Title Page
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Conducted on
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Prepared by
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Auditee's signature : I agree with the audit findings
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Auditee's name
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SOI<br>The company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and recall of products should this be required.
3.11.1 Incident management procedures
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The company shall have procedures designed to report and effectively manage incidents and potential emergency situations that impact food safety, authenticity, legality or quality. This shall include consideration of contingency plans to maintain product safety, authenticity, legality and quality. Incidents may include:
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disruption to key services such as water, energy, transport, refrigeration processes, staff availability and communications
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events such as fire, flood or natural disaster
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malicious contamination or sabotage
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product contamination indicating a product may be unsafe or illegal
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failure of, or attacks against, digital cyber-security.
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Where products which have been released from the site may be affected by an incident, consideration shall be given to the need to withdraw or recall products.
3.11.2 Documented product withdrawal and recall procedure
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The company shall have a documented product withdrawal and recall procedure. This shall include, at a minimum:
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identification of key personnel constituting the recall management team, with clearly identified responsibilities
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guidelines for deciding whether a product needs to be recalled or withdrawn and the records to be maintained
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an up-to-date list of key contacts (including out-of-hours contact details) or reference to the location of such a list (e.g. recall management team, emergency services, suppliers, customers, certification body, regulatory authority)
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a communication plan including the provision of information to customers, consumers and regulatory authorities in a timely manner
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details of external agencies providing advice and support as necessary (e.g. specialist laboratories, regulatory authority and legal expertise)
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a plan to handle the logistics of product traceability, recovery or disposal of affected product, and stock reconciliation
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a plan to record timings of key activities
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a plan to conduct root cause analysis and to implement ongoing improvements, to avoid recurrence.
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The procedure shall be capable of being operated at any time.
3.11.3 Testing incident management and recall procedures
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The incident management procedures (including those for product recall and withdrawal) shall be tested, at least annually, in a way that ensures their effective operation.
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Results of the test shall be retained and shall include timings of key activities.
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The results of the test and of any actual recall shall be used to review the procedure and implement improvements as necessary.
3.11.4 Communication with certification body
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In the event of a significant food safety, authenticity or legality incident, including a product recall, regulatory food safety non-conformity (e.g. a regulatory enforcement notice) or food safety-related withdrawal, the certification body issuing the current certificate for the site against this Standard shall be notified within 3 working days.
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The company shall then provide sufficient information to enable the certification body to assess any effects of the incident on the ongoing validity of the current certificate within 21 calendar days.
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As a minimum, this shall include corrective action, root cause analysis and a preventive action plan.
