JFS-B Standard Document(Sector：CⅠ,CⅡ,CⅢ,CⅣ/K)＜Manufacture of food products andManufacture of chemicals (including
biochemical products)＞
Version 3.0〔Guidelines〕
Edition 1.0

Japan Food Safety Management Association

May 5,2022

Table of Contents
Introduction................................................................................................................................................................................ 3
Ⅰ Food Safety Management Systems（FSM）.......................................................................................................... 8
FSM 1 Management or senior management responsibility........................................................................................... 8
FSM 2 Commitment of management or senior management....................................................................................10
FSM 4 Compliance with food safety laws.......................................................................................................................10
FSM 6 Food Safety Policy and Goals .............................................................................................................................11
FSM 7 Food Defense.........................................................................................................................................................11
FSM 9 Document and record management .................................................................................................................13
FSM 11

Procedures and Instructions.............................................................................................................................15

FSM 12

Resource Management....................................................................................................................................16

FSM 13.1

Purchasing.......................................................................................................................................................17

FSM 13.2

Supplier Performance ....................................................................................................................................21

FSM 14

Traceability ..........................................................................................................................................................22

FSM 16

Allergen Management.......................................................................................................................................24

FSM 17

Control of Measuring and Monitoring Devices ..............................................................................................25

FSM 18

Product labeling..................................................................................................................................................27

FSM 19Analysis and Inspection ....................................................................................................................................28

FSM 21 Complaint Handling ............................................................................................................................................29
FSM 22

Serious Incident Management.........................................................................................................................30

FSM 23

Product Release................................................................................................................................................32

FSM 24Control of non-conforming products...............................................................................................................32

FSM 25

Corrective Action ...............................................................................................................................................33

Ⅱ Hazard Analysis and Critical Control Point（HACCP） ........................................................................................34
HACCP Step 1 Formation of HACCP team..................................................................................................................34
HACCP Step 2

Product Information Description..........................................................................................................34

HACCP Step 3

Identification of Intended Use ..............................................................................................................35

HACCP Step 4

Construction of Flow Diagram.............................................................................................................35

HACCP Step 5

On-site Confirmation of Flow Diagram ..............................................................................................37
1

HACCP Step 6 （Principle 1） Hazard Analysis......................................................................................................38
HACCP Step 7 (Principle 2） Critical Control Points (CCPs)..................................................................................42
HACCP Step 8 （Principle 3） Establishment of Critical Limits .............................................................................43
HACCP Step 9 （Principle 4） Monitoring System .................................................................................................44
HACCP Step 10 （Principle 5） Corrective Actions ................................................................................................46
HACCP Step 11 （Principle 6） Establish HACCP plan validation and verification procedures .....................47
HACCP Step 12 （Principle 7） Documents and Record .....................................................................................48
Ⅲ Good Manufacturing Practice（GMP) .........................................................................................................................50
GMP 2

Site Management................................................................................................................................................50

GMP 3 Design, construction, layout of business site and work and product flow lines............................................51
GMP 4 Control of critical hazards that cannot be controlled by Critical Control Points (CCPs) (prevention ofcross-contamination) .............................................................................................................................................................54
GMP 5

Personnel Facilities..............................................................................................................................................56

GMP 6 Hygiene, workwear and Health management of personnel, etc. .................................................................58
GMP 7

Training..................................................................................................................................................................61

GMP 8Housekeeping, cleaning, sterilization and disinfection ...................................................................................62

GMP 11

Air and water management.............................................................................................................................64

GMP 12

Waste Management.........................................................................................................................................67

GMP 13

Pest control.........................................................................................................................................................68

GMP 15

Transport ............................................................................................................................................................71

GMP 17

Stock Management .........................................................................................................................................72

GMP 18Devices and Tools...........................................................................................................................................73

GMP 19Maintenance .....................................................................................................................................................752

Introduction
This guideline provides ideas and specific examples of what organizations should implement withregard to the JFS-B standard issued by Japan Food Safety Management Association（JFSM）.
The food safety management system established by each food business organization differs dependingon many factors such as industry, business category, business scale, and social background. This
report is intended to be used as a reference for each organization to build a food safety management
system suited to their own needs.
The overall JFS standard is shown in Table 1 and Figure 1.（Sector：CI～CⅣ/K）These guidelines arefor Sector B standards for the food manufacturing sector (CI - C IV) and the "Chemical Products(including biochemical products) Manufacturing Sector (K)". (Table 1)[A/B/C standard with
continuity]

International Trade
Standards used forstage

international tradeCStandards

B
A[Two operational
mechanisms]

JFS-C Certification
Program(Utilizes
JFS-C
認証プログラムinternationally accepted（国際的に通用する
GFSI-approved
standards,
GFSI
承認規格、ISO等の
ISO and other certification
認証の仕組みを活用）
mechanisms)

including HACCP
Sanitation
managementcentered standard
incorporating the
HACCP concept

JFS-A/B Conformity
JFS-A/B 適合証明プロ
Certification
グラム
Program(Establish a（中小規模の食品等事
system for small- and業者で独自に確認をす
medium-scale foodる仕組みを構築）
businesses to conduct
their own verification)

Types of requirements
Figure 1: Overall view of the JFS Standards and Certification/Certification ofConformity Program

Table 1: List of Sectors by GFSI
CodeSector/Subsector

Code

Sector/Subsector

AI

Farming of Animals for Meat/ Milk/ Eggs/
Honey

FI

Retail / Wholesale

AII

Farming of Fish and Seafood

FII

Food Broker / Agent

3

BI

Farming of Plants (other than grains andpulses)H

Provision of Food Safety Services

BII

Farming of Grains and Pulses

G

Provision of Storage and Distribution Services

BIII

Pre-process handling of plant products

I

Production of Food Packaging

C0

Animal primary conversion

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 productsD

Production of feedE

Catering

Hygienic Design of Food Buildings and
JI

Processing Equipment (for building constructors
and equipment manufacturers)
Hygienic Design of Food Buildings and

JII

Processing Equipment (for building andequipment users)

K

Manufacture of chemical products (including
biochemical products)(Manufacture of additives, vitamins, minerals,
cultures, flavors, enzymes, processing aids, etc.)

Reference: The GFSI Benchmarking Requirements version 2020 PART I＊：Sectors presented by GFSI that are covered by this standard document are framed.
The JFS-B standard is intended for businesses that implement HACCP in addition to general hygiene
control.
This Standard Document applies to the following“Food Manufacturing Sectors（CI, CII, CIII, CIV）“and“Chemical
Products (Including Biochemical Products) Manufacturing Sector（K）“（Table 1）※Pet food is included in the following food manufacturing sector
Food Manufacturing Sectors（CI～CⅣ）

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
Chemical Products (Including Biochemical Products) Manufacturing Sector（K）
K : Manufacture of chemicals (including biochemical products)(Production of chemical products (including biochemical products) and cultures used as food ingredients4

or processing aids in food production)
Chemical products herein refer to chemical products (including biochemical products) related to foodproducts.
In addition, the JFS-B standard refers to the requirements of the Global Markets Program (a program
to improve food safety initiatives for small and medium-sized businesses, hereinafter referred to as
GMaP) proposed by the Global Food Safety Initiative (GFSI) in order to be consistent with internationalrecognition of food safety, and includes intermediate items. This enables compliance with internationallyresearched food safety management system activities and clarifies the next food safety steps to betaken when an organization wants to improve its initiatives, such as when it expands its size or sales
channels.
JFS standards consist of Food Safety Management Systems：FSM, which are requirements for the
management of an organization's activities, HACCP, which is a method of controlling hazards, andGood Manufacturing Practices (GMP), which are requirements for general hygiene management, andare interrelated.（Figure 2）.

Figure 2: Basic structure of the JFS
standard

On the other hand, the order of standards is not the order in which implementation systems are
established. In practice, it is possible to start from GMP or FSM, and each organization should takeappropriate measures. This guideline provides ideas and specific examples to serve as a reference
when utilizing the JFS-B standards. However, these are examples only, and other ideas and methods
may be selected if it can be explained technically and scientifically that the requirements of the JFS
standards are met. They can also be used together with research data and food safety theory fromresearch institutes and industry associations that have been published in the past, making use oftechnical information and know-how possessed by individual industries.
The legal and regulatory requirements for food safety management systems vary by industry and region, andwhile the JFS Standards and these Guidelines assume compliance with those legal and regulatory requirements,
they are not all encompassed in these Guidelines and should be reviewed by each organization on an individual
basis. Therefore, it is necessary for each organization to individually confirm the compliance.

We hope that these guidelines will help you understand the JFS standards.
＜Structure of the JFS-B Guideline＞● Requirementｓ● Concepts, specific examples● Items to be referred to in the legal provisions related to food safety*※Legal provisions are taken from the Food Sanitation Law Enforcement Regulations of Japan.
5

Table 2 Comparison of JFS-A/B/C standard requirements

JFS-Astandard Version 3.0

JFS-Bstandard Version 3.0

JFS-Cstandard Version 3.0
supplementary requirements

No.

item（FSM 12 items）

No.

item（FSM 20 items）

No.

item（FSM 31 items）

FSM 1

Management or senior management
responsibility

FSM 1

Management or senior management
responsibility

FSM 1

Top Management Responsibility

FSM 2

Commitment of management or senior
management

FSM 2

Commitment of management or senior
management

FSM 2

Top Management Commitment
and Food Safety Culture

FSM 3

Management Review

FSM4

Compliance with food safety laws

FSM 4

Compliance with food safety laws

FSM 5

Food Safety Management System
and General Requirements

FSM 6

FSM 9

Food Safety Policy and Goals

Document and record management

FSM 6

Food Safety Policy and Goals

FSM 6

Food Safety Policy and Goals

FSM 7

Food Defense

FSM 7

Food Defense

FSM 8

Food Fraud Prevention

FSM 9.1

Documentation procedures

FSM 9.2

Control and storage of
documented information

FSM 10Specification Control of Purchased
or Provided Items and Services

FSM 9

Document and record management

FSM 11

Procedures and Instructions

FSM 11

Procedures and Instructions

FSM 12

Resource Management

FSM 12

Resource Management

FSM 12

Resource Management

FSM 13Purchasing

FSM 13.1

Purchasing

FSM 13.1

Purchasing

FSM 13.2

Supplier Performance

FSM 13.2

Supplier Performance

FSM 13.3

Outsourcing

FSM 14

Traceability

FSM 15

Product development

項目名をC規格に合せ
FSM 14

FSM 17

Traceability

Control of Measuring and Monitoring
Devices

FSM 14

Traceability

FSM 16

Allergen Management

FSM 16

Allergen Management

FSM 17

Control of Measuring and Monitoring
Devices

FSM 17

Control of Measuring andMonitoring Devices

FSM 18

Product labeling

FSM 18.1

Product labeling(B-to-C products)

FSM 18.2

Product labeling(B-to-B products,
work in progress,
semi-finished products)

FSM 19.1

Analysis and Testing

FSM 19.2

Environmental Monitoring

FSM 20Internal Audit

FSM 19Analysis and Inspection

FSM 21

Complaint Handling

FSM 21

Complaint Handling

FSM 22

Serious Incident Management

FSM 22

Serious Incident Management

FSM22

Serious Incident Management

FSM 23

Product Release

FSM 23

Product Release

FSM 23

Product Release

FSM 24

Identification of nonconformities andcontrol of nonconforming products

FSM 24

Identification of nonconformities andcontrol of nonconforming products

FSM 24

Identification of nonconformities
and control of nonconforming
products

FSM 25

Corrective Action

FSM 25

Corrective Action

FSM 25

Corrective Action

FSM 26

Utilization of Kaizen
suggestions from personne

6

JFS-Astandard Ver.3.0
No.

JFS-Cstandard Version 3.0
supplementary requirements

JFS-Bstandard Ver.3.0

item（ＧＭＰ１４item）

No.

item（ＧＭＰ１４item）

No.

item（ＧＭＰ２２item）

GMP 1

Facility Environment

GMP 2

Site Management

GMP 2

Site Management

GMP 2

Site Management

GMP 3

Design, construction, layout ofbusiness site and work and productflow lines

GMP 3

Design, construction, layout ofbusiness site and work andproduct flow lines

GMP 3

Design, construction, layout ofbusiness site and work andproduct flow lines

GMP 4

Control of critical hazard factorsthat cannot be controlled by criticalcontrol points (CCPs) （Preventionof cross-contamination）

GMP 4

Control of critical hazard factorsthat cannot be controlled by
critical control points (CCPs)（Prevention of crosscontamination）

GMP 4

Physical, chemical andbiological productcontamination risks andisolation

GMP 5

Personnel Facilities

GMP 5

Personnel Facilities

GMP 5

Personnel Facilities

GMP 6

Hygiene, workwear and Healthmanagement of personnel, etc.

GMP 6

Hygiene, workwear and Healthmanagement of personnel, etc.

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 nonbusinesspersonnel and visitors

GMP 7

Training

GMP 7

Training

GMP 7

Training

GMP 8Housekeeping, cleaning,sterilization and disinfection

GMP 8Housekeeping, cleaning,sterilization and disinfection

GMP 8Housekeeping,cleaning,sterilization and disinfection

GMP 9

ReworkGMP 10Patrol and inspection of thesite

GMP 11

Air and water management

GMP 11

Air and water management

GMP11

Air and water management

GMP 12

Waste Management

GMP 12

Waste Management

GMP 12

Waste Management

GMP 13

Pest control

GMP 13

Pest control

GMP 13

Pest control

GMP 14
GMP 15

Acceptance of purchased
itemsTransport

GMP 15

Transport

GMP 15

Transport

GMP 16Storage

GMP 17

Stock Management

GMP 17

Stock Management

GMP 17

Stock Management

GMP 18Devices and Tools

GMP 18Devices and Tools

GMP 18Devices and Tools

GMP 19Maintenance

GMP 19Maintenance

GMP 19Maintenance

JFS-Astandard Ver.3.0

JFS-Cstandard Version 3.0
supplementary requirements

JFS-Bstandard Ver.3.0

No.

item（ＨＡＣＣＰ１０item）

No.

item（ＨＡＣＣＰ１２item）

No.

item（ＨＡＣＣＰ１２item）

HACCP step 1

Formation of HACCP team

HACCP step 1

Formation of HACCP team

HACCP step1

HACCP Team Assembly

HACCP step 2

Product Information Description

HACCP step 2

Product Information Description

HACCP step2

Product Description

HACCP step 3

Identification of Intended Use

HACCP step 3

Identification of Intended Use

HACCP step3

Identification of Intended Use

HACCP step4

Construction of Flow Diagram

HACCP step4

Construction of Flow Diagram

HACCP step4

Construction of Flow Diagram

HACCP step 5

On-siteConfirmation
Diagram

HACCP step 5

On-site Confirmation
Diagram

HACCP step5

On-site Confirmation
Diagram

HACCP step 6、７（principle1, 2）（Principle 1） Hazard Analysis（Principle 2） Critical Control
PointsHACCP step 6（principle１）

Hazard Analysis

HACCP step6（principle1）

Hazard Analysis

HACCPstep 7（principle2）

Critical Control Points

HACCP step7（principle2）

Critical Control Points

HACCP step 8（principle3）

Establishment of Critical Limits

HACCP step8（principle3）

Establishment of Critical Limits

HACCP step 9（principle4）

Monitoring System

HACCP step9（principle4）

Monitoring System

HACCP、step 8、9（principle3, 4）

of

Flow

（Principle 3) Establishment of
Critical Limits（Principle 4) Monitoring System

of

Flow

HACCP step10（principle5）

Corrective Actions

HACCP step10（principle5）

Corrective Actions

HACCP step10（principle5）

Corrective Actions

HACCP step11（principle6）

Establish HACCP plan validation andverification procedures

HACCP step11（principle6）

Establish HACCP plan validationand verification procedures

HACCP step11（principle6）

Verification

HACCP step12（principle7）

Documents and Record

HACCP step12（principle7）

Documents and Record

HACCP step12（principle7）

Documents and Record

7

of

Flow

［JFS-B Standard Documents Version 3.0 guideline］
JFS-B Standard (Sector：CⅠ～CⅣ/K)< Manufacture of food products><Manufacture of chemicals (including biochemical products)>
Ⅰ Food Safety Management Systems（FSM）
FSM 1 Management or senior management responsibility●Requirementｓ
Management or senior management must share and operate an organizational structure that, at
a minimum, clarifies the duties and responsibilities of those who affect food safety. Management
or senior management must determine who is responsible for food safety management.
●Concepts, specific examples
１．Role of management or senior management
１）Periodically verify and review the effectiveness of the company’s own efforts to ensure foodsafety and quality and to secure consumer confidence.
２）Clearly define an organizational chart that includes a communication system for instructions,
reporting, and consultation, and share it with employees.
２．Communication system for instructions, reporting, and consultation
１）In order to clarify the communication system for instructions, reporting, and consultation, it iseasier to manage by using meeting bodies and morning meetings to determine the activities
necessary for food safety. Instructions, reporting, and consultation are as follows.
（１）Instructions: The clarification of tasks and roles by a supervisor, manager, or other 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
are undertaken.
２）A communication system should be in place to ensure that safe food products can be
shipped even in the event of major changes in the manufacturing environment, such as asudden increase in order volume, accelerated shipping times, or personnel shortages.
(Shipment decisions are also related to procedures in FSM 23 (Product Release).
３．Food safety officer
１）Determine a food safety officer as the person responsible for food safety management.
２）The food safety manager′s knowledge of food safety policies, food safety knowledge, andfield knowledge and experience in the organization will enable him or her to create an effective
system.
３）If there is a separate food safety manager or food safety officer, it is important to share
information and collaborate. They may also serve concurrently.
●Items to be referenced in legal provisions related to food safety8Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(i) Appointment of food sanitation supervisors, etc.
(a) Appointment of a person who conducts business prescribed in Article 51, paragraph (1) of the
Act (including the cases where it is applied mutatis mutandis pursuant to Article 68 and Article 62,
paragraph (3) of the Act) Hereinafter referred to as a "business person" in this table) shall appoint a
person responsible for food sanitation. Article 68 A person engaged in a business prescribed in
Article 1, paragraph (1) of the Act (including cases where it is applied mutatis mutandis under
Article 62, paragraph (3) of the Act) shall specify a person responsible for food sanitation.
However, this shall not apply to business persons prescribed in each item of Article 66-2,
paragraph (4). In addition, a food sanitation supervisor prescribed in Article 48 of the Act may also
serve as a person responsible for food sanitation.
(d) A business person shall respect the opinions of the person responsible for food sanitation.
(e) A person responsible for food sanitation shall take necessary precautions to ensurecompliance with the measures prescribed in Article 66-2, paragraph (3) and endeavor to statenecessary opinions to a business person.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of theFood Sanitation Act(i) c. Food sanitation supervisors shall comply with the following matters(1) Attend seminars held by prefectural governors, etc. or seminars approved by prefectural
governors, etc. on a regular basis, and endeavor to acquire new knowledge concerning foodsanitation (limited to business under Article 54 of the Act (including cases where it is appliedmutatis mutandis under Article 68, paragraph (3) of the Act)) (limited to businesses under Article
54 of the Act (including cases where it is applied mutatis mutandis under Article 68, paragraph (3)of the Act)) (i) To make efforts to learn new knowledge concerning food sanitation (limited tobusinesses under Article 54 of the Act (including cases where it applies mutatis mutandis to Article
68, paragraph (3) of the Act))(ii) follow the instructions of a business person and take charge of sanitation control.
(e) A person responsible for food sanitation shall take necessary precautions to ensurecompliance with the measures prescribed in Article 66-2, paragraph (3), and shall endeavor tostate necessary opinions to the business person.
■Reference: "food sanitation manager" and "food sanitation supervisor"

food sanitation manager

food sanitation supervisor

Laws and regulations
governing

Article 48 of the Food SanitationLaw

To be specified by prefectures,designated cities, etc. under
Article 50, paragraph 2 of theFood Sanitation Act.

