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GFSI Audit Checklist

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Use this GFSI Checklist to conduct a self-audit of your organisation and guarantee that you adhere to the Global Food Safety Initiative Standards.
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GFSI Audit Checklist

FOOD SAFETY MANAGEMENT SYSTEM

General Demands

Scope of the FSMS is defined

Scope of the FSMS information:

• Product categories

• Production sites

• Methods

Any outsourced methods related to food safety are examined, identified and documented in the FSMS?

Documentation Demands

Approval of documents for adequacy before the issue

Identification and control of external documents.

Obviate unintended use of out-of-date documents, and to suitably identify them if they are clutched for any purpose

Check, update and re-approve

Changes and current revision status are identified

Relevant versions of documents in place at points of use

Control of documents

Control of the correction, retrieval, classification, storage, protection, maintenance time and distribution of records

Readable and readily identifiable.

Method for efficient and accurate record-keeping to provide proof of conformity to demands and of the effective performance of the FSMS

Records readable, readily identifiable and retrievable

MANAGEMENT RESPONSIBILITY

Food Safety Policy

Acts to comply with statutory, regulatory and customer FS demands

Followed by measurable objectives

Examined for continual suitability

Communicated and understood within the whole organisation

Suitable to the role in the food chain

FOOD SAFETY MANAGEMENT SYSTEM PLANNING

... to meet the goals.

... to keep the FSM integrity when changes are performed

RESPONSIBILITY AND AUTHORITY

Designated staff to initiate and document actions

Responsibility and authority are explained and communicated within the whole organisation

Identified person/people to accept reports problems with the FSMS

COMMUNICATION

Performed effective systems for communicating with:

- Suppliers and contractors

- Customers/Consumers

- Food authorities

- Other organisations that could be influenced by that

Assigned designated staff to handle external communication?

Did the top management report the importance of meeting this standard, legal and customerFS demands to the whole organisation?

Implemented effective forms for communicating with relevant staff?

FST is noticed changes, especially concerning:

- Raw materials, ingredients and services

- Cleaning and sanitation programs

- Knowledge concerning food safety risks and control measures

- Production systems and materials/equipment

- Production premises, location of equipment, surrounding environment

- Staff qualification level/allocation of responsibilities and authorizations

- Products or new products

- Regulatory demands

- Any condition which has an impact on food safety

- Customer, sector and other

- Packaging, deposits and distribution systems

- Important enquiries from external interested people/parties

- Complaints indicating dangers connected with the product

MANAGEMENT REVIEW

Follow-up actions from earlier reviews

Communication activities (e.g. customer feedback)

Verification activities

Changes connected to FS

At scheduled intervals

Emergency situations, incidents and recalls

Revisions of the FSP and goals

System updating activities

External audits or examinations

Assurance of food safety

Records sustained

Developed effectiveness of the FSMS

Resource requirements

RESOURCE MANAGEMENT

Human Resources (HR)

Training

Special training for staff responsible of controlling, corrections, and corrective actions

Documents of training and other actions

Agreement or contracts with external experts engaged in FSM

Review of implementation and effectiveness

Knowledge of contribution to FS

Identify important competencies

Awareness of a demand for effective communication

PLANNING AND REALIZATION OF SAFEPRODUCTS

PRPs shall be:

Appropriate to the organisational demands

Conducted across general programs

Suitable to the size and kind of operation and product

Implemented across specific programs

Approved by FST according to:

Recognised guidelines

Legal demands

Customer demands

Codes of Practices

CODEX Alimentarius

ESTABLISHING THE OPERATIONAL PRPS

Documentation is in place for the following programs:

Control measures

Monitoring records

Monitoring methods

Corrections/corrective actions

Danger control

Duties and authority

Elements of PRPs

The layout, design, and construction of buildings/facilities include:

- Location

- Lighting

- Perimeter and grounds

- Floors

- Ceilings

- Ventilation

- Walls

- Windows

- Doors

The layout of premises, including workspace and employee facilities, includes

- Working space and storage

- Catering facilities

- Hand washing facilities

- Separation of Low/High risk areas/process

- Segregation design

- Washing and cleaning places

- Changing rooms

- Process flow

- Toilets

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

Supporting services including waste and sewerage disposal are available

Equipment including its precautionary maintenance, sanitary design, and accessibility for maintenance and cleaning for each section are available

Management of acquired materials, disposals and treatment of products:

- Ingredients

- Sewage

- Packaging

- Transportation

- Waste

- Chemicals

- Raw materials

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

Cleaning and sanitizing:

- Cleaning practices

- Cleaning plans

- Control and verification of effectiveness

- Recorded procedures/records

Pest Control documentation for:

- Competent pest control

- Documented methods/records

Physical measures: drains, hermetically sealed doors, screens, security perimeter for inventory in storage, etc.

