JFS-B Plus Standard Document(Sector: CⅠ, CⅡ, CⅢ, CⅣ /K)<Manufacture of food products and Manufacture ofchemicals (including biochemical products)>

Version 1.0〔Guideline〕
Edition 1.0
Japan Food Safety Management Association
July,25 2024

Table of Contents
Introduction ..................................................................................................................................................................................................4
Ⅰ Food safety management systems (FSM) ....................................................................................................................9FSM 1 Management or senior management responsibility ...............................................................................9FSM 2 Commitment of management or senior management and food safety culture .......... 12
FSM 4 Compliance with food safety laws ..................................................................................................................... 15
FSM 6 Food Safety Policy and Goals................................................................................................................................. 16
FSM 7 Food Defense ...................................................................................................................................................................... 17
FSM 8 Food Fraud Prevention ................................................................................................................................................ 19
FSM 9 Document and record management ................................................................................................................ 22
FSM 11 Procedures and Instructions ............................................................................................................................... 28
FSM 12 Resource Management ............................................................................................................................................ 29
FSM 13.1 Purchasing ..................................................................................................................................................................... 30
FSM 13.2 Supplier Performance........................................................................................................................................... 35
FSM 14.1 Traceability ................................................................................................................................................................... 38
FSM 14.2 Traceability verification ...................................................................................................................................... 40
FSM 16 Allergen Management ............................................................................................................................................... 41
FSM 17 Control of Measuring and Monitoring Devices ...................................................................................... 43
FSM 18 Product labeling ............................................................................................................................................................. 44
FSM 19 Analysis and Inspection .......................................................................................................................................... 48
FSM 21 Complaint Handling .................................................................................................................................................... 49
FSM 22.1 Serious Incident Management ...................................................................................................................... 50
FSM 22.2 Verification of food incident management manual ..................................................................... 52
FSM 23.1 product specifications .......................................................................................................................................... 53
FSM 23.2 Product Release ........................................................................................................................................................ 541

FSM 24 Control of non-conforming products ............................................................................................................ 55
FSM 25 Corrective Action .......................................................................................................................................................... 56
Ⅱ Hazard Analysis and Critical Control Point (HACCP) ......................................................................................... 58
HACC Step1 HACCP team assembly and identification of the scope of application .................. 58
HACCP Step2 Product Description ...................................................................................................................................... 60
HACCP Step3

Identification of Intended Use ......................................................................................................... 60

HACCP Step 4 Construction of Flow Diagram ........................................................................................................... 61
HACCP Step 5 On-site Confirmation of Flow Diagram ...................................................................................... 63
HACCP Step 6 (Principle 1) Hazard Analysis ............................................................................................................. 64
HACCP Step 7 (Principle 2) Critical Control Points ............................................................................................... 70
HACCP Step 8 (Principle 3) Critical Limits ................................................................................................................... 74
HACCP Step 9 (Principle 4) Monitoring System ...................................................................................................... 76
HACCP Step 10 (Principle 5) Corrective Actions .................................................................................................... 78
HACCP Step 11 (Principle 6) Establish HACCP plan validation and verification procedures......................................................................................................................................................................................................................... 79
HACCP Step 12 (Principle 7) Documents and Record ........................................................................................ 82
Ⅲ Good Manufacturing Practice (GMP) .............................................................................................................................. 84
GMP 2 Site Management ............................................................................................................................................................ 84
GMP 3 Design, construction, layout of business site and work and product flow lines ......... 86
GMP 4.1 Cross-contamination (including allergen cross-contact) and isolation .......................... 91
GMP 4.2 Control of hazards that require enhancement ................................................................................... 93
GMP 5 Personnel Facilities ........................................................................................................................................................ 95
GMP 6 Hygiene, workwear and Health management of personnel, etc. ........................................... 98
GMP 7 Training .................................................................................................................................................................................104
GMP 8 Housekeeping, cleaning, sterilization and disinfection ..................................................................107
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GMP 11 Air and water management ..............................................................................................................................110
GMP 12 Waste Management .................................................................................................................................................114
GMP 13 Pest control .....................................................................................................................................................................116
GMP 15 Transport ..........................................................................................................................................................................120
GMP 17 Stock Management ...................................................................................................................................................122
GMP 18 Devices and Tools .....................................................................................................................................................123
GMP 19 Maintenance ...................................................................................................................................................................127

3

Introduction
This guideline provides ideas and specific examples of what organizations should
implement with regard to the JFS-B Plus standard issued by Japan Food Safety
Management Association (JFSM).
The food safety management system established by each food businessorganization differs depending on many factors such as industry, business category,business scale, and social background. This report is intended to be used as areference for each organization to build a food safety management system suited totheir own needs.
These guidelines are for B Plus standards for the food manufacturing sector (CI - CIV) and the "Chemical Products (including biochemical products) Manufacturing
Sector (K)". (Table 1)

4

Table 1 List of Sectors by GFSI (Sectors presented by GFSI that are covered by thisstandard document are framed.)

Code Sector/Subsector
AI
AII
BI
BII
BIII
C0

CI

CII
CIII
CIV
D

Code Sector/Subsector

Farming of Animals for Meat/
Milk/ Eggs/Honey
Farming of Fish and Seafood
Farming of Plants (other thanFI

Retail / Wholesale

FII

Food Broker / Agent

H

grains and pulses)
Farming of Grains and Pulses

G

Pre-process handling of plantI

products

Services
Provision of Storage andDistribution Services
Production of Food Packaging
Hygienic Design of Food

Animal primary conversion

Buildings and Processing
JI

Processing of perishable animal

Equipment (for building
constructors and equipment

products

manufacturers)

Processing of perishable plantHygienic Design of Food

products

JII

Perishable animal and plant

Buildings and Processing
Equipment (for building andproducts (mixed products)

equipment users)

Processing of ambient stable

Manufacture of chemical

products

products (including biochemical

Production of feed

products)
K

E

Provision of Food Safety(Production of chemical
products (including biochemical
products) and cultures used ascatering

food ingredients or processing
aids in food production)
Reference: The GFSI Benchmarking Requirements version 2020.1 PART I【Food manufacturing sector (CI~CIV)】
CI: Processing of perishable animal products

CII : Processing of perishable plant products
CIII : Processing of perishable animal and plant products (mixed products)
5

CIV : Processing of ambient stable products
Manufacturing sector of chemical products (including biochemical products) (K)K: Manufacture of chemical products (including biochemical products)(Production of chemical products (including biochemical products) andcultures used as food ingredients or processing aids in food production)
In addition, chemical products here means a chemical product (including abiochemical product) related to food.
JFS standards consist of Food Safety Management Systems :FSM, which are
Requirements for the management of an organization's activities, HACCP, which isa method of controlling hazards, and Good Manufacturing Practices (GMP), which
are Requirements for general hygiene management, and are interrelated. (Figure
1).
And JFS-B Plus is a standard that adds to the JFS-B standard the requirements fororganizations in capacity building programs developed by international industry
associations for food-related businesses. By operating this standard, theorganizations can comply with internationally researched food safety management
system activities.
Overall view of JFS Standard Document and Certification Program is shown in
Figure 2.

Figure 1: Basic structure of the JFS standard

6

Figure 2. Overall view of JFS Standard Document and Certification Program
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 take appropriate measures.
This guideline provides ideas and specific examples to serve as a reference whenutilizing the JFS-B Plus standards. However, these are examples only, and otherideas and methods may be selected if it can be explained technically andscientifically that the Requirements of the JFS standards are met. They can also be
used together with research data and food safety theory from research 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 varyby industry and region, and while 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 individuallyconfirm the compliance.
We hope that these guidelines will help you understand the JFS standards.
<Structure of the JFS-B Plus Guideline>
7

● Requirements● Concepts, specific examples● Items to be referred to in Japanese legal provisions related to food safety**Legal provisions are taken from the Food Sanitation Law Enforcement
Regulations of Japan.

8

[JFS-B Plus Standard Version. 1.0 Guideline]
JFS-B Plus 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. There shall also be evidence that employees are madeaware of them. 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 food safety 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 is easier to manage by using meetingbodies and morning meetings to determine the activities necessary forfood 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 thefacts to a supervisor, manager, or another person.
（3）Consultation: Confirmation of appropriateness should be obtained
when it is not possible to determine whether the work is appropriate, or
when new activities are undertaken.

92） A communication system should be in place to ensure that safe foodproducts can be shipped even in the event of major changes in the
manufacturing environment, such as a sudden increase in ordervolume, accelerated shipping times, or personnel shortages. (Shipment
decisions are also related to procedures in FSM 23.2 (Product Release).
3. Informing employees.
Examples of evidence that employees are informed about theorganizational structure include, but are not limited to, meeting minutes,
morning meeting records and communication notes. This can also be
confirmed in communications during internal and external audits, etc.
4. Food safety officer
1） Determine a food safety officer as the person responsible for foodsafety management.
2） The food safety manager′s knowledge of food safety policies, foodsafety knowledge, and field knowledge and experience in theorganization will enable him or her to create an effective system.
3） If there is a separate food safety manager or food safety officer, it isimportant to share information and collaborate. They may also serve
concurrently.
●Items to be referred to in Japanese legal provisions related to food safety
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 abusiness prescribed in Article 1, paragraph (1) of the Act (including cases
where it is applied mutatis mutandis under Article 62, paragraph (3) of theAct) shall specify a person responsible for food sanitation. However, this shallnot apply to business persons prescribed in each item of Article 66-2,
paragraph (4). In addition, a food sanitation supervisor prescribed in Article 48of the Act may also serve as a person responsible for food sanitation.
(d) A business person shall respect the opinions of the person responsible forfood sanitation.

10(e) A person responsible for food sanitation shall take necessary precautions toensure compliance with the measures prescribed in Article 66-2, paragraph (3)and endeavor to state necessary opinions to a business person.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for
Enforcement of the Food Sanitation Act(i) c. Food sanitation supervisors shall comply with the following matters(1) Attend seminars held by prefectural governors, etc. or seminars approvedby prefectural governors, etc. on a regular basis, and endeavor to acquire newknowledge concerning food sanitation (limited to business under Article 54 of
the Act (including cases where it is applied mutatis 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 to businesses 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 toensure compliance with the measures prescribed in Article 66-2, paragraph (3),and shall endeavor to state necessary opinions to the business person.

11

■Reference: "food sanitation manager" and "food sanitation supervisor"

food sanitation

food sanitation

managersupervisor
To be specified byLaws and regulations

Article 48 of the Food

governing

Sanitation Law

prefectures, designatedcities, etc. under Article
50, paragraph 2 of theFood Sanitation Act.

Qualifications

national qualification

official certification

Report toprefectural governor

health care center

For each licensed facility
Targetthat manufactures or

Per business licenseprocesses the subject

facility

food, additive, etc.
Basically none.
Whether qualifications

Regular attendance atare renewed or notpractical training courses
is recommended.

Basically none.
Regular attendance atdesignated training
sessions is
recommended.

FSM 2 Commitment of management or senior management and food safety
culture●Requirements
Management or senior management shall show evidence of its commitment tobuilding, implementing, maintaining and continually improving its food safety
management systems.
This commitment shall include elements of a food safety culture, and thismeans, at a minimum, communicating with employees, responding to Kaizen
suggestions, training to improve food safety, and assessing the performanceof food safety activities. In addition, these efforts shall be incorporated andimplemented in the food safety management systems of the entire
organization.
●Concepts, specific examples
1. Management or senior management is responsible for the establishment,
implementation, maintenance, and continuous improvement of the food12

safety management system and demonstrates its commitment to theestablishment, implementation, maintenance, and continuous
improvement of the system through the implementation of the following
1）Develop a food safety policy2）All organizations involved in food safety and their respective roles areclearly defined and made known to all employees. Communicate toemployees in a timely manner the importance of compliance with laws,
standards, social norms, and rules set by the organization.
3）Ensure that employees are aware of factors that can influence fooddefense and food fraud risks. To this end, establish and maintain asystem that allows the organization to constantly obtain the following
information.
●All related laws
●Scientific and technological developments●Industry code of practice●Other information on food safety and product quality issues, etc.
4）Set 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 Step
11(Principle 6) and FSM 14.1 and 22.2.
8）Other matters necessary for the establishment, implementation andmaintenance of food safety management systems.
2. The following is a reference example of food safety culture elements forManagement or senior management to include in their commitments topromote improvement through the food safety management system. (5Dimensions)1）Clarify the vision and mission.
Is food safety integrated into your business strategy? (including
providing resources and other support).
Does the company provide direction and objective goals to employees
and clearly state what is expected of them?
Does it provide messaging with leadership to employees?

2）Conduct outreach to the people.
13

Have the necessary stakeholders been clarified and the governancestructure clarified?
Do you communicate with employees on site? (e.g., by holding
meetings)
Is there an organization in place for learning and training?
Does the company have an evaluation system (incentives, rewards,
recognition, etc.) for actions taken by employees?

3）Consistency.
Is the Management or senior management taking the responsibility
seriously as the person who is ultimately responsible for the company?
Are employees' performances properly evaluated?
Are all processes kept in writing?

4）Adaptability.
Do they demonstrate food safety expectations while understanding thepersonal cultural differences of each employee?
Does the company provide prompt feedback on employee offers?
Is the business model appropriately changed to manage risks and solve
problems?

5）Recognize hazards and risks.
Does the company provide risk prevention education, such as byproviding basic hazard information?
Are employees involved in activities to prevent near misses?
Are hazards verified when they occur and are risks communicated?
3. Fundamental to a well-functioning food safety management system is theestablishment and maintenance of a positive food safety culture thatrecognizes the importance of the actions of all employees involved inproviding safe and appropriate food. Therefore, it is advisable that not only
Management or senior management but also all employees make acommitment. Reference examples are as follows.
(Reference case)In order to prevent contamination by foreign matter, we will conduct
thorough visual checks of the manufacturing process after washing/cleaning
and before the start of manufacturing. etc.
14

FSM 4 Compliance with food safety laws
●Requirements
When developing a food safety management system, the organization shalldevelop, implement and maintain detailed procedures to ensure that allprocesses and operations that have an effect on food safety are in compliancewith the laws of both the country of manufacture and the intended country ofsale.
In addition, records of implementation shall also be maintained.
●Concepts, specific examples
1. The organization shall clarify the food safety laws and regulatory
Requirements for its own organization and define the methods of control.
The organization shall comply not only with the laws and regulations of thecountry of manufacture, but also with the laws and regulations pertaining
to food safety in the country of sale. When relevant laws and regulations
are revised or new laws and regulations are enacted, it is necessary to
grasp them in a timely manner, communicate them to the organization,and change management methods as necessary. The laws and regulatory
Requirements of the country of sale must also be understood. Evidence ofthe results of the implementation of the control procedures must be
retained. An example of a record of the implementation of the proceduresis a list of relevant laws, regulations, and Requirements, and records oftheir confirmation and updating.
2. Laws, regulations, and regulatory Requirements pertaining to food safety
to which reference should be made (this item is applicable to the scope inJapan)
Business operators engaged in manufacturing or processing shall assign afood hygiene supervisor or food hygiene manager who meets thenecessary Requirements.
1） Food Hygiene Supervisors: These are appointed in accordance with
Article 48 of the Food Sanitation Law. Target foods are whole milk
powder, sweetened milk powder, adjusted milk powder, meatproducts, fish meat ham, fish meat sausage, irradiated food, edible oils
and fats, margarine, shortening, and additives.
2） Food Hygiene Manager: A Food Hygiene Manager is appointed for eachfacility that is to obtain a business license and each facility that is tosubmit a business notification, except in cases where a Food Hygiene
15

Manager is appointed in accordance with the provisions of the
Enforcement Regulations of the Food Sanitation Law.
(See FSM 1, ● Items to be referred to in Japanese legal provisions
related to food safety.)
FSM 6 Food Safety Policy and Goals●Requirements
Management or senior management shall have a clear, concise, written foodsafety policy.
●Concepts, specific examples
1. Management or senior management should create a food safety policy thatmeets safe and appropriate quality standards and that all employees
understand and recognize. The policy should be developed with thefollowing 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 andcomply 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 regularbasis.
3） Communicating the policy at morning meetings. etc.
3. Food safety policies should be developed with the involvement ofmanagement or senior management, and food safety policies should be
reviewed periodically for adequacy

16

FSM 7 Food Defense●Requirements
The organization shall 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 therisk.
The organization shall also establish access controls for areas where fooddefense vulnerabilities have been identified.
The organization shall establish and implement procedures for responding topossible intentional contamination of product.
●Concepts, specific examples
1. Food defense means the means of preventing, avoiding, or responding tointentional food contamination by biological, chemical, or physical hazards
by persons within or outside the organization.
2. Identifying the risk of intentional food contamination by persons within or
outside the organization and assessing the magnitude of that risk is calleda food defense vulnerability assessment, and the response plan is called afood defense plan.
3. In the vulnerability assessment of food protection (analyzing threats andidentifying 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
priority of solutions such as access control.
4. Develop and implement procedures to conduct a vulnerability assessmentof the facility (analyze threats and identify weaknesses).
5. Based on the results of the vulnerability assessment, develop andimplement a food defense plan that includes methods, responsibilities, anddecision criteria to prevent intentional food contamination 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.

17

3） Procedures must be in place to ensure safety during storage anddelivery 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 found to be intentionally contaminated or defective6） Have an effective recall program (see FSM 22.2)
7） Provide necessary education and training to personnel according to theorganization's food protection plan8)8） The organization shall establish access controls for areas where fooddefense vulnerabilities have been identified.
9） Establish and implement procedures for responding to the possibility
that uncontrolled access has occurred and products have been
intentionally contaminated.
7. Access controls implemented for areas where food defense vulnerabilities
are identified are also included in the food defense plan. Access controls
can include guards, ID cards, or systems that limit or record access toauthorized personnel.

