Procedure Number: QAP-08.

6
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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

1.0 PURPOSE

1.1 This document defines the system and requirements for a closed loop
corrective and preventive action process that describes the problem solving
approach required to identify and eliminate root cause(s) of non-conformances
and potential non-conformances.

Note: Red italic text indicates a TL 9000 requirement.

Green text indicates an ISO/TS 16949 requirement.
Blue italic text indicates an AS 9100 requirement.

1.2 Sanmina uses a CAPA system which is part of the Agile PQM suite of tools.

Training in how to perform a thorough CAPA (8D) investigation can be found at

the link below.

QAT-0002-C 8D Corrective Action Training

2.0 DEFINITIONS

2.1 Closed Loop Corrective Action: A series of activities which traces the
symptoms of a problem to its root cause(s), produces solutions for preventing
recurrence of the problem, implements necessary changes, and monitors that
the changes have been effective.

2.2 Corrective Action Request (CAR): A request documenting the need to correct
an identified non-conformance of a system, process or product using an 8D
approach. Each CAR is assigned a unique CAR number for tracking
purposes. The need for a CAR may arise from, but is not limited to:

 Customer complaint
 Internal audit non-conformance (plant, corporate)
 External audit non-conformance (customer, regulatory, etc)
 Product issues
 Supplier issues
 Process issues

Approved by: Anca Thompson(Electronic Signature in Agile) Effective Date: September 18 2017,
2017
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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

2.3 Preventive Action Request (PAR): A request documenting the need to prevent
occurrence of a potential non-conformance as part of the quality improvement
process. Each PAR is assigned a unique sequential PAR number for tracking
purposes. The determination of potential non-conformities and their causes
include, but are not limited to:

 Continuous Quality Improvement Team feedback

 FMEA analysis
 Quality Alerts
 Observations from Internal/External audits
 Equipment Maintenance
 Error proofing suggestions
 Customer feedback

2.4 Escalation Process: The process of increasing awareness of overdue CARs

and PARs to obtain satisfactory closure. This process is applied to all CARs
and PARs not completed within the specified due dates.

2.5 Due Date Extension Process: The online CAR and PAR systems automatically
control extension requests.

2.5.1 If an extension is granted by the CAR/PAR Initiator, the number of days

granted are added to the original Due Date of the CAR (not from the
date of the request for extension). The new due date is recorded as an
Extended Due Date.
2.5.2 Any request for extension for a customer CAR must have written
authorization from the customer and is to be uploaded to the
Attachments tab of the CAR.
2.5.3 Requests for extension to an internal CAR based on a third party audit
such as ISO 9001, TL 9000, UL, etc, must have documented
justification uploaded to the Attachments tab of the CAR. The person
requesting the extension is to submit the request to the CAR Initiator.

3.0. RESPONSIBILITIES

3.1 Chief of Quality/designee is responsible for:

3.1.1 Reviewing, revising, issuing and controlling this procedure.

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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

3.1.2 Providing support in the escalation of overdue corrective and preventive

actions to appropriate levels of management.
3.1.3 Reviewing data and trends, driving continuous improvements, and
improving customer satisfaction.
3.1.4 Providing training in the proper implementation of this procedure and
the Agile PLM system.

3.2 Each Plant Quality Manager is responsible for:

3.2.1 Reviewing initiated CAR/PARS to be sure they are appropriate.

3.2.2 Assigning the CAR/PAR to the appropriate individual.
3.2.3 Selecting the appropriate team members.
3.2.4 Tracking status and eventual closure of the CAR/PAR and escalating as
needed.

3.2.5 Evaluation of all CAR’s related to customer complaints or concerns,

issues with a direct impact on product quality, and third party QMS or
Process Audits. For other issues, the Evaluator should be the
responsible functional department manager.

3.2.6 Ensuring 2nd level evaluation is assigned for all CAR responses to be
submitted to a customer. This 2nd level evaluation is to be completed by
the applicable division quality representative, the Medical Division
CAPA Coordinator, or the plant manager, as appropriate.

3.2.7 Ensuring 2nd level Evaluation is assigned to the appropriate

Regional/Division Quality representative for any 3 rd party audit non-
conformances.

3.2.8 Ensuring that all CAR’s include a verification step that verifies the
corrective actions were completely and correctly implemented.

3.2.9 Ensuring that all CAR’s include a verification step that verifies the
effectiveness of the CAR actions in resolving all root cause issues.
This section must include objective, quantifiable evidence that the
actions implemented have eliminated the root cause(s) of the problem.

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3.2.10 Ensuring that all CAR’s are completed in a thorough and professional
manner. Form QAF-0128-C CAPA Self Assessment may be used to
help determine the completeness of an individual CAR response.

3.2.11 Providing guidance, support, and training at the plant level as needed.

3.2.12 Ensuring that all individuals responsible for entering 8D information are
trained to QAT-0002-C 8D Corrective Action.

