JFS-C Standard Document(Sector: CI,CII,CIII,CIV/K)[Requirements for Organizations]
Version 3.0

Japan Food Safety Management Association
October 2, 2020

1． Introduction
1.1

JFS-C Standard Document

The JFS-C Standard Document (hereinafter referred to as “this Standard Document”) is a standard
document developed by the Japan Food Safety Management Association (JFSM) and is intended toassist organizations to establish, operate and improve its management systems for manufacturing
safe food products. In addition, this Standard Document can also be utilized to have the system of
the organization (*1) evaluated by external agencies including Certification Bodies. This Standard
Document is utilized by organizations that endeavor to realize a food safety management systemapplicable worldwide.
(*1) “Organization” refers to a business entity, group or individual to whom the requirements of thisStandard Document apply.
1.2

Scope of application

This Standard Document applies to the following “Food Manufacturing Sectors (CI, CII, CIII, CIV)”and “Chemical Products (Including Biochemical Products) Manufacturing Sector (K)”. (See JFS
Standard Document sector list on page 5)*Pet food is included in the following food manufacturing sector (C).
Food manufacturing sector (C)CI:
Processing of perishable animal products
CII:
Processing of perishable plant products
CIII: Processing of perishable animal and plant products (mixed products)
CIV: Processing of ambient stable products
Manufacturing sector of chemical products (including biochemical products) (K)K:
Manufacture of chemical products (including biochemical products)(Manufacture of additives, vitamins, minerals, cultures, flavors, enzymes, processing
aids, etc.)
In addition, chemical products here means a chemical product (including a biochemical
product) related to food.

1.3

Structure of this Standard Document

This Standard Document consists of three elements, namely, Food Safety Management Systems(FSM), Hazard Analysis and Critical Control Point (HACCP), and Good Manufacturing Practice (GMP).
This Standard Document only specifies common requirements for the manufacturing sector, and does
not cover individual hygiene requirements for individual product. Organizations shall use information
appropriate for the organization (e.g. laws and regulations on food safety, standards specified by therelevant industry group, “Annex of General Principles of Food Hygiene Code of Practices” by the
Codex Alimentarius Commission (*2), specific code of conduct), in addition to the requirements
stipulated in this Standard Document.

1This Standard Document is consistent with the benchmark requirement version 2020.1 (*3 hereafter,
BR 2020.1) published by GFSI in June 2020. On the other hand, since BR 2020.1 adopts
ISO22000:2018 (*4) in its scope structure and numbering structure, this Standard Document has astructure consistent with both the scope structure and numbering structure.
In addition, this Standard Document uses a process approach that incorporates the plan-do-checkact (PDCA) cycle of ISO22000:2018 and a risk-based approach as a benchmark. This Standard
Document establishes and implements a food safety management system to ensure the provision ofsafe food and services while meeting each applicable requirement and adopts a process approach
for improving its effectiveness.
The process approach indicates that each process used for providing food and services is regarded
as a system and is managed as such. In the process approach, the purpose of each process is
clarified and managed in consideration of process interactions to aid the organization to effectively
and efficiently achieve the intended results.
Risk (*5) in this Standard Document refers to all the factors that may hinder the achievement of theorganization's food safety objectives and targets. Risk-based thinking involves "focusing on what
factors may compromise the achievement of goals and objectives, identifying those factors, clarifying
their effects, and considering necessary measures." By establishing a hypothesis based on risk,
executing it, and performing verification based on the facts that are obtained, it becomes possible toaim to improve the accuracy of achieving the objectives and goals of the organization.
As shown in Figure 1, in this Standard Document the process approach adopts the concept of aplan-do-check-act (PDCA) cycle at two levels. The first level involves the FSM framework. The second
level is targeted at the Do process within the food safety management system. For this reason,communication between the two levels is extremely important.

2

PLAN（FSM）

DO（FSM）

FSM 1

Top Management Responsibility

FSM 7

Food Defense

FSM 2

Top Management Commitment and Food
Safety Culture

FSM 8

Food Fraud Prevention

FSM 4

Compliance with food safety laws

FSM 11

Procedures and Instructions

FSM 5

Food Safety Management System andGeneral Requirements

FSM 14

Traceability

FSM 15

Product development
Allergen Management
Control of Measuring and Monitoring
Devices

