GFSI Checklist (Self Audit)

Use this GFSI Checklist to perform a self-audit of your organization and

ensure that you adhere to the Global Food Safety Initiative Standards.

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 Title Page

Client / Site Text answer

Location Text answer

Conducted on Date/time

Enter Date and Time:

/ /

: AM / PM

Prepared by Text answer

2/62
FOOD SAFETY MANAGEMENT SYSTEM

General Requirements

Scope of the FSMS defined Select one

[ ] Yes
[ ] No
[ ] N/A

Scope of the FSMS specifying: Instruction

• Product categories Select one

[ ] Yes
[ ] No
[ ] N/A

• Processes Select one

[ ] Yes
[ ] No
[ ] N/A

• Production sites Select one

[ ] Yes
[ ] No
[ ] N/A

Any outsourced processes related to food safety are controlled, Select one
identified and documented within the FSMS?

[ ] Yes
[ ] No
[ ] N/A

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Documentation Requirements

Control of documents Select one

[ ] Yes
[ ] No
[ ] N/A

Approval of documents for adequacy prior to issue Select one

[ ] Yes
[ ] No
[ ] N/A

Review, update and re-approve Select one

[ ] Yes
[ ] No
[ ] N/A

Changes and current revision status identified Select one

[ ] Yes
[ ] No
[ ] N/A

Relevant versions of documents available at points of use Select one

[ ] Yes
[ ] No
[ ] N/A

Legible and readily identifiable Select one

[ ] Yes
[ ] No
[ ] N/A

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Identification and control of external documents Select one

[ ] Yes
[ ] No
[ ] N/A

Prevent unintended use of obsolete documents, and to suitably Select one

identify them if they are retained for any purpose

[ ] Yes
[ ] No
[ ] N/A

Procedure for efficient and accurate record keeping to provide Select one
evidence of conformity to requirements and of the effective
operation of the FSMS

[ ] Yes
[ ] No
[ ] N/A

Records legible, readily identifiable and retrievable Select one

[ ] Yes
[ ] No
[ ] N/A

Control of the correction, identification, storage, protection, Select one

retrieval, retention time and disposition of records

[ ] Yes
[ ] No
[ ] N/A

5/62
MANAGEMENT RESPONSIBILITY

Food Safety Policy

a) Appropriate to the role in the food chain Select one

[ ] Yes
[ ] No
[ ] N/A

b) Commits to comply with statutory, regulatory and customer FS Select one

requirements

[ ] Yes
[ ] No
[ ] N/A

c) Communicated and understood within the organization Select one

[ ] Yes
[ ] No
[ ] N/A

d) Reviewed for continual suitability Select one

[ ] Yes
[ ] No
[ ] N/A

e) Supported by measurable objectives Select one

[ ] Yes
[ ] No
[ ] N/A

FOOD SAFETY MANAGEMENT SYSTEM PLANNING

6/62
To meet the objectives Select one

[ ] Yes
[ ] No
[ ] N/A

To maintain the FSM integrity when changes are implemented Select one

[ ] Yes
[ ] No
[ ] N/A

RESPONSIBILITY AND AUTHORITY

R&A are defined and communicated within the organization Select one

[ ] Yes
[ ] No
[ ] N/A

Identified person(s) to receive reports problems with the FSMS Select one

[ ] Yes
[ ] No
[ ] N/A

Designated personnel to initiate and record actions Select one

[ ] Yes
[ ] No
[ ] N/A

COMMUNICATION

Implemented effective arrangements for communicating with: Instruction

7/62
Suppliers and contractors Select one

[ ] Yes
[ ] No
[ ] N/A

Customers/Consumers Select one

[ ] Yes
[ ] No
[ ] N/A

Food authorities Select one

[ ] Yes
[ ] No
[ ] N/A

Other organizations that could be affected Select one

[ ] Yes
[ ] No
[ ] N/A

Assigned designated personnel to manage external Select one

communication?

[ ] Yes
[ ] No
[ ] N/A

The Top management has communicated to the organization the Select one
importance of meeting this standard, legal and customer
FS requirements?

[ ] Yes
[ ] No
[ ] N/A

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Implemented effective arrangements for communicating with Select one
relevant personnel?