【Reference】
1. In addition to monitoring cameras and lock controls, communication
among employees is a deterrent to food protection.
2. Excessive reliance on hard measures of food defense may instead damage
the good relationship between employees and managers. Thus, forexample, an organization could explain to employees that the monitoring
cameras are not installed based on suspicion of employees, but so that thecompany can prove the actions of employees in the event of a foodaccident.
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 isparticularly useful.
4. A mechanism for examining trends in social cases, cases of othercompanies in the same industry, prevention cases, and predictive signs isrequired.
5. The "Guidance for Formulating a Voluntary Action Plan for Enhancing
Confidence in the Food Industry" - Five Basic Principles - published by the18

Ministry of Agriculture, Forestry and Fisheries of Japan in March 2008 is a
useful reference. (This is applicable in Japan)(Basic Principle 1) Clarify the consumer's point of view
(Basic Principle 2) Establish compliance awareness(Principle 3) Basis of proper hygiene and quality control(Basic Principle 4) Establish systems for appropriate hygiene and quality
control(Basic Principle 5) Efforts to collect, communicate, and disclose
information
FSM 8 Food Fraud Prevention●Requirements
The organization shall document, implement and maintain assessment
procedures to identify potential and overt food fraud vulnerabilities such as
tampering with records and labeling of products and intentional dilution, andprioritize food fraud mitigation measures.
The organization shall develop a documented plan that specifies the measures
the organization implements to mitigate the identified threats of food fraud.
This plan shall cover the GMP and shall be incorporated into the food safety
management system.
●Concepts, specific examples
1. "Food fraud" refers to intentional acts committed primarily for economic
reasons, such as tampering for the purpose of cost reduction or
misrepresentation of good quality. Examples include dilution, substitution,
concealment, fraudulent labeling, function enhancement by unauthorizedmeans, counterfeiting, etc. Among these, this requirement covers food
fraud as it relates to food safety.
Examples of food fraud related to food safety include the following:
1) Melamine contamination of powdered milk made in China in 20082) Horse meat contamination of beef-based food products sold in Irelandin 2013 (contamination of veterinary drugs)
2. Methods to "identify potential and actual falsification of records andlabeling and intentional dilution of products" include the following:
1)Refer to past or currently developing cases of food fraud in the supply
chain. The organization will have a process in place for accessing cases offraud. Such information can be obtained, for example, from19

●Industry Associations●Government Sources●Private information centers●Information systems established by the organization in the FSM2
2) Identify in what situations food fraud can occur.
It is also effective to assume food fraud in each production flow asfollows:（1）Fraud in raw materials used
（2）Fraud during manufacture（3）Fraud in products after shipment (including resale of discarded
defective products as food)3) Evaluate the ease of occurrence (vulnerability).
3. Supply chains are becoming more complex, extending overseas, and therisk of food fraud is increasing. "Assessing vulnerability" means analyzing
what types of food fraud are likely to occur and how likely they are tooccur due to external and internal factors in the context of such changes inthe environment surrounding the organization. Vulnerability assessors
need to understand the potential food fraud risks, which includes
knowledge of the raw materials used in the field and the concept ofvulnerability assessment described above. Vulnerability assessment isconducted from two perspectives: product/supplier.
Examples of vulnerability assessment steps include:
1） Clarify the raw materials and their specifications related to the foodproducts handled.
2） Estimate what are the events that could cause fraud (what kind of
fraud could occur).
3） Estimate the magnitude of risk for any possible fraud that may occur.
4） Estimate the magnitude of the impact of fraud on food safety.
5） Prioritize vulnerabilities by risk and magnitude of impact.
4. Based on the results of the vulnerability assessment, a management plan
to reduce food fraud shall be developed after conducting an evaluation ofcurrent control measures related to food fraud. The plan shall clearly
identify priorities. The following methods can be used as means to reducefood fraud:1） Conduct appropriate monitoring in response to vulnerabilities
2） Verification of origin and labeling3） Specification Management204） Conduct supplier audits5） Analytical testing6） Use of anti-counterfeiting technology7） Collect whistleblower testimonials from within the organization.
5. Examples of methods include the following:
1） Add fraud to the scope when conducting second-party audits.
2） Request that suppliers monitor their supply chains.
3） Change the origin/supplier of raw materials to one where there is noprecedent for fraud.
4） Strengthen controls in situations where fraud practices are likely tooccur (extremely low prices from suppliers used below market prices,soaring raw material prices, tight supply, frequent advance shipment
times, sudden increases in order volumes, and understaffed production
systems).
5） Add fraud vulnerability to the frequency of analysis/testing.
6） Review the supplier's financial situation.
6. Organizations are required to clarify the scope of the above food fraud
prevention plan and incorporate and operate it into their food safety
management system.
7. The food fraud vulnerability assessment shall be reviewed at least annually
and/or whenever significant changes occur. The food fraud reduction plan
will be revised/updated as needed.
8. Please refer to the following for concepts on fraud prevention. (1) is thescope of application in Japan.)1） The "FCP's Focus on Collaboration," which was created by the Food
Communication Project (FCP) launched by the Ministry of Agriculture,
Forestry and Fisheries (MAFF) in the wake of the food fraud, is a goodreference. This was created as an effort to curb the occurrence of food
fraud.
https://www.maff.go.jp/j/shokusan/fcp/whats_fcp/kyoudou.html
2） U.S. Pharmacopeia (USP) "Food Fraud Mitigation Guidance"
https://www.usp.org/sites/default/files/usp/document/ourwork/Foods/food-fraud -mitigation-guidance.pdf

21FSM 9 Document and record management●Requirements
The organization shall establish documented procedures to create, maintain,
and record for control processes to ensure food safety and evidence effective
operations.
In addition, the organization shall keep records necessary to prove theimplementation of food safety management, determine an appropriate storage
period, and store them.
●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 thatrecords are kept without shortages and can be reviewed at a laterdate".
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 goingon in your company, your setup, and your procedures(2) Standardize work and prevent variation in perception andunderstanding 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 thelegitimacy of your organization
2） Documented documents should be managed so that the latest version
can always be referenced and operated. For this reason, it is desirable
to establish appropriate rules for modifying 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
22

（3）Attach a setup number, obsolete number, etc. to the document tomake it clear that it is the latest version(4) Discard old versions or store them in a designated place to prevent
misuse3. 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 andrecords," there are cases where it is optimal to present them inwriting. On the other hand, the existence of a large number of
documents leads to complicated management.
If it can be judged that "it can be handled by methods other thandocuments," reducing the number of documents appropriately may beeffective for both the on-site work of workers and the operation ofmanagers.
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 ofbusiness, size, and complexity of the organization's operations.
3） Some documents, mainly records, require long-term storage.
Therefore, "appropriate storage period" should be set in considerationof the shelf life of products and other factors.
Therefore, "appropriate storage period" should be set in considerationof the shelf life of products, etc., and the documents should bemanaged 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 be suspected of being "falsification." Forexample, "Corrections should be made with double lines, and the dateof correction and the name of the person who made the correction

23

should be written on the corrected part, etc. It is desirable to establish
a method that can be clearly understood by a third party.
【Documents and records required in the requirements】
No.

item

Content of documentation orrecords

FSM4

Compliancerecords of the implementation ofwith foodcompliance procedures

safety laws
FSM6

Food Safety

Clear, concise, documented food

Policy andsafety policies

Goals
FSM8

Food Fraud

Plan that specifies the measures

Prevention

the organization implements tomitigate the identified threats offood fraud.

FSM9

Document andDocuments and records

recordmanagement procedures

management
FSM13.2

Supplier

Procedures for the evaluation,

Performance

approval, and continual monitoringof suppliers.
Documentation of results ofsurveys, evaluations, approvals,
and follow-up with suppliers.

24

check

FSM14.1

Traceability･Record of all externally procured
raw materials (including containers
and packaging materials),
products, or services･Records to identify batches, semifinished products, work-inprogress, recycled products,
reworked products, finishedproducts and packaging
throughout the manufacturing
process･Record of purchasers and delivery
destinations for all products
supplied･If the procedure has been
updated, record it

FSM14.2
FSM16

Traceability

Record results of traceability

verification

verification

AllergenAllergen management plan

Management
FSM17

Control ofRecord of actions taken when

Measuring andequipment and devices are foundMonitoring

to be inaccurate

Devices
FSM21

Complaint

A system of management to

Handling

respond to complaints and utilize
complaint data Record ofcomplaints, investigation results,
and corrective actions.

FSM22.1

SeriousFood incident management

Incident

proceduresManagement
FSM22.2

Verification ofRecords of annual testing to verify

food incident

the effectiveness of the foodmanagement

incident management procedures

manual25

FSM23.2
FSM24

Product

Appropriate procedures for

Releaseproduct release (shipping)

Control ofRules to avoid using and shipping

non-items that may cause safety

conforming

issues.

products
FSM25

Corrective

Corrective action documentation

ActionHACCP Step 12

Documents

Make the necessary documents (in(Principle 7)

and Record

HACCP) and keep records.

GMP4.1

Cross-

Procedures for necessary control

contamination

measures against cross-(including

contamination (including allergenallergen cross- cross-contact)
contact) andisolation
GMP4.2

GMP6

Control ofProcedures for control measureshazards thatfor hazards that require

requireparticularly enhanced controls,enhancement

other than CCPs.

Hygiene,Document appropriate sanitation

workwear andstandards for employees.

Healthmanagementof personnel,
etc.
GMP7

Training

Education and training
implementation records

GMP8

Housekeeping, Management procedure ofcleaning,

maintain an appropriate level ofsterilization

hygiene at all times by conducting

andtidying and cleaning operations

disinfection

throughout all processes andphases, and disinfecting where
necessary.

26

GMP11

Air and water

Records of periodic monitoring ofmanagement

air, high-pressure gas, water, etc.
used in food production.

GMP19

Maintenance

System for systematic
maintenance of all equipment
critical to product safety.

●Items to be referred to in Japanese 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 andequipment, machinery and appliances, and the processes of manufacturing,processing, cooking, transporting, storing, or selling food, a procedure
manual (hereinafter referred to as a "procedure manual") to properly
implement measures necessary for public health in these processes(iv) Verify the effectiveness of the sanitation management plan and procedure
manuals, and review 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 berecorded 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 the Food Sanitation Act(iii) Sanitation control of facilities, etc.
(d) For instruments such as thermometers, pressure gauges, and flow
meters, and for equipment used for sterilization, disinfection, sanitization, or
water purification, their functions shall be periodically inspected, and theinspection results shall be recorded.
(iv) Control of water used, etc.
(b) When water suitable for drinking is used, the water quality shall be tested
at least once a year, and the report shall be kept for one year (or longer if thefood or additive being handled has been used or consumed for more than one
27

year). However, if there is a possibility that the water source may becontaminated due to an unforeseen disaster, the water quality shall be tested
each time.
(e) When water suitable for drinking is used and sterilization or water
purification equipment is installed, periodically check that the equipment isworking properly and record the results.
(v) Rats and insect control
Rats and insects shall be exterminated at least twice a year, and records shallbe kept for a period of one year. However, if the objective can be achieved bysuch means as conducting periodic, uniform surveys of the locations, habitats,and infestation routes of rats and insects and the status of damage, andtaking necessary measures based on the results of said surveys, the survey
may be conducted in a manner and frequency appropriate to the conditions of
the facility concerned.
(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 matters concerning 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 and manufacturing processes. The organization shall establish,
implement and maintain effective 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 and procedures are to be shared.
28

2. Procedures should be disseminated in a manner that is easily understoodby 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 foodsafety.
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 be done" is clarified.
4） Depending on the situation where employees are becoming
multilingual, it is desirable to address the issue in the language usedby the employees, in writing or otherwise, whenever possible.
●Items to be referred to in Japanese 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 theseprocesses, taking into consideration the structure and materials of facilities
and equipment, machinery and appliances, and the processes ofmanufacturing, processing, cooking, transporting, storing, or selling food, and(iii) Prepare a sanitation management plan and procedure manual asnecessary.
(iv) Verify the effectiveness of the sanitation management plan and procedure
manuals, and review 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).

29

●Concepts, specific examples
1. Management or management should make management resources(people, goods, and money) available to ensure food safety.
2. Since management resources are limited, management should determine
priorities and devise ways to maximize effectiveness and ensure that foodsafety is implemented in a rational manner.
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 to changes in the manufacturing
environment.

4.

Specific management resources are as follows
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 regularbasis due to the high cost of training a large number of workers, but if one
person receives training and internal training is conducted and deployedhorizontally, 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 toprioritize items in order of their direct impact on food safety and toprepare the manufacturing environment over a period of several years,
rather than repairing everything at once.
FSM 13.1 Purchasing●Requirements
The organization must develop and implement purchasing procedures toensure that all externally procured raw materials, materials, and services that
affect food safety comply with the organization's Requirements.
When processes affecting food safety are subcontracted, control of theseprocesses must be ensured by presenting the control methods to thesubcontractor, for example, by describing the control methods inspecifications and contracts.

30

●Concepts, specific examples【Purchasing】
1. This standard requirement requires that each organization establish andimplement procedures to verify what it purchases from outside sources
according to the magnitude of the risk it poses to food safety.
2. Confirmation method means to determine whether or not what ispurchased from outside conforms to the specifications established by thecompany, and specifically includes the following.
1） Inspection of a sample representative of the lot of what is to bepurchased
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 purchasing organization.
4. FSM 13.1 requires management of what the organization purchases fromoutside (raw materials, containers and packaging materials, and services),
whereas FSM 13.2 requires management of their suppliers (suppliers andproviders).
5. In some cases, purchasing procedures are exempted from application
when purchasing from (or accepting) an intra-group company. However,this requirement requires that the same purchasing procedures be applied
when purchasing from an intra-group company as when purchasing froman 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 and damage and are properly labeled.
(2) Raw materials that are properly controlled are to be procured.
(3) Management of agricultural, forestry, livestock, and fisheryproducts (primary products) used as raw materials includes thefollowing①Prevention of contamination by dust, soil, or sewage is implemented
at the production stage.
② Appropriate management of wastes, toxic substances, etc. at the
production stage.
31

③Prevention of contamination by pesticides, veterinary drugs, feed,rodents/insects, foreign substances, microorganisms, feces, etc. isimplemented at the production stage.
④Facilities at the production stage are maintained clean and properly
managed through cleaning 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 aretaken 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 thesecannot be killed or removed to an acceptable level by normal
manufacturing and processing, such raw materials will not be accepted.
2） Requirements for packaging materials used for food products (thescope of this item applies in Japan)(1) Use appropriately controlled products that are manufactured andprocessed in accordance with laws and regulations such as theStandards for Foods and Additives (1959, Ministry of Health andWelfare Notification No. 370) and whose safety is assured.
(2) When selecting packaging materials, select materials withappropriate 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 notpeel off labeling or erase printing due to friction or adhesion ofcondensation drops during distribution and storage.
(4) When reusing packaging materials, prepare a procedure for reusein advance and manage it so as not to contaminate the product. In
case of damage or significant contamination, discontinue use anddispose of the product.
(5) Packaging containers and packaging gases should be non-toxic andshould not impair the safety and suitability of the product for storage
and use.

32

(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 foodutensils, containers, and packaging, the Law for Partial Revision of theFood Sanitation Law, etc., promulgated on June 13, 2008, introduced
the positive list system, which allows the use of only substances thathave been evaluated for safety with respect to food utensils andcontainers and packaging. (Ministry of Health, Labour and Welfare,June 2040). (Enacted on June 1, 2020 by the Ministry of Health, Laborand Welfare)【Subcontractor management】
1. Subcontracting is the process of outsourcing an organization's own
processes to another organization. The organization periodically monitors
and verifies the subcontracted process to ensure that the results of thesubcontracted process do not pose a food safety hazard to theorganization's products.
2. This Subcontracting includes not only product manufacturing bycontractors and services provided by personnel dispatch, but also theprovision of services. This subcontracting includes not only productmanufacturing by contractors and services provided by personnel dispatch,
but also the provision of services. The services provided by the provider
include transportation and storage, inventory control (see GMP 15 and 17),
insect, rodent, and sanitation consultants, sanitation of workplaces andfacilities, maintenance of equipment and facilities, cleaning of work
clothes, provision of meals for employees, etc.
3.

The ultimate responsibility for the food safety management system in thecase of subcontracting rests with the purchasing organization.

4. Any changes to the contractual arrangements must be approved by bothparties and communicated to the relevant personnel.
5.

Covered subcontractors include contract manufacturers and service
providers.

331） Contract manufacturers agree to and contract with all terms andconditions related to food safety, customer Requirements,
commercialization, shipping, etc.
The contract manufacturer shall develop and implement anorganization to ensure compliance with the terms of the contract.
2） Contracted service providers document and contract specifications forservices affecting food safety.
3） The contract shall include training of personnel involved in providing
the services as well as clarification of the services.
6. Subcontracted 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 Step
6(Principle 1). In addition, an evaluation of suppliers is performed inaccordance with FSM 13.2.
7. The following contents shall be performed as necessary to ensure theappropriateness of subcontracting.
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 subcontracting CCP
processes, etc., the management system, process control, andconformance of the final product must be equivalent to the food safety
management system established by the own organization.
Example of Supplier Data Entry Form (Product Specification)

34

FSM 13.2 Supplier Performance●Requirements
The organization shall document, implement, and maintain procedures for theevaluation, approval, and continual monitoring of suppliers, which have aneffect on food safety.
When accepting raw materials, packaging materials, and services fromunapproved suppliers in an emergency (such a natural disaster), theorganization shall confirm that the products meet the required specifications
by an evaluation, inspection, visit, etc. before use.
Results of survey, evaluations, approvals, and follow-ups with suppliers shallbe maintained.