3.3 Managers are responsible for:

3.3.1 Taking the necessary corrective actions to eliminate the causes of non-
conformities in order to prevent recurrence. These actions shall be
appropriate to the effects of the non-conformities encountered.

3.3.2 Based on the causes of non-conformities, determine if additional non-

conforming product exists and take further action as required.

3.3.3 Determine actions to eliminate the causes of potential non-conformities

in order to prevent their occurrence. These preventive actions shall be
appropriate to the effects of the potential problems.

3.3.4 Allocate resources needed for the timely and effective resolution of the
identified non-conformance.

3.3.5 Perform CAR Evaluation/Verification as necessary.

3.5 All Sanmina employees are encouraged and empowered to be proactive in

continual improvement programs by identifying potential sources of non-
conformance within their areas of responsibility and submitting Preventive
Action Requests either directly or through their immediate supervisor.

4.0 PROCEDURE

4.1 CAR Initiation: The CAR Initiator will:

4.1.1 Access the on-line CAR/PAR system

Agile CCN/CAPA Tool

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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

Ensure any customer prescribed problem-solving format is followed, if required.

Note that the use of a customer required CAPA format and/or system does not
absolve the plant of the responsibility to also complete a thorough 8D using
the Sanmina CCN/Agile system as well. A “cut and paste” from the customer
system is acceptable as long as all Sanmina CAPA requirements are met.

4.1.2 Complete all of the required fields in the CAPA Information section.

 Enter the actual due date based on the number of days assigned.

o If this is a CAR due to a Customer Complaint, the response

time and due date should be aligned with customer
expectations. The response time requested by the customer
may be any of the following:

 When the plant is expected to submit the

Containment, Root Cause, and Corrective/Preventive
Action plan.
 When the plant is expected to complete the above, as
well as full implementation of the CAR.
 When the plant has completed the two stages above,
as well as verified the effectiveness of the CAR.

o The plant must work with the customer in order to

understand the exact expectations.

o If the plant cannot meet the customer expected due date,

based on the expectations outlined above, the plant should
request a formal extension from the customer.

o If this is an internal CAR, the standard response time should

be 10 days. For a CAR that may require additional technical
investigation, enter an appropriate due date..

 When the CAR is due to a customer complaint or concern, issues

that have a direct impact on product quality, or third party QMS
and/or Process Audits, the Plant Quality Manager must be assigned

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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

as the evaluator of the CAR response and perform the actions

required in section 4.3. For other issues, the Evaluator may be the
responsible functional department manager.

 All CARs which will be submitted to a customer, must also be

Evaluated by the division quality representative/designee, the
Medical Division CAPA Coordinator, or the Plant Manager, prior to
being submitted to the customer.

 All CAR responses that are to be presented to a 3 rd party auditor

(NQA, TUV, etc) must be submitted to the appropriate
Regional/Division Quality representative for 2 nd level Evaluation.

Note: For 3rd party audit CARs related to ISO 14001, the second
level Evaluator shall be corporate EH&S.

 All CARs must include a Verification step to verify proper

implementation of the corrective actions Verification should be
conducted by the plant Quality Manager/designee or the appropriate
functional department manager/designee.

 All CARs must also include a Verification step to ensure the

effectiveness of all implemented corrective actions. Verification of
effectiveness should be conducted by the plant Quality
Manager/designee or the appropriate functional department
manager/designee. This section must include objective, quantifiable
evidence that the actions implemented have eliminated the root
cause(s) of the problem.

4.1.3 Place applicable supporting documentation into the CAR using the
Attachment tab.

4.2 CAR Response: Note: All individuals responsible for completing any of steps
1-8 must first be trained to QAT-0002-C 8D Corrective
Action.

The CAR Owner will:

4.2.1 8D Steps 1-3: Complete the required information in the Agile system
taking the following into consideration:

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 8D Team Leader- Identify an appropriate team leader based on the

problem reported.

● 8D Team Members – A cross functional team is best. Select

representatives from affected areas and/or departments. All
functions that can help to define the problem, identify the causes,
implement corrective/preventive action, and verify the effectiveness
of actions taken should be included. Select the right number of
team members with the appropriate experience to get the job done.

 Problem Description/Symptoms

Describe, in detail, the problem being reported. This step is critical

in that a poorly defined problem statement will quite often lead to
the wrong root cause and ineffective corrective and/or preventive
actions.

● Containment:

o State the actions taken to isolate the effects of the problem

that are immediate in nature. This may include sorting,
stopping production, additional sampling, etc. Focus on
preventing defect escapes and additional problem exposure.
Where inventory exists, purge action should follow. Inventory
at all locations should be considered. Sort criteria, inspection
levels and results should be detailed.

o These actions must be maintained until the root cause(s) has

been eliminated and the appropriate quality indicator/metric is
in control.

o In addition to the above actions, a determination must be

made for the potential impact of existing issues to previous
production lots. It is mandatory that supporting rationale be
provided whether it is determined that there is a potential
impact or not.

