Guide ยท Review practice
Incoming material CoA review checklist
- Short answer
- An incoming CoA review confirms that the certificate belongs to the lot in front of you, that it is complete, that every result meets the specification you hold and not only the supplier's, and that the outcome is recorded for the person who decides release. Do it before the material is used, and write down what you saw.
General background, not regulatory or GMP advice. Your quality system decides who reviews, what is checked and who releases.
Why the order matters
A review works best as a fixed sequence. Identity comes first, because a flawless certificate for the wrong lot is worthless. Limits come next, then the odd results, then shelf life. Doing it in the same order every time is what makes a missed row visible.
The checklist assumes you hold your own specification. If the supplier's limits are the only ones you have, the review confirms the supplier's claims, not your requirements. Background on reading a certificate is on Certificate of analysis explained.
The checklist, in order
Eight checks. Pause and follow your procedure at any step where something does not match.
Match the paperwork to the delivery
Product, grade, lot and quantity agree across the purchase order, delivery note, container labels and certificate. See batch and lot numbers.
Confirm the certificate is for this lot
The lot number matches character for character, dates are in a plausible order, and the certificate number and page count are present.
Check issuer and approval
The issuing manufacturer or laboratory is named, and an approver or an authorised statement with a date is present.
Compare the test list with your specification
Every test you require appears, with a method, a limit, a result and a unit. A missing test is a gap, not a pass.
Compare each result with your limit
Use your limit, not just the printed one. Mind inclusive and exclusive symbols, units, basis and decimals.
Look hard at the odd results
Below-detection values, Complies in place of a number, Report rows, a changed method, and results identical to the previous lot deserve a second look.
Check shelf life
Note the expiry or retest date and the remaining life against what your purchasing terms require. See retest date vs expiry date.
Record and route
Log lot, supplier, dates and outcome, note every discrepancy, and pass the decision to the person who owns it. A failed result goes to the out-of-specification steps. A layout for the record is on the batch release log template page.
If you see this, check that
A lookup for the findings that come up most often. The next step is typical, not prescribed.
| If you see | It may mean | Typical next step |
|---|---|---|
| Lot differs by one character | Wrong certificate or a typing error | Hold; ask the supplier to confirm the lot |
| Result equal to the limit | Passes if the limit is inclusive | Check the symbol, decimals and any rounding rule |
| A '<' value above your limit | Method too coarse to prove compliance | Ask for a result with a lower reporting level |
| Complies instead of a number | A statement, not a measurement | Ask for the value, or record the gap |
| Method differs from the last lot | A shift in results may be method related | Ask the supplier why it changed |
| A required test is absent | A gap in the certificate | Request the missing result before use |
| Results identical to the previous lot | Possibly copied data | Query the supplier; compare document dates |
| Short remaining shelf life | Below your purchasing terms | Refer to purchasing and QA |
| Dates out of order | Analysis after release, or expiry before manufacture | Query the supplier; do not correct dates yourself |
| Page 1 of 2 and no page 2 | Part of the certificate is missing | Request the complete document |
What goes wrong in a rushed review
- Checking against the supplier's limits only. The supplier's specification can be looser than yours.
- Trusting the Pass column. The supplier's conclusion can disagree with the numbers beside it.
- Reading only page one. Test tables continue, and a long certificate can carry its failing row on page two.
- Using material before the review is done. Pressure to start production is the usual reason a check is skipped.
- Reviewing from memory. Without a written order, a reviewer skips the step that seems least likely to matter.
- Not recording a clean result. With no record, nobody can show later that the check happened.
How CertiClean helps
CertiClean works as a second reader for steps 4 to 6. Upload the certificate and it returns one row per test with the printed limit read, the result compared and a status, plus the batch header card for the lot and dates and a batch log line. It compares against the limits printed on the certificate, not your own specification, so applying your own limit in step 5 stays with you. See CoA to Excel and pricing.
Free allowance: 1 file per day, up to 10 pages, no account.
Questions people ask
Who should review an incoming CoA?
That is set by your quality system. Commonly a QC or QA reviewer checks the certificate, and the release decision belongs to a designated person, for example a qualified person where that role exists.
Does every lot need a CoA review?
Typically yes, even where testing on receipt is reduced. How much else you do depends on the material, the supplier's history and your procedures.
What if the CoA arrives after the goods?
Many sites keep the material in quarantine until the certificate is reviewed. Follow your own procedure for receipt without paperwork.
Should I compare with the supplier's specification or mine?
Both. The supplier's printed limits show what they certified. Your specification decides whether the lot is acceptable to you.
What do I do with a failing result?
Do not release on the certificate alone. Hold the lot, confirm the result was read correctly and follow your procedure. The out-of-specification guide describes the usual steps.
How long should I keep reviewed certificates?
Retention periods depend on your sector, your regulations and your own procedures. Check them rather than assuming, and keep the certificate with the batch record.
Is a PDF certificate acceptable?
Commonly yes, if your procedures accept the way it was received and you can show it is the supplier's document. A scan or photo needs closer checking of digits.
Can this checklist be a spreadsheet?
Yes. Keep the controlled version in whatever system your quality procedures designate, and treat a working copy as a draft.