GFSI Checklist (Self Audit)

• Client / Site

• Location
  Address

• Conducted on

  Date

• Prepared by

General Requirements

• Scope of the FSMS defined

  Yes

  No

  N/A

• Scope of the FSMS specifying:

• • Product categories

  Yes

  No

  N/A

• • Processes

  Yes

  No

  N/A

• • Production sites

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Documentation Requirements

• Control of documents

  Yes

  No

  N/A

• Approval of documents for adequacy prior to issue

  Yes

  No

  N/A

• Review, update and re-approve

  Yes

  No

  N/A

• Changes and current revision status identified

  Yes

  No

  N/A

• Relevant versions of documents available at points of use

  Yes

  No

  N/A

• Legible and readily identifiable

  Yes

  No

  N/A

• Identification and control of external documents

  Yes

  No

  N/A

• Prevent unintended use of obsolete documents, and to suitably identify them if they are retained for any purpose

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Records legible, readily identifiable and retrievable<br>

  Yes

  No

  N/A

• Control of the correction, identification, storage, protection, retrieval, retention time and disposition of records<br>

  Yes

  No

  N/A

Food Safety Policy

• a) Appropriate to the role in the food chain

  Yes

  No

  N/A

• b) Commits to comply with statutory, regulatory and customer FS requirements

  Yes

  No

  N/A

• c) Communicated and understood within the organization

  Yes

  No

  N/A

• d) Reviewed for continual suitability

  Yes

  No

  N/A

• e) Supported by measurable objectives

  Yes

  No

  N/A

FOOD SAFETY MANAGEMENT SYSTEM PLANNING

• To meet the objectives

  Yes

  No

  N/A

• To maintain the FSM integrity when changes are implemented<br>

  Yes

  No

  N/A

RESPONSIBILITY AND AUTHORITY

• R&A are defined and communicated within the organization

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Designated personnel to initiate and record actions

  Yes

  No

  N/A

COMMUNICATION

• Implemented effective arrangements for communicating with:

• Suppliers and contractors

  Yes

  No

  N/A

• Customers/Consumers

  Yes

  No

  N/A

• Food authorities

  Yes

  No

  N/A

• Other organizations that could be affected

  Yes

  No

  N/A

• Assigned designated personnel to manage external communication?

  Yes

  No

  N/A

• The Top management has communicated to the organization the importance of meeting this standard, legal and customer<br>FS requirements?

  Yes

  No

  N/A

• Implemented effective arrangements for communicating with relevant personnel?

  Yes

  No

  N/A

• FST is informed of changes, especially:

• Products or new products

  Yes

  No

  N/A

• Raw materials, ingredients, and services

  Yes

  No

  N/A

• Production systems and equipment

  Yes

  No

  N/A

• Production premises, location of equipment, surrounding environment

  Yes

  No

  N/A

• Cleaning and sanitation programs

  Yes

  No

  N/A

• Packaging, storage and distribution systems

  Yes

  No

  N/A

• Personnel qualification level/allocation of responsibilities and authorizations

