Before you start
Estimated time 20–30 minutes.
Prerequisites Basic familiarity with a purchase quote and a certificate of analysis. Use a spreadsheet for the matrix or draw three columns for requirement, evidence and action.
Learning objectives
- Record evidence for an offer using a document identifier and a specific observation.
- Distinguish a lot conflict from a missing record and a check planned for receipt.
- Write a decision note that names the next record needed for each offer.
Use the matrix
- Set the evidence required before a decision. Use one row per requirement and offer. Record the source and revision, what it actually says and any follow-up.
- Classify each row as Documented (relevant evidence found), Open (missing or insufficient), Conflict (incompatible records), Planned (future verification) or Not applicable (record the reason).
- Review conflicts and required open rows before comparing other evidence. Keep the review record separate from receipt verification and record who owns each follow-up.
Teaching case: two offers for one material
A training lab asks for EDU-HX06, sequence GAGKLV, with free termini and an acetate counterion. Before a decision it needs an offered-lot report with a mass result and a relative area result, plus documented storage and shipment conditions. If an accreditation claim is relevant to the decision, check the scope in force on the test date for the facility, method and material.
| Requirement | Offer A | Offer B |
|---|---|---|
| Offered lot | Conflict: offer EDU-A-042; report EDU-A-041. | Documented: offer and report refer to EDU-B-071. |
| Test evidence | Open: values are available for a different lot. | Documented: specified mass and area rows available for the offered lot. |
| Laboratory | Open: issuer claims accreditation; claimed scope unsubstantiated. | Documented: issuer named; no claim, no accreditation requirement in this case. |
| Storage and transit | Documented: instructions cover storage and shipment. | Open: storage listed; transit conditions unspecified. |
| Receipt | Planned; actual label has not been inspected. | Planned; actual label has not been inspected. |
Practice decision
Which missing record should be requested from each seller before deciding? Write a two-sentence note that cites the quote and report references.
Worked decision note
Offer A. Hold for the offered-lot report. Quote A-Q-13 names EDU-A-042 and A-COA-041 covers EDU-A-041. Obtain records for EDU-A-042 and review the test scope and any relevant accreditation claim.
Offer B. Quote B-Q-09 and B-COA-071 agree on EDU-B-071 and the required test rows are documented. Request the missing transit conditions before deciding. Complete receipt verification when the vial and its records arrive.
Decision rationale. The lot conflict leaves the offered material without matching test evidence. A report for the offered lot or a documented correction would resolve the discrepancy.
Checking accreditation. Global ACI assumed the former international roles of ILAC and IAF on January 1, 2026. Its signatory directory can identify the accreditation body. Check that body’s directory and the scope in force on the test date for the facility, method and material. ICH Q7 applies to its stated API scope.
Instructor notes
- Ask pairs to compare their decisions before showing the completed CSV. Have each pair cite the exact quote and report fields supporting its decision.
- Ask what could change each decision, then distinguish those requests from the checks the lab will make when the material arrives.