FSSC22000 Vs4 Checklist
FSSC22000 Vs4 Checklist
FSSC22000 Vs4 Checklist
ISO 22000:2005
4 Food safety management system
4.1 General requirements
4.1 – 01 Has the organisation established, documented and implemented an effective food safety
management system in accordance with the requirements of ISO 22000 standard?
4.1 – 02 Is the FSMS maintained and updated?
4.1 – 03 Is the scope of the FSMS defined?
4.1 – 04 Are the products or product categories, processes and production sites that are addressed by the
food safety management system specified by scope?
4.1 – 05 Are the food safety hazards that may be reasonably expected to occur in relation to products within
the scope of the system identified, evaluated and controlled in such a manner that the products of
the organisation do not, directly or indirectly, harm the consumer?
4.1 – 06 Are the appropriate information - regarding safety issues related to the products - communicated
throughout the food chain?
4.1 – 07 Are the information - concerning development, implementation and updating of the FSMS
throughout the organisation - communicated to the extent necessary to ensure the food safety
required by the ISO 22000 standard?
4.1 – 08 Does the organisation periodically evaluate FSMS (and update when necessary) to ensure that the
system reflects the organisation's activities and incorporates the most recent information on the food
safety hazards subject to control?
4.1 – 09 Has the organisation ensured control over the outsourced processes that may affect end product
conformity?
4.1 – 10 Is the control of such outsourced processes identified and documented within the FSMS?
4.2 4.2 Documentation requirements
4.2.1 4.2.1 General
Does the FSMS documentation include:
4.2.1 – 01 a) documented statements of a food safety policy and related objectives?
4.2.1 – 02 b) documented procedures and records required by ISO 22000 standard?
4.2.1 – 03 c) documents needed by the organisation to ensure the effective development,
implementation and updating of the food safety management system?
4.2.2 4.2.2 Control of documents
4.2.2 – 01 Are the documents - which are required by the food safety management system - controlled?
4.2.2 – 02 Do the established controls ensure that all proposed changes are reviewed prior to
implementation to determine their effects on food safety and their impact on the food safety
management system?
Does a documented procedure exist to define the controls needed:
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5.6.2 –03 Does the food safety team ensure that above mentioned information is included in the updating of
the food safety management system?
5.6.2 –04 Does top management ensure that relevant information is included as input to the management
review?
5.7 Emergency preparedness and response
5.7 – 01 Has top management established, implemented and maintained procedures to manage potential
emergency situations and accidents that can impact food safety and which are relevant to the role of
the organisation in the food chain?
7.1 – 02 Does the organisation implement, operate and ensure the effectiveness of the planned activities and
any changes to those activities.
7.2 Prerequisite programmes (PRPs)
Has the organisation established, implemented and maintained PRP(s) to assist in controlling
7.2.1 – 01 a) the likelihood of introducing food safety hazards to the product through the work
environment?
7.2.1 – 02 b) biological, chemical and physical contamination of the product(s), including cross
contamination between products?
7.2.1 – 03 c) food safety hazard levels in the product and product processing environment?.
Are the PRP(s):
7.2.2 – 01 a) appropriate to the organisational needs with regard to food safety?
7.2.2 – 02 b) appropriate to the size and type of the operation and the nature of the products being
manufactured and/or handled?
7.2.2 – 03 c) implemented across the entire production system, either as programmes applicable in
general or as programmes applicable to a particular product or operational line?
7.2.2 – 04 d) approved by the food safety team.
7.2.2 – 05 Does the organisation identify statutory and regulatory requirements related to the above?
7.2.3 – 01 Does the organisation consider and utilize appropriate information, when selecting and/or
establishing PRP(s)?
7.2.3 – 02 Does the organisation consider the following (when establishing PRP(s)):
a) construction and lay-out of buildings and associated utilities;
b) lay-out of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) the suitability of equipment and its accessibility for cleaning, maintenance and preventative
maintenance;
f) management of purchased materials (e.g. raw materials, ingredients, chemicals and packaging),
supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and handling of
products (e.g. storage and transportation);
g) measures for the prevention of cross contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene;
k) other aspects as appropriate.
