GFSI Basic and Intermediate Level Checklist

How to use this document
1 Usage of this checklist

a) There are two types of user for this Checklist: the Buying Company or the Assessor.
b) This checklist can be used to undertake an assessment of a Supplier.
c) Once complete, the Supplier and the Buying Company will be able to see how the compliance of their food safety management system matches the items in the checklist, whether at Basic Level, or at Basic and
Intermediate Level.
d) Record credibility is important so the following is recommended:
i. The Assessor provides the Supplier with a PDF file as a record of the assessment outcome.
ii. The Assessor locks this file once complete before providing it to the Buying Company. Instructions on how this can be done are included in Section 5
2 Scope
a) This checklist is not a standard.
b) There is no audit process or auditors involved.
c) The listed items are to be assessed, not audited.
d) There is no governance and no central record keeping.
e) No certificate can be issued because there is no accreditation process for the Assessors.
3 Disclaimer
a) The Board of the Global Food Safety Initiative has no control over the nature of the assessments carried out using this checklist.
b) Any outcome of an assessment against the items in this checklist does not imply a recommendation or endorsement by the Global Food Safety Initiative.
c) This document is provided in English using United Kingdom spelling, in line with all documents from the GFSI. Any translations that may be used have not been provided, recognised or approved by GFSI.
d) This document may be used as a source document by Standard Owners to develop their own version of Global Markets. These may be certification schemes recognised by GFSI or others. Though described as
'Global Markets' these may be developed and commercialised differently so are not directly comparable with this checklist. There is no benchmarking of such schemes by GFSI. However, the GFSI expects that such
schemes developed from this original work will follow the aim and objectives of the GFSI Global Markets Programme:
Aim:
- Develop effective food safety management systems through a systematic continuous improvement process.
Objectives:
- Provide a route for small and less developed businesses to achieve accredited certification.
- Support capacity building efforts and improve market access opportunities for small suppliers operating locally.
4 Associated documents (these can be downloaded from the GFSI website www.mygfsi.com)
a) The Protocol for the Global Markets Programme is an essential accompaniment to this checklist. Before any assessment is started, the Users should familiarise themselves with the contents of the Protocol which
includes a flow chart for planning and assessment with detailed user guidance. This can be downloaded from the website of the GFSI.
b) The Training and Competency Framework provides guidance on good practice for delivering training for food companies that are implementing the GFSI Global Markets Programme. GFSI is not a training organisation
and does not develop or deliver any training courses. However, the Global Markets Programme Working Group has worked on the following two elements in this framework:
1. Guidance on the development and delivery of training.
2. The competencies required to achieve the GFSI Global Markets Programme Basic and Intermediate Levels.
ü Companies choosing a training provider are encouraged to specify that any training plans meet the criteria defined in this framework.
ü Training providers should use this guidance to develop their training programmes.
ü Individual learners should use this document to help them develop their own training plan.
5 Functionality
a) This Checklist and its worksheets have been designed without macros and uses only internal Excel formulas in its calculations.
b) It will work on PC and Mac on all Microsoft Excel systems from 2007 onwards.
c) Because no macros are included, there are certain processes that will remain manual, such as deleting entries. This means that there is no ‘reset’ option to return to a blank file.
d) The scoring system depends on all questions being answered.
e) The exemption system for Buying Companies allows certain clauses to be removed from the Checklist, though they will still be visible. In the event that an exemption is applied, the scoring system will be adjusted
accordingly.
f) Hyperlinks are provided to go to and from this "How to use this document worksheet" and the specified worksheet for which advice is being provided.
g) It is advised that once an assessment has been completed, the file is locked to ensure the credibility of the data. This can be done in the following way:
To lock the file from future changes:
Select each of the data sheets with a blue tab in turn and do the following for each of them:
Press the Review tab on the Excel Ribbon
If there a button on the tab called Unprotect Sheet then press it to unlock the sheet.
GFSI Global Markets Programme Manufacturing: Edition 2 April 2015

Press Control+A (Cmd+A on the Mac) twice which selects every cell on the sheet.
Press Control+1 (Cmd+1 on the Mac) which brings up the Format Cells dialog box.
Press the tab called Protection.
Mark the "Locked" option as a full tick and press OK to go back to the sheet.
Press the button on the Review tab called Protect Sheet.
Enter a password (or leave it blank) and press OK. Remember the password.
Once every sheet has been locked, Save and Exit the file.
6 Summary and report worksheet

Company Details
Name The name of the company that is to be assessed
The category of food production. These are taken from the GFSI Guidance Document Version 6. There is a provision for more than one category for companies, if needed.
Product
There are a number of categories from the GFSI Guidance Document Version 6 which are out of scope for this checklist, including: G Catering, H Retail and Wholesale, J Transport and Distribution, M Production of Food
categories
Packaging.
C Pre-process handling of animal products (Gutting, filleting, bulk freezing of fish; Storage of game)
D Pre-process handling of plant products, nuts and grain (De-shelling of nuts, Drying of grain, Grading of fruit and vegetables; Storage, Cleaning, washing, rinsing, fluming, sorting, grading, trimming, bundling, cooling, hydro-cooling, waxing,
drenching, packing, re-packing, staging, storing, loading and / or any other handling activity that does not significantly transform the product from its original harvested form)
EI Processing of perishable animal products (Production of animal products including fish and seafood; Meat, eggs, dairy and fish products; Slaughter, cutting, washing, trimming, grading, pasteurisation, cooking, curing, fermentation, smoking,
chilling, freezing, packed in modified atmosphere, packed in
EII Processing of perishable plant products (Production of plant products (including grains, nuts, and pulses); Washing, slicing, dicing, cutting, shredding, peeling, grading, pasteurisation, cooking, chilling, juicing, pressing, freezing, packed in
modified atmosphere, packed in vacuum packing or any other activity that significantly transforms the product from its original whole state)
EIII Processing of perishable animal and plant products (mixed products) (Production of animal and plant products; Mixing, cooking, chilling, freezing, packed in modified atmosphere, packed in vacuum packing)
EIV Processing of ambient stable products (Production of food products from any source that are stored and sold at ambient temperature; Aseptic filling, baking, bottling, brewing, canning, cooking, distilling, drying, extrusion, fermentation,
freeze drying, pressing, frying, hot filling, irradiating, milling, mixing and blending, packed in modified atmosphere, packed in vacuum packing, pasteurising, pickling, roasting, salting and refining)
Manufacturing
This is a free text cell in which the assessor can describe the manufacturing activities and products.
activities
Vendor /
Relevant to the Buying Company.
Supplier Code
Representative The name of the person at the company with accountability for food safety.
Telephone Include international code.
Email The email address of the person at the company with accountability for food safety.
Address Ensure full address including postcode.
Assessor Details
Name The name of the person who has actually carried out the assessment.
Company The name of the assessment company of
Telephone Include international code.
Email The email of the person at the company with accountability for the assessment process. This can be the assessor or their coordinator.
Address Ensure full address including postcode.
Assessment details & checklist settings

Date The date of the actual assessment.
Duration The number of hours that the assessor spent at the company.
Scope A description of the products and manufacturing activities that were included in the assessment.
Level a) When a selection of ‘Basic’ is made, all items for Intermediate level shall be coloured in grey on the Checklist Worksheet.
The following instruction will show: “You only need to answer the Basic questions on the checklist sheet. Click the small number 1 at the top left of the Checklist worksheet to only see those questions.”
By clicking on the small number 1, the items for Intermediate level that have been covered in grey shall all be hidden.
b) When a selection of ‘Intermediate’ is made, all items at Basic and Intermediate may be shown on the Checklist worksheet. The following instruction will show: “You should answer all questions on the Checklist
worksheet. Click the small number 2 at the top left of the Checklist worksheet to see all the questions.”
By clicking on the small number 2 at the top left of the Checklist worksheet, all items shall be visible for assessment.

a) Don’t show outcomes yet: By clicking on this box, there is no scoring functionality. However, it is possible to see the Conformity Overview worksheet. This selection is for a Buying Company that does not use the
Buying scoring system.
Company b) Show Pass/Fail: By clicking on this box, the Buying Company can see whether an assessment has passed or failed against the score that it has assigned. This selection is for a Buying Company that uses a pass/fail
Settings approach.
c) Show score: By clicking on this box, the Buying Company can show just the score. This selection is for a Buying Company that does not use a pass/fail approach, but does want to see a score.
a) This shows whether the assessment has been fully completed.
Incomplete / b) It shows the word ‘Incomplete’ against a red background until all questions have been answered in the Checklist worksheet. It adapts according to whether the assessment is against Basic or Basic and Intermediate
Complete Levels.
c) It will only change to show the word ‘Complete’ once all questions have been answered. Once it shows the word ‘Complete’ the assessment results and scoring system will be generated, depending on the Buying
Company settings.
Record of a) When all selected questions have been answered in the Checklist worksheet, the User will see a summary of the number of nonconformances identified during the assessment.
achievement b) The score out of 100 will also be displayed with a list that shows the assignment of points.
Assessment A graph shows the nonconformances with point deductions using a colour coding system against each of the three elements of the checklist: Food Safety Management Systems, Good Manufacturing Practices, and Control
Results of Food Hazards.
Scoring system a) The scoring system is supplied as an option. Buying Companies may choose to use it or not.
b) Criticals count as a 100 point deduction, Majors as 10 points and Minors as 2 points.
c) There is a calculation against the number of clauses assessed to provide a numerical point score, not a percentage.
d) In the event of a Critical or excessive Majors, the score can be zero. Negative scores are not shown.
e) Unless set by the Buying Company, there will be no 'pass/fail' except in the event of a Critical nonconformance.
f) The Excel assessment form has been automated using Excel formulae to deliver this system.
7 Checklist
a) Items are all uniquely referenced in Column A. To help the Assessor, there is a hyperlink against each Item to the relevant User Guidance. A reverse link is provided to return to the checklist item.
b) Requirements are referenced in Column B with a statement against the leading item and assessment questions against for each statement.
c) Comments and Observations are entered in Column C by the Assessor. If a nonconformance is identified, then a comment is required. As an option, if the Assessor wants to make an observation on good practice for
suggestions for improvement, they are able to. Note: as this is not an audit or a standard, the assessor is able to provide advice to the company.
d) In Column B there is the question ‘Meets requirement?’ The Assessor must select one of the options provided in the drop down box. If any of these questions are not answered, then the Summary and report
worksheet will show an incomplete assessment.
e) Column E automatically displays a message based on the response in columns D and C.
8 Conformity Overview
a) This worksheet option is provided for use for the Buying Company and the Company.
b) Once the assessment has been complete, users can view the outcome on this worksheet and identify against which items nonconformances have been identified.
9 Nonconformance
Background:
The Assessor will classify nonconformity as Critical, Major and Minor. This will directly impact the site’s result whether ‘pass/fail’ or ‘score’ option is chosen by the ‘Buying Company’ reviewing the assessment report.
Critical Nonconformance – Unacceptable. Affects food safety or regulatory compliance directly.

A finding is rated Critical when the factors related to that requirement are not met and as a result the product will be unsafe and/or does not meet regulation.
Note: A Critical Nonconformity will result in a failed assessment.
Major Nonconformance – May affect food safety.

A finding is rated Major when the factors related to that requirement are not met and as a result the product may be unsafe or present an increased food safety risk.
Minor Nonconformance – Is not likely to affect food safety.

A finding is rated Minor when the factors related to that requirement are not met and as a result the product is not likely to be unsafe or present an increased food safety risk.
Conform – Fully meeting a requirement.

Not Applicable (N/A) - When the Assessor decides a specific requirement is not applicable for a company, the assessor shall mark as “N/A” and provide a short explanation/justification in the comments section. For
example, a company does not handle allergens therefore the requirements for allergen control do not apply.
Note: the use of N/A as an answer should only be used in agreement with the Buying Company.
10 Exemptions
a) This worksheet option is provided for use by the Buying Company only.
b) If no exemption is selected then the Assessor must answer all questions.
c) Due to variations in legislation, for certain international markets there are two Checklist Items that may be exempted by the Buying Company. These are Items B.C. 2 (Control of allergens) and I.C. 4 (Food defence).
d) If an exemption is selected, the Item will be highlighted in grey in the Checklist. The assessor will be advised that the item has been exempted and should not make any decisions in Column D.
e) The scoring system shall be adjusted accordingly.
11 User Guidance
a) This worksheet option is provided for use by the Company and the Assessor.
b) Columns A and B are copied from the Checklist worksheet. Column C provides guidance for both the company and the assessor on how each item will be assessed. To help the Assessor, there is a hyperlink against
each item to the relevant Checklist item.
c) There is a standard format that answers three questions for every item.
d) What does it mean? An explanation of the item providing a rationale for its inclusion and a description of how the food safety management system is expected to operate.
e) What do I need to do? A list of what will be expected from the Company to provide evidence of conformance against that item.
f) What will the Assessor do? A series of suggestions for the Assessor on how they may assess compliance against that item. This is not intended to be a checklist for them but will support consistency in assessment
for both Company and Assessor.

Global Food Safety Initiative Food Manufacturing
Global Markets Programme Basic and Intermediate Levels Checklist
Company Details How to use this sheet Assessor Details
Name Name
Product Categories Company
Telephone
Manufacturing Activities E-mail
Vendor/Supplier Code Address
Representative
Telephone
E-mail
Address
Assessment Details & Checklist settings
Date Duration (hours)
Scope
Level Click here to answer the Checklist

Intermedia questions
Basic
te
You should answer all questions on the Checklist worksheet. Click the small number 2 at the top left of the Checklist worksheet to see all the questions.
Buying Company Settings

Don't show Show Show
outcomes yet Pass/Fail Score
Pass Mark out of 100: Incomplete
Record of achievement
Final assessment: Incomplete data, please answer all questions on the checklist
Assessment Results
Number of Critical NC - Critical (Fail) = 100 Points
Number of Major NC - Major = 10 Points
Number of Minor NC - Minor = 2 Point(s)
Score out of 100 -
Non-conformance overview
12
10
8
6
4
2 Critical NC
Points deducted
0 Major NC
s s s Minor NC
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Disclaimer:
a. The Board of the Global Food Safety Initiative has no control over the nature of the assessments carried out using this checklist.
b. Any outcome of an assessment against the items in this checklist does not imply a recommendation or endorsement by the
GFSI Global Markets Programme Manufacturing: Edition 2 April 2015 © Global Food Safety Initiative
GFSI Global Markets Programme Food Manufacturing Basic and Intermediate Levels Checklist
Items Requirements Comments and Observations Meets Requirement?
A. Food Safety Management Systems
B.A 1 Specifications including product release
The business shall ensure that product specifications are adequate, accurate and ensure compliance
with relevant safety, legislative and customer requirements.
The business shall prepare and implement appropriate product release procedures.
B.A 1.1 Are specifications available for all product inputs (raw materials, ingredients, additives, packaging
materials, rework) and finished products?
B.A 1.2 Are the available specifications compliant with relevant safety, legislative and customer requirements?
B.A 1.3 Are specifications up to date, unambiguous and available to relevant staff?
B.A 1.4 Are changes to specifications clearly communicated both internally and externally?
B.A 1.5 Is there a documented product release procedure in place?

