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Handbook

SOP AMU-074 · Part 4

CAPA — Corrective & Preventive Action

Corrective vs preventive action, a worked example and the mandatory CAPA record.

CAPA is critical for building a professional company.

  • Corrective action — fixes a problem that has already occurred
  • Preventive action — reduces the probability of recurrence or a similar future issue

CAPA Example

  1. 1Problem: 5 Experience Boxes were shipped without spoons.
  2. 2Immediate correction: send missing spoons to affected customers.
  3. 3Root cause: packing team used an old checklist.
  4. 4Corrective action: replace outdated checklist.
  5. 5Preventive action: introduce barcode / BOM verification and second-person QC.
  6. 6Verification: monitor next 500 boxes; if no recurrence, close CAPA.

CAPA Record

  • CAPA number
  • Problem
  • Date
  • Department
  • Immediate action
  • Root cause
  • Corrective action
  • Preventive action
  • Owner
  • Deadline
  • Evidence
  • Effectiveness check
  • Closure approval