Qualifications

national qualification

official certification

Report toprefectural governor

health care centre

TargetFor each licensed facility that
manufactures or processes the
subject food, additive, etc.

Per business license facility

9Whether qualifications are
renewed or not

Basically none.
Regular attendance at practicaltraining courses is recommended.

Basically none.
Regular attendance atdesignated training sessions is
recommended.

FSM 2 Commitment of management or senior management●Requirementｓ
Management or senior management shall show evidence of its commitment to building,
implementing, maintaining and continually improving its food safety management systems.
The organizational structure for the implementation of the food safety management system must
be clearly defined and the duties must be made known to all employees. Evidence must also be
maintained that employees have been made aware of them.
●Concepts, specific examples
1. Management or senior management is responsible for the establishment, implementation,
maintenance, and continuous improvement of the food safety management system anddemonstrates its commitment to the establishment, implementation, maintenance, andcontinuous improvement of the system through the implementation of the following.
1） Develop a food safety policy.
2） All organizations involved in food safety and their respective roles are clearly defined andmade known to all employees.
3） Communicate to employees in a timely manner the importance of compliance with laws andregulations, social norms, and rules set by the organization.
4） Establish business goals that support food safety.
5） Review the food safety management system in a timely manner.
6） Provide necessary resources in a timely manner.
7） Continuous improvement is required from verification of HACCP procedures 11 and FSM
14 and 22.
8） Other matters necessary for the establishment, implementation and maintenance of foodsafety management systems
2． Evidence of employee awareness" includes documentation of communication through foodsafety-related employee communication opportunities and training, as well as wall postings.

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 effect10

on food safety are in compliance with the laws of both the country of manufacture and the intended
country of sale.
●Concepts, specific examples
1. The organization shall identify the food safety laws and regulatory requirements for its own
organization and establish methods of control. Not only the laws and regulations of thecountry of manufacture, but also the laws and regulations pertaining to food safety in the
country of sale must be observed. Whenever there is a revision of relevant laws andregulations or the enactment of new laws and regulations, it is necessary to grasp them in atimely manner and communicate them within the organization to change the system. The
legal and regulatory requirements of the country of sale must also be understood.
2. Those to be referred to in the legal and regulatory requirements pertaining to food safety (thisitem is applicable to the extent in Japan)
A food sanitation manager or food sanitation supervisor who meets the necessary
requirements shall be assigned.
1) Food Hygiene Manager: This is placed in accordance with Article 48 of the Food Sanitation
Law. Target foods are whole milk powder, sweetened milk powder, adjusted milk powder, meatproducts, fish meat ham, fish meat sausage, irradiated food, edible oils and fats, margarine,
shortening, and additives.
2) Food Sanitation Manager: A food sanitation manager is appointed for each facility that is to belicensed to operate, except in cases where a food sanitation manager is appointed inaccordance with the Food Sanitation Law Enforcement Regulations.
(See FSM 1, ● Items to be referred to in the legal provisions related to food safety.)
FSM 6 Food Safety Policy and Goals●Requirementｓ
Management or senior management must have a clear, concise, written food safety policy.
●Concepts, specific examples
１． Management or senior management should create a food safety policy that meets safe andappropriate quality standards and that all employees understand and recognize. The policy
should be developed with the following in mind.
１）The organization provides safe and trusted food products to consumers based on the
consumer.
２）Respond appropriately to changes in the social environment and comply with laws,
ordinances, fair rules and social norms.
２．To ensure that all employees understand and recognize the food safety policy, for example;
１) Always teach it during employee training.
２) Posting the policy in a place where employees can see it on a regular basis.
３) Communicating the policy at morning meetings. etc.
３. Food safety policies should be developed with the involvement of management or senior
management, and food safety policies should be reviewed periodically for adequacy.
FSM 7 Food Defense●Requirementｓ
11

The organization must identify the risk of intentional food contamination by persons within or
outside the organization, assess the magnitude of the risk, and prioritize and implement response
measures to reduce or eliminate the risk.
●Concepts, specific examples
１． Food defense means the means of preventing, avoiding, or responding to intentional foodcontamination by biological, chemical, or physical hazards.
２． Identifying the risk of intentional food contamination by persons within or outside theorganization and assessing the magnitude of that risk is called a food defense vulnerability
assessment, and the response plan is called a food defense plan.
３． In the vulnerability assessment of food protection (analyzing threats and identifying weak
points), it is necessary to envision situations in which intentional food contamination or
tampering with food products is possible, discover areas with a high probability of occurrence,and then determine priorities such as access control.
４． Develop and implement procedures to conduct a vulnerability assessment of the facility(analyze threats and identify weaknesses).
５． Based on the results of the vulnerability assessment, develop and implement a food defense
plan that includes methods, responsibilities, and decision criteria to prevent intentional foodcontamination and tampering.
６． The product defense plan will include the following elements.
１）A responsible person with responsibility for food protection must be designated.
２）Have policies and procedures in place to record and control the entry and exit of employees,
contractors, and visitors to and from the facility area.
３）Procedures must be in place to ensure safety during storage and delivery of raw materials,
utensils, containers and packaging materials, drugs, and food products.
４）The site must be physically secured (security)５）Have procedures in place for how to respond when food, packaging, or equipment is foundto be intentionally contaminated or defective６）Have an effective recall program (see FSM 22)７）Provide necessary education and training to personnel according to the organization's foodprotection plan
【Reference】
１． In addition to monitoring cameras and locking controls, communication among employees is adeterrent to food protection.
２． Excessive reliance on hard measures of food defense may in fact damage the good
relationship between employees and management. Thus, for example, an organization may
explain to employees that monitoring cameras are not installed based on suspicion of
employees, but rather to provide proof of employee behavior 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 short-term workers or disgruntled
or disgruntled workers is particularly useful.
４ A mechanism is needed to examine trends in social examples, examples of other companies
in the same industry, prevention examples, and predictive signs.
５. The "Guidance for Formulating a Voluntary Action Plan for Enhancing Confidence in the Food
Industry" - Five Basic Principles - published by the Ministry of Agriculture, Forestry and
Fisheries in March 2008 is a useful reference.
(Basic Principle 1) Clarify the consumer's point of view
12

(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 information
FSM 9 Document and record management●Requirementｓ
The organization shall establish and implement procedures to control processes to ensure foodsafety and to create, maintain, and preserve documents and records to evidence effective
operations.
Records shall be taken and properly maintained as determined necessary to demonstrate theimplementation of food safety controls.
●Concepts, specific examples
１．Concepts in the FSM9１）It is important to maintain the FSM9 to" ensure that the necessary settings are retained" and"can be explained to third parties, and that records are kept without shortages and can bereviewed at a later date".
The following actions are required.
（１）Necessary documents have been selected.
（２）Selected documents are stored and used in the latest version.
２． What is "documentation"?
１）" Documentation" includes not only documents and document data, but also images,
photographs, diagrams, audio, and video, and fulfills the following purposes（１）Ensure that everyone but the creator knows exactly what is going on in your company, yoursetup, and your procedures（２）Standardize work and prevent variation in perception and understanding among individuals（３）Records are kept to enable tracing and investigation of causes (see "Records" below)（４）Facilitates correct explanations to third parties and clarifies the legitimacy of your organization２）Documented documents should be managed so that the latest version can always bereferenced and operated. For this reason, it is desirable to establish appropriate rules formodifying and storing documents, and to consider a system that can be managed as easily as
possible. An example is as follows.
（１）Specify where documents are to be stored（２）Create a list of documents（３）Attach a setup number, obsolete number, etc. to the document to make it clear that it is thelatest version(4) Discard old versions or store them in a designated place to prevent misuse
３．This standard and documentation
１）The following table lists the items that are clearly "required to be documented" in this standard.
Even if the requirements do not directly require "documentation and records," there are cases
where it is optimal to present them in writing. On the other hand, the existence of a large numberof documents leads to complicated management.
If it can be judged that "it can be handled by methods other than documents," reducing thenumber of documents appropriately may be effective for both the on-site work of workers and theoperation of managers.
13

It is desirable to consider the appropriate measures and take actions suitable for one's own
organization.
４．Record
１）Record keeping will enable the following actions to be taken.
（１）Clearly demonstrate appropriate food safety management systems to third parties（２）Able to analyze trends in activity over a 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 complexityof the organization's operations.
３）Some documents, mainly records, require long-term storage. Therefore, "appropriate storage
period" should be set in consideration of the shelf life of products and other factors.
Therefore, "appropriate storage period" should be set in consideration of the shelf life of products,
etc., and the documents should be managed so that they will not be disposed of by mistake
during that period.
４）Stablish "rules for amending records" so that corrections such as erroneous entries will not besuspected of being "falsification." For example, "Corrections should be made with double lines,
and the date of correction and the name of the person who made the correction should be written
on the corrected part, etc. It is desirable to establish a method that can be clearly understood by athird party.

【Documents and records required by the requirements】
No.

item

FSM６

Food Safety
PolicyContent of documentation orrecords
Clear, concise, documented
food safety policies

FSM13.2 SupplierManagement

Documentation of results ofsurveys, evaluations,approvals, and follow-up with
suppliers

FSM14

Traceability

Record results of traceability
verification

FSM22

Serious IncidentManagement

FSM25

Corrective
ActionRecords of annual testing toverify the effectiveness of theaccident response manualCorrective Action
Documentation

HACCP
Step12Documentation
and record
keeping

Create the necessary
documentation (in HACCP)
and keep records

GMP６

Sanitation, work
clothes andhealthDocument appropriate
sanitation standards for
employees
14

check

remarks

All documents and records
required by HACCP are
required to be documented
and recorded in thisprocedure 12.

management of
employees, etc.
GMP11

Air and water
management

Records of periodic monitoringof air, high-pressure gas,
water, etc. used in foodproduction●Items to be referenced in legal provisions related to food safety
Procedure Manual for Cleaning, Washing and Sanitizing
Food Sanitation Act Enforcement Regulations, Article 66-2, paragraph 3(ii) Taking into consideration the structure and materials of facilities and equipment, machineryand appliances, and the processes of manufacturing, processing, cooking, transporting, storing,or selling food, a procedure manual (hereinafter referred to as a "procedure manual") toproperly implement measures necessary for public health in these processes(iv) Verify the effectiveness of the sanitation management plan and procedure manuals, andreview their contents as necessary.
Record Keeping
Article 66-2, paragraph (3) of the Ordinance for Enforcement of the Food Sanitation Act(iii) The status of implementation of sanitation management shall be recorded and preserved.
The period for keeping records shall be reasonably set based on the period until the food or
additives handled are used or consumed.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of theFood Sanitation Act(iii) Sanitation control of facilities, etc.
(d) For instruments such as thermometers, pressure gauges, and flow meters, and forequipment used for sterilization, disinfection, sanitization, or water purification, their functions
shall be periodically inspected, and the inspection results shall be recorded.
(iv) Control of water used, etc.
(e) When water suitable for drinking is used and sterilization or water purification equipment isinstalled, periodically check that the equipment is working properly and record the results.
(v) Rats and insect control
Rats and insects shall be exterminated at least twice a year, and records shall be kept for aperiod of one year.
(xiv) Others(a) To the extent necessary to prevent the occurrence of food sanitation hazards, efforts should
be made to prepare and preserve records concerning the source of purchase, state of
manufacture or processing, shipping or sales destination, and other necessary mattersconcerning the food or additives handled.
(b) When self-inspections have been conducted on manufactured or processed products, efforts
shall be made to preserve the records.
FSM 11

Procedures and Instructions●Requirementｓ
Organizations must consider relevant safety requirements when designing products andmanufacturing processes. The organization shall establish, implement and maintain effective
15

procedures and instructions in all processes and activities that affect food safety. These work
procedures and instructions must be visible to employees.
●Concepts, specific examples
１． For all processes and operations that affect food safety, roles are to be determined andprocedures are to be shared.
２．Procedures should be disseminated in a manner that is easily understood by those involved,
using documents and other means as necessary.
３． The key points of the procedures and documentation are as follows.
１）Procedures should be determined for all processes that affect food safety.
２）It should be easy to understand and can be used when new employees join the company
and for re-training.
３） It will be easier to create the document if "when, where, who, what, and how it should bedone" is clarified.
4．Depending on the situation where employees are becoming multilingual, it is desirable toaddress the issue in the language used by the employees, in writing or otherwise, wheneverpossible.
●Items to be referenced in legal provisions related to food safety
Management and Operation Procedure
Article 66-2, paragraph (3) of the Ordinance for Enforcement of the Food Sanitation Act(ii) A procedure manual (hereinafter referred to as a "procedure manual") for appropriately
implementing measures necessary for public health in these processes, taking into consideration
the structure and materials of facilities and equipment, machinery and appliances, and theprocesses of manufacturing, processing, cooking, transporting, storing, or selling food, and (iii)
Prepare a sanitation management plan and procedure manual as necessary.
(iv) Verify the effectiveness of the sanitation management plan and procedure manuals, andreview their contents as necessary.

FSM 12

Resource Management●Requirementｓ
Management or senior management must ensure that the organization has the management
resources (people, goods, and money) necessary to implement the organization's food safety
initiatives (hazard control (HACCP) and Good Manufacturing Practices (GMP) in this standard).
●Concepts, specific examples
1. Management or management should make management resources (people, goods, andmoney) available to ensure food safety.
2. Since management resources are limited, management should determine priorities and devise
ways to maximize effectiveness and ensure that food safety is implemented in a rationalmanner.
3. Management or senior management must constantly check to ensure that goals and plans are
not in line with reality and that front-line employees are well educated and trained to respond tochanges in the manufacturing environment.
4. Specific management resources are as follows
16

(1) Human resources: employees (number and competence), etc.
(2) Goods: buildings, interiors, machinery, equipment, facilities, etc.
(3) Money: funds used for food safety activities
5. Example 1 of Rational Implementation: Training
External training, for example, can be difficult to conduct on a regular basis due to the high costof training a large number of workers, but if one person receives training and internal training is
conducted and deployed horizontally, it is possible to share the latest information throughout theorganization.
6. Example of Reasonable Practice 2: Interior
When a facility has deteriorated due to long-term use, it is effective to prioritize items in order of
their direct impact on food safety and to prepare the manufacturing environment over a periodof several years, rather than repairing everything at once.
FSM 13.1

Purchasing●Requirementｓ
The organization must develop and implement purchasing procedures to ensure that all
externally procured raw materials, materials, and services that affect food safety comply with theorganization's requirements.
When processes affecting food safety are subcontracted, control of these processes must be
ensured by presenting the control methods to the subcontractor, for example, by describing thecontrol methods in specifications and contracts.
●Concepts, specific examples【 Procurement】
1. This standard requirement requires that each organization establish and implement proceduresto verify what it purchases from outside sources according to the magnitude of the risk it poses tofood safety.
2. Confirmation method means to determine whether or not what is purchased from outside
conforms to the specifications established by the company, and specifically includes thefollowing.
1) Inspection of a sample representative of the lot of what is to be purchased
2) Acceptance inspection of items to be purchased
3) Compliance with specifications in Certificate of Quality and Certificate of Analysis
3. The ultimate responsibility for food safety when making purchases rests with the purchasingorganization.
4. FSM 13.1 requires management of what the organization purchases from outside (rawmaterials, containers and packaging materials, and services), whereas FSM 13.2 requires
management of their suppliers (suppliers and providers).
5. In some cases, purchasing procedures are exempted from application when purchasing from (oraccepting) an intra-group company. However, this requirement requires that the same
purchasing procedures be applied when purchasing from an intra-group company as whenpurchasing from an external source.
6. Laws, regulations and regulatory requirements pertaining to food safety to which reference
should be made1) Requirements for raw materials(1) Packaging materials are capable of adequately protecting products from contamination anddamage and are properly labeled.
(2) Raw materials that are properly controlled are to be procured.
(3) Management of agricultural, forestry, livestock, and fishery products (primary products) usedas raw materials includes the following①Prevention of contamination by dust, soil, or sewage is implemented at the production stage.
17

② Appropriate management of wastes, toxic substances, etc. at the production stage.
③Prevention of contamination by pesticides, veterinary drugs, feed, rodents/insects, foreign
substances, microorganisms, feces, etc. is implemented at the production stage.
④Facilities at the production stage are maintained clean and properly managed throughcleaning and appropriate repairs.
⑤Prevention of contamination by rodents, insects, chemical substances, foreign substances,microorganisms, etc. is implemented at the stage of collection, storage, and transportation.
⑥Clearly inedible materials are separated.
⑦Temperature and humidity control and other necessary measures are taken to prevent
spoilage and deterioration of food products.
⑧ Hygiene control is conducted for those who handle the food.
(4) When it is obvious that raw materials contain parasites, pathogenic microorganisms,
pesticides, etc., or foreign substances, and these cannot be killed or removed to an acceptablelevel by normal manufacturing and processing, such raw materials will not be accepted.
2) Requirements for packaging materials used for food products (the scope of this item applies inJapan)(1) Use appropriately controlled products that are manufactured and processed in accordancewith laws and regulations such as the Standards for Foods and Additives (1959, Ministry of
Health and Welfare Notification No. 370) and whose safety is assured.
(2) When selecting packaging materials, select materials with appropriate gas 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 with materials and surface treatments that will not peel off labeling or erase
printing due to friction or adhesion of condensation drops during distribution and storage.
(4) When reusing packaging materials, prepare a procedure for reuse in advance and manage it
so as not to contaminate the product. In case of damage or significant contamination,
discontinue use and dispose of the product.
(5) Packaging containers and packaging gases should be non-toxic and should not impair thesafety and suitability of the product for storage and use.
(6) Reusable packaging materials and containers/packaging should be durable, easy to clean
and wash, and disinfectable.
(7) Raw materials that do not conform to the acceptance criteria should be handled according to
documented procedures to avoid accidental use.
(8) In order to further enhance the safety of synthetic resin food utensils, containers, andpackaging, the Law for Partial Revision of the Food Sanitation Law, etc., promulgated on June
13, 2008, introduced the positive list system, which allows the use of only substances that havebeen evaluated for safety with respect to food utensils and containers and packaging. (Ministryof Health, Labour and Welfare, June 2040). (Enacted on June 1, 2020 by the Ministry of Health,
Labor and Welfare)【Subcontractor management】
1. Outsourcing is the process of outsourcing an organization's own processes to anotherorganization. The organization periodically monitors and verifies the outsourced process toensure that the results of the outsourced process do not pose a food safety hazard to theorganization's products.
2. This outsourcing includes not only product manufacturing by contractors and services provided
by personnel dispatch, but also the provision of services. This outsourcing includes not only
product manufacturing by contractors and services provided by personnel dispatch, but also
the provision of services. The services provided by the provider include transportation andstorage, inventory control (see GMP 15 and 17), insect, rodent, and sanitation consultants,
sanitation of workplaces and facilities, maintenance of equipment and facilities, cleaning ofwork clothes, provision of meals for employees, etc.
18

3.