Does it effectively ensure that the final product meets the specification?
B.A 1.6 Is there a designated person with responsibility for controlling specifications?
B.A 2 Traceability
The business shall establish a traceability system which enables the identification of product lots and
their relation to batches of raw materials, primary and final packaging materials, processing and
distribution records. Records shall include:
• Identification of any out sourced product, ingredient or service.
• Records of batches of in process or final product and packaging throughout the production process.
• Records of purchaser and delivery destination for all products supplied.
B.A 2.1 Is a documented traceability system in place for every product that meets regulatory and customer
requirements?
B.A 2.2 Is the traceability system, including work in progress, post-treatment and rework, fully operational and
effective?
V2 – Sept 2014” Make this ‘GFSI Global Markets Programme Manufacturing: page 6 of 43 © Global Food Safety Initiative
Edition 2 April 2015
B.A 2.3 Are records enabling product identification available through all production stages: stock / inventory,
work in progress, post processing, rework.
Are records available from purchase through production and to immediate destination for all raw
materials and packaging materials (primary and final product)?
B.A 2.4 Are there clear labelling procedures that ensure continuous identification of the product through all
stages of production and delivery?
I.A 2 Traceability
The business shall establish a traceability system which enables the identification of product lots and
their relation to batches of raw materials, primary and consumer unit packaging materials, processing
and distribution records.
The business shall ensure the traceability system is tested at least annually and updated as necessary.
Records shall include:
• Records of annual testing of the traceability system.
• Records of updating the system as applicable.
I.A 2.5 Is the traceability system tested at least annually?

Is the system updated as necessary and records maintained?
B.A 3 Food Safety Incident Management

The business shall demonstrate the ability to withdraw and recall affected product, contact relevant
customers and maintain records of these incidents.
B.A 3.1 Can the business withdraw and recall affected product?
B.A 3.2 Are records of incidents maintained?
I.A 3 Food Safety Incident Management

The business shall have an effective incident management procedure for all products including
reporting, communicating with customers, product withdrawal and recall.
Records of annual review, testing and verification of the system shall be available.
I.A 3.3 Is a documented incident management system in place that addresses incident reporting, product
withdrawal and product recall?
I.A 3.4 Is an effective communication plan in place with a designated, responsible person identified to provide
information to customers, consumers and regulatory authorities?
I.A 3.5 Is the incident management system reviewed, tested and verified at least once a year?
I.A 3.6 Are all incidents recorded and assessed to establish their severity and consumer risk?
B.A 4 Control of non-conforming product

The business shall ensure that any product which does not conform to requirements is clearly
identified and controlled to prevent unintended use or delivery.
B.A 4.1 Is a documented procedure in place to identify and manage all non-conforming raw materials, product
inputs, semi-finished and finished products, processing equipment and packaging materials?
B.A 4.2 Is the control of non-conforming product managed by competent people?
B.A 5 Corrective Action

The business shall ensure that corrective action be undertaken as soon as possible to prevent
recurrence of non-conformity.
B.A 5.1 Is a documented corrective action procedure in place to analyse any complaints and investigate non-
conformities to prevent reccurrence?
B.A 5.2 Are corrective actions (i.e. release, rework, quarantine, rejection/disposal) identified and effectively
implemented?
B.A 6 Management Responsibility

The business shall ensure there is management commitment to provide the resources to develop,
implement and comply with their food safety programme.
B.A 6.1 Is there evidence that management is committed to provide the resources to implement and comply
with their food safety programme?
I.A 6 Management Responsibility

The business shall ensure there is management commitment to provide the resources to develop,
implement and comply with their food safety programme.
The business shall establish a clear organizational structure with job descriptions, responsibilities and
reporting relationships of at least those staff whose activities affect product safety.
I.A 6.2 Is an up-to-date organizational chart outlining the business' structure available?
I.A 6.3 Are documented, clearly defined responsibilities regarding product safety and legality available and
communicated to staff?
B.A 7 Record Keeping Requirements

The business shall ensure that records are available to prove the business is complying with the food
safety system which includes all relevant regulatory and customer food safety requirements.
B.A 7.1 Are records available to support the compliance of the business with the food safety system which
includes all regulatory and customer food safety requirements that apply?
B.A 7.2 Has the business set timescales for record retention which comply with regulatory or customer
requirements?
I.A 7 General Documentation Requirements

The business shall establish and implement procedures to ensure that all documents are maintained
and kept up to date.
I.A 7.1 Is a written documentation procedure in place and effectively implemented?
B.A 8 Control of Measuring & Monitoring Devices

Measuring and monitoring devices critical to food safety and regulatory requirements shall be reliable.
B.A 8.1 Are measuring and monitoring devices critical to food safety and regulatory requrements reliable?
I.A 8 Control of Measuring & Monitoring Devices

The business shall identify measuring and monitoring devices critical to food safety, ensure that they
are calibrated and traceable to a recognised national or international standard.
I.A 8.2 Are measuring and monitoring devices critical to food safety identified, calibrated and traceable to
recognised standards and are they effectively controlled?
I.A 8.3 Are actions taken and recorded when measuring and monitoring devices are found to be outside of
specified limits?
B.A 9 Training
The business shall ensure that all people are adequately trained in food safety and practices according
to their job responsibilities.
B.A 9. 1 Have all new people been effectively trained?
B.A 9.2 Have all relevant people received refresher training?
I.A 9 Training
The business shall implement a system to ensure that all people are adequately trained, instructed and
supervised in food safety principles and practices that matches their work.
I.A 9.3 Is a people training programme in place and effectively implemented?
I.A 9.4 Is a HACCP training programme in place?
I.A 9.5 Are adequate training records available?
I.A 9.6 Is a refresher training programme documented and implemented?
I.A 10 Procedures
The business shall prepare and implement detailed procedures and instructions for all processes and
operations having an effect on product safety.
I.A 10.1 Are detailed procedures developed and effectively implemented for all processes and operations that
affect food safety?
I.A 10.2 Are procedures clearly communicated to relevant people?
I.A 11 Complaint Handling

The business shall prepare and implement an effective programme for the management of customer
and consumer complaints.
Data shall be controlled and managed to ensure that there are corrective actions for compliance and
food safety issues.
I.A 11.1 Is a documented complaint management programme in place and effectively implemented?
I.A 11.2 Are records of all customer and consumer complaints, investigations and corrective actions
maintained?
I.A 12 Product Analysis

The business shall implement a programme to ensure that analysis of products and ingredients is
systematically undertaken for issues that are identified as being critical to food safety and legal
requirements as well as customer specifications.
The business shall ensure that the methods used provide valid results (e.g. by procedures set forth in
ISO 17025 and/or industry recognised methods).
I.A 12.1 Are analysis procedures in place to ensure that all specified product requirements are met, including
legal requirements and customer specifications throughout the whole shelf life?
I.A 12.2 Are methods, relevant for food safety, used to provide valid results (e.g. by procedures set forth in ISO
17025 and/or industry recognised methods)?
I.A 13 Purchasing
The business shall control purchasing processes to ensure that all externally sourced items and services
conform to written requirements.
I.A 13.1 Do purchased products and services meet current specifications and contractual agreements?
I.A 14 Supplier Approval and Performance Monitoring

The business shall operate procedures for approval and monitoring of all its suppliers whose products
or services may affect product safety and quality.
The results of evaluations and follow-up actions shall be recorded.
I.A 14.1 Is a documented supplier approval programme in place and effectively implemented?
I.A 14.2 Is a documented supplier monitoring programme in place and effectively implemented?
B. Good Manufacturing Practices (GMPs)
B.B 1 Personal Hygiene
The business shall ensure the implementation of appropriate hygiene practices for all its people and
visitors.
Such practices shall result in sanitary handling and delivery of safe and quality products to customers.
The Codex Alimentarius Commission’s recommendation on personal hygiene shall be followed.
B.B 1.1 Are personal hygiene requirements in place and applicable to all relevant people, contractors and
visitors?
B.B 1.2 Are personal hygiene requirements compliant with legal requirements, if applicable?
B.B 1.3 Are communication procedures in place for people, contractors and visitors addressing actions to be
taken in the case of an infectious disease?
B.B 1.4 Is a qualified person responsible to decide if individuals with a suspect illness may enter food areas and
how these individuals are controlled?
B.B 1.5 Are people, contractors and visitors aware of and complying with the personal hygiene requirements?
B.B 1.6 Are people, contractors and visitors aware of and complying with the requirements for the wearing
and changing of protective clothing in specified work areas?
B.B 2 Facility Environment

The business facilities shall be located and maintained so as to reduce the risk of contamination and
enable the production of safe and legal products.
B.B 2.1 Is the facility located, designed, constructed and maintained to ensure product safety?
B.B 2.2 Is the facility effectively maintained, cleaned and disinfected to prevent physical, chemical and
microbiological product contamination?
B.B 2.3 Is the lighting of the appropriate intensity and design to ensure that food safety practice is effective?
B.B 2.4 Are structures, surfaces and materials that come in contact with food easy to maintain, clean and
where appropriate disinfect?
B.B 2.5 Is the equipment positioned to ensure that there is no compromise to food safety from waste water or
drainage?
B.B 2.6 Are the grounds and surrounding areas of the facility maintained and kept free of waste and
accumulated debris?
B.B 3 Cleaning & Disinfection

The business shall ensure appropriate standards of cleaning and disinfection shall be maintained at all
times and throughout all production stages.
B.B 3.1 Are documented cleaning and disinfection procedures in place and effective, including verification
activities, to ensure the cleanliness of the facility, utilities and equipment?
B.B 3.2 Are cleaning equipment, utensils and chemicals clearly marked, stored in a segregated area away from
product, equipment, packaging and suitable for intended use?
B.B 3.3 Are qualified, trained people used for cleaning and disinfection?
B.B 4 Product Contamination Control

The business shall ensure appropriate facilities and procedures are in place to minimise the risk of
physical, chemical, or microbiological contamination of product.
B.B 4.1 Are physical barriers or effective procedures in place to reduce and avoid the risk of any potential
physical, chemical or microbiological contamination?
B.B 5 Pest Control

The business shall ensure controls are in place to reduce or eliminate the risk of pest infestation
(including rodents, insects and birds).
B.B 5.1 Is there evidence of pest infestation?
B.B 5.2 Is an effective pest control programme in place?
B.B 5.3 Are the controls appropriate in relation to the product, raw material and facility?
B.B 5.4 Is the inspection programme undertaken by a competent person at an appropriate frequency and are
findings addressed?
B.B 6 Water Quality
The business shall ensure that the quality of water, ice or steam in contact with food product is
suitable for its intended use.
All food contact water, ingredient water and water used in cleaning and sanitising operations shall be
from a potable source.
B.B 6.1 Are there processes in place to ensure that the quality of water, steam and ice does not compromise
the food safety of the finished product?
B.B 6.2 Are documented procedures in place to prevent the cross-contamination of potable water by non-
potable water?
B.B 7 Staff Facilities

The business shall ensure that staff facilities be designed and operated so as to minimise food safety
risks.
B.B 7.1 Are suitable changing rooms provided for staff?
B.B 7.2 Are toilets provided, operational, accessible and adequately segregated from processing and food
handling areas?
B.B 7.3 Are suitable and sufficient hand-washing facilities provided and accessible?
B.B 7.4 Are separate lunch room facilities provided away from production, packaging and storage areas?
B.B 8 Waste Management

The business shall have a programme in place for the collection and disposal of waste material.
B.B 8.1 Are suitable provisions in place for the storage and removal of waste?
B.B 8.2 Are containers designated for inedible products, waste or by-products clearly marked and properly
utilised?
B.B 9 Storage and Transport

The business shall ensure that all raw materials (including packaging), semi processed product and
finished product be stored and transported under conditions that protect the product.
B.B 9.1 Are there adequate facilities for the storage of food and ingredients?
B.B 9.2 Are the food storage facilities constructed to effectively protect materials and finished product from
contamination during storage?
B.B 9.3 Is the food transport appropriate to minimize deterioration of food (e.g., by temperature and humidity
control).
I.B 9 Storage and Transport

The business shall ensure that all raw materials (including packaging), semi processed product and
finished product be stored and transported under conditions that protect product integrity. All
vehicles, including contracted vehicles used for the transportation of raw materials (including
packaging), rework, semi processed product and finished product shall be suitable for the purpose,
maintained in good repair and be clean.
I.B 9.1 Is there a product transport procedure and is it effectively implemented?
I.B 9.2 Is there a transport vehicle procedure and is it effectively implemented?
I.B 9.3 Are there maintenance and hygiene processes for vehicles and equipment used for loading and
unloading?
Are they effectively implemented?
I.B 10 Facility and Equipment Maintenance

The business shall implement a system of planned, preventive and corrective maintenance to ensure
an adequate level of food safety in the facility.
I.B 10.1 Is a documented maintenance programme established?
I.B 10.2 Is an effective maintenance programme implemented?
I.B 10.3 Is a documented hygiene and clearance procedure in place for all maintenance activities?
I.B 10.4 Are effective hygiene procedures for maintenance activities?
I.B 10.5 Are all materials used for maintenance and repair appropriate for their intended use?
C. Control of Food Hazards
B.C 1 Preliminary tasks
The business shall identify and comply with regulatory and customer requirements related to the
product and to the product category.
For all products, the following shall be included:
• Task 1: Establish a multi-disciplinary food safety team.
• Task 2: Describe the product and product category of all ingredients (including raw materials,
packaging, finished product) and the required conditions for storage and distribution.
• Task 3: Describe the intended use of the product and identify the target consumer.
• Task 4: Describe all of the steps taken to produce the product in a process flow diagram.
• Task 5: Compare the process flow diagram with the production process to ensure it is accurate.
B.C 1.1 Has the business identified and complied with regulatory and customer requirements related to the
product and product categories?
B.C 1.2 Has a team with different responsibilities for food safety undertaken the tasks described in this section
of the checklist (Tasks 2-5)?
B.C 1.3 Is there a complete product description available of the product/product category including all
ingredients including raw materials, packaging, finished product and conditions for stage and
distribution?
B.C 1.4 Has the intended use of the product been decribed and the target consumer been been identified?
B.C 1.5 Have all of the process steps taken to produce the product been described in a process flow diagram?
B.C 1.6 Has the process flow diagram(s) been compared to assure it accurately reflects the process?
B.C 2 Control of Allergens

