of Health, Labour and Welfare "Guidelines for Food Defense Measures(for Food Production Plants)" (Draft revised in 2019)2） Ministry of Health, Labour and Welfare "Guidelines for Food Protection Measures
for Large-Scale Events (Manufacturing Plants)" (Revision 2)
3） Ministry of Agriculture, Forestry and Fisheries "Voluntary Action Plan for
Enhancing Confidence in the Food Industry" Guidance for Formulation-Five Basic Principles - (Revised January 2016)(Basic Principle 1) Clarify the consumer's point of view
(Basic Principle 2) Establish compliance awareness(Principle 3) Basis of proper hygiene and quality control(Basic Principle 4) Establish systems for appropriate hygiene and quality control(Basic Principle 5) Efforts to collect, communicate, and disclose information4） FDA "Food Defense Mitigation Strategies Database (FDMSD)".
https://www.cfsanappsexternal.fda.gov/scripts/fooddefensemitigationstrategies/index.cfm

FSM 8 Food Fraud Prevention
Requirements
The organization shall document, implement, and record assessment procedures to25

identify potential and overt food fraud vulnerabilities such as tampering with records andlabeling of products and intentional dilution, and prioritize food fraud mitigation
measures.
The organization shall develop a documented plan that specifies the measures theorganization implements to mitigate the identified threats of food fraud.
This plan shall cover the GMP and shall be incorporated into the food safety management
system.
Concepts, specific examples
1. "Food fraud" refers to intentional acts committed primarily for economic reasons,such as tampering for the purpose of cost reduction or misrepresentation of goodquality. Examples include dilution, substitution, concealment, fraudulent labeling,
function enhancement by unauthorized means, counterfeiting, etc. Among these,
this requirement covers food fraud as it relates to food safety.
Examples of food fraud related to food safety include the following:
1） Melamine contamination of powdered milk made in China in 20082） Horse meat contamination of beef-based food products sold in Ireland in 2013(contamination of veterinary drugs)
2. Methods to "identify potential and actual falsification of records and labeling andintentional dilution of products" include the following:
1） Refer to past or currently developing cases of food fraud in the supply chain. The
organization will have a process in place for accessing cases of fraud.

Such

information can be obtained, for example, from●Industry Associations●Government Sources●Private information centers●Information systems established by the organization in the FSM2
2） Identify in what situations food fraud can occur.
It is also effective to assume food fraud in each production flow as follows:(1)

Fraud in raw materials used

(2)

Fraud during manufacture(3)

Fraud in products after shipment (including resale of discarded defective
products as food)3） Evaluate the ease of occurrence (vulnerability).
3. Supply chains are becoming more complex, extending overseas, and the risk of food
fraud is increasing. "Assessing vulnerability" means analyzing what types of food
fraud are likely to occur and how likely they are to occur due to external and internal
factors in the context of such changes in the environment surrounding theorganization. Vulnerability assessors need to understand the potential food fraudrisks, which includes knowledge of the raw materials used in the field and the concept26

of vulnerability assessment described above. Vulnerability assessment is conductedfrom two perspectives: product/supplier.
Examples of vulnerability assessment steps include:
1） Clarify the raw materials and their specifications related to the food products
handled.
2） Estimate what are the events that could cause fraud (what kind of fraud could
occur).
3） Estimate the magnitude of risk for any possible fraud that may occur.
4） Estimate the magnitude of the impact of fraud on food safety.
5） Prioritize vulnerabilities by risk and magnitude of impact.
4. Based on the results of the vulnerability assessment, a management plan to reducefood fraud shall be developed after conducting an evaluation of current control
measures related to food fraud. The plan shall clearly identify priorities. The following
methods can be used as means to reduce food fraud:1） Conduct appropriate monitoring in response to vulnerabilities
2） Verification of origin and labeling3） Specification Management
4） Conduct supplier audits5） Analytical testing6） Use of anti-counterfeiting technology7） Collect whistleblower testimonials from within the organization.
5. Examples of methods include the following:
1） Add fraud to the scope when conducting second-party audits.
2） Request that suppliers monitor their supply chains.
3） Change the origin/supplier of raw materials to one where there is no precedent
for fraud.
4） Strengthen controls in situations where fraud practices are likely to occur(extremely low prices from suppliers used below market prices, soaring raw
material prices, tight supply, frequent advance shipment times, sudden increases
in order volumes, and understaffed production systems).
5） Add fraud vulnerability to the frequency of analysis/testing.
6） Review the supplier's financial situation.
6. Organizations are required to clarify the scope of the above food fraud prevention
plan and incorporate and operate it into their food safety management system.
7. The food fraud vulnerability assessment shall be reviewed at least annually and/or
whenever significant changes occur. The food fraud reduction plan will berevised/updated as needed.
8. Please refer to the following for concepts on fraud prevention. (1) is the scope of
application in Japan.)27

1） The "FCP's Focus on Collaboration," which was created by the Food
Communication Project (FCP) launched by the Ministry of Agriculture, Forestry
and Fisheries (MAFF) in the wake of the food fraud, is a good reference. Thiswas created as an effort to curb the occurrence of food fraud.
https://www.maff.go.jp/j/shokusan/fcp/whats_fcp/kyoudou.html
2） U.S. Pharmacopeia (USP) "Food Fraud Mitigation Guidance"
https://www.usp.org/sites/default/files/usp/document/our-work/Foods/foodfraud -mitigation-guidance.pdf

FSM 9.1 Documentation procedures
FSM 9.2 Control and storage of documented information
Requirements
FSM 9.1
The organization shall document, implement, and maintain documentation procedures
to manage the documented information (including records) necessary for effective
operation of the food safety management system and explicit control of the process.
In addition, the organization shall keep records necessary to prove the implementationof food safety management, determine an appropriate storage period, and store them.
FSM 9.2
The organization shall provide the documented information required to demonstrate its
effective operation of the food safety management system and control of processes.
Documented information shall be stored for the period required by the customer or legal
and regulatory requirements, or if there are no applicable requirements, for a period
exceeding the shelf life of the food. In addition, the documented information shall beeffectively controlled so that it is always available when it is required.
Concepts, specific examples
1. In the requirements of this standard, it is important to maintain that "necessary
settings, etc., are securely retained and can be explained to a third party too" andthat "records are kept without shortages and can be reviewed later". The following
actions are required:
1） The required documents have been selected. (See FSM 5)2） The latest versions of selected documents are kept and used.
2. "Documented information" includes "documents" and "records", details of which are
as follows:
1） Document
Documents refer to information and the medium in which it is contained, andinclude not only written text on paper, but also images, photographs, diagrams,
audio and video, and those stored in electronic media. Examples include28

specifications, documents describing procedures, drawings, reports, standards,
and work procedure videos.
2） Record
A "record" is a document that describes the results achieved or provides evidenceof activities performed.
(1) Record keeping enables the following actions to be taken:① Appropriate food safety management systems can be clearly demonstrated
to third parties too.
② Able to analyze trends in activities over a certain period of time.
③ Information can be shared within the organization.
(2) The records required will vary depending on the industry, type of business,size, and complexity of the organization's operations.
(3) Establish "rules for amending records" so that corrections such as erroneous
entries will not be suspected of being "falsification. For example, "Corrections
should be made with double lines, and the date of correction and the name ofthe person who made the correction should be written in the corrected area,"etc., so that a third party can clearly understand the correction, too.
3. Documents are prepared for the following purposes:
1） Ensure that the company's status, settings, and procedures are known to all but
the preparer too.
2） Standardize work and prevent variation in perception and understanding amongindividuals.
3） By keeping a record, it is possible to trace and identify the cause if any problems
occur.
4） It facilitates correct explanations to third parties and clarifies the legitimacy ofown organization.
4. The "documented information necessary for the effective operation of the food safety
management system" is determined by the organization itself, taking into accountits industry, business type, size, and complexity of operations, in addition to what
this standard explicitly requires to be documented in FSM 5 (the list of documented
information explicitly required by the FSM 5 standard).
5. "Documented information necessary to clearly define the control of the process" is adocument that clearly describes the main points and cautions in controlling eachstage of the manufacturing process, which enables appropriate and effective
operation based on such information, and also provides evidence of such control.
Specific examples include temperature control such as heating and cooling, specificmeasures to prevent contamination, and conveyor speed.
6. Documented documents must be managed so that the latest version can always bereferenced and operated. For this purpose, a document management procedure
should be developed and operated to make it as easy as possible to manage

29

documents by establishing appropriate rules for modifying and storing documents.
The procedure should include all of the following points:
1） Documents are approved by an authorized person prior to issuance.
2） Documents will be reviewed and updated as necessary.
3） Clearly identify the changed part and the latest version of the document byattaching a setup number, obsolete number, etc. to the document.
4） Distribute appropriate documentation so that it is available to those who need it.
5） Documents should be legible and easily identifiable.
6） Maintain necessary documents created externally.
7） Create a list of documents.
8） Designate where documents are to be stored.
9） Obsolete documents such as old versions should be disposed of or stored inanother designated location to prevent misuse.
7. Appropriate retention periods shall be defined for documented information. The
retention period is determined by the organization itself, taking into account thefollowing:
1） Length of time the product is on the market
2） Product storage period3） Duration to be set based on the arrangement with the customer.
4） Period required by legal and regulatory requirements5） Some documents, mainly records, need to be stored for a long period of time inorder to enable investigation of the cause of problems when they occur.
Therefore, an "appropriate storage period" should be set in consideration of the
shelf life of the product, etc., and the documents should be managed so that they
will not be accidentally disposed of during that period.

FSM 10 Specification Control of Purchased or Provided Items and Services
Requirements
For all purchased or provided input items and services (including raw materials andingredients (including containers and packaging materials), equipment and tools,
utilities, and services (e.g. electricity, water, transportation, maintenance)) that have anaffect on the safety of final product, the organization shall ensure that documented
specifications are prepared, maintained, securely retained and readily accessible whenneeded.
The organization shall evaluate the risks and set the confirmation items (confirmation of
inspection certificate, condition, temperature, display, etc.) on the items to be purchasedor provided.
In addition, the organization shall define and implement a review process that includes

30the handling of changes in specifications and the frequency of regular reviews.
Concepts, specific examples
1. Maintain documentation of specifications for goods, equipment, tools, utilities, andservices that the organization procures from external sources. Specifications
requested by the organization for purchased goods, etc., or obtained from suppliers,
etc., are evaluated within the organization to ensure that they are appropriate andintended.
2. It is important to maintain and control the specifications stored as documents so thatthey can be used as needed for verification at the time of acceptance.
3. The organization shall assess the inherent risks of the items it purchases or receives
supplies from and establish checks upon acceptance (e.g., inspection certificates,
condition, temperature, labeling, etc.), as well as establish procedures for thesechecks.
4. Inherent risks include, for example, the following hazards:
1） In ground beef requiring adequate heat: enterohemorrhagic E. coli O-157
2） In redfish where temperature control is not properly implemented: histamine
accumulation
This requirement calls for attention to hazard factors in purchased products basedon the product characteristics handled by the organization.
5. If externally procured goods, equipment, tools, utilities, or services do not conformto specifications, procedures shall also be established to ensure that they are notmisused. Procedures should be documented as necessary.
6. In addition to specific requirements for goods, equipment, tools, utilities, andservices, specifications can include:
1） Statement of compliance with laws and regulations
2） Customer requirements (food safety is the subject of this standard)
3） Handling of specification changes
4） Review of specifications (e.g., frequency, timing, etc.)
5） Whether or not to re-consign and its conditions, etc.
6） Provide inspection items that conform to specifications and a certificate ofinspection (also called Certification Of Quality or Certification Of Analysis)
7. The organization shall establish and implement a review process for this information,
including the frequency of periodic reviews.
8. HACCP Steps 2 and 3 require information on the food safety of products. It is
recommended that the specifications to be maintained and controlled by suchrequirements be organized in relation to such information.

31

FSM 11 Procedures and Instructions
Requirements
The organization shall establish, implement and maintain effective procedures andinstructions in all processes and activities that affect food safety.
In addition, these procedures and instructions shall be understood by personnel who use
different languages.
Concepts, specific examples
1. The organization shall define the roles of each employee and share procedures for
all processes and operations that affect food safety.
When considering "all processes and operations affecting food safety," reference
shall be made to the following requirements, among others:
1） Hazards known to be associated with the food.
2） Hazards that may occur or increase during manufacturing, storage, distribution,etc.
3） Relevant legal and regulatory requirements
4） Requirements established by the organization in consideration of past troubles
with the same or similar foods.
2. In sharing, the organization shall use documents and other means as necessary to
make it easier for employees to understand.
3. On the other hand, it is not necessary to document everything, as long as the
personnel involved (e.g., workers, their supervisors, personnel at the relevant
management level, internal auditors who audit the procedures, etc.) are aware of
the procedures and are possible to work according to those procedures.
4. Key points for establishing procedures and instructions are listed below:
1） All processes that affect food safety are to be covered.
2） It needs to be easy to understand so that it can be used for training when new
employees start working and for retraining, etc.
3） Clarify "when, where, who, what, and how should be done".
5. Organizations should also accommodate and document the languages used by theiremployees as much as possible, given the increasingly multilingual nature of theirworkforce.

32

FSM 12 Resource Management
Requirements
Top management shall determine and provide, in a timely manner, the qualified
resources (including human resources, facilities and work environment, equipment,
systems for operating sites (including communication technology and transportation),means of measurement and traceability, intellectual property management, etc.) thatmeet the standards required to implement, maintain, and improve the food safety
management system.
Concepts, specific examples
1. Top management shall identify and provide to the organization in a timely manner
the management resources necessary to implement, maintain and improve the foodsafety management system. Required management resources include the following:1） Human resources(1) Define the required competencies and provide education and training toemployees.
(2) Utilize outside experts as necessary.
2） Infrastructure(1) Buildings, facilities, utilities (power, gas, water, etc.)(2) Equipment, devices, and instruments(3) Systems for operating the business offices① Communication technology (telephone, fax, web environment, etc.)② Transportation
3） Environment (In this requirement, this refers to the working environment of
employees.)(1) Physical Factors: Provide a comfortable environment for employees by taking
into consideration temperature, heat, humidity, light, air currents, and noise.
(2) Mental Factors: Provide a comfortable environment for employees, taking into
consideration discrimination, conflict among employees, and mental stress.
4） Traceability of measuring and monitoring equipment
Where measurement and monitoring are required to assure food safety, thisindicates providing appropriate means of measurement (see FSM 17) and ensuring
traceability of the means of measurement (see FSM 19.1). Specific examples of
ensuring traceability include the following:(1) Periodic calibration or verification of the means of measurement shall be
performed.
(2) Calibration or verification shall be traceable to international and national
standards.
(3) If the aforementioned standard does not exist, the basis used for calibration orverification shall be retained as documented information.

335） Intellectual resources
The intellectual resources required to operate a food safety management system
include the following:(1) Internal resources: Intellectual property, accumulated know-how of theorganization(2) External resources - information from administration and customers
2. Since management resources are limited, top management is required to determine
priorities, devise creative ways to maximize effectiveness, and ensure food safety ina rational manner.
3. In order to respond to changes in the manufacturing environment, it is important
for top management to check that goals and plans are realistic and that employees
are receiving adequate education and training.

FSM 13.1 Purchasing
Requirements
The organization shall control purchasing procedures to ensure that all externallysourced raw materials, packaging materials, and services, and equipment and tools thathave an effect on food safety conform to stipulated specifications, as well as legal andregulatory requirements related to food safety.
In addition, these purchasing procedures shall also apply to raw materials, packaging
materials, and services, and equipment and tools purchased from the organization'sgroup companies.
Concepts and specific examples
1. This standard requirement requires that each organization establish and implement
procedures to verify what it purchases from outside sources, depending on themagnitude of the risk to food safety.
2. Verification methods refer to determining whether or not what is purchased fromoutside sources conforms to the specifications set forth in FSM 10, and specifically
include the following:1） Inspection of a sample representative of the lot of what you are purchasing
2） Acceptance inspection of items to be purchased
3） Conformity with specifications in Certificate of Quality and Certificate of Analysis
3. The ultimate responsibility for food safety when making a purchase rests with thepurchasing organization.
4. FSM 13.1 requires control over what the organization purchases from externalsources (raw materials, containers, packaging materials, services, equipment andtools), whereas FSM 13.2 requires control over their suppliers (suppliers andproviders).

34

5. FSM 13.2 mentions the case of receiving supplies from unapproved suppliers in an
emergency, but this only allows for emergency measures: raw materials, containers,
packaging materials and services from approved suppliers, it is assumed that arepurchased. (For more information on services, see FSM 13.3).
6. In some cases, purchasing procedures are exempted from application whenpurchasing from (or accepting) intra-group companies. However, this requirement
requires that the same purchasing procedures be applied when purchasing from an
intra-group company as when purchasing from an external source.
7. Food safety statutory and regulatory requirements to refer to:1） Raw material requirements(1) Packaging materials shall be sufficient to protect the product fromcontamination and damage, and shall allow for appropriate labeling.
(2) Purchase properly controlled raw materials.
(3) Management of agricultural, forestry, livestock and fisheries products (primary
products) as raw materials includes the following:① Prevention of contamination by dust, soil, or sewage during the production
stage.
② Appropriate management of waste, toxic substances, etc. at the production
stage.
③ Prevention of contamination from pesticides, veterinary drugs, feed,rodents and insects, foreign substances, microorganisms, fecal matter, etc.
during the production stage.
④ Facilities in the production phase are clean and properly maintained throughcleaning and appropriate repairs.
⑤ Prevent contamination by rodents, insects, chemical substances, foreign
substances,microorganisms,

etc.

duringcollection,

storage,andtransportation.
⑥ Separating out items that are clearly unsuitable for eating.
⑦ Prevent spoilage and deterioration of food through temperature andhumidity control and other necessary measures.
⑧ Hygiene management of handlers is carried out.
(4) If

it

is

clear

that

the

raw

material contains

parasites, pathogenic

microorganisms, pesticides, etc., or foreign substances, and these cannot be
killed or removed to an acceptable level by normal manufacturing andprocessing, such raw material shall not be accepted.
2） Requirements for packaging materials used for food products (the scope of thisitem applies in Japan):(1) Use appropriately controlled products that are manufactured and processed inaccordance with the Standards and Regulations for Foods, Additives, etc.
(1959, Ministry of Health and Welfare Notification No. 370) and similar laws

35

and regulations, and whose safety is assured.
(2) When selecting packaging materials, select those that are suitable in terms ofgas barrier performance, tensile and puncture strength, etc., depending on
product characteristics (strong odor, distribution temperature range, etc.),
expiration date, size, capacity, etc.
(3) Select materials and surface-treated materials that will not peel off or erase
labeling due to condensation or friction during distribution and storage.
(4) When reusing packaging materials, prepare a procedure for reuse in advanceand manage it so as not to contaminate the product. Discontinue use anddispose of the product if it is damaged or significantly contaminated.
(5) Packaging containers and packaging gases shall be non-toxic and not impair
the safety and suitability of the product for storage and use.
(6) Reusable packaging materials and containers/packaging shall be durable, easy
to clean and wash, and disinfectable.
(7) Raw materials that do not conform to acceptance criteria shall be handledaccording to documented procedures to avoid accidental use.
(8) In order to further enhance the safety of synthetic resin food utensils,
containers, and packaging, a positive list system was introduced for food utensils,
containers, and packaging under the Law for Partial Revision of the Food Sanitation
Law, etc. promulgated on June 13, 2008, which allows only substances that havebeen evaluated for safety to be used. (Enacted on June 1, 2020 by the Ministryof Health, Labor and Welfare)3) Requirements for equipment and tools used with food(1) Ensure that the intended use and sanitary design specifications are met for the
products handled.

FSM 13.2 Supplier Performance
Requirements
The organization shall document, implement, and maintain procedures for theevaluation, approval, and continual monitoring of suppliers, which have an effect on foodsafety.
Supplier evaluation shall include measures for food defense and to prevent food fraud.
When accepting raw materials, packaging materials, and services from unapproved
suppliers in an emergency (such a natural disaster), the organization shall confirm thatthe products meet the required specifications by an evaluation, inspection, visit, etc.
before use.
Results of survey, evaluations, approvals, and follow-ups with suppliers shall bemaintained.

36

Concepts, specific examples
1. This requirement requires organizations to establish and implement documented
procedures to control suppliers (suppliers/providers) of raw materials, containers,
packaging materials, and services that affect food safety, based on risk assessment.
2. If supplies are received from unapproved suppliers in an emergency, this is only an
acceptable emergency measure and assumes that raw materials, containers,
packaging materials, and services are purchased from approved suppliers. (Forservices, see FSM 13.3)
3. Controls required of the organization include establishing and implementing
procedures for supplier evaluation, approval and monitoring, which are described indetail below.
1） Evaluation
After determining the person responsible for the evaluation, collect relevant
necessary information and carry out conduct the evaluation, by referring to thefollowing methods and contents.
(1) Evaluation Method① Oral Hearing② Document and record checks③ Visit and on-site verification or audit(2) Evaluation details① Information on the supplier organization: organizational reliability, productsupply capacity, manufacturing site operational status, quality assurance
system, supplier evaluation results (records related to second-party audits,
third-party certifications, etc.), compliance, traceability② Information on delivery method: delivery date, delivery location, delivery
condition (temperature, humidity, and special environment), etc.
③ Whether there are any cases of food fraud in the origin/supplier of raw
materials④ Whether there are conditions that are likely to cause fraud (extremely lower
prices of suppliers used than market price, skyrocketing raw material prices,
tight supply, frequent advance shipment times, rapid increase in ordervolumes, and understaffed production systems).
(3) Qualifications and Competencies of Evaluator
Supplier evaluations shall be conducted by personnel who are knowledgeable
about the matters described in the specifications and applicable laws andregulations, and who have received audit training.
2） Approval
The organization shall determine who approves suppliers based on the evaluation
results. Then, the organization shall establish the rules and process for the37

approver to do so and the method of sharing information with the HACCP team asprocedures.
3） Monitoring
Establish rules (e.g., method, frequency, timing, etc.) for periodic reassessment of
suppliers as a procedure. Monitoring also includes activities related to follow-up,
such as suspending business with a supplier or providing guidance to a supplier if
there are any problems in response to the results of a series of evaluations of the
supplier.
4. This requirement refers to the supplier's food protection and anti-food fraud efforts,
but it does not require a level of supplier compliance with FSM 7 and FSM 8, rather
than it allows an acceptable level where suppliers have established their own
applicable scope of applicability and have initiated food defense and food fraud
prevention efforts.
5. In emergency situations (e.g., natural disasters), it is anticipated that an immediate
decision may be required when evaluating unapproved suppliers. Under therequirements of this standard, it is not permissible to omit the point at which
suppliers are evaluated under normal circumstances, but it is acceptable to shorten
the period of time required for verification, provided that equivalence is recognizedin the method used.
6. In addition, it includes maintaining objective evidence of the equivalence of products
made with raw materials, containers and packaging materials, and services
purchased from unauthorized suppliers with normal products at the time of productshipment (release).