  Yes

  No

  N/A

• Regulatory requirements

  Yes

  No

  N/A

• Knowledge regarding food safety hazards and control measures

  Yes

  No

  N/A

• Customer, sector and other

  Yes

  No

  N/A

• Relevant enquiries from external interested parties

  Yes

  No

  N/A

• Complaints indicating hazards associated with the product

  Yes

  No

  N/A

• Any condition which have an impact on food safety

  Yes

  No

  N/A

MANAGEMENT REVIEW

• At planned intervals

  Yes

  No

  N/A

• Records maintained

  Yes

  No

  N/A

• Follow-up actions from previous reviews

  Yes

  No

  N/A

• Verification activities

  Yes

  No

  N/A

• Changes related FS

  Yes

  No

  N/A

• Emergency situations, accidents and recalls

  Yes

  No

  N/A

• System up-dating activities

  Yes

  No

  N/A

• Communication activities including customer feedback

  Yes

  No

  N/A

• External audits or inspections

  Yes

  No

  N/A

• Assurance of Food Safety

  Yes

  No

  N/A

• Improved effectiveness of the FSMS

  Yes

  No

  N/A

• Resource needs

  Yes

  No

  N/A

• Revisions of the FSP and objectives

  Yes

  No

  N/A

• Human Resources

• Identify necessary competencies

  Yes

  No

  N/A

• Training

  Yes

  No

  N/A

• Specific training for personnel responsible of monitoring, corrections, and corrective actions

  Yes

  No

  N/A

• Evaluation of implementation and effectiveness

  Yes

  No

  N/A

• Awareness of contribution to FS

  Yes

  No

  N/A

• Awareness of need for effective communication

  Yes

  No

  N/A

• Records of training and other actions

  Yes

  No

  N/A

• Agreement or contracts with external experts involved in FSM

  Yes

  No

  N/A

• PRPs shall be:

• Appropriate to the organizational needs

  Yes

  No

  N/A

• Appropriate to the size and type of operation and product

  Yes

  No

  N/A

• Implemented across general programmes

  Yes

  No

  N/A

• Implemented across specific programmes

  Yes

  No

  N/A

• Approved by FST: according to:

• Legal requirements

  Yes

  No

  N/A

• Customer requirements

  Yes

  No

  N/A

• Recognized guidelines

  Yes

  No

  N/A

• CODEX Alimentarius

  Yes

  No

  N/A

• Codes of Practices

  Yes

  No

  N/A

• Documentation is available for the following programmes:

• Hazard control

  Yes

  No

  N/A

• Control measure(s)

  Yes

  No

  N/A

• Monitoring procedures

  Yes

  No

  N/A

• Corrections/corrective actions

  Yes

  No

  N/A

• Responsibility and Authority

  Yes

  No

  N/A

• Records of monitoring

  Yes

  No

  N/A

Elements of PRPs

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

• Location

  Yes

  No

  N/A

• Perimeter and grounds

  Yes

  No

  N/A

• Walls

  Yes

  No

  N/A

• Floors

  Yes

  No

  N/A

• Ceilings

  Yes

  No

  N/A

• Windows

  Yes

  No

  N/A

• Doors

  Yes

  No

  N/A

• Lighting

  Yes

  No

  N/A

• Ventilation

  Yes

  No

  N/A

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

• Process flow

  Yes

  No

  N/A

• Working space and storage

  Yes

  No

  N/A

• Segregation Low/High risk areas/process

  Yes

  No

  N/A

• Segregation design

  Yes

  No

  N/A

• Washing and cleaning locations

  Yes

  No

  N/A

• Changing facilities

  Yes

  No

  N/A

• Hand washing facilities

  Yes

  No

  N/A

• Toilets

  Yes

  No

  N/A

• Catering facilities

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Supporting services including waste and sewage disposal are available

  Yes

  No

  N/A

• Equipment including its preventive maintenance, sanitary design, and accessibility for maintenance and cleaning for each unit are available

  Yes

  No

  N/A

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

• Raw materials

  Yes

  No

  N/A

• Ingredients

  Yes

  No

  N/A

• Packaging

  Yes

  No

  N/A

• Chemicals

  Yes

  No

  N/A

• Waste

  Yes

  No

  N/A

• Sewage

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Transportation

  Yes

  No

  N/A

• Cleaning and sanitizing:

• Cleaning practices

  Yes

  No

  N/A

• Cleaning schedules

  Yes

  No

  N/A

• Control and verification of effectiveness

  Yes

  No

  N/A

• Documented procedures/records

  Yes

  No

  N/A

• Pest Control documentation for:

• Competent pest control

  Yes

  No

  N/A

• Documented procedures/records

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Location of all measures

  Yes

  No

  N/A

• Plan/diagram for electric fly killers/baits/traps

  Yes

  No

  N/A

• Risk of product contamination with chemicals

  Yes

  No

  N/A

• Personnel Hygiene documentation for:

• GMPs

  Yes

  No

  N/A

• Protective clothing

  Yes

  No

  N/A

• Jewelry

  Yes

  No

  N/A

• Cuts and grazes

  Yes

  No

  N/A

• Hand Cleaning

  Yes

  No

  N/A

• Notification of relevant infectious disease or conditions

  Yes

  No

  N/A

• Medical screening

  Yes

  No

  N/A

• Training

  Yes

  No

  N/A

• Relevant information needed to conduct the hazard analysis documented, collected, maintained and updated

  Yes

  No

  N/A

• FST Leader appointed by Top Management with responsibility:

• To manage the FST

  Yes

  No

  N/A

• Training and education of FST members

  Yes

  No

  N/A

• To ensure that FSMS is established, implemented, maintained and updated

  Yes

  No

  N/A

• To report to Top Management about FSMS

  Yes

  No

  N/A

• Multi-disciplinary knowledge and experience

  Yes

  No

  N/A

• Records demonstrate the required expertise for all team members

  Yes

  No

  N/A

• Documentation available for:

• Product characteristics

  Yes

  No

  N/A

• Raw materials, ingredients and product-contact materials

  Yes

  No

  N/A

• Specifications with:

• Biological, chemical and physical characteristics

  Yes

  No

  N/A

• Ingredients including additives and processing aids

  Yes

  No

  N/A

• Origin

  Yes

  No

  N/A

• Method of production

  Yes

  No

  N/A

• Delivery methods and packaging

  Yes

  No

  N/A

• Storage conditions and shelf-life

  Yes

  No

  N/A

• Preparation and/or handling before use or processing

  Yes

  No

  N/A

• Food safety related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses. Relevant legislation/regulations documented

  Yes

  No

  N/A

• Specifications updated

  Yes

  No

  N/A

• Documentation for the characteristics of end products:

• Name

  Yes

  No

  N/A

• Composition

  Yes

  No

  N/A

• Biological, chemical and physical characteristics

  Yes

  No

  N/A

• Intended shelf-life and storage conditions.

  Yes

  No

  N/A

• Intended use

  Yes

  No

  N/A

• Packaging

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Method(s) of distribution

  Yes

  No

  N/A

• Relevant legislation/regulations documented

  Yes

  No

  N/A

• Specifications updated

  Yes

  No

  N/A

• Identified and documented appropriate information about:

• The reasonably expected handling of the product

  Yes

  No

  N/A

• Any unintended but reasonably expected mishandling and misuse of the product

  Yes

  No

  N/A

• Group of consumers identified, especially vulnerable groups of population

  Yes

  No

  N/A

• Descriptions updated

  Yes

  No

  N/A

• Flow diagrams, process steps and control measures

  Yes

  No

  N/A

• Flow diagrams available for:

• Each product/process category covered by the FSMS

  Yes

  No

  N/A

• Sequence/interaction of steps

  Yes

  No

  N/A

• Outsourced processes and subcontracted work

  Yes

  No

  N/A

• Inputs (raw materials, ingredients, intermediate products)

  Yes

  No

  N/A

• Reworking and recycling

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• and verified by FST (records)

  Yes

  No

  N/A

• Description of process steps and control measures available

  Yes

  No

  N/A

• Control measures/process parameters/procedures related to food safety described

  Yes

  No

  N/A

• Legal and customer requirements described

  Yes

  No

  N/A

• Descriptions updated

  Yes

  No

  N/A

• Hazard Identification and Determination of acceptable levels

  Yes

  No

  N/A

• Identified and recorded

  Yes

  No

  N/A

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

• Preliminary information about product/process and control measures

  Yes

  No

  N/A

• Experience

  Yes

  No

  N/A

• External information including epidemiological and other data historical

  Yes

  No

  N/A

• Information from the food chain

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Identified and document control measures that are to be applied