35

●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 basedon 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 thatraw materials, containers and packaging materials, and services arepurchased from approved suppliers.
3. The controls required of the organization are to establish and implement
documented procedures for the evaluation, approval and monitoring of
suppliers, which are described in detail below.
1） Evaluation
After determining the person responsible for the evaluation, thenecessary related information shall be collected and evaluated withreference to the following methods and contents.
(1) Evaluation Method
1. Verbal interview
2. Document and record checks
3. 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 tobilateral 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 of suppliers used are extremely lower thanmarket prices, market prices of raw materials soar, supply is tight,
shipping times are frequently moved forward, rapid increase in ordervolume, understaffed production system).
(3) Qualifications and competence of evaluators

36Personnel in charge of conducting supplier evaluations shall beknowledgeable 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 theevaluation results. Then, the rules/processes for the approver toapprove and the method of information sharing with the HACCP teamshall be defined as a procedure.
3） Monitoring
Rules (method, frequency, timing, etc.) for periodic re-evaluation of
suppliers are defined as a procedure. Monitoring also includes activities
related to follow-up, such as suspending transactions with suppliers orproviding guidance to suppliers in case of problems, depending on the
results of a series of evaluations of suppliers.
4. This requirement refers to the supplier's food protection, but it does not
require a level of compliance with FSM 7 (food protection) to this standard,
but rather allows a level at which suppliers have established their own
scope of applicability and have initiated efforts related to food protection.
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 thatequivalence 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 and normal products at the time of
product shipment (release).
Example of New Purchaser Data

37

FSM 14.1 Traceability●Requirements
The organization shall establish, implement, and maintain appropriate tracing
procedures covering all processes from supplier (at least one step before) torecipient (at least one step after) to ensure product identification. These
procedures must include procedures (e.g., labeling) to continuously identify
the product throughout the manufacturing process and throughout
distribution.
To ensure traceability, at least the following shall be recorded:●Record of all externally procured raw materials (including containers andpackaging materials), products, or services●Records to identify batches, semi-finished products, work-in-progress,
recycled products, reworked products, finished products and packaging
throughout the manufacturing process●Record of purchasers and delivery destinations for all products supplied●If the procedure has been updated, record it●Concepts, specific examples【Traceability in the FSM14】
1. Traceability records are important to confirm the manufacturing process ofthe subject product and to assure the safety of the food in the event of aserious product accident.
38

2. "Recipient" in this requirement basically refers to the purchaser one stepfurther in the food chain, 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 bedelivered to a warehouse designated by the purchaser. Therefore, thisrequirement requires that the owner of the product and the "recipient"where the product is actually placed be known so that speedy action canbe taken when a problem occurs. Raw materials, containers and packaging
materials, services, and outsourced processes purchased from outside(hereinafter referred to as "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 the recipient (at least one step after). In addition, eachorganization is required to identify (e.g., by labeling) its products
throughout the manufacturing process and on an ongoing basis
throughout delivery. By linking these organizations, the entire supply chain
can be traced.
【Recorded information required for traceability】
5. The maintenance and provision of record information necessary fortraceability 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, aswell 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 and outgoing shipments.
(5) Confirm that traceability is functioning, including work in process,batches, semi-finished products, recycled products, reworked products,
finished products and packaging throughout the manufacturing
process.
(6) If necessary, product samples for each lot are stored.
2） Provide records related to traceability39

(1) Establish and implement procedures for the preparation of records
and the retention of records.
(2) When requested by the government, submit records related to
traceability.
Examples of records required for process and tracing
accessioning

manufacture

custody

shipping

Product

Ingredient

Daily

Product

Product

Information

Information

Production

temperature

Shipping

Food Safety

Reportrecords

Information

Information

Inspection

Inventory

Destination

Receivingrecords

records

Information

Inspection

Process

Records

records

Environmental Delivery

GMP-RelatedInternal

DeliveryInformation

VehicleRecords

temperature

VehicleTemperature

Person inrecordTemperature

RecordchargeRecordDelivery

information

Deliveryvehiclevehiclehygienehygienerecords

records

Sampling

pre-sampled

Quality

Quality

Information

product

Control

ControlrecordInspection

ThermometerandCalibration

Acceptance

Record―FSM 14.2 Traceability verification●Requirements
The organization shall verify the documented procedures for implementing
and maintaining traceability through traceability test at least once a year toensure that they are functioning effectively. The results of verification shallalso be recorded.
40

●Concepts, specific examples
1.

The organization shall document the procedures for implementing andmaintaining tracing, verify them at least once a year to ensure that theprocedures are working effectively, and update them as necessary.

2.

The results of the verification shall be recorded. (See FSM 9.2)

FSM 16 Allergen Management●Requirements
The organization shall document and implement allergen management plans.
The allergen management plans shall include:●Control procedures to properly assess the risk of allergen cross-contact and,based on that assessment, reduce, or eliminate the risk of cross-contact.
●Procedures for handling raw materials (including containers and packaging
materials), semi-finished products, work in progress, reworked products, andfinal products to prevent cross-contact with allergens during all processes
from manufacturing to shipping.
●Cleaning procedures and verification procedures for areas that come into
contact with food
●Procedures for identifying and displaying allergens that shall be controlled in
all processes from manufacturing to shipping
All final products containing or potentially containing allergens should be
identified in accordance with the laws and regulations of the country to which
they are expected to be shipped, and appropriate customer Requirements.
●Concepts, specific examples
1. Allergens to be controlled
The substances that cause allergies are called allergens. Worldwide, there
are eight main allergens: cereals including gluten, crustaceans, eggs, fish,
milk, peanuts, soybeans, and tree nuts. Organizations need to consider
accidents caused by allergens in consumers.
*Reference cases in Japan (Source: Consumer Affairs Agency Website)
https://www.caa.go.jp/policies/policy/food_labeling/food_sanitation/allergy/(For the latest version, please check the relevant website.)
2. Organizations

need

to

manageallergens
41

from

the

followingthreeperspectives:
1） Preventing or minimizing the possibility of allergen cross-contact.
2） Information identifying allergens in food products shall be clear andaccurate. In particular, for purchased raw materials, suppliers are
required to demonstrate appropriate allergen controls and their
Requirements.
3） Ensure that allergens contained in food are communicated to each stageof the logistics process after shipment.
3. Allergens to be controlled in all processes from manufacturing to shipping
shall be identified, and a written allergen control plan shall be established,
implemented, and properly maintained:
1） Identify allergens that may be contained based on the specifications of
the raw materials used.
2） Differentiate the receiving and storage areas for each different allergen.
3） Identify allergens to be controlled according to the production plan, sothat they can be checked on each production line.
4） Distinguish between machinery and equipment used in the weighingroom.
5） Identify areas in the manufacturing facility where allergen powder isdispersed and implement measures to prevent dispersal.
6） To handle line changeovers (powders, oil and fat products (chocolate,spreads, etc.)) where water cannot be used for cleaning.
7） Control the labeling and use of allergens in recycled and work-in-process
products.
8） Implement measures to prevent incorrect labeling.
9） In controlling allergens, the laws and regulations of the country of sale(allergen labeling regulations) shall be observed.
4. Develop control procedures to reduce or eliminate the risk of cross-contact.
Examples of control procedures include the following:1） Containers and utensils used in production (plastic bags, scoops, etc.)
shall be identified for each allergen to be controlled and avoid use in
mixed.
2） Develop procedures for handling raw materials (including containers andpackaging materials), semi-finished products, work-in-process, reworked
products, and finished products to prevent allergen cross-contact at allstages of production and shipment.
3） Determine procedures and verification methods for cleaning and washing42

methods for manufacturing processes to prevent cross-contact.
4） When producing different products on the same production line, plan
production in order of the number of allergens present, from lowest to
highest, if possible.
5. During the development of products containing allergens, check the validityof controls by line testing, etc.
6. When preparing product labeling, allergens shall be indicated in accordancewith the laws and regulations (allergen labeling regulations) of the country
in which the product is supposed to be sold.
7. If verification (e.g., analysis) is required, establish and implement
procedures, and record and store the verification results.
8. Related items include FSM 4 (Compliance with food safety laws), 13.1
(Purchasing), 13.2 (Supplier Performance), FSM 18 (Product labeling), GMP
3, 4.1, 4.2, 6, 7, 8, 9, 11, 13.2, 14.1, 17 (Requirements related tocontamination in manufacturing processes, etc.) see also.
9. For more information on examples of "Allergen Management", see CODEX
Alimentarius, Code of practice on food allergen management for foodbusiness operators (CXC 80-2020).
FSM 17 Control of Measuring and Monitoring Devices●Requirements
The organization shall identify measuring and monitoring devices that are
parameters critical to ensure food safety.
In addition, the specified equipment and devices shall be calibrated regularly.
Calibration of these instruments and devices must be performed to equivalent
standards, including national and international standards, or to reasonably
accepted traceable methods.
The organization shall take appropriate action when equipment and devices
are found to be inaccurate, and these actions shall be recorded.
●Concepts, specific examples
1. It is necessary to clarify the measuring instruments for parameters thatare important to ensure food safety, and to identify those instruments thatare 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 themeasurement of numerical parameters and is a verification. It includes
43international standards, national standards, domestic
calibration/manufacturer's assurance and in-house verification, etc. Fromamong these, it is necessary to determine the appropriate method in thetarget equipment or device and inspection.
3. Calibration is required for instruments, devices, and methods used inmeasurement and monitoring 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, theschedule recommended by the equipment manufacturer, and the scheduledetermined by the organization
6. Record when measuring, monitoring, test, and inspection instruments anddevices are found to be inaccurate, and establish procedures to evaluate
and take appropriate action on potentially affected products●Items to be referred to in Japanese 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 the Food Sanitation Act(iii) Sanitation control of facilities, etc.
(d) For instruments such as thermometers, pressure gauges, and flow meters,
and for equipment used for sterilization, disinfection, sanitization, or water
purification, their functions shall be periodically inspected, and the inspection
results shall be recorded.
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 thecorrect information.

44

●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 ofsale.
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 beclarified.
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 thelabeling are correct. 5.
5. Procedures are established to ensure that products and labeled packaging
materials are not mistakenly mixed up.
Product Labeling Considerations (Example)

45

■Example of information management of raw materials containing allergenic food [1].
●Data of allergenic substances contained in raw materials ●Allergenic substances contained in final products can be grasped

Ingredients

Manufacturer

specification

A
Ingredients

Manufacturer

Manufacturer

E

wheat

egg

milk

〇

△

×

specification

・・・ gelatine

Product

×

name

wheat

egg

milk

〇

△

×

・・・ gelatine ⇒×materials used

wheat

egg

milk

A

〇

△

×

×

B

〇

△

×

×

C

〇

△

×

×

wheat

egg

milk

udon

D

〇

△

×

×

noodles

E

〇

△

×

〇

△

×

×

Allergens in final product

〇

〇

×

×

Udon

curry

noodleswith curryallergen

topping・・・ gelatine×allergenraw materials
Classification

allergenspecification

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

●Items to be referred to in Japanese legal provisions related to food safety
Labeling
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 informationnecessary for them to safely consume food or additives (hereinafter referred toas "products" in this table) that they collect, manufacture, import, process,prepare, store, transport, or sell. (a) A business person shall endeavor toprovide consumers with the information necessary for consumers to safely
consume and eat the food or additives (hereinafter referred to as "products" inthis table).
(b) A business person shall endeavor to provide consumers with informationnecessary for the safe consumption of food or additives (hereafter referred toas "products" in this table), including information on health hazards (limited tothose symptoms diagnosed by a physician as being caused by or suspected tobe caused by said food or additives. The same shall apply hereinafter in thisitem). (ii) When obtaining information on the health hazards of a product(limited to those that have been diagnosed by a physician and that are causedor suspected to be 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 leadto the occurrence of a strange taste or odor, contamination with a foreign46substance, or other health hazard, the business person shall endeavor toprovide said information to the prefectural governor, etc.

47

FSM 19 Analysis and Inspection●Requirements
The organization shall conduct appropriate inspections where and as theyaffect food safety.
Such inspections must be performed by a competent laboratory or analyticallaboratory.
In addition, the organization shall establish and implement analysis andtesting procedures (methods, standards, etc.) to confirm that the productmeets product specifications within its shelf life.
●Concepts, specific examples
1. To ensure food safety, inspection plans should be developed to ensure that
inspection of products, semi-finished products, raw materials andenvironmental wipe test specimens are conducted systematically for items
that affect food safety and legal Requirements, as well as productRequirements from customers. It also requires that analysis and testingprocedures (methods, criteria, etc.) be established and implemented toverify that products meet specifications during the shelf life of the
products.
2. The laboratory or analytical laboratory with testing competence should beusing procedures, validated methods, etc. that conform to ISO 17025 toensure that this testing method is a valid result. The results of suchinspections 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

Receiving
Control
Chart

In-processinspection
list

〇

〇

〇

〇

Final
Inspection
Chart

〇

〇

48

Records〇〇〇

Shipping
Instructions
and Shipping
Inspection
ChartFSM 21 Complaint Handling●Requirements
The organization shall document a system of management to respond tocomplaints and utilize complaint data to identify, correct, and manage
omissions and deficiencies in food safety efforts.
Additionally, organization must record and maintain complaints, investigation
results, and corrective actions.
●Concepts, specific examples
1. A distinction should be made between food safety-related events andother events, for example, those related to quality. What is required in thisitem are events related to food safety.
2. For complaints from suppliers and consumers, the key to promptly
resolving complaints is to establish a system to properly identify andpromptly respond to complaints.
3. The following are possible procedures for establishing a system to respondto complaints.
1） A manual on how to respond to complaints from suppliers andconsumers should be prepared.
2） Employees should be aware of their responsibility for handling andinvestigating 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 complainantthat the information will be provided appropriately. At that time, if
necessary, a deadline for a response will be given. (When it is foundduring the investigation process that the cause of the complaint is notwith the organization, the complainant will be informed of this as soon
as possible. (If the complaint is a false accusation or a monetary claim,
the company will consider a different method of handling thecomplaint.)
4） Reply to the complainant with the details of the investigation andresponse to the complaint from the client/consumer as described in 3)
above, and record the details.
49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.
6） For complaints from suppliers and consumers, the responsible person
shall confirm the completion of the response.
7） The organization record and maintain the record of complaints,
investigation results, and corrective actions.
4. When nonconformity is found based on a suggestion from a supplier or
consumer, corrective action shall be taken.
5. establish, implement, and maintain a system to continuously improve andcontrol the food sanitation system by utilizing complaints from suppliersand consumers and their data.
FSM 22.1 Serious Incident Management●Requirements
The organization shall document serious food incident management
procedure, implement it in the event of an incident, and maintain it in effectat all times to ensure that they can respond in the event of a serious incident.
This procedure shall also describe the methods for product withdrawal andproduct recall.
It shall also include systems and procedures for providing necessary
information to customers, consumers, and relevant authorities.
Incidents that occur shall be recorded and evaluated.
●Concepts, specific examples
1. A critical incident is a food incident that has the potential to affect foodsafety, but does not include incidents that do not affect food safety but
may affect quality.
2. Since it is often not known at first whether an incident is serious or not, it
is advisable to work on the assumption of a worst-case scenario when an
incident occurs.
3. Documented food incident management procedure for incident reporting,product withdrawal and product recall shall be prepared as follows
1） In the event of a major incident, the response shall be based on
relevant management procedures such as nonconformity handling andcomplaint handling.
502） Appoint an authorized person in charge for critical incident
management.
3） Establish and maintain an up-to-date emergency contact network forcustomers, 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.
4. To establish the severity of the incident and whether or not there is a risk
to customers, the incident t should be documented and evaluated.
Incident records should include the following
1） The product involved and the location of manufacture2） 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 referred to in Japanese 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 tothose diagnosed by a physician and diagnosed as being caused or suspected tobe caused by said food or additive; hereinafter the same shall apply in thisitem) 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 thatare or are suspected to be 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 leadto the occurrence of a strange taste or odor, contamination with a foreign
substance, or other health hazard, the business person shall endeavor toprovide said information to the prefectural governor, etc.
51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 arisingfrom a product, a business person shall, from the viewpoint of preventing
health hazards to consumers, establish a system for responsibility for recall,methods for alerting consumers, specific methods for recall, and procedures forreporting to the prefectural governor, etc. having jurisdiction over the area
where said food or additive is handled, so that said food or additive can bequickly and appropriately recovered. The procedures for reporting to theprefectural governor, etc. with jurisdiction over the area where the facility
handling the food or additive is located should be established.

