TSE/BSE Risk Assessment and CEP Management Inspection

Inspection template for verifying TSE/BSE risk controls for animal-derived materials, including supplier certificates of suitability (CEP/CoS), traceability, and receiving controls.

Inspection Scope and Material Identification

• Material is identified as animal-derived or potentially animal-derived
  Verify the item is correctly classified by origin, including bovine, ovine, caprine, porcine, or mixed-origin materials where applicable.
• Intended use and risk classification are documented
  Confirm the material's intended use, product application, and TSE/BSE risk classification are documented in the approved record.
• Material lot/batch number is recorded
  Verify the lot or batch number matches the receiving record and supplier documentation.
• Material description matches purchase order and supplier certificate
  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

• Valid CEP/CoS or equivalent TSE/BSE certificate is on file
  Confirm a current certificate of suitability, supplier declaration, or equivalent approved document is available for the material.
• Certificate number and revision are recorded
  Verify the certificate identifier, revision, and issue date are documented in the controlled record.
• Certificate covers the exact material and grade received
  Confirm the certificate scope matches the received material, including grade, processing route, and any relevant animal-origin details.
• Certificate is within validity period
  Check that the certificate has not expired and remains applicable to the current supplier and manufacturing site.
• Certificate references acceptable TSE/BSE control status
  Verify the document states the material origin, species, and control status sufficient to support the approved risk assessment.

Origin, Traceability, and Country Risk Controls

• Animal species and tissue/source are identified
  Verify the species and source material are documented, such as bovine hide, bone, or gelatin origin where applicable.
• Country of origin and processing country are documented
  Confirm the country of origin and any processing or transformation country are recorded for the material.
• Traceability to supplier lot and upstream source is maintained
  Verify traceability exists from the received lot to supplier lot and, where required, to upstream source documentation.
• No undocumented substitution or mixed-origin discrepancy is present
  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

• Material is quarantined pending documentation review
  Confirm the material is held in quarantine or equivalent status until TSE/BSE documentation is approved.
• Receiving label indicates status and any restrictions
  Verify the label clearly shows hold, quarantine, approved, or restricted-use status as applicable.
• Segregation from non-approved materials is maintained
  Confirm the material is physically segregated from materials lacking approved TSE/BSE documentation.
• Release authorization is documented by QA or designated authority
  Verify release is approved by Quality Assurance or another authorized function after documentation review.

Nonconformance and Corrective Action

• Any missing or inadequate certificate is documented as a non-conformance
  Record whether the absence, expiration, or mismatch of the certificate has been entered into the deviation or non-conformance system.
• Disposition decision is documented
  Confirm the material disposition is recorded as accept, reject, rework, return to supplier, or hold for further review.
• Corrective action owner is assigned
  Identify the responsible person or function for follow-up on documentation gaps or supplier remediation.
• Target completion date is set for corrective action
  Enter the due date for closure of the corrective action or supplier follow-up.
• Supplier follow-up is required for recurring documentation gaps
  Confirm whether the issue requires supplier escalation, requalification, or update to the approved supplier file.