The ultimate responsibility for the food safety management system in the case of outsourcing
rests with the contractor.
4. Any changes to the contractual arrangements must be approved by both parties andcommunicated to the relevant personnel.
5. Covered subcontractors include contract manufacturers and service providers.
1) Contract manufacturers agree to and contract with all terms and conditions related to foodsafety, customer requirements, commercialization, shipping, etc.
The contract manufacturer shall develop and implement an organization to ensure compliancewith the terms of the contract.
２) Contracted service providers document and contract specifications for services affecting foodsafety.
３) The contract shall include training of personnel involved in providing the services as well as
clarification of the services.
6. Outsourced supplier management is described in the flow diagram required by HACCP
Procedure 4, if necessary, and control methods are determined through the hazard factor
analysis required by HACCP Procedure 6. In addition, an evaluation of suppliers is performedin accordance with FSM 13.2.
7. The following contents shall be performed as necessary to ensure the appropriateness ofoutsourcing.
1) Confirmation of food safety management system
2) Confirmation of the product process control system
3) Verification of accuracy and results of in-process inspections
4) Periodic verification of final products
5) Ensure food safety from physical and chemical aspects
6) Verification of personnel competence and education/training system
８． With regard to the operation of HACCP, when outsourcing CCP processes, etc., themanagement system, process control, and conformance of the final product must be equivalent
to the food safety management system established by the own organization.

19

Example of Supplier Data Entry Form (Product Specification)

20

FSM 13.2

Supplier Performance●Requirementｓ
The organization shall establish, implement and maintain procedures for the evaluation, approvaland continual monitoring of suppliers, which have an effect on food safety.
When accepting raw materials, packaging materials, and services from unapproved suppliers in an
emergency (such a natural disaster), the organization shall confirm that the products meet therequired specifications by an evaluation, inspection, visit, etc. before use.
The results of investigations, evaluations, approvals, and follow-up with suppliers must be
documented.
●Concepts, specific examples
1. This requirement requires that the organization establish and implement procedures to control
suppliers (suppliers/providers) of raw materials, containers/packaging materials, and services
that affect food safety based on risk assessment.
2. In the event of an emergency, when supplies are received from unapproved suppliers, this is
only an acceptable emergency measure and assumes that raw materials, containers andpackaging materials, and services are purchased from approved suppliers.
3. The controls required of the organization are to establish and implement procedures for theevaluation, approval and monitoring of suppliers, which are described in detail below.
１）Evaluation
After determining the person responsible for the evaluation, the necessary related information
shall be collected and evaluated with reference to the following methods and contents.
(1) Evaluation Method① Verbal interview② Document and record checks③ Visit and on-site confirmation or audit(2) Assessment Contents① Information on supplier organization: organizational reliability, product supply capacity,
manufacturing site operational status, quality assurance system, supplier evaluation results(records related to bilateral audits, third-party certification, etc.), compliance, traceability② Information on delivery method: delivery date, delivery location, delivery conditions(temperature, humidity and special environment), etc.
③ Whether or not there are any cases of food product mislabeling at the raw material
origin/supplier④ Whether there are any circumstances that are likely to cause falsification (i.e., prices ofsuppliers used are extremely lower than market prices, market prices of raw materials soar,
supply is tight, shipping times are frequently moved forward, rapid increase in order volume,
understaffed production system).
(3) Qualifications and competence of evaluators
Personnel in charge of conducting supplier evaluations shall be knowledgeable of the items
listed in the specifications and applicable laws and regulations, and shall be audit-trained.
2) Approval
The organization defines who approves suppliers based on the evaluation results. Then, therules/processes for the approver to approve and the method of information sharing with the
HACCP team shall be defined as a procedure.
3) Monitoring
Rules (method, frequency, timing, etc.) for periodic re-evaluation of suppliers are defined as aprocedure. Monitoring also includes activities related to follow-up, such as suspendingtransactions with suppliers or providing guidance to suppliers in case of problems, depending on
the results of a series of evaluations of suppliers.
21

4. This requirement refers to the supplier's food protection, but it does not require a level ofcompliance with FSM 7 (food protection) to this standard, but rather allows the supplier to define
its own scope of applicability and initiate its own initiatives for food protection. This is anacceptable level. 5.
5. In emergency situations (e.g., natural disasters), it is anticipated that an immediate decision may
be required when evaluating unauthorized suppliers. This standard requirement does not permit
omitting the point at which suppliers are evaluated under normal circumstances, but it ispermissible to shorten the time period for checking, provided that equivalence is recognized in
the method.
6. In addition, this includes maintaining objective evidence of equivalence between products using
raw materials, packaging materials, and services purchased from unauthorized suppliers andnormal products at the time of product shipment (release).
Example of New Purchaser Data

●Items to be referenced in legal provisions related to food safety
Appended Table 17 (Re: Food Sanitation Enforcement Regulations, Article 66-2, paragraph 1)
14 Other(a) To the extent necessary for preventing the occurrence of food sanitation hazards, efforts shallbe made to prepare and preserve records concerning the source of purchase, the state of
manufacture or processing, the destination of shipment or sale, and other necessary mattersconcerning the food or additives handled.
(b) When self-inspections have been conducted on manufactured or processed products, efforts
shall be made to preserve the records.

FSM 14

Traceability●Requirementｓ

22

The organization must establish procedures for implementing and maintaining tracing, covering allprocesses from the supplier (at least one step before) to the recipient (at least one step after) toensure product identification.
The organization must verify such procedures at least annually through trace testing to ensure thatthey are functioning effectively. And the verification results shall also be recorded.

●Concepts, specific examples【Traceability in the FSM14】
1. Traceability records are important to confirm the manufacturing process of the subject productand to assure the safety of the food in the event of a serious product accident.
2. "Recipient" in this requirement basically refers to the purchaser one step further in the foodchain, and does not necessarily include the final consumer of the product. Recipient" may also
refer to wholesalers, retailers, etc., who handle the shipped product.
3.Shipped products are not always delivered to the purchaser, but may be delivered to awarehouse designated by the purchaser. Therefore, this requirement requires that the owner ofthe product and the "recipient" where the product is actually placed be known so that speedy
action can be taken when a problem occurs. Raw materials, containers and packaging
materials, services, and outsourced processes purchased from outside (hereinafter referred toas "raw materials, etc.") are also basically subject to traceability up to one step before.
4. each organization is required to reliably identify the supplier (at least one step before) to therecipient (at least one step after). By linking these organizations, the entire supply chain can betraced.
【Recorded information required for traceability】
５．The maintenance and provision of record information necessary for traceability is as follows
1) Maintenance of traceability(1) Establish procedures related to traceability, depending on the product (including identifiable
labels for raw materials and products, as well as external procurement).
(2) Identify the status of raw materials at the main product stage (including primary processed
products).
(3) Establish lot units for products and raw materials as necessary.
(4) Establish and implement procedures for preparing and maintaining records of incoming andoutgoing shipments.
(5) Confirm that traceability is functioning, including work in process, recycled products, andreworked products.
(6) If necessary, product samples for each lot are stored.
2) Provide records related to traceability(1) Establish and implement procedures for the preparation of records and the retention ofrecords.
(2) When requested by the government, submit records related to traceability.

23

Examples of records required for process and tracing
accessioning
Product Information

manufacture

custody

shipping

Ingredient
Information

Daily Production
ReportProducttemperature records

Product Shipping
Information

Food Safety
Information

Inspection records

Inventory records

Destination
Information

Internal temperaturerecordDelivery Vehicle
Temperature
RecordProcess records

Receiving
Inspection Records
Environmental
Information

Delivery Vehicle
Temperature
RecordDelivery vehicle
hygiene records

Sampling
Information

FSM 16pre-sampled
product record

GMP-Related
Records
Person in charge
information
Quality Control
Inspection andAcceptance

Delivery vehicle
hygiene records
Quality Control
Thermometer
Calibration Record―

Allergen Management●Requirementｓ
The organization must develop and implement an allergen control plan. The plans shall include arisk assessment of allergen cross-contamination and control measures to be implemented to reduceor eliminate the risk of cross-contamination.
All finished products containing or potentially contaminated with allergens must be identified inaccordance with the laws and regulations of the country to which they are expected to be shipped.
●Concepts, specific examples
1. Allergens to be controlled
Substances that cause allergies are called allergens. In Japan, the following allergens are requiredor recommended for labeling. In this standard, accid ents due to food allergens in consumers
should be considered.
Items subject tomandatory labeling(7 items)
Target items forwhich labeling is
recommended (21items)*From Food Labeling Standards (as of September 19, 2019)

2. Allergens to be controlled within all manufacturing facilities must be identified, a plandeveloped, implemented, and properly maintained.
1) Identify allergens that may be present based on the specifications of the raw materials used.
242） Differentiation of receiving and storage locations for each different allergen3） In accordance with the production plan, allergens to be controlled are to be identified so thatthey can be checked on each production line.
4) Distinguish between machinery and equipment used in the weighing room.
5) Identify locations in the manufacturing facility where allergen powder is dispersed andimplement measures to prevent dispersal.
6) Switch lines that cannot be cleaned with water (powder, oil and fat products (chocolate,spreads, etc.))
7) Label and control the use of allergens on recycled products and work-in-process products8） Measures to prevent labeling errors
9） In controlling allergens, the laws and regulations of the country of sale (allergen labeling
regulations) must be observed.
３．Develop control procedures to reduce or eliminate the risk of cross-contact. Examples of control
procedures include the following. Examples of control procedures include the following
1） Containers and utensils (plastic bags, shovels, etc.) used in production should be identified foreach allergen to be controlled and avoid mixed use.
2) Procedures for handling raw materials (including containers and packaging materials), semifinished products, work-in-process products, reworked products, and finished products should be
developed to prevent allergen cross-contact in all processes from manufacturing to shipping.
3) Determine methods for cleaning, washing, and verifying manufacturing processes to preventcross-contact.
4) When different products are manufactured on the same production line, plan to produce them inthe order of least allergenic to most allergenic, if possible.
4. When developing products containing allergens, confirm the validity of control by line testing, etc.
5. When preparing product labeling, allergens are labeled in accordance with the laws andregulations (allergen labeling regulations) of the assumed marketing countries.
6. If verification (analysis, etc.) is required, establish and implement the procedure, and record andstore the verification results.
7. To establish and implement procedures to ensure that items required in relation to contamination
in FSM 13-1 (Purchasing), 13-2 (Supplier Management), FSM 18 (Product Labeling), GMP 3, 4,
5, 17 (Manufacturing Processes), etc., are in compliance. (Requirements related to contaminationin manufacturing processes, etc.).
FSM 17

Control of Measuring and Monitoring Devices●Requirementｓ
The organization shall identify measuring and monitoring devices that are parameters critical toensure food safety.
In addition, the specified equipment and devices shall be calibrated regularly. Calibration of these
instruments and devices must be performed to equivalent standards, including national andinternational standards, or to reasonably accepted traceable methods.
●Concepts, specific examples25

１． It is necessary to clarify the measuring instruments for parameters that are important to ensure
food safety, and to identify those instruments that are necessary for monitoring. Measuring
instruments that are not relevant to ensuring food safety are not included in the scope.
2. "Calibration" here is one of the means to confirm the validity of the measurement of numericalparameters and is a verification. It includes international standards, national standards,
domestic calibration/manufacturer's assurance and in-house verification, etc. From among
these, it is necessary to determine the appropriate method in the target equipment or device
and inspection.
3. Calibration is required for instruments, devices, and methods used in measurement andmonitoring activities.
4. Calibrated instruments and devices for measurement/monitoring, testing, and inspection are to
be controlled to prevent damage or misadjustment.
5. Calibration is to be performed in accordance with legal requirements, the schedule
recommended by the equipment manufacturer, and the schedule determined by theorganization
6. Record when measuring, monitoring, test, and inspection instruments and devices are found to
be inaccurate, and establish procedures to evaluate and take appropriate action on potentiallyaffected products●Items to be referenced in legal provisions related to food safety
Sanitation of facilities, etc.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of theFood Sanitation Act(iii) Sanitation control of facilities, etc.
(d) For instruments such as thermometers, pressure gauges, and flow meters, and forequipment used for sterilization, disinfection, sanitization, or water purification, their functions
shall be periodically inspected, and the inspection results shall be recorded.

26

FSM 18

Product labeling●Requirementｓ
Organizations must label or attach information to their products that will enable a trading partner or
consumer to safely handle, display, store, store, prepare, or use the product.
It must also establish and implement procedures for labeling or attaching the correct information.
●Concepts, specific examples
1. Information required by laws and regulations (allergens, food additives, etc.) should be provided
in accordance with the methods and procedures specified in the laws and regulations.
2. The following items should be considered from a food safety standpoint when labeling products.
1) Clarify the intended users and target consumers, such as the point of sale.
2) Clarify the product's specific eating conditions, such as for raw consumption or for cooking.
3) Clarify the intended use of raw materials and seasonings.
4) Basis for setting expiration dates and best-before dates should be clarified.
5) Handling temperatures and methods should be clarified.
3. Information required for products should be printed or attached to packaging materials based on
product specifications.
4. Procedures are to be established to confirm that the contents of the labeling are correct. 5.
5. Procedures are established to ensure that products and labeled packaging materials are not
mistakenly mixed up.
Product Labeling Considerations (Example)■Check the expiration date labeling.
●Confirm that the date is correct.
・Check the date of expiry by multiple workers.
・Check the date on the work instructions, calendar, etc.
Common misprints

・The date should be confirmed on a work instruction sheet, calendar, etc. Record the date by attaching the printed packaging to a confirmation sheet,etc.
●Points to check・Check that the date is correct.
・Are there any errors in the printing location?

Letters are blurred・Are there any blurs, chips, blots, or omissions in the printing?
Be careful when the year or month changes!
●Present a reminder of the printed contents on the packaging line.

(Partially quoted from "Explanation of the Matters for Upgrading Infrastructure Development" (Food Industry Center, Japan))27

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

●Items to be referenced in legal provisions related to food safety
Display
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(ix) Provision of information(a) Business operators shall endeavor to provide consumers with information necessary for themto safely consume food or additives (hereinafter referred to as "products" in this table) that theycollect, manufacture, import, process, prepare, store, transport, or sell. (a) A business person
shall endeavor to provide consumers with the information necessary for consumers to safely
consume and eat the food or additives (hereinafter referred to as "products" in this table).
(b) A business person shall endeavor to provide consumers with information necessary for the safe
consumption of food or additives (hereafter referred to as "products" in this table), including
information on health hazards (limited to those symptoms diagnosed by a physician as beingcaused by or suspected to be caused by said food or additives. The same shall apply
hereinafter in this item). (ii) When obtaining information on the health hazards of a product(limited to those that have been diagnosed by a physician and that are caused or suspected tobe caused by said food or additive) and information on violations of the Law, a business person
shall endeavor to provide said information to the prefectural governor, etc.
(c) When a business person obtains information about a product from a consumer or a person who
handles the product that is undeniably likely to lead to the occurrence of a strange taste or odor,
contamination with a foreign substance, or other health hazard, the business person shallendeavor to provide said information to the prefectural governor, etc.

FSM 19Analysis and Inspection●Requirementｓ
The organization shall conduct appropriate inspections where and as they affect food safety.
Such inspections must be performed by a competent laboratory or analytical laboratory.
28

●Concepts, specific examples
１．To ensure food safety, inspection plans should be developed to ensure that inspection of
products, semi-finished products, raw materials and environmental wipe test specimens are
conducted systematically for items that affect food safety and legal requirements, as well as
product requirements from customers.
２． The laboratory or analytical laboratory with testing competence should be using procedures,
validated methods, etc. that conform to ISO 17025 to ensure that this testing method is a valid
result. The results of such inspections should be verified on a regular basis.
３． Documentation is required that defines procedures (methods, standards, etc.) for incoming
raw material inspections, as well as inspections of manufacturing processes and products.
Inspection details and records specified in the inspection control rules (example)
Inspection Contents
Inspection
Name

Subject ofInspection

supplier

name

Lot No.

volumestandard

Materials

〇

〇

〇

〇

〇

Raw
materials

〇

〇

〇

〇

〇

In-house
Acceptance
InspectionRawmaterials

〇

〇

〇

〇

〇

In-processinspection

Semifinishedproducts

〇

〇

Final
Inspection

Finishedproduct

〇

〇

〇

〇

Outgoing
Inspection

Finished
Products

〇

〇

〇

〇

Color, odor

appearance

Tasks

Temp.

time

Metals,foreignmatterSize, shape

Damage,
dirt

〇

〇

〇

〇

〇

〇

〇

〇

foreignsubstance

Shipment
Date

Shipping to

Packing
condition

microbePurchasing
Acceptance
Inspection

〇

〇

〇

Records

Receiving
Control
Chart

In-processinspection
list

〇

〇

〇

〇

Final
Inspection
Chart

〇

〇

〇

〇

〇

Shipping
Instructions
and Shipping
Inspection
Chart●Items to be referenced in legal provisions related to food safety
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of theFood Sanitation Act
14 Other(a) To the extent necessary for preventing the occurrence of food sanitation hazards, efforts shallbe made to prepare and preserve records concerning the source of purchase, state of
manufacture or processing, shipping or sales destination, and other necessary matters pertaining
to the food or additives handled.
(b) When self-inspections have been conducted on manufactured or processed products, efforts
shall be made to preserve the records.

FSM 21 Complaint Handling●Requirementｓ
The organization must establish, implement, and maintain a management system that utilizes
complaints from suppliers and consumers and their data to identify, correct, and manage
omissions and deficiencies in food safety initiatives.
●Concepts, specific examples
1. A distinction should be made between food safety-related events and other events, forexample, those related to quality. What is required in this item are events related to foodsafety.
29

2. For complaints from suppliers and consumers, the key to promptly resolving complaints is toestablish a system to properly identify and promptly respond to complaints.
3. Procedures for responding to complaints should include the following.
The following are possible procedures for establishing a system to respond to complaints.
1) A manual on how to respond to complaints from suppliers and consumers should be
prepared.
2) Employees should be aware of their responsibility for handling and investigating complaints
from clients/consumers.
3) The company shall try to understand as accurately as possible what the complainant wants in
response to a complaint from a supplier or consumer. If the complainant wants answers to
his/her questions regarding the investigation of the cause of the complaint (including
presumption), responses to the product complained of, and measures to prevent recurrence,
etc., the employee shall inform the complainant that the information will be provided
appropriately. At that time, if necessary, a deadline for a response will be given. (When it isfound during the investigation process that the cause of the complaint is not with theorganization, the complainant will be informed of this as soon as possible. (If the complaint isa false accusation or a monetary claim, the company will consider a different method ofhandling the complaint.)
4) Reply to the complainant with the details of the investigation and response to the complaint
from the client/consumer as described in 3) above, and record the details.
5) Examine the cause of the complaint and its relation to GMP and HACCP systems, find any
omissions or deficiencies in the food sanitation system, correct them if necessary, and record
the results.
6) For complaints from suppliers and consumers, the responsible person shall confirm thecompletion of the response.
2. When nonconformity is found based on a suggestion from a supplier or consumer, corrective
action shall be taken.
3. establish, implement, and maintain a system to continuously improve and control the foodsanitation system by utilizing complaints from suppliers and consumers and their data.
FSM 22

Serious Incident Management●Requirementｓ
The organization must develop an incident response manual*, implement it in the event of anincident, and maintain it in effect at all times. This manual should also describe how to remove or
recall (recall) products, if necessary.
Based on the incident response manual, products supplied by the organization must be tested atleast once a year to verify the effectiveness of the procedures and records of the verification must
be maintained.
※This manual is designed to ensure that when a food safety issue arises, appropriate actions
and controls are taken to prevent the problem from escalating.

