Traceability is usually described as a system. In practice it is a stack of small documents that either match each other or do not. When they do not, the audit finding is rarely "no traceability"; it is "inconsistent records", which is harder to answer because it implies a process problem rather than a missing form.
Consumables are especially exposed because they arrive in cases, get decanted into bags, and are recorded in batch records by a name that may not match the label. The fix is structural and cheaper than most quality projects.
Start with the label
A traceable consumable has four things on the outer pack: the product reference, the lot number, the quantity, and the date of manufacture or sterilisation. If any of those is missing, the item cannot enter the chain, no matter how good the certificate is.
For sterile items, add the sterilisation indicator and the expiry date. For double-bagged items, the lot must appear on both the outer and inner bag, otherwise the link breaks at the airlock.
The outer case has a lot number; the inner bags do not. Once the case is opened, the link to the certificate is gone.
Match the certificate to the delivery
A certificate of analysis is only useful if it names the same lot that arrived. Build a receiving check that compares three fields: reference, lot, and quantity. If the certificate covers a range of lots, confirm that the delivered lot falls inside it.
File the certificate against the goods receipt, not against the supplier folder. The question an auditor asks is "show me the certificate for the wipes used on batch 1234", and the answer should take one lookup, not three.
Record the reference in the batch record
This is where most sites lose traceability. The batch record says "sterile wipes" or "70% IPA wipes" rather than the product reference and lot. The operator knows what was used; the record does not.
Add a field for reference and lot at the point of use, and make it mandatory. For electronic records, a dropdown of qualified references with a lot field is enough. The cost is a few seconds per batch; the benefit is a closed loop.
| Document | Must contain | Stored with |
|---|---|---|
| Purchase order | Reference, quantity, specification revision | Procurement system |
| Certificate of analysis | Reference, lot, test results, method | Goods receipt |
| Goods receipt | Lot, quantity, condition, date | Warehouse record |
| Batch record | Reference, lot, quantity used | Batch file |
| Deviation log | Lot, defect, disposition | Quality system |
Handle decanting explicitly
Decanting is the weak point in every consumables chain. Wipes move from a case to a lidded container; IPA moves from a drum to a spray bottle. Both lose their identity unless the new container is labelled at the moment of transfer.
Write a one-line rule into the SOP: every secondary container carries the reference, lot and date of transfer. Provide labels at the point of decanting, not in a cupboard. Rules that require a walk are rules that get skipped.
Supplier change notification
Traceability does not end at the loading dock. If the supplier changes a raw material, a bag supplier or a sterilisation contractor, the lot is not equivalent to the previous one, even if the reference is unchanged.
Put a clause in the quality agreement requiring notification before the change ships, and name the person who receives it. Then check that the clause has been used at least once — a notification process that has never triggered is usually a process that does not exist.
The file, in practice
A workable audit file for a single consumable has five tabs: specification, supplier qualification, certificates by lot, receiving records, and change history. It should be possible for someone who did not buy the product to answer three questions in under five minutes: what is it, which lot was used, and what changed.
If that takes an afternoon, the file is not a file. It is an archive.
How long should lot records be kept?
At least as long as the batch records they support, and longer for sterile or implantable products. Check the applicable retention requirement for your market before setting a policy.
Is a certificate of conformity enough?
For non-critical items, sometimes. For sterile or product-contact consumables, you need test results and the method, not just a statement that the product conforms.
What if the supplier cannot provide lot-level certificates?
Then the item cannot be fully traced. Either qualify a different reference or document a risk-based exception with additional incoming testing. Do not leave the gap undocumented.
Traceability is not a database. It is the habit of writing the same four fields on every document in the chain. Sites that do it well make it look easy, which is the point.