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7.3.5.1- 05 Does the food safety team verify the accuracy of the flow diagrams by on-site checking?
7.3.5.1- 06 Are verified flow diagrams maintained as records?
7.3.5.2 Description of process steps and control measures
7.3.5.2- 01 Are the existing control measures process parameters and/or the rigorousness with which they are
applied, or the procedures that may influence food safety, described to the extent needed to conduct
the hazard analysis?
7.3.5.2- 02 Are external requirements (e.g. regulatory authorities or customers) that my impact the choice or
rigorousness of the control measures described and updated?
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7.4.4- 04 Are control measures - categorized as belonging to the HACCP plan – implemented?
7.4.4- 05 Are other control measures implemented as operational PRPs?
7.4.4- 06 Are the methodology and parameters - used for this categorization - described in documents?
7.4.4- 07 Are the results of the assessment recorded?
7.5 Establishing the operational prerequisite programmes (PRPs)
7.5- 01 Are the operational PRPs documented?
7.5- 02 Does the documentation for the operational PRPs include the following information for each
programme:
a) food safety hazard(s) to be controlled by the programme?
b) control measure(s)?
c) monitoring procedures that demonstrate that the operational PRPs are in place?
d) corrections and corrective actions to be taken if monitoring shows that the operational PRPs are
not in control ?
e) responsibilities and authorities?
f) record(s) of monitoring?
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7.7- 02 Are the HACCP plan and the procedures and instructions specifying the PRP(s) amended, If
necessary?
7.8 Verification planning
7.8- 01 Does verification planning define the purpose, methods, frequencies and responsibilities for the
verification activities?
Do the verification activities confirm that
7.8- 02 a) the PRP(s) are implemented?
7.8- 03 b) input to the hazard analysis is continually updated?
7.8- 04 c) the operational PRP(s) and the elements within the HACCP plan are implemented and
effective,
7.8- 05 d) hazard levels are within identified acceptable levels?
7.8- 06 e) other procedures required by the organisation are implemented and effective?
7.8- 07 Is the output of verification planning in a form suitable for the organisation's method of operations?
7.8- 08 Are verification results recorded and communicated to the food safety team?
7.8- 09 Are verification results provided on a such way to enable the analysis of the results of the
verification activities?
7.8- 10 Are the affected lots of product handled as potentially unsafe, if system verification is based on
testing of end product samples, and where such test samples show lack of conformity with the
acceptable level of the food safety hazard?
7.10.3.1- 02 Are all lots of product - that may have been affected by a nonconforming situation - held under
control of the organisation until they have been evaluated?
7.10.3.1- 03 Does the organisation notify relevant interested parties and initiate a withdrawal, if products that
have left the control of the organisation are subsequently determined to be unsafe?
7.10.3.1- 04 Are the controls and related responses and authorization for dealing with potentially unsafe products
documented?
7.10.3.2 Evaluation for release
7.10.3.2- 01 Is each lot of product affected by the nonconformity released as safe only when any of the following
conditions apply:
a) evidence other than the monitoring system demonstrates that the control measures have been
effective;
b) evidence shows that the combined effect of the control measures for that particular product
complies with the performance intended;
c) the results of sampling, analysis and/or other verification activities demonstrate that the affected
lot of product complies with the identified acceptable levels for the food safety hazard(s) concerned?
7.10.4 Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end products which have been
identified as unsafe…
7.10.4- 01 a) Has top management appointed personnel having the authority to initiate a withdrawal
and personnel responsible for executing the withdrawal?
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7.10.4- 03 Are withdrawn products secured or held under supervision until they are destroyed, used for
purposes other than originally intended, determined to be safe for the same (or other) intended use,
or reprocessed in a manner to ensure they become safe?
