Iso 22000 Audit
Iso 22000 Audit
Client: GNL
Auditor:
Clause
No
4
4.1
Date:
Clause
4.2
Documentation requirements
4.2.1
General
Does the FSMS documentation include:
- Food Safety Policy and related objectives?
- procedures, including records?
- Other documents, including records, needed for effective
development, implementation and updating of the FSMS?
Page 1 of 20
Evidence of
implementation
Clause
No
Clause
4.2.2
Control of documents
Are FSMS documents controlled?
Are records controlled?
Are documentation changes which impact on the FSMS reviewed prior
to implementation?
Does the procedure for document control require:
- approval of documents for adequacy prior to issue?
- the review, update and re-approval of amended documents?
- that changes and current revision status are identified?
- that relevant versions of documents are available at points of use?
- that documents remain legible and readily identifiable?
- that externally originating documents are identified and have a
controlled distribution?
- to prevent unintended use of obsolete documents and suitably
identify obsolete documents if retained?
- record the rationale of changes to documents?
Is this procedure documented?
4.2.3
Control of records
Are sufficient records established to substantiate conformance with the
FSMS?
Are records legible, readily identifiable and retrievable?
Is there a documented procedure for the control of records? Does the
procedure specify record correction, identification, storage, protection,
retrieval, retention time and disposition?
5
5.1
Management responsibility
Management commitment
Does evidence of top managements commitment to the development
and implementation of the FSMS include :
Business objectives supporting food safety?
Establishment of the food safety policy?
Communication to the organisation by top management regarding
- the importance of meeting the requirements of this International
Standard?
- any statutory and regulatory requirements?
- customer requirements relating to food safety?
- The conducting of management reviews?
The provision of resources by top management?
Page 2 of 20
Evidence of
implementation
Clause
No
5.2
Clause
5.3
5.4
5.5
Page 3 of 20
Evidence of
implementation
Clause
No
Clause
Page 4 of 20
Evidence of
implementation
Clause
No
Clause
5.6
Communication
5.6.1
External communication
Are there effective arrangements for communicating with:
- suppliers, vendors and contractors?
- customers or consumers, in particular in relation to product
information (eg instructions of intended use, storage requirements,
shelf life etc.)?
- statutory and regulatory food authorities?
- other organisations the FSMS may impact on or be impacted by ?
Do these communication arrangements provide adequate information
on the food safety aspects throughout the food chain?
Particularly, are known food safety hazards that need to be controlled
by other organisations satisfactorily communicated?
Are associated records maintained of this communication?
How are food safety requirements from customers and regulatory
authorities made available?
Has the responsibility and authorities been defined for the designated
personnel which have been authorised to communicate to external
parties eg suppliers, customers, regulatory authorities on information
concerning food safety?
Where has this been defined and is their evidence of communication to
the relevant personnel?
Is the external communication included during review of the System
by the Food Safety Team and also as input to the management review?
5.6.2
Internal communication
What arrangements are there for communicating food safety issues and
changes internally to the relevant personnel?
Have these arrangements been effectively established, implemented
and maintained?
How does the organisation ensure that the Food Safety Team is
informed of changes in:
- 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 and allocation of responsibilities and
authority?
- regulatory requirements?
- knowledge regarding food safety hazards and control measures?
- customer, sector and other requirements?
- relevant enquiries from external parties?
Page 5 of 20
Evidence of
implementation
Clause
No
Clause
5.7
5.8
Management review
5.8.1
General
How does top management review the FSMS?
How often is it reviewed?
Is relevant information available to top management for the review?
Are opportunities for improvement and the need for change the FSMS
assessed?
Is the Food Safety Policy included in this assessment?
Are records of management review maintained?
5.8.2
Review input
Is there an agenda for the meeting?
Does the agenda cover:
- results of external audits?
- analysis of results of verification activities ?
- changing circumstances that can affect food safety?
- emergency situations, accidents and withdrawals?
- reviewing results of system up-dating activities?
- review of communication activities (internal and external)
conducted including customer feedback?
- follow-up actions from previous meetings?
Is the data presented to enable the information to be related to the
objectives of the FSMS?
Are review intervals defined/adhered to?
Are review agenda adhered to?
Are attendees in accordance with procedures?
Are actions followed up and assigned to personnel?
Page 6 of 20
Evidence of
implementation
Clause
No
5.8.3
6
6.1
Clause
Review output
Does the review realise decisions and actions for:
- assurance of food safety?
- improvement to the effectiveness of the FSMS?
- resource requirements?
- revisions to the Food Safety Policy and FSMS objectives?
Resource management
Provision of resources
Have adequate resources been provided for the FSMS by the
organisation?
6.2
Human resources
6.2.1
General
Are any external experts required for the operation of the FSMS?
Are there records of agreements in place establishing the responsibility
and authority of these experts?
Are members of the Food Safety Team and other personnel employed
with activities affecting food safety competent?
Do competencies take into consideration appropriate education,
training, skills and experience?
6.2.2
6.3
Infrastructure
Is the infrastructure in place appropriate to achieve conformity to the
FSMS?
6.4
Work environment
Is the work environment appropriate to achieve conformity to the
Page 7 of 20
Evidence of
implementation
Clause
No
Clause
Evidence of
implementation
FSMS?
7
7.1
7.2
7.2.1
7.2.2
Clause
No
Clause
managed?
How are the PRPs verified and how is this verification planned?
Are records of these verifications available?
Have records been kept of any modifications made from the
verification process?