●Concepts, specific examples30

１． 1. A critical incident is a food accident that has the potential to affect food safety, but does notinclude accidents that do not affect food safety but may affect quality.
2. Since it is often not known at first whether an accident is serious or not, it is advisable to work on
the assumption of a worst-case scenario when an accident occurs.
3. In the event of a recall accident that has a serious impact on food safety, the incident should bereported to the audit company after the initial response is complete. (Refer to the A/B program
document.) In addition, once a voluntary recall is initiated, it should be reported to the Ministry of
Health, Labour and Welfare through the health center with jurisdiction.
4. An accident response manual documenting accident reporting, product removal, and productrecall shall be prepared as follows
1) In the event of a major accident, the response shall be based on relevant management
procedures such as nonconformity handling and complaint handling.
2) Appoint an authorized person in charge for critical incident management.
3) Establish and maintain an up-to-date emergency contact network for customers, consumers,
and relevant authorities.
4) Appoint a person responsible for providing information to customers, consumers, and relevant
authorities to ensure effective communication.
5) Clearly define internal communication mechanisms, such as notifications to employees.
6) Conduct mock drills and reviews at least once a year based on the accident response manual
to evaluate the company's ability to respond to serious accidents.
7) To establish the severity of the accident and whether or not there is a risk to customers, theaccident should be documented and evaluated. Accident records should include the following(1) The product involved and the location of manufacture(2) Quantity of product affected(3) The extent of the affected product (lot, batch, etc.)(4) Records of manufacturing(5) Quantity and location of shipments made
●Items to be referenced in legal provisions related to food safety
Emergency response
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(ix) Provision of information(b) A business person shall provide information on health hazards (limited to those diagnosed by aphysician and diagnosed as being caused or suspected to be caused by said food or additive;
hereinafter the same shall apply in this item) from consumers concerning the product. The
same shall apply hereinafter in this item). (ii) When obtaining information on the health hazardsof a product (limited to those that have been diagnosed by a physician and that are or aresuspected to be caused by said food or additive) and information on violations of the Law, abusiness person shall endeavor to provide said information to the prefectural governor, etc.
(c) When a business person obtains information about a product from a consumer or a person who
handles the product that is undeniably likely to lead to the occurrence of a strange taste or odor,
contamination with a foreign substance, or other health hazard, the business person shallendeavor to provide said information to the prefectural governor, etc.
Collection Mechanism
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(x) Recovery and disposal(a) In the event of food sanitation hazards or the threat of such hazards arising from a product, abusiness person shall, from the viewpoint of preventing health hazards to consumers, establish
a system for responsibility for recall, methods for alerting consumers, specific methods forrecall, and procedures for reporting to the prefectural governor, etc. having jurisdiction over the31

area where said food or additive is handled, so that said food or additive can be quickly andappropriately recovered. The procedures for reporting to the prefectural governor, etc. withjurisdiction over the area where the facility handling the food or additive is located should beestablished.

FSM 23

Product Release●Requirementｓ
The organization must establish and implement appropriate procedures for product release(shipment).

●Concepts, specific examples
Product Release Procedures
1. the procedures for releasing a product include the following
1) Verify that the product to be shipped conforms to the product specifications.
2) Verify that not only the product specification but also the process control is appropriate.
2. The following items must be confirmed prior to release
1) Release procedures are up-to-date and available to personnel2) Specifications of raw materials, ingredients, additives, packaging materials, recycled products,
rework and finished products are clearly identified
3) The final shipping decision makers are clearly identified.
4) Procedures are in place to verify that products to be shipped conform to product specifications
and that process controls have been properly implemented.
FSM 24Control of non-conforming products●Requirementｓ
The organization must create and enforce rules for not using or shipping raw materials (including
containers and packaging materials), semi-finished products, work-in-process products, recycled
products, reworked products, and finished products that may pose a safety hazard.
●Concepts, specific examples
１．These requirements set up barriers at each stage on the way to the final product, and play therole of stopping nonconformity when it occurs.
２．Raw materials (including containers and packaging materials), semi-finished products, work-inprocess products, recycled products, reworked products, and finished products that pose asafety problem are treated as nonconformities. The organization determines the responsible
person and manages according to procedures to prevent unintended use or erroneous shipmentof nonconforming items.
1) It is effective to have well-defined manufacturing and inspection procedures in advance todetect nonconformities in each process.
2) In addition to detection through manufacturing and inspection procedures, nonconformities
may also be detected through customer complaints.
323) Nonconforming products found are to be clearly identified and segregated so that they cannot
be mistakenly used. In identifying the scope of nonconforming products, appropriate
judgment should be made to ensure that nonconforming products are not mixed in withcompliant products.
4) Non-conforming products are disposed of or corrected (reprocessed, reworked, etc.).
5) After that, if recurrence prevention is necessary, FSM25 is implemented.
３． It is important to recognize that process control is capable of detecting nonconformities,
because if we recognize that the discovery of nonconformities is a bad thing, it will be difficult to
get reports from the field.
●Items to be referenced in legal provisions related to food safety
Nonconformity Management
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of the Food
Sanitation Act(v) Establishment of improvement measures
At individual critical control points, improvement measures shall be established when monitoring
results reveal deviations from the control standards.

FSM 25

Corrective Action●Requirementｓ
The organization shall establish and implement written corrective actions in the event of
nonconformities affecting food safety. (Corrective action is the process of correcting anonconformity to a condition that is not a nonconformity, determining the cause of thenonconformity and eliminating the cause of the nonconformity.)●Concepts, specific examples
1. The organization establishes and implements procedures to ensure that causes of detectednonconformities affecting food safety are eliminated as soon as possible and to prevent recurrence
2. Corrective actions are developed and implemented by those who have the competence toanalyze the causes and develop countermeasures.
3. The flow of corrective actions shall be handled according to the following procedures.
1) Grasp the actual situation of nonconformity (including customer complaints).
2) Identify the causes of nonconformity.
3) Implement necessary measures to prevent recurrence of nonconformity.
4) Review the effectiveness of the corrective actions taken.
5) It is desirable to document the sequence of actions related to corrective actions.

33

Ⅱ Hazard Analysis and Critical Control Point（HACCP）
Hazard Analysis and Critical Control Point（Control of Hazardous Factors）
HACCP is a tool for establishing a preventive control system in a process that identifies specifichazards (hazards) and their control measures for food safety and does not rely on testing andinspection of the final product.
The success of HACCP requires management and engaged personnel to work together andexpertise in a wide range of areas, including primary production, microbiology, and manufacturing
and processing techniques.
A HACCP plan is a document or set of documents prepared in accordance with HACCP principles(Codex General Principles of Food Hygiene 2020: from the first edition of 2021 by the Japan Food
Sanitation Association) to ensure control of critical hazards in food operations. A HACCP systemrefers to the development of a HACCP plan and the implementation of procedures according to thatplan (from Codex General Principles of Food Hygiene 2020: Japan Food Sanitation Association,
first edition 2021).
HACCP Step 1 Formation of HACCP team
●Requirementｓ
A HACCP team shall be assembled with competent staff.
●Concepts, specific examples
1. The HACCP team should be composed of people with various professional skills to the extent
possible, such as those in charge of the manufacturing and processing departments, quality
assurance, quality control, and engineering departments including facilities, maintenance, andmaintenance of machinery and equipment used in manufacturing, to eliminate blind spots inhazard factor analysis and to facilitate communication. The HACCP team leader (food safety
manager) should be a food sanitation manager or food sanitation supervisor who has
knowledge of the product, specialized skills, and knowledge of the product characteristics andprocesses, and who has good communication skills and can organize opinions within thecompany.
When the food safety manager and the HACCP team leader are different personnel,
coordination must be ensured.
2. Depending on the size of the business, there are many cases in which various tasks are
performed concurrently, and for this reason, the manager himself may be the team leader, or
one person may be responsible for all food safety-related actions, etc. However, it is important
to try to ensure the cooperation of employees within the company to the extent possible.
３． If there is a lack of knowledge or expertise within the organization, it may be useful to receive
outside training or to engage the participation and advice of outside food sanitation experts. A
guide for industry associations by the Ministry of Health, Labor and Welfare can be used as areference.
４． The HACCP team is responsible for managing food safety initiatives within the organization.

HACCP Step 2

Product Information Description●Requirementｓ
Product specifications shall be documented.
The document shall describe all product information necessary to conduct hazard analysis.
34

Scope of the HACCP system shall be defined per product or product group and per process line orprocess location.
●Concepts, specific examples
1 In order to clarify the characteristics of the product, the specifications and characteristics shallbe described for the final product in necessary items as follows
1) Specifically, for the final product, describe the name and type of product, productcharacteristics, names of raw materials, names of additives and standards for use, form of
packaging, units and quantities, materials of containers and packaging, expiration date or best
before date and storage method, internal targets for controlling hazards in the product(including standards specified by the supplier, such as ingredient standards for bacteria
specified by the Food Sanitation Law). (Including standards specified by the supplier, such as
ingredient standards for bacteria specified in the Food Sanitation Law).
2) In facilities that manufacture multiple products, it may be effective to group foods by similar
characteristics and processing steps for the purpose of creating a HACCP plan.
3) If the food contains allergens or there may be cross-contact of allergens within the facility, thisshould also be noted.
2. Identify the scope of the HACCP system and the appropriate GMP (PRP in Codex).

HACCP Step 3

Identification of Intended Use●Requirementｓ
Intended use of the product and target consumers shall be clearly described in a written
document.
●Concepts, specific examples
1. Describe the intended use (manner of use) and target consumers of the product in the
documentation as follows
1) Clarify the method of consumption or use and the intended consumers. Particular attention
should be paid to the contents in the case of vulnerable persons, young children, and theelderly.
2） If the intended use includes the need for cooking or precautions after opening the package,
the necessary information should be described.
2. For foods intended for susceptible populations, enhanced process controls, more frequentmonitoring, product testing to verify the effectiveness of controls, or other activities may benecessary to assure a high level of assurance that the food is safe.

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. A flow diagram should be prepared for a series of manufacturing or processing processes fromthe receipt of raw materials to the shipment of the final product, showing the operations of eachprocess along the flow. The same flow diagram may be used for a group of products
manufactured using similar processing steps.
35

2. The flow diagram is used as the basis for conducting a hazard analysis to evaluate thelikelihood that a hazardous factor will occur, increase, decrease, or be introduced.
3. The flow diagram should be accurate and detailed enough to perform a Hazard Analysis.
【Construction of Flow Diagram】
4. A flow diagram shall be prepared according to the following procedures
1) Briefly enumerate all processes and operations from receipt of raw materials to shipment of
final products.
2) Enclose the enumerated raw materials and processes in a frame, connect the frames witharrows, and number them in process order.
For raw materials, also include food additives, packaging containers, water used, gases (ifused), etc. These should be listed in the same column with a framework and an arrowconnecting them to the process in which they are used.
3) In the processing of raw materials, clearly indicate any wastes generated or raw materials
used in the processing that will be separately used in the product.
4) In the process, if there is a pass/fail judgment, reprocessing, reuse, or redo process, clearlystate it so that it can be controlled.
5) Outsourcing processes are also to be specified.
5. Drawings of the facility showing the outline of each process and the planar and threedimensional layout of the facility will help identify process points and possible crosscontamination areas and assist in the analysis of hazard factors.
Flow Diagram Example

36

HACCP Step 5

On-site Confirmation of Flow Diagram●Requirementｓ
The flow diagram shall be verified whether it correctly reflects the existing process steps of theoperation.
●Concepts, specific examples

37

1. A person with sufficient knowledge of the process should check on site as follows to ensure thatthe process is clearly defined in the flow diagram so that the hazard analysis in HACCP
procedure 6 can be sufficiently performed. It is recommended to check the flow diagram on siteagainst the layout diagram of the site.
1) On site, check in order from the upstream process to confirm that the appropriate process isshown, including temporary storage and management of semi-finished products.
2) If there is any inconsistency between the flow diagram and the processes or activities on site,
confirm with the person in charge the correct management method and revise the document.
3) Confirmation is made by observing the work at various times during the work period andchecking if the flow diagram and the work are consistent.

HACCP Step 6 （Principle 1） Hazard Analysis●Requirementｓ
Potential hazards in each process must be enumerated, the critical hazards must be identified,and all possible means to control them must be considered.
Hazards shall include allergens where required.
●Concepts, specific examples
1.Hazard Factor Analysis is to determine the critical hazard factors to be controlled by the HACCP
plan and to identify the control methods for each critical hazard factor. For this purpose,
information is first collected on hazardous factors that may occur in the entire process from raw
materials through manufacturing, processing, storage, and distribution to consumption, as wellas the conditions under which they may occur, to determine the likelihood of occurrence of
hazardous factors and the severity of the hazard if they do occur.
2. By conducting a risk factor analysis, it is possible to create an appropriate management system
for the facility according to the frequency and severity of possible hazardous factors.
3. The actual process of hazard factor analysis is to list the hazard factors in the final product by
raw material and process, which may lead to health hazards when consumed.
4. Following the flow diagram from raw materials to the final product, identify raw materials andprocesses that may lead to the occurrence of hazardous factors, narrow down the importanthazardous factors in terms of frequency and severity of occurrence of hazardous factors ineach process, and identify the factors (contamination, proliferation, survival, adulteration, etc.)
and control factors for those hazardous factors. The hazard factor analysis sheet should be
prepared to list the causes of occurrence (contamination, proliferation, survival, contamination,etc.) and the control measures to control them.
5. In preparing this sheet, all members of the HACCP team should share their expertise andknowledge, and discuss and summarize them.
《Steps to Create a Hazard Analysis Sheet》
６． The steps for preparing the Hazard Factor Analysis Sheet follow the "Example Hazard Analysis
Worksheet" shown in Codex GPFH2020.

38

【Step 1】（Column (1) of "Example of Hazard Factor Analysis Worksheet"）
List raw materials and manufacturing and processing processes according to the flow diagram.
List the main raw materials, secondary raw materials, water used, packaging materials, etc., andthe manufacturing and processing processes along the flow diagram, with the same numbers.
Perform a hazard analysis of all raw materials used in the food. This can be done in two ways.
①Perform hazard analysis on raw materials in the process of receiving raw materials.
②Perform hazard factor analysis separately for raw materials and processes.
This guideline describes the method in ①.
【Step 2】 （Column (2) of "Example of Hazard Factor Analysis Worksheet"）
List potential hazardous factors originating from raw materials and manufacturing andprocessing processes.
Hazard factors should be described in detail. For example, instead of "food poisoning bacteria,"
list "Salmonella," "pathogenic E. coli O-157," etc. Also, describe the source of contamination andthe reason for its presence, such as "contamination from a metal foreign body derived from a
blade broken during grinding" or "pieces of a kitchen knife," rather than simply "pieces of metal.
【Step 3】（Column (3) of "Example of Hazard Factor Analysis Worksheet"）
Based on the likelihood of the listed hazards and the magnitude of damage if they occur,
evaluate whether or not they are critical hazards that must be reduced or eliminated from thefood product to ensure the safety of the final product.
When conducting a Hazard Analysis to determine critical hazards, consider the following to theextent possible
1) Hazard factors associated with the type of food to be produced and processed, including raw
materials and processes (e.g., from hazard factor surveys or sampling and inspection, recalls,
scientific literature information, or epidemiological data in the food chain)2) Likelihood of occurrence of the hazard factor in the absence of additional controls, taking into
account GMP (PRP)
3) Frequency and severity of adverse health effects due to the hazard in the food in the absenceof controls4) Identified allowable levels of the hazardous factor in the food (e.g., based on regulations,
intended use, and scientific information)5) Nature of the facility and machinery and equipment used to produce the food6) Survival or growth of pathogens
397) Generation or persistence of toxins (e.g., mold toxins), chemicals (e.g., pesticides, veterinary
drugs, allergens) or physical hazards (e.g., glass, metal) in the food8) Potential for food to become unsafe due to its intended use and/or mishandling of the productby the consumer9) Conditions leading to the above
For the evaluation of hazard factors in Step 3, it is recommended to utilize a matrix table of"Severity of Occurrence" and "Frequency of Occurrence" as shown below and enter them
numerically on the hazard factor analysis sheet. There are various examples of creating a matrix
table, and it is recommended to adopt it in consideration of the target product, manufacturing
process, etc. However, this does not apply to cases where the product can be clearly evaluated ona "yes/no" basis.
An example of the concept of the likelihood of the listed hazard factors and the magnitude ofdamage if they occur.
(Based on the "Risk Assessment Handbook" published by the Ministry of Economy, Trade andIndustry in June 2011)

How to Read Matrix
It is an extremely high risk, suggesting that it may be a significant source
20～25
of harm, and is likely to be controlled by control measures that are CCPs
under Principle 2 of HACCP Procedure 7.
It indicates that the current control measures may become inadequate,
12～19
and that some additional measures are needed to strengthen andenforce the current GMP (General Sanitation Management Program).
Can be managed with current management tools.
1～11【Step 4】（Column (4) of "Example of Hazard Factor Analysis Worksheet"）
In this step, for significant hazard factors marked with ○ (or Yes) in 【Step 3】 ((3) in the "Example
of Hazard Factor Analysis Worksheet"), identify the causes of the occurrence and describe thebasis for the judgment in column (4). For those hazard factors marked with X or No in column(3), the basis for judgment should be described.
【Step 5】（Column (5) of "Example of Hazard Factor Analysis Worksheet"）40For each hazard factor rated as critical, identify control measures to ensure the safety of the final
product. The following is an example of a Hazard Factor Assessment (Step 3) and Hazard
Factor Analysis Sheet.
Consider which control measures to apply to each critical hazard factor; sometimes more than
one control measure is needed to control one critical hazard factor. For example, to control
Listeria monocytogenes, heat treatment may be required to kill viable organisms in the food, andthen cleaning and sanitizing the environment may be required to prevent contamination from theprocessing environment after heating.
It is possible that specific control measures can control multiple sources of harm. For example, if
Salmonella spp. and E. coli O-157 are present in the food, heat treatment may be used tocontrol both hazards.
For other hazard analysis sheets for other items, please refer to the examples provided on the
MHLW website.（http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000098735.html）
Example of Hazard Factor Analysis Sheet●Items to be referenced in legal provisions related to food safety
Analyze hazards and determine critical control points