[ ] Yes
[ ] No
[ ] N/A

FST is informed of changes, especially: Instruction

Products or new products Select one

[ ] Yes
[ ] No
[ ] N/A

Raw materials, ingredients, and services Select one

[ ] Yes
[ ] No
[ ] N/A

Production systems and equipment Select one

[ ] Yes
[ ] No
[ ] N/A

Production premises, location of equipment, surrounding Select one

environment

[ ] Yes
[ ] No
[ ] N/A

Cleaning and sanitation programs Select one

[ ] Yes
[ ] No

9/62
[ ] N/A

Packaging, storage and distribution systems Select one

[ ] Yes
[ ] No
[ ] N/A

Personnel qualification level/allocation of responsibilities and Select one

authorizations

[ ] Yes
[ ] No
[ ] N/A

Regulatory requirements Select one

[ ] Yes
[ ] No
[ ] N/A

Knowledge regarding food safety hazards and control measures Select one

[ ] Yes
[ ] No
[ ] N/A

Customer, sector and other Select one

[ ] Yes
[ ] No
[ ] N/A

Relevant enquiries from external interested parties Select one

[ ] Yes
[ ] No
[ ] N/A

10/62
Complaints indicating hazards associated with the product Select one

[ ] Yes
[ ] No
[ ] N/A

Any condition which have an impact on food safety Select one

[ ] Yes
[ ] No
[ ] N/A

MANAGEMENT REVIEW

At planned intervals Select one

[ ] Yes
[ ] No
[ ] N/A

Records maintained Select one

[ ] Yes
[ ] No
[ ] N/A

Follow-up actions from previous reviews Select one

[ ] Yes
[ ] No
[ ] N/A

Verification activities Select one

[ ] Yes
[ ] No
[ ] N/A

11/62
Changes related FS Select one

[ ] Yes
[ ] No
[ ] N/A

Emergency situations, accidents and recalls Select one

[ ] Yes
[ ] No
[ ] N/A

System up-dating activities Select one

[ ] Yes
[ ] No
[ ] N/A

Communication activities including customer feedback Select one

[ ] Yes
[ ] No
[ ] N/A

External audits or inspections Select one

[ ] Yes
[ ] No
[ ] N/A

Assurance of Food Safety Select one

[ ] Yes
[ ] No
[ ] N/A

12/62
Improved effectiveness of the FSMS Select one

[ ] Yes
[ ] No
[ ] N/A

Resource needs Select one

[ ] Yes
[ ] No
[ ] N/A

Revisions of the FSP and objectives Select one

[ ] Yes
[ ] No
[ ] N/A

13/62
RESOURCE MANAGEMENT

Human Resources Instruction

Identify necessary competencies Select one

[ ] Yes
[ ] No
[ ] N/A

Training Select one

[ ] Yes
[ ] No
[ ] N/A

Specific training for personnel responsible of monitoring, Select one

corrections, and corrective actions

[ ] Yes
[ ] No
[ ] N/A

Evaluation of implementation and effectiveness Select one

[ ] Yes
[ ] No
[ ] N/A

Awareness of contribution to FS Select one

[ ] Yes
[ ] No
[ ] N/A

Awareness of need for effective communication Select one

[ ] Yes

14/62
[ ] No
[ ] N/A

Records of training and other actions Select one

[ ] Yes
[ ] No
[ ] N/A

Agreement or contracts with external experts involved in FSM Select one

[ ] Yes
[ ] No
[ ] N/A

15/62
PLANNING AND REALIZATION OF SAFE
PRODUCTS

PRPs shall be: Instruction

Appropriate to the organizational needs Select one

[ ] Yes
[ ] No
[ ] N/A

Appropriate to the size and type of operation and product Select one

[ ] Yes
[ ] No
[ ] N/A

Implemented across general programmes Select one

[ ] Yes
[ ] No
[ ] N/A

Implemented across specific programmes Select one

[ ] Yes
[ ] No
[ ] N/A

Approved by FST: according to: Instruction

Legal requirements Select one

[ ] Yes
[ ] No
[ ] N/A

16/62
Customer requirements Select one

