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- Quality Management System
- Process
- CAPA effectiveness
CAPA effectiveness
CAPA completion depends on evidence of work and a separate effectiveness result. Tasks carry investigation, correction, prevention, verification and effectiveness phases. Quality Manager retains the final decision while Quality Engineer and Operations Manager perform their assigned work.
Step by step
-
Investigate Quality Engineer
Quality Engineer fills the root cause analysis and its cause steps with evidence.
- Explain the cause
- Updates Root cause analysis, Five whys steps
-
Review cause Quality Manager
Quality Manager reviews the analysis after it is complete and approves the conclusion.
- Approve analysis
- Updates Root cause analysis
ApprovalA person approves before the work moves on. -
Implement action Operations Manager
Assignees complete corrective and preventive tasks with dates and evidence.
- Record correction
- Updates CAP as, CAPA tasks
-
Verify completion Quality Manager
Quality Manager checks verification tasks and advances the CAPA into effectiveness check.
- Check task evidence
- Updates CAPA tasks, CAP as
-
Judge effectiveness Quality Manager
Quality Manager records Effective or not effective after observing the result.
- Record result
- Updates CAP as
ApprovalA person approves before the work moves on. -
Close or reopen Quality Manager
An effective case can close; not effective reopens the CAPA and creates corrective and verification work.
- Close or assign rework
- Updates CAP as, CAPA tasks
Who does what
Roles and permissions- Quality Engineer
- Facilitates analysis; Operations Manager executes assigned CAPA work; Quality Manager reviews cause, effectiveness and closure.
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