The business shall ensure that there are adequate control measures in place to prevent cross
contamination of allergens.
All ingredients known to cause food allergies in the product shall be clearly identified and
communicated to the customer.
B.C 2.1 Is a documented programme in place to control allergens and prevent cross-contamination of product
through all stages of production?
B.C 2.2 Were regulations and appropriate customer requirements addressed in the development of the
allergen control programme?
B.C 2.3 Are potential causes of cross contamination identified and procedures established for the handling of
raw materials, intermediate and finished products to avoid cross contamination?
B.C 2.4 Are procedures relating to the cleaning and sanitation of product contact surfaces in place and
effective to remove all potential allergens from food contact surfaces?
B.C 2.5 Is a clear labelling system in place ensuring continuous identification of the product through all stages
of production and delivery?
I.C 3 HACCP
The business shall perform a hazard analysis of their food manufacturing process as a minimum step in
order to determine if there are any hazards associated with the production of their food item.
The business shall use the HACCP [Hazard Analysis Critical Control Point] tool to accomplish this
assessment.
If hazards are identified within the manufacturing process, it is expected that the business will take
appropriate action necessary to develop a HACCP Plan that meets the 7 principles reflected within
Codex Alimentarius.
I.C 3.1 Principle 1: Is a hazard analysis conducted for each process step in the manufacturing of the food
item?
I.C 3.2 Was the hazard analysis conducted by a competent team?
I.C 3.3 Principle 2: If the hazard analysis indicates any significant hazards not minimised or eliminated by
Good Manufacturing Practices (GMPs) that are present within the food manufacturing process, are
they identified as Critical Control Points (CCPs)?
I.C 3.4 Principle 3: Are Critical Limits established for each CCP?
I.C 3.5 Principle 4: Are monitoring procedures established for each CCP?
I.C 3.6 Are CCPs effectively implemented?
I.C 3.7 Principle 5: Are corrective actions established for each CCP in the event critical limits are exceeded?
I.C 3.8 Principle 6: Are verification procedures established ?
I.C 3.9 Are verification procedures effectively implemented?
I.C 3.10 Principle 7: Are record keeping and documentation for HACCP procedures established?
I.C 3.11 Are all HACCP-related record-keeping and documentation procedures effectively implemented?
I.C 3.12 Has the business implemented specific control measures for all relevant steps not identified as CCPs?
I.C 4 Food Defence

The business shall assess its ability to prevent intentional product tampering/intentional contamination
and put in place the appropriate preventive control measures.
I.C 4.1 Have the threats to the product as a result of intentional product tampering or intentional
contamination been assessed?
I.C 4.2 Have those points in the process which are vulnerable to intentional product tampering/intentional
contamination been identified and subjected to additional access control?
I.C 4.3 Are measures in place to address what to do with the product, if prohibited access took place and the
product may have been tampered with or intentionally contaminated?
Conformity Overview
Basic: Version 2 Intermediate: Version 2

A. Food Safety Management Systems A. Food Safety Management Systems Conform
Specifications including product release Traceability
B.A 1 I.A 2
Traceability Food Safety Incident Management
B.A 2 I.A 3
Food Safety Incident Management Management Responsibility
B.A 3 I.A 6
B.A 4 Control of non-conforming product I.A 7 General Documentation Requirements
B.A 5 Corrective Action I.A 8 Control of Measuring & Monitoring Devices
Management Responsibility Training
B.A 6 I.A 9
Record Keeping Requirements Procedures
B.A 7 I.A 10
Control of Measuring & Monitoring Devices Complaint Handling
B.A 8 I.A 11
B.A 9 Training I.A 12 Product Analysis
I.A 13 Purchasing
Supplier Approval and Performance Monitoring
I.A 14
B. Good Manufacturing Practices (GMPs) B. Good Manufacturing Practices (GMPs)

Personal Hygiene Storage and Transport
B.B 1 I.B 9
B.B 2 Facility Environment I.B 10 Facility and Equipment Maintenance
Cleaning & Disinfection
B.B 3 ###
Product Contamination Control
B.B 4 ###
Pest Control
B.B 5 ###
Water Quality
B.B 6 ###
###
###
Storage and Transport
B.B 9 ###
C. Control of Food Hazards C. Control of Food Hazards

Preliminary tasks HACCP
B.C 1 I.C 3
B.C 2 Control of Allergens I.C 4 Food Defence

Exemptions
How to use this sheet

List of Items to be exempted Item
-
-

User Guidance
Items Requirements Guidance
A. Food Safety Management Systems
B.A 1 Specifications including product release
The business shall ensure that product specifications are adequate, accurate WHAT DOES IT MEAN?
and ensure compliance with relevant safety, legislative and customer a) Specifications on all product ingredients should be appropriate to ensure compliance with relevant safety, legislative and customer requirements.
requirements. b) Specifications will be managed and controlled by a designated person and should be up-to-date, clear, communicated within the business and with customers to ensure
The business shall prepare and implement appropriate product release transparency.
procedures. c) A clear procedure for product release should be documented, communicated and implemented to ensure released product meets the agreed specifications.
WHAT DO I NEED TO DO?

a) You need to ensure there is an accountable person who is responsible for the control of specifications, which should be up-to-date, appropriate and communicated to
B.A 1.1 Are specifications available for all product inputs (raw materials, relevant people. This person will also manage all changes.
ingredients, additives, packaging materials, rework) and finished products? b) The specifications for all ingredients should meet relevant safety, legislative and customer requirements and be agreed with each supplier.
c) Finished product specifications should be available so that the documented product release procedure ensures the product is either properly released or held back due to
being out-of-specification.
B.A 1.2 Are the available specifications compliant with relevant safety, legislative
and customer requirements? WHAT WILL THE ASSESSOR DO?
The Assessor will:
B.A 1.3 Are specifications up to date, unambiguous and available to relevant staff? - Discuss the control of specifications with the accountable person.
- Check that specifications for all ingredients and finished products are appropriate, clear and ensure conformance with relevant safety, legislation and customer
requirements.
B.A 1.4 Are changes to specifications clearly communicated both internally and - Check that the specifications are up-to-date and clearly communicated to relevant people with responsibility for food safety and quality.
externally? - Discuss the product release procedure with relevant people to ensure that their actions establish effectively whether a finished product is either acceptable or out-of-
B.A 1.5 Is there a documented product release procedure in place? specification.
Does it effectively ensure that the final product meets the specification?
B.A 1.6 Is there a designated person with responsibility for controlling

specifications?
B.A 2 Traceability
The business shall establish a traceability system which enables the WHAT DOES IT MEAN?
identification of product lots and their relation to batches of raw materials, a) Food manufacturers are obliged to prove to the authorities the source and buyers of the raw materials used to produce each of their products.
primary and final packaging materials, processing and distribution records. b) The source and destination of any packaging materials that come into direct contact with the product shall also be proven.
Records shall include:
• Identification of any out sourced product, ingredient or service. WHAT DO I NEED TO DO?
• Records of batches of in process or final product and packaging a) All locations should have documented procedures to maintain traceability throughout all phases of product conversion from receiving incoming materials through
throughout the production process. production, packaging and dispatch. This includes hold orders, rework etc.
• Records of purchaser and delivery destination for all products supplied. b) Labelling of lots, including those that are partially finished, should be made during actual packing to ensure clear traceability.
c) Where goods are also labelled later, there should be specific lot labelling for temporary batches.
d) The batch sizes that are selected depends on your readiness to assume risk in the case of quarantine or a recall.
e) Legal and customer requirements can be satisfied if you are able to provide credible, controlled documents as evidence.
f) In the event of a product recall you have a duty to inform the authorities and provide complete documentation quickly.
WHAT WILL THE ASSESSOR DO?

The Assessor will:
- Inspect your traceability system expecting to see effective and documented procedures from receipt to dispatch.
B.A 2.1 Is a documented traceability system in place for every product that meets - Review whether the effectiveness of the system can be proven using documented test runs.
regulatory and customer requirements? - Use current or retained samples to establish whether all responsible persons are delivering traceability procedures.
- Look for evidence that there is complete labelling of all batches, partial batches, raw materials, etc.
B.A 2.2 Is the traceability system, including work in progress, post-treatment and
rework, fully operational and effective?
B.A 2.3 Are records enabling product identification available through all production
stages: stock / inventory, work in progress, post processing, rework.
Are records available from purchase through production and to immediate
destination for all raw materials and packaging materials (primary and final
product)?
B.A 2.4 Are there clear labelling procedures that ensure continuous identification of
the product through all stages of production and delivery?
I.A 2 Traceability

User Guidance
The business shall establish a traceability programme which enables the WHAT DOES IT MEAN?
identification of product lots and their relation to batches of raw materials, a) The goal is to test the traceability programme and identify elements which might limit the effectiveness or efficiency of a recall.
primary and consumer unit packaging materials, processing and distribution b) Effective lot identification as a part of a functional traceability programme provides a cornerstone in controlling and minimising both food safety risks and the financial
records. impact of product withdrawals and recalls.
The business shall ensure the traceability programme is tested at least
annually and updated as necessary. WHAT DO I NEED TO DO?
Records shall include a) At least annually, simulated recalls are required to ensure that the traceability programme works and testing should include:
• Records of annual testing of the traceability system. • Identification of item traced (i.e. ingredient or finished product).
• Records of updating the system as applicable. • Time for completion and percentage of product traced, according to both regulatory or customer requirements.
• Key learnings, gaps, system improvement opportunities.
• Receipt and dispatch discrepancy and reconciliation.
b) All staff are to be trained in the procedures and improvements that are identified and implemented.
c) The results should be summarised and reported to provide evidence of system verification.
I.A 2.5 Is the traceability system tested at least annually? d) The expectation is that key findings, gaps and improvement opportunities are addressed.
Is the system updated as necessary and records maintained?
The Assessor will:
- Inspect your full traceability programme throughout the assessment process.
- Expect that the documents will show a traceable process that is tested systematically.
- Review whether the effectiveness can be proven using documented test runs.
- Use either current or retained samples to establish whether responsible people are delivering traceability procedures.
B.A 3 Food Safety Incident Management

The business shall demonstrate the ability to withdraw and recall affected WHAT DOES IT MEAN?
product, contact relevant customers and maintain records of these a) An incident is an event that has occurred which results in the production or supply of unsafe, illegal or non-conforming product.
incidents. b) A procedure should be defined, implemented and maintained for the management of incidents and of resulting emergency situations that impact food safety, legality and
quality.
c) This includes as a minimum: The nomination and training of a crisis team, an alert contact list including suppliers and customers, sources of legal advice, the availability of
Can the business withdraw and recall affected product? internal contacts and a communication plan that includes information to consumers.
B.A 3.1
B.A 3.2 Are records of incidents maintained? WHAT DO I NEED TO DO?
a) The feasibility, effectiveness and timeliness of implementation of the withdrawal procedure should be subject to regular internal testing, based on hazard analysis and
assessment of associated risks but carried out at least once a year.
b) This should be carried out in a manner to ensure the effective implementation and operation of the procedure.
c) A person of the business, with the authority to initiate the incident management process, should be permanently available.
d) Records to be available:
• Product involved, sizes, manufacturing location.
• Quantity of product affected.
• Details of product affected - codes, lots, pallets, batches.
• Production and quality control records.
• Quantity distributed and location.
e) Updated emergency contact details (such as names and phone numbers of suppliers, customers and competent authorities) should be available.

The Assessor will:
- Inspect the relevant process throughout the entire assessment.
- Expect when reviewing the documents that you are able to show a documented procedure that fulfils all requirements.
- Use current or retained samples to identify whether responsible people are engaged with these procedures.
- Review whether effectiveness of the procedure can be proven using documented test runs.
I.A 3 Food Safety Incident Management

User Guidance
The business shall have an effective incident management procedure for all WHAT DOES IT MEAN?
products including reporting, communicating with customers, product a) An incident is defined as any situation, which, if not properly managed, has the potential to develop into a crisis.
withdrawal and recall. b) If a crisis or a incident occurs (e.g. food product contamination, illegal ingredients or negative reporting in the press), it is important that you are able to do the following:
Records of annual review, testing and verification of the system shall be • To survey the situation in your business as fast as possible.
available. • To reach all persons (internal and external) who are able to help solve the problem.
• To communicate effectively, including making sure
that only named representatives speak for the business (note: serious incidents attract the press in no time. Any of your people may be approached for comment). Frequent,
clear and accurate communication can pre-empt or reduce the scale or complexity of a crisis.
I.A 3.3 Is a documented incident management system in place that addresses
incident reporting, product withdrawal and product recall? WHAT DO I NEED TO DO?
a) There are two stages in defining a threat: first in terms of its severity and imminence, second in terms of its topic. No matter how insignificant an event seems, it could
develop into a major, business-threatening crisis if it is ignored. It is important that every incident is treated as a full-blown crisis until you can be certain that it is not.
b) To develop, implement and maintain a crisis management procedure to include the following:
I.A 3.4 Is an effective communication plan in place with a designated, responsible ○ Detail about the steps to be taken to manage a crisis.
person identified to provide information to customers, consumers and ○ The nomination and training of a crisis team, an alert contact list, sources of legal advice (if necessary), contacts availability, customer information and a communication
regulatory authorities? plan, including information to your people, customers and consumers.
c) Communications is not a tactical option, it’s a strategic necessity and a core responsibility of the Crisis Team. Controlling and targeting of information to internal audiences
can make or break a crisis. Colleagues need to be informed and external stakeholders need to be notified and reassured.
Is the incident management system reviewed, tested and verified at least d) The incident management system should be tested at least annually. It is important that these processes are reviewed, practiced and mastered with a broad base of
I.A 3.5 employees.
once a year?
I.A 3.6 Are all incidents recorded and assessed to establish their severity and WHAT WILL THE ASSESSOR DO?
consumer risk? The Assessor will:
- Check for a procedure that describes the approach to such situations
- Review the emergency contact list of all relevant persons. Check it is up to date and available to all that need it.
- Interview people to establish that they are aware of their responsibility, at least in part (e.g. when serious process failures occur, instant information to superiors, receipt of
serious complaints, and instant information to the crisis team).
B.A 4 Control of non-conforming product

The business shall ensure that any product which does not conform to WHAT DOES IT MEAN?
requirements is clearly identified and controlled to prevent unintended use a) Standard operating procedures are required to ensure that substandard material or finished product is labelled and controlled so that it does not contaminate other
or delivery. products or get released for sale or consumption.
Is a documented procedure in place to identify and manage all non- WHAT DO I NEED TO DO?
B.A 4.1 a) Establish and document procedures for the management of non-conforming materials or finished product.
conforming raw materials, product inputs, semi-finished and finished
products, processing equipment and packaging materials? b) Ensure that relevant people understand the procedure and that there are defined responsibilities for making decisions about the use or disposal of non-conforming
product, as appropriate to the issue.
c) These procedures would include reporting, labelling, isolation, disposal and corrective actions.
B.A 4.2 Is the control of non-conforming product managed by competent people? WHAT WILL THE ASSESSOR DO?
The Assessor will:
- Review documents and compare records to establish that procedures exist and are followed when appropriate.
- Look for evidence that non-conforming product is effectively identified and segregated pending decisions on use or disposal.
B.A 5 Corrective Action

The business shall ensure that corrective action be undertaken as soon as WHAT DOES IT MEAN?
possible to prevent further occurrence of non-conformity. a) When an issue occurs regarding non-conforming materials, finished products or procedures, a process is followed to understand the root cause of the non-conformity and
actions are taken to correct the problem so that there are no further occurrences.
B.A 5.1 Is a documented corrective action procedure in place to analyse any
complaints and investigate non-conformities to prevent reoccurrence? WHAT DO I NEED TO DO?
a) Establish and document procedures for identifying non-conformities and problem solving activities to determine how the non-conformities occurred.

The Assessor will:
- Review documentation that corrective action procedures exist, are effectively communicated and followed when required.

