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Run: TSE/BSE Risk Assessment and CEP Management Inspection

Use this inspection template to verify TSE/BSE controls for animal-derived materials, including CEP/CoS review, traceability, quarantine, and QA release befo...

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Inspection Scope and Material Identification

Verify the item is correctly classified by origin, including bovine, ovine, caprine, porcine, or mixed-origin materials where applicable.
Confirm the material's intended use, product application, and TSE/BSE risk classification are documented in the approved record.
Verify the lot or batch number matches the receiving record and supplier documentation.
Confirm the material name, grade, and origin on the purchase order match the supplier certificate of suitability or equivalent declaration.

Supplier Certificate of Suitability Review

Confirm a current certificate of suitability, supplier declaration, or equivalent approved document is available for the material.
Verify the certificate identifier, revision, and issue date are documented in the controlled record.
Confirm the certificate scope matches the received material, including grade, processing route, and any relevant animal-origin details.
Check that the certificate has not expired and remains applicable to the current supplier and manufacturing site.
Verify the document states the material origin, species, and control status sufficient to support the approved risk assessment.

Origin, Traceability, and Country Risk Controls

Verify the species and source material are documented, such as bovine hide, bone, or gelatin origin where applicable.
Confirm the country of origin and any processing or transformation country are recorded for the material.
Verify traceability exists from the received lot to supplier lot and, where required, to upstream source documentation.
Confirm there is no mismatch between the declared origin and the received material, including mixed-origin or substituted material concerns.

Receiving, Storage, and Release Controls

Confirm the material is held in quarantine or equivalent status until TSE/BSE documentation is approved.
Verify the label clearly shows hold, quarantine, approved, or restricted-use status as applicable.
Confirm the material is physically segregated from materials lacking approved TSE/BSE documentation.
Verify release is approved by Quality Assurance or another authorized function after documentation review.

Nonconformance and Corrective Action

Record whether the absence, expiration, or mismatch of the certificate has been entered into the deviation or non-conformance system.
Confirm the material disposition is recorded as accept, reject, rework, return to supplier, or hold for further review.
Identify the responsible person or function for follow-up on documentation gaps or supplier remediation.
Enter the due date for closure of the corrective action or supplier follow-up.
Confirm whether the issue requires supplier escalation, requalification, or update to the approved supplier file.

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