A. Food safety management system

Procedure Manual

Records

Are there any specifications (for ingredients, packaging materials, products,
manufacturing outsourcing services)?
Do the specifications (for ingredients, packaging materials, products,
manufacturing consignment operations) meet legal and customer
Are the specifications (for ingredients, packaging materials, products,
manufacturing outsourcing services) updated?

Specifications including product When there are changes made to the specifications (for ingredients, packaging
materials, products, and manufacturing consignment operations), do
shipment
companies or business partners get notified?
Are there manuals for shipping?

Shipping manual

Are there periodical checks conducted to verify if contents of the specificationand the product actually match?
Is there a person in charge of managing the specifications (of ingredients,
packaging materials and products)?

Traceability

Are traceability systems in place and documented?
Does a traceability system work even for past work?
Can a product be identified in all manufacturing processes?
Are there any records from purchasing (ingredients, packaging materials,
products) to production and delivery?
Is there a display or printing procedure that can identify a relevant productfrom all manufacturing processes and distribution processes?
At least once a year, does the traceability system get checked to see if its

Traceability manualTraceability records

If necessary, do the traceability system as well as maintaining and managing
records get updated?
Is it possible to withdraw and recall products when food safety problems arise?

Food safety trouble
management

Management of defective
products

Are records of food safety problems kept?
Food safety troubles records
Is there a food safety troubleshooting procedure document in which reports to Food safety trouble management manual
institutions including municipal governments and removal and recall of products
Is there a person in charge of making reports to business partners, consumers
and government?
Is procedure to manage food safety problems reviewed and verified at least
Are records of food safety problems reviewed later?
Is there a procedure document to manage defective ingredients, semi-finishedproducts, products and packaging materials?
Are defective ingredients, semi-finished products, products and packing
materials managed by a person in charge?

Control procedure of defective
ingredients, semi-finished products,
products and packaging materials

Corrective actions

Responsibilities of managers

Record keeping requirements
General documents
requirements
Management of measurement
and monitoring equipment

Training

Procedure

Handling complaints

Products analysis

PurchaseIs there a manual of corrective actions to analyze complaints and also to
examine defective products?
Are the corrective actions (including shipment, reprocessing, segregation, anddisposal) performed properly?
Does management understand the operation of their food safety program andprovide necessary resources?
Is there an up-to-date organization chart that describes the outline of theCorrective action manual

Does management have written documents about product safety andresponsibility for compliance and communicate to employees about those?
Are there records to check legal and customer claims or food safety system
Does an operator set a retention period for their records necessary to meetlegal and customer claims?
Is there a written manual regarding procedure to manage documents?

Food safety standard

Document management procedure

Records that meet legal andcustomer requirements

Are measurement and monitoring devices that have significant impacts on legal
and customer requirements reliable?
Are important measurement and monitoring devices for food safety calibrated?
In case measuring and monitoring equipment deviates from the establishedstandards, are there measures taken and recorded?
Are there effective training programs offered to educate new employees?
Is there regular training for employees?
Is employees training offered?
Are there trainings offered on HACCP?
Are there records for trainings?
Are there written documents on continuous trainings that are provided for
Is detailed procedure created and implemented effectively for processes andoperations that affect food safety?

Employee training plan
Procedure document of processes andoperations affecting food safety

Is procedure communicated to employees in charge of processes and/or
operations that affect food safety?
Is the complaint management system documented?

Complaints management rule

Are records of customers' and consumers' complaints, as well as following
investigations and corrective actions stored?
Is there a product analysis procedure to check if legal and customer claims are
met within the expiration date?
Are there product sampling inspections conducted at regular intervals to
confirm that pH is less than 4.6?
Are there test results using appropriate analytical procedure (such as ISO17025
provisions and methods certified by the industry)?
If purchasing black garlic from new suppliers, does it comply with an existing
contract specifications?

Measurement and monitoring
equipment management record

Employee training record

Complaints and corrective action
records

Analytical results record

Supplier Approval and Function Does supplier exchange contracts and specifications in advance?
Monitoring
Is vendor confirmation procedure documented and implemented?