41

Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of the Food
Sanitation Act(i) Analysis of Hazard Factors
A list of factors that may cause food sanitation hazards (hereinafter referred to as "risk factors" inthis table) shall be prepared for each process of manufacturing, processing, cooking, transporting,storing, or selling food or additives. (Hereinafter in this table referred to as "control measures")
HACCP Step 7 (Principle 2） Critical Control Points (CCPs)●Requirementｓ
Critical Control Points (CCPs) shall be determined.
●Concepts, specific examples
1. What is a Critical Control Point (CCP)
1) Critical Control Point (CCP) (hereinafter referred to as "CCP") is a step in the production of a
product for which control is essential to reduce or eliminate significant risk factors from the foodto an acceptable level, and which is established in a process whose deviation leads to apotentially unsafe food. A step in a procedure or operation that is essential to control in order toreduce or eliminate the allowable level of a hazard factor, and in which deviations lead topotentially unsafe food products.
2) For each critical risk factor identified as a result of the risk factor analysis, one or more control
measures must be established to control that risk factor.
3) Among the control measures for the critical risk factors listed in Principle 1, consider control
measures that can be used as CCPs.
4) The CCP requires measures such as setting tolerance limits as described later, monitoring, andnot allowing products manufactured during deviations to be shipped when deviations occur.
5) CCPs may be required for multiple phases to control one hazard factor.
2. how to determine CCP
1) The basic principle is to establish procedures for all processes and implement GMP control.
Among them, CCPs are those steps that have a direct adverse effect on food products, such as
those related to "do not bring in," "do not let in," "do not let out," and "do not increase" foodpoisoning bacteria, which are hazard factors, and the "last resort" step in the process.
2) If the control of a hazardous factor can be controlled by GMP, the control measures are notdefined as CCPs, but if the hazardous factor cannot be fully controlled by GMP alone, theprocess in which the control measures are taken is defined as a CCP. However, if thehazardous factor cannot be controlled by GMP alone, the process in which the control
measures are taken shall be designated as CCP. If the hazardous factors can be controlled
only by GMP throughout the entire process, there are no significant hazardous factors, andtherefore, a CCP may not be set.
3) A process being analyzed should not be considered as a CCP if control measures can be usedin the process being analyzed but are also applicable at later stages of the process, or if othercontrol measures for the relevant hazard factor exist in other processes.
4) Determine if control measures in one process are used in combination with control measures inanother process to control the same hazard factor. If so, both processes should be consideredas CCPs.
5) Clearly define the method to determine the CCP.
6) If the steps that should be CCPs are controlled by GMP, there is a risk that the hazardous
factors may not be fully controlled; if processes that can be adequately controlled by GMP aremade CCPs, this may result in wasted effort and a relative lack of control over other processes.
7) The requirements for CCP are that it must be possible to monitor continuously or at areasonable frequency using a predetermined monitoring method, and that if the parameter
42

deviates from the Critical Limit (CL), production must be stopped immediately, process control
must be restored in a short time, and the food produced during the deviation must be identified
and isolated. The CCP requirement is to be able to identify and isolate the food products thatwere produced during the deviation.
8) The value of the monitoring parameter (limit value) at the boundary of whether or not the safetyof the product can be ensured is called the permissible limit (CL).
3. Examples of CCPs
1) Examples of CCPs to prevent occurrence of hazardous factors are as follows.
(1) Receiving raw materials: Prevention of residual antimicrobial substances by checking test
reports submitted by suppliers(2) Cooling ： Prevention of pathogen proliferation through appropriate temperature control(3) Refrigerated storage : Prevention of pathogen proliferation through appropriate temperature
control(4) Weighing of food additives : Prevention of excessive addition
2) Examples of CCPs that eliminate risk factors are as follows(1) Heating or chemical sterilization process: Sterilization of pathogenic bacteria(2) Metal detection: Detection by detectors and elimination of metal fragments
3) Examples of multiple CCPs that control a single hazardous factor are as follows(1) Control of patty thickness and heating time/temperature to kill non-spore-forming pathogenic
microorganisms in hamburgers.
(2) The heating process can be a CCP to kill trophozoites of spore-forming pathogens, and thecooling process can also be a CCP to prevent spore germination and growth.
If control measures for the identified critical hazards are not present at any stage, the product or
manufacturing process should be modified.

●Items to be referenced in legal provisions related to food safety
Analyze hazards and determine critical control points
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(ii) Determination of critical control points
Processes for which it is essential to take control measures to prevent, eliminate, or reduce to an
acceptable level the occurrence of the identified hazardous factors (hereinafter referred to as"Critical Control Points" in this table).
HACCP Step 8 （Principle 3） Establishment of Critical Limits●Requirementｓ
Critical limit(s) shall be stipulated for each CCP.
●Concepts, specific examples
1. What is the Critical Limit (hereinafter referred to as CL)?
1) CL is a criterion that distinguishes whether a CCP is acceptable or unacceptable forcontrolling a hazard factor.
2) CL should be measurable or observable.
3) CL may have more than one parameter.
4） CL must be set correctly based on scientific data because incorrectly set CLs can lead tothe occurrence of hazardous factors.
5） Corrective action is required in case of deviation from the CL.
436) CLs must meet the following conditions(1) Parameters that are optimal in ensuring that hazards are prevented, eliminated, controlled,
or reduced to acceptable levels, and values that are substantiated by scientific evidence.
(2) Criteria using parameters that can be determined in real time whenever possible.
If the control condition is found to be inappropriate, remedial measures must be taken
promptly, so it is desirable that the CL be presented in terms of parameters that can be
determined in real time.
7) CL is usually a minimum or maximum value of a very important parameter related to thecontrol measure (temperature, moisture content, time, pH, water activity (Aw), effective
chlorine, contact time, conveyor belt speed (velocity), viscosity, conductivity, flow rate, or othermeasured values or sensory indicators (color, gloss, odor, taste, viscosity, physical properties,
foam, sound, etc.) or observation of pump settings.
2. How to establish CL
1) CLs should be scientifically validated by evidence that, when properly implemented, they
can control the hazard factor to an acceptable level.
2) If indicated by laws, regulations, or norms, the CL should adopt a numerical value by which
the target harm factor can be controlled. In other cases, they should be set based onliterature data, experimental data for validation, etc.
3) Even if the numerical value indicated in the manufacturing standard, etc. is adopted as theCL, collecting evidence (evidence) on whether it can be applied in the organization(products, manufacturing facilities, manufacturing processes, etc.) is also a validity check.
4) In ordinary manufacturing process control, it is not common to control only by CLs, but to set
an operational limit (OL), which is a standard that can be controlled before deviation from theCLs, with more leeway than the CLs.
●Items to be referenced in legal provisions related to food safety
Establishment of management standards
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(iii) Establishment of control standards
For each critical control point, standards for preventing, eliminating, or reducing the occurrenceof hazardous factors to an acceptable level (hereinafter referred to as "control standards" in thistable) shall be established.
HACCP Step 9 （Principle 4） Monitoring System●Requirementｓ
Monitoring procedures shall be established for each CCP.
●Concepts, specific examples
1. What is monitoring?
1) Monitoring is the observation, measurement or test inspection based on a scheduledetermined in the HACCP plan, compared to the CL, to ensure that the CCP is properly
controlled and to keep accurate records that can be used during later verification. The
HACCP plan is to be followed by observations, measurements or test inspections basedon a schedule determined in the HACCP plan, compared to the CL, in order to keep
accurate records that can be used for subsequent verification.
2) In the control in CCP, monitoring is to ensure that no deviation from the CL has occurred.
3) In case of deviation from the CL, corrective action is required.
4) Monitoring records are also used to verify the HACCP plan.
44

2. How monitoring is to be conducted
1) The monitoring method must meet the following conditions(1) The monitoring must be continuous or at a reasonable frequency.
(2) The method should provide results promptly. (Physical and chemical measurements
are usually chosen over microbiological testing)2) It is important to monitor the conformity of control measures for risk factors for all
products. Monitoring should be continuous if possible (e.g., temperature and time ofheating) so that every product, from the first one to the last one, or every batch, can bemonitored to ensure that all products meet the CL. However, there are somemeasurements that cannot be monitored continuously (e.g., water activity, preservative
concentration). In such cases, the frequency of monitoring should be sufficient to ensurecompliance with the CL as much as possible and to minimize the amount of productaffected by deviations. and in a manner that allows easy corrective action to be taken.
3) If possible, process adjustments should be made when monitoring results indicate a trend
toward deviations in the CCP.
4) The [5W1H] that defines the monitoring method means the following.
(1) Rationale (Why): Is there scientific validity in monitoring the management status of the
CCP?
(2) What (What): Is the CCP within the acceptable range of CL (not deviating from CL)?
(3) Where (Where): Clarify the relevant (CCP process) process(4) How (How): Is it a rapid and accurate physical, chemical or sensory observation,measurement or inspection method?
(5) Frequency (When): Is there a frequency with which deviations are not missed, either
continuously or not continuously?
(6) Who (Who): Personnel trained in monitoring methods5) Continuous recording of measured values alone is not enough to control hazard factors. It
is necessary for someone other than the person in charge of monitoring to check them at
an appropriate and sufficient frequency.
6) When the HACCP plan is prepared, a person in charge of monitoring should bedesignated. This person should be able to perform or be instructed on the appropriate
steps to take when monitoring indicates that corrective action needs to be taken. Dataobtained from monitoring should be evaluated by a designated person with theknowledge and authority to take corrective action.
7) All records and documents related to CCP monitoring should be signed or initialed by the
person conducting the monitoring, and the results and the time the monitoring was
conducted should be recorded.

●Items to be referenced in legal provisions related to food safety
Establishment of Monitoring Methods
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(iv) Establishment of monitoring methods
Methods shall be established for monitoring the status of implementation of control of criticalcontrol points on a continuous basis or at a reasonable frequency (hereinafter referred toas “monitoring” in this table). (iii) Methods for monitoring the status of implementation(hereinafter referred to as “monitoring” in this table) of the management of critical control
points shall be established.

45

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 an immediate action taken when monitoring parameters deviate
from the CL.
2) In CCP, which is a process that should be strictly controlled to prevent the occurrence of
hazards, it is important to establish corrective action methods and procedures inadvance, because if monitoring parameters deviate from the CL, food safety risks may
occur and increase. The HACCP plan should be based on a HACCP plan.
3) During the HACCP plan, the procedures for restoring the control status of the process
and restarting the line, as well as for isolating the affected product and determining andimplementing a disposal method for the affected product, should be specified.
4) To minimize the possibility of recurrence of deviations, a cause analysis should be
performed to identify and correct the cause of the deviation, if possible. The cause
analysis should identify the reason for the deviation or limit the amount of productaffected by the deviation.
2. Items to be included in the HACCP plan as corrective actions
1) Items to be described in the HACCP plan as corrective actions are as follows.
(1) Actions to restore the process to its original state of control
Restore the process to its normal state of control by repairing, adjusting, replacing, etc.,
the machinery.
(2) Actions for products manufactured during deviations
Products that do not conform to the CL are identified, withheld, and evaluated.
Decide how to dispose of them, e.g., reprocessing or disposal.
3. Persons in charge of implementing corrective actions
1) The person in charge of implementing corrective actions is the person in charge who
has sufficient knowledge of CCP management, understands the process well, and has theauthority to make a prompt decision.
4. Corrective Action Implementation Record
1) Corrective action implementation records should include the following items(1) Details of the deviation, the manufacturing process or location where the deviation
occurred, and the date and time of occurrence(2) Name, lot number, quantity, etc. of the product subject to corrective action(3) Results of investigation into the cause of the deviation(4) Details of actions taken to restore the process to its original state(5) Details of measures to be taken for products manufactured during the deviation(6) Signature of the person in charge of implementation and recording of the above items(7) Signature of the person in charge of inspecting the contents of corrective actions andthe date of inspection●Items to be referenced in legal provisions related to food safety
Establishment of remedial measures
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(v) Establishment of improvement measures
Improvement measures shall be established for each critical control point in the event that a
violation of control standards is found as a result of monitoring.
46

HACCP Step 11 （Principle 6） Establish HACCP plan validation and verification procedures●Requirementｓ
A HACCP plan must be validated prior to implementation. Verification procedures shall beestablished 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 in processing
method and technology development in the manufacturing process.
●Concepts, specific examples
1. Necessity of validation
1) It is to ensure that the HACCP plan is capable of controlling the critical hazard factors.
Items to be validated: Identification of critical risk factors, CCP, CL, control measures,
frequency and type of CCP monitoring, corrective actions (remedial actions), frequency
and type of verification, and type of information to be recorded, etc.
2) Validation of control measures and CCP CLs shall be conducted during the preparationof the HACCP plan.
3) Validation includes review of scientific literature, use of predictive models, conducting
validation studies, use of guidelines developed by authoritative sources, etc.
4) Evidence should be obtained to demonstrate that controls were achieved consistently
during the initial implementation of the HACCP plan and under production conditions
during manufacturing.
2. Necessity of verification
1） To evaluate the effectiveness of the HACCP plan and ensure that the HACCP system
is functioning properly.
2） To modify the HACCP plan and make it better by recognizing weaknesses in one’s
own HACCP system based on the results of periodic verifications.
3.Verification of each HACCP plan
1) Verification of the HACCP plan for each CCP shall include the following items① Calibration of measuring devices (instruments) used for monitoring② Testing and inspection of raw materials, intermediate products or final products③Measurement of manufacturing and processing conditions④ Confirmation of CCP monitoring records, corrective action records, and verification
records⑤ Confirmation that workers are working in accordance with the HACCP plan
⑥ Observation that control measures are operated in accordance with the HACCP plan.
2) Verification of monitoring includes verifying whether the monitoring is correct or not byusing different measuring instruments or methods. For example, for temperature, crosschecking with a different thermometer, or for verification of the heating process,conducting a microbiological test on a sample after the heating process to confirm that no
microorganisms remain in the sample.
《Items that should be specified in the HACCP plan as internal verification work》
３）The items to be stipulated in the verification plan are as follows① Contents② Frequency③ Actions to be taken based on verification results④ Method of recording verification results47

4. testing and inspection methods
1) To assure product safety, this includes evaluating and verifying that CCPs and CLs areproperly established and controlled. Testing and inspection methods for verification are
to be conducted in a reasonable manner. Visual inspection and sensory evaluation canalso be used as a means of verification, but in this case, documented procedures andobjective criteria based on photographs and samples should be established.
5. Verification of the overall HACCP system
1) Verification of the HACCP system shall be conducted on a regular basis using thefollowing procedures as necessary(1) Analysis of the cause of consumer complaints or recalls(2) On-site confirmation that monitoring operations are being carried out in accordancewith established procedures(3) Testing and inspection of final products
2) Results of the verification are recorded and reviewed.
6. Re-validation of the HACCP system
1) Revalidation shall be conducted once a year as a rule, and also when any of thefollowing events occur(1) Change in raw materials(2) Changes in manufacturing processes or systems (including computers and theirsoftware)(3) Changes in packaging(4) Changes in the delivery system of the final product(5) Changes in the intended specifications of the final product or the intended consumers(6) When verification results indicate a deficiency or potential deficiency in the HACCP
plan(7) A new hazard factor is identified in the same food or in the same food group(8) New information regarding product safety is obtained.
●Items to be referred to in legal provisions related to food safety
Setting up a verification method
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(vi) Establishment of verification methods
Procedures shall be established to periodically verify the effectiveness of the contents of themeasures prescribed in the preceding items.
HACCP Step 12 （Principle 7） Documents and Record●Requirementｓ
Necessary documents shall be prepared and maintained.
● Concepts, specific examples
1. Required documents and records
1) Documents and records required by the 12 procedures of HACCP
HACCP team member list and role assignment, product description, flow diagram, hazard
factor analysis, CCP determination, CL determination and information to scientifically support
CL, validation of control measures, HACCP plan revision records, etc.
2) Records of activities in accordance with the HACCP plan
Monitoring records, corrective action records, verification records, personnel training records,
etc.
3) Records of HACCP plan implementation48

In addition to serving as evidence to prove control, they are also important for dealing withdeviations when they occur.

●Items to be referred to in legal provisions related to food safety
Creation of records
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(vii) Preparation of records
Depending on the size and type of business, a document concerning the details of themeasures stipulated in the preceding items and a record of the implementation of suchmeasures shall be prepared.

49

Ⅲ Good Manufacturing Practice（GMP)
GMP 2

Site Management●Requirementｓ
The organization shall establish and maintain in accordance with appropriate standards forbusiness premises.
●Concepts, specific examples
1.Concept of GMP2
1) In GMP2, it is important to take measures to prevent "influences from the vicinity and premisesof the business site from affecting the food safety risk to the products" and to maintain them.
For this purpose, the following measures are required.
(1) Identify what exists in the vicinity and on the premises of the business site.
(2) Confirm whether or not they pose a food safety risk to the company's products(3) Examine the measures to be taken and maintained so that the system can be finallyestablished to "prevent food safety risks to products.
(4) Periodically check for changes in the environment while implementing maintenancemeasures.
2. Confirmation of site boundaries
1) Ensure that the boundaries of the site are clear and in a condition that can be reliably
accounted for.
2） Even if the site is located in an industrial park or other such area, make sure that the site ofyour organization is clear.
3） It is recommended that as much as possible, drawings or other means be used to show theconfirmed settings in order to maintain clarity.
3. Confirmation of the surrounding environment1) Check the area surrounding the facility for any concerns that may affect food safety.
The following may be considered as examples.
(1) Insect and bird damage
Rivers, drainage ditches, etc.
Mountains, forests, parks, agricultural land, livestock farms, etc.
Garbage dumps, waste disposal sites, etc.
(2) Foreign matter
Garbage dumps, waste disposal sites, etc.
(3) Others (impact on buildings, odor, chemicals, etc.)
Regional effects such as salt damage, strong winds, freezing, etc.
Agricultural lands where pesticides are sprayed ・Livestock industry (feedlots, etc.)
Exhaust and smoke emissions from other factories, etc.
4. Check the business premises
1) Check for food safety concerns within the facility as well.
The following may be considered as examples.
(1) Insect and bird damage
・Green space, etc.
・Puddling areas
・Drainage, septic tanks, rainwater tanks, etc.
・Unnecessary objects and waste storage areas, etc.
(2) Foreign matter
50

・Waste dumps, treatment areas, etc.
5. Response to each impact
1) For each of the items identified as having an impact, measures to reduce the impact to a
manageable level should be considered, verified, and periodically addressed.
Possible measures include the following(1) Insect and bird damage
・ Insect and bird damage - Removal or modification of the target, isolation, etc.
・Periodic checks of plantings and water ponding areas, and measures to deal with them.
(If the site is subject to the Green Space Law, compliance is necessary, but appropriate
consideration should be given to placement and management.)
・Building treatments (e.g., positive/negative pressure, entrances/exits, broken parts or gaps that
may be points of entry, light sources, odor leaks, etc.).
・Periodic monitoring by the insect control contractor or your own organization (perimeter,building interior, etc.)(2) Foreign material related
・Removal or modification of objects, isolation, etc.
・Countermeasures against foreign objects flying into the building or adhering to workers(3) Others
・Arrangements with related parties in the surrounding environment.
・Periodic maintenance of buildings and facilities to prevent deterioration
・Periodic verification of manufacturing areas and products[Example] Building Surroundings(facilities on the site as well as outside facilities and environment (outside the dotted line)).