FSM 22.2 Verification of food incident management manual●Requirements
The organization shall verify the effectiveness of its food incident management
procedure by conducting tests at least annually on products supplied by theorganization to ensure that product recalls are implemented, and maintainrecords of the verifications.
●Concepts, specific examples
1. Conduct mock recall tests to verify and record the effectiveness of therecall program at least once a year. Based on the results of theverification, review the recall program as necessary, and also verify andrevise as necessary the food incident management procedure that contains
it.
1） In this test, it is required to be carried out under the assumption thatthe product is available on the market. However, for organizations that
manufacture products on a contract basis (OEM manufacturing) or that
conduct business-to-business (B to B) transactions, there aresituations in which it is difficult to imagine that the organization will be
the subject of a market recall. The recall test in this situation indicatesthat the recall test should be performed assuming that the products
containing the organization's products have been distributed toconsumers. In other words, the organization shall imagine a situation52

in which a consumer had purchased these products and conduct tests
to verify whether information about the traceability of the target
products can be identified from this situation, from the supplier one
step before to the shipping destination one step after.
2） In this test, it is easy to imagine if you assume that allergens are
mixed in.
FSM 23.1 product specifications●Requirements
The organization shall document and maintain specifications for raw materials(including packaging materials), semi-finished products, work in progress,
remanufactured products, reworked products, and finished products.
The organization shall have a system for communicating changes to productspecifications both internally and externally.
The organization shall designate a person responsible for managing productspecifications.
●Concepts, specific examples
1. Maintain documentation of specifications for goods and services that theorganization procures from external sources. Specifications requested by
the organization for purchased goods, etc., or obtained from suppliers,
etc., are evaluated that they are appropriate within the organization andensure that intended to.
2. It is important to maintain and control the specifications stored as
documents so that they can be used as needed for checking at the time ofacceptance.
3. The organization shall evaluate the inherent risks of the items it purchasesor receives supplies from and establish checks upon acceptance (e.g.,
inspection certificates, condition, temperature, labeling, etc.), as well as
establish procedures for these checks.
4. Inherent risks include, for example, the following hazards:
1） In ground beef requiring adequate heat: enterohemorrhagic E. coli O157
2） In redfish where temperature control is not properly implemented:
histamine accumulation
This requirement calls for attention to hazard factors in purchased
products based on the product characteristics handled by the organization.
53

5. If externally procured goods or services do not conform to specifications,procedures shall also be established to ensure that they are not misused.
Procedures should be documented as necessary.
6. When providing specifications to business partners in business
transactions, it is necessary to have a system in place that allows theprovision of the latest information at all times.
7. In addition to specific Requirements for goods and services, specifications
may include:
1） Statement of compliance with laws and regulations
2） Handling of specification changes
3） Review of specifications (e.g., frequency, timing, etc.)
4） Whether or not to re-consign and its conditions, etc.
5） Providing inspection items that conform to specifications and acertificate of inspection (also called Certificate of Quality or Certificate
Of Analysis)
8. The organization shall determine and implement a review process for thisinformation, including the frequency of periodic reviews. In addition, theorganization shall have a system for communicating changes to productspecifications both within the organization and to external parties that
require those specifications. The organization shall designate a person
responsible for managing product specifications. (The person responsible
for managing specifications may be a person who not only manages the
specifications themselves, but also evaluates and approves them; thescope of the person responsible is determined in accordance with theorganization's management system.)
9. HACCP Steps 2 and 3 require information on the food safety of products.
It is recommended that the specifications to be maintained and controlled
by this requirement be organized in relation to such information.
FSM 23.2 Product Release●Requirements
The organization shall document and implement appropriate procedures for
product release (shipping).
Product release procedures shall include steps to ensure that the final productmeets specifications●Concepts, specific examples
54

Product Release (shipping) Procedures
1. The procedures for releasing (shipping) a product includes the following.
These procedures shall be documented.
1） Verify that the product to be shipped conforms to the productspecifications.
2） Verify that not only the product specification but also the processcontrol is appropriate.
2. The following items must be confirmed prior to release (shipping).
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 conformto product specifications and that process controls have been properly
implemented.
FSM 24 Control of non-conforming products●Requirements
The organization shall document and enforce rules for not using or shipping
raw materials (including containers and packaging materials), semi-finishedproducts, work-in-process products, recycled products, reworked products,
and finished products that may pose a safety hazard.
The organization shall also determine who will be responsible for managing
nonconforming products.
●Concepts, specific examples
1. These Requirements set up barriers at each stage on the way to the final
product, and play the role of stopping nonconformity when it occurs.
2. Raw materials (including containers and packaging materials), semifinished products, work-in-process products, recycled products, reworked
products, and finished products that pose a safety problem are treated as
nonconformities. The organization determines the responsible person ofcontrol of non-conforming products and manages according to proceduresto prevent unintended use or erroneous shipment of nonconforming items.
1） It is effective to have well-defined manufacturing and inspection
procedures in advance to detect nonconformities in each process.
552） In addition to detection through manufacturing and inspection
procedures, nonconformities may also be detected through customer
complaints.
3） Nonconforming products found are to be clearly identified andsegregated so that they cannot be mistakenly used. In identifying thescope of nonconforming products, appropriate judgment should bemade 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 thefield.
●Items to be referred to in Japanese 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 establishedwhen monitoring results reveal deviations from the control standards.
FSM 25 Corrective Action●Requirements
The organization shall establish and implement documented corrective actionsin the event of nonconformities affecting food safety. (Corrective action is theprocess of correcting a nonconformity to a condition that is not anonconformity, determining the cause of the nonconformity and eliminating
the cause of the nonconformity.)●Concepts, specific examples
1. The organization establishes and implements procedures to ensure thatcauses of detected nonconformities affecting food safety are eliminated assoon as possible and to prevent recurrence56

2. Corrective actions are developed and implemented by those who have thecompetence to analyze 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 ofnonconformity.
4） Review the effectiveness of the corrective actions taken.
5） It is desirable to document the sequence of actions related tocorrective actions.

57

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 specific hazards and control measures for food safety, and takes thosecontrol measures rather than relying on testing and inspection of the final
product.
Successful HACCP requires management and engaged personnel to work
together and expertise in a wide range of areas, including primary production,
microbiology, and manufacturing and processing techniques.
HACCP plan is a document or set of documents prepared in accordance with
HACCP principles (from International Food Standards Committee (CODEX)
General Principles of Food Hygiene 2020: (Reference) Japan Food Sanitation
Association 2021 Translation First Edition) to ensure control of critical hazards infood operations.
HACCP system means the development of a HACCP plan and the implementationof procedures according to that plan (from International Food Standards
Committee (CODEX) General Principles of Food Hygiene：Good Hygiene
Practices （GHP’’s） and the Hazard Analysis and Critical Point (HCCP)
System ,2020 (English edition).
HACC Step1 HACCP team assembly and identification of the scope of application●Requirements
HACCP team shall be assembled with competent staff, and the scope of
application of the HACCP system and applicable GMPs shall be identified. The
scope shall be documented what products and processes are covered bywhich HACCP plan.
●Concepts, specific examples
1. By forming the HACCP team with people with as many specialized skills as
possible from the manufacturing/processing department, quality
assurance/quality control department, and the maintenance department
responsible for the maintenance and preservation of facilities andmachinery used in manufacturing, it is possible to eliminate blind spots inhazard analysis and facilitate communication. The HACCP team leader(food safety officer) should be a food hygiene officer or food hygiene
manager who has knowledge of the product and specialized skills, andknowledge of the product's characteristics and processes, furthermore, has58

strong communication skills and is able to summarize opinions within theorganization.
When the Food Safety Officer and the HACCP team leader are different
personnel, it is necessary to ensure that they communicate with eachother.
2. Depending on the size of the business, there are many cases in which
various tasks are performed holding multiple positions, and for this reason,
the top management himself may be the team leader, or one person may
be responsible for all food safety-related actions, etc. However, it isimportant to try to ensure the cooperation of employees within theorganization to the extent possible.
3. If the number of employees is small, the team does not necessarily need
to be composed of several people. It is also possible to use outside
resources.
4. If the organization lacks in-house knowledge or expertise, it can be also
effective to receive external training or to obtain the participation andadvice of external food hygiene experts. A guide for industry associations
by the Ministry of Health, Labor and Welfare can be used as a reference.
5. The HACCP team shall identify the scope of the HACCP system andappropriate GMPs (PRPs in ISO 22000). Examples of documentation of
products and processes covered by the HACCP plan include inclusion in
product manuals.
6. The main roles of the HACCP team, other than the above No.5, are as
follows:
1） Preparation of HACCP Plan
2） Establishment of GMP
3） Preparation of sanitation standard operating procedures
4） Education and training for personnel in charge of HACCP plan
implementation
5） Implementation of HACCP system and GMP verification
6） Review, amendment or change of the HACCP plan based onverification results7） Identification of changes in raw materials, product composition,
manufacturing processes, etc. and review of HACCP plans accordingly
8） Review, improve, or modify HACCP plans as needed based on new
food hygiene information
9） Response to external inspections59

7. The HACCP team is responsible for managing food safety efforts within theorganization.
HACCP Step2 Product Description●Requirements
Product specifications shall be documented.
The document shall describe all product information necessary to conducthazard analysis.
Scope of the HACCP system shall be defined per product or product group andper process line or process location.
This system should be systematic and comprehensive and take into accountlegal and regulatory Requirements related to food safety.
●Concepts, specific examples
1. In order to clarify the characteristics of the product, describe thespecifications and characteristics of the final product, divided into
necessary items, as follows:
1） Specifically, for the final product, describe the name and type of
product, the intended use/purpose of the product, productcharacteristics, names of raw materials, names of additives andstandards for use, form of packaging, units and quantities, materials ofcontainers and packaging, expiration date or best before date andstorage method, distribution method, internal targets for controlling
hazards in the product (Ingredient standards for bacteria specified in
the Food Sanitation Law, etc.), including the standard criteria specified
by the recipient.
2） In facilities that manufacture multiple products, it can be effective togroup foods together for purposes of developing HACCP plans,
depending on similar characteristics and processing steps.
3） If allergens are included, or if there may be cross-contact of allergens
in the same facility, this shall also be noted.
HACCP Step3

Identification of Intended Use●Requirements
Intended use of the product and target users (consumers) shall be clearly
described in a written document.
60

●Concepts, specific examples
1. The intended use (method of use) and intended users (consumers) of the
product shall be described in the document as follows:
1） Clarify the methods of consumption and use of the food and the target
consumers. Particular attention shall be paid to the content, especiallyin the case of vulnerable health consumers, young children, and theelderly.
2） If the intended use includes cases where the product requires cooking
with heat or where precautions after opening the package, thenecessary information shall be stated.
3） It shall clearly state what the risks are if the intended use is notfollowed and misused.
2. For foods intended for susceptible populations, a high level of assurance
that the food is safe can require enhanced process controls, more frequentmonitoring, product testing to verify the effectiveness of controls, or otheractivities.
HACCP Step 4 Construction of Flow Diagram●Requirements
The flow diagram that covers all steps in the operation shall be constructed.
●Concepts, specific examples
1. For a series of manufacturing or processing processes from receipt of raw
materials to shipment of the final product, a flow diagram shall be prepared
to show the operations of each process along the flow. This shall include any
applicable rework. The same flow diagram can be used for a group of
products manufactured using similar processing steps.
2. The flow diagram is used as the basis for evaluating the likelihood of
occurrence, increase, decrease, survival, or contamination of a hazard factor
when conducting a hazard factor analysis.
3. The flow diagram shall be accurate and detailed enough to perform a hazard
analysis.
4. The flow diagram shall be created according to the following procedure:
1） Briefly list all processes and operations from receipt of raw materials to
shipment of final products and applicable rework.
612） The listed raw materials and processes shall be enclosed in a frame, theframes are connected with arrows, and the process is numbered in order.
For raw materials, food additives, water and packaging materials used,gas (only if used), and other materials that come into contact with the
product shall be also written down, and these shall be written in a box in
the same row, and arrows shall be connected to the process in which
they are used.
3） In the course of raw material processing, if waste is generated or it
becomes a processed raw material to be used in other products, it shallbe clearly stated.
4） In the process, if there are processes with pass/fail judgment,
reprocessing, reusing or reworking, etc., it shall be clearly stated so thatit can be controlled.
5） The process being outsourced shall also be clearly stated.
5. By drawings of the facility showing the outline of each process and the planar
and three-dimensional layout of the facility, it is possible to identify process
key points and areas where cross-contamination is possible, which can aid
in hazard analysis.

62

Flow Diagram Example

main raw material

Other
raw materials

food additive

Water

Packagingconsumption

Materials
5 Accepted

1 accepted

2 accepted

3 Accepted

4 Accepted

Ⅰ

Ⅰ

Ⅰ

Ⅰ

6Storage

7Storage

8Storage

9Storage

Ⅰ

Ⅰ

Ⅰ

Ⅰ

11 Weighing

12 weighing

13 weighing

14 weighing

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

Ⅰ
21 Bulk Packaging
Ⅰ

Outsourcing
Packaging

22 Transport

Materials
23 Acceptance24 AcceptanceⅠⅠ

26 packaging

25 Storage

Ⅰ
27Metal Detectors→ 28 Disposal

Ⅰ
29StorageⅠ
30 Shipment

HACCP Step 5 On-site Confirmation of Flow Diagram●Requirements
The flow diagram shall be verified whether it correctly reflects the existingprocess steps of the operation.

63

●Concepts, specific examples
1. A person with sufficient knowledge of the process shall verify on-site thatthe process is clearly defined in the flow diagram so that the hazard
analysis in HACCP Step 6 (Principle 1) can be sufficiently performed. Atthat time, the on-site verification shall be performed as follows, while
checking against the site layout diagram:
1） At the site, verification shall be carried out step by step from the
upstream process, to check that appropriate processes are shown,including temporary storage of products and management of semifinished products.
2） If a process or activity is inconsistent with the flow diagram at the site,check with the responsible person for the correct control method andcorrect the documentation.
3） Verification shall be observing the work during various work periods toensure that the flow diagram matches the work.
HACCP Step 6 (Principle 1) Hazard Analysis●Requirements
The HACCP team shall list all the hazards that are reasonably likely to occur ineach process steps.
Potential hazards in each process shall be identified, the critical hazards shallbe identified, and all measures to control them must be considered.
Hazards shall include allergens, if necessary.
●Concepts, specific examples
1. Hazard analysis is to identify potential hazards to be controlled by the
HACCP plan, determining critical hazards, and clarifying control measuresfor each critical hazard. For this purpose, information is first collected on
potential hazards and the conditions under which they can occur throughout
the entire process from raw materials, manufacturing and processing,storage and distribution to consumption, and the likelihood of occurrence ofthe hazards and the severity of the hazards when they do occur are
identified.
1） Hazards shall be specific and shall explain the cause or reason for theirpresence. The potential misuse of the product by potential consumers
64that would make the food unsafe, as well as any unintended uses that
could be known from known cases, shall also be considered.
2） Hazards should also be identified and considered whenever possible.
Examples are provided below:(In the case of metallic foreign bodies, which are physical hazards)●A certain part A in the manufacturing process is subject to routine
maintenance, but it has been missing in the past, and since there is apossibility that it may get mixed into the product in the future and cause
injury to consumers who eat it, it is identified as a major hazard andmanagement measures are required.
●On the other hand, a certain part B in the manufacturing process ismanaged through daily maintenance, and there have been no cases in thepast of it being missing and contaminating the product, so, it is considered
to be controlled through general hygiene management and is not identified
as a significant hazard.
2. By conducting a Hazard Analysis, an appropriate management system canbe created for the facility according to the frequency of possible hazards andthe severity of the consequences.
3. The actual process of hazard analysis is to first list, by raw material andprocess, the hazards in the final product that can lead to health hazards
when eaten.
4. Following the flow diagram from raw materials to final products, identify raw
materials and processes that can lead to the occurrence of hazards, narrow
down important hazards in terms of the frequency of occurrence of hazards
in each process and the severity of the results, prepare the Hazard Analysis
Sheet that lists the causes of occurrence (contamination, proliferation,
survival, contamination, etc.) and the control measures to control them.
5. When preparing the Hazard Analysis Sheet, it is necessary for all membersof the HACCP team to share their expertise and knowledge, and to discussand summarize these findings.
《Steps to prepare the Hazard Analysis Sheet》
6. The steps for creating the Hazard Analysis Sheet are explained using the"Example Hazard Analysis Worksheet" given in the International Commission
on Food Standards (CODEX) Committee's General Principles of Food Safety65

CXC 1-1969, Rev.2022.
Example of Hazard Factor Analysis Worksheet (Prepared from Codex General Principles of Food Hygiene 2020: Japan Food
Sanitation Association 2021 First Edition Figure 2)（1）column
Raw Materials /Operation works(stage)（2）column
Identify hazards
that are expected
to occur or are
likely to increasein this process.
B: Biological
C: Chemical
P: Physical（3）column
Do these potential
hazards need to beaddressed in the
HACCP plan?
（Yes or No）（4）column
Justify your judgment in column(3).

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

B：
C：
P：
B：
C：
P：
B：
C：
P：

[Step 1] (Column (1) of "Example of Hazard Analysis Worksheet")
List raw materials and manufacturing and processing processes according to
the flow diagram.
Write the same numbers along the flow diagram for materials that come incontact with the product, such as main raw materials, secondary raw
materials, water used, and packaging materials, as well as for the
manufacturing and processing processes.
Perform the hazard analysis of all raw materials used in the food product.
This can be done in two ways:
1） Methods to analyze hazards related to raw materials in the process ofreceiving raw materials2） Methods to conduct hazard analysis separately for raw materials andprocesses
This guideline describes the method in 1).
[Step 2] (Column (2) of "Example of Hazard Analysis Worksheet")
List potential hazards originating from raw materials and manufacturing andprocessing processes.
Hazards shall be described specifically. For example, instead of "foodpoisoning bacteria," list "Salmonella," "pathogenic E. coli O-157" and so on
are enumerated. Also, instead of just "metal fragments," describe the sourceof contamination and the reason for their presence, such as "contaminationfrom metal foreign bodies derived from broken blades from crushing," "piecesof kitchen knives," etc.
66

[Step 3] (Column (3) of "Example of Hazard Analysis Worksheet")
Based on the frequency of occurrence (likelihood of occurrence) and theseverity of the consequences (the extent of damage if they occur) of thelisted hazards, evaluate whether or not they are significant hazards that shallbe reduced/eliminated from the food to guarantee the safety of the final
product.
When conducting a Hazard Analysis to determine critical hazards, consider
the following whenever possible:
1） Hazards related to the type of food to be produced and processed,
including ingredients and processes (e.g., results of hazard surveys or
sampling and testing in the food chain, recall cases, information fromscientific literature or epidemiological data)
2） Likelihood of a hazard occurring in the absence of additional controls,
taking into account GMP (PRP in ISO22000)
3） Frequency of occurrence and severity of consequences of adverse healtheffects due to hazards in food in the absence of controls4） Identified acceptable levels of hazards in the food (e.g., based on
regulations, intended uses, and scientific information)5） Nature of the facility and machinery and equipment in which the food is
produced
6） Survival or growth of pathogenic microorganisms
7） Generation or persistence of toxins (e.g., mold toxins), chemicals (e.g.,
pesticides, veterinary drugs, allergens) or physical hazards (e.g., glass,metals) in food8） Potential for food to become unsafe as a result of its intended use, and/or
mishandling of the product by the consumer9） Conditions leading to the above
For the evaluation of hazards in Step 3, recommend using a matrix table of"frequency of occurrence" and "severity of results" as shown below, andentering the numbers into the hazard analysis sheet. There are various
examples of matrix tables created, and it is advisable to adopt one inconsideration of the target product, manufacturing process, etc.
However, this does not apply to cases that can be clearly evaluated with
"yes/no".