WHAT DOES IT MEAN?
a) When an issue occurs regarding non-conforming materials, finished products or procedures, a process is followed to understand the root cause of the non-conformity and
actions are taken to correct the problem so that there are no further occurrences.
WHAT DO I NEED TO DO? User Guidance
Items Requirements a) Establish and document procedures for identifying non-conformities and problem solving activities to determine how the non-conformities occurred.
Guidance
B.A 5.2 Are corrective actions (i.e. release, rework, quarantine, rejection/disposal) WHAT WILL THE ASSESSOR DO?
identified and effectively implemented? The Assessor will:
- Review documentation that corrective action procedures exist, are effectively communicated and followed when required.
B.A 6 Management Responsibility

The business shall ensure there is management commitment to provide the WHAT DOES IT MEAN?
resources to develop, implement and comply with their food safety a) There should be clear accountability for the production management team.
programme. b) The team should demonstrate commitment to provide the appropriate amount of resources to develop, implement and ensure compliance with the food safety
programme.
B.A 6.1 Is there evidence that management is committed to provide the resources c) Although development of many of these activities may be conducted by quality assurance and food safety people, the production management team should be actively
to implement and comply with their food safety programme? involved in the support and leadership of these activities.
d) The food safety programme should not be a "Quality owned activity". Instead, management should show active leadership to ensure a food safety culture.

a) The production management team should have systematic documented discussions about the food safety programme as part of its periodic staff meetings where non-
conformance trend analysis, resources allocation, corrective action and strategy for continuous improvement will be actively discussed.
b) Management should show that food safety is as important as production and people's health and safety and operates with an adequate budget.

The Assessor will:
- Check for evidence that food safety programme elements are discussed and documented in production management team staff meetings, looking for prominent discussions
and follow-up activities.
- Interview the quality team about management commitment for appropriate resources, support for their activities and to ensure that those employees with responsibility for
food safety activities are held accountable for compliance.
- Ask production operations people about management commitment, seeking to establish whether management are receptive to continuous improvement suggestions.
I.A 6 Management Responsibility

The business shall ensure there is management commitment to provide the WHAT DOES IT MEAN?
resources to develop, implement and comply with their food safety a) In addition to those items already identified in Requirement B. A. 6, production management should document the organizational structure which supports the food safety
programme. programme and the activities that impact product safety. Documented job descriptions and reporting relationships should be included.
The business shall establish a clear organizational structure with job
descriptions, responsibilities and reporting relationships of at least those WHAT DO I NEED TO DO?
staff whose activities affect product safety. a) A clear organizational chart should be created and kept updated.
b) Employees whose activities and responsibilities support the food safety programme should be identified.
c) These documented responsibilities should be shared with and discussed with relevant employees to ensure understanding of their accountabilities.

I.A 6.2 Is an up-to-date organizational chart outlining the business' structure The Assessor will:
available? - Check for evidence of production management's commitment to the food safety programme
- Check to ensure the organizational chart is up-to-date and will look for documents (such as job descriptions) which define indivuals responsibilities that support the food
I.A 6.3 Are documented, clearly defined responsibilities regarding product safety safety programme.
and legality available and communicated to staff? - Discuss how production management supports and has communicated the responsibilities.
B.A 7 Record Keeping Requirements

The business shall ensure that records are available to prove the business is WHAT DOES IT MEAN?
complying with the food safety system which includes all relevant a) The business needs to prove it is meeting both regulatory and customer requirements that apply to its product and process.
regulatory and customer food safety requirements. b) Records provide legal proof that you did what you said you were going to do to manufacture, store and distribute products.
c) You need to identify when records will be completed and who will complete them.
d) These records are kept for a period of time (this is 'record retention'). The period of time will be mandated by law or by customers and will depend on the type of products,
processes and product liability.
e) Identify which of these time periods is longest to decide on your record retention policy.
f) You can set the same retention policy for all of your records or have different time periods for specific records.
g) These records can be Markets
GFSI Global in paper form or they can
Programme be electronic Edition
Manufacturing: and should be factual
2 April 2015 and genuine.
a) You need to identify the requirements within the food safety system for which you need to prove compliance, including both customer and regulatory, .
WHAT DOES IT MEAN?
a) The business needs to prove it is meeting both regulatory and customer requirements that apply to its product and process.
b) Records provide legal proof that you did what you said you were going to do to manufacture, store and distribute products.
User
c) You need to identify when records will Guidance and who will complete them.
be completed
Items Requirements d) These records are kept for a period of time (this is 'record retention'). The period of time will be mandated by law or by customers and will depend on the type of products,
Guidance
processes and product liability.
B.A 7.1 Are records available to support the business' compliance with the food e) Identify which of these time periods is longest to decide on your record retention policy.
safety system which includes regulatory and customer food safety f) You can set the same retention policy for all of your records or have different time periods for specific records.
requirements that apply? g) These records can be in paper form or they can be electronic and should be factual and genuine.
B.A 7.2 Has the business set timescales for record retention which comply with WHAT DO I NEED TO DO?
regulatory or customer requirements? a) You need to identify the requirements within the food safety system for which you need to prove compliance, including both customer and regulatory, .
b) Some of these records may come from your suppliers (e.g., letter of conformity, specification, etc.).
c) You will also need to create forms which will allow you to record your own information.
The Assessor will:
- Check whether you have identified the records that you need to retain and set the timescales for retention.
- Review a sample of your records to prove they exist and that they are available for the set period of time.
I.A 7 General Documentation Requirements

The business shall establish and implement procedures to ensure that all WHAT DOES IT MEAN?
documents are maintained and kept up to date. a) Documents provide instruction for people so they can do their job and deliver a safe and consistent product.
These documents are required to demonstrate the effective operational b) Documents also provide records so that the business is able to collect data and provide evidence to show that it is meeting customer and regulatory requirements as well
control of its processes and its management of product safety. as the requirements of this checklist.
c) They should be maintained, kept up to date and controlled so to ensure that only correct documents are used.
d) Usage of out of date documents by people may not only resulting a product that is out of conformance with specifications but also that the appropriate data to prove
compliance is not gathered.
I.A 7.1 Is a written documentation procedure in place and effectively
implemented? WHAT DO I NEED TO DO?
a) You need to document and implement a procedure for keeping documents up to date and assuring out of date documents are not used.
b) You should appoint an individual to be responsible for documents with accountability for approving documents.
c) Only authorised people are able to replace existing documents so they should be protected against unauthorised change.
d) As procedures change there should be a way to control and archive obsolete documents.
The Assessor will:
- Check there is a procedure there has been implemented effectively for document control.
- Check procedures and forms during the assessment looking for correct usage including issues such as dates, signatures and frequency of recording.
B.A 8 Control of Measuring & Monitoring Devices

Measuring and monitoring devices critical to food safety and regulatory WHAT DOES IT MEAN?
requirements shall be reliable. a) The business should identify the critical control points in their process that may create a food safety issue.
b) Once those points have been identified you should have a means to measure and monitor the process using appropriate devices.
B.A 8.1 Are measuring and monitoring devices critical to food safety and regulatory c) Those devices should be verified on a regular basis to ensure their reliability.
requrements reliable? d) For example, to ensure destruction of all pathogenic microorganisms in raw milk, time and temperature combinations of the pasteurization process should be regulated. A
manufacturer will need to ensure that the device used to measure and monitor the time and temperature is accurate and reliable.

a) Create a master list of all measuring and monitoring devices required to control the food safety of your food and list the method and frequency for calibration and
maintenance.
b) Each measuring and monitoring unit should have a unique identifier and the acceptable variance range identified.
c) Examples of measuring and monitoring devices critical to food safety include thermometers and metal detectors

The Assessor will:
- check that the measuring and monitoring device is accurately measuring the required parameters
- select a measuring and monitoring device and check that there is evidence that it is calibrated to a recognised standards.
I.A 8 Control of Measuring & Monitoring Devices

User Guidance
The business shall identify measuring and monitoring devices critical to food WHAT DOES IT MEAN?
safety, ensure that they are calibrated and traceable to a recognised a) In addition to those items already identified in Requirement B. A. 7, the business shall ensure that calibration of measuring and monitoring devices that are critical to food
national or international standard. safety is undertaken against a recognised national or international standard.
a) Create a master list of all measuring and monitoring devices, ensure there is unique identification for each and that the acceptable variance range is identified.
I.A 8.2 Are measuring and monitoring devices critical to food safety identified, b) Examples of measuring and monitoring devices critical to food safety include: Thermometers, Metal detectors, X-Ray units, pH and water activity meters, scales, oven
calibrated and traceable to recognised standards and are they effectively speeds and other important processing measuring and monitoring units.
controlled? c) Develop Standard Operating Procedures (SOP) for each listed device to provide detailed, written instructions that will achieve uniformity of performance.
d) Each SOP should list what the device is, why it is needed, how it is used, who is authorised to use it and when it is to be calibrated.
I.A 8.3 Are actions taken and recorded when measuring and monitoring devices e) Each SOP should include requirements for documented corrective action and remediation in the event of deviation to standards.
are found to be outside of specified limits? f) Maintain and retain records of the following activities: calibration, service providers with contact information; maintenance records, monitoring frequency signed by
approved operator, deviation and corrective action.
g) Implement a training programme to ensure all relevant people are adequately trained.

The Assessor will:
- Check for procedures for the operation of measuring and monitoring devices critical to food safety.
- Check the calibration and maintenance log to validate that devices are maintained and calibrated against in recognised national or international standard as recommended
by the manufacturer.
- Review samples of signed operator logs for accuracy and to verify corrective action and remediation for any documented deviations.
- Check training records for the relevant people, looking for evidence that they have been adequately trained.
B.A 9 Training
The business shall ensure that all people are adequately trained in food WHAT DOES IT MEAN?
safety and practices according to their job responsibilities. a) All new people performing work that affects product safety, legality and quality shall have the required competence by education, work experience and training, that
matches their work, based on risk assessment.
b) Training should address both personal health and safety as well as relevant food safety issues with a focus on avoiding contamination.
c) All people (management, full-time, part-time, or temporary) shall receive relevant training.
B.A 9. 1 Have all new people been effectively trained? d) Each qualification or competency related to best practise and food safety shall be systematically "refreshed" and confirmed.
B.A 9.2 Have all relevant people received refresher training?
a) Ensure that people are aware and understand the consequences of improper food handling.
b) Make sure that induction training of new employees is targeted towards their future duties in your business.
c) For members of the management team, create an induction programme that takes into account all relevant processes and departments.
d) Training should be conducted regularly and the contents should be adapted to current business conditions such as incidents, improvements and current legal situation.
e) For simple tasks create a check list with relevant topics that can be efficiently communicated.
f) You will need to provide evidence about training topics, including hygiene and safety in the workplace, with participating employees and refresher training..

The Assessor will:
- Check whether you can prove that all your people have undergone relevant training, with special attention to induction for temporary and part-time people.
- Interview people and ask them about the training they have received and how appropriate it was for the job that they must do.
- Check that you can prove that you have delivered refresher training to all relevant people.
- Review whether the refresher training content has been adapted to current business conditions such as incidents, improvements and current legal situation.
I.A 9 Training
The business shall implement a system to ensure that all people are WHAT DOES IT MEAN?
adequately trained, instructed and supervised in food safety principles and a) All people performing work that affects product safety, legality and quality should have the required competence by education, work experience and training, that matches
practices that matches their work. their work, based on hazard analysis and risk assessment.
b) A training programme should apply to all people, including part-time and temporary workers.
c) Before starting work, they should be trained in accordance with the training programme.

a) The business should implement a training programme relevant to the product requirements and the training needs of the people which should include:
• trainingGFSI
content
Global Markets Programme Manufacturing: Edition 2 April 2015
• training frequency
• people’s tasks
• relevant language
WHAT DOES IT MEAN?
a) All people performing work that affects product safety, legality and quality should have the required competence by education, work experience and training, that matches
their work, based on hazard analysis and risk assessment.
b) A training programme should apply to User Guidance
all people, including part-time and temporary workers.
c) Before starting work, they should be trained in accordance with the training programme.
I.A 9.3 Is a people training programme in place and effectively implemented?
a) The business should implement a training programme relevant to the product requirements and the training needs of the people which should include:
• training content
• training frequency
• people’s tasks
• relevant language
• qualified trainer
• evaluation methodology
b) There should be a procedure that proves the effectiveness of training.
c) The contents of the training programme should be reviewed and updated systematically to take into account specific issues, food safety, food related legal requirements
and product and process modifications.
d) You will need to prove what training topics have been delivered for each individual.
e) Training topics include HACCP, hygiene and safety in the workplace.

The Assessor will:
- Check for evidence that there is a training programme and that all people have undergone relevant training.
- Will interview people and ask them about the training they have received and how appropriate it was for the job that they do.
- Will examine training records for individual people to verify that the training programme has achieved its objectives.
- Will pay special attention to the training of all new employees, temporary workers and part-time employees.
- Will check that the procedure for review of the training programme is implemented and results in improvements.
I.A 9.4 Is a HACCP training programme in place? WHAT DOES IT MEAN?

a) Those responsible for the development and maintenance of the HACCP plan should have an internal team leader and received adequate training.
b) The production people in charge of the monitoring of CCP’s should have received specific training.
c) All training should be documented and managed through a HACCP training programme where content, frequency, tasks and evaluation methodology are defined.

a) The business should ensure the training programme includes HACCP training for relevant staff.
b) The training content should be reviewed and updated regularly with consideration of business specific issues, food safety, food related legal requirements and product and
process modifications.
c) You will need to prove what training topics have been delivered for relevant people.

The Assessor will:
- Check for evidence that those responsible for the development and maintenance of the HACCP plan have undergone a HACCP training programme.
- Interview people and ask them about the HACCP training they have received and how appropriate it was for the job that they do.
- Look for evidence of training topics and participating employees.
- Check that the procedure for review of the HACCP training programme is implemented and results in improvements.

User Guidance
I.A 9.5 Are adequate training records available? WHAT DOES IT MEAN?
a) There should be evidence that training has been carried out.

a) Records should be available of all training events, stating:
– list of participants (this should include their signature)
– date
– duration
– contents of training
– name of trainer/tutor.

The Assessor will:
- Check the availability, accuracy and adequacy of the training records.
I.A 9.6 Is a refresher training programme documented and implemented? WHAT DOES IT MEAN?
a) Each qualification or competency related to best practice and food safety should be systematically " refreshed" and confirmed.
b) This programme should be documented and implemented according to a predefined plan.
a) Develop a refresher training programme where activities, roles and responsibilities are defined.
b) Training activities should be documented.

The Assessor will:
- Check the documentation of the refresher training programme to confirm that planned training is delivered and the outcomes are monitored.
- Assess the efficacy of this programme through a comparison of the procedures and the records.
I.A 10 Procedures
The business shall prepare and implement detailed procedures and WHAT DOES IT MEAN?
instructions for all processes and operations having an effect on product a) Procedures are controlled documents that provide instruction for people so they can consistently deliver the particular process as defined.
safety. b) A procedure may include instructions on using particular equipment, how to carry out specific tests, follow a recipe, repair equipment or other essential steps in
manufacturing a product.
I.A 10.1 Are detailed procedures developed and effectively implemented for all c) Procedures are important training tools as new staff members are inducted or for refresher training.
processes and operations that affect food safety? d) Procedures can be made available for staff either as paper copies, in a reference manual or in electronic format.

a) Ensure all processes and instructions used to manufacture, test, store and ship the product have been documented in paper or electronic format, that relevant staff are
I.A 10.2 Are procedures clearly communicated to relevant staff? trained against these and always have them available.
b) Ensure that procedures are communicated in a consistent manner, either because they are new or because they have been changed or as a part of refresher training. This
can happen during production meetings, management review meetings etc.

