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Quality Corrective Action Form Guide

This document outlines a corrective action form used by a quality assurance department to document problems, assign corrective actions, and track issues to resolution. The form includes sections to describe the nonconformity, immediate corrective actions taken, root cause analysis, long-term corrective actions proposed with timelines and responsibilities, verification of corrective actions, and sign off to close the issue. Issues are classified as major, minor, or opportunities for improvement depending on their potential impact.

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227 views2 pages

Quality Corrective Action Form Guide

This document outlines a corrective action form used by a quality assurance department to document problems, assign corrective actions, and track issues to resolution. The form includes sections to describe the nonconformity, immediate corrective actions taken, root cause analysis, long-term corrective actions proposed with timelines and responsibilities, verification of corrective actions, and sign off to close the issue. Issues are classified as major, minor, or opportunities for improvement depending on their potential impact.

Uploaded by

yzarvelasco
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
  • Root Causes: Identifies the underlying causes of the problem to prevent recurrence, completed by the recipient.
  • Correction Plan: Outlines the immediate action required to correct the nonconformity along with responsibilities and timelines.
  • Identification: Captures key identifiers including problem details, date, requestor, and recipient to start the corrective action process.
  • Nonconformity Statement: Details the nonconformity statement or problem description, documenting the issue to be addressed.
  • Verification and Closure: Records the verification of corrective actions and includes final checks for closing the case by QA.
  • Corrective Action Plan: Describes the action plan for corrective measures, including responsibilities, timelines, and required resources.

QUALITY ASSURANCE

DEPARTMENT

Problem

Date CAF Number


Requestor/
Recipient
Originator
CORRECTIVE ACTION FORM
Identified Through:
Daily Operation Customer Feedback

Operations Review Others: _________________

Criticality of CA:

Major (must be closed within 7 working days*) Any nonconformity which has a significant effect on product quality, safety and efficacy.

Minor (must be closed within 30 working days*) Any nonconformity which may result in failure or reduce the usability of the product for the
intended purpose.

Improvement (can or cannot be considered as compliance) Any nonconformity which can be a tool for improvements of the product and/or
system.

NOTE: *Duration of CLOSURE of MAJOR & MINOR CAs will depend on the nature of compliance.

I. Nonconformity Statement/Problem Description: (To be completed by the Originator)

Reported by/Date: Approved by/Date:

II. Correction: (Immediate Action) (To be completed by the Recipient)


Timeline
Action Plan Responsibility Resources
Start End

Potential Risk:

Performed by/Date: Approved by/Date:

III. Root Causes (To be completed by the Recipient)

SF-OXY-06
Page No. 1 of 2
Mar2018; Rev 0
IV. Corrective Action (To be completed by the Recipient)
Timeline
Action Plan Responsibility Resources
Start End

Performed by/Date: Approved by/Date:

V. Corrective Action Verification (please attach evidence of action taken)

VI. Corrective Action Status


Open/Closed Date of Verification:

Checked by Verified by QA/Date: Approved for Closing/Date:


Originator/date:

SF-OXY-06
Page No. 2 of 2
Mar2018; Rev 0

Problem Date CAF Number Requestor/ Originator Recipient CORRECTIVE ACTION FORM Identified Through: Da
IV. Corrective Action (To be completed by the Recipient) Action Plan Responsibility Timeline Resources Start End Performed by

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