SOPWAREHOUSESOP

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

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.

  1. 01

    Purpose

    Fixed

    This procedure defines how this facility turns problems into permanent fixes.

  2. 02

    Scope: What Opens a CAPA

    Customized

    A 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.

  3. 03

    Responsibilities

    Customized

    The 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, escalates overdue items...

  4. 04

    Procedure: Opening, Numbering, and Containment

    Customized

    1. Open the CAPA in the log the day the trigger is confirmed.

  5. 05

    Procedure: Root Cause Analysis

    Fixed

    1. 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.

  6. 06

    Procedure: Corrective and Preventive Actions, Owners, and Due Dates

    Customized

    1. Corrective action addresses the problem that occurred: it removes the root cause so this problem stops recurring in the place it happened.

  7. 07

    Procedure: Effectiveness Verification and Closure

    Customized

    Effectiveness 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.

  8. 08

    Escalation, Management Review, and Trend Reporting

    Fixed

    1. The CAPA coordinator reviews the log weekly.

  9. 09

    References

    Fixed

    Facility 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

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

Waitlist

Generate this SOP for your facility

At launch you answer the facility questionnaire once and this template comes back with your equipment, your titles, and your sign-off sheet attached.

First access at launch, plus launch pricing locked for a year.

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.