FSM 6
FSM 9.1

Food Safety Policy and Goals
Documentation procedures

FSM 16

FSM 9.2

Control and storage of documented
information

FSM 17

FSM 10Specification Control of Purchased orProvided Items and Services

FSM 19.1

FSM 12

Resource Management

FSM 19.2

FSM 13.1

FSM 22

FSM 13.2

Purchasing
Supplier Performance

FSM 13.3

Outsourcing

FSM 24

FSM 18.1

Product labeling (B-to-C products)

FSM 18.2

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

FSM 23

Analysis and Inspection
Environmental Monitoring for Food
Manufacturing
Serious Incident Management
Product Release
Identification of nonconformities andcontrol of nonconforming products

CHECK（FSM）Performance evaluation
FSM 3

Management Review

FSM 20Internal Audit
Complaint Handling

FSM 21ACT（FSM）Improvement
FSM 25
FSM 26

Corrective Action
Utilization of Kaizen suggestions frompersonnel

Figure 1 Conceptual diagram of two PDCA cycles in the JFS-C Standard Document Food Safety Management System3

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

Fig. 2 Conceptual diagram of the organic functions of the three elements (FSM, HACCP, GMP)

The association also prepares guidelines on the requirements of the Standard Document andrecommends that organizations refer to them.
（*2）Codex Alimentarius Commission“RECOMMENDED INTERNATIONAL CODE OF PRACTICE GENERAL PRINCIPLES OF FOOD
HYGIENE” CAC/RCP 1-1969, Rev.4(2003)（*3）GFSI “The GFSI Benchmarking Requirements version 2020.1”（*4）The International Organization for Standardization“Food safety management systems – Requirements for any organization in the food chain”
ISO22000：2018(*5) Unlike the risk defined in ISO22000:2018 (ISO22000:2018 3.39), the term risk is usedin the JFS-C Standard Document as something limited more to food safety.
1.4

Exclusion from Application of Requirements

All the requirements in this Standard Document shall be applied in principle. However, in case anyof the requirements in this Standard Document is not able to apply for reasons arising from thebusiness scale, business form and so on of an organization, the organization shall provide a document4which indicates proof of non-applicability with explanations demonstrating the proper maintenance offood safety management system.
(Reference) Category is as shown in the table below:

List of JFS Standard Document Sectors
The following sectors apply to this JFS (Food Safety Management) Standard Document.
Code

Sector/Subsector

Code

Sector/Subsector

FI

Retail / Wholesale

FII

Food Broker / Agent

H

Provision of Food Safety Services

Farming of Animals for Meat/ Milk/ Eggs/
AI
Honey
AII

Farming of Fish and Seafood
Farming of Plants (other than grains andBIpulses)
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

Hygienic Design of Food Buildings and
JI

Processing Equipment (for building constructors
and equipment manufacturers)

CII

Processing of perishable plant productsHygienic Design of Food Buildings andProcessing of perishable animal and JII
plant products (mixed products)

Processing Equipment (for building and

CIII

Processing of ambient stable products

Manufacture of chemical products (including

CIV

equipment users)

biochemical products)
K
D

Production of feed

(Manufacture of additives, vitamins, minerals,
cultures, flavors, enzymes, processing aids, etc.)

E

Catering

Reference: The GFSI Benchmarking Requirements version 2020 PART I

5

２．Specific Requirements (Standard Document)
2.1 Food safety management systems (FSM)

Number Clause Name
FSM 1
Top

Requirements
Top management shall establish a clear organizational structure which

Management

unambiguously defines the job functions, responsibilities, directing andResponsibility

reporting structure and information sharing of at least the personnel
whose activities affect food safety.
Top management shall appoint personnel responsible for theoperation of the organization’s food safety management system.

FSM 2

Top
Management
Commitment
and Food
Safety Culture

Top management shall show evidence of its commitment to building,
implementing, maintaining and continually improving its food safety
management systems.
This commitment shall include elements of a food safety culture, andthis means, at a minimum, communicating with employees,
responding to Kaizen suggestions, training to improve food safety, andassessing the performance of food safety activities. In addition, these
efforts shall be incorporated and implemented in the food safety
management systems of the entire organization.

FSM 3

Management
Review

Top management shall conduct management reviews on a regularbasis and record them in an appropriate manner to review allelements of the overall food safety management system, including
HACCP plans for managing food safety hazards and risks.
In the event of changes that have an effect on food safety, top
management shall ensure that the food safety management systemremains relevant and effective.

FSM 4

Compliance
When developing a food safety management system, the organization
with food safety shall develop, implement and maintain detailed procedures to ensure
lawsthat all processes and operations that have an effect on food safety arein compliance with the laws of both the country of manufacture and theintended country of sale.