7.10.4- 04 Are the cause, extent and result of a withdrawal recorded and reported to top management as input
to the management review?
7.10.4- 05 Does the organisation verify and record the effectiveness of the withdrawal programme through the
use of appropriate techniques (e.g. challenge testing, mock withdrawal or practice withdrawal)?
8.2- 02 Are the control measure and/or combinations thereof modified and re-assessed when the result of
the validation shows that one or both of the above elements cannot be confirmed?
8.3 Control of monitoring and measuring
8.3- 01 Are there evidences that the specified monitoring and measuring methods and equipment are
adequate to ensure the performance of the monitoring and measuring procedures?
Are the measuring equipment and methods used:
8.3- 02 a) calibrated or verified at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards?
Is the basis used for calibration or verification recorded, where no
such standards exist?
8.3- 03 b) adjusted or re-adjusted as necessary?
8.3- 04 c) identified to enable the calibration status to be determined?
8.3- 05 d) safeguarded from adjustments that would invalidate the measurement results?
8.3- 06 e) protected from damage and deterioration?
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8.4.1- 02 Is an audit programme planned, taking into consideration the importance of the processes and
areas to be audited, as well as any updating actions resulting from previous audits?
8.4.1- 03 Are the audit criteria, scope, frequency and methods defined?
8.4.1- 04 Do the selection of auditors and the conduct of audits ensure objectivity and impartiality of the audit
process?
8.4.1- 05 Is it ensured that auditors do not audit their own work?
8.4.1- 06 Are the responsibilities and requirements for planning and conducting audits, and for reporting
results and maintaining records defined in documented procedure?
8.4.1- 07 Does the management responsible for the area being audited ensure that actions are taken without
undue delay to eliminate detected nonconformities and their causes?
8.4.1- 08 Do follow-up activities include the verification of the actions taken and the reporting of verification
results?
8.4.2 Evaluation of individual verification results
8.4.2- 01 Does the food safety team systematically evaluate the individual results of planned verification?
8.4.2- 02 Does the organisation take action to achieve the required conformity, when verification does not
demonstrate conformity with the planned arrangements?
8.4.2- 03 Does action – taken for achieving the required conformity – include (but is not limited to), review of
a) existing procedures and communication channels?
b) the conclusions of the hazard analysis, the established operational PRP(s) and the HACCP plan?
c) the PRP(s)?
d) the effectiveness of human resource management and of training activities?
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8.4.3- 03 Are the results of the analysis and the resulting activities recorded and reported, in an appropriate
manner, to top management as input to the management review?
8.4.3- 04 Are the results of the analysis and the resulting activities used as an input for updating the food
safety management system?
8.5 Improvement
8.5.1 Continual improvement
8.5.1-01 Does top management ensure that the organisation continually improves the effectiveness of the
food safety management system through the use of:
- communication,
- management review,
- internal audit,
- evaluation of individual verification results,
- analysis of results of verification activities,
- validation of control measure combinations,
- corrective actions and
- food safety management system updating?.
8.5.2- 05 Are system updating activities recorded and reported, in an appropriate manner, as input to the
management review?
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5.7 -01 Are facilities used to store ingredients, packaging and products providing protection from dust,
condensation, drains, waste and other sources of contamination?
5.7 -02 Are storage areas dry and well ventilated? Is there monitoring and control of temperature and
humidity?
5.7 -03 Are storage areas designed or arranged to allow segregation of raw materials, work in progress and
finished products?
5.7 -04 Are materials and products stored off the floor with sufficient space between the material and the
walls to allow inspection and pest control activities to be carried out?
5.7 -05 Is the storage area designed to allow maintenance and cleaning , prevent contamination and
minimise deterioration?
5.7 -06 Is there a separate and secure storage area provided for cleaning materials, chemicals and other
hazardous substances?
5.7 -07 Are exceptions for bulk or agricultural crop materials documented in the FSMS?
