ISO 22000 Audit Checklist

UR Startup Inc. / 22 Mar 2023 / Andy Dion Complete

Score 61.04% Flagged items 3 Actions 0

Client / Site UR Startup Inc.

Conducted on (Date and Time) 22.03.2023 15:42 PST

Inspected by Andy Dion

Chemin de sous le Clos 16 1232

Location
Confignon Switzerland

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Flagged items 3 flagged

Clause 4 / Food Safety Management System / Documentation Requirements / Control of records

Do records remain legible, readily identifiable and

No
retrievable?

Some documents need to be reprinted because of they’re faded.

Photo 1

Clause 7 / Planning and realization of safe products / Preliminary steps to enable hazard analysis /
Product characteristics / Raw material, ingredients, and product contacted material

c) Origin? No

Need to clarify what “other” means on the document pertaining to origin.

Clause 8 / Validation, verification, and improvement of the FSMS / FSMS verification / Internal audit

Is it ensured that auditors do not audit their own work? No

Get external auditors to do the assessment when applicable.

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Clause 4 1 flagged, 96%  

 
Food Safety Management System 1 flagged, 96%

 
General Requirements 100%

Has the organization established, documented and

implemented an effective food safety management system in Yes
accordance with the requirements of ISO 22000 standard?

Is the FSMS maintained and updated? Yes

Is the scope of the FSMS defined? Yes

Are the products or product categories, processes and

production sites that are addressed by the food safety Yes
management system specified by scope?

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 manner that the Yes
products of theorganization do not, directly or indirectly,
harm the consumer?

Are the appropriate information - regarding safety issues

related to the products - communicated throughout the food Yes
chain?

Are the information - concerning development,

implementation and updating of the FSMS throughout the
Yes
organization - communicated to the extent necessary to
ensure the food safety required by the ISO 22000 standard?

Does the organization periodically evaluate FSMS (and update

when necessary) to ensure that the system reflects the
Yes
organization's activities and incorporates the most recent
information on the food safety hazards subject to control?

Has the organization ensured control over the outsourced

Yes
processes that may affect end product conformity?

Is the control of such outsourced processes identified and

Yes
documented within the FSMS?

 
Documentation Requirements 1 flagged, 93.33%

General 100%  

Does the FSMS documentation include:

a) Documented statements of a food safety policy and related

Yes
objectives?

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b) Documented procedures and records required by ISO 22000
Yes
standard?

c) Documents needed by the organization to ensure the

effective development, implementation and updating of the Yes
food safety management system?

Control of documents 100%  

Are the documents - which are required by the food safety

Yes
management system - controlled?

Do the established controls ensure that all proposed changes

are reviewed prior to implementation to determine their
Yes
effects on food safety and their impact on the food safety
management system?

Does a documented procedure exist to define the controls needed:

a) To approve documents for adequacy prior to issue? Yes

b) To review and update as necessary and re-approve

Yes
documents?

c) To ensure that changes and the current revision status of

Yes
documents are identified?

d) To ensure that relevant versions of applicable documents

Yes
are available at points of use?

e) To ensure that documents remain legible and readily

Yes
identifiable?

f) To ensure that relevant documents of external origin are

Yes
identified and their distribution controlled?

g) To prevent the unintended use of obsolete documents, and

to apply suitable identification to them if they are retained for Yes
any purpose?

Control of records 1 flagged, 66.67%  

Are required records established and maintained in order to

provide evidence of conformity to requirements and evidence
Yes
of the effective operation of the food safety management
system?

Do records remain legible, readily identifiable and

No
retrievable?

Some documents need to be reprinted because of they’re faded.

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Photo 1

Does a documented procedure exist in order to define the

controls needed for the correction, identification, storage,
Yes
protection, retrieval, retention time and disposition of
records?

Please proceed to Section 5.

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Clause 5 100%  

 
Management responsibility 100%

 
Management commitment 100%

Is top management able to provide evidence of its

commitment to the development and implementation of the Yes
food safety management system?