  Yes

  No

  N/A

• Categorized in General Control Measures (managed through PRPs) or Specific Control Measures (related to CCP's), pertaining to:

• Effect on identified food safety hazards relative to the intensity applied

  Yes

  No

  N/A

• Feasibility for monitoring

  Yes

  No

  N/A

• Place within the system relative to other control measures

  Yes

  No

  N/A

• Likelihood of failure in the functioning

  Yes

  No

  N/A

• Severity of the consequence

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Synergistic effects

  Yes

  No

  N/A

• Methodology of categorization documented and results recorded

  Yes

  No

  N/A

Identification of CCPs

• Hazard to be controlled by specific control measure documented

  Yes

  No

  N/A

Determination of Critical Limits

• For the monitoring of each CCP

  Yes

  No

  N/A

• Requirement of legislation-regulations-internal risk analysis-clients are met

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Selection documented

  Yes

  No

  N/A

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

  Gloves

  Eye protection

  Laboratory coat

  Other PPE

• Procedures + instructions + records including:

• Measurements that provide results within an adequate time frame

  Yes

  No

  N/A

• Monitoring devices identified

  Yes

  No

  N/A

• Calibration methods

  Yes

  No

  N/A

• Frequency

  Yes

  No

  N/A

• Records and methods

  Yes

  No

  N/A

• Actions when monitoring results exceed critical limits

  Yes

  No

  N/A

• A procedure to dentify and assess of affected end products

  Yes

  No

  N/A

• Review the corrections carried out

  Yes

  No

  N/A

• Approved by the responsible person

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Corrective Actions (CAs)

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• A procedure to:

• Review NCs (complaints included)

  Yes

  No

  N/A

• Review trends

  Yes

  No

  N/A

• Determine cause of NCs

  Yes

  No

  N/A

• Evaluate the need for CAs

  Yes

  No

  N/A

• Determine and implementing CAs

  Yes

  No

  N/A

• Records of CAs

  Yes

  No

  N/A

• Reviewing CAs

  Yes

  No

  N/A

• Handle potentially unsafe products

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• A procedure with responses + authorization + actions and controls

  Yes

  No

  N/A

• Product is released as safe when:

• Evidence indicates that the control measures have been effective

  Yes

  No

  N/A

• Combined elements of the control measures have proven themselves to be effective

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Disposition of non-conforming products:

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

• Raw materials (from the immediate suppliers)

  Yes

  No

  N/A

• Processing

  Yes

  No

  N/A

• Distribution records (to the immediate distributors)

  Yes

  No

  N/A

• Records maintained for a defined period

  Yes

  No

  N/A

• Meet customers and regulatory requirements based on the shelf life

  Yes

  No

  N/A

Withdrawals

• To facilitate a recall:

• There is authority and responsibility appointed bytop management<br>

  Yes

  No

  N/A

• Procedure for:

• Notification

  Yes

  No

  N/A

• Handling of recalled products as well as involved products still in stock

  Yes

  No

  N/A

• Defining the sequence of actions

  Yes

  No

  N/A

• Recalled products held under supervision until their treatment

  Yes

  No

  N/A

• Effectiveness of the programme recall verified with records

  Yes

  No

  N/A

• Emergency preparedness and response

  Yes

  No

  N/A

• Procedures to manage potential emergency situations established by Top Management

  Yes

  No

  N/A

• Establish, document and implement procedures for verification of the HACCP system: purpose-methods-frequencies-responsibilities-records

  Yes

  No

  N/A

• Confirmed that:

• The PRPs are implemented

  Yes

  No

  N/A

• The hazard analysis is continually updated

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Hazard levels are within identified acceptable levels

  Yes

  No

  N/A

• Records communicated to the FST

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are evaluated systematically by the FST

  Gloves

  Eye protection

  Laboratory coat

  Other PPE

• NCs with the planned arrangements – actions to achieve conformity. Review available.

