This is a ready-to-use investigation record for a Certificate of Analysis that does not support release: a result failing your specification, a lot mismatch, a missing test, or an authenticity concern raised at incoming review. It is a different instrument from a routine OOS investigation, because the root cause branches differently when the failure originates on a supplier’s certificate rather than in your own laboratory. Replace every <<FILL: ...>> placeholder and complete every field contemporaneously and signed. A worked filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Record title | CoA Discrepancy and Rejection Investigation |
| Form / template number | <<FILL: FORM-ID>> |
| Governing SOP | <<FILL: SOP-ID for CoA review, and for deviations>> |
| Investigation ID | <<FILL: e.g. DEV-YYYY-NNNN>> |
| Date opened | <<FILL>> |
Section A: Event identification
| Field | Entry |
|---|---|
| Material and code | <<FILL>> |
| Supplier / manufacturer | <<FILL>> |
| Lot number | <<FILL>> |
| CoA reference | <<FILL>> |
| Specification and version | <<FILL>> |
| Nature of the discrepancy | Result fails internal spec / Lot or material mismatch / Test missing from CoA / Certificate authenticity concern / Other: <<FILL>> |
| Discrepancy found by, date | <<FILL>> |
| Lot status | Quarantined / Held (confirm quarantine has not been released) |
Section B: Root-cause branch
Work through the branches in order. Stop at the first one that explains the finding, and document why the others were ruled out.
| # | Branch | Evidence reviewed | Ruled in / Ruled out |
|---|---|---|---|
| 1 | Transcription or clerical error on the certificate (value differs from the supplier’s own underlying data) | <<FILL: raw data requested and reviewed>> | <<FILL>> |
| 2 | Genuine out-of-specification material (the certificate accurately reports a result that fails your specification) | <<FILL: your in-house per-lot check result, any confirmatory testing>> | <<FILL>> |
| 3 | Specification-alignment gap (the certificate is accurate and the supplier’s own limit is looser than yours, with no product quality concern beyond the tighter internal limit) | <<FILL: comparison of your spec to the supplier's stated internal limit>> | <<FILL>> |
| 4 | Certificate integrity concern (the certificate itself, or the chain it arrived through, cannot be verified) | <<FILL: outcome of the CoA authenticity screening, if run>> | <<FILL>> |
| Field | Entry |
|---|---|
| Root cause determined | <<FILL>> |
| Other lots or shipments potentially affected | <<FILL: list, or "none identified">> |
Section C: Disposition
| Field | Entry |
|---|---|
| Disposition | Release (with justification) / Reject / Return to supplier / Hold pending further information |
| Disposition rationale (must follow from the root cause in Section B) | <<FILL>> |
| Supplier quality notified | Yes, date: <<FILL>> |
| Escalation to supplier audit | Yes / No, reference: <<FILL>> |
| QA disposition approval, signature, date | <<FILL>> |
Section D: CAPA and closure
| Field | Entry |
|---|---|
| CAPA required | Yes / No |
| CAPA reference | <<FILL>> |
| Actions | <<FILL>> |
| Target and actual closure date | <<FILL>> |
| Final QA approval, signature, date | <<FILL>> |
References
21 CFR 211.192 (investigation of any unexplained discrepancy or failure of a batch or component to meet specifications). 21 CFR 211.84(d)(2) and (d)(3) (the mandatory per-lot in-house check that generates the evidence for Section B, branch 2). ICH Q7, Section 11.4 (a certificate must present the genuine results actually obtained on the batch, which frames branch 4).
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
The following shows the record completed for an example excipient lot where the loss-on-drying result on the supplier’s CoA read as “conforms” against the supplier’s own limit but failed the internal specification.
| Field | Entry |
|---|---|
| Material and code | Example excipient, RM-0142 |
| Supplier | ASL-088 |
| Lot number | MNT-2606-041 |
| Nature of the discrepancy | Result fails internal spec: loss on drying 0.7% against internal NMT 0.5%; supplier CoA states “conforms” against its own NMT 1.0% |
| Branch 1 (transcription) | Raw data matched the certificate value exactly. Ruled out. |
| Branch 2 (genuine OOS) | In-house identity test passed; loss on drying was not independently retested in-house, since it is not part of the required per-lot check for this material. |
| Branch 3 (spec-alignment gap) | Confirmed: the supplier’s internal limit, NMT 1.0%, is looser than the internal specification, NMT 0.5%. The material is not adulterated or mistested; the result genuinely falls between two different limits. Ruled in. |
| Root cause determined | Specification-alignment gap, not a supplier data or material quality failure |
| Disposition | Hold, pending supplier quality confirming whether the internal 0.5% limit remains appropriate given process capability, or whether the lot should be rejected on the current limit |
| Supplier quality notified | Yes, 21 June 2026 |
Outcome: this record kept the disposition tethered to the actual root cause rather than defaulting to either extreme, an automatic reject on a spec technicality or a release on the supplier’s “conforms” stamp. The distinction mattered because it pointed the corrective action at a specification review rather than at the supplier’s testing, which a generic OOS investigation template, built for in-house laboratory failures, would not have surfaced as cleanly.
Common inspection findings this record prevents
- A CoA discrepancy closed informally with no investigation record, because the material was eventually released.
- A specification-alignment gap treated and recorded as a supplier quality failure, misdirecting the corrective action.
- A genuine out-of-specification result released on the strength of the supplier’s own looser “conforms” statement.
- A certificate integrity concern folded into a routine OOS investigation template that has no place to record chain-of-custody or source verification.
How to adapt this record
- Set the form number and governing SOP to match your deviation and CoA review procedures.
- Point Section B, branch 4 to your CoA authenticity screening checklist where one is used.
- Tie Section D to your CAPA system so the reference and closure are traceable.
- Confirm every regulation cited against the current published version before issue.