67

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

4
3

frequency ofoccurrence

2

1

0

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

0

Ⅰ

Severity of ResultsⅡ

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

Ⅲ

Ⅳ

recallserious illness

lethalrisk

Serious
risk

risk

risk

Seriousrisk
Seriousrisk

Seriousrisk
Seriousrisk

risk

Serious
risk

risk

risk

OK to manage OK to manage

risk

OK to manage OK to manage OK to manage

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

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

risk

OK to manage

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

[Step 4] (Column (4) of "Example of Hazard Analysis Worksheet")
In this step, for significant hazards marked with ○ or Yes in [Step 3] ((3) inthe "Example of Hazard Analysis Worksheet"), identify the factors causing thehazard and describe the basis for the decision in column (4). For thosehazards marked with X or No in column (3), describe the basis for judgment.
[Step 5] (Column (5) of "Example of Hazard Analysis Worksheet")
For each hazard rated as critical, identify control measures to ensure thesafety of the final product. The following is an example of a hazard evaluation(Step 3) and a hazard analysis sheet.
Consider which control measures to apply to each critical hazard, as multiple
control measures may be needed to control one hazard. For example, tocontrol Listeria monocytogenes, heat treatment may be required to kill viableorganisms in the food, and environmental cleaning and disinfection can be68required to prevent contamination from the processing environment after
heating.
It can be possible to control multiple hazards through specific control
measures. For example, if Salmonella spp. and E. coli O-157 are present in afood, heat treatment can control both hazards.
*Reference examples of the Hazard Analysis Sheet are as follows.
Source: Ministry of Health, Labour and Welfare of Japan website(http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000098735.html)
Example of Hazard Analysis Sheet
Product name: Catering Bento
⑴

⑵

⑶

⑷

⑸

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

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

Organisms: Presence of pathogenic（Vegetables)

Harmful Microorganisms
Salmonella spp.
Pathogenic Escherichia coli

Contamination is possible due to unsanitary handling during manufacturing andNO

Staphylococcus aureus

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

Heat-resistant spore bacteria
Clostridium botulinum
Welch bacillus

NO

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

Bacillus cereusNO

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

Chemical: None
Physical: Presence of metallic foreign
bodiesYES

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

Controlled by metal detection (NO.9)

Product name: Boiled soba noodles
⑴

⑵

⑶

⑷

⑸

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

Organisms: Presence of pathogenic
Harmful Microorganisms
Salmonella spp.

6

May be more contaminated than soil

Can be controlled in the sterilization

Pathogenic Escherichia coli

6

May be more contaminated than soil

Can be controlled by Sterilization

Bacillus cereus

7

May be more contaminated than soil

Can be controlled by cooling (NO.33)

Welch bacillus

19

Not likely to proliferate since not placed under anaerobic conditions thereafter

Clostridium botulinum

15

Heat-resistant spore bacteria

Chemical: Residual pesticides

17

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

Physical: Presence of foreign matter
Hard foreign body13

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

Metallic foreign body18

Can be eliminated by visual check at weighing (NO.14)●Items to be referred to in Japanese 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 the Food Sanitation Act(i) Analysis of Hazard Factors
A list of factors that may cause food sanitation hazards (hereinafter referred toas "risk factors" in this table) shall be prepared for each process of69

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●Requirements
Critical Control Points (CCPs) shall be determined.
●Concepts, specific examples
1. What are Critical Control Points (CCPs)?
1） Critical control points (hereafter referred to as CCPs) are steps atwhich control is essential for the manufacture of a product in order toreduce or eliminate significant hazards from the food to acceptablelevels, they are set in processes where deviations could lead to foodthat can be unsafe, and they are stages with procedures or operations
that require especially strict control.
2） For each hazard that is identified as a significant hazard as a result of
the hazard analysis, it is always necessary to establish one or more
control measures that can control that hazard.
3） Among the control measures for the critical hazards listed in HACCPStep 6 (Principle 1), consider control measures that could serve as
CCPs.
4） At CCPs, it is necessary to set permissible limits as described below,
conduct monitoring, and take measures such as not allowing products
manufactured during the period when the limit was exceeded to be
shipped if there is a deviation.
5） CCPs can be needed at multiple stages to control a single hazard.
2. how to determine CCP
1） The basic principle is to establish procedures for all processes andimplement GMP control. Among them, CCPs are those steps that havea direct adverse effect on food products, such as those related to "donot bring in," "do not let in," "do not let out," and "do not increase"food poisoning 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, thecontrol measures are not defined as CCPs, but if the hazardous factor
cannot be fully controlled by GMP alone, the process in which thecontrol measures are taken is defined as a CCP. However, if the70

hazardous factor cannot be controlled by GMP alone, the process inwhich the control measures are taken shall be designated as CCP. If
the hazardous factors can be controlled only by GMP throughout theentire 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 used in the process being analyzed but are also
applicable at later stages of the process, or if other control 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 in another process to control the same hazard
factor. If so, both processes should be considered as 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 riskthat the hazardous factors may not be fully controlled; if processes
that can be adequately controlled by GMP are made CCPs, this may
result in wasted effort and a relative lack of control over otherprocesses.
7） The Requirements for CCP are that it must be possible to monitor
continuously or at a reasonable frequency using a predetermined
monitoring method, and that if the parameter deviates from theCritical Limit (CL), production must be stopped immediately, processcontrol 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 that were produced
during the deviation.
8） The value of the monitoring parameter (limit value) at the boundary ofwhether or not the safety of the product can be ensured is called thepermissible limit (CL).
3. How to determine CCPs - Example of Decision Tree application. (This is an
example of a CCP decision tool, and CCP decision methods are not limited
to Decision Tree.)See the figure below for the procedure / The main points are as follows:
1） The Requirements for CCPs are that it can be monitored continuously
or with a reasonable frequency using a pre-defined monitoring
method, and if the parameter deviates critical limit (CL), production
can be stopped immediately and process control can be restored to the71original state in a short period of time, and food produced during theperiod of deviation can be identified and isolated.
2） Only those processes for which significant hazards are identified in thehazard analysis are subject to Decision Tree application.
3） Consider the significance of the hazard (i.e., the likelihood of its
occurrence and the severity of the effect of the hazard in the absenceof controls) and whether it can be adequately controlled by the GMP. A
GMP can be a normal GMP, or it can be a GMP that requires greaterattention (e.g., monitoring and recording) to control the hazard (socalled GMP 4.2). (See *)4） If CCPs were not identified in Q2-Q4, review the process and control
measures again and re-conduct the hazard analysis. (See **)5） Determine whether a control measure at a process where a significant
hazard has been identified is used in combination with a control
measure at another process to control the same hazard, in which caseboth processes should be considered CCPs (See ***).
6） If there are no specific and special control measures, the process andcontrol measures should be reviewed again and the hazard analysis
shall be re-performed. (See ****)

72

(Above figure taken from CXC 1-1969, Rev. 2022, General Principles of Food
Hygiene of the International Commission on Food Standards (CODEX).)
4. Specific examples of CCPs
1） Examples of CCPs that prevent the occurrence of hazards are as
follows:(1) Acceptance of raw materials: Prevention of antimicrobial residues
by checking raw material inspection reports submitted by suppliers(2) Cooling: Prevention of pathogen growth through appropriate
temperature control(3) Refrigerated storage: Prevention of pathogen growth throughappropriate temperature control(4) Weighing of food additives: Prevention of over-additives
2） Examples of CCPs that eliminate hazards include the following:(1) Heating process or sterilization process with chemicals: Sterilizationof pathogenic bacteria(2) Metal detection: Detection by detector and elimination of metalfragments
3） Examples of multiple CCPs that control a single hazard are as follows:(1) Control patty thickness and heating time/temperature to kill nonspore-forming pathogenic microorganisms in hamburgers.
(2) The heating process can be a CCP to kill vegetative cells of sporeforming pathogens, and the cooling process can also be a CCP toprevent spore germination and growth.
If control measures for identified significant hazards do not exist at any stage,
the product or manufacturing process should be modified.
73

●Items to be referred to in Japanese 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 the Food 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 thistable).
HACCP Step 8 (Principle 3) Critical Limits●Requirements
Validated critical limit(s) shall be stipulated for each CCP.
●Concepts, specific examples
1. What is the Critical Limit (CL)?
1） CL is a monitoring criterion that distinguishes between acceptable andunacceptable conditions of a control measure of hazards and is anobservable or measurable criterion that distinguishes between
acceptable and unacceptable conditions of food in relation to thecontrol measures applied as a critical hazard (CCP). A CL can have one
or more parameters.
2） Since incorrectly set, CL can lead to the occurrence of hazards, theyshall be validated based on scientific data and set appropriately.
3） Deviations from the CL require corrective action.
4） The CL shall meet the following conditions:(1) The most appropriate parameters for ensuring that hazards areprevented, eliminated, controlled or reduced to acceptable levels, andwhose value is scientifically proven(2) Criteria using parameters that can be determined in real time
whenever possible.
If it is found that the control condition is not appropriate, corrective
measures shall be taken immediately, so it is desirable for this to be
indicated by parameters that can be judged in real time.
5） CL is usually the minimum or maximum value of a critically importantparameter related to the control measure and can be used, such astemperature, moisture, time, pH, water activity (Aw), available
74

chlorine, contact time, conveyor belt speed, viscosity, conductivity,
flow rate, etc., or sensory indicators (color, gloss, odor, taste,viscosity, physical properties, foam, sound, etc.) or observed pumpsettings, etc.
As an alternative to the parameters indicating CL, another indicator canbe established, but this indicator shall also be based on scientific data.
Example: If the CL for the boiling process of a certain product is"product center temperature 63°C, heating time 30 minutes," it is notpractical to measure the center temperature of all products; therefore,apart from this indicator, "water temperature of boiling tank, amountof product put in, and heating time" are measured as non-destructive
and efficient CLs.
2. How to set CL
1） CL should be scientifically validated by evidence that, when properly
implemented, they can control hazards to an acceptable level.
2） If indicated by laws, regulations, etc., values that allow the target
hazard to be controlled reliably are adopted. In other cases, values are
set based on literature data, experimental data, etc.
3） Even if the values indicated in manufacturing standards, etc. are
adopted as CL, collecting evidence (evidence) on whether they areapplicable to the organization (products, manufacturing facilities,
manufacturing processes, etc.) is also a validity check.
4） In normal manufacturing process control, it is rare to use CL alone forcontrol, and it is common to set a standard (Operational Limit: OL)
that provides more leeway than the CL and allows control before CL
deviations occur.

●Items to be referred to in Japanese 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 the Food Sanitation Act(iii) Establishment of control standards
For each critical control point, standards for preventing, eliminating, or
reducing the occurrence of hazardous factors to an acceptable level(hereinafter referred to as "control standards" in this table) shall beestablished.
75

HACCP Step 9 (Principle 4) Monitoring System●Requirements
Monitoring procedures shall be established for each CCP.
●Concepts, specific examples
1. What is monitoring?
1） To ensure that CCP is properly controlled and to keep accurate records
for later verification, monitoring is the comparison with CL, and, to do
the observation, measurement, or test inspection based on a scheduleestablished in the HACCP plan.
2） In the management of CCP, the act of watching to ensure that there
are no deviations from CL is called monitoring.
3） Any deviation from the CL requires corrective action.
4） Monitoring records are also used when verifying the HACCP plan.
2. How to monitor
1） The monitoring method shall meet the following conditions:(1) To be carried out continuously or with reasonable frequency.
(2) The method shall provide rapid results (physical and chemicalmeasurements are usually chosen over microbiological tests).
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 of heating), so that every product, fromthe first one to the last one, or every batch, can be monitored toensure 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 ofmonitoring should be sufficient to ensure compliance with the CL asmuch as possible and to minimize the amount of product affected bydeviations. and in a manner that allows easy corrective action to betaken.
3） If possible, process adjustments should be made when monitoring
results indicate a trend toward deviation in the CCP.
4） The [5W1H] that defines the monitoring method means the following:(1) Rationale (Why): Is there scientific validity for monitoring thecontrol status of CCP?

76

(2) What (What): Is the CCP within the acceptable range of the CL(does not deviate from the CL)?
(3) In which process (Where): Clarify the applicable process (CCP
process)(4) How (How): Is it a rapid and accurate physical, chemical, or
sensory observation, measurement, or inspection method(5) Frequency (When): Is it continuous? Or, if not, is there a frequency
of not missing deviations?
(6) Who (Who): Personnel trained in monitoring methods5） Continuous recording of measured values is not enough to control
hazardous factors. They shall be checked by someone other than the
person in charge of monitoring at an appropriate and sufficientfrequency.
6） When the HACCP plan is developed, a monitoring person shall beidentified. This person should be able to implement by oneself or
implement by instructed on the appropriate procedures that need to
be implemented when monitoring indicates the need to take corrective
action. To take corrective action, data obtained from monitoring shouldbe evaluated by a designated person with the knowledge andauthority.
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 of the monitoring should be recorded.
●Items to be referred to in Japanese 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 the Food Sanitation Act(iv) Establishment of monitoring methods
Methods shall be established for monitoring the status of implementation ofcontrol of critical control points on a continuous basis or at a reasonablefrequency (hereinafter referred to as “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.

77

HACCP Step 10 (Principle 5) Corrective Actions●Requirements
A procedure of corrective actions (correction, and investigation and removal ofroot cause) shall be established for deviations from a critical limit.
●Concepts, specific examples
1. What is corrective action?
1） Corrective action is the immediate action taken when monitoring
parameters deviate from the CL.
2） In CCP, which is a process that should be especially strictly controlled
to prevent the occurrence of hazards, it is important to determine themethods and procedures for corrective action in advance because any
deviation of the monitoring parameters from the CL may result in theoccurrence and escalation of food safety risks. (See FSM 24, 25)
3） In the HACCP plan, the actions to restore process control andprocedures for restarting the line, as well as the actions to isolate
affected product and determine and implement its disposition, shall bedefined.
4） To minimize the likelihood that the deviation will recur, the cause
analysis shall be performed to identify and correct the cause of thedeviation, if possible. The cause analysis shall identify the reason forthe deviation or limit the amount of product affected by the deviation.
2. Items to be included in the HACCP plan as corrective actions
Items to be included in the HACCP plan as corrective action are as follows:
1） Action to restore the control status of the process●Repair, adjust, or replace machinery, etc., to return the process to anormal state of control.
2） Treatment for products manufactured during the deviation● Identify and withhold products that deviate from the CL andevaluate them.
● Decide on treatment methods, such as reprocessing or disposal.
3. Person in charge of implementing corrective actions
Shall be done by an authorized person in charge who has sufficientknowledge of CCP management, understands the process well, and canmake quick decisions.
4. Corrective Action Implementation Records

78

The corrective action implementation record shall include the following
items:
1） Details of the deviation, the manufacturing process or location where it
occurred, and the date and time of occurrence2） Name, lot number, quantity, etc. of the product that was the subjectof the action
3） Results of investigation into the cause of deviation
4） Details of actions taken to restore the process to its original state5） Details of treatment to be done to the product manufactured during
the deviation
6） Signature of the person in charge who carried out and recorded theabove items
7） Signature of the person who inspected the corrective action and thedate of inspection
HACCP Step 11 (Principle 6) Establish HACCP plan validation and verification
procedures●Requirements
HACCP plan shall be validated prior to implementation.
Verification procedures shall be established to confirm whether the definedhandling (HACCP Plans) is carried out as specified and to judge whether it isnecessary 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
The following is a procedure showing the Requirements of this item inchronological order of actual activities.
1. validation
1） Validation is the assurance that the HACCP plan is capable ofcontrolling the critical hazards and shall be performed before the
HACCP plan is implemented. Items for which validation should be
performed include the following:⇒ Identification of hazards, and CCP, CL, control measures, frequency
and type of CCP monitoring, corrective actions (improvement79measures), frequency, and type of verification and type of information
to be recorded, etc.
2） Validation of control measures and CL of CCP shall be conductedduring the development of the HACCP plan.
3） Validation involves reviewing the scientific literature, using predictivemodels, conducting validation studies, and using guidelines developedby authoritative sources (e.g., Guidelines for the Validation of Food
Safety Control Measures (CAC/GL 69 - 2008)).
4） Evidence should be obtained that demonstrates that control has been
consistently achieved, during production under the first
implementation period and production conditions of the HACCP plan.
2. Implementation of HACCP Plan
Implement activities in accordance with the established HACCP plan.
3. Verification
1） After implementation of the HACCP plan, evaluate its effectiveness andverify that the HACCP system is functioning properly. Verification isbasically conducted once a year, or as needed.
2） By recognizing weaknesses in their own HACCP system from theresults of periodic verifications, modify their HACCP plan to make itbetter.
3） Verification shall be conducted respectively, for HACCP plans. and forthe entire HACCP system.
(1) HACCP plansi. Verify the HACCP plan for each CCP. The cases to be covered are as
follows:① Calibration of measuring devices (instruments) used for monitoring② Testing and inspection of raw materials (including containers andpackaging materials), semi-finished products, work-in-process
products, reworked products, and finished products③ Measurement of manufacturing and processing conditions④ Review CCP monitoring records, corrective action records, andverification records⑤ Confirmation that operators are working in accordance with the
HACCP plan
⑥ Observation that control measures are operated according to the
HACCP plan80ii. Verification of monitoring also includes verifying that the monitoringis correct by using a different measuring instrument or method. For
example, for temperature, cross-checking with another thermometer ormeasuring the center temperature if the steam temperature of theheater is monitored instead of the center temperature, and forverification of the heating process, conducting a microbiological test on
the sample after the heating process to confirm that no
microorganisms remain in the sample.
《Items that should be stipulated in the HACCP plan as internalverification work.》iii. The items to be stipulated in the verification plan are as follows:① Contents② frequency③ Action based on verification results④ Method of recording the results of the verification
iv. Verification should be performed by someone other than the person
performing monitoring and corrective action.
(2) Entire HACCP system
i. Verification of the entire HACCP system shall be conducted on aregular basis using the following procedures as needed:① Analysis of consumer complaints or cause for recall② On-site confirmation that monitoring work is being performed
according to established procedures③ Testing and inspections to verify product safety
ii. The results of the verification are recorded, inspected, and the
HACCP system is reviewed as necessary.
4. Re-validation of the HACCP system
In addition to the validation at the time of HACCP plan development, revalidation shall be performed when any of the following occur:
1） Change in raw materials
2） Changes in manufacturing processes or systems (including computers
and their software)3） Change of packaging
4） Change in final product delivery system
5） Changes in the intended specifications or the intended consumer, ofthe final product816） When verification results indicate deficiencies or potential deficiencies
in the HACCP plan
7） When a new hazard is identified in the same food or in the same foodgroup8） When new information regarding product safety becomes available※. Requirements for testing and inspection methods used for verification are
as follows:① This includes evaluating and verifying whether CCPs and CLs are properly
established and controlled to ensure product safety.
② The test and inspection methods for verification shall be validated. For
details, see FSM19.1 (Note that the test and inspection methods forverification shall include visual inspection and confirmation by sensory
indicators).
HACCP Step 12 (Principle 7) Documents and Record●Requirements
Necessary documents shall be prepared and maintained.
These documents shall contain documents related to the standard operatingprocedures (SOP) and the work instructions (WI) necessary and applicable tothe scope of conformity assessment of the organization.
●Concepts, specific examples
What documents and records are required?
1. Documents and records required by the 12 steps of HACCP include thefollowing:
1） HACCP Team Member List and Role Assignment2） Product Description3） Flow diagram4） Hazard Analysis5） HACCP Plan
6） Determination of CCP
7） Determination of CL and information providing scientific support for
the CL
8） Validation of control measures
9） HACCP plan revision records, etc.
2. Records of activities according to the HACCP plan include the following:821） Monitoring records
2） Corrective action records
3） Verification records
4） Training records of the person in charge, etc.
3. Records of HACCP plan implementation
This is important to provide evidence to prove control (scientific literatureused during validation, minutes of HACCP team meetings, etc.) as well as
to address deviations when they occur. Records can be maintained
electronically, if necessary.
4. The organization shall document standard operating procedures and work
instructions covering the scope of certification.
5. "Standard Operating procedures (SOPs)" are documented procedures for
performing standard tasks.
6. "Work Instructions (WI)" means documents that instruct employees whatwork is to be performed.
●Items to be referred to in Japanese legal provisions related to food safety
Creation of records
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for
Enforcement of the Food Sanitation Act(vii) Preparation of records
Depending on the size and type of business, a document concerning thedetails of the measures stipulated in the preceding items and a record of
the implementation of such measures shall be prepared.