FSM 13.3 Outsourcing
Requirements
The organization shall ensure, when the organization chooses to outsource any processthat that may have an effect on food safety (including contract manufacturers, service
providers for existing process, and other service providers), that it complies with thecustomer requirements and takes into account the JFS-C standard requirements required
for food safety risk management.
Control of such outsourced processes shall be identified, documented and monitored asa part of the food safety management system.
Changes to the contract content shall be approved by both parties and communicatedto the relevant personnel.
Concepts, specific examples
1. Outsourcing is the process of outsourcing an organization's own processes to anotherorganization. The organization approves the outsourced contractor and periodically38monitors and verifies the outsourced process to ensure that the results of theoutsourced process do not pose a food safety problem to the organization's products.
These processes are risk-based and shall take into account the following:●Risks to product safety and quality●Compliance with specific legal requirements●Potential risks to product security (i.e., vulnerabilities, and risks identified in thefood defense assessment)
2. This outsourcing includes not only the manufacturing of products or the dispatch of
personnel by contractors, but also the provision of services. The services provided
by the provider include transportation and storage (see GMP 15 and 16), preventing
insects and rodents from breeding, and sanitation consultants, sanitation of offices
and facilities, maintenance of facilities and equipment, cleaning of work clothes, andprovision of meals for employees.
3. When outsourcing, the final responsibility for the food safety management systemlies with the organization that commissioned the work. (Legal responsibility is subject
to the laws and regulations of each country.)
4. Any changes to the contractual content shall be approved by both parties andcommunicated to the parties involved.
5. Eligible outside contractors include contract manufacturers and service providers.
1） Contract manufacturers agree and contract on all terms and conditions related tofood safety, customer requirements, merchandising, shipping, etc. Contract
manufacturers shall develop and implement an organization to comply with theterms of the contract.
2） The contracted service provider documents and contracts for specifications ofservices that affect food safety.
The contract shall include training of the personnel involved in the provision ofservices, as well as clarification of the services.
6. Controls according to FSM 13.3 shall be described in the flow diagram required by
HACCP Step 4, if necessary, and control methods shall be determined through thehazard factor analysis required by HACCP Step 6 (Principle 1). In addition, anevaluation of suppliers shall be conducted in accordance with FSM 13.2.
7. To ensure the appropriateness of outsourcing, the following details shall be
performed as necessary:1） Confirmation of food safety management system
2） Confirmation of product process control system
3） Verify accuracy and results of in-process inspections
4） Periodic verification of the final product5） Ensuring food safety from a physical and chemical aspect
6） Confirmation of competence of personnel and education and training system
8. Regarding the operation of HACCP, when outsourcing CCP processes, etc., the39

management system, process control, and conformance of the final product shall beequivalent to the food safety management system established by the own
organization.

FSM 14.1 Traceability
Requirements
The organization shall establish, implement, and maintain appropriate tracing
procedures covering all processes from supplier (at least one step before) to recipient(at least one step after) to ensure product identification. These procedures must include
procedures (e.g., labeling) to continuously identify the product throughout the
manufacturing process and throughout distribution.
To ensure traceability, at least the following shall be recorded:●Record of all externally procured raw materials (including containers and packaging
materials), products, or services● Records to identify batches, semi-finished products, work-in-progress, recycled
products, reworked products, finished products and packaging throughout the
manufacturing process●Records of all product suppliers and recipients●If the procedure has been updated, record it
Concepts, specific examples
1. In the event of a serious product accident or food fraud, traceability records areimportant in verifying the manufacturing process of the subject product and inguaranteeing the safety of the food.
2. The "recipient" in this requirement basically means the purchaser one step later inthe food chain, and does not necessarily include the final consumer of the product.
The "recipient" may also refer to a wholesaler or retailer that handles the shipped
product.
3. Shipped products are not always delivered to the purchaser, but may be delivered
to a warehouse or other location designated by the purchaser. Therefore, thisrequirement requires that the owner of the product and the "recipient" where theproduct is actually placed be known so that speedy action can be taken in the eventof trouble. Raw materials, containers and packaging materials, services, andoutsourced processes purchased from outside (hereinafter referred to as "rawmaterials, etc.") are also basically subject to traceability up to one step before.
4. Each organization is required to reliably identify the product from the supplier (atleast one step before) to the recipient (at least one step after). It is also required tocontinuously identify the product (by labeling, etc.) throughout the entire
manufacturing process and distribution. By connecting these organizations, it is40

possible to trace the entire supply chain.
5. The maintenance and provision of record information necessary for traceability is
as follows:
1） Maintenance of traceability(1) Depending on the product, document procedures related to traceability(including raw materials purchased from outside sources, container andpackaging materials, and outsourced processes, each of which shall beidentified in the notation).
(2) Identify the status of raw materials, etc. (when, from where, what, and howmuch) at all product stages (including primary processed products).
(3) Establish units for product and raw material lots, as necessary.
(4) Procedures for preparing records of incoming and outgoing shipments basedon (1) through (3) and procedures for storing records shall be established andimplemented.
(5) Ensure that traceability is functioning, including work-in-process, recycled
products, reworked products, and finished products.
(6) Keep product samples for each lot, if necessary.
2） Provision of records related to traceability(1) Establish and implement procedures for the preparation of records and theretention of records. (See FSM 9.2)
(2) Submit records related to traceability when requested by the administration.
(3) Examples of traceability records
The main examples of records required to ensure traceability are as follows:
Examples of records required for process and traceability
Acceptance

Storage

Shipping

Product Raw Material  Daily production  Product Product

Information

Information

temperature

Shipping

records

Information

 FoodManufacturing
reports

Safety  Inspection

Information

records

 Inventory Destination

 Acceptance Process records

records

Information

Environmental  Delivery

 GMP-related Temperature Delivery

Information

vehiclerecords

records inside

vehicletemperature Information

the warehousetemperaturerecords

about personnel

Inspection
Records

records

 Delivery

 Delivery

vehiclevehicle41sanitation

sanitation

records

records

sampling Pre-sampled Quality Control

 Calibration

 Product

information

product

Inspection andrecords ofsamplesrecordAcceptancethermometersstorage) Semi-finishedfor quality

product

control

samples (for

 Calibration

storage)records for Calibration

measuring andrecords formonitoringmeasuring andequipment(formonitoring
equipment
FSM 14.2 Traceability verification
Requirements
The organization shall verify the documented procedures for implementing andmaintaining traceability through traceability test at least once a year to ensure that they
are functioning effectively. The results of the verification shall also be recorded.
Concepts, specific examples
The organization shall document the procedures for implementing and maintaining
tracing, verify them at least once a year to ensure that the procedures are working
effectively, and update them as necessary.
※The results of the verification shall be recorded. (See FSM 9.2)

FSM 15 Product development
Requirements
The organization shall establish, implement and maintain product design anddevelopment procedures to ensure that new products or products whose specifications
and manufacturing processes have changed are manufactured safely and in accordancewith legal and regulatory requirements.
These development procedures shall clearly confirm that the products and services
provided conform to specifications, and after identifying all the hazards of food safety,
shall include a review to evaluate and approve the adequacy of food safety assurance inthe design and development.
Concepts, specific examples

421. These requirements pertain to the design and development procedures for new
products or products with changes in specifications, manufacturing processes, etc.,
and include the following requirements:
1） Establish, implement and maintain product design and development procedures.
2） In the procedure, a review is conducted to evaluate and approve the adequacy offood safety assurance in design and development.
1） Product design and development procedures
Design and development include not only the development of new products, butalso changes to the specifications and manufacturing processes, etc., of existingproducts, and ISO 9001:2015 8.3 shall be used as a reference in establishing theprocedures.
In the development of a new product or a product with a modified manufacturing
process, unexpected problems can sometimes occur. The developer of a new productshall take into consideration the hazards of the product and compliance with laws andregulations. Specific issues to consider during product development include thefollowing:(1) Are product-specific hazard factors fully considered and designed to minimize
risk?
(2) Are product shelf life tests conducted with sufficient frequency in advance toensure product safety?
(3) Are considerations given to the flow of products, the layout of machines, thecharacteristics of machines, etc. so as not to affect the products?
(4) Are cross-contamination and allergen cross-contact considered?
(5) Are there any legal restrictions on the raw materials used and the content of
the labeling?
(6) Is the product labeled in a way that would lead to misuse of the product, or isthe product form unreasonable?
(7) Have the personnel developing or designing the product been trained in hazard
factors and safety?
2） On the review process for evaluation and approval(1) In demonstrating conformity to the requirements of this standard, a process isrequired for a person or department other than those in charge of development
to objectively evaluate and approve the adequacy of safety assurance for new
products or products whose manufacturing process has been changed. Thisevaluation and approval process may also be conducted by a HACCP team ora group of several departments.
(2) However, it is important that the person or department in charge ofdevelopment is most familiar with the hazard analysis of the developed

43

product. Even if there is a process to evaluate the adequacy of the safety ofthe developed product, the person or department in charge of the development
is the main subject of the hazard analysis.
(3) The person, position hierarchy, and department responsible for conducting theevaluation and approval review required by this standard requirement should
be clearly stated in the rules for division of duties.

FSM 16 Allergen Management
Requirements
The organization shall document and implement allergen management plans andmaintain them appropriately. The allergen management plans shall include:●Control procedures to properly assess the risk of allergen cross-contact and, based onthat assessment, reduce, or eliminate the risk of cross-contact.
●Procedures for handling raw materials (including containers and packaging materials),semi-finished products, work in progress, reworked products, and final products toprevent cross-contact with allergens during all processes from manufacturing toshipping.
●Cleaning procedures and verification procedures for areas that come into contact withfood.
● Procedures for identifying and displaying allergens that shall be controlled in allprocesses from manufacturing to shipping.
The plan shall also ensure that all products containing or potentially containing allergens
that are shipped and offered for sale are labeled in accordance with the laws andregulations of the country to which they are expected to be shipped, and appropriate
customer requirements.
Concepts, specific examples
1. Allergens to be controlled
The substances that cause allergies are called allergens. Worldwide, there are eightmain allergens: cereals including gluten, crustaceans, eggs, fish, milk, peanuts,
soybeans, and tree nuts. Organizations need to consider accidents caused byallergens in consumers.
*Reference cases in Japan（Source：Consumer Affairs Agency Website）
https://www.caa.go.jp/policies/policy/food_labeling/food_sanitation/allergy/(For the latest version, please check the relevant website.)
2. Organizations need to manage allergens from the following three perspectives:
1） Preventing or minimizing the possibility of allergen cross-contact.
2） Information identifying allergens in food products shall be clear and accurate. In

44particular, for purchased raw materials, suppliers are required to demonstrate
appropriate allergen controls and their requirements.
3） Ensure that allergens contained in food are communicated to each stage of thelogistics process after shipment.
3. Allergens to be controlled in all processes from manufacturing to shipping shall beidentified, and a written allergen control plan shall be established, implemented, andproperly maintained:
1） Identify allergens that may be contained based on the specifications of the raw
materials used.
2） Differentiate the receiving and storage areas for each different allergen.
3） Identify allergens to be controlled according to the production plan, so that they
can be checked on each production line.
4） Distinguish between machinery and equipment used in the weighing room.
5） Identify areas in the manufacturing facility where allergen powder is dispersed
and implement measures to prevent dispersal.
6） To handle line changeovers (powders, oil and fat products (chocolate, spreads,etc.)) where water cannot be used for cleaning.
7） Control the labeling and use of allergens in recycled and work-in-process
products.
8） Implement measures to prevent incorrect labeling.
9） In controlling allergens, the laws and regulations of the country of sale (allergenlabeling regulations) shall be observed.
4. Develop control procedures to reduce or eliminate the risk of cross-contact. Examples
of control procedures include the following:1） Containers and utensils used in production (plastic bags, scoops, etc.) shall beidentified for each allergen to be controlled and avoid use in mixed.
2） Determine control procedures to prevent cross-contact through work clothes,
gloves, etc.
3） To prevent cross-contact by powder, physically demarcate the area with walls,
partitions, curtains, etc. Air conditioner and dust collector filters shall be regularly
inspected and cleaned.
4） Develop procedures for handling raw materials (including containers andpackagingmaterials),semi-finishedproducts,

work-in-process,reworked

products, and finished products to prevent allergen cross-contact at all stages of
production and shipment.
5） Determine procedures and verification methods for cleaning and washing methods
for manufacturing processes to prevent cross-contact.
6） When producing different products on the same production line, plan productionin order of the number of allergens present, from lowest to highest, if possible.
5. During the development of products containing allergens, check the validity of45

controls by line testing, etc.
6. When preparing product labeling, allergens shall be indicated in accordance with thelaws and regulations (allergen labeling regulations) of the country in which the
product is supposed to be sold.
7. If verification (e.g., analysis) is required, establish and implement procedures, andrecord and store the verification results.
8. All employees involved in food production shall be trained on allergens. This includes
temporary and maintenance personnel.
9. Related items include FSM 4 (Compliance with food safety laws), 13.1 (Purchasing),
13.2 (Supplier Performance), 13.3 (Outsourcing), FSM 15 (Product development),
FSM 18.1 (Product labeling (B-to-C products)), FSM 18.2 (Product labeling (B-to-B
products, work in progress, semi-finished products) ), GMP 3, 4.1, 4.2, 5, 6.1, 6.2,
7, 8, 9, 11, 13, 14, 15, 17 (requirements related to contamination in manufacturing
processes, etc.) see also.
10. For more information on examples of "Allergen Management", see CODEX
Alimentarius, Code of practice on food allergen management for food business
operators (CXC 80-2020).

FSM 17 Control of Measuring and Monitoring Devices
Requirements
The organization shall identify measuring and monitoring devices that are parameters
critical to ensure food safety.
In addition, the specified equipment and devices shall be calibrated regularly.
This calibration shall be performed in accordance with national or international standards
concerned, or by a reasonably accepted traceable method.
The organization shall take appropriate action when equipment and devices are foundto be inaccurate, and these actions shall be recorded.
Concepts, specific examples
1. First, measuring instruments and devices to measure essential parameters affecting
food safety, including CCPs, shall be identified as objects of control. The measuring
instruments and devices to be controlled here shall be capable of measuring theparameters necessary to assure food safety and have the appropriate range andaccuracy for the target of measurement. Specific measuring instruments and devices
include metal detectors, X-ray inspection equipment, weighing instruments, andthermometers.
2. In measuring parameters to assure food safety, another measuring instrument anddevice may be used to set and measure alternative parameters. For example, aweighing instrument may be used as an alternative to a thermometer or in46

conjunction with a thermometer to control the amount of water fed into the boilingtank or the weight of ingredients in order to ensure the center temperature of thefood during the boiling process. Note that measuring instruments and equipmentused for such applications shall also be subject to control. When setting alternative
parameters, it is important to confirm their validity through scientific evidence(literature and experimental results). (See HACCP Step 8 (Principle 3))
3. Second, identify the monitoring methods for the measurement instrument anddevice that are to be controlled.
4. Third, each of the measuring instruments and devices under control requires
calibration. Calibration" of measuring instruments and devices is one of the means
to confirm the validity of the measurement of numerical parameters and is a formof verification. It includes internal calibration, etc., in addition to calibration
performed by an external contractor.
5. Calibration shall be performed and recorded according to legal requirements,
manufacturer's

recommended

schedule, andschedules determinedby theorganization.
6. Calibration shall be performed to national or international standards in question or
by a reasonably accepted traceable method. If necessary, a traceability system chartor other documentation should be obtained. However, if no international standard
or method exists, as an alternative, the adequacy can and shall be proved by areasonable method that has been objectively validated and verified by the company
or an industry organization, or if there is a warranty by the manufacturer on themeasuring instrument, etc., the adequacy can and shall be proved based on thecontents of that warranty.
7. If no official standards exist, the standards used for calibration or verification shallbe retained as documented information.
8. Calibrated measuring/monitoring, testing, and inspection instruments and devices
shall be controlled to prevent damage or adjustment miss.
9. If measuring, monitoring, testing, or inspection instruments and devices are foundto be inaccurate, their records shall be kept, and procedures shall be established andimplemented to evaluate and take appropriate action on potentially affected
products. The actions taken shall be recorded.

47

FSM 18.1 Product labeling (B-to-C products)
Requirements
The organization shall ensure that all product labels or attached information to enable
the safe handling, display, storage, preparation and use of the product in the food supply
chain or by the consumer.
The finished product shall be labeled according to the applicable food regulations in theintended country of sale.
Concepts, specific examples
1. Organizations shall give sufficient information about food hygiene so that theconsumers are aware of the following:
1） Recognize the importance of reading and understanding information on labels orother media.
2） Include information about allergens and make choices appropriate for eachindividual.
3） Prevent contamination and the growth and survival of foodborne pathogens bycorrectly storing, preparing, and using food.
2. For B to C products (products that are in the form being sold to general consumers),
obtain information on labeling (allergens, food additives, etc.) as specified in the laws
and regulatory requirements of the countries in which they are manufactured andsold, and accurately label them.
3. The following items shall be clarified for food safety when labeling products:
1） Users and target consumers of the sales destination, etc.
2） Product-specific eating conditions, such as for eating raw or for cooking
3） Usage of raw materials, seasonings, etc.
4） Basis for setting expiration dates and best-before dates
5） Handling temperatures and methods
4. Information required for the product shall be printed or attached to the packaging
materials based on the product specifications.
5. Establish procedures to check that the contents of the labeling are correct.
6. Establish procedures to prevent mismatch between products and labeled packaging,etc.
7. It is important that the information to be labeled on the product shall be checkedagainst the documented information in HACCP Step 2 "Product Description" and Step
3 "Identification of Intended Use".

48

■Example of information management of raw materials containing allergenic food [1].
●Data of allergenic substances contained in raw materials

Ingredients

Manufacturer

specification

A
Ingredients

Manufacturer

Ingredients

ManufacturerEallergen
wheat

egg

milk

〇

△

×

specification

・・・ gelatine
×

Product
name

wheat

egg

milk

〇

△

×

・・・ gelatine ⇒×materials used

wheat

egg

milk

A

〇

△

×

×

B

〇

△

×

×

C

〇

△

×

×

udon

D

〇

△

×

wheat

egg

milk

×

noodles

E

〇

△

×

〇

△

×

×

Allergens in final product

〇

〇

×

×

Udon

curry

noodleswith curryallergen

topping・・・ gelatine×allergenraw materials
Classification

allergenspecification

B●Allergenic substances contained in final products can be grasped

・・・ gelatine(Partially quoted from "Explanation of the Matters Related to the Development of Advanced Infrastructure" (Food Industry Center, Japan).

(Partially quoted from "The Next Section of Explanation of the Advanced Infrastructure Development"(Food Industry Center, Japan).

FSM 18.2 Product labeling (B-to-B products, work in progress, semi-finished products)
Requirements
The organization shall define and implement procedures to provide information, such as
on primary processed foods, commercial ingredients, or intermediates in the processing
process, so that customers or consumers can be informed about product safety, even if
the information is not labeled on or attached to the product.
Concepts, specific examples
1. Organizations shall provide sufficient information on food Hygiene so that consumers
are aware of the following:491） Recognize the importance of reading and understanding labels or other media
information.
2） Include information about allergens and make choices appropriate for eachindividual.
3） Prevent contamination and the growth and survival of foodborne pathogens bycorrectly storing, preparing, and using food.
2. Similarly, information on labeling (allergens, food additives, etc.) required by thelaws and regulations of the country of manufacture and the country of sale for B to
B products, work in process, and semi-finished products (products other than thosesold to general consumers) and provide accurate product labeling and necessary
information, etc. to suppliers in a manner consistent with laws and regulations.
3. The following items shall be clarified for food safety when labeling or providing
information:
1） Product-specific eating conditions, such as for eating raw or for cooking
2） Uses of raw materials, seasonings, etc.
3） Basis for setting expiration dates and best-before dates
4） Handling temperatures and methods
4. Establish procedures to check that the labeling or information provided is correct.
5. Establish procedures to avoid discrepancies between the product and information on
the product's safety.
6. It is important that the information on product safety shall be checked against the
documented information in HACCP Step 2 "Product Description" and Step 3"Identification of Intended Use".