Location of all measures

Plan for electric fly killers/baits/traps

Risk of product contamination with chemicals

Staff hygiene documentation for:

- Washing hands

- PPE

- Jewelry

- GMPs

- Cuts and grazes

Information on important infectious disease or conditions

Training

Medical screening

PRELIMINERY STEPS TO ENABLE HAZARD ANALYSIS

Important information required to conduct the danger analysis documented, collected, kept and updated

FST leader selected by top management with responsibility:

- training of FST members

Documents demonstrate the needed expertise for all team members

- Multi-disciplinary understanding and experience

- to make sure that FSMS is built, implemented, kept and updated

- to document to top management about FSMS

- to manage the FST

Documentation in place for:

- Raw materials, ingredients and product-contact materials

- Product details

Specifications with:

- Ingredients including additives and processing support

- Process of production

- Biological, chemical and physical details

- Delivery processes and packaging

Food safety-related acceptance criteria or specs of purchased materials and ingredients relevant for their intended uses. Appropriate legislation/regulations documented

- Origin

- Storage states and shelf-life

- Preparation and/or treatment before use or processing

Specifications are updated

Records for the characteristics of end products:

- Name

- Important legislation/regulations documented

- Composition

- Biological, chemical and physical details

- Intended use

- Packaging

- Labelling describing food safety and/or directions for handling, preparation and use

- Planned shelf-life and storage conditions

- Method/s of distribution

- Specifications are updated

Identified and reported appropriate information about:

- Flow diagrams, process steps and control measures

- Any unintended but fairly expected mishandling and misuse of the product

- The reasonably expected treatments of the product

- Group of consumers recognised, especially vulnerable groups of the population

- Descriptions are updated

Flow diagrams in place for:

- Outputs (end, intermediate, by-product, waste,...)

- Inputs (raw materials, ingredients, intermediate products,...)

- Reworking and recycling

- Frequency/interaction of steps

- Each product/method category covered by the FSMS

- Outsourced methods and subcontracted work

...and verified by FST (records available)

Descriptions are updated

Description of the process steps and control measures are in place

Control measures/process parameters/procedures connected to food safety described

Legal and customer demands described

HAZARD ANALYSIS

Hazard identification and definition of acceptable levels

They are identified and documented

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

- Experience

- Identified and documented control measures that are to be implemented

- Preliminary knowledge about product/process and control measures

- External knowledge including epidemiological and other data historical

- Information about the food chain

- Step(s) connected which each risk in the end product established in compliance with legal/customer demands and the proposed use (records available)

Categorised in General Control Measures (managed through PRPs) or Specific Control Measures (related to CCP's), connected to:

- Effect on identified food safety risks relative to the intensity applied

- Methodology of categorisation documented and results documented

- Location within the system relative to other control measures

- Synergistic consequences

- Probability of failure in the functioning

- Severity of the consequence

- Specifically to prevent/reduce the level of hazard(s)

- Feasibility for monitoring

ESTABLISHING HACCP PLAN

Identification of CCPs

Hazard to be controlled by special control measure documented

Determination of Critical Limits

In terms of measurable parameters maintained by instructions, specifications, education/training

Determination of critical limits for the monitoring of each CCP

The need for legislation-regulations-internal risk, analysis-clients are met

Selection reported

MONITORING OF THE CCPs

A monitoring system for effective and efficient control of CCPs (measurements relative to the critical limits) organised and sustained

Procedures, instructions and records include:

- Records and processes

- Monitoring devices distinguished

- Calibration methods

- Measurements that give results within a sufficient time frame

- Regularity

- Actions when monitored results exceed critical limits

CONTROL OF NONCONFORMITY

A method to identify and evaluate affected end products

Examine the corrections carried out

Approved by the right responsible person

Records with information on the kind of the nonconformity, cause, result and traceability are in place

Corrective Actions (CAs)

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

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

A method to:

- Review trends

- Determine the cause of NCs

- Handle possible unsafe products

- Assess the need for CAs

- Determine and using CAs

- Records of CAs

- Review NCs (complaints included)

- Examining CAs

- A procedure with responses, authorisation, actions and controls

- NCs products don’t access the food chain unless it is possible to guarantee that the hazards have been decreased to acceptable levels and the product is safe

- All lots of products influenced by NC identified and controlled until they have been assessed

The product is released as safe when:

- Analysis (or other verification activities) show that the product is safe

- Proof indicates that the control measures have been useful

- Combined elements of the control measures have shown themselves to be useful

Storage of non-conforming products:

- Products not adequate for release are destroyed if reprocessing is not an alternative

- Products not adequate for release are reprocessed (when possible) to guarantee that the dangers are controlled

TRACEABILITY SYSTEM

Identification of product lots and their connection to batches of:

- Meet customers and regulatory demands based on the shelf life

- Processing

- Distribution records (to the immediate distributors)

- Raw materials

- Records kept for a defined time period

Withdrawals

To facilitate a recall:

There are authority and responsibility appointed by top management

Procedure for:

- Treatment of recalled products as well as connected products still in stock

- Emergency preparedness and answers

- Notification

- Recalled products kept under supervision until their handling

- Methods to manage potential emergency situations established by top management

- Describing the sequence of actions

- Effectiveness of the programme recall supported with records

VERIFICATION PLANNING

Establish, record and perform methods for verification of the HACCP system: purpose-methods-frequencies-responsibilities-records

Confirmed that:

- Records communicated to the FST

- The risk analysis is always updated

- The operational PRPs and the details within the HACCP plan are performed and effective

- Danger levels are within identified acceptable levels

- The PRPs are performed

- NCs outcomes in test samples of end products – affected lots treated as potentially unsafe

EVALUATION OF INDIVIDUAL VERIFICATION RESULTS

Are evaluated systematically by FST

Methods and communication channels are available

Human resources/Training

NCs with the scheduled arrangements – actions to get conformity. Inspection records available.

Results of the risk analysis/operational PRPs/HACCP Plan

PRPs

ANALYSIS OF RESULTS OF VERIFICATION ACTIVITIES

Are analysed by the FST, including the conclusions of internal and external reviews, in order to:

- Identify the demand for updating/improving the FSMS

- Confirm effectiveness of improvements and CAs

- Identify trends

- Confirm that FSMS meets the established arrangements

- Establish information for planning internal audits

- Records are reported to top management. Input to the management evaluation and for updating the FSMS

VALIDATION OF CONTROL MEASURECOMBINATIONS

Before implementation and after any change of any kind of control measures, make sure that:

a) Associate risks are effectively controlled

b) Outcomes meet the defined acceptable levels

If a/b failed, adjustment and reassessment of the following are documented:

- Product details

- Raw materials

- Technologies

-Control measures

- Distribution

- Intention of use

CONTROL OF MONITORING AND MEASURING

To make sure valid results and measuring equipment have to be controlled for:

- Protected from any damage

- Adjusted or re-adjusted as required

- The calibration status is identified

- Safeguarded

- Calibrated/confirmed against measurement standards; where no such standards exist, the base used shall be registered

- Reports of calibrations, if no conformance – evaluate the validity of the earlier results and handling of the equipment/product.

- Records appropriateness of software confirmed: before initial use and reconfirm

FSMS VERIFICATION

A documented method that defines duties – reporting – records

To decide whether the FSMS system:

- Effectively used and maintained

- Conforms with the intended arrangements

Audit programme planned:

- Results of earlier findings

- Value of processes

- arease to be examined

- Considers status

- Verification of actions are recorded

- Evidence of auditor's objectivity and impartiality

- Criteria, scope, frequency, and processes are all defined

- Corrective actions are carried out on time by the employee responsible for the area

IMPROVEMENT

FSMS always improved through:

- Assessment of individual verification outcomes

- Management review

- Internal inspections

- Analysis of results of verification activities

- Validation of control measure combinations

- Communication

- FSMS updates

FSMS is updated at scheduled intervals

If necessary, the HA, PRPs, and the HACCP Plan are examined

FSMS updates consider:

- Management review

- Analysis of conclusions of verification activities;

- Communication

- Suitability, adequacy and effectiveness of FSMS

Completion

Name and signature of the supervisor