Is top management able to provide evidence that the effectiveness of the food safety management
system is continually improved by:

a) Showing food safety is supported by the business objectives

Yes
of the organization?

b) Communicating to the organization the importance of

meeting the requirements of ISO 22000 standard, any relevant
Yes
statutory and regulatory requirements, as well as customer
requirements relating to food safety?

c) Establishing the food safety policy? Yes

d) Conducting management reviews? Yes

e) Ensuring the availability of resources? Yes

 
Food safety policy 100%

Has top management defined, documented and

Yes
communicated its food safety policy?

Does top management ensure that the food safety policy:

a) Is appropriate to the role of the organization in the food

Yes
chain?

b) Conforms with both statutory and regulatory requirements

and with mutually agreed food safety requirements of Yes
customers?

c) Is communicated, implemented and maintained at all levels

Yes
of the organization?

d) Is reviewed for continued suitability? Yes

e) Adequately addresses communication? Yes

f) Is supported by measurable objectives? Yes

 
Food safety management system planning 100%

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Does top management ensure that:

a) The planning of the food safety management system is

carried out to meet the requirements in clause 4.1, as well as Yes
the objectives of the organization that support food safety?

b) The integrity of the food safety management system is

maintained when changes to the food safety management Yes
system are planned and implemented?

 
Responsibility and authority 100%

Does top management ensure that the responsibilities,

authorities are defined and communicated within the
Yes
organization to ensure the effective operation and
maintenance of the food safety management system?

Is the responsibility assigned to all personnel to report the

problems with the food safety management to identified Yes
person(s)?

Are there designated personnel with defined responsibility

Yes
and authority to initiate and record actions?

 
Food safety team leader 100%

Has top management appointed a food safety team leader who, irrespective of other
responsibilities, shall have responsibility and authority:

a) To manage a food safety team and organize its work? Yes

b) To ensure relevant training and education of the food

Yes
safety team member?

c) To ensure that the food safety management system is

Yes
established, implemented, maintained and updated?

d) To report to the organization's top management on the

effectiveness and suitability of the food safety management Yes
system?

NOTE: The responsibility of the food safety team leader may include liaison with external parties on
matters relating to the food safety management system.

 
Communication 100%

External communication 100%  

Has the organization established, implemented and maintained effective arrangements for
communicating with:

a) Suppliers and contractors? Yes

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b) Customers or consumers, in particular in relation to
product information (including instructions regarding
intended use, specific storage requirements and, as
Yes
appropriate, shelf life), inquiries, contracts or order handling
including amendments, and customer feedback including
customer complaints?

c) Statutory and regulatory authorities? Yes

d) Other organizations that have an impact on, or will be

affected by, the effectiveness or updating of the food safety Yes
management system?

Does such communication provide information on food safety

aspects (especially to known food safety hazards that need to
be controlled by other organizations in the food chain) of the Yes
organization's products that may be relevant to other
organizations in the food chain?

Are records of communications maintained? Yes

Are the food safety requirements - from statutory and

Yes
regulatory authorities and customers – available?

Are there designated personnel with defined responsibility

and authority to communicate externally any information Yes
concerning food safety?

Is information obtained through external communication

included as input to system updating and management Yes
review?

Internal communication 100%  

Has the organization established, implemented and

maintained effective arrangements for communicating with Yes
personnel on issues having an impact on food safety?

Has the organization ensured that the food safety team is informed in a timely manner of changes,
including but not limited to the following:

a) Products or new products? Yes

b) Raw materials, ingredients, and services? Yes

c) Production systems and equipment? Yes

d) Production premises, location of equipment, and

Yes
surrounding environment?

e) Cleaning and sanitation programmes? Yes

f) Packaging, storage and distribution systems? Yes

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g) Personnel qualification levels and/or allocation of
Yes
responsibilities and authorizations?

h) Statutory and regulatory requirements? Yes

i) Knowledge regarding food safety hazards and control

Yes
measures?

j) Customer, sector, and other requirements that the

Yes
organization observes?

k) Relevant inquiries from external interested parties? Yes

l) Complaints indicating food safety hazards associated with

Yes
the product?

m) Other conditions that have an impact on food safety? Yes

Does the food safety team ensure that above mentioned

information is included in the updating of the food safety Yes
management system?