6

Number

Clause Name

Requirements

FSM 5

Food Safety
Management
System andGeneralRequirements

The organization shall document the elements of the Food Safety
Management Systems and shall establish, implement and maintainthem appropriate to the scope of the products covered by its businessactivities.
In addition, the Food Safety Management Systems shall be
continuously improved by properly adapting to changes in thesurrounding social environment.

FSM 6

Food Safety
Policy and
Goals

The organization shall have a clear, concise and documented foodsafety policy statement and objectives specifying the extent of theorganization’s commitment to meet the safety needs of its products.
Top management shall ensure the organization to establish
measurable objectives consistent with the organization’s food safety
policy, formulate plans to achieve the objectives, monitor the
progresses against the objectives, and to update the objectives asnecessary.

FSM 7

Food Defense

The organization shall document, implement, and record assessment
procedures to identify potential and overt threats to food defense andprioritize response to those threats.
The organization shall document and implement a food defense planthat specifies the actions that the organization implements to mitigate
the identified food defense threat.
This plan shall cover GMP and shall be incorporated into the foodsafety management system.

FSM 8

Food Fraud
Prevention

The organization shall document, implement, and record assessment
procedures to identify potential and overt tampering with records andlabeling of products and intentional dilution, and prioritize food fraud
mitigation measures.
The organization shall develop a documented plan that specifies themeasures the organization implements to mitigate the identified
threats of food fraud.
This plan shall cover the GMP and shall be incorporated into the foodsafety management system.

7

Number

Clause Name

Requirements

FSM 9.1 Documentation The organization shall have documented procedures in place toprocedures
formulate, implement and maintain the documented information(including records) needed to demonstrate the effective operation of
its food safety management systems and process controls.

FSM 9.2 Control andstorage of
documented
information

The organization shall provide the documented information required todemonstrate its effective operation of the food safety management
system and control of processes. Documented information shall be
stored for the period required by the customer or legal and regulatory
requirements, or if there are no applicable requirements, for a period
exceeding the shelf life of the food. In addition, the documented
information shall be effectively controlled so that it is always available
when it is required.

FSM 10 Specification
Control ofPurchased orProvided Items
and Services

For all purchased or provided input items and services (including raw
materials and ingredients, utilities and services (e.g. electricity, water,transportation, maintenance)) that have an effect on the safety of final
product, the organization shall ensure that documented specifications
are prepared, maintained, securely retained and readily accessible
when needed.
The organization shall evaluate the risks and set the confirmation
items (confirmation of inspection certificate, condition, temperature,display, etc.) on the items to be purchased or provided.
In addition, the organization shall define and implement a review
process that includes the handling of changes in specifications andthe frequency of regular reviews.

FSM 11 Procedures and The organization shall establish, implement and maintain effective
Instructions
procedures and instructions in all processes and activities that affectfood safety.
In addition, these procedures and instructions shall be understandable
by personnel in different languages.

FSM 12 Resource
Management

Top management shall determine and provide, in a timely manner, thequalified resources (including human resources, facilities and work
environment, equipment, systems for operating business sites(including communication technology and transportation), means ofmeasurement and traceability, intellectual property management, etc.)that meet the standards required to implement, maintain, and improve
the food safety management system.

8

Number

Clause Name

Requirements

FSM
13.1

Purchasing

The organization shall control purchasing procedures to ensure that all
externally sourced raw materials, packaging materials, and services
that have an effect on food safety conform to stipulated specifications,as well as legal and regulatory requirements related to food safety.
In addition, these purchasing procedures shall also apply to raw
materials, packaging materials, and services purchased from theorganization's group companies.

FSM
13.2

Supplier
Performance

The organization shall establish, implement and maintain proceduresfor the evaluation, approval and continual monitoring of suppliers,
which have an effect on food safety.
Supplier evaluation shall include measures for food defense and toprevent food fraud.
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 the required
specifications by an evaluation, inspection, visit, etc. before use.
The organization shall maintain evaluation, approval and monitoring
records for suppliers.

FSM
13.3

Outsourcing

The organization shall ensure, when the organization chooses to
outsource any process that that may have an effect on food safety(including contract manufacturers, service providers for existingprocess, and other service providers), that it complies with thecustomer requirements and takes into account the JFS-C standard
requirements required for food safety risk management.
Control of such outsourced processes shall be identified, documented
and monitored as a part of the food safety management system.
Changes to the contract content shall be approved by both parties andcommunicated to the relevant personnel.