FSM 19.1 Analysis and Testing
Requirements
The organization shall establish, implement, and maintain procedures to ensure theanalysis of raw materials, semi-finished products, finished products, manufacturing
environments, etc. that affect food safety.
The analysis and testing shall be conducted by a competent analysis institution or testinglaboratory institution using appropriate sampling and analytical / testing methods.
The testing that has a significant effect on food safety shall be conducted in accordancewith the applicable requirements of ISO/IEC 17025.
In addition, the organization shall establish and implement analysis and testingprocedures (methods, standards, etc.) to confirm that the product meets productspecifications within its shelf life.
Concepts, specific examples50

1. This standard requirement requires that organizations establish and implement
testing procedures to ensure that testing of raw materials, semi-finished products,
products, and manufacturing environments that affect food safety is conducted in asystematic manner. It also requires that analysis and testing procedures (methods,
criteria, etc.) be established and implemented to verify that products meet
specifications during the shelf life of the products. The scope and level of
documentation or record keeping required by this standard requirement is based on
FSM 9.1 and FSM 9.2.
2. These tests are required to be "conducted using appropriate sampling and analyticalmethods," but these methods can be determined by the organization itself, taking
into account its industry, type of business, size, and the complexity of its work.
3. It requires that these tests be performed by sampling and analytical methods
determined by the organization, and is allowed to be performed by external analysis
agencies as well as internal inspection departments.
4. The scope of "tests with significant impact on food safety" includes, as specificexamples, verification of CCPs, acceptance tests of purchased products, and tests
related to shipping decisions, the scope of which shall be determined by theorganization, taking into consideration the characteristics of the product. Tests
related to quality are not included in the scope of this requirement.
5. It is important for food safety that traceability of test results as well as raw materials
and products (see FSM 14) be ensured, too. This is to ensure that when a trouble
occurs, including one related to food safety, the cause is promptly investigated.
6. ISO/IEC 17025 is the standard for accreditation of the competence of testing andcalibration laboratories by accreditation bodies.
This standard requirement requires that testing performed internally and externallyby the organization be conducted in accordance with ISO/IEC 17025, which states:
1） The inspection department or external analysis organization (hereinafter referred
to as "testing organization") shall specify the competence required for test
administrators and have competent, educated, trained test administrators
perform the tests. (ISO/IEC 17025 6.2 Reference)2） The testing organization shall have an environment that does not affect thereliability of the test results. (ISO/IEC 17025 6.3 Reference)3） The testing organization shall have objective evidence that the equipment
involved in the test is functioning properly. For example, this includes records ofinspection, calibration, adjustment, and maintenance practices. (ISO/IEC 17025
6.4 Reference)4） The testing organization shall identify the necessary equipment and substances,and establish and maintain metrological traceability of the measurement results
obtained from them. This indicates that calibration is performed using standards
or reference materials that are ensured to be traceable to the International

51

System of Units (SI) so that the same measurement results can be obtainedeven if the location and personnel change. (ISO/IEC 17025 6.5 Reference)5） Where externally provided products and services are incorporated into theactivities of the testing organization, are provided to customers in an as-is
condition, or affect testing operations, the testing organization ensures that only
appropriate ones are used. (ISO/IEC 17025 6.6 Reference)6） The testing department in the organization should perform validation to ensurethat the methods and procedures used and any modifications to them aresuitable for the intended use. Examples of validation include checking the limitsof

detection,

reproducibility,

linearityofcalibration

curves,andtheappropriateness of pretreatment of test samples, etc., and these should be
confirmed through investigation, indicating that objective evidence and rationale
should be confirmed.
In addition, when the methods and procedures used conform to official methods
or are commonly used, etc., it is acceptable to monitor whether appropriate test
results are obtained during verification activities, based on official methods or
past literature (ISO/IEC 17025 6.5, 7.2 References).
7） The testing department in the organization shall have procedures for monitoring
the validity of test results. Specific methods include the following This program
is not required to be conducted once a year, but it is acceptable to check all test
items once a year in principle, or once every three to four years for less important
tests, based on the organization's risk-based assessment of the importance ofthe test. (ISO/IEC 17025 7.7 Reference)(1) Including monitoring the testing capabilities of each test item by crosschecking its own test results with the results of at least one other testingorganization accredited by ISO 17025, etc. on the same sample for each test
item, establish and implement the program.
(2) Participate in proficiency tests accredited by ISO/IEC 17043:2023(Conformity
assessment -- General requirements for the competence of proficiency testing
providers), etc. (where available and suitable for the intended purpose)

FSM 19.2 Environmental Monitoring
Requirements
The organization shall establish, implement and maintain a microbial environmental
monitoring program to reduce the risk of food contamination.
This program shall consider microbial risks specific to the manufacturing process andfacility environment and include evaluation methods tailored to the risks.
Concepts, specific examples52

1. The identification of risks in the manufacturing process and how to control thoserisks are linked to the steps for establishing CCP in HACCP Step 6 (Principle 1) andStep 7 (Principle 2). On the other hand, this requirement requires organizations to
identify contamination risks to products not only in the manufacturing process but
also in the food manufacturing environment (on-site), and to develop an
environmental monitoring program including verification measures.
2. Environmental monitoring refers to the control of microorganisms, etc. that may
become hazardous factors when exposed to the environment during the processingof prepared foods and other products.
3. In particular, it is important to develop environmental monitoring programs in suchareas where products that are pre-packaged after heating or where ready-to-eat
foods are handled exposed, because the risk of contamination is high and sufficientconsideration shall be given to these areas.
4. For specific examples of environmental monitoring program development, see:1） Identification of food poisoning-causing bacteria, etc. that are likely to becontaminated from the manufacturing environment and can be hazards
Examples: Listeria monocytogenes contamination of dairy and meat products
derivedfromthemanufacturing

process,

Listeria

monocytogenes

contamination of ready-to-eat foods, Salmonella contamination of room
temperature processed foods2） Determination of sampling method and location
Examples: Before packaging, swab tests are performed on raw materials, semifinished products, work-in-progress, intermediate processed products, andsurrounding equipment through which the finished product passes, andcollection of fallen and airborne bacteria is performed.
3） Determination of sampling frequency per location
4） Determinationofmethods

to

check

for

the

presenceorabsenceofmicroorganisms that may be hazards5） Determination of alert levels and develop action plans
6） Conducting sampling, and recording and reporting of results

FSM 20 Internal Audit
Requirements
The organization shall establish, implement and maintain documented internal audit
procedures for all applicable food safety management systems (including HACCP plans,
food defense plans, and food fraud prevention plans).
The procedures shall include at least the following content.
a) Timing of internal audits. Schedules including frequency of at least once a year.

53b) Corrective action for nonconformity.
c) Rules that ensure the objectivity and fairness of internal audits.
The organization shall maintain a record of the performance of the internal audit asevidence.
The organization shall specify the competence required for internal auditors and provide
training for internal auditors.
Concepts, specific examples
1. Internal audits are one of the verification activities of the overall food safety
management system, and the results serve as input information for management
reviews. Internal audits shall be conducted at predetermined intervals throughout
the food safety management system (including all HACCP systems and GMP), andmay also be conducted on an ad hoc basis as needed.
2. Internal audits are conducted to verify the following:1） The food safety management system established by the organization complies
with legal and regulatory requirements.
2） The organization's activities comply with the procedures, etc., set forth in thefood safety management system.
3） Food safety management systems are effectively implemented and maintained.
3. In addition to a) through c) listed in the requirements, the internal audit procedure
should include the method of implementation, audit responsibilities, audit criteria,etc.
4. Individual audits shall be conducted by preparing a specific audit plan in accordancewith the audit procedures. The audit plan shall be prepared in consideration of thefollowing:
1） Materiality of the processes and areas to be audited
2） Previous Audit Results3） Status within the organization, such as changes to the food safety management
system4） Food safety-related situations outside the organization
When preparing the audit plan, for example, the audit criteria and scope aredetermined, the audit objectives are set, the schedule is adjusted, auditors areappointed and their scope of responsibility is determined, and the audit methodology
is reviewed.
5. Internal audits are important activities to review and improve the organization's
activities, and quality audits can further enhance the value of the management
system. In order to conduct good audits, the following should be considered:
1） Prior to the audit, confirm the scope of one's own audit and prepare checklists,
etc.

54

2） There are two methods of auditing: checking according to the requirements ofthe standard and the requirements of the system, and checking according to theorganization's workflow. By changing the method of checking, it can be easier
to detect problems.
3） Review the suitability and effectiveness of the system and activities based on it,
keeping in mind that the system can be improved if necessary. (Changes to thesystem are not considered taboo.)4） Problems found in the audit, including the reasons for them, shall be explained
to the audited department and reported after obtaining their consent.
5） The auditor should identify and report not only the inadequacies of the audited
department, but also the good points that can be used as a reference by otherdepartments.
6） In addition to checking the organization's activities through records and othermeans, the audit can also check the work site.
7） Upon completion of all planned audit activities, the results shall be summarized
and reported to the audited department and the audit client (top management),
and audit records shall be prepared. Audit results shall include responses to theaudit objectives8） For problems identified in the audit, corrective actions, corrections, and system
improvements should be taken as nonconformities, if necessary. In such cases,
it is recommended to use mechanisms such as FSM 3, 24, 25, etc.
9） When corrective actions, etc. are taken, the responsibility for such actions rests
with the person in charge of the audited department. The internal audit
personnel shall conduct follow-up audits to confirm that responses to audit
results (corrective actions, etc.) have been properly implemented, and report
the results.
10） The internal audit personnel shall monitor and review the overall audit progressand make suggestions to improve subsequent audits. These suggestions can
include the content of the audit plan, auditor competency requirements, andresources needed for the audit.
6. "Competence of internal auditors" is indicated by knowledge, skills, work experience,
audit experience, etc. There are no general standards for competence. Eachorganization shall develop its own standards that it deems necessary for its own
audits, and shall train its personnel to meet the standards it has established. For
example, the following skills and knowledge:
1） Skills required to perform audits(1) Ability to interview (communication skills. appropriate language skills for eachlevel)(2) Ability to take notes and prepare reports (ability to prepare reports that can
express nonconformities)55

(3) Presentation skills(4) Ability to prepare audit plans(5) Time management skills(6) Information gathering and risk identification skills (ability to identify risks andgather audit evidence from interviews, on-site observations, and document
review results)(7) Risk analysis and assessment capability (ability to analyze the severity ofidentified risks and evaluate nonconformities)
2） Knowledge related to food safety management systems(1) Knowledge of the organization's situation (organizational structure, issues in
the organization from an external perspective)(2) Knowledge of this standard(3) Knowledge of HACCP(4) Knowledge of GMP(5) Knowledge of food safety hazards (biological, chemical, physical) and related
legal and regulatory requirements(6) Knowledge of products and manufacturing processes
7. As a way to ensure objectivity and impartiality of internal audits, if it is difficult toassign auditors who are independent from the subject of the audit, it isrecommended that the organization make provisions, so that they do not audit theirown work, for example, to form audit teams with personnel from other departments,
etc.
8. Internal auditors (candidates) should attend third-party audits to the extent possible,
learn how auditors conduct audits and how they view the system, and use this as areference when conducting their own audits.
9. To improve the competence of internal auditors, it is possible to receive training
outside the company. JFSM recommends attending the JFS-C internal auditor
training course. It is also effective to refer to ISO 19011 as a guideline for internal
audit activities.

FSM 21 Complaint Handling
Requirements
The organization shall document, implement, and maintain a system of management to
respond to complaints and utilize complaint data to identify, correct, and manage
omissions and deficiencies in food safety efforts.
Control procedures shall include analyzing complaints, evaluating the magnitude of the
impact threatening food safety, and implementing corrective action as necessary.
Additionally, organization must record and maintain complaints, investigation results,

56

and corrective actions.
Concepts, specific examples
1. Complaints shall be distinguished between food safety-related events and otherevents, for example, quality-related events. This section covers food safety-related
events. However, the term "complaint" is used in various definitions (e.g., claim,
offer, suggestion, inquiry, etc.) by different organizations. To avoid terminologicalconfusion, this standard uses the term "complaint" to refer to a variety of terms.
2. In responding to complaints, what may seem to be a minor event can lead to thediscovery of a serious food safety-related defect. Therefore, it is important to collecta wide range of information in the initial stages of complaint handling. Then, thecomplaint shall be analyzed and its impact on food safety shall be evaluated in orderto clarify that it is a food safety-related event.
3. The key to promptly resolving complaints from business partners and consumers is
to create a system that allows for proper identification and prompt response.
4. Organizations shall establish and implement a documented management system for
responding to complaints and utilizing complaint data. The established system shallbe reviewed, and it shall be revised as necessary. Elements to be included in the
management procedures pertaining to complaints include the following:1） Establish a manual and system for handling complaints from business partners
and consumers.
2） Employees shall recognize their responsibility for handling and investigatingcomplaints from business partners and consumers.
3） To understand as accurately as possible what the complainant wants in response
to a complaint from business partners or consumers. If the complainant wants
answers to his/her questions regarding the cause of the complaint (including
presumptions), the responses to the product, the measures to prevent
recurrence, etc., the organization shall inform the complainant that the
information will be provided appropriately. At that time, if necessary, thecomplainant shall be given an estimated date for a response. (When it is foundduring the investigation process that the cause of the complaint is not theorganization, the complainant shall be informed of this as soon as possible. If thecomplaint is a false accusation or is motivated by money, the organization should
consider other ways to deal with the situation.)
4） With regard to complaints from business partners and consumers, the details of
the investigation and response in 3) shall be responded to complainants.
5） Record and maintain the details of the complaint, the results of the investigation,and corrective actions.
6） For complaints received, the relevant department shall classify those that canpertain to food safety and those that do not.

57

7） For complaints that can be related to food safety, the HACCP team, etc., shalltake the lead in promptly investigating the cause of the complaint and its
relevance to GMP and HACCP systems, involving the departments related to thecomplaint, and investigate the cause. For other complaints, the relevant
department shall investigate the cause.
8） When nonconformities are found based on complaints, correction shall be taken
and corrective actions shall be taken as necessary in accordance with proceduresin FSM 24 and 25. The results of both correction and corrective actions shall berecorded. Examples of specific actions are as follows:(Correction) Recall of product / (Corrective action) Change of manufacturing andcooking procedures / (Sequentially, depending on the situation) Report and publicannouncement to the administration
9） Determine a person responsible for confirming the termination of complaints
and confirm the termination.
10) Analyze complaint trends, provide input to management reviews, and conduct
reviews.
11) Accumulate and utilize complaint data to help continuously improve the foodhygiene system.

FSM 22.1 Serious Incident Management
Requirements
The organization shall document food incident management manual, implement it in theevent of an accident, and maintain it in effect at all times. This manual shall also describe
the methods for product withdrawal and product recall and include tests to ensure that
product recalls are carried out reliably.
It shall also include systems and procedures for providing necessary information tocustomers, consumers, and relevant authorities.
Incidents that occur shall be recorded and evaluated.
Concepts, specific examples
1. Serious incident refers to a food incident that has the potential to affect food safetyand does not include incidents that do not affect food safety but may affect quality.
2. Since it is often not possible to determine whether an incident is serious at the time
it occurs, it is advisable to work with a worst-case scenario when an incident occurs.
3. Procedures for responding to serious incidents include the following, but are notlimited to:1） In the event of a serious incident, respond in accordance with relevant
management procedures such as nonconformity response (FSM 24) andcomplaint response (FSM 21)582） Determine who in management is responsible for decision-making and practicalhandling of serious incidents
3） Appointment and training of incident response team
4） Create and maintain up-to-date emergency contact lists (customers, consumers,
relevant authorities, and internal stakeholders)5） Securing information sources

that

get advice on

legal andregulatory

requirements and professional advice6） Determining who is responsible for handling internal communications andcommunications with the relevant authorities and relevant external organizations,and methods how to communicate with them7） Determining who is responsible for providing information to consumers and the
media and methods how to communicate with them
4. Record and evaluate the incident to establish the severity of the incident and whether
there is a risk to the customer. The record of the incident shall include the following:
1） Related products, manufacturing location2） Quantity of products that have affected
3） Range of products that have affected (lot, batch, etc.)
4） Manufacturing records5） Quantity and location of shipments made
5. Establish deciding criteria for product recall or removal implementation in advance.
The relationship between "recall" and "removal" of products in this requirement issummarized below.
"Recall" refers to the removal by a supplier from the supply chain of a product thathas been sold or is being sold to end consumers and is deemed to be unsafe.
"Removal" refers to the removal by a supplier from the supply chain of a productbefore it is offered for sale to the final consumer and is deemed unsafe.
The supply chain used in this standard requirement refers to a series of production
and distribution processes from primary production to consumers, and issynonymous with the food chain. (See JFS-C Standard Document Version 3.1 Annex,
Definition of Terms)
Generally, the word "recall" is used for "collect" and "removal" is used for "pull-back"or "distribution recall," but since this is not the case for some industries ororganizations, please refer to the "Definitions of Terms" in the appendix of thestandard document for interpretation. (Reference: JFS-C Standard Document
Version: 3.1 Annex Definitions of Terms)
6. In order to promptly recall or remove a lot of a product that has already been shipped
if it is determined to be unsafe, procedures shall be established to implement thefollowing:1） Top management shall appoint an employee to direct the product recall or
removal and an employee to conduct the collecting.

592） The organization shall specify and document the following:(1) Notificationofstakeholders(e.g.,

regulatory

agencies,

customersorconsumers, distribution)
Reference Information (Scope of this item applies in Japan)
Based on the revised Food Sanitation Law and the revised Food Labeling Law,it will be mandatory to notify the government of any food recalls. (Effective
June 1, 2021)
See Law for Partial Revision of the Food Sanitation Law, etc. (promulgated onJune 13, 2008)https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000197196.html
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/ki
gu/index_00011.html(2) Handling of products that have been recalled or removed and products thathave not yet been shipped(3) A series of actions to be taken(4) Identifying the cause leading to the recall or removal, the scope of the recall
or removal, and recording all results3） A review shall be conducted when the recall or removal is converged, and theresults shall be used as input information for the management review.
7. Ensure that product recalls or removed products are identified and quarantined until
it is confirmed that they are safe.
8. In the event of a product recall, the organization shall promptly contact thecertification body and JFSM after the initial response is implemented. (Reference:
JFS-C Certification Program Document Version 3.2 5.2.5 Notification of informationthat affects an organization's certification status)
9. Recall procedures for food allergens should include the following (see FSM 16)●In the event of a food allergen incident (e.g. an allergic reaction to an undeclaredallergen), procedures and processes shall be established and implemented tofacilitate a review of traceability along the food chain, from the supplier (at least
one step before from own organization) to the recipient (at least one step after
from own organization).
FSM 22.2 Verification of food incident management procedure
Requirements
The organization shall verify the effectiveness of its food incident management procedureby conducting tests at least annually on products supplied by the organization to ensurethat product recalls are implemented, and maintain records of the verifications.
Concepts, specific examples

60

1. Conduct mock recall tests to verify and record the effectiveness of the recall
program at least once a year. Based on the results of the verification, review therecall program as necessary, and also verify and revise as necessary the foodincident management procedure that contains it.
1) In this test, it is required to be carried out under the assumption that the productis available on the market. However, for organizations that manufacture products
on a contract basis (OEM manufacturing) or that conduct business-to-business (Bto B) transactions, there are situations in which it is difficult to imagine that theorganization will be the subject of a market recall. The recall test in this situation
indicates that the recall test should be performed assuming that the products
containing the organization's products have been distributed to consumers. In
other words, the organization shall imagine a situation in which a consumer had
purchased these products and conduct tests to verify whether information about
the traceability of the target products can be identified from this situation, fromthe supplier one step before to the shipping destination one step after.
2) In this test, it is easy to imagine if you assume that allergens are mixed in.

FSM 23.1 Management of product specifications
Requirements
The organization shall document and maintain specifications for raw materials (including
packaging materials), semi-finished products, work in progress, remanufactured
products, reworked products, and finished products.
The organization shall have a system for communicating changes to productspecifications both internally and externally.
The organization shall designate a person responsible for managing productspecifications.
Concepts, specific examples
1. Maintain documentation of specifications for goods and services that the organization
procures from external sources. Specifications requested by the organization forpurchased goods, etc., or obtained from suppliers, etc., are evaluated that they areappropriate within the organization and ensure that intended to.
2. It is important to maintain and control the specifications stored as documents so thatthey can be used as needed for checking at the time of acceptance.
3. The organization shall evaluate the inherent risks of the items it purchases or
receives supplies from and establish checks upon acceptance (e.g., inspection
certificates, condition, temperature, labeling, etc.), as well as establish proceduresfor these checks.
4. Inherent risks include, for example, the following hazards:

611） In ground beef requiring adequate heat: enterohemorrhagic E. coli O-157
2） In redfish where temperature control is not properly implemented: histamine
accumulation
This requirement calls for attention to hazard factors in purchased products basedon the product characteristics handled by the organization.
5. If externally procured goods or services do not conform to specifications, procedures
shall also be established to ensure that they are not misused. Procedures should be
documented as necessary.
6. When providing specifications to business partners in business transactions, it isnecessary to have a system in place that allows the provision of the latest information
at all times.
7. In addition to specific requirements for goods and services, specifications may
include:1） Statement of compliance with laws and regulations
2） Handling of specification changes
3） Review of specifications (e.g., frequency, timing, etc.)
4） Whether or not to re-consign and its conditions, etc.
5） Providing inspection items that conform to specifications and a certificate ofinspection (also called Certificate Of Quality or Certificate Of Analysis)
8. The organization shall determine and implement a review process for theseinformation, including the frequency of periodic reviews. In addition, the organization
shall have a system for communicating changes to product specifications both within
the organization and to external parties that require those specifications. The
organization

shalldesignateapersonresponsibleformanaging

product

specifications. (The person responsible for managing specifications may be a person
who not only manages the specifications themselves, but also evaluates andapproves them; the scope of the person responsible is determined in accordancewith the organization's management system. See FSM15 1. 2) (3).)
9. HACCP Steps 2 and 3 require information on the food safety of products. It is
recommended that the specifications to be maintained and controlled by thisrequirement be organized in relation to such information.

FSM 23.2 Product Release
Requirements
The organization shall document and implement and maintain appropriate proceduresfor product release (shipping).
Product release procedures shall include steps to ensure that the final product meetsspecifications.

62

Concepts, specific examples
1. For product release (shipment) decisions, the procedures specified below shall be
documented, implemented, and maintained:
1） Complete inspections of raw materials (including containers and packaging
materials), semi-finished products, work-in-process, reworked products, andfinished products to confirm that the products conform to the productspecifications.
2） Ensure that not only the product specifications but also process management are
carried out properly.
3） The authorized person shall make the decision of acceptability.
4） Maintain records of product release decisions.
2. The following information shall be confirmed prior to releasing products:
1） Releasing procedures are up-to-date and available to engaged personnel.
2） Specifications for raw materials, ingredients, additives, packaging materials, andfinished products are clear, and the process for ensuring that recycled andreworked products are consistent with the final product specifications is also
clear.
3） The final releasing decision maker is clear.
4） Procedures are in place to confirm that releasing products conform to productspecifications and that proper process controls have been implemented.

FSM 24 Identification of nonconformities and control of nonconforming products
Requirements
The organization shall document, implement, and maintain effective procedures for raw
materials (including containers and packaging materials), semi-finished products, workin progress, recycled products, reworked products, and final products to identify
nonconformities affecting its food safety and to clearly identify, control, dispose of, andrework nonconforming products resulting from such nonconformities in order to prevent
misuse and mis-shipment of nonconforming products affecting food safety.
The organization shall also determine who will be responsible for managing
nonconforming products.
Concepts, specific examples
1. This requirement is responsible for setting up a barrier at each step along the way
to the final product to stop any nonconformity, and documenting the procedure inadvance.
2. When nonconformity occurs in raw materials (including containers and packaging
materials), semi-finished products, work-in-process products, recycled products,
reworked products, and finished products, determine whether or not there is a risk63

of affecting the safety of the finished products. If there is a possibility of affecting
safety, the scope of the effect is to be identified and the response to thenonconformity is to be implemented according to pre-designed procedures. The
organization shall determine the person responsible for the management of thenonconforming product and manage it in accordance with the procedures to ensurethat the nonconforming product is not used unintentionally or shipped incorrectly.
3. Nonconformities can be detected not only by inspection activities, but also by
business activities or customer complaints, and can include nonconformities inmanufacturing processes as well as nonconformities in JFS standard requirements.
4. It is effective to have well-defined manufacturing and inspection procedures in placein advance to detect nonconformities in each process.
5. It is important to recognize that being able to detect nonconformities means that theprocess is under control. If the occurrence of nonconformity is perceived as a badthing, it will be difficult to get reports from the field.
6. Clearly identify and isolate nonconforming products found so that they cannot be
misused or used in an unintended manner. In identifying the scope of nonconforming
products, appropriate judgment shall be made to ensure that nonconforming
products are not mixed in with compliant products.
7. Non-conforming products shall be discarded or reworked and clearly identified andtraceable. The rework shall be clearly documented in the HACCP flow diagram. (SeeGMP 9)
8. If preventing recurrences of non-conformity is required, FSM 25 shall be
Implemented.
9. If a product shipped is determined to be unsafe, the organization shall conduct a
recall or removal. (See FSM 22.1)
10. When a nonconformity occurs, a release decision shall be made after confirming thecontents of the nonconformity and that food safety is ensured regardless of whether
or not the correction is implemented. Such a decision can require a different
authority than that for a normal release decision.

FSM 25 Corrective Action
Requirements
The organization shall define, implement, and maintain the document of procedures forthe determination and implementation of corrective actions in the event of any
nonconformities arising relating to food safety.
In case of deviation or violation, the organization shall identify the root cause, takemeasures to prevent recurrence, and review the effectiveness for the series of corrective
actions.

