CAPA and root cause

A major or critical nonconformance creates a corrective CAPA once. The CAPA can also refer to an audit finding. When a CAPA moves into progress without an analysis, the start-work workflow creates a Five Whys root cause analysis, scaffold steps and an investigation task. Quality Engineer uses the problem statement, evidence and answers to identify the cause. Fishbone categories are available for a different analysis method.

The analysis moves through in progress, complete, reviewed and approved states. Approval is a human decision by the responsible quality authority. It is distinct from completing a task. CAPA tasks each carry a phase, assignee, due date, status and evidence. Operations Manager can execute assigned corrective work; Quality Manager retains closure and effectiveness authority.

A CAPA moves through implementation, verification and effectiveness check. The result records whether the action worked. If effectiveness is not effective, the reopen workflow sets the CAPA to Reopened and creates fresh corrective and verification tasks. It is guarded against firing again while already reopened. The original tasks and analysis remain part of the case history, so the team can explain the repeated effort.

• Source and owner. The CAPA identifies the report or finding and names an accountable owner.
• Cause and tasks. Analysis explains why the issue happened; tasks show who changes what.
• Effectiveness decision. The result determines closure or renewed work.

Decide who facilitates root cause analysis, how evidence is attached and which Quality Manager approves its conclusion. Set due dates that leave time for implementation and verification. Agree what observation will show the action worked. The team should distinguish verification of task completion from effectiveness of the correction in later operations.

Use a major inspection defect that created a nonconformance report and CAPA. Move the CAPA to in progress and confirm that a single analysis and investigation task appear. Have Quality Engineer record a problem statement, cause chain and supporting evidence. Assign corrective work to Operations Manager and record its completion. Have Quality Manager review verification and enter not effective. Confirm that the CAPA reopens and that new corrective and verification tasks appear once. A later Effective result can support closure after the work is checked.

• Open CAP as — Active and reopened cases with owner, due date and status.
• Pending CAPA Tasks — Work awaiting an assignee’s action.
• Pending RCA Approvals — Reviewed analyses awaiting a quality decision.

See nonconformance to CAPA and CAPA effectiveness.