Does top management ensure that relevant information is

Yes
included as input to the management review?

 
Emergency preparedness and response 100%

Has top management established, implemented and

maintained procedures to manage potential emergency
situations and accidents that can impact food safety and Yes
which are relevant to the role of the organization in the food
chain?

 
Management review 100%

General 100%  

Does top management review the organization’s food safety

management system, at planned intervals, to ensure its Yes
continuing suitability, adequacy and effectiveness?

Does this review include assessing opportunities for

improvement and the need for changes to the food safety Yes
management system, including the food safety policy?

Are records from management reviews maintained? Yes

Review input 100%  

Does the input to management review include information about:

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a) Follow-up actions from previous management reviews? Yes

b) Analysis of results of verification activities? Yes

c) Changing circumstances that can affect food safety? Yes

d) Emergency situations, accidents and withdrawals? Yes

e) Reviewing results of system-updating activities? Yes

f) Review of communication activities, including customer

Yes
feed-back?

g) External audits or inspections? Yes

Are the data presented in a manner that enables top

management to relate the information to stated objectives of Yes
the food safety management system?

Review output 100%  

Does the output from the management review include any decisions and actions related to:

a) Assurance of food safety? Yes

b) Improvement of the effectiveness of the food safety

Yes
management system?

c) Resource needs? Yes

d) Revisions of the organization's food safety policy and

Yes
related objectives?

Please proceed to Section 6

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Clause 6 100%  

 
Resource management 100%

 
Provision of resources 100%

Does the organization provide adequate resources for the

establishment, implementation, maintenance and updating of Yes
the food safety management system?

 
Human resources 100%

General 100%  

Are the food safety team and the other personnel carrying out
activities having an impact on food safety, competent on the
Yes
basis of appropriate education, training, skills and
experience?

Are there available records of agreement or contracts

defining the responsibility and authority of external experts,
where the assistance of external experts is required for the Yes
development, implementation, operation or assessment of
the food safety management system?

Competence, awareness and training 100%  

Does the organization:

a) Identify the necessary competencies for personnel whose

Yes
activities have an impact on food safety?

b) Provide training or take other action to ensure personnel

Yes
have the necessary competencies?

c) Ensure that personnel responsible for monitoring,

corrections and corrective actions of the food safety Yes
management system are trained?

d) Evaluate the implementation and the effectiveness of the

Yes
actions taken in a), b) and c)?

e) Ensure that the personnel are aware of the relevance and

importance of their individual activities in contributing to Yes
food safety?

f) Ensure that the requirement for effective communication is

understood by all personnel whose activities have an impact Yes
on food safety?

g) Maintain appropriate records of training and actions

Yes
described in b) and c)?

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Infrastructure 100%

Does the organization provide the resources for the

establishment and maintenance of the infrastructure needed Yes
to implement the requirements of ISO 22000 standard?

 
Work environment 100%

Does the organization provide the resources for the

establishment, management and maintenance of the work
Yes
environment needed to implement the requirements of ISO
22000 standard?

Please proceed to Section 7.

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Clause 7 1 flagged, 29.38%  

 
Planning and realization of safe products 1 flagged, 29.38%

 
General 100%

Does the organization plan and develop the processes needed

Yes
for the realization of safe products?

Does the organization implement, operate and ensure the

effectiveness of the planned activities and any changes to
Yes
those activities? Note: This includes PRP(s) as well as
operational PRP(s) and/or the HACCP plan.

 
Prerequisite programmes (PRPs) 100%

Has the organization established, implemented and maintained PRP(s) to assist in controlling:

a) The likelihood of introducing food safety hazards to the

Yes
product through the work environment?

b) Biological, chemical and physical contamination of the

Yes
product(s), including cross-contamination between products?

c) Food safety hazard levels in the product and product

Yes
processing environment?