64

Concepts, specific examples
1. The organization shall establish, document, implement and maintain procedures toensure the elimination as quickly as possible of the causes of detectednonconformities affecting food safety and to prevent their recurrence.
2. Personnel with the competence to analyze causes and plan countermeasures shallplan and implement corrective actions.
3. The following flow of corrective actions shall be addressed:
1） To ascertain the actual status of nonconformity (including customer complaints).
2） Identify causes of nonconformity.
3） Implement necessary measures to prevent recurrence of nonconformities.
4） Review the effectiveness of corrective actions taken.
5） Record the sequence of actions related to corrective actions.

FSM 26 Change management
Requirements
The organization shall document, implement, and maintain procedures to evaluate theimpact to the necessary extent in advance when changes occur in all processes andoperations (including equipment and devices) that affect the safety of the final product.
The organization shall also determine who will be responsible for change management.
Concepts, specific examples
1. In operating a food safety management system, it is important to manage changes
in all processes and operations (including equipment and tools) that affect the safetyof the final product, and it is necessary for organizations to reliably establish andaddress the process of such changes. Therefore, procedures shall be documented,
implemented, and maintained to assess the impact of changes to the extent
necessary before they occur. (FSM3, 10, 15, 20, 23.1, and HACCP Step 11 (Principle
6) are relevant for responding to changes that occur. FSM26 also includes theseprocedures for responding.)
2. The key points in establishing and operating the above procedures are as follows:
1） The organization shall determine the "definition of change" appropriate for thecharacteristics of the products it handles and its own business activities, anddescribe it in the procedures. (Referring to the examples below, determine thescope of change and management appropriate for own organization.)Managed subject
PersonExamples of changes
New hires/reassignments/return to work

Equipment and Tools New installations/repairs and specification
changes/restarting idle equipment

65

Raw materials

New adoption/change in specifications/use after a longtime

Methods

First time manufacturing, inspection, andmanagement / Changes in manufacturing, inspection,and management / First time in a long time
manufacturing, inspection, and management

Environment

Factory transfers/seasonal changes/extreme weather

2） In addition to planned changes, there may be unexpected changes (such as inresponse to customer complaints). The definition of such unexpected changes
and how to respond to them shall be also described in the procedures as muchas possible.
3） To ensure control of the change, its "change flow" shall be clarified and describedin the procedure. The main contents of the "change flow" are as follows:●

Application for change ⇒Preliminary evaluation of change ⇒Trialoperation ⇒ Judgment/permission ⇒ Check of effectiveness ⇒ Completion
Based on this process, it is important to create a record of the entire processfrom application to completion of the change.
4） If changes are implemented, new and different risks may arise. (For example, if
equipment in one process is changed/modified, equipment in another process
can also need to be changed/modified.) Therefore, it is important to verify therisks associated with this change from multiple perspectives during the"Preliminary evaluation of change".
5） During the "Trial operation," a plan shall be developed and implemented toevaluate the change work, including the criteria necessary for subsequent"Judgment/permission". The number of samples required, etc., shall also be
determined in advance.
6） After the "Judgment/permission" is completed and the product is successfullytransferred to mass production, the "Check of effectiveness" is conducted for thechange. The main items to be checked are as follows:●Does what's changed function without any problems?
●Are the intended results being achieved continuously? etc.
7） The person responsible for change management shall confirm up to the "Checkof effectiveness" step above and make a final pass/fail decision. If it passes
successfully, it is complete.

66

FSM 27 Utilization of Kaizen suggestions from personnel
Requirements
The organization shall establish and implement a system to properly utilize food safety
Kaizen suggestions from personnel.
Concepts, specific examples
1. This requirement calls for organizations to establish and implement a system foreffective for improvement activities by bottom-up. This incorporates employee
improvement activities, which have long been emphasized in Japan, into the foodsafety management system, and is a feature of this standard.
2. Suggestions for improvement made by employees should not just be adopted as is.
Since some suggestions may have negative side effects for food safety efforts, thecontent of the suggestions should be professionally verified before being adopted. In
addition, the results should be communicated not only to the proposer but also to
the entire organization.
3. It is most important that food safety initiatives be properly implemented by frontline employees, and to motivate them to do so, it is effective for front-line employees
to think for themselves and make suggestions for improvement.
4. Encouraging suggestions by educating each personnel on how they can contributeto food safety can be included in establishing systems of the "Training" section of
GMP 7.
5. This initiative, like any other initiative, shall function substantially. In addition, there
shall be daily communication between supervisors and subordinates.
6. Note the relevance of FSM 2 and FSM 27, as FSM 2 requires that top management
commitments include this requirement as part of the food safety culture component.

67

II Hazard Analysis and Critical Control Point (HACCP)
HACCP is a tool for establishing a preventive control system in a process that identifies
specific hazards and control measures for food safety, and takes those control measuresrather than relying on testing and inspection of the final product.
Successful HACCP requires management and engaged personnel to work together andexpertise in a wide range of areas, including primary production, microbiology, andmanufacturing and processing techniques.
HACCP plan is a document or set of documents prepared in accordance with HACCP
principles (from International Food Standards Committee (CODEX) General Principles ofFood Hygiene 2020: (Reference) Japan Food Sanitation Association 2021 Translation First
Edition) to ensure control of critical hazards in food operations.
HACCP system means the development of a HACCP plan and the implementation ofprocedures according to that plan (from International Food Standards Committee (CODEX)
General Principles of Food Sanitation 2020: (Reference) Japan Food Sanitation Association
2021 Translation First Edition).
HACCP Step 1 HACCP team assembly and identification of the scope of application
Requirements
HACCP team shall be assembled with competent staff, and the scope of application of
the HACCP system and applicable GMPs shall be identified. The scope shall be
documented what products and processes are covered by which HACCP plan.
Concepts, specific examples
1. By forming the HACCP team with people with as many specialized skills as possible
from the manufacturing/processing department, quality assurance/quality control
department, and the maintenance department responsible for the maintenance andpreservation of facilities and machinery used in manufacturing, it is possible toeliminate blind spots in hazard analysis and facilitate communication. The HACCP
team leader (food safety officer) should be a food hygiene officer or food hygiene
manager who has knowledge of the product and specialized skills, and knowledge ofthe product's characteristics and processes, furthermore, has strong communication
skills and is able to summarize opinions within the organization.
When the Food Safety Officer and the HACCP team leader are different personnel, it
is necessary to ensure that they communicate with each other.
2. Depending on the size of the business, there are many cases in which various tasks
are performed holding multiple positions, and for this reason, the top management
himself may be the team leader, or one person may be responsible for all food safetyrelated actions, etc. However, it is important to try to ensure the cooperation of
employees within the organization to the extent possible.

683. If the number of employees is small, the team does not necessarily need to becomposed of several people. It is also possible to use outside resources.
4. If the organization lacks in-house knowledge or expertise, it can be also effective to
receive external training or to obtain the participation and advice of external foodhygiene experts.
5. The HACCP team shall identify the scope of the HACCP system and appropriate GMPs
(PRPs in ISO 22000). Examples of documentation of products and processes coveredby the HACCP plan include inclusion in product manuals.
6. The main roles of the HACCP team, other than the above No.5, are as follows:
1） Preparation of HACCP Plan
2） Establishment of GMP
3） Preparation of sanitation standard operating procedures
4） Education and training for personnel in charge of HACCP plan implementation
5） Implementation of HACCP system and GMP verification
6） Review, amendment or change of the HACCP plan based on verification results7） Identification of changes in raw materials, product composition, manufacturing
processes, etc. and review of HACCP plans accordingly
8） Review, improve, or modify HACCP plans as needed based on new food hygiene
information
9） Response to external inspections
7. The HACCP team is responsible for managing food safety efforts within theorganization.

HACCP Step 2 Product Description
Requirements
Product specifications shall be documented.
The document shall describe all product information necessary to conduct hazard
analysis.
Scope of the HACCP system shall be defined per product or product group and perprocess line or process location.
This system should be systematic and comprehensive and take into account legal andregulatory requirements related to food safety.
Concepts, specific examples
1. In order to clarify the characteristics of the product, describe the specifications andcharacteristics of the final product, divided into necessary items, as follows:
1） Specifically, for the final product, describe the name and type of product, theintended use/purpose of the product, product characteristics, names of raw
materials, names of additives and standards for use, form of packaging, units and69

quantities, materials of containers and packaging, expiration date or best before
date and storage method, distribution method, internal targets for controlling
hazards in the product (Ingredient standards for bacteria specified in the Food
Sanitation Law, etc.), including the standard criteria specified by the recipient.
2） In facilities that manufacture multiple products, it can be effective to group foods
together for purposes of developing HACCP plans, depending on similar
characteristics and processing steps.
3） If allergens are included, or if there may be cross-contact of allergens in the samefacility, this shall also be noted.
HACCP Step 3 Identification of Intended Use
Requirements
Intended use of the product and target users (consumers) shall be clearly described ina written document.
Concepts, specific examples
1. The intended use (method of use) and intended users (consumers) of the productshall be described in the document as follows:
1） Clarify the methods of consumption and use of the food and the target
consumers. Particular attention shall be paid to the content, especially in the caseof vulnerable health consumers, young children, and the elderly.
2） If the intended use includes cases where the product requires cooking with heator where precautions after opening the package, the necessary information shallbe stated.
3） It shall clearly state what the risks are if the intended use is not followed andmisused.
2. For foods intended for susceptible populations, a high level of assurance that the
food is safe can require enhanced process controls, more frequent monitoring,product testing to verify the effectiveness of controls, or other activities.

HACCP Step 4 Construction of Flow Diagram
Requirements
The flow diagram that covers all steps in the operation shall be constructed.
Concepts, specific examples
1. For a series of manufacturing or processing processes from receipt of raw materials
to shipment of the final product, a flow diagram shall be prepared to show theoperations of each process along the flow. This shall include any applicable rework.
The same flow diagram can be used for a group of products manufactured using
similar processing steps.

702. The flow diagram is used as the basis for evaluating the likelihood of occurrence,increase, decrease, survival, or contamination of a hazard factor when conducting a
hazard factor analysis.
3. The flow diagram shall be accurate and detailed enough to perform a hazard analysis.
【Creating a flow diagram】
4. The flow diagram shall be created according to the following procedure:
1） Briefly list all processes and operations from receipt of raw materials to shipmentof final products and applicable rework.
2） The listed raw materials and processes shall be enclosed in a frame, the frames
are connected with arrows, and the process is numbered in order. For raw
materials, food additives, water and packaging materials used, gas (only if used),
and other materials that come into contact with the product shall be also written
down, and these shall be written in a box in the same row, and arrows shall beconnected to the process in which they are used.
3） In the course of raw material processing, if waste is generated or it becomes aprocessed raw material to be used in other products, it shall be clearly stated.
4） In the process, if there are processes with pass/fail judgment, reprocessing,reusing or reworking, etc., it shall be clearly stated so that it can be controlled.
5） The process being outsourced shall also be clearly stated.
5. By drawings of the facility showing the outline of each process and the planar andthree-dimensional layout of the facility, it is possible to identify process key points andareas where cross-contamination is possible, which can aid in hazard analysis.

71

Flow Diagram Example

main raw material

Other
raw materials

food additive

Water

Packagingconsumption

Materials
5 Accepted

1 accepted

2 accepted

3 Accepted

4 Accepted

Ⅰ

Ⅰ

Ⅰ

Ⅰ

6Storage

7Storage

8Storage

9Storage

Ⅰ

Ⅰ

Ⅰ

Ⅰ

11 Weighing

12 weighing

13 weighing

14 weighing

Ⅰ
10StorageⅠ
15 Mixed
reworkⅠ
16 Molding
Ⅰ
17HeatingⅠ
18 CoolingⅠ
19 sorting→ 20 Disposal

Ⅰ
21 Bulk Packaging
Ⅰ

Outsourcing
Packaging

22 Transport

Materials
23 Acceptance24 AcceptanceⅠⅠ

26 packaging

25 Storage

Ⅰ
27Metal Detectors→ 28 Disposal

Ⅰ
29StorageⅠ
30 Shipment

HACCP Step 5 On-site Confirmation of Flow Diagram
Requirements
The flow diagram shall be verified whether it correctly reflects the existing process stepsof the operation.
Concepts, specific examples
1. A person with sufficient knowledge of the process shall verify on-site that the process
is clearly defined in the flow diagram so that the hazard analysis in HACCP Step 6(Principle 1) can be sufficiently performed. At that time, the on-site verification shallbe performed as follows, while checking against the site layout diagram:

72

1） At the site, verification shall be carried out step by step from the upstream
process, to check that appropriate processes are shown, including temporarystorage of products and management of semi-finished products.
2） If a process or activity is inconsistent with the flow diagram at the site, check withthe responsible person for the correct control method and correct the
documentation.
3） Verification shall be observing the work during various work periods to ensurethat the flow diagram matches the work.

HACCP Step 6 (Principle 1) Hazard Analysis
Requirements
The HACCP team shall list all the hazards that are reasonably likely to occur in eachprocess steps.
Potential hazards in each process shall be identified, the critical hazards shall beidentified, and all measures to control them must be considered.
Hazards shall include allergens, if necessary.
Concepts, specific examples
1. Hazard analysis is to identify potential hazards to be controlled by the HACCP plan,
determining critical hazards, and clarifying control measures for each critical hazard.
For this purpose, information is first collected on potential hazards and the conditions
under which they can occur throughout the entire process from raw materials,
manufacturing and processing, storage and distribution to consumption, and thelikelihood of occurrence of the hazards and the severity of the hazards when they dooccur are identified.
1） Hazards shall be specific and shall explain the cause or reason for their presence.
The potential misuse of the product by potential consumers that would make thefood unsafe, as well as any unintended uses that could be known from known
cases, shall also be considered.
2） Hazards should also be identified and considered whenever possible. Examples areprovided below:(In the case of metallic foreign bodies, which are physical hazards)●A certain part A in the manufacturing process is subject to routine maintenance,
but it has been missing in the past, and since there is a possibility that it may
get mixed into the product in the future and cause injury to consumers who eat
it, it is identified as a major hazard and management measures are required.
●On the other hand, a certain part B in the manufacturing process is managed
through daily maintenance, and there have been no cases in the past of it being
missing and contaminating the product, so it is considered to be controlled73through general hygiene management and is not identified as a significant
hazard.
2. By conducting a Hazard Analysis, an appropriate management system can be created
for the facility according to the frequency of possible hazards and the severity of theconsequences.
3. The actual process of hazard analysis is to first list, by raw material and process, thehazards in the final product that can lead to health hazards when eaten.
4. Following the flow diagram from raw materials to final products, identify raw materials
and processes that can lead to the occurrence of hazards, narrow down importanthazards in terms of the frequency of occurrence of hazards in each process and theseverity of the results, prepare the Hazard Analysis Sheet that lists the causes ofoccurrence (contamination, proliferation, survival, contamination, etc.) and the control
measures to control them.
5. When preparing the Hazard Analysis Sheet, it is necessary for all members of the
HACCP team to share their expertise and knowledge, and to discuss and summarize
these findings.
《Steps to prepare the Hazard Analysis Sheet》
6. The steps for creating the Hazard Analysis Sheet are explained using the "Example
Hazard Analysis Worksheet" given in the International Commission on Food Standards(CODEX) Committee's General Principles of Food Safety CXC 1-1969, Rev.2022.
Example of Hazard Factor Analysis Worksheet (Prepared from Codex General Principles of Food Hygiene 2020: Japan Food
Sanitation Association 2021 First Edition Figure 2)（1）column
Raw Materials /Operation works(stage)（2）column
Identify hazards
that are expected
to occur or are
likely to increasein this process.
B: Biological
C: Chemical
P: Physical（3）column
Do these potential
hazards need to beaddressed in the
HACCP plan?
（Yes or No）（4）column
Justify your judgment in column(3).

（5） column
What measures can be applied
to prevent, eliminate or reduce
to an acceptable level the(If rated "0": Indicate the basis for hazards?
the judgment and the cause of thehazardous factor.
(Specify the means to control
×(If rated "x": Indicate thethe hazards rated as critical inreason(s) for the rating.）column (3)).

B：
C：
P：
B：
C：
P：
B：
C：
P：

[Step 1] (Column (1) of "Example of Hazard Analysis Worksheet")
List raw materials and manufacturing and processing processes according to the flow
diagram.

74

Write the same numbers along the flow diagram for materials that come in contact withthe product, such as main raw materials, secondary raw materials, water used, andpackaging materials, as well as for the manufacturing and processing processes.
Perform the hazard analysis of all raw materials used in the food product. This can bedone in two ways:
1) Methods to analyze hazards related to raw materials in the process of receiving raw
materials
2) Methods to conduct hazard analysis separately for raw materials and processes
This guideline describes the method in 1).
[Step 2] (Column (2) of "Example of Hazard Analysis Worksheet")
List potential hazards originating from raw materials and manufacturing and processing
processes.
Hazards shall be described specifically. For example, instead of "food poisoning
bacteria," list "Salmonella," "pathogenic E. coli O-157" and so on are enumerated. Also,
instead of just "metal fragments," describe the source of contamination and the reason
for their presence, such as "contamination from metal foreign bodies derived frombroken blades from crushing," "pieces of kitchen knives," etc.
[Step 3] (Column (3) of "Example of Hazard Analysis Worksheet")
Based on the frequency of occurrence (likelihood of occurrence) and the severity of theconsequences (the extent of damage if they occur) of the listed hazards, evaluate
whether or not they are significant hazards that shall be reduced/eliminated from thefood to guarantee the safety of the final product.
When conducting a Hazard Analysis to determine critical hazards, consider the following
whenever possible:
1） Hazards related to the type of food to be produced and processed, including
ingredients and processes (e.g., results of hazard surveys or sampling and testing
in

the

food

chain,

recallcases,

informationfromscientific

literatureorepidemiological data)
2） Likelihood of a hazard occurring in the absence of additional controls, taking into
account GMP (PRP in ISO22000)
3） Frequency of occurrence and severity of consequences of adverse health effects due
to hazards in food in the absence of controls4） Identified acceptable levels of hazards in the food (e.g., based on regulations,
intended uses, and scientific information)5） Nature of the facility and machinery and equipment in which the food is produced6） Survival or growth of pathogenic microorganisms
7） Generation or persistence of toxins (e.g., mold toxins), chemicals (e.g., pesticides,
veterinary drugs, allergens) or physical hazards (e.g., glass, metals) in food758） Potential for food to become unsafe as a result of its intended use, and/or
mishandling of the product by the consumer9） Conditions leading to the above
For the evaluation of hazards in Step 3, recommend using a matrix table of "frequencyof occurrence" and "severity of results" as shown below, and entering the numbers into
the hazard analysis sheet. There are various examples of matrix tables created, and it
is advisable to adopt one in consideration of the target product, manufacturing process,etc.
However, this does not apply to cases that can be clearly evaluated with "yes/no".

An example of the concept of thelikelihood of an enumerated cause of harm and the magnitude of damage if it(Based on "Risk Assessment Handbook", METI 2011.6)

4
3

frequency ofoccurrence

2

1

0

Often
OccursOccasionally
OccursOccurred atothercompanies
Has occurredat othercompanies
No
informationon othercompanies
There is no
unthinkable

0

Ⅰ

Severity of ResultsⅡ

not (verbnegating suffix;
may indicate
question or
invitation withrising intonation)complaintrisk
OK to manage

Ⅲ

Ⅳ

recallserious illness

lethalrisk

Serious
risk

risk

risk

Seriousrisk
Seriousrisk

Seriousrisk
Seriousrisk

risk

Serious
risk

risk

risk

OK to manage OK to manage

risk

OK to manage OK to manage OK to manage

OK to manage OK to manage OK to manage OK to manage OK to manage

How to read the matrix
It is an extremely high risk, suggesting the potential to become asignificant source of harm, which would likely be controlled by control
major risk
measures that would be CCPs under HACCP Procedure 7, Principle 2.

risk

OK to manage

The current control measures are likely to be inadequate, indicating theneed to add some means to strengthen and enforce the current GMP(General Sanitation Management Program).
The current means of management is adequate to manage thesituation.

76

[Step 4] (Column (4) of "Example of Hazard Analysis Worksheet")
In this step, for significant hazards marked with ○ or Yes in [Step 3] ((3) in the"Example of Hazard Analysis Worksheet"), identify the factors causing the hazard anddescribe the basis for the decision in column (4). For those hazards marked with X or
No in column (3), describe the basis for judgment.
[Step 5] (Column (5) of "Example of Hazard Analysis Worksheet")
For each hazard rated as critical, identify control measures to ensure the safety of the
final product. The following is an example of a hazard evaluation (Step 3) and a hazard
analysis sheet.
Consider which control measures to apply to each critical hazard, as multiple control
measures may be needed to control one hazard. For example, to control Listeria
monocytogenes, heat treatment may be required to kill viable organisms in the food,and environmental cleaning and disinfection can be required to prevent contaminationfrom the processing environment after heating.
It can be possible to control multiple hazards through specific control measures. For
example, if Salmonella spp. and E. coli O-157 are present in a food, heat treatment cancontrol both hazards.
*Reference examples of the Hazard Analysis Sheet are as follows.
Source: Ministry of Health, Labour and Welfare website(http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000098735.html)

77

Example of Hazard Analysis Sheet
Product name: Catering Bento
⑴

⑵

⑶

⑷

⑸

Is it an important hazard
Ingredients/Process Hazards expected to occur in (1)that needs to be
reduced or eliminatedControl measures for hazards identified

Basis for decision in column (3)as important in column (3)from the food supply?
Refrigerated

Organisms: Presence of pathogenic（Vegetables)

Harmful Microorganisms
Salmonella spp.
Pathogenic Escherichia coli

Contamination is possible due to unsanitary handling during manufacturing andNO

Staphylococcus aureus

processing, but can be controlled by adhering to hygienic handling of food andother products.

Heat-resistant spore bacteria
Clostridium botulinum
Welch bacillus

NO

Contamination is possible due to unsanitary handling during manufacturing andprocessing, but the bacteria are anaerobic and cannot grow during storage.
Possible contamination due to unhygienic handling during manufacturing and

Bacillus cereusNO

processing, but can be controlled by adhering to hygienic handling of food andother products.

Chemical: None
Physical: Presence of metallic foreign
bodiesYES

Possible presence of metallic foreign matter due to improper handling during
manufacturing and processing

Controlled by metal detection (NO.9)

Product name: Boiled soba noodles
⑴

⑵

⑶

⑷

⑸

Is it an important hazard
Ingredients/Process Hazards expected to occur in (1)that needs to be
reduced or eliminatedBasis for decision in column (3)Control measures for hazards identified
as important in column (3)from the food supply?
Buckwheat

Organisms: Presence of pathogenic
Harmful Microorganisms
Salmonella spp.

6

May be more contaminated than soil

Can be controlled in the sterilization

Pathogenic Escherichia coli

6

May be more contaminated than soil

Can be controlled by Sterilization

Bacillus cereus

7

May be more contaminated than soil

Can be controlled by cooling (NO.33)

Welch bacillus

19

Not likely to proliferate since not placed under anaerobic conditions thereafter

Clostridium botulinum

15

Heat-resistant spore bacteria

Chemical: Residual pesticides

17

No possibility of proliferation, as the material will not be placed under anaerobic
conditions thereafter.
Inspection certificate is issued once a year to confirm that the product has
passed the inspection.