83

Ⅲ Good Manufacturing Practice (GMP)
GMP 2 Site Management●Requirements
The organization shall establish and maintain in accordance with appropriate
standards for business premises. These standards shall include themanagement of waste and unnecessary materials on the premises.
●Concepts, specific examples
1. Concept in GMP2
1） In GMP2, it is important to take measures to ensure that "influencesfrom around and on the premises do not affect the food safety risk to
the product" and to maintain them. To this end, the following actions
are required.
(1) Identify what exists in the vicinity and premises of the businesssite.
(2) Check whether they pose food safety risks to own products.
(3) Consideration of measures to be taken and maintained so that thesystem can ultimately be capable of "preventing food safety risks to
products.
(4) Regularly check for changes in the environment, in parallel withcarrying out maintenance measures.
2. Confirmation of site boundaries
1） Ensure that the boundaries of the site are clear and in a condition thatcan be reliably accounted for.
2） Even if the site is located in an industrial park or other location, theorganization's own site shall be clearly identified.
3） It is recommended that as much as possible, drawings or other means
be used in order to clearly maintain the confirmed settings.
3. Confirmation of the surrounding environment1） Identify any food safety concerns regarding the area surrounding thefacility. One example can include the following:(1) Insect and bird damage relatedRivers, drainage ditches, etc.



Mountains, forests, parks, agricultural land, livestock, etc.



Garbage dumps, waste disposal sites, etc.

(2) Foreign body related84

Garbage dumps, waste disposal sites, etc.

(3) Others (impact on buildings, odor, chemicals, etc.)
Regional effects of salt damage, strong winds, freezing, etc.



Agricultural lands where pesticide spraying is conducted - Livestockindustry (feedlots, etc.)

Exhaust and smoke emissions from other factories, etc.

4. Confirmation of business premises
1） Identify any food safety concerns that can also be present in thefacility. One example can include the following:(1) Insect and bird damage relatedGreen space, etc.

Areas where puddles can formDrainage, septic tanks, rainwater tanks, etc.

Unnecessary items, waste storage, etc.

(2) Foreign body related
5.

Waste storage, treatment areas, etc.

Response to each impact
1） For each of the items identified as having an impact, measures toreduce the impact to a manageable level shall be considered, verified,and periodically addressed. Possible measures include the following:(1) Insect and bird damage related

Removal or modification of the subject, isolation, etc.

Periodic check, maintenance and repair of plantings and water
ponding areas(If the site is subject to the Green Space Act, compliance is required
but proper consideration shall be given to placement andmanagement)

Maintenance of the building, including repairs (positive andnegative pressure, entrances and exits, damaged areas and gapsthat serve as entry points, light sources, odor leaks, etc.)Periodic monitoring by insect control contractors or own
organization (perimeter, building interior, etc.)(2) Foreign body related

Removal or modification of the subject, isolation, etc.

Countermeasures against contamination by foreign matter flying
into buildings or adhering to workers(3) Others85

Arrangements with stakeholders in the surrounding environmentDeterioration countermeasures through periodic maintenance ofbuildings and facilities



Periodic verification of production areas and products[Example] Building Surroundings(facilities on the site as well as outside facilities and environment (outside thedotted line)).

GMP 3 Design, construction, layout of business site and work and product flow
lines
●Requirements
The organization shall design, construct and maintain the factory buildings
and facilities (storage area, raw material and product handling area,
preparation area, packaging and storage area, etc.) of the business site bothoutside and inside the plant to minimize food safety risks.
In addition, the equipment layout (including drainage system and lighting)and the flow lines of people, goods, and work shall be designed to meet theintended purpose and minimize food safety risks.
The organization shall set the lighting necessary for food safety to an
appropriate level of illuminance.

86Additionally, the organization shall ensure that facilities and equipment thatcome into contact with food are constructed and made of materials that allow
for appropriate maintenance, cleaning, and disinfection.
●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, andconsider the impact on food safety from this flow of movement (flowlines).
2. Lines of flow include the following, of which "goods" and "people" are themost important. As much as possible, "objects" and "people" should bemanaged to avoid cross-contamination.
1） Objects: Routes from receipt of raw materials to shipment of final
products
2） 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 fromthe workplace to the outdoors4） Drainage: routes for drainage of work area
5） Utilities: Routes for utilities such as steam, compressed air, carbon
dioxide, nitrogen and other gases, air conditioning and ventilation,lighting, and water used directly or indirectly in manufacturing andprocessing87

【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 and dead insects do not accumulate on the top, and theyshould be installed in locations where they can be easily cleaned.
3. If fluorescent lamps or light bulbs are damaged, protective covers (dustproof type) should be installed or shatterproof tubes should be used toprevent shards and other physical hazards from affecting products andproduction/processing lines.
4. For windows used for daylighting, select plastic windows made of materials
that are resistant to deterioration and shattering, and glass windows madeof glass that are resistant to condensation, and apply shatterproof plastic
film.
5. Illumination and color tones should be such that they do not cause
misidentification of the workplace.
1） Brightness that allows food handlers to work safely and hygienicallymust be provided.
2） If the illuminance of the area where work such as appearance
inspection is performed is insufficient, it is necessary to take measures
such as installing supplementary lighting such as electric stands.
3） When conducting color tone inspections, etc., the color tone of lamps
should be considered in addition to illuminance.
【Illuminance of the work environment】(This item is applicable to the scope inJapan)
1. The illuminance of the work environment is specified in Article 604 of theIndustrial Safety and Health Regulations and JIS. The work classificationand standards in Article 604 are as follows: precision work: 300 lux or
more, ordinary work: 150 lux or more, and rough work: 70 lux or more;
the JIS illuminance standard is 500 lux for ordinary visual work in generalmanufacturing plants, etc.
【Drainage system】
1. Drainage routes should be designed and managed to minimize thepossibility of contamination of products, etc.

88

2. Floors and drainage basins should be sloped to prevent puddles and beeasy to clean.
【Temperature control】
1. Depending on the characteristics of the food, appropriate facilities fortemperature control of the ambient environment in which the food ishandled shall be available when necessary.
【Air (air conditioning and ventilation) in the manufacturing environment】
1. Provide appropriate means of natural or mechanical ventilation, especiallyfor:1） Minimize airborne contamination of food by aerosols and condensation
droplets, etc.
2） Assistance in controlling ambient temperature3） Control of odors that can affect food conformity4） Control humidity to ensure food safety and suitability. (e.g., to prevent
moisture gain in dried foods that can allow microbial growth and theformation of toxic metabolites)
2. Ventilation systems shall be designed and constructed so that air does notflow from contaminated areas to clean areas. Systems shall be easy tomaintain and clean.
【Specifications and general information in the production area】
1. The specifications of the facility should be designed to ensure that there isno cross-contamination or adverse effects on food products.
2. The specifications shall be easy to maintain, clean, and wash, and shall be
resistant to deterioration.
3. Consider durability, such as the ability to handle heavy objects used in thework, 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 interferewith food safety.

89

●Items to be referred to in Japanese 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 Health Regulations of Japan, No. 604 and JIS.
task organization

Illuminance (lux)

Precision work

More than 300
lux

normal operation

More than 150
lux

rough work

More than 70 lux

Facility Management: Sanitation
Appended Table 17 (Re: Article 66-2, paragraph (1)) (Ordinance of the Ministryof Health, Labour and Welfare No. 68; addition)(ii) Sanitation management of facilities

90

(a) The facility and its surroundings shall be cleaned regularly and kept clean toprevent the occurrence of food sanitation hazards while the facility is inoperation.
(b) Do not place unnecessary articles, etc. in places where food or additives areproduced, 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, andthe temperature and humidity 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 aredamaged.

GMP 4.1 Cross-contamination (including allergen cross-contact) and isolation●Requirements
The organization shall prevent physical, chemical (including allergens),
biological contamination, and cross-contamination (including allergen crosscontact) of raw materials (including containers and packaging materials),semi-finished products, work in progress, reworked products, and finishedproducts.
The necessary control measures, including isolation, shall be established tocover all aspects of food safety, and these procedures shall be documented
and maintained effectively through periodic review.
●Concepts, specific examples
1. This standard requirement is related to HACCP Steps 4 and 5 in the actual
work performed.
2. As sources of contamination, all aspects of food safety are covered,including foreign substances, microorganisms, chemicals, and allergens.
3. An effective way to prevent cross-contamination (including allergen crosscontact) is to isolate raw materials (including containers and packaging
materials), semi-finished products, work-in-process, reworked products,
and finished products from the sources of contamination or objects thatcan contain such sources of contamination as described in Section 2 during
the manufacturing process. Normally, the degree of product contamination91

decreases as processing proceeds, but in the case of pathogenic
microorganisms, they have a tendency to spread from highly contaminatedto less contaminated locations and objects. Isolation is effective inpreventing this contamination. When storing the above-mentioned objects
to be isolated, it is recommended that each object be placed in a specificlocation, such as a storage room or refrigerator, and that dedicatedcontainers be used to protect the objects from cross-contamination(including allergen cross-contact).
4. For contamination associated with the movement of people and objects, aswell as cross-contamination (including allergen cross-contact), it is also
effective to identify the areas where it occurs and establish preventive
measures.
[Improve zoning and flow lines to prevent cross-contamination (including
allergen cross-contact).]
1. When evaluating and formulating, it can be easier to understand thecontrol points of pollution sources if a manufacturing and processing
process diagram, air supply and exhaust plan, and product and raw
material entry and exit plan are prepared.
2. The flow of zoning and flow line improvements to prevent crosscontamination (including allergen cross-contact) is as follows:1）

Clarify the movement of people and goods, and create a flowline diagram.
2）

Evaluate the possibility for cross-contamination (including

allergen cross-contact) due to the movement of people and goods, taking
into account the characteristics of the product and the potential forcontamination.
3）

As a result of the evaluation, control measures for cross-contamination prevention (including allergen cross-contact prevention) aredeveloped.
●Items to be referred to in Japanese 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

92

(a) Regularly clean the facility and its surroundings, and maintain cleanliness toprevent the occurrence of food sanitation hazards while the facility is inoperation.
(b) Do not place unnecessary articles, etc. in places where food or additives areproduced, 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 to maintain hygiene.
(b) Machinery, equipment, and parts thereof shall be cleaned and sanitized andstored hygienically in 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 andmaintained for proper use.
(c) When detergent is used for cleaning machinery, equipment, and their parts,
the detergent shall be used in an appropriate manner.
(e) Equipment, cleaning materials, and protective gear that may come incontact with food or additives shall be disinfected with hot water, steam, or
disinfectants each time they are contaminated or work is completed, and thendried.
(f) Detergents, disinfectants, and other chemical substances must be handledwith care and, if necessary, the names of the contents must be indicated on
the containers and packaging to prevent contamination of food or additives.

GMP 4.2 Control of hazards that require enhancement●Requirements
The organization must establish control measures for hazards that requireparticularly enhanced controls, other than CCPs, document those proceduresas necessary, and maintain them effectively through periodic review.
●Concepts, specific examples
1. Controls according to GMP 4.2
1） The Requirements of this standard require that for potential hazards
identified in HACCP Step 6 (Principle 1) hazard analysis, for which① Of the hazards that did not result in the establishment of a criticalcontrol point (CCP),② And for those hazards that require particularly strong control,93

Necessary control measures be established, those procedures
documented as necessary, and those procedures be maintained
effectively through regular review.
2） 1) is synonymous with "GHPs requiring more attention" in CXC 1-1969,
Rev. 2022, General Principles of Food Hygiene of the International
Commission on Food Standards (CODEX).
* Hazards identified by the HACCP Step 6 Hazard Analysis that areconsidered to have the potential to cause significant food safety
hazards if mistakes are made that do not meet the Requirements forcontrol by GMP, are considered to be "GHPs that require more
attention " and consequently are considered to be controlled by GMP
4.2.
2. Points to note for controls according to GMP 4.2
1） Depending on the type of product, manufacturing process, hazard
analysis, frequency and severity, etc., the hazards controlled in GMP 4.2
will vary. These should be considered and identified. The matrix in
HACCP Step 6 (Principle 1) and other information can be used as areference.
2） Control procedures according to GMP 4.2 can involve not only GMP
Requirements, but also controls according to FSM Requirements.
Although they vary depending on the industry and products of anorganization, examples of relevant Requirements are provided below:
FSM 13.1, 13.2, Purchasing and Supplier Management
FSM 16 Allergen Management
FSM 19.2 Environmental Monitoring
GMP 3 Design, construction, layout of business site and work andproduct flow lines
GMP 6 Hygiene, workwear and Health management of personnel, etc.
GMP 8 Housekeeping, cleaning, sterilization, and disinfection
GMP 11 Air and water Management
GMP 13 Pest control
GMP 18 Equipment and Tools
GMP 19 Maintenance3） When implementing the above, monitoring, corrective action, andverification records should be established at a frequency appropriate to
the characteristics of the product and the size of the organization.
Monitoring can include the following:94

●Definition of monitoring methods (including who is responsible,
frequency, and, if applicable, sampling regime)●Monitoring of records to be kept
3. Examples of Hazards Controlled by GMP 4.2
1） Allergen management:
Cleaning the line after manufacturing products containing allergens canbe a control measure to be managed under GMP 4.2. If the allergens
cannot be removed by cleaning, there is a risk of the next productcontaining no allergens containing allergens being included. In addition,
if there are multiple production lines in the same production area, thesimultaneous production of products containing allergens can cause
cross-contact of allergens with products from different lines.
2） Management of Listeria monocytogenes:
If RTE foods (ready-to-eat foods that do not require heating before
consumption) after heat sterilization are contaminated with Listeria
monocytogenes from lines, utensils, or the environment, they canmultiply even at temperatures below 10°C, and food poisoning canoccur if stored for long periods. Therefore, lines and utensils that comeinto direct contact with RTE food products shall be monitored carefully.
In addition, it is necessary to set up lines so that RTE foods and contactlines are kept at lower temperatures (preferably 4°C or lower).
4. Required control measures
1） See HACCP Steps 5, 6, and 11.
2） However, in-depth analysis/consideration shall be conducted by paying
attention to "Controls according to GMP 4.2" listed in "1".
3） Records of the results of the implementation of the procedures shall be
kept as necessary.

GMP 5 Personnel Facilities●Requirements
The organization shall provide changing rooms and hand washing facilities.
Facilities for employees, including these, must be properly managed tominimize food safety risks, including allergens.
The organization shall separate toilets and areas where food and drinks are
stored and consumed such as cafeterias, and break rooms, from areas where
food is manufactured, packaged, and stored.
95

●Concepts, specific examples【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 of contaminants
or foreign substances into the manufacturing or processing site.
【Changing rooms】
1. Provide a sufficient number of lockers, etc. In lockers and changing rooms,
clean work clothes worn in the production area shall be kept from crosscontamination with personal clothing or used work clothes.
2. Changing rooms shall be located so that food handlers' clothing does not
become contaminated before moving to the work area.
3. Changing rooms, if necessary, shall be suitable facilities for employees tochange clothes for the work they perform.
【Hand washing facilities】
1. The facility shall be capable of washing and drying hands in a sanitarymanner.
2. It is important to have a sufficient number of facilities in appropriate
locations based on the number of food handlers, and to have washing,drying, sterilization, disinfection facilities, and hot water facilities, as
needed.
3. Maintain an adequate supply of water (or hot water if necessary for proper
hand washing), and provide soap, paper towels, disinfectants, etc. suitablefor hand washing shall be provided, clean, and ready to use at all times.
Hand disinfectants shall not be used as a substitute for hand washing, butshall only be used after hand washing.
4. To prevent re-contamination of washed hands after hand washing, thefaucet should be designed so that it can be opened and closed without
touching it by hand.
5. Post easy-to-understand hand washing and disinfection procedures.
6. Hand washing facilities shall not be used for washing food or mechanicalequipment.