7.3
7.3.1
General
Is all relevant information needed to enable hazard analysis maintained
updated and documented ie Food safety team details, raw material
and end product characteristics, intended use, flow diagrams, process
steps and control measures ?
Are relevant records retained?
7.3.2
7.3.3
Product characteristics
7.3.3.1
Evidence of
implementation
Clause
No
Clause
Intended use
Has the intended use and the reasonably expected handling of the end
product been considered and documented?
Has any unintended use but reasonable expected mishandling and
misuse been considered and documented?
Is it included in the product specifications?
Are users and consumers identified for each product?
Have groups especially vulnerable to food safety hazards been
considered?
Are specifications kept up to date?
7.3.5
7.3.5.1
Flow diagrams
Page 10 of 20
Evidence of
implementation
Clause
No
Clause
7.4
Hazard analysis
7.4.1
General
Has the Food safety Team conducted the hazard analysis to determine
degree of control and combination of controls required for food safety?
7.4.2
7.4.2.1
7.4.2.3
Has the acceptable level of food safety in the end product been
determined for each food safety hazard identified considering:
- established regulatory requirements?
- customer food safety requirements?
- experience?
- intended use by customer?
Has this acceptable level identified been recorded and justified?
7.4.3
Page 11 of 20
Hazard assessment
Has a hazard assessment been conducted for each food safety hazard
identified?
Has this assessment determined if elimination or reduction of the
hazard to acceptable levels is essential for safe food?
Has this assessment determined if control of this hazard is needed for
defined acceptable levels to be met?
Also has each food safety hazard been evaluated and categorised
according to its severity and likelihood of occurring?
Has this methodology used for hazard assessment been described?
Have the results of hazard assessment been recorded?
Evidence of
implementation
Clause
No
Clause
7.4.4
7.5
7.6
7.6.1
HACCP Plan
Page 12 of 20
Evidence of
implementation
Clause
No
Clause
Is the HACCP Plan documented and does it contain the following for
each CCP :
- food safety hazard to be controlled?
- the corresponding control measure?
- monitoring parameters showing the control measure is functioning?
- critical limits?
- monitoring?
- corrective action if critical limits are exceeded?
- responsibility for monitoring?
- records of monitoring?
7.6.2
Identification of CCPs
Have all CCPs been identified for those control measures?
7.6.3
7.6.4
7.6.5
Page 13 of 20
Evidence of
implementation
Clause
No
7.7
Clause
7.8
Verification planning
Is verification of the HACCP Plan documented?
Is the purpose, methods, frequencies and responsibilities for the
verification activities defined?
Does verification confirm:
- PRP are implemented?
- analysis of hazards is continually updated?
- operational PRPs and the HACCP Plan are implemented and
effective?
- hazard levels are within acceptable levels?
- any other procedures are implemented and effective?
Are records for verification defined?
Are verification results recorded and communicated to the Food Safety
Team?
7.9
Traceability system
How does the organisation identify product?
How is raw product traceable back to the supplier?
How is end product traceable?
Are traceability records retained? For how long?
Are the traceability records consistent with the shelf life of the
product?
7.10
Control of nonconformity
7.10.1
Corrections
Is corrective action initiated when critical limits are exceeded and
when operation PRPs are not adhered to?
Are nonconforming products affected identified and controlled in
regards to their use?
Page 14 of 20
Evidence of
implementation
Clause
No
Clause
Corrective actions
Are monitoring records of CCPs & OPRPs evaluated by designated
personnel with sufficient knowledge and authority to initiate corrective
action?
Are documented procedures in place to identify and specify
appropriate actions to handle nonconformities, including:
- reviewing customer complaints and nonconformities?
- reviewing trends in monitoring and verification results?
- determining the causes of nonconformities?
- evaluating the need for preventive action?
- determining and actioning corrective action?
- records of results of corrective action?
- reviewing corrective action to ensure it is effective?
Are corrective actions recorded and signed by the responsible person?
7.10.3
7.10.3.1
General
Page 15 of 20
Evidence of
implementation
Clause
No
Clause
8
8.1
Withdrawals
Does the organisation have a documented procedure for notifying
interested parties of product withdrawal?
Does the product withdrawal procedure establish:
- the authority to initiate a withdrawal and execute a withdrawal
appointed by top management?
- notification to interested parties?
- handling of withdrawn products and affected products still in
stock?
- the sequence of actions to be taken?
- records required?
How does the organisation ensure withdrawn product is not used
inadvertently?
In the case of a withdrawal, has the cause, extent and result been
recorded and reported to top management as input to the management
review?
How does the organisation verify the effectiveness of the withdrawal
program (e.g. mock/practice withdrawal)?
Page 16 of 20
Evidence of
implementation
Clause
No
8.2
Clause
8.3
8.4
8.4.1
Internal audit
Are internal audits planned to determine if the FSMS:
- conforms to this Standard and the FSMS documented
requirements?
- is effectively implemented and updated?
Does the audit program consider the status and importance of
processes and the results of previous audits?
Are audit criteria, scope, frequency and methods defined?
Are auditors impartial?
Do they audit their own work?
Are responsibilities for planning and conducting audits, and for
reporting results and maintaining records documented in a procedure?
Is corrective action resulting from discrepancies found during internal
audits taken without undue delay?
Is this corrective action verified?
Page 17 of 20
Evidence of
implementation
Clause
No
Clause
8.4.3
8.5
Improvement
8.5.1
Continual improvement
Is the effectiveness of the FSMS continually improved 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?
- FSMS updating?
8.5.2
Page 18 of 20
Evidence of
implementation
Clause
No
Clause
Page 19 of 20
Evidence of
implementation