GMP 3 Design, construction, layout of business site and work and product flow lines●Requirementｓ

51

The organization shall design, construct and maintain the factory buildings and facilities (storage
area, raw material and product handling area, preparation area, packaging and storage area,etc.) of the business site both outside and inside the plant to minimize food safety risks.
In addition, the equipment layout and the flow lines of people, goods, and work shall be designed
to meet the intended purpose and minimize food safety risks.
●Concepts, specific examples【Regarding the location, design, and layout of the facility】
1.When designing a manufacturing or processing facility, the most important thing is to fully
understand the impact on manufacturing and processing. In ascertaining the impact, reference
should be made to the following1) Layout drawings of the manufacturing/processing area2) Flow diagrams showing the manufacturing/processing process
3) Equipment, personnel, raw material and product transport methods, process capacity, etc.
4) Work classification appropriate to the manufacturing/processing process【Lines of movement of "goods," "people," etc.】
1. It is effective to describe manufacturing flow lines, personnel flow lines, etc. on the layout
diagram of the manufacturing/processing area, and consider the impact on food safety fromthis flow of movement (flow lines).
2. Lines of flow include the following, of which "goods" and "people" are the most important. Asmuch as possible, "objects" and "people" should be managed to avoid cross-contamination.
1) Objects: Routes from receipt of raw materials to shipment of final products2) Personnel: Routes for personnel entering and leaving the workplace, routes for movement
between workplaces, and routes for outside workers entering and leaving the workplace.
3） Waste: Routes for transporting leftover and unwanted materials from the workplace to the
outdoors
4） Drainage: routes for drainage of work area
5） Utilities: Routes for utilities such as steam, compressed air, carbon dioxide, nitrogen andother gases, air conditioning and ventilation, lighting, and water used directly or indirectly in
manufacturing and processing【Lighting】
1. The specifications shall be such that maintenance and cleaning are easy and that deterioration
is minimized.
2. When installing ducts for electrical wiring, etc., they should be constructed so that dust anddead insects do not accumulate on the top, and they should be installed in locations where
they can be easily cleaned.
3. If fluorescent lamps or light bulbs are damaged, protective covers (dust-proof type) should beinstalled or shatterproof tubes should be used to prevent shards and other physical hazards
from affecting products and production/processing lines.
4. For windows used for daylighting, select plastic windows made of materials that are resistant todeterioration and shattering, and glass windows made of glass that are resistant tocondensation, and apply shatterproof plastic film.
5. Illumination and color tones should be such that they do not cause misidentification of theworkplace.
1) Brightness that allows food handlers to work safely and hygienically must be provided.
2) If the illuminance of the area where work such as appearance inspection is performed isinsufficient, it is necessary to take measures such as installing supplementary lighting suchas electric stands.
3) When conducting color tone inspections, etc., the color tone of lamps should be consideredin addition to illuminance.
52

【Illuminance of the work environment】
1. The illuminance of the work environment is specified in Article 604 of the Industrial Safety and
Health Regulations and JIS. The work classification and standards in Article 604 are as follows:
precision work: 300 lux or more, ordinary work: 150 lux or more, and rough work: 70 lux ormore; the JIS illuminance standard is 500 lux for ordinary visual work in general manufacturing
plants, etc.
【Drainage system】
1. Drainage routes should be designed and managed to minimize the possibility of contaminationof products, etc.
2. Floors and drainage basins should be sloped to prevent puddles and be easy to clean.
【Specifications and general information in the production area】
1. The specifications of the facility should be designed to ensure that there is no crosscontamination or adverse effects on food products.
2. The specifications shall be easy to maintain, clean, and wash, and shall be resistant todeterioration.
3. Consider durability, such as the ability to handle heavy objects used in the work, wear, etc.
4. The material shall be capable of withstanding cleaning, washing, sterilization, and disinfection.
5. Design wastewater and wastewater systems so that they do not interfere with food safety.

Insects andMold androdents

insectcome in.

infestation

Hard to

Dark.

wash

Hard toequipment

inspect

Designed for hygienic operations andproduct/ingredient workers as well as theenvironment.

●Items to be referenced in legal provisions related to food safety
Facility specifications: General
Illuminance of the work environment
The illuminance of the work environment is specified in the Industrial Safety and HealthRegulations No. 604 and JIS.
53

Facility Management: Sanitation
Appended Table 17 (Re: Article 66-2, paragraph (1)) (Ordinance of the Ministry of Health, Labourand Welfare No. 68; addition)(ii) Sanitation management of facilities(a) The facility and its surroundings shall be cleaned regularly and kept clean to prevent theoccurrence of food sanitation hazards while the facility is in operation.
(b) Do not place unnecessary articles, etc. in places where food or additives are produced,
processed, prepared, stored, or sold.
(c) Maintain the interior walls, ceilings, and floors of the facility in a clean condition.
(d) Lighting, lighting, and ventilation inside the facility shall be adequate, and the temperature andhumidity shall be controlled appropriately as needed.
(f) Drainage ditches shall be cleaned to prevent the inflow of solids and ensure proper drainage,
and shall be repaired promptly in the event that they are damaged.

GMP 4 Control of critical hazards that cannot be controlled by Critical Control Points (CCPs) (prevention ofcross-contamination)●Requirementｓ
Based on the results of the HACCP Procedure 6 (Principle 1) Hazard Analysis, the organization
shall establish procedures to prevent contamination and cross-contamination of raw materials(including containers and packaging materials), semi-finished products, work in process, reworked
products, and finished products by controlling critical hazard factors identified that are not controlled
by control measures at the critical control points (CCP) and that are difficult to effectively control
outside this item (GMP 4). The organization shall regularly review these procedures and keepthem in effect.
●Concepts, specific examples54

1. Control by GMP 4
GMP 4 includes the management of hazard factors controlled by the GHP (GMP) that require
more attention of Codex HACCP, as well as the management of significant hazard factors thatcannot be controlled by the HACCP plan.
1) Control of Hazard Factors Controlled by GHP (GMP) that Require More Attention in Codex
GPFH2020 and GMP4 Hazardous factors identified by the hazard analysis in HACCP
Procedure 6 that could cause significant food safety hazards if there is an error in GMP controls
are considered to be controlled under "GHPs (GMPs) requiring more attention" and arecontrolled under GMP4. controlled by GMP 4.
2) Significant Hazardous Factors Hazardous factors controlled by GMP4
(1) Critical Hazard Factors are "Hazard Factors identified by the Hazard Factor Analysis in
HACCP Procedure 6 that, in the absence of controls, are reasonably likely to occur to an
unacceptable level and whose control is essential for the intended use of the food" ( Codex
General Principles of Food Hygiene 2020: from the first edition of 2021 by the Japan Food
Sanitation Association).
(2) For critical hazard factors, control measures for critical control points (CCPs) are establishedand controlled by the HACCP plan.
However, there are hazardous factors that are judged to be important hazardous factors but
cannot be controlled by CCP control measures because continuous monitoring cannot be
implemented or quantified CLs cannot be set. Control of these hazardous factors by GMP
control measures corresponds to GMP4. Control procedures (monitoring methods, remedial
measures, verification, etc.) are required.
(3) The critical hazard factors controlled by GMP4 are almost the same concept as the OPRP in
ISO 22000; 2018.
2. Points to note for control by GMP4
1) Hazard factors controlled by GMP4 differ depending on the type of product, manufacturing
process, hazard factor analysis, frequency and severity, etc. These should be considered andidentified. The matrix of HACCP procedure 6, etc. can be used as a reference.
2) The procedures for control by GMP4 may involve not only the requirements of GMP, but also
the control by the requirements of FSM. Examples of relevant requirements, which are notuniform depending on the industry and products of the organization, are shown below.
FSM 13.1, 13.2, Purchasing, supplier management
FSM 16 Control of allergens
GMP 3 Design, construction, and layout of facilities and equipment, and work and product flowlines
GMP 6 Hygiene, work clothes and health management of employees, etc.
GMP 8 Tidiness, cleanliness, hygiene, sterilization and disinfection
GMP 11 Air and water management
GMP 13 Pest control
GMP 18 Equipment and instruments
GMP 19 Maintenance
３．Examples of Hazard Factors Controlled by GMP4
1) Allergen control
Line cleaning after manufacturing products containing allergens can be a control measure thatshould be controlled under GMP 4. If allergens cannot be removed by washing, the next productthat does not contain allergens may contain allergens.
2) Control of Listeria monocytogenes :.
If RTE foods (ready-to-eat foods that do not require heating before consumption) after heatsterilization are contaminated with Listeria monocytogenes from the line, utensils, or
environment, they can multiply even at temperatures below 10°C, and food poisoning can occur
if stored for a long time. Therefore, lines and utensils that come into direct contact with RTE
foods should be monitored carefully. In addition, it is necessary to set up lines so that RTE
foods and contact lines are kept at lower temperatures (preferably 4°C or lower).
55

4. measures to prevent cross-contamination
1) Cross-check the detailed process flow diagram prepared by the HACCP team with the
manufacturing site to enumerate the points where the work flow lines of on-site employeesintersect with the flow lines of raw materials (including containers and packaging materials),semi-finished products, work-in-process products, recycled products, reworked products, andfinished products.
2) For each of the listed locations, hazard factors are extracted, the frequency of occurrence andseverity of results are evaluated (comprehensive evaluation), and control measures, including
appropriate isolation, are established for each.
The Hazard Factor Analysis Sheet used in HACCP Procedure 6 (Principle 1) can be utilized
for setting up the measures, and the following list of identified hazard factors can also be usedeffectively. The evaluation of the frequency of occurrence and severity of consequences canrefer to HACCP Procedure 6 (Principle 1).
3) Control procedures should be validated, implemented, monitored, verified, and periodicallyreviewed as necessary. When evaluating control measures, it is necessary to consider what isalready in place in operating procedures, GMP work rules, etc. and what new measures areneeded.
4) Overall control over allergens is implemented in FSM 16.
●Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(ii) Facility sanitation(a) Regularly clean the facility and its surroundings, and maintain cleanliness to prevent theoccurrence of food sanitation hazards while the facility is in operation.
(b) Do not place unnecessary articles, etc. in places where food or additives are produced,
processed, prepared, stored, or sold.
(iii) Hygiene control of equipment, etc.
(a) Machinery and equipment shall be used appropriately for their intended purposes in order tomaintain hygiene.
(b) Machinery, equipment, and parts thereof shall be cleaned and sanitized and stored hygienicallyin designated locations to prevent metal fragments, foreign substances, or chemical substances,
etc. from mixing with food or additives. In the event of malfunction or damage, they shall be
repaired promptly and maintained for proper use.
(c) When detergent is used for cleaning machinery, equipment, and their parts, the detergent shallbe used in an appropriate manner.
(e) Equipment, cleaning materials, and protective gear that may come in contact with food or
additives shall be disinfected with hot water, steam, or disinfectants each time they arecontaminated or work is completed, and then dried.
(f) Detergents, disinfectants, and other chemical substances must be handled with care and, if
necessary, the names of the contents must be indicated on the containers and packaging toprevent contamination of food or additives.

GMP 5

Personnel Facilities●Requirementｓ
Organizations must ensure that facilities for employees are designed and operated to minimize
food safety risks, including allergens.
●Concepts, specific examples
56

【Facilities for Employees】
１． Facilities for employees include shoe boxes and shoe lockers for changing from commuting
shoes to on-premises footwear, changing rooms, toilets, hand washing facilities, cafeterias, rest
rooms, and smoking areas. These must be kept clean at all times to prevent the introduction ofcontaminants or foreign substances into the manufacturing or processing site.
【Changing rooms】
１. A sufficient number of lockers, etc. should be provided. Lockers and changing rooms should belocated so that clean work clothes worn in the production area are not cross-contaminated withpersonal clothing or used work clothes.
2. Changing rooms should be located in areas where work clothes are not contaminated before
food handlers move to the work area.
【Hand washing facilities】
１． Facilities for washing and drying hands in a hygienic manner are required.
１） It is important that there be a sufficient number of such facilities in appropriate locations forfood handlers, and that there be facilities for washing, drying, and sanitizing, and hot water
facilities, if necessary.
２） Maintain an adequate supply of water (or hot water if necessary for proper hand washing),
and provide liquid soap, nail brushes, paper towels, disinfectants, etc. appropriate for handwashing, which are clean and always available for use.
3） To prevent re-contamination of washed hands after hand washing, faucets should bedesigned so that they can be opened and closed without touching them with the hands.
4） Hand washing and disinfection procedures should be posted in an easily understoodmanner.
５）Hand washing facilities should not be used for washing food or mechanical equipment.
【Toilets】
1. It is important that toilets be of hygienic construction.
1) There should be a sufficient number of toilets for the number of employees.
2) They should be sufficiently separated from areas where food is handled.
2. Hand washing and disinfection facilities and means to dry hands should be provided.
3. Always keep the area clean and perform periodic cleaning and disinfection.
【Cafeteria, Break Rooms, and Smoking Areas】
1. Places where food and beverages are stored and consumed, such as company cafeterias andbreak rooms, should be set up to minimize the possibility of cross-contamination with the
production area. 2.
2. Cafeterias should be kept clean and controlled so that waste materials are not left unattended toprevent them from becoming a source of pests.
3. Smoking areas should be located and controlled to minimize the potential for crosscontamination with work clothes and manufacturing areas.
●Items to be referenced in legal provisions related to food safety
Facilities for food handlers, hand washing and lavatories
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(ii) Sanitation of facilities(g) Latrines shall be kept clean at all times, and shall be cleaned and disinfected regularly.
57

(iii) Hygiene control of facilities, etc.
(h) Hand washing facilities shall be equipped with soap, paper towels, etc., and disinfectants, andshall be maintained in a state whereby hands can be washed and dried appropriately.
(iii) Hand washing facilities shall be equipped with soap, paper towels, etc. and disinfectants, andshall be maintained in a condition that enables hand washing and drying to be performed
properly. (2) Hand washing and drying facilities shall be maintained in such a way that they canbe used appropriately and that a sufficient supply of water can be provided. In addition, handwashing facilities shall be equipped with appropriate soap, etc. for hand washing, and shall beclean and ready for use at all times.

GMP 6 Hygiene, workwear and Health management of personnel, etc.
●Requirementｓ
The organization must document and enforce appropriate hygiene standards for employees inaccordance with the laws and regulations of the country in which the employees are working.
This must include hand washing methods and frequency, health check methods, work clothing
and footwear rules, entry and exit from the manufacturing facility, food handling methods, andforeign material contamination control.
These requirements must be made known to employees and applied without exception tocontractors and visitors.
●Concepts, specific examples
１．Concepts in GMP6
1) In GMP6, the organization needs to take appropriate sanitation standards to prevent
contamination factors.
(1) Provide appropriate guidance and control to prevent contamination from occurring due toemployee behavior.
(2) Establish a manufacturing environment that prevents contamination and foreign matter fromentering the product.
(3) External visitors are also to be handled in such a way that they do not affect food safety.
2) The important point in this section is to "ensure that workers are properly trained and instructed
so that there are no problems with on-site operations.
To this end, "documentation" is required to ensure that the information is accurately
communicated to each worker.
2. Management of employees' health conditions
1) Managers shall explain the health conditions and food safety risks to employees when they join
the company, etc., and seek their understanding of their pre-existing medical conditions to theextent necessary, what to do in case of illness, and what to do in case of food poisoning, etc.,
so that they can maintain appropriate knowledge and awareness of food safety.
2) Managers are to ascertain employees' pre-existing medical conditions as necessary for foodsafety.
3) The health condition of employees shall be checked before work. If any physical abnormality isobserved, the employee must report it to the person in charge of the work site, etc. If an
employee reports an abnormality in his/her physical condition, he/she should not be allowed towork handling products unless it is clear that the abnormality does not affect food safety (e.g.,
minor tooth decay, etc.).
4) In the event of a suspected infectious disease or food poisoning, report it to management, thefood safety manager, etc. If necessary, disinfect the facility, equipment, etc., check with theparties (including outside visitors) who came in contact with the product, and take action on
products manufactured or shipped prior to the suspected infection or food poisoning.
585) Conduct periodic stool samples to confirm that there are no abnormalities.
6) For external visitors, especially those entering manufacturing areas (equipment, inspectors,
consultants, etc.), confirm their length of stay, health status, and contact information so that
confirmation can be obtained in the event of an abnormality. Visitors (including maintenanceworkers), especially those visiting food production, processing or handling areas, should be
instructed and supervised, where appropriate, and, like employees, should wear protective
clothing that will not contaminate food and comply with other employee hygiene requirements.
Instruct visitors to report any type of illness/injury that could cause cross-contamination problems
through the business's sanitation policy prior to the visit.
3. management of personal hygiene of employees
1) Establish and document basic hygienic behaviors in the series of work from start to finish, andprovide explanations at the time of employment, etc., to properly align and maintain employees'
personal hygiene levels. Examples of employee hygiene behaviors include the following It isnecessary to set them appropriately by selecting and choosing the appropriate ones andconsidering unique items according to the organization's situation.
(1) Hand washing and disinfection at specified times(2) No unhygienic behavior with items (hands, gloves, utensils, etc.) that may come in contact withproducts(3) Refrain from sneezing or coughing at the work site, and make efforts to avoid splashing,especially in areas related to the product.
(4) Wear masks properly as specified, covering the nose and mouth.
(5) To prevent the introduction of foreign substances into the manufacturing area, wear thedesignated work clothes properly to prevent hair and body hair from mixing in. In addition, airshowers, adhesive rollers, and other measures should be taken at designated times.
(6) When wearing work clothes or work shoes, do not carelessly go outside the production area ortake any actions that may result in contamination.
(7) Do not wear ornaments or other items to prevent foreign matter from falling out.
(8) Keep fingernails appropriately short and clean. Do not wear nail polish.
(9) Do not wear makeup that could fall off and affect the product (e.g., lame powder, etc.).
(10) No use of perfume(11) No food or drink is allowed to be stored or consumed in the work area. Observe operation indesignated areas.
(12)When work clothes are stored in common in lockers where personal clothes and belongings
are owned, handle them in such a way that they will not be contaminated.
(13)Do not bring unnecessary items to the work site. If there is a need for regular medication, etc.,
consult with the manager and take measures to ensure that contamination of products isprevented.
(14)Wash hair and bathe regularly to maintain proper hygiene.
2) Appropriate consideration shall be given to the shape of work clothes and shoes to prevent hairand body hair from falling out and mixing with products.
3) Rules for washing and replacing work clothes and footwear are to be established andimplemented so that employees can wear clean work clothes and footwear in good condition
according to their work needs, to prevent contamination and foreign matter from entering the
products.
4) When gloves are used, the material is selected according to the purpose, the usage andstorage methods are specified, and the gloves are handled in a clean and good condition. If
disposable gloves are used, check the material and strength of the gloves according to thework to be performed, determine the appropriate replacement frequency, and strive to prevent
damage. Control external visitors as necessary in relation to the above. 4.
4. Maintenance of hygienic environment
1) Appropriate consideration shall be given to the shape of work clothes and shoes to prevent hairand body hair from falling out and mixing with products.
2) Rules for washing and changing work clothes and footwear are to be established so that
employees can wear clean and good condition work clothes and footwear according to the59necessity of the work, and they are to be operated reliably to prevent contamination andcontamination by foreign substances.
3) When gloves are used, the material is selected according to the purpose, the usage andstorage methods are specified, and the gloves are handled in a clean and good condition.
4) When disposable gloves are used, check the material and strength according to the work,
determine the appropriate replacement frequency, and strive to prevent damage. Rules forwashing hands before wearing gloves should be established and implemented.
5) In relation to the above, control external visitors as necessary.
●Items to be referenced in legal provisions related to food safety
Food handlers and health conditions
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(vii) Hygiene Control for Persons Handling Food or Additives(a) Health examinations of persons who handle food or additives (hereinafter referred to as "foodhandlers") (a) Medical examinations of persons who handle food or additives (hereinafterreferred to as "food handlers") shall be conducted for the purpose of ascertaining the healthconditions necessary to prevent food sanitation hazards from occurring.
(b) When a prefectural governor, etc. has given instructions that a person handling food, etc.
should undergo a stool examination, the person handling food, etc. shall be instructed toundergo a stool examination.
(c) When a food handler is showing any of the following symptoms, efforts should be made to
grasp the details of the symptoms and to determine whether the symptoms require medical
examination by a physician and suspension of work to handle food or additives(1) Jaundice(2) Diarrhea(3) Abdominal pain
(4) Fever(5) Pyogenic skin disease, etc.
(6) Secretions from the ears, eyes, or nose (limited to those that may infect infect infectious
diseases, etc.)(7) Nausea and vomiting(d) When a person who has a skin injury is engaged, the area shall be covered with a waterresistant covering. Foods or additives that may be contaminated by vomit should be discarded.
In the event of vomiting in the facility, the area should be disinfected immediately with adisinfectant.
(e) When food handlers are engaged in work to handle food or additives, they should wear work
clothes specially designed for the purpose, and hats and masks as necessary. In addition, theyshall use special footwear in the work area and shall not leave the designated area while
wearing the footwear used in the work area.
(f) Personnel handling food shall not bring into the facility where food is handled any ornaments orother items that may interfere with hand washing or cause foreign matter to be mixed in.
(g) When using gloves, food handlers shall, in principle, use gloves made of water-resistantmaterials for the parts that come into direct contact with raw materials.
(h) Personnel who handle food, etc. must cut fingernails short, wash hands, and keep fingers cleanso as not to cause food sanitation hazards.
(h) Food handlers shall wash and sanitize their fingers thoroughly when they finish urinating or
handling fresh raw materials or raw materials before heating. In cases where disposable gloves
are used to handle fresh raw materials or raw materials before heating, the gloves shall bechanged after the work.
(3) In handling food or additives, food handlers shall not do the following while handling food or
additives from the viewpoint of preventing the occurrence of food sanitation hazards(1) Unnecessarily contaminate fingers, utensils or containers/packaging
60