FSM 14 Traceability

The organization shall establish, implement and maintain appropriate
tracing procedures covering all processes from supplier (at least one
step before) to recipient (at least one step after) to ensure productidentification.
Documented procedures shall be verified at least once a year by trace
testing to ensure that they are working effectively, and the verification
results shall also be recorded.

9

Number

Clause Name

Requirements

FSM 15 Productdevelopment

The organization shall establish, implement and maintain productdesign and development procedures to ensure that new products or
products whose specifications and manufacturing processes havechanged are manufactured safely and in accordance with legal andregulatory requirements.
These development procedures shall clearly confirm that the products
and services provided conform to specifications, and after identifying
all the hazards of food safety, shall include a review to evaluate andapprove the adequacy of food safety assurance in the design anddevelopment.

FSM 16 Allergen
Management

The organization shall develop and implement allergen management
plans and maintain them appropriately.
The plans shall include a risk assessment of allergen crosscontamination and control measures to be implemented to reduce or
eliminate the risk of cross-contamination.
In addition, the plans shall ensure that products that are shipped andsold are labeled according to the allergen labeling regulations in the
country where they are to be sold.

FSM 17 Control of
Measuring andMonitoring
Devices

The organization shall identify measuring and monitoring devices thatare parameters critical to ensure food safety.
In addition, the specified equipment and devices shall be calibrated
regularly.
The calibration shall be traceable by the relevant national orinternational standards and methods.

FSM
18.1

Product labeling The organization shall ensure that all product labels or attached(B-to-C
information to enable the safe handling, display, storage, preparation
products)
and use of the product in the food supply chain or by the consumer.
The finished product shall be labeled according to the applicable foodregulations in the intended country of sale.

FSM
18.2

Product labeling The organization shall define and implement procedures to provide(B-to-B
information, such as on primary processed foods, commercial
products, work ingredients, or intermediates in the processing process, so thatin progress,
customers or consumers can be informed about product safety, evensemi-finished
if the information is not labeled on or attached to the product.
products)

10

Number

Clause Name

Requirements

FSM
19.1

Analysis andInspection

The organization shall establish, implement, and maintain procedures
to ensure the analysis of raw materials, semi-finished products,
finished products, manufacturing environments, etc. that affect foodsafety.
The inspection shall be conducted by a competent inspection
department or analysis institution using appropriate sampling andanalytical methods.
Inspections that have a significant effect on food safety shall be
conducted in accordance with the applicable requirements of ISO/IEC
17025.

FSM
19.2

Environmental
Monitoring

The organization shall establish, implement and maintain a microbial
environmental monitoring program to reduce the risk of foodcontamination.
This program shall consider microbial risks specific to the
manufacturing process and facility environment and include evaluation
methods tailored to the risks.

FSM 20 Internal Audit

The organization shall establish, implement and maintain documented
internal audit procedures for all applicable food safety management
systems (including HACCP plans, food defense plans, and food fraud
prevention plans).
The procedures shall include at least the following content.
a) Timing of internal audits. Schedules including frequency of at least
once a year.
b) Corrective action for nonconformity.
c) Rules that ensure the objectivity and fairness of internal audits.
The organization shall maintain a record of the performance of theinternal audit as evidence.
The organization shall specify the competence required for internal
auditors and provide training for internal auditors.

FSM 21 Complaint
Handling

The organization shall establish, implement, and maintain complainthandling and complaint data management procedures.
Control procedures shall include analyzing complaints, evaluating themagnitude of the impact threatening food safety, and implementing
corrective action as necessary.

11

Number

Clause Name

Requirements

FSM 22 Serious Incident The organization shall establish, implement and maintain an effective
Management
management procedure of serious incidents. The incident
management procedure shall cover planning for product withdrawal
and product recall as required, and be regularly tested for all products
it supplies.
The effectiveness of the incident management procedure shall beverified at least once a year, and the results shall be recorded.

FSM 23 ProductReleaseThe organization shall establish and implement appropriate
procedures for product release.

FSM 24 Identification of The organization shall establish, implement and maintain effective
nonconformities procedures to identify nonconformities that have an effect on foodand control ofsafety and to clearly identify, control, discard and rework
nonconforming nonconforming products resulting from nonconformities in order toproducts
prevent misuse and mis-shipment.

FSM 25 Corrective
ActionThe organization shall establish procedures for the determination andimplementation of corrective actions in the event of any
nonconformities arising relating to food safety.
In case of deviation or violation, the organization shall identify the root
cause, take measures to prevent recurrence, and review theeffectiveness for the series of corrective actions.

