Corrective and Preventive Action (CAPA)
Facility-wide corrective and preventive action process covering what opens a CAPA, the numbered CAPA log, immediate containment before analysis, root cause analysis that reaches process causes, corrective versus preventive action with named owners and due dates, effectiveness verification at a defined interval with evidence, escalation of overdue actions to management review, closure criteria, and trend reporting.
- Audience
- The CAPA coordinator, department managers and supervisors who own actions, the quality and safety program owners who feed findings into the process, and the site leadership team that reviews CAPA status
- Review cycle
- annual
- Last reviewed
- 2026-08-17
- Revision
- 1
Corrective and Preventive Action (CAPA): what is in the procedure
9 sections. Regulatory language is fixed and passes through verbatim. Sections marked customized get rewritten around your facility, your equipment, and your job titles.
- 01
Purpose
FixedThis procedure defines how this facility turns problems into permanent fixes.
- 02
Scope: What Opens a CAPA
CustomizedA CAPA is opened for any problem whose cause is, or may be, systemic: a problem that will recur if only the immediate symptom is cleaned up.
- 03
Responsibilities
CustomizedThe CAPA coordinator owns the process: opens and numbers each CAPA, maintains the CAPA log, assigns or confirms the action owner, sets and tracks due dates, schedules effectiveness verification...
- 04
Procedure: Opening, Numbering, and Containment
Customized1. Open the CAPA in the log the day the trigger is confirmed.
- 05
Procedure: Root Cause Analysis
Fixed1. Assign the analysis to the action owner with a due date, normally within ten working days of opening, and involve the people who actually do the work: the picker, the receiver, the counter, the loader.
- 06
Procedure: Corrective and Preventive Actions, Owners, and Due Dates
Customized1. Corrective action addresses the problem that occurred: it removes the root cause so this problem stops recurring in the place it happened.
- 07
Procedure: Effectiveness Verification and Closure
CustomizedEffectiveness verification is the step that separates a corrective action process from a to-do list, and it is the step auditors probe hardest because it is the one most facilities skip.
- 08
Escalation, Management Review, and Trend Reporting
Fixed1. The CAPA coordinator reviews the log weekly.
- 09
References
FixedFacility CAPA log and CAPA request form.
Best practice
Corrective and Preventive Action (CAPA): no regulation to cite
No public-domain regulation governs this procedure, so it cites nothing rather than inventing authority. It documents the process discipline customers, insurers, and auditors ask to see in writing.
Compliance checklist
Corrective and Preventive Action (CAPA): what an inspector looks for
A single facility-wide CAPA log exists with unique sequential numbering, and every entry shows source, owner, due dates, status, verification result, and closure date
Every CAPA shows containment recorded before root cause analysis, and no CAPA is closed on containment alone
Every CAPA contains a structured root cause analysis worksheet whose stated cause is a process cause, not a person, and passes the reversibility test
Every CAPA answers the preventive question explicitly: where else the same cause exists was checked and the answer recorded, even when it is nowhere
Every action has one named owner and a specific due date, and completion is recorded with evidence rather than claimed
Effectiveness verification is performed at the defined interval by someone independent of the action owner, using recurrence data and direct observation, and a failed verification reopens the CAPA at root cause analysis
Overdue actions are escalated to management review by number with the owner present, and no due date slips more than once without a site leader decision
A quarterly trend report is produced from the log, and repeat causes across departments are consolidated into a single systemic CAPA
Document changes arising from CAPAs are issued through the Document Control SOP and the revision is traceable from the CAPA file
At least three closed CAPA files with full evidence, including verification, can be produced on request for a customer audit
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This page is informational and is not legal advice. Have a qualified safety professional review any procedure before it goes into service at your facility.