Physical: Presence of foreign matter
Hard foreign body13

Can be eliminated by visual check at weighing (NO.14)

Metallic foreign body18

Can be eliminated by visual check at weighing (NO.14)

HACCP Step 7 (Principle 2) Critical Control Points
Requirements
Critical Control Points (CCPs) shall be determined.
Concepts, specific examples
1. What is Critical Control Points (CCPs)?
1） Critical control points (hereafter referred to as CCPs) are steps at which control
is essential for the manufacture of a product in order to reduce or eliminate
significant hazards from the food to acceptable levels, they are set in processes
where deviations could lead to food that can be unsafe, and they are stages withprocedures or operations that require especially strict control.
2） For each hazard that is identified as a significant hazard as a result of the hazard
analysis, it is always necessary to establish one or more control measures thatcan control that hazard.
3） Among the control measures for the critical hazards listed in HACCP Step 6(Principle 1), consider control measures that could serve as CCPs.
4） At CCPs, it is necessary to set permissible limits as described below, conduct
monitoring, and take measures such as not allowing products manufactured

78during the period when the limit was exceeded to be shipped if there is adeviation.
5） CCPs can be needed at multiple stages to control a single hazard.
2. How to determine CCPs - Example of Decision Tree application
See the figure below for the procedure / The main points are as follows:
1） The requirements for CCPs are that it can be monitored continuously or with areasonable frequency using a pre-defined monitoring method, and if theparameter deviates critical limit (CL), production can be stopped immediately
and process control can be restored to the original state in a short period of time,and food produced during the period of deviation can be identified and isolated.
2） Only those processes for which significant hazards are identified in the hazard
analysis are subject to Decision Tree application.
3） Consider the significance of the hazard (i.e., the likelihood of its occurrence andthe severity of the effect of the hazard in the absence of controls) and whether
it can be adequately controlled by the GMP. A GMP can be a normal GMP, or it
can be a GMP that requires greater attention (e.g., monitoring and recording) tocontrol the hazard (so-called GMP 4.2). (See *)4） If CCPs were not identified in Q2-Q4, review the process and control measuresagain and re-conduct the hazard analysis. (See **)5） Determine whether a control measure at a process where a significant hazard
has been identified is used in combination with a control measure at anotherprocess to control the same hazard, in which case both processes should beconsidered CCPs (See ***).
6） If there are no specific and special control measures, the process and control
measures should be reviewed again and the hazard analysis shall be reperformed. (See ****)

79

(Above figure taken from CXC 1-1969, Rev. 2022, General Principles of Food
Hygiene of the International Commission on Food Standards (CODEX).)
3. Specific examples of CCPs
1） Examples of CCPs that prevent the occurrence of hazards are as follows:(1) Acceptance of raw materials: Prevention of antimicrobial residues bychecking raw material inspection reports submitted by suppliers(2) Cooling: Prevention of pathogen growth through appropriate temperature
control(3) Refrigerated storage: Prevention of pathogen growth through appropriate
temperature control(4) Weighing of food additives: Prevention of over-additives
2） Examples of CCPs that eliminate hazards include the following:(1) Heating process or sterilization process with chemicals: Sterilization ofpathogenic bacteria(2) Metal detection: Detection by detector and elimination of metal fragments
3） Examples of multiple CCPs that control a single hazard are as follows:(1) Control patty thickness and heating time/temperature to kill non-sporeforming pathogenic microorganisms in hamburgers.
(2) The heating process can be a CCP to kill vegetative cells of spore-forming
pathogens, and the cooling process can also be a CCP to prevent spore
germination and growth.
If control measures for identified significant hazards do not exist at any stage, theproduct or manufacturing process should be modified.

80

HACCP Step 8 (Principle 3) Critical Limits
Requirements
Validated critical limit(s) shall be stipulated for each CCP.
Concepts, specific examples
1. What is the Critical Limit (CL)?
1） CL is a monitoring criterion that distinguishes between acceptable andunacceptable conditions of a control measure of hazards and is an observable ormeasurable criterion that distinguishes between acceptable and unacceptableconditions of food in relation to the control measures applied as a critical hazard(CCP). A CL can have one or more parameters.
2） Since incorrectly set CL can lead to the occurrence of hazards, they shall bevalidated based on scientific data and set appropriately.
3） Deviations from the CL require corrective action.
4） The CL shall meet the following conditions:(1) The most appropriate parameters for ensuring that hazards are prevented,
eliminated, controlled or reduced to acceptable levels, and whose value isscientifically proven(2) Criteria using parameters that can be determined in real time wheneverpossible
If it is found that the control condition is not appropriate, corrective measures
shall be taken immediately, so it is desirable for this to be indicated byparameters that can be judged in real time.
5） CL is usually the minimum or maximum value of a critically important parameter
related to the control measure and can be used, such as temperature, moisture,time, pH, water activity (Aw), available chlorine, contact time, conveyor belt
speed, viscosity, conductivity, flow rate, etc, or sensory indicators (color, gloss,
odor, taste, viscosity, physical properties, foam, sound, etc.) or observed pumpsettings, etc.
As an alternative to the parameters indicating CL, another indicator can beestablished, but this indicator shall also be based on scientific data.
Example: If the CL for the boiling process of a certain product is "product center
temperature 63°C, heating time 30 minutes," it is not practical to measure thecenter temperature of all products; therefore, apart from this indicator, "watertemperature of boiling tank, amount of product put in, and heating time" aremeasured as non-destructive and efficient CLs.
2. How to set CL
1） CL should be scientifically validated by evidence that, when properly
implemented, they can control hazards to an acceptable level.

812） If indicated by laws, regulations, etc., values that allow the target hazard to becontrolled reliably are adopted. In other cases, values are set based on literature
data, experimental data, etc.
3） Even if the values indicated in manufacturing standards, etc. are adopted as CL,
collecting evidence (evidence) on whether they are applicable to the organization(products, manufacturing facilities, manufacturing processes, etc.) is also avalidity check.
4） In normal manufacturing process control, it is rare to use CL alone for control,and it is common to set a standard (Operational Limit: OL) that provides moreleeway than the CL and allows control before CL deviations occur.

HACCP Step 9 (Principle 4) Monitoring System
Requirements
Monitoring procedures shall be established for each CCP.
Concepts, specific examples
1. What is monitoring?
1） To ensure that CCP is properly controlled and to keep accurate records for later
verification, monitoring is the comparison with CL, and, to do the observation,measurement, or test inspection based on a schedule established in the HACCP
plan.
2） In the management of CCP, the act of watching to ensure that there are no
deviations from CL is called monitoring.
3） Any deviation from the CL requires corrective action.
4） Monitoring records are also used when verifying the HACCP plan.
2. How to monitor
1） The monitoring method shall meet the following conditions:(1) To be carried out continuously or with reasonable frequency.
(2) The method shall provide rapid results (physical and chemical measurements
are usually chosen over microbiological tests).
2） It is important to monitor to be conformed the control measures against hazards
for all products. This shall be done continuously or with reasonable frequency toenable monitoring that the CL is met for every product, from the first one to thelast one, or for every batch. When deviations from the CL occur, they shall bedone in a manner that minimizes the impact as much as possible and in a waythat allows easy corrective actions to be taken.
3） If possible, process adjustments should be made when monitoring results
indicate a trend toward deviation in the CCP.
4） The [5W1H] that defines the monitoring method means the following:82

(1) Rationale (Why): Is there scientific validity for monitoring the control statusof CCP?
(2) What (What): Is the CCP within the acceptable range of the CL (does notdeviate from the CL)?
(3) In which process (Where): Clarify the applicable process (CCP process)(4) How (How): Is it a rapid and accurate physical, chemical, or sensory
observation, measurement, or inspection method(5) Frequency (When): Is it continuous? Or, if not, is there a frequency of not
missing deviations?
(6) Who (Who): Personnel trained in monitoring methods5） Continuous recording of measured values is not enough to control hazardous
factors. They shall be checked by someone other than the person in charge ofmonitoring at an appropriate and sufficient frequency.
6） When the HACCP plan is developed, a monitoring person shall be identified. This
person should be able to implement by oneself or implement by instructed on
the appropriate procedures that need to be implemented when monitoring
indicates the need to take corrective action. To take corrective action, dataobtained from monitoring should be evaluated by a designated person with theknowledge and authority.
7） All records and documents related to CCP monitoring should be signed or initialedby the person conducting the monitoring, and the results and the time of themonitoring should be recorded.

HACCP Step 10 (Principle 5) Corrective Actions
Requirements
A procedure of corrective actions (correction, and investigation and removal of root
cause) shall be established for deviations from a critical limit.
Concepts, specific examples
1. What is corrective action?
1） Corrective action is the immediate action taken when monitoring parametersdeviate from the CL.
2） In CCP, which is a process that should be especially strictly controlled to preventthe occurrence of hazards, it is important to determine the methods andprocedures for corrective action in advance because any deviation of themonitoring parameters from the CL may result in the occurrence and escalationof food safety risks. (See FSM 24, 25, GMP 9)

833） In the HACCP plan, the actions to restore process control and procedures forrestarting the line, as well as the actions to isolate affected product anddetermine and implement its disposition, shall be defined.
4） To minimize the likelihood that the deviation will recur, the cause analysis shallbe performed to identify and correct the cause of the deviation, if possible. The
cause analysis shall identify the reason for the deviation or limit the amount of
product affected by the deviation.
2. Items to be included in the HACCP plan as corrective actions
Items to be included in the HACCP plan as corrective action are as follows:
1） Action to restore the control status of the process● Repair, adjust, or replace machinery, etc., to return the process to a normal
state of control.
2） Treatment for products manufactured during the deviation● Identify and withhold products that deviate from the CL and evaluate them.
● Decide on treatment methods, such as reprocessing or disposal.
3. Person in charge of implementing corrective actions
Shall be done by an authorized person in charge who has sufficient knowledge of
CCP management, understands the process well, and can make quick decisions.
4. Corrective Action Implementation Records
The corrective action implementation record shall include the following items:
1） Details of the deviation, the manufacturing process or location where it occurred,
and the date and time of occurrence2） Name, lot number, quantity, etc. of the product that was the subject of the action
3） Results of investigation into the cause of deviation
4） Details of actions taken to restore the process to its original state5） Details of treatment to be done to the product manufactured during the deviation
6） Signature of the person in charge who carried out and recorded the above items
7） Signature of the person who inspected the corrective action and the date ofinspection

HACCP Step 11 (Principle 6) Establish HACCP plan validation and verification procedures
Requirements
HACCP plan shall be validated prior to implementation.
Verification procedures shall be established to confirm whether the defined handling(HACCP Plans) is carried out as specified and to judge whether it is necessary to modify
the defined handling.
Verification shall be carried out considering the design of equipment, change inprocessing method and technology development in the manufacturing process.

84Concepts, specific examples
The following is a procedure showing the requirements of this item in chronological orderof actual activities.
1. validation
1） Validation is the assurance that the HACCP plan is capable of controlling thecritical hazards and shall be performed before the HACCP plan is implemented.
Items for which validation should be performed include the following:⇒ Identification of hazards, and CCP, CL, control measures, frequency and typeof CCP monitoring, corrective actions (improvement measures), frequency, andtype of verification and type of information to be recorded, etc.
2） Validation of control measures and CL of CCP shall be conducted during thedevelopment of the HACCP plan.
3） Validation involves reviewing the scientific literature, using predictive models,conducting validation studies, and using guidelines developed by authoritative
sources (e.g., Guidelines for the Validation of Food Safety Control Measures(CAC/GL 69 - 2008)).
4） Evidence should be obtained that demonstrates that control has been
consistently achieved, during production under the first implementation period
and production conditions of the HACCP plan.
2. Implementation of HACCP Plan
Implement activities in accordance with the established HACCP plan.
3. Verification
1） After implementation of the HACCP plan, evaluate its effectiveness and verify
that the HACCP system is functioning properly. Verification is basically conducted
once a year, or as needed. For verification of the overall food safety management
system, please refer to FSM5.
2） By recognizing weaknesses in their own HACCP system from the results ofperiodic verifications, modify their HACCP plan to make it better.
3） Verification shall be conducted respectively, for HACCP plans for each CCP, andfor the entire HACCP system.
(1) HACCP plans for each CCPi.

Verify the HACCP plan for each CCP. The cases to be covered are as
follows:① Calibration of measuring devices (instruments) used for monitoring② Testing and inspection of raw materials (including containers andpackagingmaterials),semi-finishedproducts,

work-in-process

products, reworked products, and finished products③ Measurement of manufacturing and processing conditions85

④ Review CCP monitoring records, corrective action records, andverification records⑤ Confirmation that operators are working in accordance with the
HACCP plan
⑥ Observation that control measures are operated according to the
HACCP planii.

Verification of monitoring also includes verifying that the monitoring iscorrect by using a different measuring instrument or method. For
example, for temperature, cross-checking with another thermometer ormeasuring the center temperature if the steam temperature of theheater is monitored instead of the center temperature, and forverification of the heating process, conducting a microbiological test on
the sample after the heating process to confirm that no microorganisms
remain in the sample.

《Items that should be stipulated in the HACCP plan as internal verification work.》iii.

The items to be stipulated in the verification plan are as follows:① Contents② frequency③ Action based on verification results④ Method of recording the results of the verificationiv.

Verification should be performed by someone other than the person
performing monitoring and corrective action.

(2) Entire HACCP systemi.

Verification of the entire HACCP system shall be conducted on a regularbasis using the following procedures as needed:① Analysis of consumer complaints or cause for recall② On-site confirmation that monitoring work is being performed
according to established procedures③ Testing and inspections to verify product safetyii.

The results of the verification are recorded, inspected, and the HACCP
system is reviewed as necessary.

4. Re-validation of the HACCP system
In addition to the validation at the time of HACCP plan development, re-validation
shall be performed when any of the following occur:
1） Change in raw materials
2） Changes in manufacturing processes or systems (including computers and theirsoftware)
3） Change of packaging

864） Change in final product delivery system
5） Changes in the intended specifications or the intended consumer, of the final
product6） When verification results indicate deficiencies or potential deficiencies in the
HACCP plan
7） When a new hazard is identified in the same food or in the same food group
8） When new information regarding product safety becomes available※. Requirements for testing and inspection methods used for verification are as follows:① This includes evaluating and verifying whether CCPs and CLs are properly establishedand controlled to ensure product safety.
② The test and inspection methods for verification shall be validated. For details, see
FSM19.1 (Note that the test and inspection methods for verification shall include
visual inspection and confirmation by sensory indicators).

HACCP Step 12 (Principle 7) Documents and Record
Requirements
Necessary documents shall be prepared and maintained.
These documents shall contain documents related to the standard operating procedures(SOP) and the work instructions (WI) necessary and applicable to the scope of
certification of the organization.
Concepts, specific examples
What documents and records are required?
1. Documents and records required by the 12 steps of HACCP include the following:
1） HACCP Team Member List and Role Assignment2） Product Description3） Flow diagram4） Hazard Analysis5） HACCP Plan
6） Determination of CCP
7） Determination of CL and information providing scientific support for the CL8） Validation of control measures
9） HACCP plan revision records, etc.
2. Records of activities according to the HACCP plan include the following:
1） Monitoring records
2） Corrective action records
3） Verification records
4） Training records of the person in charge, etc.

87

3. Records of HACCP plan implementation
This is important to provide evidence to prove control (scientific literature usedduring validation, minutes of HACCP team meetings, etc.) as well as to addressdeviations when they occur. Records can be maintained electronically, if necessary.
4. The organization shall document standard operating procedures and work
instructions covering the scope of certification.
5. "Standard Operating procedures (SOPs)" are documented procedures for performing
standard tasks.
6. "Work Instructions (WI)" means documents that instruct employees what work is tobe performed.

88III Good Manufacturing Practice (GMP)
GMP 1 Facility Environment
Requirements
The organization shall locate and maintain their business site in a location where pollution
can be prevented and products can be safely received, stored, manufactured anddelivered.
Concepts, specific examples
1. If a new business establishment is being built, the location shall be surveyed toensure that there are no contamination risks that would affect the food safety of theorganization. In the case of an existing establishment that does not meet thisrequirement, relocation is not necessarily required.
2. The contamination risk in the vicinity of the site must be considered relative to thecontamination risk measures taken by the organization, and if sufficient measures
are in place to address the contamination risk that exists, then it can be said thatthe site is "located in a location that will produce safe products.
3. When taking measures to address contamination risks that exist in the vicinity of abusiness establishment, it is necessary to be able to explain what is considered to
be a contamination risk, what is being done to address it, and that the contamination
risk is being controlled by the measures being taken. If a new contamination riskarises in the vicinity of the business establishment after the aforementioned
measures have been taken, the assessment and countermeasures shall be madeagain.
4. Examples of surrounding environments to be aware of include waste disposal
facilities, ranches and poultry farms, and chemical handling facilities.

GMP 2 Factory premise environment
Requirements
The organization shall establish and maintain appropriate standards for the area aroundand on the premises of the business so that contamination can be prevented, and safe
products can be made accordingly.
These Standards shall include the management of waste and unnecessary materials on
the premises.
Concepts, specific examples
1. Concept in GMP2
In GMP2, it is important to take measures to ensure that "influences from aroundand on the premises do not affect the food safety risk to the product" and to maintainthem. To this end, the following actions are required.

891） Identify what exists in the vicinity and premises of the business site2） Check whether they pose food safety risks to own products
3） Consideration of measures to be taken and maintained so that the system canultimately be capable of "preventing food safety risks to products.
4） Regularly check for changes in the environment, in parallel with carrying out
maintenance measures
2. Confirmation of site boundaries
1） Ensure that the boundaries of the site are clear and in a condition that can bereliably accounted for.
2） Even if the site is located in an industrial park or other location, the organization's
own site shall be clearly identified.
3） It is recommended that as much as possible, drawings or other means be usedin order to clearly maintain the confirmed settings.
3. Confirmation of the surrounding environment
Identify any food safety concerns regarding the area surrounding the facility. One
example can include the following:1） Insect and bird damage related●Rivers, drainage ditches, etc.
●Mountains, forests, parks, agricultural land, livestock, etc.
●Garbage dumps, waste disposal sites, etc.
2） Foreign body related●Garbage dumps, waste disposal sites, etc.
3） Others (impact on buildings, odor, chemicals, etc.)●Regional effects of salt damage, strong winds, freezing, etc.
●Agricultural lands where pesticide spraying is conducted - Livestock industry(feedlots, etc.)●Exhaust and smoke emissions from other factories, etc.
4. Confirmation of business premises
Identify any food safety concerns that can also be present in the facility. One example
can include the following:1） Insect and bird damage related●Green space, etc.
●Areas where puddles can form
●Drainage, septic tanks, rainwater tanks, etc.
●Unnecessary items, waste storage, etc.
2） Foreign body related●Waste storage, treatment areas, etc.
5. Response to each impact
For each of the items identified as having an impact, measures to reduce the impact
to a manageable level shall be considered, verified, and periodically addressed.

90

Possible measures include the following:1） Insect and bird damage related●Removal or modification of the subject, isolation, etc.
●Periodic check, maintenance and repair of plantings and water ponding areas(If the site is subject to the Green Space Act, compliance is required but properconsideration shall be given to placement and management)●Maintenance of the building, including repairs (positive and negative pressure,entrances and exits, damaged areas and gaps that serve as entry points, lightsources, odor leaks, etc.)● Periodic monitoring by insect control contractors or own organization(perimeter, building interior, etc.)
2） Foreign body related●Removal or modification of the subject, isolation, etc.
●Countermeasures against contamination by foreign matter flying into buildings
or adhering to workers3） Others●Arrangements with stakeholders in the surrounding environment●Deterioration countermeasures through periodic maintenance of buildings andfacilities●Periodic verification of production areas and products

91GMP 3 Design, construction, layout of business site and work and product flow lines
Requirements
The organization shall design, construct and maintain the factory buildings and facilities(storage area, raw material and product handling area, preparation area, packaging andstorage area, etc.) of the business site both outside and inside the plant to minimize
food safety risks.
In addition, the equipment layout (including drainage system and lighting) and the flowlines of people, goods, and work shall be designed to meet the intended purpose andminimize food safety risks.
The organization shall set the lighting necessary for food safety to an appropriate levelof illuminance.
Additionally, the organization shall ensure that facilities and equipment that come into
contact with food are constructed and made of materials that allow for appropriate
maintenance, cleaning, and disinfection.
Concepts, specific examples
1. The first half of this requirement requires that food manufacturing facilities within
the factory buildings and facilities, at the business site that are used to produce foodbe designed, constructed, and maintained to minimize food safety risks, and theseare primarily hardware measures.
Factory buildings and facilities" include roads, fences, and other structures on thepremises.
On the other hand, the second half of the requirements call for equipment layout
and lines of flow of people, goods, and operations to be designed to minimize foodsafety risks, and these are mainly soft measures.
2. The following points shall be considered in the design, construction, and layout offactory buildings and facilities:
Factory buildings and facilities
1） It is appropriately located on the site and is of appropriate size and construction
for the intended use.
2） The structure is easy and feasible to maintain, clean and wash.
3） Select durable materials that can handle the weight of work equipment, wear,etc.
4） The material is capable of withstanding cleaning and washing.
5） When designing manufacturing and processing facilities, refer to the following
and fully identify impacts to manufacturing and processing:(1) Layout diagram of manufacturing and processing area
(2) Flow diagram showing manufacturing and processing processes(3) Equipment, personnel, methods of transporting raw materials and products,
process capabilities, etc.

92(4) Work classification commensurate with the manufacturing and processing
process(5) Install appropriate cleaning facilities for food handling equipment andutensils, etc., in the facility.
6） Structures in food facilities shall meet the following specific requirements, asnecessary:(1) Wall, partition, and floor surfaces: use materials that are easy to clean, canbe sterilized as needed, and are impervious to water and dirt.
(2) Walls and partitions: to be suitable heights for operation and smoothsurfaces.
(3) Ceilings and overhead fixtures (including lighting): constructed to be
shatterproof where necessary and finished to minimize dirt and condensationbuildup and particle falling.
(4) Windows: installed for ease of cleaning and to minimize dirt buildup, withremovable and cleanable insect screens installed as needed.
(5) Doors: smooth, non-permeable surface, easy to clean and can be disinfected
as needed.
7） In particular, the following measures shall be implemented to deal with foods
containing allergens. (For details, see FSM 16.)
(1) For example, if separate production lines are used in the manufacture offoods that do not contain a particular allergen and foods that do, the potential
for allergen cross-contact from one line to another be prevented orminimized to a level that does not affect food safety.
(2) To prevent food from spilling from one line to another, eliminate intersections
or implement means to contain or defend food.
(3) To prevent or minimize cross-contact of allergens by workers, consider theplacement of handwashing sinks in appropriate locations and facilities thatallow workers to change protective clothing, depending on the situation.
(4) Equipment, tool containers, and utensils that come in contact with allergencontaining foods shall be designed and constructed to effectively eliminate
allergens.
Lighting
1） Provide brightness that allows food handlers to work safely and hygienically.
Illumination and color tones shall not cause misidentification in the work area.
2） If there is insufficient illumination in the area where work such as visualinspection is performed, take measures such as installing supplemental lighting
such as electric stands.
3） When conducting color tone inspections, etc., lamp color tone shall be consideredin addition to illuminance.