Are the PRP(s):

a) Appropriate to the organizational needs with regard to

Yes
food safety?

b) Appropriate to the size and type of the operation and the

Yes
nature of the products being manufactured and/or handled?

c) Implemented across the entire production system, either as

programmes applicable in general or as programmes Yes
applicable to a particular product or operational line?

d) Approved by the food safety team? Yes

Does the organization identify statutory and regulatory

Yes
requirements related to the above?

Does the organization consider and utilize appropriate

Yes
information, when selecting and/or establishing PRP(s)?

Does the organization consider the following (when establishing PRP(s)):

a) Construction and layout of buildings and associated

Yes
utilities?

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b) Layout of premises, including workspace and employee
Yes
facilities?

c) Supplies of air, water, energy and other utilities? Yes

d) Supporting services, including waste and sewage disposal? Yes

e) The suitability of equipment and its accessibility for

Yes
cleaning, maintenance, and preventative maintenance?

f) Management of purchased materials (e.g. raw materials,

ingredients, chemicals, and packaging), supplies (e.g. water,
Yes
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? Yes

h) Cleaning and sanitizing? Yes

i) Pest control? Yes

j) Personal hygiene? Yes

k) Other aspects as appropriate? Yes

Is verification of PRP(s) planned? Yes

Are PRP(s) modified as necessary? Yes

Are records of verifications and modifications maintained? Yes

Do documents specify how activities included in the PRP(s) are

Yes
managed?

 
Preliminary steps to enable hazard analysis 1 flagged, 66.67%

General 100%  

Are all relevant information - needed to conduct the hazard

Yes
analysis - collected, maintained, updated and documented?

Are the records related to hazard analysis maintained? Yes

Food safety team 100%  

Has a food safety team been appointed? Yes

Do the members of the food safety team provide a

combination of multi-disciplinary knowledge and experience
Yes
in developing and implementing the food safety management
system? Note: This includes, but need not be limited to, the

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organization's products, processes, equipment and food
safety hazards within the scope of the food safety
management system.

Are records - that demonstrate that the food safety team has
Yes
the required knowledge and experience - maintained?

Product characteristics 1 flagged, 94.74%  

Raw material, ingredients, and product contacted material 1 flagged, 90%  

Are all raw materials, ingredients and product-contact materials described in documents to the
extent needed to conduct the hazard analysis, including the following, as appropriate:

a) Biological, chemical, and physical characteristics? Yes

b) Composition of formulated ingredients, including additives

Yes
and processing aids?

c) Origin? No

Need to clarify what “other” means on the document pertaining to origin.

d) Method of production? Yes

e) Packaging and delivery methods? Yes

f) Storage conditions and shelf life? Yes

g) Preparation and/or handling before use or processing? Yes

h) Food safety-related acceptance criteria or specifications of

purchased materials and ingredients appropriate to their Yes
intended uses?

Does the organization identify statutory and regulatory food

safety requirements related to the raw materials, ingredients Yes
and product-contact materials?

Are the descriptions kept up-to-date including, when

Yes
required?

Characteristics of end products 100%  

Are the characteristics of end products described in documents to the extent needed to conduct
the hazard analysis, including information on the following, as appropriate:

a) Product name or similar identification? Yes

b) Composition? Yes

c) Biological, chemical and physical characteristics relevant to Yes

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food safety?

d) Intended shelf life and storage conditions? Yes

e) Packaging? Yes

f) Labeling relating to food safety and/or instructions for

Yes
handling, preparation, and usage?

g) Method(s) of distribution? Yes

Does the organization identify statutory and regulatory food

safety requirements related to the characteristics of end Yes
products?

Are the descriptions kept up-to-date including, when

Yes
required?

Intended use 100%  

Are the intended use, the reasonably expected handling of the

end product, and any unintended but reasonably expected
mishandling and misuse of the end product considered and Yes
described in documents to the extent needed to conduct the
hazard analysis?