FSM 26 Utilization of
Kaizensuggestions
from personnel

The organization shall establish and implement a system to properly
utilize food safety Kaizen suggestions from personnel.

122.2 Hazard Analysis and Critical Control Point (HACCP)

Clause Name

Requirements

HACCP
Step 1HACCP Team A HACCP team shall be assembled with competent staff.
Assembly

HACCP
Step 2

Product
Description

Product specifications shall be documented.
The document shall describe all product information necessary to
conduct hazard analysis.
Scope of the HACCP system shall be defined per product or productgroup and per process line or process location.
This system should be systematic and comprehensive and take into
account legal and regulatory requirements related to food safety.

HACCP
Step 3

Identificationof Intended
Use

Intended use of the product and target consumers shall be clearly
described in a written document.

HACCP
Step 4

Constructionof Flow
Diagram

The flow diagram that covers all steps in the operation shall be
constructed.

HACCP
Step 5On-siteConfirmationof Flow
Diagram

The flow diagram shall be verified whether it correctly reflects theexisting process steps of the operation.

HACCP
Step 6(Principle 1)

HazardAnalysis

The HACCP team shall list all of the hazards that are reasonably
likely to occur in each process steps, conduct an analysis, andidentify any necessary measures to control them. Hazards shall
include allergens where required.

HACCP
Step 7(Principle 2)

CriticalCritical Control Points (CCPs) shall be determined.
Control Points

HACCP
Step 8(Principle 3)

Establishment Critical limit(s) shall be stipulated for each CCP.
of Critical
Limits13

Clause Name

Requirements

HACCP
Step 9(Principle 4)

Monitoring
SystemMonitoring procedures shall be established for each CCP.

HACCP
Step 10(Principle 5)

Corrective
Actions

A procedure of corrective actions (correction, and investigation andremoval of root cause) shall be established for deviations from a
critical limit.

HACCP
Step 11(Principle 6)

Verification

Verification procedures shall be established to confirm whether thedefined handling (HACCP Plans) is carried out as specified and tojudge 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.

HACCPStep 12(Principle 7)Documents
and Record

Necessary documents shall be prepared and maintained.
These documents shall contain documents related to the standard
operating procedures (SOP) and the work instructions (WI)
necessary and applicable to the scope of certification of theorganization.

142.3 Good Manufacturing Practice (GMP)

NumberClause Name

Requirements

Facility Environment

The organization shall locate and maintain their business site
in a location where pollution can be prevented and products
can be safely received, stored, manufactured and delivered.

Site Management

The organization shall establish and maintain appropriate
standards for the grounds of their workplaces to prevent
pollution and produce safe products.

Design, construction,layout of business site
and work and productflow lines

The organization shall design, construct and maintain thefactory buildings and facilities (storage area, raw material andproduct handling area, preparation area, packaging andstorage area, etc.) of the business site both outside and inside
the plant to minimize food safety risks.
In addition, the equipment layout and the flow lines of people,
goods, and work shall be designed to meet the intended
purpose and minimize food safety risks.

Physical, chemicaland biological productcontamination risks
and isolation

The organization shall clarify that all hazard factors (physical,
chemical (including allergens), and biological) for eachprocess have been identified based on consistency checks
between the process flow created by the HACCP team andthe site. The frequency of occurrence and the magnitude of
the consequences of the identified hazards shall be evaluatedand appropriate control measures shall be set for each.
Procedures shall be established and documented to control
identified hazards other than critical control points (CCPs) thatare difficult to manage effectively with a general hygiene
control program to prevent contamination of raw materials(including packaging materials), semi-finished products, workin-process, rework and finished products, and crosscontamination.
The organization shall regularly review these procedures andkeep them in effect.

Personnel Facilities

Personnel facilities, including washbasins and toilets, andapplicable shared facilities shall be provided, designed, andutilized to minimize food safety risks.

GMP 1

GMP 2

GMP 3

GMP 4

GMP 5

15

Number

Clause Name

Requirements

Personal hygiene
criteria for personnel

The organization shall develop, implement and maintainhygiene criteria that evaluate and document product-specificrisks to minimize food safety risks.
The criteria shall include provisions of hand washing and toilet
facilities, ways and frequency of hand washing, medical
screening procedure to identify conditions impacting foodsafety, proper protective clothing, rules on the clothing andshoes, rules on accessing production area, ways of foodhandling, and control measures for foreign materials.
These hygiene criteria shall also be understandable bypersonnel in different languages.

Personnel workwear

The organization shall evaluate product-specific risks andprovide appropriate work clothing to minimize food safety
risks.

