Corrective and Preventive Action (CAPA) Process

Based on SQF Code Edition 10 – System Element 2.11.1

Requirement Overview

SQF Edition 10, System Element 2.11.1 requires:

“A documented corrective and preventive action procedure shall be prepared and implemented to address non-conformities impacting food safety, legality, or regulatory compliance, and to prevent their recurrence.”

A CAPA program is essential to identify root causes of non-conformities and ensure lasting improvements in your food safety management system.

Disclaimer: Food Safety Systems is an independent training and advisory resource. This content is not affiliated with, endorsed by, or certified by the Safe Quality Food Institute (SQFI). Please visit www.sqfi.com for official certification details.

Key Compliance Objectives

  • ✓ Establish a documented CAPA procedure

    ✓ Conduct structured root cause analysis

    ✓ Implement and verify corrective actions

    ✓ Maintain complete records for accountability and audits

Step-by-Step Compliance Implementation

1. Develop a Documented CAPA Procedure

  • Your Procedure Should Cover:

    • • Identification and documentation of non-conformities

      • Root cause analysis (RCA) methodology

      • Implementation of corrective and preventive actions

      • Assignment of responsibilities and deadlines

      • Verification of action effectiveness and closure

    Evidence to Maintain:

    • • Approved CAPA SOP (Standard Operating Procedure)

      • Records of staff training on CAPA roles

2. Identify and Record Non-Conformities

  • Common Sources:

    • • Internal or external audit findings

      • Customer complaints

      • Product deviations

      • Equipment or process failures

    Evidence to Maintain:

    • • Non-conformance reports

      • Classification records (minor, major, critical)

      • Incident documentation

3. Perform Root Cause Analysis

  • RCA Techniques:

    • • 5 Whys

      • Fishbone (Ishikawa) diagrams

      • Cause-and-effect mapping

    Evidence to Maintain:

    • • Completed RCA forms

      • Justification of identified root cause(s)

      • Investigator notes or facilitator sign-off

4. Implement Corrective and Preventive Actions

  • Plan Requirements:

    • • Defined tasks and responsible personnel

      • Implementation timeline

      • Preventive actions to reduce recurrence

    Evidence to Maintain:

    • • Corrective Action Request (CAR) forms

      • Preventive action plans

      • Task completion logs with responsible party signatures

5. Verify CAPA Effectiveness

  • Verification Steps Include:

    • • Re-auditing affected process or area

      • Confirming root cause has been eliminated

      • Reviewing data for recurrence

    Evidence to Maintain:

    • • Closed CAPA forms with verification sign-off

      • Effectiveness review documentation

      • Updated SOPs or training records as needed

Common Audit Findings & Solutions

Audit Finding Recommended Action
No written CAPA procedure Develop and approve a formal CAPA SOP
Root cause not identified or documented Train on structured RCA techniques
Incomplete corrective action tracking Use a CAPA tracking log and accountability form
No verification of effectiveness Schedule follow-ups and maintain closure logs

Auditor Verification Checklist

Auditors will typically:

  • • Review your CAPA SOP

    • Examine open and closed CAPA records

    • Validate the use of RCA methods

    • Confirm documented evidence of CAPA implementation and results

CAPA Program Roadmap

Build Your Program

  • ✓ Approve your CAPA SOP

    ✓ Assign team roles and responsibilities

Train and Validate

  • ✓ Train teams on reporting and RCA practices

    ✓ Conduct CAPA simulations or case studies

Operate and Monitor

  • ✓ Record non-conformities and track actions

    ✓ Monitor deadlines and resolution

Improve Continuously

  • ✓ Analyze CAPA trends

    ✓ Revise SOPs and training to prevent repeat issues

Why This Matters?

A strong CAPA process:

  • ✓ Reduces repeat food safety issues

    ✓ Demonstrates regulatory readiness

    ✓ Supports a culture of continuous improvement

    ✓ Increases operational efficiency and accountability

Need Support Materials?

Food Safety Systems provides:

  • ✓ CAPA SOP templates and workflows

    ✓ Root cause analysis tools and examples

    ✓ Action planning forms and closure logs

    ✓ Auditor-ready CAPA recordkeeping sheets

GET STARTED NOW

This document is for internal training and compliance use only. It is not affiliated with or endorsed by the Safe Quality Food Institute (SQFI).

Please refer to www.sqfi.com for official certification requirements.

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