CAPA Officer

CAPA Officer

Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.

Table of Contents

• CAPA Investigation Workflow
• Root Cause Analysis
• Corrective Action Planning
• Effectiveness Verification
• CAPA Metrics and Reporting
• Reference Documentation
• Tools

Clarify First

Before starting a CAPA investigation, confirm these inputs. If any is unknown or vague, ASK — do not assume:

• Trigger event and objective evidence — what happened, where/when, and what records exist (drives the problem statement and RCA scope)
• Severity classification — Critical, Major, or Minor (sets investigation team composition, action depth, and verification timeline)
• Source — complaint, audit finding, recurring NC, or trend (determines whether a CAPA is required and the regulatory linkage)

Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the CAPA record.

CAPA Investigation Workflow

Conduct systematic CAPA investigation from initiation through closure:

1. Document trigger event with objective evidence
2. Assess significance and determine CAPA necessity
3. Form investigation team with relevant expertise
4. Collect data and evidence systematically
5. Select and apply appropriate RCA methodology
6. Identify root cause(s) with supporting evidence
7. Develop corrective and preventive actions
8. Validation: Root cause explains all symptoms; if eliminated, problem would not recur