Student worksheet

Part 1

Trace the vial and review the CoA

Student worksheet · Suggested total time 35–45 minutes

Use documents D1–D4. Work alone or in pairs. Basic decimal comparison and familiarity with a lot number are enough. Record document IDs next to your conclusions.

1. Match each vial

For A, B and C, record the visible supplier lot, the matching CoA if one can be established, and the evidence or gap. Use the supplier lot and material identifier together. Identify the kind of identifier represented by R-243.

2. Compare each test with its criterion

For each matched CoA, enter the reported value with its unit and whether it meets its own criterion. Use the interval endpoints as inclusive. For any value outside its criterion, calculate the shortfall or excess.

In one sentence, explain how Vial B’s reported area percentage and peptide content can lead to different outcomes.

Part 2

Decide what to record

Student worksheet · Use the decision rule in D1

3. Evaluate the external report

Identify the two reference codes in D4. Can the external sample be assigned to Vial B from the records provided? Name the record you would request and the identifiers it would need to connect.

If that link were later documented, could D4 resolve the result outside its criterion in D3? Explain using the scope of D4.

4. Document the decision and next step

Give each vial one status from D1. Include the document ID and one next action where a hold is needed. End with a sentence explaining which sample the results actually describe.