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GFSI Audit Checklist

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Obviate unintended use of out-of-date documents, and to suitably identify them if they are clutched for any purpose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