Company Name
Division or Address
Division or Address
Corrective and Preventive Action
Doc. No.
Rev. No.
Date: 6/28/2016
Page 1 of x
ISO Procedure
Corrective and Preventive Action
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
A
Responsible
Person
Description of Change
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
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Company Name
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Division or Address
1.
2.
Corrective and Preventive Action
Doc. No.
Rev. No.
Date: 6/28/2016
Page 2 of x
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.
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>.
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Division or Address
Corrective and Preventive Action
Doc. No.
Rev. No.
Date: 6/28/2016
Page 3 of x
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>
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Division or Address
Corrective and Preventive Action
Doc. No.
Rev. No.
Date: 6/28/2016
Page 4 of x
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
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Corrective and Preventive Action
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Rev. No.
Date: 6/28/2016
Page 5 of x
<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>
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For Internal Use Only