The Assessor will:
- Collect a sample of procedures, check how people use them through observation or interview and determine whether actual usage reflects the stated intentions.
I.A 11 Complaint Handling

The business shall prepare and implement an effective programme for the WHAT DOES IT MEAN?
management of customer and consumer complaints. a) Customer and consumer complaints can identify whether the finished product achieved the specification requirements or otherwise resulted in non-conformance.
Data shall be controlled and managed to ensure that there are corrective b) The business needs to ensure the complaint and its cause is resolved which may require further investigation using root cause analysis (which is a process of solving the
actions for compliance and food safety issues. fundamental causes of an incident).
c) Once the non-conformance is accurately understood, corrective action can be taken so that the risk of recurrence is minimised.
a) Complaints should be recorded, investigated and resolved. Resolution is also referred to as corrective action.
I.A 11.1 Is a documented complaint management programme in place and b) Create a method of requesting, capturing and investigating customer complaints.
effectively implemented? c) Ensure staff are made aware of their responsibilities for handling the complaints and investigations.
d) Ensure that complaints, their investigations and resolutions are recorded.
The Assessor will:
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- Will check that Global Markets
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place for receiving, Edition
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and acting customer complaints.
- Check if records of complaints are readily available.
- Will select a sample of records of complaints and compare them against the procedure from receipt to resolution.
- Interview those with responsibilities in the complaints process.
c) Once the non-conformance is accurately understood, corrective action can be taken so that the risk of recurrence is minimised.
a) Complaints should be recorded, investigated and resolved. Resolution is also referred to as corrective action.
User Guidance
b) Create a method of requesting, capturing and investigating customer complaints.
c) Ensure staff are made aware of their responsibilities for handling the complaints and investigations.
I.A 11.2 Are records of all customer and consumer complaints, investigations and d) Ensure that complaints, their investigations and resolutions are recorded.
corrective actions maintained?
The Assessor will:
- Will check that a procedure is in place for receiving, documenting and acting on customer complaints.
- Check if records of complaints are readily available.
- Will select a sample of records of complaints and compare them against the procedure from receipt to resolution.
- Interview those with responsibilities in the complaints process.
- Will look for evidence of resulting activities which may be affected. These may include staff training, testing, management of non-conforming product, etc.
I.A 12 Product Analysis

The business shall implement a programme to ensure that analysis of WHAT DOES IT MEAN?
products and ingredients is systematically undertaken for issues that are a) You need to be able to provide evidence that the food safety, legality and customer issues that you have identified during a risk assessment are being critically analysed for
identified as being critical to food safety and legal requirements as well as compliance with agreed limits.
customer specifications. b) The business should have a risk based procedure to ensure that you are analysing relevant issues.
The business shall ensure that the methods used provide valid results (e.g.
by procedures set forth in ISO 17025 and/or industry recognised methods). WHAT DO I NEED TO DO?
a) This procedure will ensure that you are able to demonstrate you are evaluating and meeting food safety, legal requirements and customer specifications.
b) The test methodology that you use will need to ensure the accuracy and precision of the results obtained.
c) You should determine which are the relevant tests that complement your HACCP plan and its associated prerequisite programmes to ensure you are meeting food safety,
legal requirements and customer specifications.
d) The tests should be carried out to produce credible and accurate results.
I.A 12.1 Are analysis procedures in place to ensure that all specified product WHAT WILL THE ASSESSOR DO?
requirements are met, including legal requirements and customer The Assessor will:
specifications throughout the whole shelf life? - Will check your risk assessment to see whether your testing procedure has successfully in a review to demonstrate that you meet food safety, legal requirements and
customer specifications.
I.A 12.2 Are methods, relevant for food safety, used to provide valid results (e.g. by - Will review whether your testing has been done by laboratories with ISO 17025 certification or instead you can provide credible evidence of industry recognised methods.
procedures set forth in ISO 17025 and/or industry recognised methods)?
I.A 13 Purchasing
The business shall control purchasing processes to ensure that all externally WHAT DOES IT MEAN?
sourced items and services conform to written requirements. a) A food business relies on its suppliers because achieving both product safety and deliveries on time depends on their level of conformance to your requirements, which
should be written and mutually agreed through specifications and contracts.
I.A 13.1 Do purchased products and services meet current specifications and WHAT DO I NEED TO DO?
contractual agreements? a) Your purchasing procedures should include agreed specifications for raw materials, ingredients, packaging and services which may impact the safety and quality of the
product.
b) Determine which risks are relevant to the product or service. With this information, decide the relevant criteria for evaluating each supplier and implement appropriate
procedures for quality control and service level (Service level is a calculation of the volume of goods provided to specification against goods ordered, expressed as a
percentage).
c) Inform your suppliers both systematically and reactively on their performance, highlighting issues where they can make improvements.

The Assessor will:
- Review your specifications, ensuring these are up-to-date and looking for evidence of approval such as signatures or e-mails.
- Check your quality control records and compare them with your procedures for product and service evaluation.
- Review how you have dealt with supplier non-conformance, from receipt to resolution.
I.A 14 Supplier Approval and Performance Monitoring

User Guidance
The business shall operate procedures for approval and monitoring of all its WHAT DOES IT MEAN?
suppliers whose products or services may affect product safety and quality. a) A risk based programme should be developed and implemented to effectively manage and monitor the approval of suppliers.
The results of evaluations and follow-up actions shall be recorded. b) The resulting activities related to each supplier should be based on your risk assessment, such as supplier capability assessments, supplier visits, quality control for
incoming materials, etc.
c) If visiting isn't practical, alternative means of capability assessment would include the up-to-date evidence of certification to a food safety management scheme.
d) Monitoring their performance against your requirements will provide you with data to assess their performance and ongoing capability.
I.A 14.1 Is a documented supplier approval programme in place and effectively WHAT DO I NEED TO DO?
implemented? a) There should be a supplier management programme in place for the approval and monitoring of suppliers who may have an impact on food safety and quality.
b) The programme should be able to demonstrate that it is effective, with evidence that objective decisions are made about supplier capability.
I.A 14.2 Is a documented supplier monitoring programme in place and effectively c) For approved suppliers there should be evidence that there is an ongoing systematic approach to maintain approval.
implemented?
The Assessor will:
- Will evaluate the procedures of the supplier management programme to determine the effectiveness of the approval and monitoring process.
- Confirm that there is evidence that the relevant procedures are implemented and reviewed.
- Check your approved supplier list looking for evidence that you have considered and assessed their capability and that you have a systematic approach to maintain
approval.
B. Good Manufacturing Practices (GMPs)

B.B 1 Personal Hygiene
The business shall ensure the implementation of appropriate hygiene WHAT DOES IT MEAN?
practices for all its people and visitors. a) All food businesses should manage and control the personal hygiene requirements of its people and visitors to the site.
Such practices shall result in sanitary handling and delivery of safe and b) There should be documented personal hygiene requirements to include the following: the use of protective clothing, hand washing and disinfection, eating and drinking,
quality products to customers. controls over smoking, actions to be taken in case of cuts or skin abrasions, control over fingernails, jewellery, perfume, personal belongings and the control of hair and
The Codex Alimentarius Commission’s recommendation on personal beards.
hygiene shall be followed. c) The resulting procedures must match any legal requirements.

Are personal hygiene requirements in place and applicable to all relevant a) A risk analysis should be conducted to determine the appropriate personal hygiene requirements. The outcomes of this analysis should be implemented as appropriate to
B.B 1.1 your product and process.
people, contractors and visitors?
b) The resulting procedures that will enforce the personal hygiene requirements should apply to all relevant people, contractors and visitors, all of whom should be made
B.B 1.2 Are personal hygiene requirements compliant with legal requirements, if aware their responsibilities.
applicable? ○ Hand cleaning should be performed on entry to the production areas and that the frequency that is appropriate to minimise the risk of product contamination.
○ People with infectious diseases should not enter the production areas.
○ People who have been in contact with others with infectious diseases should identify themselves and may be excluded from entering production areas.
B.B 1.3 Are communication procedures in place for people, contractors and visitors ○ Visible jewellery, including piercing and watches, should not be worn.
addressing actions to be taken in the case of an infectious disease? ○ Any exceptions that may be granted should have been comprehensively evaluated by hazard analysis and assessment of associated risks in relation to product and process.
○ Cuts and skin abrasions should be covered by a coloured plaster or bandage that shows a different colour to the product and where appropriate contains a metal strip to
enable metal detection.
○ For hand injuries, in addition to a plaster or bandage, a single use glove should be worn.
○ Protective clothing, which should not leave the site, should be provided and used by all people and visitors.
B.B 1.4 Is a qualified person responsible to decide if individuals with a suspect ○ In production areas where wearing headgear and beard snood (coverings) is required, the hair should be covered completely so that product contamination is prevented.
illness may enter food areas and how these individuals are controlled? c) All of these procedures should be enforced by a qualified person within the business.
d) Compliance should be effectively managed and checked systematically.
B.B 1.5 Are people, contractors and visitors aware of and complying with the The Assessor will:
personal hygiene requirements? - Check for a risk analysis and the related implementation of appropriate procedures.
- Interview people to evaluate their understanding and implementation of the personal hygiene requirements.
- Check that there is a procedure for systematic review of the outcomes with appropriate testing.
B.B 1.6 Are people, contractors and visitors aware of and complying with the
requirements for the wearing and changing of protective clothing in
specified work areas?

User Guidance
B.B 2 Facility Environment
The business facilities shall be located and maintained so as to reduce the WHAT DOES IT MEAN?
risk of contamination and enable the production of safe and legal products. a) Facilities where food ingredients, raw materials, packaging materials, semi-processed products and finished products are stored should be designed and constructed so
that food safety is ensured.

Is the facility located, designed, constructed and maintained to ensure a) Inspect the storage areas, considering contamination risk: temperature fluctuations, humidity, pests, dusts, odours, splintering objects (wood pallets, glass, etc.).
B.B 2.1 b) Optimize the storage conditions. If necessary, arrange for structural alterations or new facilities.
product safety?
c) Walls should be designed and constructed to prevent the accumulation of dirt as well as to reduce condensation and mould growth.
B.B 2.2 Is the facility effectively maintained, cleaned and disinfected to prevent d) The surfaces of walls and floors should be in good condition, impervious, wear resistant and easy to clean.
physical, chemical and microbiological product contamination? e) The junctions between walls, floors and ceilings should be easy to clean.
f) Waste water and other liquids should reach drainage easily with no possibility of puddles.
g) In food handling areas, machinery and piping should be arranged so that waste liquids go directly into a drain.
B.B 2.3 Is the lighting of the appropriate intensity and design to ensure that food h) Drainage systems should be in good condition, easy to clean and designed to minimise the risk of product contamination (e.g. ingress of pests, etc.).
safety practice is effective? i) Ceilings (or, where no ceilings exist, the inside of roofs) and overhead fixtures, such as piping, cables and lighting, should be constructed to minimise the accumulation of
dirt and should not pose any risk of physical or microbiological contamination. Where false ceilings are used, access to the void should be provided to allow cleaning,
B.B 2.4 Are structures, surfaces and materials, those in contact with food easy to maintenance and pest control inspections.
maintain, clean and where appropriate disinfect? j) Windows and other openings should be designed and constructed to avoid the accumulation of dirt.
k) Where there is risk of contamination, windows and roof glazing should remain closed and fixed during production.
B.B 2.5 Are the drainage and waste water systems of equipment locations designed l) Where windows and roof glazing are designed to be opened for ventilation purposes, they should be fitted with easily removable, good condition pest screens or other
so as not to compromise food safety? measures in order to prevent contamination.
B.B 2.6 Are the grounds and surrounding areas of the facility maintained and kept m) In areas where unpackaged product is handled, windows should be protected against breakage.
free of waste and accumulated debris? n) Doors and gates should be in good condition and easy to clean (e.g. no splintering parts, flaking paints or corrosion).
o) External doors and gates should be constructed to prevent the entry of pests. If possible, they should be self-closing.
p) All working areas should have adequate lighting.
q) All lighting equipment should be protected by shatter proof covers and installed to minimise the risk of breakage.
r) Adequate natural and/or artificial ventilation should exist in all areas.
s) If ventilation equipment is installed, filters and other ingredient which require cleaning or replacement should be easily accessible.
t) Air conditioning equipment and artificially generated airflow should not lead to any product safety or quality risks.
u) Dust extraction equipment should be installed in areas where considerable amounts of dust are generated.
v) Water which is used as an ingredient in the production process, or for cleaning, should be of potable quality and supplied in sufficient quantity. This also applies to steam
and ice used within the food handling area. A supply of potable water should be available at all times.
w) Recycled water which is used in the process should not pose a contamination risk. In such cases, the water should comply with applicable legal requirements for potable
water; records of compliance testing should be available.
x) The quality of water, steam or ice should be monitored following a risk based sampling plan.
y) Non-potable water should be transported in separate, properly marked piping. Such piping should not be connected to the drinking water system, or allow the possibility
of flowing back to contaminate potable water sources or the food handling area environment.
z) The surrounding areas of the facility should be maintained and kept free of waste and accumulated debris. This will help to minimise risk of pest activity.

