FOOD SAFETY MANAGEMENT SYSTEM

General Requirements

  • Scope of the FSMS defined

  • Scope of the FSMS specifying:

  • • Product categories

  • • Processes

  • • Production sites

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

Documentation Requirements

  • Control of documents

  • Approval of documents for adequacy prior to issue

  • Review, update and re-approve

  • Changes and current revision status identified

  • Relevant versions of documents available at points of use

  • Legible and readily identifiable

  • Identification and control of external documents

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

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

  • Records legible, readily identifiable and retrievable

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

MANAGEMENT RESPONSIBILITY

Food Safety Policy

  • a) Appropriate to the role in the food chain

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

  • c) Communicated and understood within the organization

  • d) Reviewed for continual suitability

  • e) Supported by measurable objectives

FOOD SAFETY MANAGEMENT SYSTEM PLANNING

  • To meet the objectives

  • To maintain the FSM integrity when changes are implemented

RESPONSIBILITY AND AUTHORITY

  • R&A are defined and communicated within the organization

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

  • Designated personnel to initiate and record actions

COMMUNICATION

  • Implemented effective arrangements for communicating with:

  • Suppliers and contractors

  • Customers/Consumers

  • Food authorities

  • Other organizations that could be affected

  • Assigned designated personnel to manage external communication?

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

  • Implemented effective arrangements for communicating with relevant personnel?

  • FST is informed of changes, especially:

  • Products or new products

  • Raw materials, ingredients, and services

  • Production systems and equipment

  • Production premises, location of equipment, surrounding environment

  • Cleaning and sanitation programs

  • Packaging, storage and distribution systems

  • Personnel qualification level/allocation of responsibilities and authorizations

  • Regulatory requirements

  • Knowledge regarding food safety hazards and control measures

  • Customer, sector and other

  • Relevant enquiries from external interested parties

  • Complaints indicating hazards associated with the product

  • Any condition which have an impact on food safety

MANAGEMENT REVIEW

  • At planned intervals

  • Records maintained

  • Follow-up actions from previous reviews

  • Verification activities

  • Changes related FS

  • Emergency situations, accidents and recalls

  • System up-dating activities

  • Communication activities including customer feedback

  • External audits or inspections

  • Assurance of Food Safety

  • Improved effectiveness of the FSMS

  • Resource needs

  • Revisions of the FSP and objectives

RESOURCE MANAGEMENT

  • Human Resources

  • Identify necessary competencies

  • Training

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

  • Evaluation of implementation and effectiveness

  • Awareness of contribution to FS

  • Awareness of need for effective communication

  • Records of training and other actions

  • Agreement or contracts with external experts involved in FSM

PLANNING AND REALIZATION OF SAFE
PRODUCTS

  • PRPs shall be:

  • Appropriate to the organizational needs

  • Appropriate to the size and type of operation and product

  • Implemented across general programmes

  • Implemented across specific programmes

  • Approved by FST: according to:

  • Legal requirements

  • Customer requirements

  • Recognized guidelines

  • CODEX Alimentarius

  • Codes of Practices

ESTABLISHING THE OPERATIONAL PRPS

  • Documentation is available for the following programmes:

  • Hazard control

  • Control measure(s)

  • Monitoring procedures

  • Corrections/corrective actions

  • Responsibility and Authority

  • Records of monitoring

Elements of PRPs

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

  • Location

  • Perimeter and grounds

  • Walls

  • Floors

  • Ceilings

  • Windows

  • Doors

  • Lighting

  • Ventilation

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

  • Process flow

  • Working space and storage

  • Segregation Low/High risk areas/process

  • Segregation design

  • Washing and cleaning locations

  • Changing facilities

  • Hand washing facilities

  • Toilets

  • Catering facilities

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

  • Supporting services including waste and sewage disposal are available

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

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

  • Raw materials

  • Ingredients

  • Packaging

  • Chemicals

  • Waste

  • Sewage

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

  • Transportation

  • Cleaning and sanitizing:

  • Cleaning practices

  • Cleaning schedules

  • Control and verification of effectiveness

  • Documented procedures/records

  • Pest Control documentation for:

  • Competent pest control

  • Documented procedures/records

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

  • Location of all measures

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

  • Risk of product contamination with chemicals

  • Personnel Hygiene documentation for:

  • GMPs

  • Protective clothing

  • Jewelry

  • Cuts and grazes

  • Hand Cleaning

  • Notification of relevant infectious disease or conditions

  • Medical screening

  • Training

PRELIMINERY STEPS TO ENABLE HAZARD ANALYSIS

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

  • FST Leader appointed by Top Management with responsibility:

  • To manage the FST

  • Training and education of FST members

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

  • To report to Top Management about FSMS

  • Multi-disciplinary knowledge and experience

  • Records demonstrate the required expertise for all team members

  • Documentation available for:

  • Product characteristics

  • Raw materials, ingredients and product-contact materials

  • Specifications with:

  • Biological, chemical and physical characteristics

  • Ingredients including additives and processing aids

  • Origin

  • Method of production

  • Delivery methods and packaging

  • Storage conditions and shelf-life

  • Preparation and/or handling before use or processing

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

  • Specifications updated

  • Documentation for the characteristics of end products:

  • Name

  • Composition

  • Biological, chemical and physical characteristics

  • Intended shelf-life and storage conditions.