Supplier confirmation procedure

B. Good Manufacturing Practices, GMPs

Are there rules of personal hygiene and are they applied to employees, agentsand visitors?
Do the personal hygiene rules comply with legal requirements, if they exist?

Personal hygiene

Is there procedure for notifying employees, vendors and visitors about what to
do if an infection occurs?
Is there a person responsible to decide if a person with a suspicion of being
infected can enter the manufacturing area?
Do people who may be sick get managed?
Do employees, vendors and visitors strictly follow the personal hygiene rules?
Are employees, vendors and visitors aware that they have to change theirclothes in a particular work area?
Are facilities located, designed, constructed and maintained to ensure product

Facility environment

Are facilities effectively maintained, cleaned and disinfected to prevent
biological, chemical and physical contamination?
Are there lights with appropriate illumination and design, and do they let
employees work effectively?
Are areas that have contacts with food kept clean and disinfected if necessary
Are drainages designed to be food safe?
Are areas around a site and building clean without wastes?

Cleaning and disinfection

Control of productcontamination

In order to keep the facilities, equipment and machines clean, is there cleaningand disinfection procedure put in order, and also, are there checks conducted
after cleaning and washing?
Are cleaning / disinfecting equipment, tools and chemicals clearly labeled?
Are cleaning and disinfecting equipment, tools and chemicals stored
appropriately for the purpose of use in a place isolated from products,
Are cleaning and sterilization conducted by trained staff?
Is there zoning or other effective procedure to reduce or avoid possibility ofcontamination of biological, chemical and physical hazards?
Are there traces of insect, mouse and pest invasion?
Are there effective insect, mouse and pest control methods?

Insect control, mouse control
and pest control

Are Insect, mouse and pest control measures appropriate for products,
ingredients and facilities?
Are insect, mouse and pest controls conducted by an appropriate person andare there measures taken to deal with examination results?

Cleaning and disinfection procedure forfacilities, equipment and equipment

Water quality management

Employee facility

Is there control procedure for water, ice and steam that do not compromise
product safety?
Is there procedure to prevent cross contamination of non-drinking water anddrinking water?
Are there changing rooms for employees?

Procedure to control water, ice andsteam
Procedure to prevent crosscontamination of non-drinking water andAre there appropriate restrooms in place and are they isolated from production
Are there appropriate hand-washing facilities in place?
Are eating facilities placed away from manufacturing, packaging, and storage

Waste management

Are there rules for waste disposal and storage?
Are waste containers clearly distinguished by use?
Are there enough storage places for products and ingredients?
Are storage facilities protected against contamination during storage ofingredients and products?
Does product shipping process minimize degradation (such as by temperatureand humidity control)?

Shipping and storage

Is product handling procedure in place and implemented effectively?
Is transport vehicle procedure in place and conducted effectively?
Is maintenance and sanitation procedure documented for loading vehicles andequipment?
Is maintenance and sanitation procedure effectively implemented for loading
vehicles and equipment?
Are maintenance systems for facilities and equipment in place?

Maintenance management offacilities and equipment

C. Food hazard control

Pre-procedure

Are maintenance of facilities and equipment carried out effectively?
Is facility and equipment cleaning procedure documented?
Is facility and equipment cleaning operated effectively?
Are materials used for maintenance and repair suitable for purpose of use?

Maintenance and sanitation procedure
for loading vehicles and equipment

Maintenance management rules forfacilities and equipment
Facility and equipment cleaning

Do business operators comply with legal and product requirements?
Procedure1：Is there a food safety team consisting of members with different
job responsibilities (food safety, manufacturing, engineering, procurement,
Procedure 1: Are all members of food safety team properly qualified and canthey demonstrate the evidence for receiving specialized training?
Procedure 2: Are product specifications for materials, packaging materials,
storage conditions, etc. maintained?
Procedure 3: Are intended use of the product specified and intended consumers
identified?
Procedure 4: Is there a manufacturing flow chart?
Procedure 5: Is created flow chart verified on site?