(2) Spitting phlegm, dandruff or spit
(3) Mixing or causing the possibility of mixing comb or cough droplets with food or additives.
(vi) Persons handling food, etc. shall not change clothes, smoke, or eat or drink outside of thedesignated areas.
(w) When persons other than food handlers enter the facility, have them change into clean,exclusive work clothes and follow the hygiene control regulations for food handlers as indicatedin this section.

GMP 7

Training●Requirementｓ
The organization must ensure that all employees receive adequate education and training in foodsafety principles (including HACCP) and practices appropriate to their jobs.
In addition, a system must be established to ensure that employees receive appropriate guidanceand supervision.
This education and training should enable employees to recognize their role in food safety and thesignificance of their efforts.
●Concepts, specific examples
１．1. food safety managers
1) The person in charge of food safety shall enhance his/her own knowledge, techniques andskills, and shall set up education programs (content, timing, method, frequency (including
refresher courses), etc.) for food handlers, and conduct education and training accordingly, andrecord the results.
2. Food Hygiene Manager
Refer to the explanation in FSM2.
3. Education and training
1) Education and training are to be conducted and recorded for all employees, including new
employees, according to their roles in handling food products, in order to provide them with theknowledge and skills necessary for food safety.
2) Ensure that current rules and procedures can be reviewed at any time, incorporating theopinions of on-site food handlers.
3) Records created from education and training can be used for individual evaluation.
4) Re-training (hygiene training) is conducted for employees as necessary, and records are kept.
5） Conduct HACCP training.
●Items to be referenced in legal provisions related to food safety
Education and Training
Article 66-5 Standards specified by an Ordinance of the Ministry of Health, Labour and Welfare
under Article 50-3, paragraph (1), item (i) of the Act concerning matters listed in the same
paragraph shall be as follows(v) Education and training shall be provided for those who manage the manufacture of utensils orcontainers and packaging and for workers, and information and efforts necessary for preventing
food sanitation hazards shall be shared among persons concerned.
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(i) Appointment of a person responsible for food sanitation, etc.
61

(a) Appointment of a person who conducts business prescribed in Article 50-2, paragraph (1) of the
Act (including the cases where it is applied mutatis mutandis pursuant to Article 62, paragraph (3)of the Act) Hereinafter referred to as a "business person" in this table) shall appoint a person
responsible for food sanitation. Article 63 A person engaged in a business prescribed in Article 562, paragraph (1) of the Food Sanitation Act (including cases where it is applied mutatis mutandis
under Article 62, paragraph (3) of the Act) shall designate a person responsible for food sanitation.
However, this shall not apply to business operators prescribed in each item of Article 66-2,
paragraph (4). In addition, a food sanitation supervisor prescribed in Article 48 of the Act may also
serve as a person responsible for food sanitation.
(b) A person responsible for food sanitation shall be a person who falls under any of the following(1) A person who satisfies the qualification requirements for a food sanitation inspector prescribedin Article 30 of the Act or a food sanitation supervisor prescribed in Article 48 of the Act(2) Cooks, confectionery sanitarians, nutritionists, ship's cooks, sanitation supervisors prescribed in
Article 7 of the Slaughterhouse Act (Act No. 114 of 1953), occupational health supervisorsprescribed in Article 10 of the same Act, or poultry slaughtering sanitation supervisors prescribed in
Article 12 of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act (Act No. 70
of 1990)(iii) A person who has attended a training session conducted by a prefectural governor, etc. or a
training session deemed appropriate by a prefectural governor, etc.
(c) Food sanitation supervisors shall comply with the following matters(1) Attend seminars held by prefectural governors, etc. or seminars that are recognized by
prefectural governors, etc. on a regular basis and endeavor to acquire new knowledge concerning
food sanitation (limited to those concerning business under Article 51 of the Act (including cases
where it is applied mutatis mutandis under Article 62, paragraph (3) of the Act)). (Limited tobusinesses under Article 51 of the Act (including cases where it is applied mutatis mutandis under
Article 62, paragraph (3) of the Act)) (2) To follow the instructions of the business person.
(d) A business person shall follow the instructions of a person responsible for food sanitation.
(d) A business person shall respect the opinions of the person responsible for food sanitation.
(e) A person responsible for food sanitation shall take necessary precautions to ensure compliancewith the measures prescribed in Article 66-2, paragraph (3), and shall endeavor to state necessary
opinions to the business person.
(xiii) Education and training(a) Provide education necessary for sanitation management to persons who handle food, etc.
(b) Education and training shall be provided for those who handle chemical substances so thatthey can safely handle the chemical substances used.
(c) Periodically verify the effectiveness of education and training in (a) and (b) above, and review
the content of education and training as necessary.

GMP 8Housekeeping, cleaning, sterilization and disinfection●Requirementｓ
The organization must maintain an appropriate level of hygiene at all times by conducting tidying
and cleaning operations throughout all processes and phases, and disinfecting where necessary.
62And cleaning tools, cleaning agents and disinfectants must be used for their intended purpose andproperly stored.
●Concepts, specific examples【Method Plan】
1. Cleaning removes food residues and contaminants that may be sources of contamination,
including allergens. Cleaning methods and materials required depend on the nature of the foodoperation, the type of food, and the surfaces to be cleaned. Disinfection may be necessary after
cleaning, especially for surfaces that come in contact with food.
2. Attention should be paid to sanitation during cleaning and maintenance operations so that foodsafety and appropriateness are not compromised. Food preparation and storage areas should
use cleaning agent materials appropriate for food contact surfaces.
3. Chemicals used for cleaning and disinfection should be handled with care and used according to
the manufacturer's instructions. For example, they should be used at the appropriate dilution andcontact time and, if necessary, stored away from food in clearly identified containers to avoid
food contamination.
4. Organizing, cleaning, and sanitation procedures are to be effective and documented
procedures.
5．Train food handlers in standardized methods. It is also effective to show actual cleaning
procedures and to post pictures or illustrations of the procedures. Trained personnel should
perform cleaning, washing, and sanitizing.
6. Monitor whether the cleaning and disinfection program is being implemented according to therules and regulations by visual inspection and other means, and verify whether it is effective byusing sanitary inspections such as product inspection and wipe-down inspections. Monitoring
methods will depend on the nature of the procedure, but may include pH, water temperature,
conductivity, detergent concentration, disinfectant concentration, and other parameters
important to ensure that the cleaning and disinfection program is being implemented asplanned and to verify its effectiveness.
7. Training is provided based on the results of basic training and sanitation inspections.
8．Care should be taken to ensure that cleaning procedures do not lead to food contamination. For
example, sprays from high-pressure washing can spread contamination from dirty areas suchas floors and drains to large areas, and can contaminate food contact surfaces or bare food.
9. In some operations and/or food processing areas where water increases the potential for
microbial contamination, such as when the food handled is low moisture and the product ismanufactured under dry conditions, controlling the amount of water used in cleaning (e.g.,
removing and collecting residues and dry cleaning) can reduce the risk of microbiologicalcontamination.
10. The following items are to be implemented for the handling of detergents and chemicals used
for cleaning, sterilization, and disinfection.
1) Appoint a person responsible for the management
2） Inventory control of chemicals and other materials (incoming and outgoing shipments,
amount used, number of items in stock, user and first-in first-out)
3) Locking and key management of drug storage4) Training of food handlers on the handling of chemicals, etc. (including proper dilution, contact
time, etc.)
5) Prevention of mixing of detergents and chemicals with food (e.g., labeling of containers withnames of contents, etc.)
11. To ensure that cleaning and washing of the facility is carried out systematically, plans andprocedures are to be prepared as follows
1) Plan for cleaning and washing facilities
63

The frequency of the work, the date of implementation, the person who performs the work, andthe method of recording the work should be described.
2) Written procedures for cleaning and washing facilities
Ensure to describe the person responsible for the work, subject, method, frequency, monitoring
and verification procedures, designation of work tools, post-work inspection procedures, andinspection procedures prior to the start of production, etc.
【Cleaning Tools, Cleaning Equipment, etc.】
1. If foreign matter or microorganisms adhere to equipment, facilities, or utensils used for cleaning,
washing, sterilization, or disinfection, it may lead to contamination of products with foreign matteror microorganisms. Use separate cleaning machinery, equipment, and utensils designed for
different sanitation zones (areas), such as for food-contact surfaces and non-contact surfaces, tosuit the purpose.
Contaminated cleaning equipment and utensils can also spread contamination.
2. Inspection and maintenance
1) Check operation and deterioration before and after use, and immediately repair or replace any
defective items.
2) Since dirt remains on the back and bottom of equipment, facilities, and utensils, disassemble
them to check for contamination. Cleaning equipment should be kept clean, maintained, andreplaced regularly to avoid contact surfaces and sources of cross-contamination of food.
3. Storage location
1) Cleaning equipment should be stored in an appropriate location to prevent contamination.
2) Cleaning utensils should be hung and stored to dry so that they do not stick to the floor or othersurfaces.
3) Storage areas should be designated and kept clean so that food handlers can use them
immediately. Posting a notice to this effect is another way to keep the area clean.
4. Identification
1) It is necessary to devise ways to ensure that cleaning and washing utensils used incontaminated areas are not misused in clean areas. It is important to color-code themaccording to their use, such as "red" for floors and "blue" for cooking utensils, and to separate
their storage locations.
●Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(iii) Sanitation of equipment, etc.
(c) When detergents are used to clean machinery, equipment, and their parts, they must be usedin an appropriate manner.
(f) Detergents, disinfectants, and other chemical substances shall be handled with due care, and if
necessary, the names of the contents shall be indicated on the containers and packaging toprevent contamination of food or additives.
(g) Equipment and materials for cleaning facilities and equipment are to be used appropriately for
their intended purpose, cleaned and dried each time they are used, and stored in a designatedplace.

GMP 11

Air and water management●Requirementｓ

64

The organization shall define the required quality criteria according to the application, and regularly
monitor and record the air, high-pressure gas, and water (including ice and steam) used in foodproduction in order to minimize the effect on food safety.
Water not intended for use in food production, and water that has been used but is acceptable forcontact with food, must be controlled so that it is not mixed with water used exclusively for
production.

●Concepts, specific examples
1. When manufacturing food products, it is possible to use different types of water for different
purposes, and in such cases, standards should be established according to the intended use.
2. Water quality is to be checked by water quality tests, etc., and if necessary, filtered, sterilized,
etc., to ensure water quality before use
3. If necessary, comply with microbiological and water quality standards for drinking waterrecognized by local, national, or international authorities.
4. In Japan, in principle, water used for food production or water suitable for drinking should be
used, and water for food production means water that complies with applicable laws andregulations.
5. In Japan, should be referred to in the legal and regulatory requirements.
1） Water quality standards based on the Water Supply Law (51 items): Ministerial Ordinanceon Water Quality Standards (Ordinance of the Ministry of Health, Labour and Welfare No. 101,
May 30, 2003)
2) Water for food production: Standards for foods, additives, etc. (26 items) (Ministry of Healthand Welfare Notification No. 370, 1959)
3) Water suitable 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)
6. In order to reduce the cost of water, there are cases where water other than water for foodproduction is used in the manufacturing process (e.g., for primary washing of food, heating andcooling), and these waters must be controlled to prevent contamination of water for foodproduction. Specific examples include the following.
1) Well water that is only pumped up2) Water that has not been disinfected with hypochlorous acid or chlorine
7. In the food industry, water that has been used but is acceptable for contact with food may bereused in food production for the effective use of water resources. Specific examples include
the following.
1） Water used for heating and sterilizing equipment
2) Water used for heating and cooling prepackaged foods
3） Secondary washing water for cut vegetables (water used in the final stage of the washingprocess)4) Reused steam drain water
8. In addition to water, ice and steam used in food production must also be addressed tominimize their impact on food safety, including the following1) Ice and steam should be made and handled in a manner that prevents contamination. In
particular, ice machine cleaning agents and can-cleaning agents (chemical agents) used inboilers that generate steam should be approved for food use and should not be mixed with ice
and steam.
2) A filtration device (filter) should be installed near the end of the ice maker's water supply andsteam piping.
653) Make sure that ice/steam in direct contact with food products does not have any adverse
effects (odor, coloration, etc.) on food products.
4） Description of air and gas
９． Compressed air, carbon dioxide, nitrogen, and other gases
1) Equipment for gases used in manufacturing and filling should be of specifications that do notpresent a risk of food contamination, and should be properly maintained.
2) Gases that come in contact with foodstuffs shall be those approved for general use in foodadditives.
3) Ensure that air and gases that come into contact with food are free of dust, oil, and water.
4) Gases should be filtered as close to the point of use as possible.
10. Air conditioning and ventilation
1) To prevent dust, debris, insects, etc. from entering and contaminating the air, the following
points should be taken into consideration when devising air conditioning and ventilation systems.
(1) The air conditioning and ventilation system should be designed to be easy to clean, wash, andreplace filters.
(2) Consideration should be given to the air balance between intake and exhaust air in the facility.
(3) Avoid inflow of outside air through windows, doors, and crevices.
(4) Soot and vapor should be easily excluded (to prevent condensation and mold formation, etc.).
(5) If necessary, maintain differential pressure to prevent air from flowing into the clean area.
2) Periodically check the outside air intakes for damage, clogging of filters due to suction of dust,
insects, etc., and deterioration due to rust and corrosion.
3) It is convenient to have inspection ports for both intake and exhaust for inspection, cleaning andwashing, and filter replacement.
4） When aiming to step up to the JFS-C standard, it is desirable to monitor and control thecleanliness of the air in areas where products that are prone to the development and survival of
microorganisms are manufactured, in accordance with procedures.
●Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(iv) Control of water used, etc.
(a) Water used in the manufacture, processing, or cooking of food or additives shall be watersupplied by waterworks provided under Article 3, paragraph (2) of the Waterworks Act (Act No. 177
of 1957), dedicated waterworks provided under paragraph (6) of the said Article, or simplified
exclusive waterworks provided under paragraph (7) of the said Article, or other water suitable fordrinking (hereinafter referred to as "water suitable for drinking"). (hereinafter referred to as "water fit
for drinking"). (2) The water shall be water that is suitable for drinking (hereinafter referred to as"water suitable for drinking"). However, this shall not apply to use in cooling or other processes that
do not affect the safety of food or additives.
(b) In the case of using water fit for drinking, water quality tests shall be conducted at least once a
year, and a written report shall be kept for one year (or for the period of one year or more if the foodor additive to be handled is to be used or consumed for one year or more). However, if there is apossibility that the water source, etc. has been contaminated due to an unforeseen disaster, awater quality test shall be conducted each time.
(c) If, as a result of the inspection in (b), it becomes clear that the conditions in (a) are not met,
immediately discontinue use.
(d) When water storage tanks are used, the water storage tanks must be cleaned regularly andkept clean.
(e) When water suitable for drinking is used and a sterilization or water purification device isinstalled, periodically check that the device is working properly and record the results.
66

(f) Ice that comes in direct contact with food shall be made from water that meets the conditions in(a) above, which is supplied by a properly controlled water supply system. Ice should be handled
and stored in a hygienic manner.
(g) When used water is to be reused, necessary treatment is to be performed so as not to affectthe safety of the food or additives.

GMP 12

Waste Management●Requirementｓ
The organization shall establish adequate systems for segregation, collection and disposal ofwaste.
Waste placement and containers must be controlled to prevent the attraction of pests and thedevelopment of harmful organisms and microorganisms.
Waste flow lines must be set up so as not to cause cross-contamination of food.

●Concepts, specific examples
1. Waste and other materials generated as a result of food production and processing (including
by-products not suitable for food use) can become a breeding ground for microorganisms, pests,
insects, and other harmful organisms and lead to contamination of the production andprocessing environment if not properly managed.
2. Contact between wastes and raw materials, materials, and manufacturing/processing
equipment should be avoided.
3. A person in charge of consistent management (identification, accumulation, segregation,
storage, removal, and disposal) of wastes, etc., should be designated, and a written procedure
for such management work should be prepared. It is important to periodically check the status ofwaste management, such as whether the work has been carried out according to the procedure
manual.
4. Confirm that wastes are promptly disposed of according to the following procedures.
Waste, etc. generated in manufacturing/processing lines → Containers of waste, etc. →Temporary storage location → Indoor/outdoor storage location of waste, etc. → Pickup by
designated contractor → Issuance and storage of manifest slip (in accordance with laws andregulations)
5. Control and store wastes in such a way that they do not affect products, raw materials, andmaterials and equipment that come in contact with products.
6. In order to prevent cross-contamination of wastes with products, in principle, wastes should not
be stored in areas where food is handled or stored (except for temporary storage during
manufacturing - even then, be aware of cross-contamination with products). Containers for
wastes should be stored in a manner that prevents cross-contamination.
7. Ensure that waste containers are clearly distinguishable from other containers.