Are groups of users and, where appropriate, groups of

consumers identified for each product, and consumer groups
Yes
are known to be especially vulnerable to specific food safety
hazards considered?

Are the descriptions kept up-to-date including, when

Yes
required?

Flow diagrams, process steps, and control measures 0%  

Flow diagrams 0%  

Do flow diagrams, as appropriate, include the following:

 
Hazard analysis 0%

Hazard identification and determination of acceptable levels 0%  

Is the identification based on:

Is the consideration - when identifying the hazards - given to:

Selection and assessment of control measures 0%  

Is each selected control measure categorized as to whether it needs to be managed through

operational PRP(s) or by the HACCP plan, using a logical approach that includes assessments with

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regard to the following:

 
Establishing the operational prerequisite 0%
programmes (PRPs)

Are the operational PRPs included the following information for each programme:

 
Establishing the HACCP plan 0%

HACCP plan 0%  

Is the HACCP plan included the following information for each identified critical control point (CCP):

System for the monitoring of critical control points 0%  

Does the monitoring system consist of relevant procedures, instructions, and records that cover
the following:

Actions when monitoring results exceed critical limits 0%  

Do the actions ensure that:

 
Updating of preliminary information and
documents specifying the PRPs and the HACCP 0%

plan

Does the organization update the following information in operational PRP(s) and/or the HACCP
plan, if necessary:

 
Verification planning 0%

Do the verification activities confirm that:

 
Control of nonconformity 0%

Corrections 0%  

Is a documented procedure established and maintained defining:

Handling of potentially unsafe products 0%  

General 0%  

Does the organization handle nonconforming products by taking action(s) to prevent the
nonconforming product from entering the food chain unless it is possible to ensure that

Evaluation for release 0%  

Is each lot of product affected by the nonconformity released as safe only when any of the
following conditions apply:

Disposition of nonconforming products 0%  

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Is the lot of product - which is not acceptable for release - handled (after evaluation) by one of the
following activities:

 
Control of nonconformity 0%

Withdrawals 0%  

To enable and facilitate the complete and timely withdrawal of lots of end products which have
been identified as unsafe

Please proceed to Section 8.

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Clause 8 1 flagged, 97.96%  

 
Validation, verification, and improvement 1 flagged, 97.96%
of the FSMS
 
General 100%

Does the food safety team plan and implement the processes
needed to validate control measures and/or control measure
Yes
combinations, and to verify and improve the food safety
management system?

 
Validation of control measure combinations 100%

Does the organization validate (prior to implementation of control measures to be included in

operational PRP(s) and the HACCP plan and after any change therein) that:

a) The selected control measures are capable of achieving the

intended control of the food safety hazard(s) for which they Yes
are designated?

b) The control measures are effective and capable of, in

combination, ensuring control of the identified food safety
Yes
hazard(s) to obtain end products that meet the defined
acceptable levels?

Are the control measure and/or combinations thereof

modified and re-assessed when the result of the validation
Yes
shows that one or both of the above elements cannot be
confirmed?

Note: Modifications may include changes in control measures

(i.e. process parameters, rigorousness and/or their
combination) and/or change(s) in the raw materials,
Yes
manufacturing technologies, end product characteristics,
methods of distribution and/or intended use of the end
product.

 
Control of monitoring and measuring 100%

Is there evidence that the specified monitoring and

measuring methods and equipment are adequate to ensure
Yes
the performance of the monitoring and measuring
procedures?

Are the measuring equipment and methods used:

a) Calibrated or verified at specified intervals, or prior to use,

against measurement standards traceable to international or
Yes
national measurement standards? Note: Where necessary to
ensure valid results

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b) Adjusted or re-adjusted as necessary? Yes

c) Identified to enable the calibration status to be

Yes
determined?

d) Safeguarded from adjustments that would invalidate the

Yes
measurement results?

e) Protected from damage and deterioration? Yes

Are records of the results of calibration and verification

Yes
maintained?

Does the organization assess the validity of the previous

measurement results when the equipment or process is found Yes
not to conform to requirements?