Product specifications

Manufacturing process flow chart

Are there documents referring to managing allergen materials to prevent cross- Allergic substance management
contamination in manufacturing processes?
procedure

Allergy management

HACCP

Food defense

Are both legal and customers' claims considered in the process of allergen
Is there procedure for handling ingredients and products to identify and prevent
possibility of cross-contamination of allergens?
Is there a manual to clean surfaces that touch products?
Product contact-surface cleaning
Are all allergens with possibilities to cause cross-contamination of allergens
removed from surfaces that come into contact with products?
Throughout manufacturing process including production and sales, is there asystem to separate each process?
Procedure 6: Is hazard analysis performed at each process step?
Has the analysis been performed by a qualified person (team)?
Procedure 7: As a result of the analysis, if hazard can not be reduced oreliminated by the Good Manufacturing Practices (GMP), are there important
control points (CCPs) specified?
Procedure 8: Are allowable limits established for each CCP?
Procedure 9: Is monitoring procedure established for each CCP?
Are CCPs conducted effectively?
Procedure 10: In case of exceeding an allowable limit, are corrective actions set
for each CCP associated?
Procedure 11: Are verification means established?
Is verification done effectively?
Procedure12: Are records and documents managed for the HACCP method?
Are all HACCP related records and documentation procedure implemented
Does an operator have a clear control over all steps considered to be influential,
including for those not CCP.
Are possibilities of intentional forgery and contamination of products analyzed?
Are weak defense points in the manufacturing procedure identified, andadditional measures for access control are taken to deal with intentional forgery
and contamination of products?
Is there procedure in place to determine product disposition in an event ofintentional product tampering or contamination?

Hazard factors analysis chart

HACCP plans

Food safety management of black garlic
Food safety management items
Summary

As an organization, there is acommitment for high standard foodsafetyFood safety management items（Revised GFSI GMaP）
Responsibilities ofmanagers
Training

Procedure
There are rules about food safety andthey are followed properly

Food safety
manageme
nt system

Is detailed procedure created and implemented effectively for processes andoperations affecting food safety?

●●●

Is procedure communicated to employees in charge of processes and/or
operations affecting food safety?

Are there records to check legal and customer claims or food safety system

Is complaint management system documented?

Records

Food safety policy

Employee training
Employee training
plan
recordProcedure documentof processes andoperations affecting
food safety

Records that meetlegal and customer
requirements

Does an operator set a retention period for records necessary to meet legal andcustomer claims?

Are there any specifications (for ingredients, packaging materials, products,
manufacturing outsourcing services)?
Do the specifications (for ingredients, packaging materials, products,
manufacturing consignment operations) meet legal and customer
Are the specifications (for ingredients, packaging materials, products,
manufacturing outsourcing services) updated?
When there are changes made to the specifications (for ingredients, packaging
Specifications
materials, products, and manufacturing consignment operations), do
companies or business partners get notified?
Are there manuals for shipping?
Are there periodical checks conducted to verify if contents of the specificationand the product actually match?
Is there a person in charge of managing the specifications (of ingredients,
packaging materials and products)?
Approving suppliers Does a supplier exchange contracts and specifications in advance?
and monitoring
Is vendor confirmation procedure documented and implemented?
functionsIf purchasing black garlic from new suppliers, does it comply with existing
Purchase
contract specifications?
Are traceability system in place and documented?
Can a product be identified in all manufacturing processes?
Are there any records from purchasing (ingredients, packaging materials,
products) to production and delivery?
Is there a display or printing procedure that can identify a relevant product
Traceability
from all manufacturing and distribution processes?
At least once a year, does traceability system get checked to see if its working?
If necessary, do the traceability system as well as maintaining and managing
records get updated?
Handling

Manuals

Document
management
procedure

General documents
Is there a written manual regarding procedure to manage documents?
requirements
Record keeping
requirements

Manage quality information from
ingredients to products

Do managements have written documents about product safety andresponsibility for compliance and communicate to employees about those?
Do managements provide necessary resources to operate food safety
Is there an up-to-date organization chart that describes an outline of the
Are there effective training programs offered to educate new employees?
Are there written documents on continuous trainings that are provided for
employees?

Req Recuire omd men●

Shipping procedure●●

Supplier verification
procedure
Traceability●

Traceability record

Complaints
management rules

Examination results
Prior
Document
On-site checkconfirmation
checkFood safety management items
Summary

Handling
complaints

Food safety management items（Revised GFSI GMaP）
Are records of customers' and consumers' complaints, as well as following
investigations and corrective actions stored?

