Investigation Results: Contaminated Batch #7B

Timeline of Events

  • 2025-06-05 08:00 UTC

    Batch #7B production started. Raw material Lot #RM-45 sourced. [batch-record.pdf, p. 2]

  • 2025-06-05 11:30 UTC

    Operator notes unusual odor from mixing tank 3. Continues process per SOP. [operator-log.txt, line 112]

  • 2025-06-06 09:00 UTC

    QC sample from Batch #7B fails microbial testing. [qc-report-7b.pdf, p. 5]

  • 2025-06-06 09:45 UTC

    Batch #7B is quarantined. Investigation is launched. [quarantine-log.csv, row 88]

Five Whys Analysis

1.

Why was Batch #7B contaminated?

Because a contaminated raw material (Lot #RM-45) was used in production. [qc-report-7b.pdf, p. 7]

2.

Why was a contaminated raw material used?

Because the incoming raw material did not undergo microbial testing before being released to production. [materials-sop.pdf, p. 3]

3.

Why was the material not tested?

Because the current SOP only requires testing for identity and purity, not microbial load, based on the supplier's Certificate of Analysis (CoA). [materials-sop.pdf, p. 5]

4.

Why did we rely solely on the supplier's CoA?

Because the supplier was on the "approved" list, which has looser incoming inspection requirements to save time and costs. [supplier-management.pdf, p. 12]

5.

Why was the supplier's quality not re-evaluated?

Because the periodic supplier re-evaluation program was postponed due to budget cuts, and there was no process to flag suppliers for re-evaluation based on minor historical deviations. [q4-budget-meeting.eml]

Root Cause:

The supplier qualification and management process is inadequate. It overly relies on supplier CoAs for critical materials without sufficient incoming verification, and the re-evaluation program was not robust enough to adapt to changing priorities or risks.