[ ] Yes
[ ] No
[ ] N/A

Recognized guidelines Select one

[ ] Yes
[ ] No
[ ] N/A

CODEX Alimentarius Select one

[ ] Yes
[ ] No
[ ] N/A

Codes of Practices Select one

[ ] Yes
[ ] No
[ ] N/A

17/62
ESTABLISHING THE OPERATIONAL PRPS

Documentation is available for the following programmes: Instruction

Hazard control Select one

[ ] Yes
[ ] No
[ ] N/A

Control measure(s) Select one

[ ] Yes
[ ] No
[ ] N/A

Monitoring procedures Select one

[ ] Yes
[ ] No
[ ] N/A

Corrections/corrective actions Select one

[ ] Yes
[ ] No
[ ] N/A

Responsibility and Authority Select one

[ ] Yes
[ ] No
[ ] N/A

Records of monitoring Select one

[ ] Yes
[ ] No
18/62
[ ] N/A

Elements of PRPs

Lay-out, design, and construction of buildings and facilities: Instruction

Location Select one

[ ] Yes
[ ] No
[ ] N/A

Perimeter and grounds Select one

[ ] Yes
[ ] No
[ ] N/A

Walls Select one

[ ] Yes
[ ] No
[ ] N/A

Floors Select one

[ ] Yes
[ ] No
[ ] N/A

Ceilings Select one

[ ] Yes
[ ] No
[ ] N/A

Windows Select one

19/62
[ ] Yes
[ ] No
[ ] N/A

Doors Select one

[ ] Yes
[ ] No
[ ] N/A

Lighting Select one

[ ] Yes
[ ] No
[ ] N/A

Ventilation Select one

[ ] Yes
[ ] No
[ ] N/A

Lay-out of premises, including workspace and employee facilities: Instruction

Process flow Select one

[ ] Yes
[ ] No
[ ] N/A

Working space and storage Select one

[ ] Yes
[ ] No
[ ] N/A

Segregation Low/High risk areas/process Select one

20/62
[ ] Yes
[ ] No
[ ] N/A

Segregation design Select one

[ ] Yes
[ ] No
[ ] N/A

Washing and cleaning locations Select one

[ ] Yes
[ ] No
[ ] N/A

Changing facilities Select one

[ ] Yes
[ ] No
[ ] N/A

Hand washing facilities Select one

[ ] Yes
[ ] No
[ ] N/A

Toilets Select one

[ ] Yes
[ ] No
[ ] N/A

Catering facilities Select one

[ ] Yes
[ ] No

21/62
[ ] N/A

Supplies of air, water, energy, and other utilities are available Select one

[ ] Yes
[ ] No
[ ] N/A

Supporting services including waste and sewage disposal are Select one
available

[ ] Yes
[ ] No
[ ] N/A

Equipment including its preventive maintenance, sanitary design, Select one

and accessibility for maintenance and cleaning for each unit are
available

[ ] Yes
[ ] No
[ ] N/A

Management of purchased materials, disposals and handling of products: Instruction

Raw materials Select one

[ ] Yes
[ ] No
[ ] N/A

Ingredients Select one

[ ] Yes
[ ] No
[ ] N/A

Packaging Select one

22/62
[ ] Yes
[ ] No
[ ] N/A

Chemicals Select one

[ ] Yes
[ ] No
[ ] N/A

Waste Select one

[ ] Yes
[ ] No
[ ] N/A

Sewage Select one

[ ] Yes
[ ] No
[ ] N/A

Storage of raw materials/packaging/in process/end products Select one

[ ] Yes
[ ] No
[ ] N/A

Transportation Select one

[ ] Yes
[ ] No
[ ] N/A

Cleaning and sanitizing: Instruction

Cleaning practices Select one

23/62
[ ] Yes
[ ] No
[ ] N/A

Cleaning schedules Select one

[ ] Yes
[ ] No
[ ] N/A

Control and verification of effectiveness Select one

[ ] Yes
[ ] No
[ ] N/A

Documented procedures/records Select one

[ ] Yes
[ ] No
[ ] N/A

Pest Control documentation for: Instruction

Competent pest control Select one

[ ] Yes
[ ] No
[ ] N/A

Documented procedures/records Select one

[ ] Yes
[ ] No
[ ] N/A

Physical measures: drains, hermetically sealed doors, screens, Select one

24/62
security perimeter for inspection in storage, etc.