Health managementof personnel

The organization shall develop, implement and maintain healthcare procedures that evaluate and document product-specificrisks to minimize food safety risks.
These shall include procedures for personnel suspected ofillness to promptly report illness or symptoms to their superiors
according to the laws and regulations of the country in which
personnel are working.

Application to nonbusiness personnel
and visitors

The organization shall ensure that GMP 6.1, 6.2, and 6.3 are
well known to personnel who have an impact on food safety,
and apply them to contractors and visitors without exception.

Training

All personnel shall be trained in their appropriate language onfood safety (including management, culture, HACCP, GMP),and there shall be a system for each personnel to deepen theirunderstanding, implement, and maintain food safety in theirrespective work.
In addition, there shall be a system to improve comprehension
by repeating the training as necessary after evaluatingcompetence.

GMP 6.1

GMP 6.2

GMP 6.3

GMP 6.4

GMP 7

16Number

Clause Name

Requirements

Housekeeping,cleaning, sterilizationand disinfection

The organization shall identify product-specific risks based ona hazard analysis and establish, implement and maintaindocumented organization, cleaning, sterilization anddisinfection procedures.
In addition, the organization shall also verify that proceduresthat can minimize product-specific risks are working
effectively.
Cleaning tools, cleaning agents and disinfectants shall besuitable for their intended use and stored appropriately.
Food safety information on potentially harmful chemicals shallbe obtained and confirmed.

ReworkThe organization shall control product rework in a traceable
manner with minimal food safety risk.
The food safety risks involved in rework shall be evaluatedand included in HACCP flow diagrams.
Records shall be maintained as evidence of control.

Patrol and inspectionof the site

The organization shall establish a patrol plan and regularly
inspect the environment, facilities, and process design(people, goods, work flow lines) of the entire site.
Records shall be maintained as evidence of the inspection.
The patrol plan shall ensure that the workplace is maintainedin an appropriate state according to its activities and that foodsafety is ensured.

Air and water
management

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 food production in order to minimize the effect on foodsafety.
If water that has been used but is acceptable in contact withfood is applied to food production, it shall be controlled toprevent it from being contaminated with dedicated production
water.

GMP 8

GMP 9

GMP 10

GMP 1117

Number

Clause Name

Requirements

Waste Management

The organization shall establish adequate systems forsegregation, collection and disposal of waste (including waste
water). The flow lines of waste shall be established so as not
to cause cross-contamination of food.
Locations and containers for placing waste shall be controlled
to prevent attraction of pests or growth of harmfulorganisms/micro-organisms.

Pest control

The organization shall establish, implement and maintainprocedures to control or remove food safety risks caused bypests (pests and vermin) on the premises and in the facilities.
These procedures shall be implemented using the following
cycle.
1. Understanding of the pest outbreak situation andformulation of monitoring plans.
2. Implementation of pest control and invasion prevention.
3. Pest monitoring and dissemination of results to personnel.
The organization shall establish procedures for eliminatingpests and vermin as necessary.

Acceptance ofpurchased items

The organization shall establish, implement and maintainacceptance procedures for all externally sourced raw
materials, packaging materials and services that have aneffect on food safety. In addition, in order to ensure that thesafety of the final product is not compromised and that thematerials are suitable for the intended use, verification of raw
materials, containers and packaging materials shall be carriedout.

Transport

The organization shall establish a system to ensure that
containers and vehicles, including contracted vehicles, used
for the transportation of raw materials and ingredients(including packaging materials), partially processed products,
works in progress, reworks, and finished products (including
packed fresh products in final packaging) are suitable for theintended use, maintained in good repair and clean.

GMP 12

GMP 13

GMP 14

GMP 1518

Number

Clause Name
Storage

The organization shall hold or store foods (raw materials,
semi-finished products, work in progress, reworked products,
and final products) at designated locations, and manage themunder appropriate conditions to minimize food safety risks.

Stock Management

The organization shall establish, implement and maintain asystem to use raw materials and ingredients (including
packaging materials), partially processed products, work inprogress, reworks, and finished products in a designated order
and within the defined expiry period, and shall store thesematerials under the proper conditions to avoid contaminationand deterioration.

Devices and Tools

Devices and tools shall be suitably designed and selected forthe intended uses and shall be used, maintained and stored
so as to minimize food safety risks.

MaintenanceA system of planned maintenance covering all items ofequipment which are critical to product safety shall beestablished.

GMP 16

GMP 17

GMP 18

GMP 19Requirements

19Annex●Definitions
1.