96

【Toilet】
1. The toilet shall be of hygienic construction.
2. Install a sufficient number of them for the number of employees.
3. The area shall be sufficiently separated from the area where food is
manufactured, packaged, and stored. However, if sufficient isolation canbe achieved, zoning (such as using separate rooms) is not required.
4. Establish hand washing and disinfection facilities and means to dry hands.
5. Always keep the area clean, and clean and disinfect it regularly.
【Dining room, rest room, smoking room】
1. Dining rooms, rest rooms, etc., and places where food and drink arestored and consumed shall be sufficiently isolated from areas where foodis manufactured, packaged, and stored to minimize the possibility of crosscontamination. (Pay particular attention to the bringing in of hard foreign
objects and allergens.) However, if sufficient isolation is possible, zoning,such as separate rooms, is not required.
2. Dining rooms, rest rooms, etc., and other areas where food and drink arestored and consumed shall be kept clean, and food, drink, and waste must
be controlled to be not left lying around to prevent them from becoming asource of harmful organisms.
3. Smoking areas shall be located and controlled so that
●Items to be referred to in Japanese 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 anddisinfected regularly.
(iii) Hygiene control of facilities, etc.
(h) Hand washing facilities shall be equipped with soap, paper towels, etc., anddisinfectants, and shall be maintained in a state whereby hands can be washedand dried appropriately.
(iii) Hand washing facilities shall be equipped with soap, paper towels, etc. anddisinfectants, and shall be maintained in a condition that enables hand washingand drying to be performed properly. (2) Hand washing and drying facilities
shall be maintained in such a way that they can be used appropriately and that97

a sufficient supply of water can be provided. In addition, hand washing 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 in accordance with the laws and regulations of the country inwhich the employees are working.
The criteria shall include provisions of hand washing and toilet facilities, ways
and frequency of hand washing, medical screening procedure to identify
conditions impacting food safety, proper protective clothing, rules on theclothing and shoes, rules on accessing production area, ways of food handling,
and control measures for foreign materials, and management procedures andreporting system in the event of an infected person that poses food safety
risks.
These Requirements must be made known to employees and applied without
exception to contractors and visitors.
The organization shall also determine who will be responsible for managing
personnel with health conditions.
●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 contaminationfrom occurring due to employee behavior.
(2) Establish a manufacturing environment that prevents
contamination and foreign matter from entering 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 areproperly trained and instructed so that there are no problems with onsite operations.
To this end, "documentation" is required to ensure that the information isaccurately communicated to each worker.
982. Health management of personnel
1） In advance, determine a manager who shall be responsible for the
management of employees with health conditions in case they arise.
2） The manager shall explain the health conditions and food safety risks
to employees when they join the company, etc., and seek theirunderstanding of identifying illnesses to the extent necessary, what to
do in case of illness, what to do in case of food poisoning, etc., andtake actions to ensure that they maintain appropriate knowledge andawareness of food safety.
3） The manager shall ascertain the employee's illnesses as needed forfood safety.
4） Have them undergo periodic medical examinations.
5） Conduct periodic stool analysis to confirm that there are noabnormalities.
6） Check the health condition before work and record the results.
Employees are to be trained and informed that they shall report any
abnormalities in their physical condition to the person in charge of thework site, etc. If an employee reports an abnormality in his/her
physical condition, he/she should not be allowed to work handling
products unless it is clear that the abnormality does not affect foodsafety (e.g., minor tooth decay, etc.). The following are examples of
illness symptoms that shall be reported to the person in charge of thesite, etc.:⚫

Jaundice / diarrhea / vomiting / fever / sore throat with fever /visible infected skin lesions (furuncles, cuts, etc.) / discharge fromears, eyes, or nose.

7） If there is a suspicion of infection or food poisoning accompanied byfever, diarrhea, vomiting, etc., or if there is a suspicion of infection
among skin injuries (burns, cuts, etc.), etc., report the problem tomanagement, food safety manager, etc. If necessary, disinfect thefacility, equipment, etc., check on the persons (including external
visitors) who came in contact with the product, and take action
regarding products manufactured or shipped prior to that time.
8） A response procedure should be developed in case an employee
becomes ill while working and there is a risk of infection or foodpoisoning. Procedures should include cleaning the facility as needed99and contacting other employees, contractors, visitors, etc. with whomthey came in contact.
9） There are some illnesses for which it is appropriate to prohibit entry to
the processing area even after symptoms have resolved. In suchcases, seek the results of a physician's diagnosis, if necessary.
10)

Persons with cuts or wounds shall be assigned to work in areas
where they cannot be in direct contact with food, if necessary. If theemployee is allowed to continue working, the cut or wound shall becovered with an appropriate waterproof bandage and gloves shall beworn when appropriate. Take appropriate measures to ensure that the
bandage does not become a source of contamination. (e.g., colorcoded, detectable by metal detectors)11) For contracted businesses and visitors, contact information shall beobtained in advance in preparation for the above-mentioned
emergencies.
12) Do not ship food that can have been touched by workers with healthconditions until you have confirmed that there are no safety issues.
See FSM 24. If the food has already been shipped before confirmingthat it is not unsafe, follow the procedures in FSM 22.1.
13) 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 beobtained in the event of an abnormality. Visitors (including
maintenance workers), 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 workfrom start to finish, and provide explanations at the time of
employment, etc., to properly align and maintain employees' personal
hygiene levels. Examples of employee hygiene behaviors include thefollowing It is necessary to set them appropriately by selecting and100

choosing the appropriate ones and considering 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 with products(3) Refrain from sneezing or coughing at the work site, and makeefforts 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 the designated work clothes properly toprevent hair and body hair from mixing in. In addition, air showers,
adhesive rollers, and other measures should be taken at designatedtimes.
(6) When wearing work clothes or work shoes, do not carelessly gooutside the production area or take any actions that may result incontamination.
(7) Do not wear ornaments or other items to prevent foreign matterfrom falling out.
(8) Keep fingernails appropriately short and clean. Do not wear nailpolish.
(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 workarea. Observe operation in designated areas.
(12) When work clothes are stored in common in lockers where
personal clothes and belongings are owned, handle them in such a waythat they will not be contaminated.
(13) Do not bring unnecessary items to the work site. If there is aneed for regular medication, etc., consult with the manager and takemeasures to ensure that contamination of products is prevented.
(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 hair and body hair from falling out and mixing
with products.
3） Rules for washing and replacing work clothes and footwear are to beestablished and implemented so that employees can wear clean work101

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 and storage methods are specified, and the gloves
are handled in a clean and good condition. If disposable gloves areused, 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 asnecessary 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 hair and body hair from falling out and mixing
with products.
2） Rules for washing and changing work clothes and footwear are to beestablished so that employees can wear clean and good condition work
clothes and footwear according to the 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 and storage 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 for washing hands
before wearing gloves should be established and implemented.
5） In relation to the above, control external visitors as necessary.
●Items to be referred to in Japanese 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 (hereinafterreferred to as "food handlers") (a) Medical examinations of persons who handle
food or additives (hereinafter referred to as "food handlers") shall be conducted102

for the purpose of ascertaining the health conditions necessary to prevent foodsanitation 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 handlingfood, etc. shall be instructed to undergo 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 andsuspension 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 infectinfectious diseases, etc.)(7) Nausea and vomiting(d) When a person who has a skin injury is engaged, the area shall be covered
with a water-resistant covering. Foods or additives that may be contaminatedby vomit should be discarded. In the event of vomiting in the facility, the area
should be disinfected immediately with a disinfectant.
(e) When food handlers are engaged in work to handle food or additives, theyshould wear work clothes specially designed for the purpose, and hats andmasks as necessary. In addition, they shall use special footwear in the work
area and shall not leave the designated area while wearing the footwear usedin the work area.
(f) Personnel handling food shall not bring into the facility where food ishandled any ornaments or other 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 ofwater-resistant materials 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 clean so as not to cause food sanitation hazards.
(h) Food handlers shall wash and sanitize their fingers thoroughly when theyfinish urinating or handling fresh raw materials or raw materials before heating.

103

In cases where disposable gloves are used to handle fresh raw materials or raw
materials before heating, the gloves shall be changed after the work.
(3) In handling food or additives, food handlers shall not do the following whilehandling food or additives from the viewpoint of preventing the occurrence offood sanitation hazards(1) Unnecessarily contaminate fingers, utensils or containers/packaging(2) Spitting phlegm, dandruff or spit
(3) Mixing or causing the possibility of mixing comb or cough droplets with foodor additives.
(vi) Persons handling food, etc. shall not change clothes, smoke, or eat or drink
outside of the designated areas.
(w) When persons other than food handlers enter the facility, have themchange into clean, exclusive work clothes and follow the hygiene control
regulations for food handlers as indicated in this section.

GMP 7 Training●Requirements
The organization must ensure that all employees, including new employees,
receive adequate education and training in food safety principles (including
HACCP) and practices appropriate to their jobs.
In addition, a system must be established to ensure that employees receive
appropriate guidance and supervision.
The organization shall keep records of the implementation of education andtraining. Additionally, the system for retraining as necessary shall be
documented and implemented.
This education and training shall enable employees to recognize their role infood safety and the significance of their efforts.
This education and training should enable employees to recognize their role infood safety and the significance of their efforts.
●Concepts, specific examples
1. Food safety managers
The person in charge of food safety shall enhance his/her own knowledge,
techniques and skills, and shall set up education programs (content,
timing, method, frequency (including refresher courses), etc.) for foodhandlers, and conduct education and training accordingly, and record the104results. It is important to periodically review the training programs andupdate them as necessary so that food handlers, maintenance staff, andother personnel involved in food operations continue to be aware of allprocedures necessary to maintain food safety and suitability (see FSM 2).
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 inhandling food products, in order to provide them with the knowledge
and skills necessary for food safety.
2） Ensure that current rules and procedures can be reviewed at any time,
incorporating the opinions 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 asnecessary, and records are kept. This retraining system shall beestablished and implemented in writing.
5） Conduct HACCP training.
6） In addition to the above, the educational program shall include, at aminimum, the following items:●Product reliability, including food fraud●Product Characteristics●Food Defense●Food-related legal Requirements●Product/process changes●Feedback from previously documented training/instructional
programs●Items to be referred to in Japanese 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 or containers and packaging and for workers, and105

information and efforts necessary for preventing food sanitation hazards shallbe 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.
(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 forfood sanitation. Article 63 A person engaged in a business prescribed in Article
56-2, paragraph (1) of the Food Sanitation Act (including cases where it isapplied mutatis mutandis under Article 62, paragraph (3) of the Act) shalldesignate 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 prescribed in 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 supervisors prescribed 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 arerecognized by prefectural governors, etc. on a regular basis and endeavor toacquire new knowledge concerning food sanitation (limited to those concerningbusiness under Article 51 of the Act (including cases where it is applied mutatis
mutandis under Article 62, paragraph (3) of the Act)). (Limited to businesses
106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 forfood sanitation.
(d) A business person shall respect the opinions of the person responsible forfood sanitation.
(e) A person responsible for food sanitation shall take necessary precautions toensure compliance with 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 that they 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 8 Housekeeping, cleaning, sterilization and disinfection●Requirements
The organization shall document and implement a management procedure ofmaintain an appropriate level of hygiene at all times by conducting tidying andcleaning operations throughout all processes and phases, and disinfecting
where necessary.
This procedure should include procedures for verifying that sanitary conditions
are ensured.
Cleaning tools, cleaning agents and disinfectants shall be suitable for theirintended purpose, clearly identified and stored in areas separated from foodproduction areas.
●Concepts, specific examples【Method Plan】
1. Cleaning removes food residues and contaminants that may be sources ofcontamination, including allergens. Cleaning methods and materials
required depend on the nature of the food operation, the type of food, and107

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 food safety 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 careand used according to the manufacturer's instructions. For example, theyshould be used at the appropriate dilution and contact 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 anddocumented procedures.
5. Train food handlers in standardized methods. It is also effective to show
actual cleaning procedures and to post pictures or illustrations of theprocedures. Trained personnel should perform cleaning, washing, andsanitizing.
6. Monitor whether the cleaning and disinfection program is being
implemented according to the rules and regulations by visual inspection
and other means, and verify whether it is effective by using sanitaryinspections 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 thatthe cleaning and disinfection program is being implemented as planned
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 tofood contamination. For example, sprays from high-pressure washing canspread contamination from dirty areas such as 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 is manufactured under dry conditions,controlling the amount of water used in cleaning (e.g., removing and108

collecting residues and dry cleaning) can reduce the risk of microbiologicalcontamination.
10. The following items are to be implemented for the handling of detergentsand chemicals used for cleaning, sterilization, and disinfection.
1） Appoint a person responsible for the management
2） Inventory control of chemicals and other materials (incoming andoutgoing shipments, amount used, number of items in stock, user andfirst-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 with names of contents, etc.)
11. To ensure that cleaning and washing of the facility is carried out
systematically, plans and procedures are to be prepared as follows
1） Plan for cleaning and washing facilities
The frequency of the work, the date of implementation, the person
who performs the work, and the 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, designationof work tools, post-work inspection procedures, and inspection
procedures prior to the start of production, etc.
【Management of cleaning tools, washing equipment, etc.】.
1. If foreign matter or microorganisms adhere to equipment, facilities, orutensils used for cleaning, washing, sterilization, or disinfection, it may
lead to contamination of products with foreign matter or microorganisms.
Use separate cleaning machinery, equipment, and utensils designed for
different sanitation zones (areas), such as for food-contact surfaces andnon-contact surfaces, to suit the purpose.
Contaminated cleaning equipment and utensils can also spreadcontamination.
2. Inspection and maintenance
1） Check operation and deterioration before and after use, andimmediately repair or replace any defective items.
1092） Since dirt remains on the back and bottom of equipment, facilities, andutensils, disassemble them to check for contamination. Cleaning
equipment should be kept clean, maintained, and replaced regularly to
avoid contact surfaces and sources of cross-contamination of food.
3. Storage location
1） Cleaning supplies, cleaning agents, and sanitizers should be clearly
identified and stored in areas separated from areas where food is
produced, packaged, and stored. If they can be stored away from eachother, this is not a problem.
2） Cleaning utensils should be hung and stored to dry so that they do not
stick to the floor or other surfaces.
3） Storage areas should be designated and kept clean so that foodhandlers can use them immediately. Posting a notice to this effect isanother way to keep the area clean.
4. Identification
1） It is necessary to devise ways to ensure that cleaning and washingutensils used in contaminated areas are not misused in clean areas. It
is important to color-code them according to their use, such as "red"for floors and "blue" for cooking utensils, and to separate their storage
locations.

GMP 11 Air and water management●Requirements
The organization shall establish application-specific standards and regularmonitoring procedures for air, high-pressure gas, and water (including ice andsteam) used in food production to minimize impacts on food safety, and therecords shall be kept.
If water not intended for use in food production and water that has been used
and is still acceptable in contact with food is applied to food production, it
shall be controlled to prevent it from being contaminated with water for foodproduction.

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●Concepts, specific examples
1. Air, high-pressure gases, and water (including ice and steam) used infood production can cause physical/chemical/biological contamination offood depending on their use. To minimize the impact on food safety, it isessential to establish standards required for each application, establish
procedures for regular monitoring, and keep records of such monitoring.
2. When manufacturing food products, it is possible to use different types ofwater for different purposes, in which case standards shall be establishedfor each application.
3. The quality of water to be used shall be checked by water quality tests,
etc., and if necessary, filtered, sterilized, or otherwise treated to ensure
water quality before use.
4. Where appropriate, municipality, national or internationally recognized
microbiological and water quality standards for drinking water shall befollowed.
5. In Japan, water that comes in contact with food is, in principle, water forfood production or water suitable for drinking, and water for foodproduction means water that complies with applicable laws andregulations.
6. In Japan, it should be referred to in legal and regulatory Requirements:
1） Water quality standards based on the Water Supply Law (51 items):
Ministerial Ordinance on Water Quality Standards (May 30, 2003,
Ministry of Health, Labor and Welfare Ordinance No. 101)
2） Water for food production: Specifications and Standards for Foods,
Additives, etc. (26 items) (Ministry of Health and Welfare Notification
No. 370, 1959)
3） Water fit for drinking: Regulated by the Food Sanitation Law
Enforcement Regulations following the revision of the Food Sanitation
Law (enacted on June 1, 2020). (Reference: Appended Table 17 of theFood Sanitation Law Enforcement Regulations, July 14, 2020)
7. In order to reduce the cost of water, there are cases where water other thanwater for food production is used in the manufacturing process (e.g., forprimary washing of food, heating and cooling), and these waters must be
controlled to prevent contamination with water for food production. Specificexamples include the following:1） Well water that has simply been pumped
1112） Water that has not been sterilized with hypochlorous acid or chlorine,etc.
8. In addition, in some food industries, water that has been used but isacceptable for contact with food can be reused for food production in orderto make effective use of water resources, as in 6. above, these waters shallalso be controlled to prevent contamination to water used for foodproduction. Specific examples include the following:1） Water used to heat and sterilize facilities
2） Water used to heat and cool prepackaged foods
3） Secondary washing water for cut vegetables (water used in the final
stage of the washing process)4） Steam condensate reuse water
9. In addition to water, ice and steam used in food production must also be
addressed to minimize 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 cancleaning agents (chemical agents) used in boilers that generate steam
should be approved for food use and should not be mixed with ice andsteam.
2） A filtration device (filter) should be installed near the end of the ice
maker's water supply and steam piping.
3） Make sure that ice/steam in direct contact with food products does nothave any adverse effects (odor, coloration, etc.) on food products.
4） Description of air and gas
10. Compressed air, carbon dioxide, nitrogen, and other gases
1） Equipment for gases used in manufacturing and filling should be of
specifications that do not present a risk of food contamination, andshould be properly maintained.
2） Gases that come in contact with foodstuffs shall be those approved forgeneral use in food additives.
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.
11. 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 whendevising air conditioning and ventilation systems.
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(1) The air conditioning and ventilation system should be designed tobe easy to clean, wash, and replace 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 condensationand mold formation, etc.).
(5) If necessary, maintain differential pressure to prevent air fromflowing 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 andcorrosion.
3） It is convenient to have inspection ports for both intake and exhaustfor inspection, cleaning and washing, and filter replacement.
4） When aiming to step up to the JFS-C standard, it is desirable tomonitor and control the cleanliness of the air in areas where productsthat are prone to the development and survival of microorganisms are
manufactured, in accordance with procedures.