The Assessor will:
- Check the adequacy of the storage facilities for ensuring food safety and if every food, ingredient, raw material, semi-processed and finished product is stored under
conditions ensuring food safety.
- Inspect the fabrication of the facility both externally and internally, looking for any risks of contamination that may adversely affect the production of safe and legal finished
products.
B.B 3 Cleaning & Disinfection

The business shall ensure appropriate standards of cleaning and disinfection WHAT DOES IT MEAN?
shall be maintained at all times and throughout all production stages. a) The business should ensure that raw materials, ingredients, packaging materials and finished products are stored in a sanitary environment so that the finished product will
be safe and legal. To achieve this, the aim is to at all times operate and maintain a clean and hygienic environment, using clean equipment and with an expectation and
understanding of hygiene and cleanliness from your people.
b) An unsanitary environment will result in finished products that are not safe, not suitable for consumption and with reduced shelf-life.
c) Put simply, a food facility that does not constantly strive to achieve the highest level of cleanliness is a risk to its owners, its people, customers and its consumers.
d) A systematic cleaning programme with comprehensive cleaning instructions and schedule will be required. There should be procedures, a definition of acceptable cleaning,
well-trained people and the appropriate resources and equipment. Monitoring of sanitary standards will provide evidence of compliance and identify areas for improvement.

a) You need to document and implement a cleaning programme and schedule. The programme will consist of cleaning instructions (Standard Sanitary Operating Procedures
[SSOPs]) that provide
GFSI comprehensive
Global detail about
Markets Programme everything that
Manufacturing: is cleaned
Edition including
2 April 2015 equipment and the environment (e.g., floors, walls, ceilings, etc.). It will also include a
cleaning schedule.
b) The SSOPs will be used to train people and will include details of the materials that are used, the personal protective equipment that must be worn, who is responsible for
cleaning and for checking before the area is used for production.
WHAT DOES IT MEAN?
a) The business should ensure that raw materials, ingredients, packaging materials and finished products are stored in a sanitary environment so that the finished product will
be safe and legal. To achieve this, the aim is to at all times operate and maintain a clean and hygienic environment, using clean equipment and with an expectation and
understanding of hygiene and cleanliness User
fromGuidance
your people.
Items Requirements b) An unsanitary environment will result in finished products that are not safe, not suitable for consumption and with reduced shelf-life.
Guidance
Are documented cleaning and disinfection procedures in place and c) Put simply, a food facility that does not constantly strive to achieve the highest level of cleanliness is a risk to its owners, its people, customers and its consumers.
B.B 3.1 d) A systematic cleaning programme with comprehensive cleaning instructions and schedule will be required. There should be procedures, a definition of acceptable cleaning,
effective, including verification activities, to ensure the cleanliness of the
facility, utilities and equipment? well-trained people and the appropriate resources and equipment. Monitoring of sanitary standards will provide evidence of compliance and identify areas for improvement.
a) You need to document and implement a cleaning programme and schedule. The programme will consist of cleaning instructions (Standard Sanitary Operating Procedures
B.B 3.2 Are cleaning equipment, utensils and chemicals clearly marked, stored in a [SSOPs]) that provide comprehensive detail about everything that is cleaned including equipment and the environment (e.g., floors, walls, ceilings, etc.). It will also include a
segregated area away from product, equipment, packaging and suitable for cleaning schedule.
intended use? b) The SSOPs will be used to train people and will include details of the materials that are used, the personal protective equipment that must be worn, who is responsible for
cleaning and for checking before the area is used for production.
c) The programme will establish cleaning thresholds, training procedures including health and safety, supervision controls, records to be maintained, monitoring checks and a
Are qualified, trained people used for cleaning and disinfection? process for review.
B.B 3.3 d) The programme will establish how to deal with significant changes in production process or equipment.
e) The cleaning schedule will identify what is to be cleaned, when, by whom and to which SSOP.
f) The business needs to ensure specified chemicals and cleaning equipment are suitable for their intended use and properly stored.
g) Specified chemicals should be appropriate for the application and not pose a risk of contamination such as having strong odours or leaving any residue after rinsing.
o They should come with a safety data sheet which addresses how to safely handle the chemical and steps to take in the event of accidental exposure.
o They should be stored in labelled containers and have instructions on their safe and proper use in a food production application.
o They should be stored safely to minimise risk of reaction with other chemicals, avoid contamination of product, ingredients or equipment and not put people at risk.
h) Verification activities are those which prove the cleaning and sanitation activities have been carried our as per the specified procedure.

The Assessor will:
- Observe the production, handling and storage environment and inspect the production and cleaning equipment.
- In the event that production is in progress during the assessment, the assessor will look for physical evidence that a production area and its equipment is being maintained
in a sanitary state.
- Check documents including the cleaning programme, schedule, training records, cleaning records and SSOPs procedures, monitoring records and employee training records.
B.B 4 Product Contamination Control

The business shall ensure appropriate facilities and procedures are in place WHAT DOES IT MEAN?
to minimise the risk of physical, chemical, or microbiological contamination a) The business should have in place procedures to prevent, control and detect contamination. Measures to prevent physical, allergen and microbiological contamination
of product. should be included.
b) Allergens are a known component of food which causes physiological reactions due to an immunological response, such as nuts or shellfish.

a) All production and processing procedures should be systematically analysed to identify any potential hazards (physical, chemical and biological) that could occur with
consideration of the susceptibility of the raw materials, ingredients and the final product. The hazards should be described and the most appropriate preventive and
corrective actions implemented. In particular, consider these issues:
b) Microbiological:
- Separation of raw from finished or ready to eat products.
- Structural segregation such as physical barriers, walls and separate buildings.
- Access controls with requirements to change into required work wear.
- Traffic patterns within the production area and equipment segregation: people, materials, equipment and the use of dedicated tools.
- Air pressure differentials.
c) Allergen:
- Products should be protected from unintended allergen cross contact by effective cleaning and comprehensive line change-over practices and product sequencing.
- The manufacturing of products which contain allergens that require labelling should be carried out as to ensure cross contamination is minimized.
d) Metal:
- Where metal detectors are required, they should be installed to ensure maximum efficiency of detection and to avoid any subsequent contamination.
- Detectors should be subjected to regular maintenance and calibration to avoid malfunction.
e) Glass:
- Remove glass wherever possible from production facilities.
- Create a complete glass register, including location.
- Inspect or glass locations systematically and record all breakages.

WHAT DOES IT MEAN?
a) The business should have in place procedures to prevent, control and detect contamination. Measures to prevent physical, allergen and microbiological contamination
User Guidance
should be included.
b) Allergens are a known component of food which causes physiological reactions due to an immunological response, such as nuts or shellfish.
B.B 4.1 Are physical barriers or effective procedures in place to reduce and avoid
the risk of any potential physical, chemical or microbiological WHAT DO I NEED TO DO?
contamination? a) All production and processing procedures should be systematically analysed to identify any potential hazards (physical, chemical and biological) that could occur with
consideration of the susceptibility of the raw materials, ingredients and the final product. The hazards should be described and the most appropriate preventive and
corrective actions implemented. In particular, consider these issues:
b) Microbiological:
- Separation of raw from finished or ready to eat products.
- Structural segregation such as physical barriers, walls and separate buildings.
- Access controls with requirements to change into required work wear.
- Traffic patterns within the production area and equipment segregation: people, materials, equipment and the use of dedicated tools.
- Air pressure differentials.
c) Allergen:
- Products should be protected from unintended allergen cross contact by effective cleaning and comprehensive line change-over practices and product sequencing.
- The manufacturing of products which contain allergens that require labelling should be carried out as to ensure cross contamination is minimized.
d) Metal:
- Where metal detectors are required, they should be installed to ensure maximum efficiency of detection and to avoid any subsequent contamination.
- Detectors should be subjected to regular maintenance and calibration to avoid malfunction.
e) Glass:
- Remove glass wherever possible from production facilities.
- Create a complete glass register, including location.
- Inspect or glass locations systematically and record all breakages.

The Assessor will:
- Inspect areas where there is potential for microbiological cross contamination due to airborne or traffic patterns within the production facility.
- Check the use of chemicals, looking for evidence that they are suitable for their intended use.
- Will assess the potential for foreign material contamination from glass, metal, wood and plastic as well as the controls that are in place to minimise risk.
- Examine procedures for line changeover, looking for evidence that contamination risks between different products or through cleaning processes have been addressed with
appropriate procedures for control that will minimise risk.
- Interview people to establish whether they understand about contamination hazards and have been trained on how they can reduce risks.
- Look for the presence of allergens within the facility and if present, examine evidence of how they are controlled and contamination risks are minimised.
B.B 5 Pest Control

The business shall ensure controls are in place to reduce or eliminate the WHAT DOES IT MEAN?
risk of pest infestation (including rodents, insects and birds). a) Pests and vermin can introduce bacteria and filth into the production and storage environment making the product unsuitable for use. They want to enter the facility to
get access to food, water, bedding and to breed and should be excluded.
b) Effective pest and vermin control is not just eliminating them once they appear. Good practice in pest control addresses a broad range of issues including attraction, places
Is there evidence of pest infestation? of refuge, access to the site and to food and monitoring.
B.B 5.1
B.B 5.2 Is an effective pest control programme in place? a) The business should have an effective preventive pest control programme that will minimise the risk of infestation. There should be someone with competence and
Are the controls appropriate in relation to the product, raw material and responsibility. All activities will be monitored and verified. It should competently deal with any issues which occur so that risk to product is prevented.
B.B 5.3 b) External areas should be kept free of waste, debris and food sources.
facility?
c) A 0.5m perimeter around all buildings should be maintained that is completely clear and provides no place of refuge.
d) Out of use equipment, construction debris and any other redundant materials should not be stored close to the site.
e) All doors and windows are to be kept closed whenever possible and when closed should provide no gaps that would allow access.
f) Ensure that the cleaning schedule removes all food debris with resulting proper waste containment and management.
g) Monitor or target pest and vermin species with the appropriate equipment outside (e.g. bait stations) and inside (e.g. electronic fly killers, rodent catch traps, pheromone
traps etc.).
h) Bait stations should not be used inside the facility as there is a risk of rodents having contact with raw materials, ingredients, finished products, equipment etc.
i) Monitoring devices should not be positioned where their operation or checking may cause contamination.
j) A map should be maintained which shows all pest control stations, each of which should be numbered and monitored.
k) Monitoring will provide data about typical pests in the area, with consideration for seasonality and the possibility that pests enter with incoming goods.
l) It is good practice to appoint a third party pest control specialist that is licensed by the local regulatory authority.
m) If your own people are undertaking pest and vermin control activity, they should be trained and properly licensed.
n) Check with the local regulatory authority to ensure your monitoring and corrective action are appropriate and recognised.
o) All monitoring activities need to be identified, planned, carried out and recorded.
WHAT WILL THE ASSESSOR DO? The Assessor will:

- Check the site for
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2 April pests or vermin, droppings, etc.).
- Check that there is someone responsible for pest control (whether internal or external) and examine evidence of their activities.
- Look for a map identifying pest monitoring and control devices, considering whether there is proper placement and looking for evidence that each one is numbered and
regularly monitored.
of refuge, access to the site and to food and monitoring.
a) The business should have an effective preventive pest control programme that will minimise the risk of infestation. There should be someone with competence and
responsibility. All activities will be monitored
User and verified. It should competently deal with any issues which occur so that risk to product is prevented.
Guidance
b) External areas should be kept free of waste, debris and food sources.
c) A 0.5m perimeter around all buildings should be maintained that is completely clear and provides no place of refuge.
B.B 5.4 Is the inspection programme undertaken by a competent person at an d) Out of use equipment, construction debris and any other redundant materials should not be stored close to the site.
appropriate frequency and are findings addressed? e) All doors and windows are to be kept closed whenever possible and when closed should provide no gaps that would allow access.
f) Ensure that the cleaning schedule removes all food debris with resulting proper waste containment and management.
g) Monitor or target pest and vermin species with the appropriate equipment outside (e.g. bait stations) and inside (e.g. electronic fly killers, rodent catch traps, pheromone
traps etc.).
h) Bait stations should not be used inside the facility as there is a risk of rodents having contact with raw materials, ingredients, finished products, equipment etc.
i) Monitoring devices should not be positioned where their operation or checking may cause contamination.
j) A map should be maintained which shows all pest control stations, each of which should be numbered and monitored.
k) Monitoring will provide data about typical pests in the area, with consideration for seasonality and the possibility that pests enter with incoming goods.
l) It is good practice to appoint a third party pest control specialist that is licensed by the local regulatory authority.
m) If your own people are undertaking pest and vermin control activity, they should be trained and properly licensed.
n) Check with the local regulatory authority to ensure your monitoring and corrective action are appropriate and recognised.
o) All monitoring activities need to be identified, planned, carried out and recorded.
- Check the site for active infestations and evidence of pest activity (live or dead pests or vermin, droppings, etc.).
- Check that there is someone responsible for pest control (whether internal or external) and examine evidence of their activities.
- Look for a map identifying pest monitoring and control devices, considering whether there is proper placement and looking for evidence that each one is numbered and
regularly monitored.
- Look at records of monitoring activities and pesticide applications.
- Check the external areas for potential refuge and breeding areas.
- Check opportunities for pest and vermin access to the facility (doors, windows, bay doors, exhaust fans and structural deficiencies).
B.B 6 Water Quality

The business shall ensure that the quality of water, ice or steam in contact WHAT DOES IT MEAN?
with food product is suitable for is intended use. a) Water, ice or steam used within your facility can be a source of microbial and chemical contamination for your equipment or product.
All food contact water, ingredient water and water used in cleaning and b) As a food manufacturer it is your responsibility to ensure that sufficient measures are taken to ensure its suitability for use within your operation and that your procedures
sanitising operations shall be from a potable source. ensure that water, ice or steam used within your operations meet the required water quality standards.
c) Procedures for water quality, including the identification of chemical and microbial elements that should be included in required water analysis, the frequency of analysis
and sampling points should be based on a risk analysis that takes into account the water source ( i.e. municipal water source, well, etc.), previous sample history and any on-
site storage.

B.B 6.1 Are there processes in place to ensure that the quality of water, steam and a) Ensure that a risk analysis has been completed in relation to the water used within your operations which will provide the basis for your water quality procedures and
ice does not compromise the food safety of the finished product? policies.
b) Ensure that water used for either the washing, thawing and treating of food or as a food ingredient complies with local, national or internationally recognised potable
water quality and microbiological standards.
c) Your sources of water, steam or ice should be tested at least annually by your local water authority or by an independent, university or government laboratory. These
records should be retained.
d) If you purchase and use ice from an outside source, you should require them to provide annual verification that the ice meets the required standards and a copy of the
report should be retained.
e) Procedures should be established to ensure that water is not a source of contamination for your facility or product.
f) Employees should be trained to ensure they understand the established procedures established in your operations.
g) If your operations have in-house water treatment equipment you should ensure that the equipment is included in your preventative maintenance programme and treated
water is monitored to ensure that it meets your established standards. Maintenance and testing records should be retained.
The Assessor will:
- Check your procedures and policies addressing water quality
- Examine your training documentation,
- Review annual water quality reports for your water, ice & steam
- Check the preventative maintenance documentation for any water treatment equipment you may use
- Inspect the signage or other visual identification (such as colour coding) to confirm that any non-potable water piping or outlets is clearly identified.

a) Ensure that a risk analysis has been completed in relation to the water used within your operations which will provide the basis for your water quality procedures and
policies.
b) Ensure that water used for either theUser
washing, thawing and treating of food or as a food ingredient complies with local, national or internationally recognised potable
Guidance
water quality and microbiological standards.
c) Your sources of water, steam or ice should be tested at least annually by your local water authority or by an independent, university or government laboratory. These
B.B 6.2 Are there processes in place to prevent the cross-contamination of potable records should be retained.
water by non-potable water? d) If you purchase and use ice from an outside source, you should require them to provide annual verification that the ice meets the required standards and a copy of the
report should be retained.
e) Procedures should be established to ensure that water is not a source of contamination for your facility or product.
f) Employees should be trained to ensure they understand the established procedures established in your operations.
g) If your operations have in-house water treatment equipment you should ensure that the equipment is included in your preventative maintenance programme and treated
water is monitored to ensure that it meets your established standards. Maintenance and testing records should be retained.

The Assessor will:
- Check your procedures and policies addressing water quality
- Examine your training documentation,
- Review annual water quality reports for your water, ice & steam
- Check the preventative maintenance documentation for any water treatment equipment you may use
- Inspect the signage or other visual identification (such as colour coding) to confirm that any non-potable water piping or outlets is clearly identified.

The business shall ensure that staff facilities be designed and operated so as WHAT DOES IT MEAN?
to minimize food safety risks. a) Staff facilities, such as toilets, changing rooms and eating areas should be designed and operated to make sure that employees using these facilities do not accidently
create a food safety hazard.
B.B 7.1 Are suitable changing rooms provided for staff?
B.B 7.2 Are toilets provided, operational, accessible and adequately segregated WHAT DO I NEED TO DO?
from processing/ food handling areas? a) Establish and document rules and procedures for staff facilities to ensure that the employee activities in these facilities are separated from the food handling area to
reduce food safety risk.
B.B 7.3 Are suitable and sufficient hand-washing facilities provided and accessible? WHAT WILL THE ASSESSOR DO?
The Assessor will:
- Inspect the facilities to ensure they are fit for the purpose.
- Review documentation and procedures to show that the staff facilities are regulated to minimize food safety risk.
B.B 7.4 Are separate lunch room facilities provided away from production,
packaging and storage areas?

