Eight Pieces, an Outdated Form, and a Verbal Agreement
You are auditing incoming inspection at a device assembler. Work instruction WI-114 rev C specifies AQL 0.65, general inspection level II. You watch inspector Tran receive a lot of 3,200 molded housings: he pulls 8 pieces, checks three dimensions with calipers, and signs the receiving record as "AQL 0.65 completed." For a lot size of 3,200 at level II, the applicable sample size is far larger than 8. When asked, Tran says, "We've always done 8. The supervisor told us the procedure is out of date - the real requirement is in the customer quality agreement." The quality agreement on file, signed in 2019, specifies AQL 1.0, level II. The supervisor says the customer "verbally agreed" to reduce inspection about a year ago and that no one wrote it down because "they were fine with it." The receiving inspection record form in use is rev A; WI-114 rev C references a rev C form.
1. Separate what you observed from what you were told. State each candidate nonconformity with its criterion and its objective evidence.
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Objective evidence = records, documents, and directly observed conditions - not statements about them.
- Acceptance sampling not performed as specified. Criterion: WI-114 rev C (AQL 0.65, level II) and the quality agreement on file (AQL 1.0, level II). Evidence: direct observation of 8 pieces drawn from a 3,200-piece lot; the signed receiving record with an "AQL 0.65 completed" entry; the work instruction; the sample-size table. Note both criteria yield a sample size larger than 8, so the nonconformity exists under either document - a useful point, because it means the finding does not depend on resolving which document governs.
- Obsolete form in use. Criterion: document control requirements (ISO 13485:2016 4.2.4; 21 CFR 820.40) - the revision in use must be the current approved revision. Evidence: physical rev A form, WI-114 rev C referencing rev C, document master list showing rev C as current.
- Change to a customer quality agreement without documented amendment. Criterion: control of documents and of customer-related requirements; the signed 2019 agreement remains the controlled record. Evidence: the agreement on file; absence of any amendment, change record, or correspondence in the file.
Not evidence: the supervisor's statement that the customer verbally agreed; Tran's statement that "we've always done 8." These are leads, not findings. A verbal agreement, if it exists, would change the criterion - so it must be pursued, but a finding cannot rest on it and it cannot be accepted as a defence without a document.
2. How do you handle the conflicting statements from the inspector and the supervisor without turning the audit into an interrogation?
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Technique: separate the factual question from the accountability question, and corroborate everything.
- Start open, stay neutral. To the supervisor: "Walk me through how the inspection requirement gets set for this part number." Do not open with "Tran says you told him to ignore WI-114." A defensive answer shuts down the trail.
- Ask for the artifact, not the assurance. "Can you show me where the customer's agreement to AQL 1.0 is recorded - an email, an amended agreement, a change request?" The answer "it was verbal" is itself the finding; you do not need to argue about it.
- Test the claim against the system. If a real change existed, it should appear in the document change record, the contract review/order review records, and the inspection records for other part numbers. Absence across all three is corroboration that no change occurred.
- Do not adjudicate the truthfulness of individuals in the report. The finding is about the process: an unrecorded change to acceptance criteria. Personality conflicts and blame produce defensiveness in the closing meeting and disputes in the CAPA.
- Protect the inspector. Tran is junior and gave you honest information. Do not quote him by name in the finding in a way that makes him the cause. His statement is a lead; the observation stands on its own.
- Closing meeting: present the evidence, not the conclusion about people - "8 pieces were inspected against a documented requirement for a larger sample; here is the record; here is WI-114; here is the agreement on file."
3. Classify and write the finding(s). What would change your classification?
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Classification reasoning - grade by systemic extent, product risk, and whether the control exists at all.
Finding 1 (major): Incoming acceptance sampling for molded housings was not performed in accordance with documented acceptance criteria; 8 pieces were inspected and the record signed as complete against an AQL requirement specifying a substantially larger sample. Why major: the control that is supposed to detect nonconforming components (dimensional nonconformity in a housing that affects assembly and function) is not operating; it is not a single lapse but the standard practice, stated independently by the inspector and the supervisor.
Finding 2 (minor, unless the form review shows otherwise): A superseded revision of the receiving inspection record form (rev A) is in use while WI-114 rev C references the rev C form. Why minor: records still capture the data; this is a control-of-documents lapse. Reclassify to major if the form revision removed required data fields (e.g., sample size, AQL, accept/reject counts) so that the records cannot demonstrate acceptance - then the record-keeping failure is systemic and affects product acceptance evidence.
Finding 3 (major): The customer quality agreement in effect was not updated to reflect an intended change in acceptance criteria; no documented amendment exists. Why major: the agreed acceptance criteria are unverified, and there is no control preventing informal deviation from customer-specified requirements.
What would change the picture: a genuine documented customer amendment (email from an authorized customer representative accepted under the firm's change control) would remove Finding 3 and change Finding 1 to "inspection per the amended agreement" - but Finding 2 (document control) would stand and would likely grow, because the amendment was never flowed into WI-114 or the forms. Conversely, if 8 were shown to be traceable to a documented reduced-inspection justification (validated process, historical data), Finding 1 could fall away. Demand the evidence; do not infer it.