4.2.1.1 Place applicable supporting documentation into the CAR using

the Attachment tab.

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4.2.2 8D Steps 4-6: Complete, in detail, the following sections:

 Root Cause(s): A root cause is a factor that caused a

nonconformance and should be permanently eliminated through
process improvement. Root cause analysis is a collective term that
describes a wide range of approaches, tools, and techniques used
to uncover causes of problems.

o This step is critical. Use the “5 why” method of asking “why”

many times to drill through the symptoms and down to the
root causes. In many cases, multiple causes may contribute
to defect introduction. Use fishbone, fault tree analysis, and
other methods of investigation where appropriate. Note that
5 is not an absolute number. Whether Root Cause can be
determined with one “why” or it needs 100 does not matter.
Keep asking the question until true Root Cause has been
determined.

o Consider the root cause(s) of both the occurrence of the

problem and, where applicable, the reason for the escape or
non-detection. When determining the causes, consider,
human factors (as applicable) and review/analyze any other
issues that could potentially occur. Where applicable, clearly
list these separately in the Root Cause of the 8D.

 Corrective Action: Describe the actions that have been

implemented or will be implemented to correct the non-
conformance that initiated the CAR.

o State actions to be completed that are specific to the

affected product or process. These actions should be
permanent in nature and address specific cause factors
individually.

o If multiple Root Causes are defined, take care to align

Corrective Actions with the appropriate Root Cause so that
the relationship is clear. A numbering/lettering approach is
one way to accomplish this.

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o If both occurrence and escape Root Causes are defined, be

sure to address each in the Corrective Action.

o If a root cause is due to a supplier issue/external provider,

describe the actions to contain the problem until such time as
it is corrected by the supplier. Flow down the corrective
action requirements to the supplier/external provider. Issue
a SCAR to the supplier and reference the SCAR number in
the CAR response.

o Take specific actions when timely and effective corrective

actions are not achieved.

o Ensure these actions and controls are applied to other

similar processes and products to eliminate the cause of
similar non-conformance.

o When possible, corrective actions shall prevent the

manufacture of non-conforming products (error-proofing).

o Training should be considered when determining the

corrective actions required.

● Preventive Measures/Standardization: Building on the Corrective

Action(s), consider the risk to other products and/or processes
where the Root Cause identified could have an impact in the future.
Consider similar machines, processes, product designs, etc.
Consider whether the changes have been communicated to all
affected individuals or groups. Consider updating control plans,
FMEAs, training methods, materials or processes, etc

4.2.2.1 Place applicable supporting documentation into the CAR

using the Attachment tab.

4.3 Corrective Action Evaluation (1st and 2nd Level): The CAR evaluator will:

4.3.1 Review the corrective action response and ensure that the Problem
Description, Containment, Root Cause, Corrective and Preventive
actions all adequately address the problem. Consider the risk of any

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unintended, negative, consequences that implementation the Corrective

and Preventive actions may have.

4.3.2 Provide a Corrective Action Effectiveness Plan. This Plan shall serve as
a guide at the Verification step for verifying that corrective actions were
effective in resolving all root cause issues. This can be entered into the
Evaluation block or uploaded using the Attachments tab.

4.3.3 If the response is acceptable, Approve the CAR and move it to either
the 2nd Level Evaluation or Verification step as applicable.

4.3.3.1 All CAR responses that are to be presented to a customer

must be submitted to the appropriate Regional/Division Quality
representative for 2nd level Evaluation.

4.3.3.2 All CAR responses that are to be presented to a 3 rd party

auditor (NQA, TUV, etc) must be submitted to the appropriate
Regional/Division Quality representative for 2 nd level
Evaluation. Once the 2nd level Evaluation has been accepted,
the CAR response can then be entered into the appropriate 3 rd
party audit form and submitted to the appropriate third party
auditor.

Note: For 3rd party audit CARs related to ISO 14001, the second
level Evaluator shall be corporate EH&S.

4.3.4 If the response is unacceptable:

 Reject the CAR with a detailed explanation of your reasons for
rejection.

 The system will send the CAR Owner your response via email and
the CAR status is moved back to “8D Steps 1-3”.

4.3.5 Upon the rejection of a CAR, the Owner will:

 Review the CAR Evaluator’s comments and correct the previous

response. Work with the evaluator if any of the comments are
unclear.
 Update the CAR based on the Evaluator’s feedback and resubmit.