934） Lighting shall be of specifications that facilitate maintenance and cleaning andminimize deterioration.
5） When installing ducts for electrical wiring, etc., the structure shall be such that
dust and dead insects do not accumulate on the top, and the ducts shall be
installed in a location that is easy to clean. When removing the ducts, they shallbe pulled out vertically rather than horizontally to prevent dust from falling out.
6） To prevent physical hazards such as debris from affecting products or
manufacturing and processing lines in the event of damage to lighting fixtures,protective covers (dust-proof type) shall be installed or anti-scattering measures
shall be taken with anti-scattering film, etc.
7） For windows used for lighting, select materials that are resistant to deteriorationand shattering if they are made of resin, and materials that are resistant to dew
condensation if they are made of glass, and provide shatterproof measures suchas shatterproof film.
8） Illuminance of the working environment (this item is applicable to the scope inJapan)

task organization

Illuminance (lux)

Precision work

More than 300 lux

normal operation

More than 150 lux

rough work

More than 70 lux(See Article 10,
Paragraph 1 of the

Office Sanitation Standards Regulations: Enforcement date: December
1, 2022)
Illuminance Standards in Business Establishments
Work Classification

standard

General office work

More than 300 lux

Incidental clerical work

More than 150 lux

Drainage System
1） Drainage routes shall be designed and controlled to minimize the possibility ofcontamination of products, etc.
2） The floor and drainage basins shall be designed, with a slope to prevent puddles,
and to make cleaning easy.
Temperature control
Depending on the characteristics of the food, appropriate facilities for temperature
control of the ambient environment in which the food is handled shall be available
when necessary.

94

Air (air conditioning and ventilation) in the manufacturing environment1） Provide appropriate means of natural or mechanical ventilation, especially for:● Minimize airborne contamination of food by aerosols and condensation
droplets, etc.
●Assistance in controlling ambient temperature●Control of odors that can affect food conformity● Control humidity to ensure food safety and suitability. (e.g., to prevent
moisture gain in dried foods that can allow microbial growth and the formationof toxic metabolites)
2） Ventilation systems shall be designed and constructed so that air does not flowfrom contaminated areas to clean areas. Systems shall be easy to maintain andclean.
3. In this standard, "flow lines of people, goods, and operations" refers to the flow ofpeople, goods, and operations taken as a whole, rather than individually, and is
described as process design. Efforts to ensure that the flow of people, goods, andoperations minimizes food safety risks include the following:1） Describe manufacturing flow lines, personnel flow lines, etc. on layout drawingsof manufacturing and processing areas, and analyze risks to food safety fromthese flow lines.
2） Flow lines shall be separated as much as possible so that they do not intersect.
Lines of flow include the following. "Goods" and "people" are the most importantamong them. Control "goods" and "people" as much as possible to avoid crosscontamination.
(1) Goods: Routes from receipt of raw materials to shipment of final products(2) People: Routes for personnel to enter and leave the work area, routes for
movement between work areas, and routes for outside workers to enter andleave the work area
(3) Work: Routes between each process to receive and deliver work(4) Waste: Routes for transporting workshop residues and unwanted materials
outside(5) Drainage: Routes of drainage in the work area
(6) Utilities: Routes of utilities such as steam, compressed air, carbon dioxide,
nitrogen and other gases, air conditioning and ventilation, lighting, water,etc. used directly or indirectly in manufacturing and processing3） Areas that implement different levels of sanitation control (e.g., raw material andfinished product areas) are separated to minimize cross-contamination by meansof physical separation (e.g., walls, partitions) and/or location (e.g., distance),
goods or people flow (e.g., unidirectional production flow), air flow, or temporalseparation, and are properly cleaned and sterilized between uses.

95

GMP 4.1 Cross-contamination (including allergen cross-contact) and isolation
Requirements
The organization shall prevent physical, chemical (including allergens), biologicalcontamination, and cross-contamination (including allergen cross-contact) of raw
materials (including containers and packaging materials), semi-finished products, workin progress, reworked products, and finished products.
The necessary control measures, including isolation, shall be established to cover all
aspects of food safety, and these procedures shall be documented and maintained
effectively through periodic review.
Concepts, specific examples
1. This standard requirement is related to HACCP Steps 4 and 5 in the actual work
performed.
2. As sources of contamination, all aspects of food safety are covered, including foreign
substances, microorganisms, chemicals, and allergens.
3. An effective way to prevent cross-contamination (including allergen cross-contact) is
to isolate raw materials (including containers and packaging materials), semifinished products, work-in-process, reworked products, and finished products fromthe sources of contamination or objects that can contain such sources ofcontamination as described in Section 2 during the manufacturing process. Normally,96

the degree of product contamination decreases as processing proceeds, but in thecase of pathogenic microorganisms, they have a tendency to spread from highly
contaminated to less contaminated locations and objects. Isolation is effective inpreventing this contamination. When storing the above-mentioned objects to beisolated, it is recommended that each object be placed in a specific location, such asa storage room or refrigerator, and that dedicated containers be used to protect theobjects from cross-contamination (including allergen cross-contact).
4. For contamination associated with the movement of people and objects, as well as
cross-contamination (including allergen cross-contact), it is also effective to identify
the areas where it occurs and establish preventive measures.
[Improve zoning and flow lines to prevent cross-contamination (including allergencross-contact).]
1） When evaluating and formulating, it can be easier to understand the control pointsof pollution sources if a manufacturing and processing process diagram, air supply
and exhaust plan, and product and raw material entry and exit plan are prepared.
2） The flow of zoning and flow line improvements to prevent cross-contamination(including allergen cross-contact) is as follows:(1) Clarify the movement of people and goods, and create a flow line diagram.
(2) Evaluate the possibility for cross-contamination (including allergen crosscontact) due to the movement of people and goods, taking into account thecharacteristics of the product and the potential for contamination.
(3) As a result of the evaluation, control measures for cross-contamination
prevention (including allergen cross-contact prevention) are developed.

GMP 4.2 Control of hazards that require enhancement
Requirements
The organization must establish control measures for hazards that require particularly
enhanced controls, other than CCPs, document those procedures as necessary, andmaintain them effectively through periodic review.
Concepts, specific examples
1. Controls according to GMP 4.2
1） The requirements of this standard require that for potential hazards identified in
HACCP Step 6 (Principle 1) hazard analysis, for which① Of the hazards that did not result in the establishment of a critical control
point (CCP),② And for those hazards that require particularly strong control,97

Necessary control measures be established, those procedures documented asnecessary, and those procedures be maintained effectively through regularreview.
2） 1) is synonymous with "GHPs requiring more attention" in CXC 1-1969, Rev.
2022, General Principles of Food Hygiene of the International Commission on
Food Standards (CODEX).
* Hazards identified by the HACCP Step 6 Hazard Analysis that are considered
to have the potential to cause significant food safety hazards if mistakes are
made that do not meet the requirements for control by GMP, are considered tobe "GHPs that require more attention " and consequently are considered to becontrolled by GMP 4.2.
2. Points to note for controls according to GMP 4.2
1） Depending on the type of product, manufacturing process, hazard analysis,
frequency and severity, etc., the hazards controlled in GMP 4.2 will vary. Theseshould be considered and identified. The matrix in HACCP Step 6 (Principle 1)
and other information can be used as a reference.
2） Control procedures according to GMP 4.2 can involve not only GMP requirements,
but also controls according to FSM requirements. Although they vary dependingon the industry and products of an organization, examples of relevant
requirements are provided below:
FSM 13.1, 13.2, 13.3 Purchasing, Supplier and Outsourcing Management
FSM 16 Allergen Management
FSM 19.2 Environmental Monitoring
GMP 3 Design, construction, layout of business site and work and product flowlines
GMP 6.1, 6.2, 6.3 Personal hygiene criteria, Workwear and Health managementof personnel
GMP 8 Housekeeping, cleaning, sterilization, and disinfection
GMP 11 Air and water Management
GMP 13 Pest control
GMP 18 Equipment and Tools
GMP 19 Maintenance3） When implementing the above, monitoring, corrective action, and verification
records should be established at a frequency appropriate to the characteristicsof the product and the size of the organization. Monitoring can include thefollowing:●Definition of monitoring methods (including who is responsible, frequency,
and, if applicable, sampling regime)●Monitoring of records to be kept
3. Examples of Hazards Controlled by GMP 4.2

981） Allergen management:
Cleaning the line after manufacturing products containing allergens can be acontrol measure to be managed under GMP 4.2. If the allergens cannot be
removed by cleaning, there is a risk of the next product containing no allergens
containing allergens being included. In addition, if there are multiple productionlines in the same production area, the simultaneous production of products
containing allergens can cause cross-contact of allergens with products fromdifferent lines.
2） Management of Listeria monocytogenes:
If RTE foods (ready-to-eat foods that do not require heating before consumption)
after heat sterilization are contaminated with Listeria monocytogenes from lines,
utensils, or the environment, they can multiply even at temperatures below 10°
C, and food poisoning can occur if stored for long periods. Therefore, lines andutensils that come into direct contact with RTE food products shall be monitored
carefully. In addition, it is necessary to set up lines so that RTE foods and contactlines are kept at lower temperatures (preferably 4°C or lower).
4. Required control measures
1） See HACCP Steps 5, 6, and 11.
2） However, in-depth analysis/consideration shall be conducted by paying attention
to "Controls according to GMP 4.2" listed in "1".
3） Records of the results of the implementation of the procedures shall be kept asnecessary.

GMP 5 Personnel Facilities
Requirements
The organization shall design, install, and manage personnel facilities, includingchanging rooms, washbasins and toilets, and applicable shared facilities to minimize
food safety hazards including allergens.
The organization shall separate toilets and areas where food and drinks are stored andconsumed such as cafeterias, and break rooms, from areas where food is manufactured,
packaged, and stored.
Concepts, specific examples
1. Facilities for employees include the following, which must be kept clean at all times
to prevent the introduction of sources of contamination or foreign materials into the
manufacturing or processing site:
1） Shoe boxes or shoe lockers (to change from commuting shoes to on-premises
shoes)
2） Changing rooms993） Toilet and hand washing facilities
4） Dining room, rest room, smoking room
2. Changing rooms
1） Provide a sufficient number of lockers, etc. In lockers and changing rooms, clean
work clothes worn in the production area shall be kept from cross-contamination
with personal clothing or used work clothes.
2） Changing rooms shall be located so that food handlers' clothing does not becomecontaminated before moving to the work area.
3） Changing rooms, if necessary, shall be suitable facilities for employees to change
clothes for the work they perform.
3. Hand washing facilities
1） The facility shall be capable of washing and drying hands in a sanitary manner.
2） It is important to have a sufficient number of facilities in appropriate locations
based on the number of food handlers, and to have washing, drying, sterilization,
disinfection facilities, and hot water facilities, as needed.
3） Sufficient supplies of tap water and water for food production shall be maintained,
and soap, paper towels, disinfectants, etc. suitable for hand washing shall be
provided, clean, and ready to use at all times. Hand disinfectants shall not be
used as a substitute for hand washing, but shall only be used after hand washing.
4） To prevent re-contamination of washed hands after hand washing, the faucet
should be designed so that it can be opened and closed without touching it byhand.
5） Post easy-to-understand hand washing and disinfection procedures.
6） Hand washing facilities shall not be used for washing food or mechanicalequipment.
4. Toilet
1） The toilet shall be of hygienic construction.
2） Install a sufficient number of them for the number of employees.
3） The area shall be sufficiently separated from the area where food is
manufactured, packaged, and stored. However, if sufficient isolation can beachieved, zoning (such as using separate rooms) is not required.
4） Establish hand washing and disinfection facilities and means to dry hands, anddetermine and display procedures for hand-washing and disinfection.
5） Always keep the area clean, and clean and disinfect it regularly.
5. Dining room, rest room, smoking room
1） Dining rooms, rest rooms, etc., and places where food and drink are stored andconsumed shall be sufficiently isolated from areas where food is manufactured,
packaged, and stored to minimize the possibility of cross-contamination. (Payparticular attention to the bringing in of hard foreign objects and allergens.)
However, if sufficient isolation is possible, zoning, such as separate rooms, is not100required.
2） Dining rooms, rest rooms, etc., and other areas where food and drink are stored
and consumed shall be kept clean, and food, drink, and waste must be controlled
to be not left lying around to prevent them from becoming a source of harmfulorganisms.
3） Smoking areas shall be located and controlled so that there is no crosscontamination with work clothes or production areas.

GMP 6.1 Personal hygiene criteria for personnel
GMP 6.2 Personnel workwear
GMP 6.3 Health management of personnel
GMP 6.4 Application to subcontractors and visitors
Requirements
GMP 6.1
The organization shall establish, implement, and maintain appropriate hygiene
standards that be assessed and documented product-specific hazards to minimize foodsafety hazards, for its employees in accordance with the laws and regulations of thecountries in which they work.
The criteria shall include provisions of hand washing and toilet facilities, ways andfrequency of hand washing, medical screening procedure to identify conditions
impacting food safety, proper protective clothing, rules on the clothing and shoes, ruleson accessing production area, ways of food handling, and control measures for foreignmaterials, and management procedures and reporting system in the event of an infected
person that poses food safety risks.
These hygiene criteria shall also be understood by personnel who use different
languages.
GMP 6.2
The organization shall evaluate product-specific risks and provide appropriate work
clothing to minimize food safety risks.
GMP 6.3
The organization shall develop, implement and maintain health care procedures that
evaluate and document product-specific risks to minimize food safety risks.
These shall include procedures for personnel suspected of illness to promptly report
illness or symptoms to their superiors according to the laws and regulations of thecountry in which personnel are working.
The organization shall also determine who will be responsible for managing personnel
with health conditions.
GMP 6.4

101

The organization shall ensure that GMP 6.1, 6.2, and 6.3 are well known to personnel
who have an impact on food safety, and apply them to subcontractors and visitors
without exception.
Concepts, specific examples
1. Personal hygiene criteria for personnel
Hygiene control of workers shall be implemented at all times, and care shall be taken
to prevent them from becoming a source of contamination. Personal hygiene
standards for employees shall be documented and implemented, according to thecharacteristics of the products handled, and the laws and regulations of the country
in which the employees are engaged in the work, and taking into consideration thefollowing items as well as work clothes and health care. To this end, training shallbe provided to employees. The personal hygiene standards for employees shall also
include procedures and reporting systems in the event of an outbreak of an infected
person that poses a risk to food safety. In addition, to ensure that the personal
hygiene standards are properly communicated to all employees, if there are
employees who use different languages, the standards can be provided in multiple
languages as necessary.
In determining the extent of training required, factors to be considered include:● Nature of the hazard associated with the food. Growth characteristics ofpathogenic or spoilage microorganisms, presence of potential physical contaminants
or known allergens● Methods of manufacturing, processing, handling, and packaging food, including
the possibility of contamination● Degree of processing and cooking of food before consumption● Conditions under which food is stored● Estimated time until the food is consumed● Use and maintenance of food-related equipment and instruments
1） Establish and document "basic hygiene rules for a series of operations from thestart of work to the end of work" in each organization according to thecharacteristics of the products handled, and provide explanations at the time of
employment, etc., to ensure that employees' personal hygiene levels areproperly aligned and maintained.
2） Documented sanitation standards describe the standards and behaviors requiredof employees in processing, packaging, and storage areas.
3） Establish and post a list of goods (positive list) that can be brought into the
manufacturing and processing area. Education shall also be provided as
appropriate.

1024） The following are "examples of employee hygiene practices". It is necessary to
set them appropriately by discarding them or considering unique items
depending on the organization's situation.
① Wash and disinfect hands at designated timing. Examples of designatedtiming are as follows:●At the start of food handling operations●When returning to work after a break●Immediately after using the toilet●After handling contaminants that can contaminate other foods, such aswaste or unprocessed food●After handling foods with different allergen profiles and foods that cancontain allergens② Do not act in an unhygienic manner with objects (hands, gloves, utensils,etc.) that can come into contact with the product.
③ On the site, refrain from sneezing or coughing, and make efforts to prevent
splashing, especially in areas where the product is involved.
④ Masks shall be worn correctly as specified, covering the nose and mouth.
⑤ To prevent the introduction of foreign substances into the production area,
the designated work clothes shall be worn properly to prevent hair and bodyhair from being mixed in. Also, air showers, adhesive rollers, and othermeasures shall be taken at designated timing.
⑥ Do not take any actions that can result in contamination, such as carelessly
going outside the production area while wearing work clothes or work shoes.
⑦ Do not wear any equipment other than those permitted (glasses, hearing
aids, etc.). Do not wear any ornaments, etc. to prevent foreign objects fromfalling off and becoming mixed in.
⑧ Fingernails shall be properly short, clean and trimmed. No manicures. False
nails and false eyelashes are also prohibited.
⑨ No makeup that can fall off and affect the product (e.g., lame powder, etc.).
⑩ No use of perfume.
⑪ No food or beverages are allowed to be brought into, stored in, or consumed
in the work area (especially areas where products, raw materials, andprimary packaging are exposed). These shall be done at designated areas.
Refer to FSM 16 for allergen control plan.
⑫ When work clothes are stored in a common locker with personal clothing
and belongings, they shall not be handled in such a way that they can becontaminated. And lockers shall not be used to store unsanitary items(including exposed food) or equipment or devices that come in contact withproducts, etc.

103

⑬ Bringing unnecessary items to the work site is prohibited. If there is a needfor regular medication, etc., consult with the manager and take measures
to ensure that contamination of products is prevented.
⑭ Wash hair and bathe regularly and maintain proper personal hygiene.
⑮ Immediately report to the supervisor, if a deviated condition is found that
was attached to you is missing, etc.
⑯ Do not engage in inappropriate behavior that could contaminate food.
Examples include:● Smoking or e-cigarettes● Spitting● Chewing (gum, etc.), eating, drinking● Touching the mouth, nose, or other potentially contaminated areas● Sneezing or coughing on unprotected food
● Touching hair, nose, mouth, or ears, with hands or equipment forhandling products, etc.
5） In Japan, in addition to the Food Sanitation Act, the following national guidelines
shall be used as a reference:(1)

Guideline for Management and Operation Standards to be implemented byfood business operators(2)

Sanitation Management Manual for Large-Scale Food Preparation Facilities(3)

Various hygiene norms developed by the Ministry of Health, Labor andWelfare2. Personnel workwear
Food handlers shall maintain a high degree of personal cleanliness and, if necessary,change into or out of work clothes, head and beard covers, and footwear that areclean and in good condition for the intended purpose.
1） Appropriate consideration shall be given to the shape of work clothes and shoes
to prevent hair and body hair from falling out and getting mixed in with the
product. In addition, materials suitable for the working environment shall be used.
2） Prevent contamination and the introduction of foreign matter by establishing rules
for washing and changing work clothes and footwear so that employees can wear
clean and good condition work clothes and footwear for their work, as needed,and ensure that these rules are followed.
3） Work clothes handling food shall only be worn when working in the facility.
4） Hairnets and masks used by food handlers to ensure food hygiene are also
maintained in a sanitary condition that prevents contamination of products.
5） Do not enter contaminated areas, including toilets, while wearing sanitary work
clothes, hats, masks, or special footwear for the workplace.

1046） Hats shall be worn that are designed to completely cover the hair of the head(including the sideburns).
7） When using gloves, select the material according to the purpose, specify the use
and storage method, and handle them in a clean and good condition to prevent
secondary contamination.
8） When disposable gloves are used, check the material and strength according to
the work to be performed, establish an appropriate replacement frequency, andstrive to prevent damage. Establish and implement rules for hand washing before
wearing.
3. Health management of personnel
Depending on the product-specific risks, health management procedures shall be
developed, taking into account the following items:
1） In advance, determine a manager who shall be responsible for the managementof employees with health conditions in case they arise.
2） The manager shall explain the health conditions and food safety risks toemployees when they join the company, etc., and seek their understanding ofidentifying illnesses to the extent necessary, what to do in case of illness, what
to do in case of food poisoning, etc., and take actions to ensure that they maintainappropriate knowledge and awareness of food safety.
3） The manager shall ascertain the employee's illnesses as needed for food safety.
4） Have them undergo periodic medical examinations.
5） Conduct periodic stool analysis to confirm that there are no abnormalities.
6） Check the health condition before work and record the results. Employees are to
be trained and informed that they shall report any abnormalities in their physicalcondition to the person in charge of the work site, etc. If an employee reports anabnormality in his/her physical condition, he/she should not be allowed to work
handling products unless it is clear that the abnormality does not affect foodsafety (e.g., minor tooth decay, etc.). The following are examples of illness
symptoms that shall be reported to the person in charge of the site, etc:
●Jaundice / diarrhea / vomiting / fever / sore throat with fever / visible infectedskin lesions (furuncles, cuts, etc.) / discharge from ears, eyes, or nose.
7） If there is a suspicion of infection or food poisoning accompanied by fever,diarrhea, vomiting, etc., or if there is a suspicion of infection among skin injuries(burns, cuts, etc.), etc., report the problem to management, food safety
manager, production manager, etc., and have them refrain from engaging inwork handling the product and receive medical advice. If necessary, disinfect thefacility, equipment, etc., check on the persons (including external visitors) who
came in contact with the product, and take action regarding products
manufactured or shipped prior to that time.

1058） A response procedure should be developed in case an employee becomes ill whileworking and there is a risk of infection or food poisoning. Procedures should
include cleaning the facility as needed and contacting other employees,
contractors, visitors, etc. with whom they came in contact.
9） There are some illnesses for which it is appropriate to prohibit entry to theprocessing area even after symptoms have resolved. In such cases, seek theresults of a physician's diagnosis, if necessary.
10) Persons with cuts or wounds shall be assigned to work in areas where they can
not be in direct contact with food, if necessary. If the employee is allowed tocontinue working, the cut or wound shall be covered with an appropriate
waterproof bandage and gloves shall be worn when appropriate. Take appropriate
measures to ensure that the bandage does not become a source ofcontamination. (e.g., color-coded, detectable by metal detectors)11) For contracted businesses and visitors, contact information shall be obtained inadvance in preparation for the above-mentioned emergencies.
12) Do not ship food that can have been touched by workers with health conditions
until you have confirmed that there are no safety issues. See FSM 24. If the foodhas already been shipped before confirming that it is not unsafe, follow theprocedures in FSM 22.1.
4. Application to subcontractors and visitors
For external visitors such as contractors, outsourced contractors, suppliers, andconstruction workers, employee personal hygiene management, work clothes, andhealth management shall be applied without exception. In particular, when entering
the manufacturing site (equipment, inspection, consultants, etc.), the time spent
there, health condition, and contact information shall be confirmed, and confirmation
shall be made in the event of an abnormality.

GMP 7 Training
Requirements
The organization shall ensure that all personnel, including new personnel, be trained intheir appropriate language on food safety (including management, culture, HACCP,
GMP), and be a system for each personnel to deepen their understanding, implement,
and maintain food safety in their respective work.
The organization shall keep records of the implementation of education and training.
Additionally, the system for retraining as necessary shall be documented andimplemented.

