- COA doc
- COA | TPL-LOT-006
- Linked lot
- TPL-LOT-006
- Confidence
- high
- Match reason
- Subject batch reference and sender both resolve to TPL-LOT-006. Document batch reference agrees.
- Parse method
- regex
- Review
- Pass
Audits are not failed in the audit. They are failed in the eleven months before it.
Most manufacturers have a supplier approval and monitoring procedure. It is written down, it is sensible, and it is approved.
The evidence that it operated is somewhere else. It is in an inbox, a shared drive, and a spreadsheet that one person maintains. Two weeks before the audit, someone assembles it.
Assembly does not create evidence. It reveals what was never captured in the first place.
Evidence captured, by month
3 months with nothing recorded
Two of your approved suppliers may have no approval basis right now
Not expired. Never filed.
Expiry monitoring can only warn you about dates it already holds. It is structurally incapable of telling you about a supplier approved on a certification basis whose certificate was never recorded, or a certificate filed without an expiry date so it is not tracked at all.
Those are the findings that surface at audit, because an auditor does not check your reminder system. They pick a supplier off your approved list and ask to see the basis.
Opscera reviews the approval basis of every supplier every week and reports the ones that do not hold up.
A certificate on file is not a certificate for this lot.
BRCGS Issue 9 is specific about what acceptance can be based on. Clause 3.5.2.1 permits certificates of analysis, and then adds three words in brackets:
“certificates of analysis (specific to the consignment)”
A folder of PDFs named after suppliers does not meet that. The failure is rarely a missing certificate. It is a generic or mismatched certificate accepted as though it were consignment-specific, because a supplier attached the wrong file and a busy person filed it without checking the batch number.
Opscera checks the batch reference and the sender against the lot, then reconciles both against the contents of the certificate itself. When those signals disagree, nothing is filed against the lot and the chase continues.
- COA doc
- COA | UNMATCHED - coa_scan_final_v2.pdf
- Linked lot
- not linked
- Confidence
- conflict
- Match reason
- Subject batch reference resolves to TPL-LOT-008. Document batch reference reads TPL-LOT-002. Signals disagree, no lot linked.
- Parse method
- regex
- Review
- Needs Review
Five things the system holds
- Nothing is silently dropped.
- Every lot is received, in chase, or an open exception. Nothing ages out of view.
- Certificates are matched to consignments.
- Two independent signals, reconciled against the document. Disagreement means nothing gets filed.
- The chase is a defined ladder that terminates.
- Initial request, follow-ups at intervals you set, then escalation to your QA lead and automated chasing stops. A named person owns it from there.
- The audit trail is written as events happen.
- Timestamped at the moment of the event, not reconstructed afterwards.
- Approvals are checked for basis, not just for dates.
- Expiry alerts at 90, 60, 30, 14 and 7 days, plus a weekly review of the approvals with no supporting certificate at all.
You are going to want to see this working before you believe any of it. Reasonable.
The whole pipeline. Purchase order raised through to audit record, with the actual emails your suppliers receive. How it works 
What happens when it breaks. Mismatched certificates, unparseable documents, suppliers who never reply. Matching and exceptions What an auditor is handed. The audit log, and what it records. Audit trail Where your data lives. Sub-processors, residency, retention, and the parsing opt-in. Security and data
What happens when it breaks. Mismatched certificates, unparseable documents, suppliers who never reply. Matching and exceptions What an auditor is handed. The audit log, and what it records. Audit trail Where your data lives. Sub-processors, residency, retention, and the parsing opt-in. Security and data