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Corrective and Preventive Action Procedure

The document outlines the Corrective and Preventive Action Procedure (CAPA-7862) for AR Distributors, aimed at identifying and eliminating non-conformities in their Quality Management System to comply with ISO 9001:2015. It details processes for documenting non-conformities, conducting root cause analysis, implementing corrective and preventive actions, and maintaining records for continuous improvement. The procedure emphasizes systematic approaches and responsibilities to ensure effective resolution and monitoring of quality issues.

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Shahzad Shah
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50 views3 pages

Corrective and Preventive Action Procedure

The document outlines the Corrective and Preventive Action Procedure (CAPA-7862) for AR Distributors, aimed at identifying and eliminating non-conformities in their Quality Management System to comply with ISO 9001:2015. It details processes for documenting non-conformities, conducting root cause analysis, implementing corrective and preventive actions, and maintaining records for continuous improvement. The procedure emphasizes systematic approaches and responsibilities to ensure effective resolution and monitoring of quality issues.

Uploaded by

Shahzad Shah
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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AR DISTRIBUTORS

Corrective and Preventive Action Procedure

1. Document Information
 Document Number: CAPA-7862
 Prepared By: MR
 Reviewed By: Director
 Approved By: CEO
 Date: 10/03/2025

2. Purpose & Scope


This procedure establishes a systematic approach to identifying, investigating, and eliminating
the causes of actual or potential non-conformities within AR Distributors' Quality Management
System (QMS), ensuring compliance with ISO 9001:2015.

3. Definitions
 Corrective Action: A process to eliminate the root cause of a detected non-conformity to
prevent recurrence.
 Preventive Action: A proactive approach to eliminate potential non-conformities before
they occur.
 Non-Conformity: A deviation from a specified requirement, standard, or process.
 Root Cause Analysis (RCA): A method used to determine the underlying cause of a
problem.

4. Identification of Non-Conformities
Non-conformities may arise from:

 Internal audits
 Customer complaints
 Process failures
 Supplier performance issues
 Management review findings

5. Corrective Action Process


5.1 Initiation
 Non-conformities are documented in the Corrective Action Request (CAR) Form.
 The Process Owner is assigned responsibility for analysis and resolution.

5.2 Root Cause Analysis

 Root cause determination is conducted using tools such as:


o 5 Whys Analysis
o Fishbone Diagram (Ishikawa)
o Failure Mode and Effects Analysis (FMEA)

5.3 Implementation & Verification

 The corrective action plan must include:


o Steps to prevent recurrence
o Responsible personnel
o Implementation timeline
 Effectiveness is verified through:
o Follow-up audits
o Performance monitoring
o Employee feedback

6. Preventive Action Process


6.1 Identification

 Potential issues are identified through trend analysis and risk assessment.
 Preventive actions are documented in a Preventive Action Request (PAR) Form.

6.2 Implementation & Monitoring

 The Quality Manager ensures corrective/preventive actions are effectively implemented.


 Results are reviewed during Management Review Meetings.

7. Record-Keeping & Retention


 All CARs and PARs must be maintained for a minimum of 3 years.
 Records include:
o Non-Conformity Reports
o Root Cause Analysis Documentation
o Action Plans & Implementation Records

8. Continuous Improvement
 Lessons learned from corrective and preventive actions are used to enhance QMS
effectiveness.
 The process is continuously reviewed for efficiency and effectiveness.

Prepared By: MR
Reviewed & Approved By: CEO
Date: 10/03/2025

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