[ ] Yes
[ ] No
[ ] N/A

Location of all measures Select one

[ ] Yes
[ ] No
[ ] N/A

Plan/diagram for electric fly killers/baits/traps Select one

[ ] Yes
[ ] No
[ ] N/A

Risk of product contamination with chemicals Select one

[ ] Yes
[ ] No
[ ] N/A

Personnel Hygiene documentation for: Instruction

GMPs Select one

[ ] Yes
[ ] No
[ ] N/A

Protective clothing Select one

[ ] Yes
[ ] No
[ ] N/A

25/62
Jewelry Select one

[ ] Yes
[ ] No
[ ] N/A

Cuts and grazes Select one

[ ] Yes
[ ] No
[ ] N/A

Hand Cleaning Select one

[ ] Yes
[ ] No
[ ] N/A

Notification of relevant infectious disease or conditions Select one

[ ] Yes
[ ] No
[ ] N/A

Medical screening Select one

[ ] Yes
[ ] No
[ ] N/A

Training Select one

[ ] Yes
[ ] No
[ ] N/A

26/62
PRELIMINERY STEPS TO ENABLE HAZARD ANALYSIS

Relevant information needed to conduct the hazard analysis Select one

documented, collected, maintained and updated

[ ] Yes
[ ] No
[ ] N/A

FST Leader appointed by Top Management with responsibility: Instruction

To manage the FST Select one

[ ] Yes
[ ] No
[ ] N/A

Training and education of FST members Select one

[ ] Yes
[ ] No
[ ] N/A

To ensure that FSMS is established, implemented, maintained and Select one

updated

[ ] Yes
[ ] No
[ ] N/A

To report to Top Management about FSMS Select one

[ ] Yes
[ ] No
[ ] N/A

Multi-disciplinary knowledge and experience Select one

27/62
[ ] Yes
[ ] No
[ ] N/A

Records demonstrate the required expertise for all team members Select one

[ ] Yes
[ ] No
[ ] N/A

Documentation available for: Instruction

Product characteristics Select one

[ ] Yes
[ ] No
[ ] N/A

Raw materials, ingredients and product-contact materials Select one

[ ] Yes
[ ] No
[ ] N/A

Specifications with: Instruction

Biological, chemical and physical characteristics Select one

[ ] Yes
[ ] No
[ ] N/A

Ingredients including additives and processing aids Select one

[ ] Yes
[ ] No
[ ] N/A

28/62
Origin Select one

[ ] Yes
[ ] No
[ ] N/A

Method of production Select one

[ ] Yes
[ ] No
[ ] N/A

Delivery methods and packaging Select one

[ ] Yes
[ ] No
[ ] N/A

Storage conditions and shelf-life Select one

[ ] Yes
[ ] No
[ ] N/A

Preparation and/or handling before use or processing Select one

[ ] Yes
[ ] No
[ ] N/A

Food safety related acceptance criteria or specifications of Select one

purchased materials and ingredients appropriate to their intended
uses. Relevant legislation/regulations documented

[ ] Yes
[ ] No
[ ] N/A

29/62
Specifications updated Select one

[ ] Yes
[ ] No
[ ] N/A

Documentation for the characteristics of end products: Instruction

Name Select one

[ ] Yes
[ ] No
[ ] N/A

Composition Select one

[ ] Yes
[ ] No
[ ] N/A

Biological, chemical and physical characteristics Select one

[ ] Yes
[ ] No
[ ] N/A

Intended shelf-life and storage conditions. Select one

[ ] Yes
[ ] No
[ ] N/A

Intended use Select one

[ ] Yes
[ ] No
[ ] N/A

30/62
Packaging Select one

[ ] Yes
[ ] No
[ ] N/A

Labeling relating to food safety and/or instructions for handling, Select one
preparation and usage