The business shall have a programme in place for the collection and WHATS DOES IT MEAN:
disposal of waste material. a) If handled incorrectly, waste materials can accumulate and become a source of contamination or a refuge for pests.
b) Food facilities should have procedures for waste management that include the allocation of responsibility and the methods used to collect, handle and remove waste
Are suitable provisions in place for the storage and removal of waste? materials.
B.B 8.1 c) These procedures should also address any legal requirements.

a) Establish procedures that address the responsibility for and methods used to collect handle and remove waste materials from the facility. These procedures should include
the following:
○ Detailed cleaning practices associated with waste containers and waste storage areas. In both cases, these should be easy to clean, covered or kept closed (as appropriate)
and included in the cleaning programme.
○ Waste containers should only be used for the storage of waste.
○ Procedures for waste collection containers and waste storage areas including handling, marking, usage and colour coding.
○ The exact usage and marking or visual identification of containers that are designated to be used for inedible food waste materials.
○ Required waste management training for employees.
○ Actions to take if procedures are not followed.

The Assessor will:
- Review the waste management programme and associated procedures.
- Review adherence to waste management procedures for containers including handling, markings, usage and colour coding.
- Observe the usage and marking or visual identification of containers designated for use for inedible, waste materials or by products (e.g. animal feed)
- Observe if signage clearly informs people about the colour code system.
- Check training records verifying that people have been trained in waste management procedures.
- Check sanitation records for waste containers and waste storage areas, assessing whether planned cleaning has been carried out according to procedures.

WHATS DOES IT MEAN:
a) If handled incorrectly, waste materials can accumulate and become a source of contamination or a refuge for pests.
b) Food facilities should have procedures for waste management that include the allocation of responsibility and the methods used to collect, handle and remove waste
materials.
c) These procedures should also addressUser
any legal requirements.
Guidance
B.B 8.2 Are containers designated for inedible products, waste or by-products a) Establish procedures that address the responsibility for and methods used to collect handle and remove waste materials from the facility. These procedures should include
clearly marked and properly utilised? the following:
○ Detailed cleaning practices associated with waste containers and waste storage areas. In both cases, these should be easy to clean, covered or kept closed (as appropriate)
and included in the cleaning programme.
○ Waste containers should only be used for the storage of waste.
○ Procedures for waste collection containers and waste storage areas including handling, marking, usage and colour coding.
○ The exact usage and marking or visual identification of containers that are designated to be used for inedible food waste materials.
○ Required waste management training for employees.
○ Actions to take if procedures are not followed.

The Assessor will:
- Review the waste management programme and associated procedures.
- Review adherence to waste management procedures for containers including handling, markings, usage and colour coding.
- Observe the usage and marking or visual identification of containers designated for use for inedible, waste materials or by products (e.g. animal feed)
- Observe if signage clearly informs people about the colour code system.
- Check training records verifying that people have been trained in waste management procedures.
- Check sanitation records for waste containers and waste storage areas, assessing whether planned cleaning has been carried out according to procedures.
B.B 9 Storage and Transport

The business shall ensure that all raw materials (including packaging), semi WHAT DOES IT MEAN?
processed product and finished product be stored and transported under a) During the storage and transportation of food products all relevant contamination and deterioration parameters (such as temperature, humidity etc.) should be evaluated.
conditions that protect the product. b) All necessary measures should be taken to avoid contamination and deterioration.
a) Before loading food for delivery, the condition of the vehicle (e.g. odours, dust, adverse humidity, cleanliness, pests, mould) should be checked. If required, action should
B.B 9.1 Are there adequate facilities for the storage of food and ingredients? be taken.
b) Adequate hygienic requirements for all transport vehicles and for the equipment used for loading and unloading should be in place. There should be records of the
measures taken.
c) Procedures to prevent contamination during transport should be implemented (food should not be mixed with other types of goods).
B.B 9.2 Are the food storage facilities constructed to effectively protect materials d) Where goods should be transported at certain temperatures, before loading, the temperature inside the vehicle should be checked and documented.
and finished product from contamination during storage? e) Where goods should be transported at certain temperatures, the maintenance of an adequate range of temperatures during transport should be checked and
documented.
f) Loading and unloading areas should be of appropriate construction or have equipment in place to protect transported products from contamination, adverse temperature
B.B 9.3 Is the food transport appropriate to minimize deterioration of food (e.g., by conditions etc.
temperature and humidity control). g) In the event that food goods are transferred during their journey, there should be procedures that ensure protection against contamination or deterioration.
h) Where a business hires a third-party transport service provider, all the requirements specified above should be defined in the respective contract.
i) Security of transport vehicles should be appropriately maintained.
The Assessor will:
- check if the above mentioned requirements are fulfilled for minimizing any possible contamination or deterioration of food.
- Observe arrangements for storage and transport, looking at storage areas, vehicles, loading bays and equipment.
- Inspect third-party service contracts as relevant, assessing whether the necessary requirements for food protection are formally agreed.
I.B 9 Storage and Transport

User Guidance
The business shall ensure that all raw materials (including packaging), semi WHAT DOES IT MEAN?
processed product and finished product be stored and transported under a) The business should ensure that all raw materials (including packaging), semi processed product and finished product be transported under conditions that protect product
conditions that protect product integrity. integrity.
All vehicles, including contracted vehicles used for the transportation of raw b) A procedure should be implemented that assigns roles and responsibilities, control processes and a corrective action plan.
materials (including packaging), rework, semi processed product and
finished product shall be suitable for the purpose, maintained in good WHAT DO I NEED TO DO?
repair and be clean. a) The product storage and transport procedure should provide full details so that people with responsibility will understand the relevant principles of the quality and food
safety management system.
b) The procedure will include the following:
○ identification of the required processes with a definition of the sequence and interaction
○ the criteria and methods required to ensure effective operation and control
○ the availability of information necessary to support both operation and monitoring
I.B 9.1 Is there a product transport procedure and is it effectively implemented? ○ measure, monitor and analyse the procedure, implementing any necessary action to achieve planned results and drive improvement.
Is there a transport vehicle procedure and is it effectively implemented? WHAT WILL THE ASSESSOR DO?
I.B 9.2 The Assessor will:
- Check the relevant procedures and the instructions concerning their implementation, compare with the associated records and assess whether the procedures are affected.
I.B 9.3 Are there maintenance and hygiene processes for vehicles and equipment - Interview relevant staff to confirm their understanding of the requirements for storage and transport.
used for loading and unloading? - Check training records.
Are very effectively implemented?
I.B 10 Facility and Equipment Maintenance

The business shall implement a system of planned, preventive and WHAT DOES THIS MEAN:
corrective maintenance to ensure an adequate level of food safety in the a] A process for maintenance and repair needs to be created and followed to ensure all critical equipment is functioning properly to maintain food safety standards.
facility.
I.B 10.1 Is a documented maintenance programme established? a] Identify the critical processing equipment and develop procedures for the inspection and maintenance of critical equipment.
b] Maintenance programmes need to be developed which inspects and repairs equipment before a food safety failure occurs.
I.B 10.2 Is an effective maintenance programme implemented?
I.B 10.3 Is a documented hygiene and clearance procedure in place for all WHAT WILL THE ASSESSOR DO?
maintenance activities? The Assessor will:
- Check the documentation of the preventative maintenance programme, key pieces of equipment identified, frequency of inspection, inspection findings and corrective
I.B 10.4 Are effective hygiene procedures implemented for maintenance activities? actions taken.
I.B 10.5 Are all materials used for maintenance and repair appropriate for their
intended use?
C. Control of Food Hazards

B.C 1 Preliminary tasks
The business shall identify and comply with regulatory and customer WHAT DOES THIS MEAN?
requirements related to the product and to the product category. a) The effective control of food hazards require the business to fully understand their products and product categories and how they are manufactured.
For all products, the following shall be included: b) This understanding must be accurately described and maintained in the event of change.
• Task 1: Establish a multi-disciplinary food safety team. c) A multidisciplinary team with decision-making authority should be formed that can jointly research and answer the following questions:
• Task 2: Describe the product and product category of all ingredients ○ What legal and customer requirements apply?
(including raw materials, packaging, finished product) and the required ○ How is the finished product described?
conditions for storage and distribution. ○ Who will consume the specific products?
• Task 3: Describe the intended use of the product and identify the target ○ How are the products manufactured?
consumer.
• Task 4: Describe all of the steps taken to produce the product in a process WHAT DO I NEED TO DO?
flow diagram. a) Develop and implement a procedure to check that the relevant legal and customer requirements are reviewed and that the business is in conformity with those
• Task 5: Compare the process flow diagram with the production process to requirements.
ensure it is accurate. b) Form a multi-disciplinary team, with knowledge and experience in manufacturing, food safety, engineering, procurement and distribution.
c) Authorise the team to make decisions on topics related to food safety.
d) Develop and maintain accurate and detailed descriptions of each product or groups of products that considers the following: raw materials, packaging, processes and their
parameters, characteristics of product, finished product, conditions for storage and distribution, and others (see the list provided in B.C 1.3).
e) Develop and maintain specifications about who can consume the products, how it should be used, how it should be consumed and to whom it is not recommended.
f) Develop and maintain a comprehensive flowchart that reliably represents the processes or stages of manufacture of the products or product groups.

User Guidance
Items Requirements
The business shall identify and comply with regulatory and customer Guidance
WHAT DOES THIS MEAN?
requirements related to the product and to the product category. a) The effective control of food hazards require the business to fully understand their products and product categories and how they are manufactured.
For all products, the following shall be included: b) This understanding must be accurately described and maintained in the event of change.
• Task 1: Establish a multi-disciplinary food safety team. c) A multidisciplinary team with decision-making authority should be formed that can jointly research and answer the following questions:
• Task 2: Describe the product and product category of all ingredients ○ What legal and customer requirements apply?
(including raw materials, packaging, finished product) and the required ○ How is the finished product described?
conditions for storage and distribution. ○ Who will consume the specific products?
• Task 3: Describe the intended use of the product and identify the target ○ How are the products manufactured?
consumer.
• Task 4: Describe all of the steps taken to produce the product in a process WHAT DO I NEED TO DO?
flow diagram. a) Develop and implement a procedure to check that the relevant legal and customer requirements are reviewed and that the business is in conformity with those
• Task 5: Compare the process flow diagram with the production process to requirements.
ensure it is accurate. b) Form a multi-disciplinary team, with knowledge and experience in manufacturing, food safety, engineering, procurement and distribution.
c) Authorise the team to make decisions on topics related to food safety.
d) Develop and maintain accurate and detailed descriptions of each product or groups of products that considers the following: raw materials, packaging, processes and their
parameters, characteristics of product, finished product, conditions for storage and distribution, and others (see the list provided in B.C 1.3).
e) Develop and maintain specifications about who can consume the products, how it should be used, how it should be consumed and to whom it is not recommended.
f) Develop and maintain a comprehensive flowchart that reliably represents the processes or stages of manufacture of the products or product groups.

The Assessor will:
- Check that there is a system in place to identify legal and customer requirements that apply to the products or product categories, that these are reviewed and that the
business is in conformity with those requirements.
- Check that there is an internal multi-disciplinary team in place, with responsibilities defined, that they are knowledgeable and competent and have the capacity and
authority to make decisions and implement change.
- Review the detailed description of each product (as per B.C 1.3); checking that there is information about shelf life, nutritional analysis and other relevant food safety issues.
- Check finished product labels, confirming there is identification of the intended use of the product with accompanying description of any consumer groups that may be at
risk
- Check the production flowcharts and confirmed that they compare accurately with the manufacturing process.
B.C 1.1 Has the business identified and complied with regulatory and customer Supplementary guidance. You should:
requirements related to the product and product categories? ○ Define the principles on which the production of a safe product is based.
○ Identify the specifications or any agreement relating to the product has been agreed with all customers.
○ Define which specific regulations are applicable and are assured by the procedure.
○ In the event of export, identify regulations of the destination country, specifically for labelling.
○ Ensure a systematic and appropriate approach to recording key information, with frequency and responsibility defined.
○ Ensure the food safety management system is reviewed on a regular basis or when changes occur.
B.C 1.2 Has a team with different responsibilities for food safety undertaken the Supplementary guidance. You should:
tasks described in this section of the checklist (Tasks 2-5)? ○ Developed a multi-disciplinary team with members from the following areas: food safety, production, engineering, procurement, distribution.
○ Ensure that the team member representing food safety has appropriate qualifications and can provide evidence of their education and advanced training topics.
○ In the event that there are no such qualified people, the business should have a service contract with an external expert who can provide evidence of their expertise.

User Guidance
B.C 1.3 Is there a complete product description available of the product/product Supplementary guidance. You should:
category including all ingredients including raw materials, packaging, a) Generate an accurate and complete hazard analysis by the preparation and maintenance of comprehensive information about your products ('product descriptions') and
finished product and conditions for stage and distribution? processes ('process descriptions').
b) The specifications designated for this purpose should include the following information:
○ Composition
○ Ingredients
○ Physical, sensory, chemical, and microbiological parameters
○ Methods of treatment
○ Packaging procedures and materials
○ Shelf life
○ Storage and transport conditions.
c) The business should consider:
○ Allergenic ingredients
○ Genetically modified materials
○ The purpose of the product, from the point of view of the end consumer (e.g. baby food, dietary products, nutritional supplements, etc.).
d) From the point of view of the manufacturer, it should be pre-emptively determined how the products change when used as intended. For this purpose, the business should
consider:
○ list of ingredients (where applicable fresh, frozen)
○ packaging type
○ chemical analysis
○ nutritional information
○ storage information
○ warnings
○ suggestions for preparation
○ suitability of the packaging for heating or freezing
○ quantitative restrictions, e.g. for especially vulnerable consumer groups.
B.C 1.4 Has the intended use of the product been decribed and the target Supplementary guidance. You should:
consumer been been identified? ○ Accurately document the intended use describing how it will be prepared, consumed and whether there are any guidelines required to ensure that it is safe for
consumption.
○ For products where additional preparation is required, described what should be done with the product once opened, how long it can be stored and in what conditions
and what are the recommended portion sizes.
○ For intended use, identify how to prevent misuse that could cause harm to the consumer.
○ Describe the target consumer. Who can consume the product and to whom it is not recommended. Consider vulnerable groups, such as children, infants, the elderly,
pregnant women, people with food intolerance, allergies, diabetes etc.
B.C 1.5 Have all of the process steps taken to produce the product been described Supplementary guidance. You should:
in a process flow diagram? ○ Develop and maintain a flow chart that shows all stages of the manufacturing process, including any rework.
○ Describe in the flowchart relevant inputs and outputs of each process (raw materials, ingredients, packaging material, rework, nonconforming product, process aids,
finished goods, etc.)
B.C 1.6 Has the process flow diagram(s) been compared to assure it accurately Supplementary guidance. You should:
reflects the process? ○ Having defined your flowchart, the multidisciplinary team must verify that their analysis accurately represents the manufacturing of the product.
○ The process of verification should be recorded with all team members committing in writing to the credibility of the flowchart.
○ Verification should be repeated systematically.
B.C 2 Control of Allergens