Req Recuire omd men

Manuals

Complaint record,
corrective action
recordIs it possible to withdraw and recall products when food safety problems arise?
Are records of food safety problems kept?

Capable of handling food safety
troubles when they arise

Management ofdefective products

Corrective actions

Product analysis
Have scientific data to secure
products' food sanitation

Have Good Manufacturing Practices,
GMPs: Man●Is there food safety troubleshooting procedure document in which reports toManagement ofinstitutions including municipal governments and removal and recall of products
food safety troubles Is there a person in charge of making reports to business partners, consumers
and government?
Is the procedure to manage food safety problems reviewed and verified at least
once a year?
Are the records of food safety problems reviewed later?

Management of
measurement andmonitoring
equipment

Personal hygiene

Facilityenvironment

Food safety trouble
shooting procedure

Corrective action
procedure●

Analysis result
recording●
Measurement andmonitoring
equipment

Are measurement and monitoring devices that have significant impacts on legal
and customer requirements reliable?
Are important measurement and monitoring devices for food safety calibrated?
If the measuring and monitoring equipment deviates from the establishedstandards, are there measures taken and recorded?
Are there rules of personal hygiene and are they applied to employees, agentsand visitors?
Do the personal hygiene rules comply with legal requirements, if they exist?
Is there procedure for notifying employees, vendors and visitors about what to
do if an infection occurs?
Is there a person responsible to decide if a person with a suspicion of being
infected can enter manufacturing area?
Do people who may be sick get managed?
Do employees, vendors and visitors strictly follow the personal hygiene rule?
Are employees, vendors and visitors aware that they have to change theirclothes in a particular work area?
Are facilities located, designed, constructed and maintained to ensure product
Are the facilities effectively maintained, cleaned and disinfected to prevent
biological, chemical and physical contamination?
Are lights with appropriate illumination and design, and do they let employees
work effectively?
Are areas that have contacts with food kept clean and disinfected if necessary
Are drainages designed to be food safe?
Are areas around a site and building clean without wastes?

Record of foodsafety problems

Control procedure ofdefective
ingredients, semifinished products,
products andIs there a procedure document to manage defective ingredients, semi-finishedproducts, products and packaging materials?
Are defective ingredients, semi-finished products, products and packing
materials managed by a person in charge?
Is there a manual of corrective actions to analyze complaints and also to
examine defective products?
Are the corrective actions (including shipment, reprocessing, segregation, anddisposal) performed properly?
Is there a product analysis procedure to check if legal and customer claims are
met within its expiration date?
Are product sampling inspections conducted at regular intervals to confirm that
pH is less than 4.6?
Are there test results using appropriate analytical procedure (such as ISO17025
provisions and methods certified by the industry)?

Records

●

●

●

●

Examination results
Prior
Document
On-site checkconfirmation
checkFood safety management items
Summary
Have Good Manufacturing Practices,
GMPs: Facility, equipment (Machine)

Food safety management items（Revised GFSI GMaP）
Are there changing rooms for employees?
Employee facility

Maintenancemanagement offacilities andequipment

Good
Manufacturi
ng Practices(GMPs)

Cleaning anddisinfection

Control of productcontamination
Insect control,mouse control andpest control
Have Good Manufacturing Practices,
GMPs: Method

Req Recuire omd men

Water quality
management
Waste
management

Are there appropriate restrooms in place and are they isolated from production
Are there appropriate hand-washing facilities in place?
Are eating facilities placed away from manufacturing, packaging, and storage
Are maintenance systems for facilities and equipment in place?
Are maintenance of facilities and equipment carried out effectively?
Is facility and equipment cleaning procedure documented?
Are facilities and equipment cleaning operated effectively?
Are materials used for maintenance and repair suitable for the purpose of use?
In order to keep facilities, equipment and machines clean, is there cleaning anddisinfection procedure put in order, and also, are there checks conducted after
cleaning and washing?

