An audit of consumables is not a search for a missing certificate. It is a test of whether the site can reconstruct a decision: why this product, why this lot, what changed and who approved it. The documents are only the evidence that the reconstruction is possible.
The four questions
First, what is the specification and who approved it. Second, which lots were received and where they went. Third, what changed since the specification was written. Fourth, what happened when a result was out. A site that can answer those four in under ten minutes is in good shape.
Most findings come from the third question. A supplier changes a bag, a fibre source or a converting line, the product behaves slightly differently, and nobody inside the plant knows because the change was never notified. The audit trail is what makes that visible.
Traceability from carton to batch
The lot number on the carton should be recorded at goods-in and linked to the batch record where the consumable was used. That link is what allows a deviation investigation to move from "a wipe" to "this lot, these packs, these batches".
For a large site, the link is usually a goods-in entry and a line issue record. For a small site, it may be a handwritten log. Either is acceptable if it is complete and legible; neither is acceptable if the lot number is only on the pallet that went to the skip.
Change control across the supplier boundary
A change notification clause is only useful if someone reads the notifications. Assign an owner, log the notification, assess the impact and record the decision, even when the decision is "no action". An inspector who sees a notification with no assessment will ask why.
The assessment should name the parameter that could change: particle release, extractables, dimensions, pack count or sterility. If none of them changes, say so and close it.
| Record | Owner | Retention |
|---|---|---|
| Specification and approval | Quality | Life of product + 1 year |
| Goods-in lot log | Warehouse | Per site procedure |
| Supplier CoA | Quality | Lot life + traceability window |
| Change notification and assessment | Procurement / Quality | Life of product + 1 year |
| Deviation and disposition | Quality | Per quality system |
Keeping it findable
The best documentation is useless if it takes a day to find. File by lot, keep the specification in the same folder as the certificates, and name files with the product reference and the lot rather than the date of the scan. A simple index at the front of the folder saves more audit time than a thicker procedure.
Review the file annually. Remove superseded specifications to an archive, confirm the retention dates and check that the change log is complete. The review itself is evidence that the system is alive.
The ten-minute self-audit
Pick one lot at random. Find the specification, the certificate, the goods-in entry and the batch where it was used. Then find the last change notification for that product and the assessment that followed it. If any of the five takes more than two minutes, the filing needs work before an auditor tests it.
Run the exercise twice a year with someone who did not build the file. Their difficulty finding things is the finding. Keep a short note of what they could not find and what was changed as a result; that note is the evidence that the review was real.
Do we need to keep every carton label?
No. Keep the lot log and a sample label per lot. The log is the traceability record; the label is a convenience.
How long should supplier certificates be kept?
At least as long as the lot could be in use plus the traceability window required by the quality system. For sterile products, align it with the batch record retention.
Is an electronic log acceptable?
Yes, if it is controlled, backed up and attributable. An editable spreadsheet with no access control is not a record; it is a draft.