106

This education and training shall enable employees to recognize their role in food safety
and the significance of their efforts.
In addition, there shall be a system to improve comprehension by repeating the training
as necessary after evaluating competence.
Concepts, specific examples
1. This requirement requires that the organization ensure that all employees, including
newcomers, receive education and training in food safety.
2. The organization shall determine, systematically implement, and record training
programs(contents,

implementation

timing,methods,

frequency(including

retraining), etc.) for employees according to their respective roles. It is important toperiodically review the training programs and update them as necessary so that foodhandlers, maintenance staff, and other personnel involved in food operations
continue to be aware of all procedures necessary to maintain food safety andsuitability (see FSM 2).
3. Ensure that current rules and procedures can be reviewed at any time, incorporating
the opinions of on-site food handlers.
4. As food manufacturing employees are becoming increasingly multilingual, theorganization shall make training and education tools available in the appropriate
language for training and educating employees whenever possible.
5. This education and training is not intended to be a one-time effort, but shall be basedon an evaluation of the competence of each employee in his or her role, and shall bea system to improve understanding through repeated efforts.
6. Under this system, employees shall develop an understanding of the procedures
pertaining to food safety in their respective jobs until they are able to implement
them as prescribed.
7. The important idea is not to remove employees who lack the skills from their work,
but to educate and train them within this system so that they can acquire the skills
they need.
8. In addition, education and training not only contributes to food defense (FSM 7), but
can also be used for the individual evaluation of each employee. This is importantfor building a food safety culture in an organization because it also relates tocommunication with employees and performance evaluation of food safety activities,
which are part of the elements of food safety culture (FSM 2).
9. Specific actions that the organization will take in its educational program include thefollowing:
1） Relate each employee's work procedures to food safety policies and goals (FSM
6).
2） Demonstrate that adherence to operational procedures contributes to ensuring
food safety.

1073） It is not that "deviation" or "nonconformity" is a bad thing that occurs in thecourse of business, but it indicates "what kind of thing" or "what kind of state"is a deviation or nonconformity, and how to take measures and actions(reporting, communication, and consultation) after the occurrence of a deviation
or nonconformity.
4） Within each job, procedures pertaining to food safety shall be provided andtrained until they can be implemented.
5） At a minimum, train HACCP team members to a level that they can build theorganization's HACCP plan.
6） Employees who monitor CCPs shall be educated and trained to a level where
they understand and can implement correction and corrective actions to betaken in the event of a deviation from the CL.
7） In addition to the above, the educational program shall include, at a minimum,
the following items:●Product reliability, including food fraud●Product Characteristics●Food Defense●Food-related legal requirements●Product/process changes●Feedback from previously documented training/instructional programs
8） Establish and implement training programs for all personnel, including
newcomers, to obtain the necessary knowledge and skills according to their rolein handling food products.
9） Ensure that the current rules and procedures for each job can be reviewed at
any time, with input from employees. (See FSM 27)
10） Records created in education and training can be used for individual evaluationand other purposes. (See FSM 2)11） Based on an evaluation of the employee's competence, education and training
shall be repeated as necessary. This retraining system shall be established andimplemented in writing.

GMP 8 Housekeeping, cleaning, sterilization, and disinfection
Requirements
The organization shall identify product-specific risks based on a hazard analysis
throughout all processes and stages and establish, implement, and maintaindocumented organization, cleaning, sterilization, and disinfection procedures.
In these procedures, the organization shall include steps to verify that product-specificrisks have been minimized.

108

Cleaning tools, cleaning agents and disinfectants shall be suitable for their intended
purpose, clearly identified and stored in areas separated from areas where food is
manufactured, packaged, and stored.
Food safety information on potentially harmful chemicals shall be obtained andconfirmed.
Concepts, specific examples
1. Establish procedures based on hazard analysis
1） Tidying, cleaning, sterilization and disinfection procedures shall take into accountproduct-specific risks throughout all processes and stages, and effective
procedures shall be developed and documented. Since cleaning shall remove foodresidues (including allergens), this procedure shall include the target facility,
equipment, areas of the facility, cleaning tools, detergents, procedures,
disassembly, monitoring, and actions for food in case of deviation from theprocedure, as required by the scope of the food operation. The procedure shall be
reviewed periodically to reflect changing conditions, and revised as necessary.
2） It is important that cleaning equipment, cleaning agents, and disinfectants
themselves be risk-assessed and selected before use to ensure that they do notpose hazards. In addition, they shall be clearly identified and stored in areas
separated from food manufacturing, packaging, and storage areas. However, if
sufficient separation is possible, zoning (such as separate rooms) is not required.
3） In establishing procedures, the required frequency of tidying, cleaning, sterilizing
and disinfecting shall be included according to the manufacturing environment andproduct characteristics.
4） Cleaning shall remove food residues and contaminants that could be a source ofcontamination, including allergens. Containers and other items that have been
exposed to allergens shall be cleaned as soon as they are emptied. Cleaning
methods and materials required depend on the nature of the food business, thetype of food, and the surfaces to be cleaned. Some surfaces, especially those incontact with food, can require disinfection after cleaning.
5） Attention should be paid to sanitation during cleaning and maintenance operations
so that food safety and appropriateness are not compromised. In food preparationand storage areas, use cleaning agent materials appropriate for food contact
surfaces.
6） Chemicals used for cleaning and disinfection shall be handled with care and usedaccording to the manufacturer's instructions. For example, they shall be used at
the appropriate dilution and contact time and, if necessary, stored away from foodin clearly identified containers to avoid food contamination.
7） Care should be taken to ensure that cleaning procedures do not lead to foodcontamination. For example, it could happen that spray from high-pressure109washing could spread contamination from dirty areas such as floors and drains
over a large area. It could also contaminate food contact surfaces or bare food.
8） In some operations and/or food processing areas where water increases thepotential for microbial contamination, such as when handling low-moisture foods
and manufacturing products under dry conditions, controlling the amount of waterused in cleaning (e.g., implementing dry cleaning to remove and collect residues
and debris) can reduce microbial risks.
2. Education and Implementation
1） Educate food handlers on standardized methods. It is also effective to educate
them by showing them the actual cleaning process, or by posting pictures orillustrations of the procedures. Trained personnel shall perform cleaning, washing,and sanitizing. Educate those who handle cleaning agents and other potentiallyrisky chemicals, including methods for handling them.
2） Whether cleaning and disinfection shall be implemented according to the rules ismonitored by visual inspection, and its effectiveness shall be verified by using
hygiene tests such as product testing and wipe testing. Monitoring methods candepend on the nature of the procedure, but can include pH, water temperature,
conductivity, detergent concentration, disinfectant concentration, and otherparameters important to ensure that the cleaning and disinfection program is being
carried out as planned and to verify its effectiveness.
3） Education shall be provided based on the results of basic education and hygiene
inspections.
4） To cleaning and washing shall be implemented planned accordingly, a plan andprocedures shall be created as follows:(1) Plan sheet for cleaning and washing facilities① Include in the plan consideration of areas that are easily overlooked forcontamination, such as the backs and bottoms of equipment, facilities, andfixtures.
② Describe the frequency of the work, the date it is performed, who performs
it, and how it is recorded.
(2) Written procedures for cleaning and washing facilities① Describe the person responsible for the work, the target, the method, thefrequency, the monitoring and verification procedures, the work tools to be
used, the inspection procedures after the work is completed, and theinspection procedures before production begins, etc.
3. Selection and maintenance of chemicals used for cleaning and sterilization
1） In selecting chemicals to be used for cleaning, sterilization, and disinfection, notonly shall the chemicals be suitable for the intended use, but also their effects on
the product and safety for employees shall be evaluated, and if necessary, safety
data sheets (SDS) shall be obtained and their contents confirmed before making a110

decision on their use.
2） The following items shall be implemented for the handling of detergents andchemicals used for cleaning, sterilization and disinfection:(1) Appointment of a person in charge of management(2) Inventory management of chemicals, etc. (stock receipt, stock withdrawal,
usage amount, stock quantity, user and first in, first out)
(3) Locking and key management of chemical storage cabinets(4) Maintenance of procedures for formulating detergents and chemicals fromundiluted solutions(5) Education for food handlers regarding handling of chemicals, etc. (including
proper dilution, contact time, etc.)(6) Preventing detergents and chemicals from being mixed into food (e.g., labelingcontainers with the names of their contents)
4. Management of cleaning tools, washing equipment, etc.
1） Selection, inspection and maintenance(1) If foreign matter or microorganisms adhere to equipment, facilities, orutensils used for cleaning, washing, sterilization, or disinfection, it can leadto contamination of products with foreign matter or microorganisms.
Separate cleaning machinery, equipment, and utensils designed for different
sanitation zones (areas), such as for food-contact surfaces and non-contact
surfaces, shall be used for different purposes. Contaminated cleaning tools
and washing equipment can also spread contamination.
(2) Check operation and deterioration, etc. before and after use, andimmediately repair or replace any defects.
(3) Since dirt remains on the undersides and bottoms, etc. of equipment,
facilities, and utensils, disassemble them and check them. Cleaning
equipment shall be kept clean, maintained, and replaced regularly so as not
to become a source of cross-contamination of contact surfaces or food.
(4) Separate facilities shall be provided for cleaning fixtures of highly
contaminated areas such as restrooms, wastewater treatment and waste
areas. As needed,●Separate facilities for washing food and washing cooking utensils.
●Separate sinks for hand washing and washing food.
2） Storage(1) When selecting a storage location, select an appropriate location that does
not pose a risk of contamination to products or the manufacturing
environment.
(2) Cleaning tools shall be stored properly to prevent contamination of the tools
themselves, for example by hanging them so that they do not touch thefloor, etc.

111

(3) Designate a storage location and keep it clean so that it is readily available
to food handlers.
(4) Posting of indicating the storage location.
3） Identification(1) Measures shall be taken to prevent the misuse of cleaning and washingequipment used in contaminated areas in clean areas. It is important tocolor-code equipment according to its use, such as "red" for floors and "blue"
for cooking utensils, or to store them in separate locations.
(2) Allergen-specific cleaning utensils (sponges, cloths, cleaning solutions, etc.)
shall be designated and used for allergens only.

GMP 9 Rework
Requirements
The organization shall control product rework in a traceable manner with minimal foodsafety risk.
The food safety risks involved in rework shall be evaluated and included in HACCP flow
diagrams.
Records shall be maintained as evidence of control.
Concepts, specific examples
1. Rework can occur when nonconformity occurs in raw materials (including containers
and packaging materials), semi-finished products, work-in-process products,
reworked products, and finished products.
In this standard, the term "correct" includes the meaning of "fix product" and"eliminate nonconformities" in this standard requirement (see HACCP Step 10(Principle 5)) as well as the meaning of "correct records".
To avoid confusion, this standard uses the term "rework" when referring to "fixproduct".
2. Rework is required to be managed so that procedures are established according to
the requirements of FSM 24 and do not impact legal and regulatory requirements
and food safety in the final product. In addition, it is required to make it possible totrace reworked products by recording and maintaining the rework process.
3. Food safety risks associated with rework shall be evaluated according to GMP 4.1
and 4.2, documented in the HACCP plan flow diagram, and control procedures shouldbe established and implemented. It shall be ensured that reworked products do nothave any impact on food safety before they are released.
4. The following items shall be considered in the management of rework:
1） Competence of personnel involved in rework1122） Identification methods in rework operations (In particular, for reprocessed
products containing allergens, food allergen information shall be appropriately
displayed to prevent the possibility of contamination of different products or to alevel that does not affect food safety.)3） Criteria and procedures for pre-release inspection and release determination of
products for which rework has been performed
5. The following items are included in the record of rework management:
1） What was conducted (when, where, what, how)2） Quantity of products made compliant by rework
3） Personnel involved4） inspection results

GMP 10 Patrol and inspection of the site
Requirements
The organization shall establish a patrol plan and regularly inspect the environment,
facilities, and process design (people, goods, workflow lines) of the entire site.
Records shall be maintained as evidence of the inspection.
The patrol plan shall ensure that the workplace is maintained in an appropriate stateaccording to its activities and that food safety is ensured.
Concepts, specific examples
1. This requirement requires the establishment of an inspection plan to be conducted
at a specified frequency and actual patrols of the site to confirm whether the businessis in a suitable state to safely produce food, and the patrols cover the environment,
equipment, and process design (people, materials, and work flow).
2. This requirement also aims to identify food safety problems and lead to
improvements (FSM 27) through these patrols, and during the patrols, it is important
not only to observe conditions, but also to communicate with employees and gather
information about actual problems and concerns at the site.
3. As a result, this requirement is closely related to the establishment of a food safety
culture, as it results in increased food safety awareness among employees, whichleads to an environment that encourages employees to take action on food safetyissues themselves and facilitates management's consolidation of this information.
4. The following are examples of how patrols and inspections are conducted:
1） Report problems to the organization's management using small group activities
such as QC circles.
2） Establish a mechanism for information sharing across the organization throughmutual patrol activities among other departments.
5. The following items are listed as viewpoints for patrols and inspections:

1131） Facility flow lines and risk management status of cross-contamination (GMP 3,
GMP 4.1, GMP 12)2） Status of employee hygiene management (GMP 5, GMP 6.1, GMP 6.2, GMP 6.3)
3） 5S implementation status of employees and workplaces (GMP 8, GMP 12, GMP
16)4） Status of pest monitoring (GMP 13)5） Status of facility management (GMP 11, GMP 18, GMP 19)

GMP 11 Air and water management
Requirements
The organization shall establish application-specific standards and regular monitoringprocedures for air, high-pressure gas, and water (including ice and steam) used in foodproduction to minimize impacts on food safety, and the records shall be kept.
If water not intended for use in food production and water that has been used and is still
acceptable in contact with food is applied to food production, it shall be controlled toprevent it from being contaminated with water for food production.
Concepts, specific examples
1. Air, high-pressure gases, and water (including ice and steam) used in foodproduction can cause physical/chemical/biological contamination of food dependingon their use. To minimize the impact on food safety, it is essential to establish
standards required for each application, establish procedures for regularmonitoring, and keep records of such monitoring.
2. When manufacturing food products, it is possible to use different types of water fordifferent purposes, in which case standards shall be established for each application.
3. The quality of water to be used shall be checked by water quality tests, etc., and if
necessary, filtered, sterilized, or otherwise treated to ensure water quality beforeuse.
4. Where appropriate, municipality, national or internationally recognized
microbiological and water quality standards for drinking water shall be followed.
5. In Japan, water that comes in contact with food is, in principle, water for foodproduction or water suitable for drinking, and water for food production means waterthat complies with applicable laws and regulations.
6. In Japan, it should be referred to in legal and regulatory requirements:
1） Water quality standards based on the Water Supply Law (51 items): Ministerial
Ordinance on Water Quality Standards (May 30, 2003, Ministry of Health, Laborand Welfare Ordinance No. 101)
2） Water for food production: Specifications and Standards for Foods, Additives, etc.
(26 items) (Ministry of Health and Welfare Notification No. 370, 1959)

114

3） Water fit for drinking: Regulated by the Food Sanitation Law Enforcement
Regulations following the revision of the Food Sanitation Law (enacted on June 1,2020). (Reference: Appended Table 17 of the Food Sanitation Law Enforcement
Regulations, July 14, 2020)
7. In order to reduce the cost of water, there are cases where water other than waterfor food production is used in the manufacturing process (e.g., for primary washingof food, heating and cooling), and these waters must be controlled to prevent
contamination with water for food production. Specific examples include thefollowing:1） Well water that has simply been pumped2） Water that has not been sterilized with hypochlorous acid or chlorine, etc.
8. In addition, in some food industries, water that has been used but is acceptable forcontact with food can be reused for food production in order to make effective useof water resources, as in 6. above, these waters shall also be controlled to prevent
contamination to water used for food production. Specific examples include thefollowing:1） Water used to heat and sterilize facilities
2） Water used to heat and cool prepackaged foods
3） Secondary washing water for cut vegetables (water used in the final stage of thewashing process)4） Steam condensate reuse water5） Allergens, or water that has come in contact with food containing allergens
9. In addition to water, ice, steam, air, and high-pressure gases used in food production
shall also be taken measures to minimize their impact on food safety. These include
the following:1） Ice, steam(1) Ice and steam shall be made and handled in a way that does not contaminate
them. In particular, cleaning agents for ice makers and boiler cleaning agents(chemical agents) used in the boilers that generate steam shall be approvedfor food use and shall not be mixed into the ice or steam.
(2) Install a filtration device (filter) in the water supply section of the ice makerand near the end of the steam piping.
(3) Confirm that ice and steam that come into direct contact with food, etc. do
not have any adverse effects (odor, coloration, etc.) on food, etc.
2） Compressed air, carbon dioxide, nitrogen, and other gases(1) Equipment for gases used in manufacturing and filling shall be of
specifications that do not present a risk of contamination of food products,
and shall be properly maintained.
(2) Gases that come in contact with food shall be approved for use in food in
general as food additives.

115

(3) Ensure that air and gases in contact with food are free of dust, oil, and water.
(4) Gases shall be filtered as close to the point of use as possible.
(5) When gases are produced in facilities within the business premises,
standards shall be established and monitored to ensure that there is nocontamination.
(6) Piping, etc. used shall be marked for identification purposes.
10. Air Conditioning and Ventilation
1） To prevent dust, debris, insects, etc. from entering the building andcontaminating the air, the following points shall be considered in the air
conditioning and ventilation system:(1) The air conditioning and ventilation systems are constructed in a way thatmakes them easy to clean, wash, and replace filters.
(2) Consider the air balance between intake and exhaust air in the facility.
(3) Avoid inflow of outside air through windows, doors, and crevices.
(4) To facilitate the elimination of soot and steam (to prevent condensation andmold formation, etc.).
(5) If necessary, maintain differential pressure to prevent air from entering theclean area.
2） Periodically check the outdoor air intake for damage, clogging of the filter due todust, insects, etc., and deterioration due to rust or corrosion, etc.
3） Inspection ports for both intake and exhaust for inspection, cleaning andwashing, and filter replacement would be convenient.
4） Monitor and control the cleanliness of the air in areas where products are
manufactured that are prone to the growth and survival of microorganisms, inaccordance with procedures.

GMP 12 Waste Management
Requirements
The organization shall establish adequate systems for segregation, collection anddisposal of waste (including wastewater). The flow lines of waste shall be established so
as not to cause cross-contamination of food.
Locations and containers for placing waste shall be controlled to prevent attraction ofpests or growth of harmful organisms/micro-organisms. Containers for storing wastematerials (including by-products not suitable for food use) shall be clearly distinguishedfrom other containers.
Concepts, specific examples
1. Waste, etc. (including by-products not suitable for food use) generated as a resultof food production and processing shall be properly managed because they can

116become a breeding ground for microorganisms, rodents, insects, and other harmfulorganisms, which may lead to contamination of the production and processing
environment. For example, the purpose is to prevent contamination of thesurrounding environment and attraction of pests due to overflowing waste (including
by-products not suitable for food use) in waste containers in factories and outdoor
waste storage areas, as well as outbreaks of sanitary pests and microorganisms due
to long-term storage, etc.
2. Avoid

contact

between

waste

and

raw

materials,

ingredients,

food,

or

manufacturing/processing facilities. Keep disposal facilities away from foodproduction facilities.
3. Designateapersoninchargeofconsistent

management(identification,

accumulation, segregation, storage, removal, and disposal) of waste, etc., preparea written procedure for such management work, and provide training. The status ofwaste management shall be periodically checked to ensure that the procedures arebeing followed, etc. Records of disposal shall be maintained.
4. For example, check that the following flow is being processed promptly:
Waste, etc. generated in manufacturing/processing lines → Containers of waste,etc. → Temporary storage area → Indoor/outdoor waste storage area → Pickup
by designated contractors → issue and storage of manifest slips (according to laws
and regulations)
5. Waste, etc. shall be managed and stored so as not to affect products, raw materials,
and materials and equipment that come in contact with the products.
6. In order to prevent cross-contamination between wastes, etc. and products, inprinciple, wastes, etc. should not be stored in areas where food is handled or stored.
(Excluding temporary storage during production, and similar activities. However,even in this case, care shall be taken to prevent cross-contamination with products.)
7. Containers (trash cans, containers, etc.) for storing waste shall be clearly
distinguishable from other containers and made of a material suitable for the waste
application. They should be impermeable if necessary. Containers used to holdhazardous substances prior to disposal shall be stored in specific containers andlocked as necessary to prevent intentional or accidental contamination of food. In
addition, tools used to store and handle allergen-containing wastes shall be garbage
cans, transport tools, or containers, with a lid that are handled in a manner thatprevents or minimizes the potential for allergen cross-contact.
8. Design and construct effluent and wastewater systems so that they do not interferewith food safety.
1） Effluent: All water discharged from food establishments
2） Wastewater: Water discharged from manufacturing processes that needs to betreated, including organic matter, cleaning agents, chemicals, etc.

1173） For piping used, measures shall be taken to prevent backflow of effluent andwastewater (including backflow of gases generated in sewers, etc.) and crossconnections.
4） Ensure that effluent does not flow from highly contaminated areas (e.g.,
restrooms and production areas) to areas where finished food is placed.

GMP 13 Pest control
Requirements
The organization shall establish, implement and maintain procedures to control or
remove food safety risks caused by pests (pests and vermin) on the premises and in thefacilities.
These procedures shall be implemented using the following cycle.
1. Understanding of the pest outbreak situation and formulation of monitoring plans.
2. Implementation of pest control and invasion prevention.
3. Pest monitoring and dissemination of results to personnel.
The organization shall establish procedures for eliminating pests and vermin asnecessary. If chemicals are used, handling procedures shall be established to ensurethat food is not affected.
Pest control shall be carried out by persons with the necessary competence.
Concepts, specific examples
Procedures to control or eliminate the risks to food safety posed by pests shall beaccomplished in cycles described in the requirements, the details of which are as follows:
1. Identification of pest outbreaks and development of monitoring plans
This step includes the following efforts:
1） Collect and understand information about the occurrence status (type, number,
location, etc.) of harmful organisms (rodents, insects, etc.) within the facility.
2） The target pests shall be identified based on past occurrences in the facility,
biological evidence, and the characteristics of the products handled, and amonitoring plan shall be developed.
3） It is important that pest control, including surveys and monitoring plans, iscarried out frequently enough and appropriately by competent personnel with
the necessary skills. It is also effective to obtain the cooperation of external pest
control contractors with expertise in the field.
2. Implementation of control and infestation prevention of pest
This step includes the following efforts:
1） pest control

118

(1) Remove internal sources of pests. (e.g., Cleaning areas that slime aroundwater areas, and work shoe storage areas, etc.)(2) Design the layout and specifications of the facility to make it easy to clean.
Examples are as follows:●Sloping the floor to drain water, installing R skirting at the joint between thewall and the floor, etc.
●Openings and pits caused by damage in floors and walls can easily become
entry points or internal breeding sites for pests, so repair damaged areas assoon as possible.
●Keep equipment and objects away from the walls of the facility to makeinspection and cleaning easier.
(3) Plantings on the site shall be avoided plants that bear flowers or fruit that
attract pests, and regularly weed and prune.
(4) Since puddles are a source of chironomid and other fungi, measures shall betaken to prevent their occurrence, such as frequent grading of unpaved
parking lots.
(5) Maintain the area so as not to spread the odor of waste and sewage.
(6) Install yellow or green fluorescent lights or vinyl curtains that do not attract
insects, in outdoor lighting near indoor areas such as shipping entrances, andin entranceways and walkways.
(7) Be careful not to allow birds and other animals to nest in the eaves of the
facility and around the air intake facilities. Inspect mesh and filters regularly.
2） Intrusion Prevention(1) It is advisable to keep the facility free from negative pressure to prevent
insects and other infestations.
(2) Take care to cover the ends of air intake and exhaust vents, drains, etc.
around the factory with netting or water seals to prevent pests from entering
the facility through openings.
(3) Ensure that lighting does not leak outside around windows and shutter
openings in the facility. Placing shading film or insect repellent sheets on
windows is also an effective method. Roll-up doors shall be closed tightly
against the floor.
(4) Windows that do not open and close should be gap-filled and removed asnecessary. Ensure that entrances and exits for employees and objects areclosed except when necessary. Wire mesh screens shall be installed on
windows, doors, etc. that open and close to reduce the risk of entry byharmful small animals.
(5) To avoid dust dispersal and insect infiltration due to wind pressure when
opening and closing the doors, take measures such as installing screens on
swing-door windows.