●●●

Are there enough storage places for products and ingredients?
Are storage facilities protected against contamination during storage ofingredients and products?
Shipment andstorage

Does product shipping process minimize degradation (such as by temperatureand humidity control)?
Is product handling procedure in place and implemented effectively?
Is product handling procedure in place and implemented effectively?
Is vehicle transporting procedure in place and conducted effectively?
Is maintenance and sanitation procedure documented for loading vehicles andtheir equipment?
Do business operators comply with legal and product requirements?
Procedure1：Is there a food safety team consisting of members with different
job responsibilities (food safety, manufacturing, engineering, procurement,
Procedure 1: Are all members of food safety team members properly qualified
and can they demonstrate evidence for receiving specialized training?

Cleaning anddisinfection
procedure forfacilities, equipment

Water, ice andsteam management
procedure
Cross-contamination
prevention
procedure for nondrinking water andAre cleaning / disinfecting equipment, tools and chemicals clearly labeled?
Are cleaning and disinfecting equipment, tools and chemicals stored
appropriately for the purpose of use in a place isolated from products,
equipment and packaging materials?
Are cleaning and sterilization conducted by trained staff?
Is there zoning or other effective procedure to reduce or avoid possibility ofcontamination of biological, chemical and physical hazards?
Are there effective insect, mouse and pest control methods?
Are Insect, mouse and pest control measures appropriate for products,
ingredients and facilities?
Are insect, mouse and pest controls conducted by an appropriate person andare there measures taken to deal with examination results?
Is there control procedure for water, ice and steam that do not compromise
product safety?
Is there procedure to prevent cross contamination of non-drinking water anddrinking water?
Are there rules for waste disposal and storage?
Are waste containers clearly distinguished by use?

Manuals

Loading vehicles andequipment,
maintenance andsanitation procedure●
Maintenancemanagement rules
for facilities andFacility andEquipment Cleaning

Records

Examination results
Prior
Document
On-site checkconfirmation
checkFood safety management items
Summary

Food safety management items（Revised GFSI GMaP）
Pre-procedure

Procedure 2: Are product specifications with materials, packaging materials,
storage conditions, etc. maintained?
Procedure 3: Are intended use of a product specified and intended consumers

Req Recuire omd men

Manuals

Product specification
Manufacturing
process flow chart

Procedure 4: Is there a manufacturing flow chart?
Procedure 5: Is created flow chart verified on site?
Procedure 6: Is hazard analysis performed at each process step?
Working on Codex HACCP

HACCP
Food hazard
control

Taking measures against intentional
product tampering and contamination

Managing allergen (if applicable)

Food defense

Allergenmanagement

Has the analysis been performed by a qualified person (team)?
Procedure 7: As a result of the analysis, if hazard can not be reduced oreliminated by the Good Manufacturing Practices (GMP), are there important
control points (CCPs) specified?
Procedure 8: Are allowable limits established for each CCP?
Procedure 9: Is monitoring procedure established for each CCP?
Are CCPs conducted effectively?
Procedure 10: In case of exceeding allowable limit, are corrective actions set
for each CCP associated?
Procedure 11: Are verification means established?
Are verification done effectively?
Procedure12: Are records and documents managed for the HACCP method?
Are all HACCP related records and documentation procedure implemented
Does an operator have a clear control over all steps considered to be
influential, including for those not CCP.
Are possibilities of intentional forgery and contamination of products analyzed?
Are weak defense points in manufacturing procedure identified, and additional
measures for access control are taken to deal with intentional forgery andcontamination of products?
Is there procedure in place to determine product disposition in an event ofintentional product tampering or contamination?
Are there documents referring to managing allergen materials to prevent crosscontamination in manufacturing processes?
Are both legal and customers' claims considered in process of allergen
Are there documents referring to managing allergen materials to prevent crosscontamination in the manufacturing processes?
Is there a manual to clean surfaces that touch products.
Are all allergens with possibilities to cause cross-contamination of allergens
removed from surfaces that come into contact with products?
Throughout manufacturing process from production to sales, is there a system
to separate each process?

Records

Hazard factor
analysis chart

●

●
●
●
●
●
●

HACCP plans●●

Allergy management
procedure

Product contactsurface cleaning
Procedure

Examination results
Prior
Document
On-site checkconfirmationcheck