[ ] Yes
[ ] No
[ ] N/A

Method(s) of distribution Select one

[ ] Yes
[ ] No
[ ] N/A

Relevant legislation/regulations documented Select one

[ ] Yes
[ ] No
[ ] N/A

Specifications updated Select one

[ ] Yes
[ ] No
[ ] N/A

Identified and documented appropriate information about: Instruction

The reasonably expected handling of the product Select one

[ ] Yes
[ ] No
[ ] N/A

31/62
Any unintended but reasonably expected mishandling and misuse Select one
of the product

[ ] Yes
[ ] No
[ ] N/A

Group of consumers identified, especially vulnerable groups of Select one

population

[ ] Yes
[ ] No
[ ] N/A

Descriptions updated Select one

[ ] Yes
[ ] No
[ ] N/A

Flow diagrams, process steps and control measures Select one

[ ] Yes
[ ] No
[ ] N/A

Flow diagrams available for: Instruction

Each product/process category covered by the FSMS Select one

[ ] Yes
[ ] No
[ ] N/A

Sequence/interaction of steps Select one

[ ] Yes

32/62
[ ] No
[ ] N/A

Outsourced processes and subcontracted work Select one

[ ] Yes
[ ] No
[ ] N/A

Inputs (raw materials, ingredients, intermediate products) Select one

[ ] Yes
[ ] No
[ ] N/A

Reworking and recycling Select one

[ ] Yes
[ ] No
[ ] N/A

Outputs (end, intermediate, by-product, waste) Select one

[ ] Yes
[ ] No
[ ] N/A

and verified by FST (records) Select one

[ ] Yes
[ ] No
[ ] N/A

Description of process steps and control measures available Select one

[ ] Yes
[ ] No
[ ] N/A

33/62
Control measures/process parameters/procedures related to food Select one
safety described

[ ] Yes
[ ] No
[ ] N/A

Legal and customer requirements described Select one

[ ] Yes
[ ] No
[ ] N/A

Descriptions updated Select one

[ ] Yes
[ ] No
[ ] N/A

34/62
HAZARD ANALYSIS

Hazard Identification and Determination of acceptable levels Select one

[ ] Yes
[ ] No
[ ] N/A

Identified and recorded Select one

[ ] Yes
[ ] No
[ ] N/A

Specific for the type of product/process and facilities based on: Instruction

Preliminary information about product/process and control Select one

measures

[ ] Yes
[ ] No
[ ] N/A

Experience Select one

[ ] Yes
[ ] No
[ ] N/A

External information including epidemiological and other data Select one

historical

[ ] Yes
[ ] No
[ ] N/A

Information from the food chain Select one

35/62
[ ] Yes
[ ] No
[ ] N/A

Step (s) related which each hazard in the end product defined in Select one
compliance with legal/customer requirements, and the intended
use (Records)

[ ] Yes
[ ] No
[ ] N/A

Identified and document control measures that are to be applied Select one

[ ] Yes
[ ] No
[ ] N/A

Categorized in General Control Measures (managed through PRPs) or Instruction

Specific Control Measures (related to CCP's), pertaining to:

Effect on identified food safety hazards relative to the intensity Select one
applied

[ ] Yes
[ ] No
[ ] N/A

Feasibility for monitoring Select one

[ ] Yes
[ ] No
[ ] N/A

Place within the system relative to other control measures Select one

[ ] Yes
[ ] No
[ ] N/A

36/62
Likelihood of failure in the functioning Select one

[ ] Yes
[ ] No
[ ] N/A

Severity of the consequence Select one

[ ] Yes
[ ] No
[ ] N/A

Specifically to eliminate/reduce the level of hazard(s) Select one

[ ] Yes
[ ] No
[ ] N/A

Synergistic effects Select one

[ ] Yes
[ ] No
[ ] N/A

Methodology of categorization documented and results recorded Select one

[ ] Yes
[ ] No
[ ] N/A

37/62
ESTABLISHING HACCP PLAN

Identification of CCPs

Hazard to be controlled by specific control measure documented Select one

[ ] Yes
[ ] No
[ ] N/A

Determination of Critical Limits

For the monitoring of each CCP Select one

[ ] Yes
[ ] No
[ ] N/A

Requirement of legislation-regulations-internal risk analysis-clients Select one

are met

[ ] Yes
[ ] No
[ ] N/A

In terms of measurable parameters supported by instructions, Select one

specifications, education/training

[ ] Yes
[ ] No
[ ] N/A

Selection documented Select one

[ ] Yes
[ ] No
[ ] N/A

38/62
MONITORING OF THE CCPs

A monitoring system for effective and efficient control of CCPs Select one
(measurements relative to the critical limits) established and
maintained