  • Intended use

  • Packaging

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

  • Method(s) of distribution

  • Relevant legislation/regulations documented

  • Specifications updated

  • Identified and documented appropriate information about:

  • The reasonably expected handling of the product

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

  • Group of consumers identified, especially vulnerable groups of population

  • Descriptions updated

  • Flow diagrams, process steps and control measures

  • Flow diagrams available for:

  • Each product/process category covered by the FSMS

  • Sequence/interaction of steps

  • Outsourced processes and subcontracted work

  • Inputs (raw materials, ingredients, intermediate products)

  • Reworking and recycling

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

  • and verified by FST (records)

  • Description of process steps and control measures available

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

  • Legal and customer requirements described

  • Descriptions updated

HAZARD ANALYSIS

  • Hazard Identification and Determination of acceptable levels

  • Identified and recorded

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

  • Preliminary information about product/process and control measures

  • Experience

  • External information including epidemiological and other data historical

  • Information from the food chain

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

  • Identified and document control measures that are to be applied

  • 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

  • Feasibility for monitoring

  • Place within the system relative to other control measures

  • Likelihood of failure in the functioning

  • Severity of the consequence

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

  • Synergistic effects

  • Methodology of categorization documented and results recorded

ESTABLISHING HACCP PLAN

Identification of CCPs

  • Hazard to be controlled by specific control measure documented

Determination of Critical Limits

  • For the monitoring of each CCP

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

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

  • Selection documented

MONITORING OF THE CCPs

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

  • Procedures + instructions + records including:

  • Measurements that provide results within an adequate time frame

  • Monitoring devices identified

  • Calibration methods

  • Frequency

  • Records and methods

  • Actions when monitoring results exceed critical limits

CONTROL OF NONCONFORMITY

  • A procedure to dentify and assess of affected end products

  • Review the corrections carried out

  • Approved by the responsible person

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

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 procedure to:

  • Review NCs (complaints included)

  • Review trends

  • Determine cause of NCs

  • Evaluate the need for CAs

  • Determine and implementing CAs

  • Records of CAs

  • Reviewing CAs

  • Handle potentially unsafe products

  • 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

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

  • A procedure with responses + authorization + actions and controls

  • Product is released as safe when:

  • Evidence indicates that the control measures have been effective

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

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

  • Disposition of non-conforming products:

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

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

TRACEABILITY SYSTEM

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

  • Raw materials (from the immediate suppliers)

  • Processing

  • Distribution records (to the immediate distributors)

  • Records maintained for a defined period

  • Meet customers and regulatory requirements based on the shelf life

Withdrawals

  • To facilitate a recall:

  • There is authority and responsibility appointed bytop management

  • Procedure for:

  • Notification

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

  • Defining the sequence of actions

  • Recalled products held under supervision until their treatment

  • Effectiveness of the programme recall verified with records

  • Emergency preparedness and response

  • Procedures to manage potential emergency situations established by Top Management

VERIFICATION PLANNING

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

  • Confirmed that:

  • The PRPs are implemented

  • The hazard analysis is continually updated

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

  • Hazard levels are within identified acceptable levels

  • Records communicated to the FST

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

EVALUATION OF INDIVIDUAL VERIFICATION RESULTS

  • Are evaluated systematically by the FST

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

  • Procedures and communication channels available

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

  • PRPs

  • Human resources/Training

ANALYSIS OF RESULTS OF VERIFICATION ACTIVITIES

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

  • Confirm that FSMS meets the planned arrangements

  • Identify the need for updating/improving the FSMS

  • Identify trends

  • Establish information for planning internal audits

  • Confirm effectiveness of corrections and CAs

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

VALIDATION OF CONTROL MEASURE
COMBINATIONS

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

  • Associate hazards are effectively controlled

  • End Products meet the defined acceptable levels

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

  • Control measures

  • Raw materials

  • Technologies

  • Product characteristics

  • Distribution

  • Intent of use

CONTROL OF MONITORING AND MEASURING

  • 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

  • Adjusted or re-adjusted as necessary

  • The calibration status identified

  • Safeguarded

  • Protected from damage

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

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

FSMS VERIFICATION

  • Documented procedure that defines responsibilities – reporting – records

  • To determine whether the FSMS system:

  • Conforms with the planned arrangements

  • Effectively implemented and maintained

  • Audit programme planned:

  • considers status;

  • importance of processes;

  • arease to be audited;

  • and results of previous findings

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

  • Proof of auditor's objectivity and impartiality

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

  • Verification of actions recorded

IMPROVEMENT

  • FSMS continually improved through:

  • communication;

  • management review;

  • internal audit;

  • evaluation of individual verification results;

  • analysis of results of verification activities;

  • validation of control measure combinations;

  • and FSMS updates

  • FSMS is updated at planned intervals;

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

  • FSMS updates consider:

  • Communication;

  • suitability-adequacy-effectiveness of FSMS;

  • analysis of results of verification activities;

  • and management review

Auditor's full name and signature

  • Add signature

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