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Run: Certificate of Analysis Review Log

Review supplier Certificates of Analysis against incoming material specs before you release a lot. This log captures traceability, spec checks, discrepancies...

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Receiving and Traceability

Confirm the COA was issued by the approved supplier or authorized manufacturer listed on the approved supplier list.
Verify the COA material description, item code, and purchase/receiving record identify the same material.
Record the supplier lot or batch number shown on the COA and confirm it matches the received container labeling.
Enter the quantity received for the lot being reviewed.

COA Receipt and Document Control

Verify the lot has not been released to production, use, or storage for use prior to COA review completion.
Check that the COA includes all pages, readable results, and no missing or obscured fields.
Capture the date the COA was issued by the supplier.
Confirm the COA format, revision, or version is acceptable per the current quality agreement or SOP.

Specification Review Against COA

Verify the COA identity result meets the approved material specification.
Confirm all critical or release-defining attributes listed on the COA meet the approved acceptance criteria.
Document any key COA test values reviewed against specification limits, including units where applicable.
Confirm there are no OOS, OOT, or other unexplained discrepancies on the COA.
Verify the COA results are within all required acceptance limits for the material.

Exceptions, Discrepancies, and Non-Conformance

Document any mismatch between the COA, receiving record, and approved specification.
Confirm non-conforming or pending-review material is segregated and not released for use.
Record whether a supplier complaint, deviation, or corrective action request was opened.
Describe the deficiency, affected lot, and any immediate containment action taken.

Disposition and Release Authorization

Select the final disposition for the lot after COA review.
Confirm the lot was released only after COA acceptance and required review completion.
Add any final notes regarding acceptance rationale, exceptions, or follow-up actions.
Signature of the person approving the COA review and lot disposition.

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