●Items to be referenced in legal provisions related to food safety
general67

Regulations for Enforcement of the Food Sanitation Act
Article 66-5 The standards specified by an Ordinance of the Ministry of Health, Labour and Welfare
set forth in Article 50-3, paragraph (1), item (i) of the Act with regard to the matters listed in thesame paragraph shall be as follows(iv) Proper implementation of cleaning and maintenance inspections of facilities and disposal ofwaste in order to maintain a clean working environment.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(vi) Handling of waste and wastewater(a) Procedures shall be established for the storage of waste and its disposal.
(b) Containers for waste shall be clearly distinguishable from other containers, and shall be kept
clean to prevent leakage of contaminated liquids or odors.
(c) Waste shall not be stored in areas where food or additives are handled or stored (including
adjacent areas), unless it is deemed possible to prevent the occurrence of food sanitation
hazards. (d) Waste shall not be stored in areas where food or additives are handled or stored(including adjacent areas) unless it is deemed possible to prevent food sanitation hazards.
(d) Waste should be stored in a location that can be properly controlled so as not to adversely
affect the surrounding environment.
(e) Waste and wastewater shall be treated appropriately.

GMP 13

Pest control●Requirementｓ
The organization must implement controls (surveys and countermeasures) to minimize the risk of
insects, rodents, birds, and other pests occurring or entering the premises and facilities.
If chemicals are used, handling procedures must be established to ensure that they do not affectfood products.
●Concepts, specific examples

68【Pest control measures】
１． Pest control measures shall be taken as follows
１）Analysis and inspection plan for pests such as rodents and insects
Target pests are identified based on past occurrences in the facility, biological evidence, andcharacteristics of products handled, and inspection plans are formulated.
2) Pest control and invasion prevention measures
Remove internal sources of pests and implement measures to prevent external invasions andincursions.
3) Monitoring and extermination of pests such as rodents and insects
Monitoring will periodically confirm that sanitation and pest control measures within the facility
are secured and that there is no evidence of pest infestation. If extermination is necessary
based on the results of monitoring, countermeasures that do not affect food or interfere withfacility operations should be formulated and implemented by competent personnel. Identify thecause of the infestation, take corrective action to prevent the problem from reoccurring, anddocument monitoring and eradication.
2. When pest control is outsourced to a specialized contractor, the above information should also
be confirmed with the specialized contractor and measures should be promoted. Even whenmonitoring and eradication are outsourced, the organization reviews monitoring reports and, if
necessary, ensures that its designated pest control operators take remedial action (e.g.,
eradication of small pests, elimination of hiding places or entry routes).
3. Plantings that produce flowers or fruits that attract pests such as rodents and insects should be
avoided, and the smell of wastes and sewage should be prevented from spreading. Mowing andpruning of plants should be done regularly to avoid sources of pests.
4. Areas prone to puddling can be a source of chironomids and other pests. For example, in
unpaved parking lots, it is possible to prevent outbreaks by frequently adding gravel to theparking lot.
5. Yellow or green fluorescent lights or plastic curtains, which are considered to be less visible toinsects, should be installed in outdoor lighting, entrances, corridors, etc.
6. The eaves of the facility and areas around the air supply facilities should be designed to prevent
birds and other insects from nesting in them. Mesh and filters should be inspected regularly. 7.
7. Drainage ditches around the plant should be designed to prevent rodents and insects fromentering through the openings of the facility. Measures such as netting or water sealing at theends of drains are effective. 8.
8. Windows that are not opened and closed should have their gaps filled and be removed asnecessary. Ensure that entrances and exits for employees and goods are closed except whennecessary. 8. wire mesh screens should be installed on windows, doors, etc. that open andclose to reduce the risk of entry of small pests.
9. Use screens on swinging door windows to prevent dust and insects from entering the building
due to wind pressure when opening and closing the doors.
10. Make sure that lighting around window and shutter openings does not leak to the outside.
Attaching light-blocking film or insect repellent sheets to windows is also an effective method.
Roll-up doors should be closed tightly against the floor.
11. Insect traps at work area entrances should be located inside the building where light cannot beseen from the outside.
【Measures for facilities that are easy to clean】
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１． Insufficient cleaning leads to the internal generation of pests. The gap between walls and floors
should have an easy-to-clean structure, such as an arched joint.
2. Openings and pits caused by damage to floors and walls are likely to become entryways forpests and internal emergence sites, so damaged areas should be repaired as soon as possible.
3. Equipment and objects should be kept away from the walls of the facility and arranged for easyinspection and cleaning.
【Drug Control】
1. it is important to have established procedures for chemical administration, spraying, and initiationof production and processing after spraying
2. Ensure that the use of chemicals is restricted to well-trained personnel.
3． The amount of chemicals entering and leaving the warehouse should be controlled and stored
in a locked area isolated from the manufacturing/processing area.
4. It is necessary to record the type of chemical used, the amount used, the concentration used(dilution factor), the date and time of application, and the location of application.
5. It is acceptable to outsource the entire pest control to a specialized contractor because more
efficient measures can be expected and chemical management can be omitted.
6. It is important to inspect regularly for pest infestation and internal development of pests, such as
once a week or once a month, depending on the season and other factors.
7. To prevent pests from mixing with products, poisonous bait should not be used in the production
area.

●Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(ii) Sanitary management of facilities(e) As a rule, windows and entrances shall not be left open. When they are left open, measures
shall be taken to prevent the entry of dust, rats, insects, etc.
(v) Measures against rats and insects(a) The facility and its surroundings shall be maintained in a condition that allows for proper
maintenance and management, and breeding grounds for rats and insects shall be eliminated.
(b) Extermination of rats and insects shall be carried out at least twice a year, and the records ofthe extermination shall be kept for one year. However, if the objective can be achieved byconducting periodic, uniform surveys of the locations of rats and insects, their habitats androutes of entry, and the state of damage, and taking necessary measures based on the resultsof said surveys, then the method and frequency may be implemented in accordance with theconditions of the facility in question.
(c) When using pesticides or insecticides, care must be taken in handling them so as not to
contaminate food or additives.
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(d) To prevent contamination by rats and insects, raw materials, products and packaging materials
shall be stored in containers and kept away from floors and walls. Once opened, the productshall be stored in a container with a lid or other measures to prevent contamination.

GMP 15

Transport●Requirementｓ
The organization shall establish a system to ensure that containers and vehicles used to transport
raw materials (including packaging materials), semi-finished products, work-in-process, recycled
products, reworked products, and finished products (including perishable products in their final
packaging and packaging), including outsourced vehicles, are fit for their intended use and aremaintained, kept clean and protected from contamination, and transported within their intended
temperature range.
●Concepts, specific examples
1. Concepts in GMP15
1) In GMP15, organizations need to ensure that raw and packaging materials are free of defects
prior to use to prevent food safety risks to the product.
It is also required to ensure that the product (including intermediate stages) can proceed to thecustomer or the next process without any abnormality.
2. When receiving raw and packaging materials
1) With respect to materials used in the manufacture of products, they must be in a condition freeof abnormalities prior to use.
When purchasing or using items that are already packaged as ready-to-use products, thespecifications of each raw or packaging material should be checked, and only if no problems
arise when delivered under general transportation conditions, such as "refrigerated", "frozen", or"room temperature" temperature control, rather than in a specialized vehicle, should it beallowed.
2) If abnormal temperature, damage, contamination, etc. are found upon receipt, the productshould not be used, but should be checked and returned as necessary.
3) When semi-finished products or work-in-progress are received from related parties and used as
raw materials, if the counterparty uses a special vehicle, confirm the transportation conditions,establish items to be checked upon receipt, and take action such as returning the product if any
abnormality is found.
Examples of items to be checked: appearance (presence of damage, sealed condition, etc.),
temperature zone during transportation, pallets used, etc.
3 When transporting semi-finished products, work-in-process, reworked products, reworked
products and finished products
1) When delivering products to the destination, check the product specifications and consider thenecessary conditions that allow delivery without abnormalities.
(e.g., 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 any problems and that theenvironment is such that the product can be delivered without damage or contamination.
(1) Can the temperature and humidity be set to the required temperature and humidity? Can thetemperature and humidity be maintained at the maximum loading capacity? If not, can the
maximum loading capacity be changed?
(2) Is the temperature and humidity recorded at the required frequency? (2) Is the temperature andhumidity recorded as often as necessary, and is it possible to confirm that there are noabnormalities in the thermo-hygrometer as needed?
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(3) If containers and pallets are not manufactured by the company, check the frequency ofcleaning, disinfecting, and replacement.
(4) Is the interior of the vehicle kept in an appropriate state of cleanliness?
(5) Confirm whether mixed loads with non-products are allowed, and if so, the loading capacity andthe items that can be loaded.
(6)Confirm that no outsiders other than the person in charge of delivery are involved.
4. If necessary, the organization will also conduct checks to maintain the delivery environment. If
any abnormality is found, it is necessary to seek appropriate improvement.
●Items to be referenced in legal provisions related to food safety
Transport
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(xi) Transportation(a) Vehicles, containers, etc. used for transporting food or additives shall be cleaned anddisinfected as necessary to prevent contamination of the food, additives, or their containers
and packaging.
(b) Vehicles, containers, etc. shall be maintained in a clean condition, and shall be kept in an
appropriate condition by repairing, etc.
(c) When food or additives and cargo other than food or additives are mixed, food or additives shallbe placed in appropriate containers or otherwise classified, as necessary, to prevent
contamination from cargo other than food or additives.
(d) Foods or additives in transit shall be managed so as not to be contaminated by dust andexhaust gases, etc.
(e) When vehicles, containers, etc. used for transporting food or additives of different items andcargo other than food or additives are used, they are to be cleaned by effective methods anddisinfected as necessary.
(f) In the case of food or additives in bulk, vehicles, containers, etc. exclusively for food or additives
shall be used as necessary, and it shall be clearly indicated that they are exclusively for food or
additives.
(g) Care shall be taken to control temperature and humidity during transportation.
(h) Delivery times shall be set based on the temperature and humidity during transportation, andshall be properly controlled so as not to exceed the prescribed delivery time.
(h) In the case of delivering and serving cooked food, the time until it is served for eating anddrinking shall be taken into account and properly controlled.

GMP 17

Stock Management●Requirementｓ
The organization shall establish a system to use raw materials and ingredients (including
packaging materials), partially processed products, work in progress, reworks, and finishedproducts in a designated order and within the defined expiry period, and shall store these materials
under the proper conditions to avoid contamination and deterioration.

●Concepts, specific examples【Storage period】

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1. Raw materials (including containers and packaging materials), semi-finished products, work-inprocess, recycled products, reworked products, and finished products should be stored for an
appropriate period of time and used within the specified period, utilizing first-in, first-out, etc.
2. During storage, the traceability of raw materials (including containers and packaging materials),semi-finished products, work-in-process, recycled products, reworked products, and finishedproducts (see FSM 14) should be managed so that they can be linked to the records.
【Storage location】
1. Raw materials (including containers and packaging materials), semi-finished products, work-inprocess products, recycled products, reworked products, and finished products shall be stored instorage facilities that are not contaminated and do not deteriorate due to temperature, humidity, orother factors.

GMP 18Devices and Tools●Requirementｓ
The organization shall design and select equipment and instruments to be suitable for theirintended use, and shall use, maintain, and store them in a manner that minimizes food safety risks.
●Concepts, specific examples
1. Concept in GMP181) GMP18 requires organizations to prevent food safety risks derived from equipment andinstruments.
Examples of risks include the following(1) Biological: Contamination due to residual food residues, etc.
(2) Chemical: Mold and allergen residues due to inadequate cleaning and drying, chemical
damage due to detergent residues, etc.
(3) Physical: Foreign matter contamination due to breakage, deterioration, or loss.
It is necessary to consider how to sufficiently prevent these risks before enabling production
activities.
2. When selecting equipment and instruments
1) Cleaning and drying(1) As much as possible, it is desirable to be able to "wash the entire unit in a washing room, etc."
and "reliably dry the unit in a drying room, etc.". For equipment that needs to be fixed to thefloor, consider specifications that can be accommodated without difficulty, such as disassemblyof cleaning parts.
(2) Assuming actual operation, the necessary capacity and quantity should be provided to allow
sufficient time for cleaning and drying.
(3) Confirm that periodic cleaning and confirmation of water and residue in pipes, ducts, etc. are
possible.
2) Specifications(1) Check that areas that come in contact with foodstuffs are food-compliant, and take action toensure that this can be verified.
(2) For parts that come in contact with food, confirm that they can be easily cleaned, inspected, andreplaced, and consider the degree of deterioration that should be addressed and the frequencyof such action to be realistically feasible.
(3) Avoid items (screws, labels, etc.) that may fall off the top of the food as much as possible, andmonitor as necessary.
(4) Check carefully before initial use to ensure that there are no paint chips, facets, or othercontaminants.
(5) If the product is made of metal, it should be made of a material that is resistant to rust andcorrosion.
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3. After installation of equipment
1) Establish procedures for cleaning, drying, and, if necessary, disinfection.
(1) Cleaning method: cleaning tools to be used, water temperature during cleaning, whether or not
detergent is used, etc.
(2) Drying method: temperature setting of drying room, temperature setting for drying with warm air,time required for drying, etc.
(3) Others: Whether alcohol spray is used or not, etc.
2) It is desirable to verify whether any of the intended hazardous factors will remain if theprocedures are implemented as discussed. As an example, after actual washing and drying
according to the procedures, the residual allergens may be confirmed by means of a bacterial
test or ELISA test of wiped specimens.
3) If workers need to be informed and educated about the established procedures, it is desirable tohave a procedure manual or visual explanation materials. In addition, it is recommended thatrecords be kept to ensure that the procedures are followed, such as records of checks onareas prone to insufficient cleaning and records of the completion of drying, if necessary.
4) Monitoring should be conducted at an appropriate frequency for damage, deterioration, andother areas where food safety risks may be a concern. When monitoring is conducted, it isdesirable to keep records.
5) Inform workers to report any abnormalities such as breakage, parts falling off, or abnormal
noise.
■Activities to maintain sanitation of food handling equipment, facilities, and utensils

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●Items to be referenced in legal provisions related to food safety
Sanitation of equipment and instruments
Regulations for Enforcement of the Food Sanitation Act
Article 66-5 The standards specified by Ordinance of the Ministry of Health, Labour and Welfare
set forth in Article 50-3, paragraph (1), item (i) of the Act concerning matters listed in the same
paragraph shall be as follows(i) Allocation of necessary personnel, establishment of work contents, and maintenance of facilities
and equipment, etc., so that the containers and packaging are manufactured appropriately(ii) Maintaining the cleanliness and health of personnel engaged in the manufacture of containers
and packaging (hereinafter referred to as "workers" in this Article and the following Article). (iii) The
facility or work area shall be designed to maintain the cleanliness and health of the equipment,
containers, and packaging (hereinafter referred to as "equipment, containers, and packaging"), andto ensure that the workers understand the work procedures and matters necessary for hygiene
management, and that they perform their work in accordance with those procedures and matters.
(iii) The facility or work area shall be designed to prevent contamination by dust, dirt, or othercontaminants as necessary, based on the usage of the equipment or containers and packaging,and shall be maintained in a clean condition.

Sanitation of equipment and instruments
Appended Table 17 (Re: Article 66-2, paragraph (1))(iii) Hygiene control of facilities, etc.
(a) To maintain hygiene, machinery and equipment shall be used appropriately for their intended
purposes.
(b) Machinery, equipment, and parts thereof shall be cleaned and sanitized to prevent metalfragments, foreign substances, or chemical substances from mixing with food or additives, andshall be stored hygienically in designated locations. In the event of malfunction or damage, it shallbe repaired promptly and maintained for proper use. e. Equipment, cleaning equipment, and parts
shall be stored in a hygienic location.
(e) Items that may come in contact with food or additives, such as utensils, cleaning equipment,
and protective gear, shall be disinfected with hot water, steam, or disinfectants and dried each timethey are contaminated or work is completed.
(li) Cleaning facilities are to be kept clean.
GMP 19Maintenance●Requirementｓ
The organization must establish a system for the planned maintenance of all equipment andinstruments critical to the safety of the product.
Maintenance activities must be performed in such a way that they do not pose a food safety risk.
●Concepts, specific examples
1. maintenance and management of equipment and instruments
1) Procedures shall be developed and implemented for the maintenance of all equipment andinstruments that are important for product safety. The procedures shall include the following
concepts(1) After-the-fact maintenance: A management method in which maintenance is performed after
a failure has occurred and the equipment has stopped or its functions have deteriorated.
(2) Preventive maintenance: Management methods that focus on prevention, such as equipment
inspection and periodic parts replacement.
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(3) Improved maintenance: Management method that focuses on improvement andreinforcement to prevent recurrence of breakdowns.
2) Procedures for maintenance and management of equipment and instruments include thefollowing items(1) Planning of maintenance and inspection(2) Persons in charge of maintenance and inspection(3) Identification of equipment and instruments 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 inspections(7) Procedures for returning to a state in which food production can be performed after
maintenance (including cleaning, etc.)
2. maintenance precautions
1) Repair the equipment so as not to contaminate food, etc.
2) Make sure that equipment (facilities) and instruments are not damaged or missing screws,
etc.
3) Implement preventive maintenance as well as after-the-fact maintenance in a systematicmanner.
4) Preventive maintenance plans should include equipment that monitors or controls foodsafety.(e.g., sieves, air conditioning filters, magnetic traps, metal detectors, etc.)
5) In the event of malfunction or damage, promptly repair the equipment and return it to normal
condition.
6) When performing maintenance, avoid contaminating surrounding manufacturing/processing
lines and equipment.
7) Lubricants and heat media that may come in direct or indirect contact with food should beselected that will not impair safety even if they come in contact with food.
●Items to be referenced in legal provisions related to food safety
Maintenance of equipment and instruments
Article 66-5 The standards specified by an Ordinance of the Ministry of Health, Labour and Welfare
set forth in Article 50-3, paragraph (1), item (i) of the Act with regard to the matters listed in thesame paragraph shall be as follows(iv) Proper implementation of cleaning and maintenance inspections of facilities and disposal ofwaste materials in order to maintain a clean working environment.
The end76

Disclaimer：This translated document is machine translated by JFSM and is provided for information purposes
only. In the event of a difference of interpretation or a dispute, the original Japanese version of this document isbinding.

JFS-B Standard Document (Sector：CI,CII,CIII,CIV/K) Version 3.0 〔Guidelines〕 Edition 1.0
May 25, 2022 Issued
Editing and publishing Japan Food Safety Management Association

The copyright of this guideline belongs to the Food Safety
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us in advance at
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Tel: 03-6268-9691 Email: info@jfsm.or.jp
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