Does the organization take action appropriate for the

equipment and any product affected, If the measuring Yes
equipment is non-conforming?

Are records of such assessment and resulting actions

Yes
maintained?

Is the ability of computer software confirmed to satisfy the

intended application when used in the monitoring and Yes
measurement of specified requirements?

Is the confirmation of computer software undertaken prior to

Yes
initial use and reconfirmed as necessary?

 
FSMS verification 1 flagged, 95.65%

Internal audit 1 flagged, 88.89%  

Does the organization conduct internal audits at planned intervals to determine whether the food
safety management system:

a) Conforms to the planned arrangements, to the food safety

management system requirements established by the
Yes
organization, and to the requirements of this International
Standard?

b) Is effectively implemented and updated? Yes

Is an audit programme planned, taking into consideration the

importance of the processes and areas to be audited, as well Yes
as any updating actions resulting from previous audits?

Are the audit criteria, scope, frequency, and methods defined? Yes

Do the selection of auditors and the conduct of audits ensure Yes

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objectivity and impartiality of the audit process?

Is it ensured that auditors do not audit their own work? No

Get external auditors to do the assessment when applicable.

Are the responsibilities and requirements for planning and

conducting audits, and for reporting results and maintaining Yes
records defined in documented procedure?

Does the management responsible for the area being audited

to ensure that actions are taken without undue delay to Yes
eliminate detected nonconformities and their causes?

Do follow-up activities include the verification of the actions

Yes
taken and the reporting of verification results?

Evaluation of individual verification results 100%  

Does the food safety team systematically evaluate the

Yes
individual results of planned verification?

Does the organization take action to achieve the required

conformity, when verification does not demonstrate Yes
conformity with the planned arrangements?

Does action – taken for achieving the required conformity – include (but is not limited to), review of:

a) Existing procedures and communication channels? Yes

b) The conclusions of the hazard analysis, the established

Yes
operational PRP(s) and the HACCP plan?

c) The PRP(s)? Yes

d) The effectiveness of human resource management and of

Yes
training activities?

Analysis of results of verification activities 100%  

Does the food safety team analyze the results of verification

activities, including the results of the internal audits and Yes
external audits?

Is the analysis carried out in order

a) To confirm that the overall performance of the system

meets the planned arrangements and the food safety
Yes
management system requirements established by the
organization?

b) To identify the need for updating or improving the food

Yes
safety management system?

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c) To identify trends which indicate a higher incidence of
Yes
potentially unsafe products?

d) To establish information for planning of the internal audit

programme concerning the status and importance of areas to Yes
be audited?

e) To provide evidence that any corrections and corrective

Yes
actions that have been taken are effective?

Are the results of the analysis and the resulting activities

recorded and reported, in an appropriate manner, to top Yes
management as input to the management review?

Are the results of the analysis and the resulting activities used
Yes
as an input for updating the food safety management system?

 
Improvement 100%

Continual improvement 100%  

Does top management ensure that the organization

continually improves the effectiveness of the food safety
management system through the use of:
- communication,
- management review,
- internal audit, Yes
- evaluation of individual verification results,
- analysis of results of verificationactivities,
- validation of control measurecombinations,
- corrective actions and
- food safety management system updating?

Updating the food safety management system 100%  

Does top management ensure that the food safety

Yes
management system is continually updated?

Does the food safety team evaluate the food safety

management system at planned intervals in order to achieve Yes
that FSMS is continually updated?

Does the team consider whether it is necessary to review the

hazard analysis, the established operational PRP(s) and the Yes
HACCP plan?

Are the evaluation and updating activities based on:

a) Input from communication, external as well as internal? Yes

b) Input from other information concerning the suitability,

adequacy, and effectiveness of the food safety management Yes
system?

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c) Output from the analysis of results of verification activities? Yes

d) Output from management review? Yes

Are system updating activities recorded and reported, in an

Yes
appropriate manner, as input to the management review?

 
Completion  

Inspector's Full name and Signature  

Andy Dion
22.03.2023 15:54 PST

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Media summary

Photo 1

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