  Gloves

  Eye protection

  Laboratory coat

  Other PPE

• Procedures and communication channels available

  Gloves

  Eye protection

  Laboratory coat

  Other PPE

• Conclusions of the hazard analysis/operational PRPs/HACCP Plan

  Gloves

  Eye protection

  Laboratory coat

  Other PPE

• PRPs

  Gloves

  Eye protection

  Laboratory coat

  Other PPE

• Human resources/Training

  Gloves

  Eye protection

  Laboratory coat

  Other PPE

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

• Confirm that FSMS meets the planned arrangements

  Yes

  No

  N/A

• Identify the need for updating/improving the FSMS

  Yes

  No

  N/A

• Identify trends

  Yes

  No

  N/A

• Establish information for planning internal audits

  Yes

  No

  N/A

• Confirm effectiveness of corrections and CAs

  Yes

  No

  N/A

• Records reported Top Management. Input to the management review and for updating the FSMS

  Yes

  No

  N/A

• Prior to implementation and after any change of General/Specific Control Measures, ensure that:

  Yes

  No

  N/A

• Associate hazards are effectively controlled

  Yes

  No

  N/A

• End Products meet the defined acceptable levels

  Yes

  No

  N/A

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

• Control measures

  Yes

  No

  N/A

• Raw materials

  Yes

  No

  N/A

• Technologies

  Yes

  No

  N/A

• Product characteristics

  Yes

  No

  N/A

• Distribution

  Yes

  No

  N/A

• Intent of use

  Yes

  No

  N/A

• To ensure valid results (if necessary), measuring equipment have to be controlled:

• Calibrated/verified against measurement standards; where no such standards exist, the basis used shall be recorded

  Yes

  No

  N/A

• Adjusted or re-adjusted as necessary

  Yes

  No

  N/A

• The calibration status identified

  Yes

  No

  N/A

• Safeguarded

  Yes

  No

  N/A

• Protected from damage

  Yes

  No

  N/A

• Records of calibrations, if no conformance – assess the validity of the previous results + treatment of the equipment/product.

  Yes

  No

  N/A

• Records suitability of software confirmed: prior to initial use + reconfirm

  Yes

  No

  N/A

• Documented procedure that defines responsibilities – reporting – records

  Yes

  No

  N/A

• To determine whether the FSMS system:

• Conforms with the planned arrangements

  Yes

  No

  N/A

• Effectively implemented and maintained

  Yes

  No

  N/A

• Audit programme planned:

• considers status;

  Yes

  No

  N/A

• importance of processes;

  Yes

  No

  N/A

• arease to be audited;

  Yes

  No

  N/A

• and results of previous findings

  Yes

  No

  N/A

• criteria, scope, frequency, and methods are all defined

  Yes

  No

  N/A

• Proof of auditor's objectivity and impartiality

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Verification of actions recorded

  Yes

  No

  N/A

• FSMS continually improved through:

• communication;

  Yes

  No

  N/A

• management review;

  Yes

  No

  N/A

• internal audit;

  Yes

  No

  N/A

• evaluation of individual verification results;

  Yes

  No

  N/A

• analysis of results of verification activities;

  Yes

  No

  N/A

• validation of control measure combinations;

  Yes

  No

  N/A

• and FSMS updates

  Yes

  No

  N/A

• FSMS is updated at planned intervals;

  Yes

  No

  N/A

• and if necessary, the HA, PRPs, and the HACCP Plan are reviewed

  Yes

  No

  N/A

• FSMS updates consider:

• Communication;

  Yes

  No

  N/A

• suitability-adequacy-effectiveness of FSMS;

  Yes

  No

  N/A

• analysis of results of verification activities;

  Yes

  No

  N/A

• and management review

  Yes

  No

  N/A

Auditor's full name and signature

• Add signature

  Sign