[ ] Gloves
[ ] Eye protection
[ ] Laboratory coat
[ ] Other PPE

Procedures + instructions + records including: Instruction

Measurements that provide results within an adequate time frame Select one

[ ] Yes
[ ] No
[ ] N/A

Monitoring devices identified Select one

[ ] Yes
[ ] No
[ ] N/A

Calibration methods Select one

[ ] Yes
[ ] No
[ ] N/A

Frequency Select one

[ ] Yes
[ ] No
[ ] N/A

Records and methods Select one

39/62
[ ] Yes
[ ] No
[ ] N/A

Actions when monitoring results exceed critical limits Select one

[ ] Yes
[ ] No
[ ] N/A

40/62
CONTROL OF NONCONFORMITY

A procedure to dentify and assess of affected end products Select one

[ ] Yes
[ ] No
[ ] N/A

Review the corrections carried out Select one

[ ] Yes
[ ] No
[ ] N/A

Approved by the responsible person Select one

[ ] Yes
[ ] No
[ ] N/A

Records with information on the nature of the nonconformity, cause Select one
and consequence and traceability available

[ ] Yes
[ ] No
[ ] N/A

Corrective Actions (CAs)

Data derived from the monitoring of PRPs + CCPs evaluated by Select one
designated person to initiate corrective actions

[ ] Yes
[ ] No
[ ] N/A

Initiated when critical limits are exceeded or lack if conformity with Select one
PRPs.

41/62
[ ] Yes
[ ] No
[ ] N/A

A procedure to: Instruction

Review NCs (complaints included) Select one

[ ] Yes
[ ] No
[ ] N/A

Review trends Select one

[ ] Yes
[ ] No
[ ] N/A

Determine cause of NCs Select one

[ ] Yes
[ ] No
[ ] N/A

Evaluate the need for CAs Select one

[ ] Yes
[ ] No
[ ] N/A

Determine and implementing CAs Select one

[ ] Yes
[ ] No
[ ] N/A

Records of CAs Select one

42/62
[ ] Yes
[ ] No
[ ] N/A

Reviewing CAs Select one

[ ] Yes
[ ] No
[ ] N/A

Handle potentially unsafe products Select one

[ ] Yes
[ ] No
[ ] N/A

NCs product don’t enter the food chain unless it is possible to assure Select one
that the hazards have been reduced to acceptable levels, and the
product is safe

[ ] Yes
[ ] No
[ ] N/A

All lots of products affected by NC identified and controlled until Select one
they have been evaluated

[ ] Yes
[ ] No
[ ] N/A

A procedure with responses + authorization + actions and controls Select one

[ ] Yes
[ ] No
[ ] N/A

Product is released as safe when: Instruction

43/62
Evidence indicates that the control measures have been effective Select one

[ ] Yes
[ ] No
[ ] N/A

Combined elements of the control measures have proven Select one

themselves to be effective

[ ] Yes
[ ] No
[ ] N/A

Analysis (or other verification activities) indicate that the product is Select one
safe

[ ] Yes
[ ] No
[ ] N/A

Disposition of non-conforming products: Instruction

Products not acceptable for release are reprocessed (when possible) Select one
to ensure that the hazards are controlled

[ ] Yes
[ ] No
[ ] N/A

Products not acceptable for release are destroyed if reprocessing is Select one
not an option