Term
intended use

Definition
Methods of use and consumption methods established at the timeof planning and design for products, buildings and equipment.
Outsourcing refers to an organization commissioning its own
processes to be performed by an external party.
This commissioning includes not only the services provided by acontractor, but also the provision of the services by the contractor.
Services provided by contractors include provision of lunch forpersonnel, cleaning of work clothes, insect, vermin and sanitation
consultants, sanitation of facilities at business sites, maintenanceof facilities and equipment, etc.
Range of application of certification.

2.

outsourced processes

3.

categories

4.

control measure

Any action or activity that can be used to prevent, eliminate, or
reduce food safety hazards to acceptable levels.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)
This is also defined as a control measure in the glossary of the“Guide to Implementing HACCP in Food Manufacturing” (inJapanese) published by the Ministry of Health, Labor and Welfare.

5.

hazard6.

critical limit

7.

recordA biological, chemical or physical material in, or condition of, foodwith the potential to cause an adverse health effect.
(Cited from the definition in the Codex General Principles of foodhygiene)Criterion which separates acceptability from unacceptability.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)
Document stating results achieved or providing evidence ofactivities performed.
Note 1 to entry: Records can be used, for example, to formalize
traceability and to provide evidence of verification, preventive
action and corrective action.
Note 2 to entry: Generally records need not be under revisioncontrol.
(Cited from the definition in ISO 9000:2015)

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8.

Term
verification9.

raw materials andingredients

10.

updating

11.

CCP（critical control point）

Definition
Confirmation, through the provision of objective evidence, thatspecified requirements have been fulfilled.
Note 1 to entry: The objective evidence needed for a verification
can be the result of an inspection or of other forms ofdetermination such as performing alternative calculations orreviewing documents.
Note 2 to entry: The activities carried out for verification are
sometimes called a qualification process.
Note 3 to entry: The word “verified” is used to designate thecorresponding status.
(Cited from the definition in ISO 9000:2015)
Ingredients refer to those used as part of product including
packaging materials and water as well.
Immediate and/or planned activity to ensure application of themost recent information.
(Cited from the definition in ISO 22000:2018)
Controls can be applied and are essential steps to prevent or
eliminate food safety hazards, or bring food safety hazards toacceptable levels.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)

12.

employee, personnel

All personnel in an organization who are involved in work related tofood safety, including part-timers, contractors, and dispatchedpersonnel.

13.

correction

Action to eliminate a detected nonconformity.
Note 1 to entry: A correction can be made in advance of, in
conjunction with or after a corrective action.

14.

serious incident

15.

food

Note 2: As terms with the same notation but different meanings inthis Standard Document: Modification, which is the act of revising
documents, records, and items to be stated, and Rework, which isthe act of remedying a product in process.
(Refer to the definition in ISO 9000:2015)
Food incident that may have an effect on food safety. Does notinclude incidents that do not have an effect on food safety but
may have an effect on the quality.
All substances that are processed, semi-processed or
unprocessed with the intention of human consumption.
Note to entry: Food includes all substances used for
manufacturing, preparation and processing of beverages, chewing
gums and foods. However, it does not include substances usedsolely for cosmetics, cigarettes and drugs.

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16.

Term
food safety policy

Definition
Overall intentions and direction of an organization related to foodsafety as formally expressed by top management.
(Cited from the definition in ISO 22000:2018)17.

a culture of food safety

Shared values, beliefs and norms that affect mind-set and behavior
toward food safety in, across and throughout an organization.
(Cited from A Culture of Food Safety, a position paper from the
Global Food Safety Initiative (GFSI) 4/11/18 V1.0)

18.

food safety management
system

19.

scope

20.

control

21.

product

A system to specify policies and objectives and to achieve theseobjectives so that food does not harm the consumer for when thefood is cooked and/or consumed in accordance with the intendeduse.
(Referenced to ISO 9000:2015 and ISO 22000:2018)
GFSI defined certification scope. A code with a specificclassification is assigned to each food, feed, and food-related
service industry, and a detailed business category for eachclassification is indicated.
The state wherein correct procedures are being followed andcriteria are being met.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)
Output of an organization that can be produced without any
transaction taking place between the organization and thecustomer.
Note 1 to entry: Production of a product is achieved without any
transaction necessarily taking place between provider andcustomer, but can often involve this service element upon its
delivery to the customer.
Note 2 to entry: The dominant element of product is that it isgenerally tangible.
Note 3 to entry: Hardware is tangible and its amount is acountable characteristic (e.g. tires). Processed materials are
tangible and their amount is a continuous characteristic (e.g. fueland soft drinks). Hardware and processed materials are often
referred to as goods. Software consists of information regardlessof delivery medium (e.g. computer program, mobile phone app,
instruction manual dictionary content, musical composition
copyright, driver’s license).
(Cited from the definition in ISO 9000:2015)22.