●Items to be referred to in Japanese 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 water supplied 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 for drinking (hereinafter referred to as "water suitable for drinking").
(hereinafter referred to as "water fit for drinking"). (2) The water shall bewater that is suitable for drinking (hereinafter referred to as "water suitablefor drinking"). However, this shall not apply to use in cooling or otherprocesses 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 food or additive to be113

handled is to be used or consumed for one year or more). However, if there
is a possibility that the water source, etc. has been contaminated due to an
unforeseen disaster, a water 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 and kept clean.
(e) When water suitable for drinking is used and a sterilization or water
purification device is installed, periodically check that the device is working
properly and record the results.
(f) Ice that comes in direct contact with food shall be made from water thatmeets the conditions in (a) above, which is supplied by a properly controlledwater 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 affect the safety of the food or additives.

GMP 12 Waste Management●Requirements
The organization shall establish adequate systems for segregation, collection
and disposal of waste.
Waste placement and containers must be controlled to prevent the attractionof pests and the development of harmful organisms and microorganisms.
Containers for storing waste materials (including by-products not suitable forfood use) shall be clearly distinguished from other containers.
Waste flow lines must be set up so as not to cause cross-contamination offood.
●Concepts, specific examples
1. Waste, etc. (including by-products not suitable for food use) generated asa result of food production and processing shall be properly managed
because they can become a breeding ground for microorganisms, rodents,
insects, and other harmful organisms, which may lead to contamination of
the production and processing environment. For example, the purpose isto prevent contamination of the surrounding environment and attraction ofpests due to overflowing waste (including by-products not suitable for fooduse) in waste containers in factories and outdoor waste storage areas, as
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well as outbreaks of sanitary pests and microorganisms due to long-term
storage, etc.
2. Avoid contact between waste and raw materials, ingredients, food, or
manufacturing/processing facilities. Keep disposal facilities away from foodproduction facilities.
3. Designate a person in charge of consistent management (identification,
accumulation, segregation, storage, removal, and disposal) of waste, etc.,
prepare a written procedure for such management work, and provide
training. The status of waste management shall be periodically checked toensure that the procedures are being followed, etc. Records of disposal shallbe maintained.
4. For example, check that the following flow is being processed promptly:
Waste, etc. generated in manufacturing/processing lines → Containers ofwaste, etc. → Temporary storage area → Indoor/outdoor waste storage
area → Pickup by designated contractors → issue and storage of manifest
slips (according to laws and regulations)
5. Waste, etc. shall be managed and stored so as not to affect products, rawmaterials, and materials and equipment that come in contact with the
products.
6. In order to prevent cross-contamination between wastes, etc. and products,
in principle, wastes, etc. should not be stored in areas where food is handled
or stored. (Excluding temporary storage during production, and similar
activities. However, even in this case, care shall be taken to prevent crosscontamination with products.)
7. Containers (trash cans, containers, etc.) for storing waste shall be clearly
distinguishable from other containers and made of a material suitable forthe waste application. They should be impermeable if necessary. Containers
used to hold hazardous substances prior to disposal shall be stored in
specific containers and locked as necessary to prevent intentional or
accidental contamination of food. In addition, tools used to store and handle
allergen-containing wastes shall be garbage cans, transport tools, or
containers, with a lid that are handled in a manner that prevents or
minimizes the potential for allergen cross-contact.
●Items to be referred to in Japanese legal provisions related to food safety
GeneralRegulations for Enforcement of the Food Sanitation Act
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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 the same paragraph shall be as follows(iv) Proper implementation of cleaning and maintenance inspections offacilities and disposal of waste 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 orstored (including adjacent areas), unless it is deemed possible to prevent theoccurrence 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 shall monitor pests and implement controls (surveys andcountermeasures) to minimize the risk of insects, rodents, birds, and otherpests occurring or entering the premises and facilities.
If chemicals are used, handling procedures shall be established to ensure thatfood is not affected.
Pest control shall be carried out by persons with the necessary competence.
●Concepts, specific examples【Pest control measures】
1. Pest control measures shall be taken as follows
1） Analysis and inspection plan for pests such as rodents and insects

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Target pests are identified based on past occurrences in the facility,
biological evidence, and characteristics of products handled, andinspection plans are formulated.
2） It is important that pest control, including surveys and monitoringplans, is carried out frequently enough and appropriately by competentpersonnel with the necessary skills. It is also effective to obtain thecooperation of external pest control contractors with expertise in thefield.
3） Pest control and invasion prevention measures
Remove internal sources of pests and implement measures toprevent external invasions and incursions.
4） 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 evidenceof pest infestation. If extermination is necessary based on the resultsof monitoring, countermeasures that do not affect food or interferewith facility operations should be formulated and implemented bycompetent personnel. Identify the cause of the infestation, takecorrective 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 andmeasures should be promoted. Even when monitoring 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 and pruning of plants should bedone 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 the parking lot.
5. Yellow or green fluorescent lights or plastic curtains, which are considered
to be less visible to insects, should be installed in outdoor lighting,entrances, corridors, etc.
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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. Meshand filters should be inspected regularly. 7.
7. Drainage ditches around the plant should be designed to prevent rodents
and insects from entering through the openings of the facility. Measures
such as netting or water sealing at the ends of drains are effective. 8.
8. Windows that are not opened and closed should have their gaps filled andbe removed as necessary. Ensure that entrances and exits for employees
and goods are closed except when necessary. 8. wire mesh screens should
be installed on windows, doors, etc. that open and close to reduce the riskof entry of small pests.
9. Use screens on swinging door windows to prevent dust and insects fromentering the building due to wind pressure when opening and closing thedoors.
10. Make sure that lighting around window and shutter openings does not leakto the outside. Attaching light-blocking film or insect repellent sheets towindows 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 be seen from the outside.
【Measures for facilities that are easy to clean】
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 for pests 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 easy inspection and cleaning.
【Drug Control】
1. it is important to have established procedures for chemical administration,
spraying, and initiation of production and processing after spraying
2. Ensure that the use of chemicals is restricted to well-trained personnel.

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3. The amount of chemicals entering and leaving the warehouse should becontrolled 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, theconcentration used (dilution factor), the date and time of application, andthe 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, dependingon 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 referred to in Japanese 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 thatallows 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 of the extermination shall be kept for one year. However, if theobjective can be achieved by conducting periodic, uniform surveys of thelocations of rats and insects, their habitats and routes of entry, and the state ofdamage, and taking necessary measures based on the results of 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 themso as not to contaminate food or additives.
(d) To prevent contamination by rats and insects, raw materials, products andpackaging materials shall be stored in containers and kept away from floors and119walls. Once opened, the product shall be stored in a container with a lid orother measures to prevent contamination.

GMP 15 Transport●Requirements
The organization shall establish a system to ensure that containers andtransportation vehicles, including contracted vehicles, used for thetransportation of raw materials and ingredients (including packaging
materials), partially processed products, works in progress, recycled products,
reworks, and finished products (including packed fresh products in final
packaging) are suitable for the intended use, maintained in good repair andclean, protected from contamination, and transported within its 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 tothe product.
It is also required to ensure that the product (including intermediatestages) can proceed to the customer 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, theymust be in a condition free of abnormalities prior to use.
When purchasing or using items that are already packaged as readyto-use products, the specifications of each raw or packaging material
should be checked, and only if no problems arise when delivered undergeneral transportation conditions, such as "refrigerated", "frozen", or"room temperature" temperature control, rather than in a specialized
vehicle, should it be allowed.
2） If abnormal temperature, damage, contamination, etc. are found uponreceipt, the product should not be used, but should be checked andreturned 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 a120

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, recycled
products, reworked products, and finished products
1） When delivering to the destination, check the product specifications
and consider the necessary conditions for a trouble-free delivery.
Examples: temperature and humidity settings, stacking and loading
methods, pallet-related items used, delivery containers, and otherspecial conditions.
2） Confirm that the delivery vehicle can handle the set conditions without
problems and that the environment is such that the product can bedelivered without damage or contamination.
(1) Can the required temperature and humidity be set? Also, can therequired temperature and humidity range be maintained even whenthe vehicle is fully loaded? If not, can the maximum load be changed?
(2) Is the temperature and humidity recorded at the required
frequency? Also, is it possible to check that there are no abnormalities
with the thermometer and hygrometer as appropriate?
(3) If containers and pallets are not the company's own, check thefrequency of cleaning, disinfecting, and replacement.
(4) Is the interior of the vehicle kept in proper clean condition?
(5) Confirmation of whether mixed loading with non-products isallowed, and if so, the loading capacity, items that can be loaded, etc.
(6) Confirmation that no outsiders other than the person in charge ofdelivery are involved.
4. On the organization, too, if necessary, check and make efforts to maintainthe delivery environment. If any abnormalities are found, it shall benecessary to request appropriate improvements.
●Items to be referred to in Japanese legal provisions related to food safety
Transport
Regulations for Enforcement of the Food Sanitation Act Appended Table 17(Re: Article 66-2, paragraph (1))
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(xi) Transportation(a) Vehicles, containers, etc. used for transporting food or additives shall becleaned and disinfected 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 shallbe 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 shall be placed in appropriate containers or otherwiseclassified, as necessary, to prevent contamination from cargo other thanfood or additives.
(d) Foods or additives in transit shall be managed so as not to be contaminatedby dust and exhaust gases, etc.
(e) When vehicles, containers, etc. used for transporting food or additives ofdifferent items and cargo other than food or additives are used, they are to
be cleaned by effective methods and disinfected 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 duringtransportation.
(h) Delivery times shall be set based on the temperature and humidity duringtransportation, and shall be properly controlled so as not to exceed theprescribed delivery time.
(h) In the case of delivering and serving cooked food, the time until it is servedfor eating and drinking 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 inprogress, recycled products, reworks, and finished products in a designatedorder and within the defined expiry period, and shall store these materials
under the proper conditions to avoid contamination and deterioration.
Storage facilities and equipment shall be designed to allow food to be stored
under appropriate storage conditions.

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●Concepts, specific examples【Storage period】
1. Raw materials (including containers and packaging materials), semifinished products, work-in-process, recycled products, reworked products,
and finished products shall be used within a specified period by
establishing an appropriate shelf life and utilizing first-in, first-out, etc.
2. During storage, the traceability (see FSM 14.1) of raw materials (including
containers and packaging materials), semi-finished products, work-inprocess, recycled products, reworked products, and finished products shallbe managed so that they can be linked to the records.
【Storage location】
1. Facilities and equipment for storing food shall be designed to store thefood under appropriate conditions according to the specifications of thefood.
1） Raw materials (including container and packaging materials), semifinished products, work in progress, reworked products, and finishedproducts shall be stored in storage facilities, that are notcontaminated, and do not deteriorate due to temperature, humidity,
etc. This is related to GMP 4.1 and 4.2.
2） Storage conditions that do not degrade means storing the productunder appropriate conditions that ensure the required specifications.

GMP 18 Devices and Tools●Requirements
The organization shall suitably design and select equipment and tools for theintended uses and shall use, maintain, and store so as to minimize food safety
hazards.
●Concepts, specific examples
1. Concept in GMP181） GMP18 requires organizations to prevent food safety risks derived fromequipment and instruments.
Examples of risks include the following(1) Biological: Contamination due to residual food residues, etc.

123(2) Chemical: Mold and allergen residues due to inadequate cleaningand 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 the floor, consider
specifications that can be accommodated without difficulty, such as
disassembly of 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 andresidue in pipes, ducts, etc. are possible.
2） Specifications(1) Check that areas that come in contact with foodstuffs are foodcompliant, and take action to ensure that this can be verified.
(2) For parts that come in contact with food, confirm that they can beeasily cleaned, inspected, and replaced, and consider the degree ofdeterioration that should be addressed and the frequency of suchaction to be realistically feasible.
(3) Avoid items (screws, labels, etc.) that may fall off the top of thefood as much as possible, and monitor as necessary.
(4) Check carefully before initial use to ensure that there are no paintchips, facets, or other contaminants.
(5) If the product is made of metal, it should be made of a material
that is resistant to rust and corrosion.
3. After installation of equipment
1） Establish procedures for cleaning, drying, and, if necessary,disinfection.
(1) Cleaning method: cleaning tools to be used, water temperatureduring 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.
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(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 the procedures 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 establishedprocedures, it is desirable to have a procedure manual or visualexplanation materials. In addition, it is recommended that records bekept to ensure that the procedures are followed, such as records ofchecks on areas prone to insufficient cleaning and records of thecompletion of drying, if necessary.
4） Monitoring should be conducted at an appropriate frequency fordamage, deterioration, and other areas where food safety risks may be
a concern. When monitoring is conducted, it is desirable to keep
records.
5） Inform workers to report any abnormalities such as breakage, parts
falling off, or abnormal noise.

●Items to be referred to in Japanese legal provisions related to food safety
Sanitation of equipment and instruments
Regulations for Enforcement of the Food Sanitation Act

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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, andmaintenance of facilities and equipment, etc., so that the containers andpackaging 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, andpackaging"), and to ensure that the workers understand the work procedures
and matters necessary for hygiene management, and that they perform theirwork in accordance with those procedures and matters.
(iii) The facility or work area shall be designed to prevent contamination by
dust, dirt, or other contaminants as necessary, based on the usage of theequipment 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 toprevent metal fragments, foreign substances, or chemical substances frommixing with food or additives, and shall be stored hygienically in designatedlocations. In the event of malfunction or damage, it shall be 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 time they are contaminated or work iscompleted.
(li) Cleaning facilities are to be kept clean.

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GMP 19 Maintenance●Requirements
The organization shall document and implement a system for systematic
maintenance of all equipment critical to product safety. Maintenance activities
shall be performed in such a way that they do not pose a food safety risk.
This system shall include procedures (such as cleaning, washing, andsterilization procedures) for returning the food production facility to a state
capable of producing food after maintenance activities.
Maintenance activities shall not represent food safety hazards.
All materials used for maintenance shall be suitable for the intended purpose.
●Concepts, specific examples
1. Maintenance of facilities and equipment
1） Maintenance activities need to be carried out in a way that does notpose a risk to food safety. Therefore, the organization develops andimplements documented procedures for the maintenance of all
facilities and equipment that are important to product safety. The
procedures include the following concepts:(1) Ex-post maintenance: Maintenance method in which maintenanceis performed after a breakdown has caused a shutdown or a decline infunctionality(2) Preventive maintenance: Management methods that focus on
prevention, such as equipment inspections and periodic parts
replacement(3) Improvement maintenance: Management methods that focus on
improvement and reinforcement to prevent recurrence of breakdowns
2） Procedures for the maintenance of facilities and equipment shall
include the following items:(1) Developing a maintenance and inspection plan(2) Person in charge of maintenance and inspection(3) Identification of facilities and equipment requiring maintenance andinspection(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 andinspection127

(7) Procedures for restoring food production to a condition ready for
use after maintenance (including cleaning, etc.) Procedures forrestoring food production to a condition where it can be performed
after maintenance (including cleaning, washing, sterilization, etc.)
2. Maintenance Notes
1） Repair so as not to contaminate food, etc.
2） All materials used for maintenance shall be suitable for their intended
use so that they do not pose a food safety risk.
3） Check that equipment (facilities) and tools are not damaged or haveany missing screws or other parts.
4） Preventive maintenance shall be carried out in a planned manner, in
addition to ex-post maintenance.
5） Ensure that preventive maintenance plans include equipment thatmonitors and controls food safety. (e.g., sieves, air conditioning filters,
magnetic traps, metal detectors, etc.)
6） In the event of malfunction or damage, promptly repair the equipment
and return it to normal condition.
7） When performing maintenance, do not contaminate surrounding
manufacturing or processing lines or equipment.
8） Lubricants and heat transfer media that can come into direct orindirect contact with food shall be selected so that they do not impair
safety even if they come into contact with food.
●Items to be referred to in Japanese 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 the same paragraph shall be as follows(iv) Proper implementation of cleaning and maintenance inspections of facilities
and disposal of waste materials in order to maintain a clean working
environment.
The end128

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

JFS-B Plus Standard Document (SectorⅠ,CⅡ,CⅢ,CⅣ/K)Version. 1.0 〔Guideline〕
Edition 1.0
July 25,2024 Issued
Edited and published by Japan Food Safety Management Association

The copyright of this guideline belongs to Japan Food Safety Management
Association or legitimate third parties. If you wish to use any of the contentsof these guideline, please contact us in advance at
17-5, Ginza 8-chome, Chuo-ku, Tokyo 104-0061, JapanTHE HUB Ginza OCT Room 605
Japan Food Safety Management Association (JFSM)
Tel: 03-6268-9691 Email: info@jfsm.or.jp
Unauthorized reproduction or use of this guideline is strictly prohibited, withthe exception of copyright law.

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