[ ] Yes
[ ] No
[ ] N/A

44/62
TRACEABILITY SYSTEM

Identification of product lots and their relation to batches of: Instruction

Raw materials (from the immediate suppliers) Select one

[ ] Yes
[ ] No
[ ] N/A

Processing Select one

[ ] Yes
[ ] No
[ ] N/A

Distribution records (to the immediate distributors) Select one

[ ] Yes
[ ] No
[ ] N/A

Records maintained for a defined period Select one

[ ] Yes
[ ] No
[ ] N/A

Meet customers and regulatory requirements based on the shelf life Select one

[ ] Yes
[ ] No
[ ] N/A

Withdrawals

To facilitate a recall: Instruction

45/62
There is authority and responsibility appointed bytop management Select one

[ ] Yes
[ ] No
[ ] N/A

Procedure for: Instruction

Notification Select one

[ ] Yes
[ ] No
[ ] N/A

Handling of recalled products as well as involved products still in Select one

stock

[ ] Yes
[ ] No
[ ] N/A

Defining the sequence of actions Select one

[ ] Yes
[ ] No
[ ] N/A

Recalled products held under supervision until their treatment Select one

[ ] Yes
[ ] No
[ ] N/A

Effectiveness of the programme recall verified with records Select one

[ ] Yes
[ ] No
[ ] N/A

46/62
Emergency preparedness and response Select one

[ ] Yes
[ ] No
[ ] N/A

Procedures to manage potential emergency situations established Select one

by Top Management

[ ] Yes
[ ] No
[ ] N/A

47/62
VERIFICATION PLANNING

Establish, document and implement procedures for verification of Select one

the HACCP system:
purpose-methods-frequencies-responsibilities-records

[ ] Yes
[ ] No
[ ] N/A

Confirmed that: Instruction

The PRPs are implemented Select one

[ ] Yes
[ ] No
[ ] N/A

The hazard analysis is continually updated Select one

[ ] Yes
[ ] No
[ ] N/A

The operational PRPs and the elements within the HACCP plan are Select one
implemented and effective

[ ] Yes
[ ] No
[ ] N/A

Hazard levels are within identified acceptable levels Select one

[ ] Yes
[ ] No
[ ] N/A

Records communicated to the FST Select one

48/62
[ ] Yes
[ ] No
[ ] N/A

NCs results in test samples of end products – affected lots handled Select one
as potentially unsafe

[ ] Yes
[ ] No
[ ] N/A

49/62
EVALUATION OF INDIVIDUAL VERIFICATION RESULTS

Are evaluated systematically by the FST Select one

[ ] Gloves
[ ] Eye protection
[ ] Laboratory coat
[ ] Other PPE

NCs with the planned arrangements – actions to achieve Select one

conformity. Review available.

[ ] Gloves
[ ] Eye protection
[ ] Laboratory coat
[ ] Other PPE

Procedures and communication channels available Select one

[ ] Gloves
[ ] Eye protection
[ ] Laboratory coat
[ ] Other PPE

Conclusions of the hazard analysis/operational PRPs/HACCP Plan Select one

[ ] Gloves
[ ] Eye protection
[ ] Laboratory coat
[ ] Other PPE

PRPs Select one

[ ] Gloves
[ ] Eye protection
[ ] Laboratory coat
[ ] Other PPE

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Human resources/Training Select one

[ ] Gloves
[ ] Eye protection
[ ] Laboratory coat
[ ] Other PPE

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ANALYSIS OF RESULTS OF VERIFICATION ACTIVITIES

Are analyzed by the FST, including the results of internal and external Instruction
audits, in order to:

Confirm that FSMS meets the planned arrangements Select one

[ ] Yes
[ ] No
[ ] N/A

Identify the need for updating/improving the FSMS Select one

[ ] Yes
[ ] No
[ ] N/A

Identify trends Select one

[ ] Yes
[ ] No
[ ] N/A

Establish information for planning internal audits Select one

[ ] Yes
[ ] No
[ ] N/A

Confirm effectiveness of corrections and CAs Select one

[ ] Yes
[ ] No
[ ] N/A

Records reported Top Management. Input to the management Select one

review and for updating the FSMS

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[ ] Yes
[ ] No
[ ] N/A

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VALIDATION OF CONTROL MEASURE
COMBINATIONS

Prior to implementation and after any change of General/Specific Select one

Control Measures, ensure that:

[ ] Yes
[ ] No
[ ] N/A

Associate hazards are effectively controlled Select one

[ ] Yes
[ ] No
[ ] N/A

End Products meet the defined acceptable levels Select one

[ ] Yes
[ ] No
[ ] N/A

If a/b failed, modification and reassessment of the following are Instruction

documented:

Control measures Select one

[ ] Yes
[ ] No
[ ] N/A

Raw materials Select one

[ ] Yes
[ ] No
[ ] N/A

Technologies Select one

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[ ] Yes
[ ] No
[ ] N/A

Product characteristics Select one

[ ] Yes
[ ] No
[ ] N/A

Distribution Select one

[ ] Yes
[ ] No
[ ] N/A

Intent of use Select one

[ ] Yes
[ ] No
[ ] N/A

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CONTROL OF MONITORING AND MEASURING

To ensure valid results (if necessary), measuring equipment have to be Instruction

controlled:

Calibrated/verified against measurement standards; where no such Select one

standards exist, the basis used shall be recorded

[ ] Yes
[ ] No
[ ] N/A

Adjusted or re-adjusted as necessary Select one

[ ] Yes
[ ] No
[ ] N/A

The calibration status identified Select one

[ ] Yes
[ ] No
[ ] N/A

Safeguarded Select one

[ ] Yes
[ ] No
[ ] N/A

Protected from damage Select one

[ ] Yes
[ ] No
[ ] N/A

Records of calibrations, if no conformance – assess the validity of Select one

the previous results + treatment of the equipment/product.

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[ ] Yes
[ ] No
[ ] N/A

Records suitability of software confirmed: prior to initial use + Select one

reconfirm

[ ] Yes
[ ] No
[ ] N/A

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FSMS VERIFICATION

Documented procedure that defines responsibilities – reporting – Select one

records

[ ] Yes
[ ] No
[ ] N/A

To determine whether the FSMS system: Instruction

Conforms with the planned arrangements Select one

[ ] Yes
[ ] No
[ ] N/A

Effectively implemented and maintained Select one

[ ] Yes
[ ] No
[ ] N/A

Audit programme planned: Instruction

considers status; Select one

[ ] Yes
[ ] No
[ ] N/A

importance of processes; Select one

[ ] Yes
[ ] No
[ ] N/A

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arease to be audited; Select one

[ ] Yes
[ ] No
[ ] N/A

and results of previous findings Select one

[ ] Yes
[ ] No
[ ] N/A

criteria, scope, frequency, and methods are all defined Select one

[ ] Yes
[ ] No
[ ] N/A

Proof of auditor's objectivity and impartiality Select one

[ ] Yes
[ ] No
[ ] N/A

Corrective actions carried out on time by the personnel responsible Select one
for the area

[ ] Yes
[ ] No
[ ] N/A

Verification of actions recorded Select one

[ ] Yes
[ ] No
[ ] N/A

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IMPROVEMENT

FSMS continually improved through: Instruction

communication; Select one

[ ] Yes
[ ] No
[ ] N/A

management review; Select one

[ ] Yes
[ ] No
[ ] N/A

internal audit; Select one

[ ] Yes
[ ] No
[ ] N/A

evaluation of individual verification results; Select one

[ ] Yes
[ ] No
[ ] N/A

analysis of results of verification activities; Select one

[ ] Yes
[ ] No
[ ] N/A

validation of control measure combinations; Select one

[ ] Yes
[ ] No
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[ ] N/A

and FSMS updates Select one

[ ] Yes
[ ] No
[ ] N/A

FSMS is updated at planned intervals; Select one

[ ] Yes
[ ] No
[ ] N/A

and if necessary, the HA, PRPs, and the HACCP Plan are reviewed Select one

[ ] Yes
[ ] No
[ ] N/A

FSMS updates consider: Instruction

Communication; Select one

[ ] Yes
[ ] No
[ ] N/A

suitability-adequacy-effectiveness of FSMS; Select one

[ ] Yes
[ ] No
[ ] N/A

analysis of results of verification activities; Select one

[ ] Yes
[ ] No
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[ ] N/A

and management review Select one

[ ] Yes
[ ] No
[ ] N/A

Auditor's full name and signature

* Signature

Date: / /

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