119

(6) Insect traps at the entrance to the work area shall be placed in a location
inside the building where the light cannot be seen from outside.
3. Monitoring for pests and disseminating results to employees
This step includes the following efforts:
1） Regularly monitor pests according to the plan in 1. to see if the control activities
implemented in 2. were effective, and record the results.
2） The results of monitoring shall be communicated to employees and each
employee shall be involved in pest control activities.
3） Analyze monitoring results and improve monitoring plans.
4. If the intended effect cannot be achieved in the cycle from 1. to 3. above,
extermination shall be performed. When extermination is performed, a work planthat does not affect food or interfere with facility operation shall be developed andimplemented by personnel who have secured competence. When extermination isconducted, the following shall be taken into consideration:
1） Have established procedures for chemical control, spraying procedures, andprocedures

totake measures both

after

spraying

andbefore starting

manufacturing and processing.
2） Ensure that drug use is restricted to well-trained personnel.
3） Control the amount of chemicals received and shipped, and store them in a locked
location isolated from the manufacturing and processing areas.
4） The type of chemical used, the amount and concentration (dilution ratio) used,the date and time of application, the location of the application, and so on shallbe recorded.
5） The entire pest control can be outsourced to a specialized contractor. (For reasons
such as more efficient measures, omission of chemical control, etc.)
6） Inspect if there are any points of pest entry or internal infestation, such as oncea week or once a month, depending on the season, regularly.
7） In principle, the use of poisonous bait is prohibited in the production area.
*To ensure that the use of poisoned bait does not pose a food safety risk, a special
container shall be used that cannot be easily removed when use.
8） Do not use allergens (e.g., peanut butter, cheese) as bait for traps. Whencontracting pest control service providers, make them aware of the possibility ofallergen cross-contact and do not allow them to use allergens.
5. Pest control and eradication activities can require specialized knowledge and skills,
and it is acceptable for some organizations to outsource part or all of their pest
control activities to pest control contractors. However, this requirement does not120allow pest control activities to be left to the contractor, and the organization that
outsources pest control activities shall be the main body of the pest control activities.
The organization that outsources pest control activities and the outsourced
contractor shall develop and share a pest management program that includes theactivities described in 1. through 4. above and the following, and the organizationthat outsources pest control activities shall take the initiative in evaluating theperformance of the outsourced contractor. (See FSM 13.3)
1） Identify methods and responsibilities for developing, implementing, andmaintaining a pest management program.
2） Record pest sightings for the purpose of chemical (insecticidal and rodenticidal
agents) use and indicate trends in pest activity frequency.
3） Outline the methods used to prevent pests.
4） Outline methods of eliminating pests.
5） Outline how often to check for pest status.
6） Include the type of chemical to be set (chemical intended to kill insects androdents), its number, and a diagram of its placement.
7） Clarify and store chemicals used in accordance with Safety Data Sheets (SDS).
8） Clarify and educate employees on anthelmintic control procedures (handling,shipping and receiving control, storage, etc.) and what to do if they come incontact with placed anthelmintic.
9） Outline employee education and training on the use of pest control chemicals
and pesticides.
10） Measure the effectiveness of the program to assess the effectiveness of targetedpest elimination.

GMP 14 Acceptance of purchased items
Requirements
The organization shall establish, implement, and maintain acceptance procedures for all
externally sourced raw materials, packaging materials and services that influence foodsafety. In addition, in order to ensure that the safety of the final product is notcompromised and that the materials are suitable for the intended use, verification of raw
materials, containers and packaging materials shall be carried out.
Concepts, specific examples

121

Organizations need to ensure that raw and packaging materials are free of abnormalities
before use to prevent food safety risks to their products.
1. The organization shall document (see FSM 10) all specifications of all raw materials,
packaging materials, and services, including raw materials and additives (but notlimited to these), that are purchased from external sources and that can affect thesafety of the final product, and keep them up to date at all times.
2. All raw materials, packaging materials, raw material ingredients, etc. shall comply
with the relevant laws and regulations of the country of manufacture and the countryof sale.
3. Verification of raw materials, packaging materials, raw material ingredients, etc. toensure that the safety of the final product is not compromised and that the materials
are suitable for their intended use.
1） With regard to items used in the manufacture of products, they shall be in acondition free of abnormalities prior to use. When purchasing or using items thatare already packaged as ready-to-use products, this should be allowed only if
the specifications for each raw material and packaging material are confirmed
and no problems arise when delivering the product under general transportation
conditions, such as refrigerated, frozen, or ambient control, rather than in a
specialized vehicle.
2） If the temperature is abnormal, damaged, or contaminated at the time of receipt,
do not use the product, checking necessary, take measures such as returning
the product.
3） In regarding semi-finished products and work-in-progress received from relatedparties to be used as raw materials, if the counterparty uses a dedicated vehicle,
confirm the transportation conditions, establish items to be checked uponreceipt, and be able to take action such as returning the product if there is any
abnormality.
4. Verification shall include a certificate of conformity, certificate of analysis, inspectionof extracted samples, etc.
5. All packaging materials that come in direct contact with food shall be checked for thefollowing:
1） A register of specifications and labels for raw materials and packaging materials
shall be maintained and kept current.
2） Obtain a certificate of compliance with either food-related regulations or approval
standards.
3） In the absence of a certificate of conformity, certificate of analysis, or certificate
of guarantee, testing/analysis shall be performed and records maintained to verify
that there is no possibility of chemical migration from the packaging material to
the food contents.

1224） With regard to 2) and 3) above, in order to further enhance the safety of synthetic
resin food utensils, containers, and packaging, a positive list system wasintroduced under the Law for Partial Revision of the Food Sanitation Law, etc.
promulgated on June 13, 2008, which allows the use of only substances whose
safety has been evaluated for food utensils, containers, and packaging. (Enacted
on June 1, 2020 by the Ministry of Health, Labor and Welfare) (Scope of this item
applies in Japan)
6. The contract manufacturer/contract service provider shall confirm compliance withthe contract by performance management (see FSM 13.2 and 13.3) of thepurchasing party.

GMP 15 Transport
Requirements
The organization shall establish a system to ensure that containers and transportation
vehicles, including contracted vehicles, used for the transportation of raw materials andingredients (including packaging materials), partially processed products, works inprogress, recycled products, reworks, and finished products (including packed fresh
products in final packaging) are suitable for the intended use, maintained in good
repair and clean, protected from contamination, and transported within its intended
temperature range.
Concepts, specific examples
The organization is required to ensure that products (including intermediate stages) aredelivered to the customer or proceed to the next process without any abnormalities.
1. When transporting semi-finished products, work-in-process, recycled products,
reworked products, and finished products
1） When delivering to the destination, check the product specifications and consider
the necessary conditions for a trouble-free delivery.
Examples: temperature and humidity settings, stacking and loading methods,
pallet-related items used, delivery containers, and other special conditions.
2） Confirm that the delivery vehicle can handle the set conditions without problems
and that the environment is such that the product can be delivered without
damage or contamination.
(1) Can the required temperature and humidity be set? Also, can the required
temperature and humidity range be maintained even when the vehicle isfully loaded? If not, can the maximum load be changed?
(2) Is the temperature and humidity recorded at the required frequency? Also,
is it possible to check that there are no abnormalities with the thermometer123

and hygrometer as appropriate?
(3) If containers and pallets are not the company's own, check the frequency ofcleaning, disinfecting, and replacement.
(4) Is the interior of the vehicle kept in proper clean condition?
(5) Confirmation of whether mixed loading with non-products is allowed, and if
so, the loading capacity, items that can be loaded, etc.
(6) Confirmation that no outsiders other than the person in charge of delivery
are involved.
2. On the organization, too, if necessary, check and make efforts to maintain thedelivery environment. If any abnormalities are found, it shall be necessary to request
appropriate improvements.
3. The following are points to be considered in transportation equipment:
1） Transport vehicles(1) Vehicles and containers used to transport products shall be clean andconstructed to prevent external contamination.
Carry carts, etc. used on site are not considered vehicles under this item, andtheir management shall be conducted in accordance with GMP 18.
(2) Controlled by temperature and humidity according to the characteristics of the
products to be transported, and equipped with refrigeration/freezing anddehumidification functions when necessary.
(3) If products are transported refrigerated or frozen, be sure to regularly inspect andrecord the instrumentation of the thermometer in the vehicle.
(4) Use vehicles with sufficient capacity for the items and quantities of foodhandled, and that can be effectively separated in the vehicle.
(5) Cross-check thermometers (e.g., install two different types of thermometersand confirm that there is no difference between them) as appropriate to ensurethat accurate temperatures are maintained.
(6) Do not allow unauthorized persons to enter the loading area, and do not place
unnecessary items, etc. in the loading area.
(7) For pallets used for transportation and storage, avoid using wooden pallets
from the viewpoint of pest generation/contamination, and damage.
(8) When transportation is outsourced, manage it with reference to FSM 13.3
(Outsourcing Management).
2） Containers for transportation(1) Containers used to transport food are designated and labeled for food and used
only for that purpose.
(2) To maintain cleanliness, the materials shall be washable, and they shall be
washed and disinfected regularly. If stains or unusual odors are observed,
clean immediately.
(3) If the container serves as both a shipping container and a storage container,

124

check for damage during transportation, and take action if any leaks, etc. arefound.

GMP 16 Storage
Requirements
The organization shall hold or store foods (raw materials, semi-finished products, workin progress, reworked products, and final products) at designated locations, and manage
them under appropriate conditions to minimize food safety risks.
Concepts, specific examples
Design, construct and operate appropriate storage facilities for the safe and hygienic
storage of food products (raw materials, semi-finished products, work-in-process
products, reworked products and finished products).
1. Food storage facilities shall be designed and constructed with the following in mind
1） Prevent pests from entering and living in the area.
2） Specifications shall effectively protect food and prevent contamination.
(Contamination includes cross-contact of allergens.)
3） The environment shall minimize deterioration of food due to temperature andhumidity.
4） Non-food chemicals (including cleaning agents, lubricants, fuels, etc.) should be
stored in a secure storage facility separate from food.
2. Food storage facilities shall be operated with the following in mind:
1） Control the product in consideration of pre-sterilization, post-sterilization,
distribution temperature (ambient, chilled, frozen), expiration date, and bestbefore date.
2） Establish procedures to avoid mixing the test product with the genuine products.
3） Distinguish between raw and cooked foods.
4） Distinguish between foods that contain allergens and those that do not.

GMP 17 Stock Management
Requirements
The organization shall establish, implement and maintain a system to use raw materials
and ingredients (including packaging materials), partially processed products, work inprogress, recycled products, reworks, and finished products in a designated order andwithin the defined expiry period, and shall store these materials under the properconditions to avoid contamination and deterioration.

125

Storage facilities and equipment shall be designed to allow food to be stored underappropriate storage conditions.
Concepts, specific examples
1. Storage period
1） Raw materials (including containers and packaging materials), semi-finishedproducts, work-in-process, recycled products, reworked products, and finishedproducts shall be used within a specified period by establishing an appropriate
shelf life and utilizing first-in, first-out, etc.
2） During storage, the traceability (see FSM 14.1) of raw materials (including
containers and packaging materials), semi-finished products, work-in-process,recycled products, reworked products, and finished products shall be managed sothat they can be linked to the records.
2. Storage location
Facilities and equipment for storing food shall be designed to store the food underappropriate conditions according to the specifications of the food.
1） Raw materials (including container and packaging materials), semi-finishedproducts, work in progress, reworked products, and finished products shall be
stored in storage facilities, that are not contaminated, and do not deteriorate due
to temperature, humidity, etc. This is related to GMP 4.1 and 4.2.
2） Storage conditions that do not degrade means storing the product underappropriate conditions that ensure the required specifications.
3. For storage of containers and packaging materials, the following shall be consideredin addition to food storage conditions:
1） Container and packaging materials whose manufacturer is clear and suitable forthe intended use
Ensure that specifications and history can be identified and food safety can be
guaranteed, such as that the manufacturer is not using potentially unsanitaryingredients.
2） Locations where containers and packaging materials are stored and theirappropriate management(1)

Avoid dust and dirt by covering the product when not in use.

(2)

Establish procedures for handling aseptic packaging materials and glass
containers. (Including procedures in case of glass container breakage)(3)

For containers and packaging materials stored for long periods, establish
procedures to confirm that they comply with specifications.

(4)

Storage location and proper management of container packaging materials
and products(5)

To allow for inspection and cleaning of container and packaging materials,
they are stored off the floor and there is space between pallets.

126

(6)

Avoid areas where condensation can occur.

(7)

Returnable containers used for storage shall be clean and not contaminated.

(8)

Also be careful of contamination caused by sterilization, rodenticides, andfumigation.

(9)

Isolate from chemical storage areas to prevent contamination.

(10) When storing, check laws and regulations, etc. related to containers andpackaging (especially synthetic resin).

GMP 18 Equipment and Tools
Requirements
The organization shall suitably design and select equipment and tools for the intended
uses and shall use, maintain, and store so as to minimize food safety hazards.
Concepts, specific examples
1. Concept of Equipment and Tools
1） Organizations are required to prevent food safety risks from equipment and tools.
The following are examples of hazards:●Biological: Contamination by residual food residues, etc.
● Chemical: Residual mold and allergens due to insufficient cleaning anddrying, etc. and chemical damage due to detergent residues, etc.
● Physical: Foreign matter contamination due to breakage, deterioration,
dropout, etc.
Consideration shall be given to sufficiently preventing these hazards before
allowing production activities.
2） "Suitably for the intended use" means meeting specifications that ensure andmaintain food safety (e.g., temperature setting of heating and coolingequipment, ease of cleaning, etc.).
2. Design, selection, installation, and operation of equipment and tools
Equipment (facilities) and tools for manufacturing and processing shall be designed
and selected to be effective against product hazards (biological, chemical, andphysical), taking the following points into consideration. In addition, sufficientnumberandcapacity

shall

be

securedaccordingtotheamountofmanufacturing/processing, and they shall be properly installed and operated inconsideration of their handling methods, flow lines, etc.
1） Design and selection(1)

The structure shall be easy to clean, wash, disinfect, and maintain, and if water
is used, shall be designed to drain as well as possible.

(2)

Select that do not cause contamination of foreign materials (paint, etc.).

(3)

If necessary, use that can be disassembled for maintenance, cleaning, washing,127

disinfection, and monitoring.
(4)

Ensure that food contact surfaces are durable and easy to maintain, clean,inspect, replace, wash, sanitize, and monitor, and consider how muchdeterioration should be addressed and how often it can realistically be
addressed.

(5)

It is important that surfaces in contact with food be made of materials that do
not be affected by leaching of ingredients due to interaction with food or bycleaning and washing. Confirm that the material is compatible with foodproducts and take action to ensure that it is provable.

(6)

Whenever possible, surfaces in contact with food shall be impervious and, if
made of metal, of materials that are resistant to rust and corrosion, and shallbe monitored for rust and corrosion, if necessary.

(7)

It is important that equipment and tools be made of materials that do not
adversely affect the product.

(8)

Parts and components, etc. attached to equipment and instruments are to bechecked to ensure that they do not affect the safety of the product.

(9)

Items that can fall off (screws, labels, etc.) shall be avoided from the top of thefood whenever possible, and monitoring shall be carried out as necessary.

(10) Check carefully before initial use to ensure that there are no paint chips, metal
chips, etc. mixed in.
(11) Equipment used for cooking, heating, cooling, storing, or freezing food shall be
designed to achieve the required food temperature as quickly as necessary, tomaintain food temperature effectively, and to monitor and control temperature
as needed. Monitoring equipment used to monitor temperatures shall becalibrated, if necessary, to ensure that the food temperatures in the process
are accurate.
(12) Equipment monitoring food control conditions should have effective means ofcontrolling and monitoring humidity, air flows, and other characteristics that
can affect food safety or suitability, as necessary.
2） Installation(1)

When cleaning/cleaning piping (pipes and ducts), ensure that there is gooddrainage, no difficult-to-clean areas, and no unused branch pipes.

(2)

As much as possible, it is desirable to be able to "wash everything in a washingroom, etc." and "dry thoroughly in a drying room, etc.". For equipment thatneeds to be fixed to the floor, consider making it possible to handle this without
difficulty, such as by making the parts to be cleaned disassembled.

(3)

Prepare the necessary capacity and quantity to allow sufficient time for washingand drying, assuming actual operation.

(4)

Confirm that periodic cleaning and checking is possible for water and residue
on pipes, ducts, etc.

1283） Operation(1)

Establish procedures for washing, drying, and, if necessary, disinfecting.
① Washing methods: washing tools used, water temperature during washing,whether or not detergents are used, etc.
② Drying method: temperature setting for drying room, temperature setting
for drying with warm air, time required for drying, etc.
③ Others: Alcohol spraying or not, etc.

(2)

It is desirable to verify whether there is no residual of the intended hazards if
the procedure is implemented as studied. As an example, after actual washingand drying according to the procedure, the residual allergens could be
confirmed by means of a bacterial test of wiped specimens, ELISA test, etc.

(3)

If the established procedures require special training and education of workers,
it is desirable to have a procedure manual or visual explanation materials. In
addition, it is recommended that records be kept to confirm areas that areprone to insufficient washing, to record that drying has been completed, etc.,
as necessary, to increase certainty.

(4)

Monitor for damage, deterioration, and other areas of food safety risk concern
at an appropriate frequency. When monitoring is conducted, it is desirable tokeep records.

(5)

Make sure workers are aware of the need to report any abnormalities they
notice, such as damage, missing parts, or strange noises.

(6)

Carts, etc. shall be kept clean between uses to prevent contamination and/or
allergen cross-contact with subsequently used foods, tools, etc.

129

GMP 19 MaintenanceRequirements
The organization shall document and implement a system for systematic maintenanceof all facility and equipment critical to product safety.
Maintenance activities shall be performed in such a way that they do not pose a foodsafety risk.
This system shall include procedures (such as cleaning, washing, and sterilization
procedures) for returning the food production facility to a state capable of producing
food after maintenance activities.
Maintenance activities shall not represent food safety hazards.
All materials used for maintenance shall be suitable for the intended purpose.
Concepts, specific examples
1. Maintenance of facilities and equipment
1） Maintenance activities need to be carried out in a way that does not pose a risk
to food safety. Therefore, the organization develops and implements documented
procedures for the maintenance of all facilities and equipment that are importantto product safety. The procedures include the following concepts:(1) Ex-post

maintenance:

Maintenance method

in

which

maintenance isperformed after a breakdown has caused a shutdown or a decline infunctionality(2) Preventive maintenance: Management methods that focus on prevention, suchas equipment inspections and periodic parts replacement(3) Improvement maintenance: Management methods that focus on improvement
and reinforcement to prevent recurrence of breakdowns
2） Procedures for the maintenance of facilities and equipment shall include thefollowing items:(1) Developing a maintenance and inspection plan(2) Person in charge of maintenance and inspection(3) Identification of facilities and equipment requiring maintenance and inspection(4) Frequency of maintenance and inspection(5) Procedures for performing maintenance and inspections (including chemicals
to be used)(6) Methods for checking and recording the status of maintenance and inspection(7) Procedures for restoring food production to a condition ready for use after
maintenance (including cleaning, etc.) Procedures for restoring food production
to a condition where it can be performed after maintenance (including
cleaning, washing, sterilization, etc.)
2. Maintenance Notes
1） Repair so as not to contaminate food, etc.

1302） All materials used for maintenance shall be suitable for their intended use so thatthey do not pose a food safety risk.
3） Check that equipment (facilities) and tools are not damaged or have any missing
screws or other parts.
4） Preventive maintenance shall be carried out in a planned manner, in addition to
ex-post maintenance.
5） Ensure that preventive maintenance plans include equipment that monitors andcontrols food safety. (e.g., sieves, air conditioning filters, magnetic traps, metal
detectors, etc.)
6） In the event of malfunction or damage, promptly repair the equipment and returnit to normal condition.
7） When performing maintenance, do not contaminate surrounding manufacturing
or processing lines or equipment.
8） Lubricants and heat transfer media that can come into direct or indirect contact
with food shall be selected so that they do not impair safety even if they comeinto contact with food.

Disclaimer：This translated document is provided for information purposes only. In the eventof a difference of interpretation or a dispute, the original Japanese version of this document
is binding.

131JFS-C Standard Document (Sectors: CI,CII,CIII,CIV/K) Version 3.1 [Guideline] Edition
1.0
August 20, 2024 Issued
Edited and published by Japan Food Safety Management Association
The copyright of this guideline belongs to Japan Food SafetyThe
copyrightAssociationof this guideline
belongsthird
to theFood Safety
Management
or legitimate
parties.
If youManagement
Associationof Japan ofor legitimate
third parties.
wish to use anyof the contents
these guideline,
pleaseIf
you wish
use any
contact
us intoadvance
at of the contents of these guidelines,
please contact us in advance at the following address.
17-5, Ginza 8-chome, Chuo-ku, Tokyo 104-0061, Japan
Shintomicho THE
Building
3-10-9Chuo-ku, Tokyo
HUB8F,Ginza
OCTIrifune,
Room 605
104-0042,
Japan
Japan Food Safety
Management
Association (JFSM)
JapanTel:
Food
Safety Management
Association (JFSM)
03-6268-9691
Email: info@jfsm.or.jp
Tel: 03-6268-9691 Email: info@jfsm.or.jp
Unauthorized reproduction or use of this guideline is strictly
Unauthorizedcopyingor reproduction(photocopying,etc.) ofprohibited, withthe exceptionof copyrightlaw.
these guidelines is prohibited, except for exceptions undercopyright law.
132