A quality system that survives the audit and the shift change

The quality management system was documented, certified and largely fictional between audits. Controlled documents lived in a network folder where the current revision and three superseded ones sat side by side, and there was no way to prove an operator had read the work instruction governing their station.

Non-conformance reports were written on a pad and stapled into a lever-arch file, and the corrective action that followed was a discussion. Internal audits were scheduled in a spreadsheet, and findings from the previous cycle were frequently still open at the next one. Test certificates for despatched product were compiled by hand from bench records, which took hours and occasionally went out against the wrong batch. Customer complaints were handled by whoever took the call.

There is one live revision of every controlled document and it is the only one anyone can open; superseded revisions are retained for audit but cannot be reached from the shop floor. When a work instruction changes, the operators governed by it are required to acknowledge the new revision, and that register is the evidence.

A non-conformance raised at a station routes by product and severity to a disposition — use as is, rework, scrap, return to supplier — and a repeat non-conformance against the same cause triggers a corrective action rather than another disposition. Inspection and test results are captured at the point of test against the batch, so the certificate is generated from the records rather than transcribed from them. Audit findings, calibration due dates, complaints and corrective action status all feed the management review pack continuously.