6 Utilities - air, water, energy
6.1 General Requirements
6.1- 01 Are provision and distribution routes for utilities to and around processing and storage areas
designed to minimise product contamination risk?
6.1- 02 Is the quality of utilities monitored to minimise product contamination risk?
6.2 Water Supply
6.2- 01 Is the supply of potable water sufficient to meet the needs of the production purposes?
6.2- 02 Are storage, distribution and, where needed, temperature control of the water designed to meet
specified water quality requirements?
6.2- 03 Is water used as a product ingredient, including ice or steam, or in contact with products or product
surfaces meeting the specified quality and microbiological requirements relevant to the product?
6.2- 04 Is water for cleaning or applications where there is a risk of indirect product contact meeting
specified quality and microbiological requirements relevant to the application?
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8.2- 03 Is equipment made of materials compatible with intended products and cleaning or flushing agents?
8.2- 04 Is the framework of the equipment not penetrated by holes or nuts and bolts?
8.2- 05 Is the piping and ductwork cleanable and without dead ends?
8.2- 06 Is the equipment designed to minimise contact between the operator's hands and the products?
8.3 Product contact surfaces
8.3- 01 Are product contact surfaces constructed from materials designed for food use? Are they
impermeable and rust or corrossion free?
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10.3- 04 Is rework containing allergens only limited to products which contain the same allergens through a
process which is demonstrated to remove or destroy the allergenic material?
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12.2- 02 Are there documented pest management programmes that identify target pests, and address plans,
methods, schedules, control procedures and, where necessary, training requirements?
12.2- 03 Do the programmes include a list of approved chemicals?
12.3 Preventing access
12.3- 01 Are buildings maintained in good repair and are holes, drains and other potential pest access points
sealed?
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14.2- 02 Are segregation requirements for rework (e.g. allergen) documented and met?
14.2- 03 Is rework clearly identified and/or labelled to allow traceability? Are traceability records for rework
maintained?
14.2- 04 Is there rework classification or is the reason for rework designation recorded? (e.g. product name,
production date, shift, line of origin, shelf-life)
14.3 Rework Usage
14.3- 01 Where rework is incoporated as an "in-process" step, is the acceptable quantity, type and conditions
of rework specified? Is the process step and method of addition, including any necessary pre-
processing stages defined?
14.3- 02 Where rework activities involve removing a product from filled or wrapped packages, are controls
put in place to ensure the removal and segregation of packaging materials and to avoid
contamination of the product with extraneous matter?
2.1.4.3-02 Are these supplied materials described in documents to the extent needed to conduct hazard
analysis?
2.1.4.3-03 Do all supplied materials comply with applicable regulatory requirements (e.g. control of prohibited
substances)?
2.1.4.3-04 Does the company have an implemented system to assure that analysis (according to ISO 17025 or
equivalent) of all input critical to the verfication of product safety is done?
2.1.4.4 Management of Natural Resources (for Animal Production only)
2.1.4.4-01 Does the company (animal farm) identify the risks it exposes from animal production to both animal
and public health?
2.1.4.4-02 Does the company (animal farm) assess the hazards that expose these risks derived from on-farm
used natural resources?
2.1.4.4-03 Has the company (animal farm) put appropriate protective and control measures in place to protect
public and animal health?
2.1.4.5 Food Defence
Does the company have a documented, established and maintained procedure for a food defence
threat assessment that:
2.1.4.5.1- 01 a) Identifies potential threats?
2.1.4.5.1- 02 b) Develops preventative measures?
2.1.4.5.1- 03 c) Prioritise the preventative measures against the threats?
2.1.4.5.1- 04 Does the company assess the susceptibility of its products to potential acts of sabotage, vandalism
and terrorism?
2.1.4.5.2- 01 Have the company put in place appropriate preventaibe measures to protect consumer health?
2.1.4.5.2- 02 Are these measures controlled within the scope of the FSMS?
2.1.4.5.2- 03 Are these measures in compliance with applicable legistlation?
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