corrective action

Action to eliminate the cause of a nonconformity and to prevent
recurrence.
Note to entry: There can be more than one cause for anonconformity.
(Cited from the definition in ISO 9000:2015)

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Term

Definition

23.

product withdrawal

Removal of products from the supply chain that are consideredunsafe before they are sold to the end consumer.
(Cited from the definition of GFSI Benchmarking Requirement ver.
2020.1)

24.

reworkIndicates the action to be taken when returning to the
manufacturing flow a product that complies with the requirementsfor products that have deviated from the regular series ofprocesses, including final products, semi-finished products, workin-process, and raw materials in all processes.
Rework includes the action of returning a product from a series ofprocesses to an upstream process for reworking, and the action of
returning a product to a process again without processing.

25.

top management26.

food chain

Person or group of people who directs and controls anorganization at the highest level.
Note 1 to entry: Top management has the power to delegate
authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system covers
only part of an organization, then top management refers to those
who direct and control that part of the organization.
(Cited from the definition in ISO 9000:2015. Note 3 to entry is notincluded in the definition of “top management” in this document.)
A series of steps from primary production to consumption thatinvolve the production, processing, distribution, storage andhandling of food and its ingredients.
Note 1: Production also includes the production of feed and foodfor animals.
Note 2: The food chain also includes the production of ingredients
intended to come into contact with food or ingredients.
Note 3: The food chain also includes service providers.
(Cited from the definition of ISO 22000:2018)27.

flow diagram

28.

document

29.

nonconformities

Diagrams constructed to show all the process steps for specified
product.
Information and the medium on which it is contained.
Example: Record, specification, procedure document, drawing,
report, Standard Document
Note to entry: The medium can be paper, magnetic, electronic or
optical computer disc, photographic or master sample, or
combination thereof.
(Cited from the definition in ISO 9000:2015. Notes 2 and 3 toentry are not included in the definition of “document” in thisdocument.)
Non-fulfilment of a requirement.
(Cited from the definition in ISO 9000:2015)

23

30.

Term
management

31.

management system

32.

monitoring

Definition
Coordinated activities to direct and control an organization.
Note to entry: Management can include establishing policies andobjectives, and processes to achieve these objectives.
(Cited from the definition in ISO 9000:2015. Note 2 to entry is notincluded in the definition of “management” in this document.)
Set of interrelated or interacting elements of an organization toestablish policies and objectives, and processes to achieve theseobjectives.
(Cited from the definition in ISO 9000:2015)
Definitions related to CCP
A planned observation procedure or measurement of control
parameters performed to assess whether the CCP is undercontrol.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)
Definitions other than CCP
Determination of the status of a system, process or activity
Note 1: Inspection, supervision or careful observation may berequired to determine the situation.
Note 2: Monitoring in food safety involves a series of planned
observations or measurements to assess whether a process is
operating as intended.
Note 3: ISO 22000:2018 makes a distinction between validation,
monitoring and verification.
- Validation is applicable prior to the activity and provides
information on the ability to produce the intended result.
- Monitoring is applicable during the activity and provides
information on the activity within a specified period of time.
- Verification is applicable after the activity and provides
information to confirm conformance.
(Cited from ISO 22000:2018)33.

packaging materials

Materials used for packaging food products, such as papers,
plastics, wooden boxes, cardboards, PET bottles, and tin cans.

34.

competence

Ability to apply knowledge and skills to achieve intended results.
Note to entry: Demonstrated competence is sometimes referred toas qualification.
(Cited from the definition in ISO 9000:2015. Note 2 to entry is notincluded in the definition of “competence” in this document.)

24

35.

Term
product recall

Definition
Products that have been or are being sold to the end consumer
and are considered unsafe are removed from the supply chain by
the supplier.
(Cited from the definition of GFSI Benchmarking Requirement ver.
2020.1)36.

review

Determination of the suitability, adequacy or effectiveness of an
object to achieve established objectives
EXAMPLE: Management review, design and development review,
review of customer requirements, review of corrective action andpeer review.
Note to entry: Review can also include the determination ofefficiency.
(Cited from the definition in ISO 9000:2015)

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

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