The business shall ensure that there are adequate control measures in place WHAT DOES IT MEAN?
to prevent cross contamination of allergens. a) An allergen is a known component of food which causes physiological reactions due to an immunological response (e.g. nuts and others identified in the legislation
All ingredients known to cause food allergies in the product shall be clearly relevant to the country of production or sale).
identified and communicated to the customer. b) Allergens can lead to allergic reactions that may pose considerable health hazards for consumers such as skin reactions, shock and even death.
c) You should identify, manage and control all allergens that are present on the site whether as ingredients or through process cross-contamination.
Is a documented programme in place to control allergens and prevent d) The labelling of allergens contained in manufactured food products should be done on the basis of the hazard analysis.
B.C 2.1 e) The manufacturing of products which contain allergens that require labelling should be carried out as to ensure that any risk of cross contamination is minimised.
cross-contamination of product through all stages of production?
a) You should determine which allergens are relevant to your product or process.
b) Once this is achieved, you will be able to determine the risk and your options to eliminate, minimise and/or control their presence.
c) During risk identification, consider customer requirements and regulations in country of production and of sale.
d) Once allergens are identified, develop and maintain a list of all relevant raw materials and ingredients.
e) For ingredients and raw materials identified as allergens, you should write specifications that include the following: risk analysis, mitigation, control procedures and their
implementation
GFSI including analytical
Global Markets results and Manufacturing:
Programme final product labelling.
f) For products that contain allergens requiring labelling, the manufacturing process should be carried out to minimise cross contamination with close attention to cleaning
and sanitation.
g) Finished products that contain allergens and require labelling should be declared in accordance with legal requirements in the country of sale.
b) Allergens can lead to allergic reactions that may pose considerable health hazards for consumers such as skin reactions, shock and even death.
c) You should identify, manage and control all allergens that are present on the site whether as ingredients or through process cross-contamination.
d) The labelling of allergens contained in manufactured food products should be done on the basis of the hazard analysis.
e) The manufacturing of products which contain allergens that require labelling should be carried out as to ensure that any risk of cross contamination is minimised.
User Guidance
a) You should determine which allergens are relevant to your product or process.
B.C 2.2 Were regulations and appropriate customer requirements addressed in the b) Once this is achieved, you will be able to determine the risk and your options to eliminate, minimise and/or control their presence.
development of the allergen control programme? c) During risk identification, consider customer requirements and regulations in country of production and of sale.
d) Once allergens are identified, develop and maintain a list of all relevant raw materials and ingredients.
e) For ingredients and raw materials identified as allergens, you should write specifications that include the following: risk analysis, mitigation, control procedures and their
implementation including analytical results and final product labelling.
B.C 2.3 Are potential causes of cross contamination identified and procedures f) For products that contain allergens requiring labelling, the manufacturing process should be carried out to minimise cross contamination with close attention to cleaning
established for the handling of raw materials, intermediate and finished and sanitation.
products to avoid cross contamination? g) Finished products that contain allergens and require labelling should be declared in accordance with legal requirements in the country of sale.
h) For any accidental and unintentional presence, the labelling of legally declared allergens should be based on hazard analysis and risk assessments.
Are procedures relating to the cleaning and sanitation of product contact WHAT WILL THE ASSESSOR DO?
B.C 2.4 The Assessor will:
surfaces in place and effective to remove all potential allergens from food
contact surfaces? - Confirm that comprehensive and relevant risk analysis has been carried out and that its outcomes are included in relevant procedures.
- Check if the programme for allergen control is documented and implemented.
- Assess the delivery of the programme in the food handling area, examine records and review manufacturing and storage practices.
B.C 2.5 Is a clear labelling system in place ensuring continuous identification of the
product through all stages of production and delivery?
I.C 3 HACCP
The business shall perform a hazard analysis of their food manufacturing WHAT DOES THIS MEAN?
process as a minimum step in order to determine if there are any hazards a) For each manufacturer of food products, the Hazard Analysis and Critical Control Point (HACCP) concept is a fundamental element of the business's internal food safety
associated with the production of their food item. management system.
The business shall use the HACCP [Hazard Analysis Critical Control Point] b) HACCP is an internationally recognised instrument for controlling food safety in the manufacturing process. It enables the recognition and control of potential consumer
tool to accomplish this assessment. risks by implementing suitable preventative measures.
If hazards are identified within the manufacturing process, it is expected c) Control measures may be identified which are critical to maintaining product safety and will minimise the potential for biological, chemical and physical hazards which if
that the business will take appropriate action necessary to develop a HACCP not properly controlled may produce illness, injury or death to the consumer. These will be identified as Critical Control Points (CCPs), with critical limits and monitoring
Plan that meets the 7 principles reflected within Codex Alimentarius. processes established.
d) Corrective actions will be established which are designed to ensure if the critical limits are violated. In such cases, the finished product does not leave the facility.
e) There should be records of monitoring the CCPs and corrective action taken.

User Guidance
a) It is not sufficient to just define a CCP and implement inspections. An effective HACCP concept, with adequate documentation, requires:
○ a systematic approach.
○ an expert multi-disciplinary team.
○ a comprehensive analysis of all products and procedures.
○ a risk analysis with definition of CCPs and critical limits.
○ a demonstrable system for corrective measures with a regular, systematic review of effectiveness.
b) Codex Alimentarius provides 12 steps with seven principles for implementing HACCP and the business needs to follow these.
c) The following principles should govern your HACCP system:
○ Principle 1 - Develop a hazard analysis for each level of the flow charts.
○ Principle 2 - Determine the CCPs within the scope of your HACCP plan.
○ Principle 3 - Determine critical limit values for all CCPs.
○ Principle 4 - Develop a system for inspecting and controlling the CCPs.
○ Principle 5 - Determine corrective measures and implement them when necessary.
○ Principle 6 - Regularly review the effectiveness of your HACCP programme.
○ Principle 7 - Create documentation for all steps of the concept including processes and procedures.
d) Begin by defining where your process starts and where it ends. This is the scope of your system as it relates to departments and products.
e) Define the area of application by establishing which production departments, products, product and packaging lines, storage areas and transport routes should be
considered, including the following:
○ Number of production lines and differentiation of product categories.
○ Existing hygiene, production, and control standards
f) Evaluate the risk of harm to consumers as result of consumption of your food product using: literature data, objective and proven values, market observations, effects of
customer complaints and assessment of residual risk.
- Check for evidence that HACCP principles 1-7 have been developed and implemented.
- Assess your documentation, looking to establish that it is complete, current, correct, and sufficiently known to all responsible people.
- Check that there is an internal multi-disciplinary team in place, with responsibilities defined, that they are knowledgeable and competent and have the capacity and
authority to make decisions and implement change.
I.C 3.1 Principle 1: Is a hazard analysis conducted for each process step in the Supplementary guidelines. You should:
manufacturing of the food item? ○ Consider in your hazard analysis the potential for all chemical (including allergens), microbiological, and physical hazards that could occur within the process.
○ Address the potential hazards (biological, chemical, physical) associated with the production inputs from raw materials and ingredients (including water, steam, ice or gases
used as ingredients).
○ Undertake hazard analysis for each process step, considering chemical, microbiological and physical hazards each time.
○ Undertake risk analysis for all product groups including consideration of potential harm and likelihood.
I.C 3.2 Was the hazard analysis conducted by a competent team? Supplementary guidelines. You should:
○ Create a multidisciplinary team to include members with knowledge and experience from food safety, production, engineering, procurement and design.
○ Ensure that team members have been trained in the principles of HACCP based on Codex Alimentarius
○ Ensure that the team member representing food safety has appropriate qualifications and can provide evidence of their education and advanced training topics.
○ Ensure that in the event that there is no such qualified person, the business should have a service contract with an external expert who can provide evidence of their food
safety expertise.
I.C 3.3 Principle 2: If the hazard analysis indicates any significant hazards not Supplementary guidelines. You should:
minimised or eliminated by Good Manufacturing Practices (GMPs) that are ○ When determining that there is a CCP, used a decision tree or other adequate method and documented the process.
present within the food manufacturing process, are they identified as ○ Consider on your defined CCPs whether the existing process can be influenced to prevent, eliminate or reduce a food safety hazard.
Critical Control Points (CCPs)? ○ Identify associated control points and existing controls that are in place.
○ CCPs are defined with consideration of many 'pre-requisite measures' that are associated with Good Manufacturing Practice, such as cleaning and training programmes.
When defining a CCP, such considerations should be documented.
I.C 3.4 Principle 3: Are Critical Limits established for each CCP? Supplementary guidelines. You should:
○ Apply critical limits only to the specific operation, product or groups of products being processed.
○ Only apply critical limits that have been specified and validated.
○ Define the critical limit for each CCP.

User Guidance
I.C 3.5 Principle 4: Are monitoring procedures established for each CCP? Supplementary guidelines. You should:
○ Be able to detect a loss of control in the process through your monitoring procedures.
○ Ensure that your monitoring records are evaluated by a trained and competent people.
I.C 3.6 Are CCPs effectively implemented? ○ Assign a frequency that is adequate to ensure that the CCP remains in control in the event that monitoring is not continuous.
○ Ensure that monitoring records are signed by individuals that are conducting the monitoring and reviewing the records.
○ Ensure that monitoring records are documented and include: date, time, responsible person and result.
○ Ensure that monitoring records are retained in line with business procedures.
I.C 3.7 Principle 5: Are corrective actions established for each CCP in the event Supplementary guidelines. You should:
critical limits are exceeded? ○ Ensure that any corrective actions resulting in return to control of the CCP and that affected products are disposed of in accordance with waste management procedures.
○ Ensure that product deviations and final disposal is documented.
○ Ensure that monitoring is understood as defined in Codex Alimentarius ("The act of conducting a planned sequence of observations or measurements of control
parameters to assess whether a CCP is under control").
I.C 3.8 Principle 6: Are verification procedures established ? Supplementary guidelines. You should:
Are verification procedures effectively implemented? ○ Ensure that the frequency of the verification procedures establishes that the HACCP system is working effectively.
I.C 3.9 ○ Ensure that verification is undertaken by someone other than the people responsible for monitoring and corrective actions.
I.C 3.10 Principle 7: Are record keeping and documentation for HACCP procedures Supplementary guidelines. You should:
established? ○ Ensure that all established HACCP procedures have been documented, including preliminary steps and pre-requisite programmes.
○ Ensure that the record-keeping is effective and clearly communicated to the relevant people.
I.C 3.11 Are all HACCP-related record-keeping and documentation procedures
effectively implemented?
I.C 3.12 Has the business implemented specific control measures for all relevant Supplementary guidelines. You should:
steps not identified as CCPs? ○ Ensure that pre-requisite measures have been taken and documented for other control points.
I.C 4 Food Defence

The business shall assess its ability to prevent intentional product WHAT DOES IT MEAN?
tampering/intentional contamination and put in place the appropriate a) Food defence is the means of preventing, protecting, and responding to the deliberate contamination of food by bacterial agents, toxins, chemicals, radiation or a physical
preventive control measures. object.
b) Threats to food defence might occur at any level in the business’s food-supply chain.
I.C 4.1 Have the threats to the product as a result of intentional product tampering c) The most important aspect of a food defence programme is prevention.
or intentional contamination been assessed? d) This is a regulatory requirement for food exports into the USA.
a) Develop and implement a procedure for conducting a facility vulnerability assessment.
I.C 4.2 Have those points in the process which are vulnerable to intentional b) Develop and implement a food defence plan based on the result of the vulnerability assessment that includes methods, responsibility and criteria for preventing food
product tampering/intentional contamination been identified and subjected adulteration or contamination caused by deliberate acts of sabotage.
to additional access control? c) The food defence plan should include the following key elements:
○ A designated member of senior management with responsibility for food defence
I.C 4.3 Are measures in place to address what to do with the product, if prohibited ○ Policies and procedures for recording and controlling access to areas of the facility by employees, contractors and visitors.
access took place and the product may have been tampered with or ○ Procedures for secure storage and transportation of raw materials, equipment, packaging material, hazardous chemicals and finished food products.
intentionally contaminated? ○ Facility physical security.
○ A process for managing food, packaging and equipment that has been intentionally adulterated.
○ Training programme.
○ An effective recall programme.
The Assessor will:
- Review your documented food defence plan.
- Check to see that the production has conducted a vulnerability assessment and identified sensitive areas
- Review your training programme and interview people to establish their knowledge of the food defence plan.

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1 Usage of this checklist

GFSI Global Markets Programme Manufacturing: Edition 2 April 2015

6 Summary and report worksheet

Assessment details & checklist settings

GFSI Global Markets Programme Manufacturing: Edition 2 April 2015

Critical Nonconformance – Unacceptable. Affects food safety or regulatory compliance directly.

Major Nonconformance – May affect food safety.

Minor Nonconformance – Is not likely to affect food safety.

Conform – Fully meeting a requirement.

GFSI Global Markets Programme Manufacturing: Edition 2 April 2015

GFSI Global Markets Programme Manufacturing: Edition 2 April 2015

Product Categories Company

Manufacturing Activities E-mail

Vendor/Supplier Code Address

Assessment Details & Checklist settings

Date Duration (hours)

Level Click here to answer the Checklist

Buying Company Settings

B.A 1.5 Is there a documented product release procedure in place?

I.A 2.5 Is the traceability system tested at least annually?

B.A 3 Food Safety Incident Management

B.A 3.2 Are records of incidents maintained?

I.A 3 Food Safety Incident Management

B.A 4 Control of non-conforming product

B.A 4.2 Is the control of non-conforming product managed by competent people?

B.A 5 Corrective Action

B.A 6 Management Responsibility

I.A 6 Management Responsibility

B.A 7 Record Keeping Requirements

I.A 7 General Documentation Requirements

B.A 8 Control of Measuring & Monitoring Devices

I.A 8 Control of Measuring & Monitoring Devices

B.A 9.2 Have all relevant people received refresher training?

I.A 9.5 Are adequate training records available?

I.A 9.6 Is a refresher training programme documented and implemented?

I.A 10.2 Are procedures clearly communicated to relevant people?

I.A 11 Complaint Handling

I.A 12 Product Analysis

I.A 14 Supplier Approval and Performance Monitoring

B.B 2 Facility Environment

B.B 3 Cleaning & Disinfection

B.B 4 Product Contamination Control

B.B 5 Pest Control

B.B 5.2 Is an effective pest control programme in place?

B.B 7 Staff Facilities

B.B 8 Waste Management

B.B 9 Storage and Transport

I.B 9 Storage and Transport

I.B 9.1 Is there a product transport procedure and is it effectively implemented?

I.B 9.2 Is there a transport vehicle procedure and is it effectively implemented?

I.B 10 Facility and Equipment Maintenance

I.B 10.1 Is a documented maintenance programme established?

I.B 10.2 Is an effective maintenance programme implemented?

I.B 10.4 Are effective hygiene procedures for maintenance activities?

B.C 2 Control of Allergens

I.C 3.2 Was the hazard analysis conducted by a competent team?

I.C 3.6 Are CCPs effectively implemented?

I.C 3.8 Principle 6: Are verification procedures established ?

I.C 3.9 Are verification procedures effectively implemented?