Division or Address / Doc. No. / Rev. No.
Division or Address / Date: / Page XXX of x
ISO Procedure
Corrective and Preventive Action
Approved: ______
title Name
Approved: ______
title Name
Approved: ______
title Name
Approved: ______
title Name
Approved: ______
title Name
Change Record
Rev / Date / Responsible Person / Description of ChangeA / Name / Initial Release
Distribution List
(list the departments that receive controlled copies)
1. Purpose
• To establish and specify systematic steps for corrective action in the resolution of quality-related problems.
• To analyze and resolve quality problems.
• To create a permanent solution that prevents recurrence of nonconformance or potential nonconformance.
2. Scope
This procedure applies to internal or external customers related to quality, reliability, safety, or performance of any product offered by <COMPANY>.
Any written or oral expression of dissatisfaction by either internal or external customers related to the identity, quality, reliability, safety, or performance of any product or service offered by <COMPANY> is subject to investigation for root cause and irreversible corrective action.
3. Responsibilities
<Job titles> review problems for resolution.
<Job titles> implement permanent changes through the <name of group or team>.
4. Procedure
4.1 Written Procedures
<Job title> prepares the written procedure for corrective action activities. These procedures are maintained in the Document Control system and revised when changes to processes occur.
<Job title> prepares the written procedure for preventive action activities. These procedures are maintained in the Document Control system.
4.2 Request for Corrective Action
Corrective actions are required for supplier nonconformance, for parts that cannot be reworked, and for quality audit findings.
For product corrective actions, <job title> initiates a corrective action request by completing the <name of form>. <Job title> reviews the <name of form>. <Job title> assigns an employee to resolve the nonconformance within <timeframe>.
For supplier corrective actions, <job title> initiates a corrective action request by completing the <name of form>. <Job title> reviews the <name of form>. <Job title> assigns an employee to resolve the nonconformance within <timeframe>.
For corrective actions resulting from quality audit findings, <job title> initiates a corrective action request by completing the <name of form>. <Job title> reviews the <name of form>. <Job title> assigns an employee to resolve the nonconformance within <timeframe>.
<Job title> maintains the <corrective action log>. The <corrective action log> is stored <location> for <length of time>.
4.3 Execute Corrective Action System
<Job title> analyzes <items> to eliminate potential causes of nonconformance.
<Job title> can offer solutions to a corrective action by completing the <name of form>.
If an extension is needed, a <name of form> is submitted to the originator of the corrective action stating the amount of additional time needed and reason for the extension. The request is filed with the <job title>.
The <job title> reviews the resolution and indicates acceptance on the <name of form>. If not acceptable, the <job title> may review and reassign the investigation. If the problem is not resolved it is brought to <team>. Upon approval, the <job title> ensures that the corrective action instructions are passed to appropriate personnel for implementation.
The <job title> indicates the corrective action closure on the <name of corrective action log>.
4.4 Investigate Root Cause
To determine the root cause <job title> does the following:
• <activity>
• <activity>
• <activity>
<Job title> completes a report of the investigation and recommends solutions to prevent recurrence on the <name of report>. <Job title> reviews the <name of report>. <Job title> is responsible for ensuring that the corrective action instructions are implemented.
4.5 Corrective Action Meetings
At <frequency> <name of meeting> corrective actions are reviewed. <Job titles> attend the <name of meeting>. At the <name of meeting> the following is reviewed:
• <item>
• <item>
• <item>
<Job title> maintains records of the <name of meeting>. The <name of record> is stored in <location> for <length of time>.
4.6 Resolve Corrective Actions
Solutions to corrective actions are maintained in <name of log>.
If a change to a process or document is required <name of form> is used to initiate the change.
<Job title> handles disputes between the company and the vendor. Problematic vendors are removed from the approved vendor list.
4.7 Verification of Effectiveness
Test data from <name of tests> are used to verify the effectiveness of the corrective action.
Statistical analysis is performed to determine the effectiveness of the corrective action using <measurements>.
<Frequency>, Management examines the corrective action log to determine any trends in defects. If any trends exist appropriate corrective action is taken.
4.8 Permanent Changes
<Job title> can request a change to a design or process. Major changes to the design or process are implemented through <activity>. A permanent change to a design or process affects <documentation>.
4.9 Preventive Action System
<Job title, department> evaluates <activities> to assess potential causes of nonconformity.
If a potential nonconformity is determined, <job title> completes the <name of form>. <Job title> reviews the <name of form> and assigns a responsible person to assess a solution for preventive action.
<Timeframe> is given for the resolution of a preventive action.
Preventive actions are logged in the <name of log>. The <name of log> is stored <location>.
5. Related Documentation
<Corrective Action Request form>
<Corrective Action Data log>
<status report>
<meeting minutes>
<Preventive Action Request form>
<Preventive Action log>
Management Review
Document and Data Control
Purchasing
Control of Nonconforming Product
Internal Quality Audits
<list work instructions>
Controlled Copy, Do Not Duplicate For Internal Use Only