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4.4 Corrective/Preventive Action Verification

4.4.1 Verification/ Implementation: The CAR Verifier will:

4.4.1.1 Determine whether all of the corrective/preventive actions defined are

completely and appropriately implemented in accordance with the root
cause analysis and defined corrective actions:

 Verify that all training has been conducted and revised

documents issued, if required.

 Verification should ensure that the actions and controls are applied
to other similar processes and products, where applicable, to
eliminate the cause of similar nonconformance’s.

4.4.1.2 Place applicable supporting documentation into the CAR using the
Attachment tab.

4.4.1.3 If implementation of corrective/preventive action is deemed

acceptable, Save and then Approve the CAR and move it to the next
Verification Step (Effectiveness).

4.4.1.4 If implementation of corrective/preventive actions is not acceptable:

 Reject the CAR with a detailed explanation of your reasons for

rejection.
 The system will send the CAR Owner your response via email and
the CAR status is moved back to “8D Steps 1-3”.

4.4.2 Verification/ Effectiveness: The CAR Verifier will:

4.4.2.1 Determine whether the corrective/preventive actions defined were

effective in eliminating the root cause issues:

 Complete the required information including a description of what

was reviewed as objective evidence to determine adequacy and
effectiveness.

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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

o Verification of effectiveness must take into consideration all

items listed under Containment, Corrective Action and
Preventive Action, as well as any additional information
uploaded into the CAR by the CAR Owner.

o Review and monitor activities should also include ensuring

the root causes have been properly identified and
addressed, appropriate containment was taken,
implementation of activities have been completed, evaluation
of the effectiveness of the results and that corrective actions
have not introduced additional problems.

o The Corrective Action Effectiveness Plan shall be used as a

guide for identifying the effectiveness indicators and the
timetable for completing effectiveness verification activities,
as applicable.

4.4.2.2 Place applicable supporting documentation into the CAR using the
Attachment tab.

4.4.2.3 If the corrective action is deemed effective and acceptable, Save and
then Approve the CAR and move it to Close.

4.4.2.4 If the corrective/preventive actions are not adequately effective in

resolving all root cause issues:

 Reject the CAR with a detailed explanation of your reasons for

rejection.
 The system will send the CAR Owner your response via email and
the CAR status is moved back to “8D Steps 1-3”.

4.5 PAR Initiation: The PAR Initiator will:

4.5.1 Access the on-line CAR/PAR system

Agile CCN/CAPA Tool

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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

4.5.2 Complete the appropriate information to begin the process:

 Select the PAR Workflow from the drop down menu:

 The PAR number will be automatically assigned.
 Click on “Save”

4.5.3 Complete all of the required information in the CAPA Information

section as well as the Description of Potential Non-Conformity and the
PAR Owner.

4.5.4 Place applicable supporting documentation into the PAR using the
Attachment tab.

4.6 PAR Response: The PAR Owner will:

4.6.1 Complete all sections of the “PAR Owner to be Filled Out”

4.7 PAR Evaluation: The PAR evaluator will:

4.7.1 Review the information entered by the PAR owner to ensure that the
problem and subsequent suggested actions are appropriate.

4.7.2 If the response is acceptable, enter appropriate comments, determine a

verification date, Approve the PAR and move it to the Verification step.

4.7.3 If the response is unacceptable:

 Reject the PAR with a detailed explanation of your reasons for
rejection.
 The system will send the PAR Owner your response via email and
the PAR status is moved back to pending status.

4.8 Preventive Action Verification: The PAR Verifier will:

4.8.1 Determine whether the corrective/preventive actions defined are

effective:

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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

 Complete the required information including a description of what

was reviewed as objective evidence to determine adequacy and
effectiveness.

4.8.2 Place applicable supporting documentation into the PAR using the
Attachment tab.

4.8.3 If the response is acceptable, Save and then Approve the PAR and
move it to Close.

4.8.4 If the Preventive Actions are not adequate and effective:

 Reject the PAR with a detailed explanation of your reasons for
rejection.
 The system will send the PAR Owner your response via email and
the PAR status is moved back to pending status.

4.9 SCAR Initiation: The SCAR Initiator will:

4.9.1 Access the on-line CAR/PAR system

Agile CCN/CAPA Tool

4.9.2 Complete the appropriate information to begin the process:

 Select the SCAR Workflow from the drop down menu:

 The SCAR number will be automatically assigned.
 Select the Division within which your plant resides.
 Click on “Save”

4.9.3 Under “Response Time” enter the number of working days being
allowed to complete the SCAR. Also, enter the actual due date based
on the number of days assigned.

 Reference QAP-07.4 Supplier Quality Management Practices for

guidelines pertaining to appropriate supplier response times.

4.9.4 Under “SCAR Supplier (Internal or External)” select External if being

issued to an External supplier or Internal if being issued to another
Sanmina plant.

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CORRECTIVE AND PREVENTIVE ACTION PROCEDURE

4.9.5 The assigned internal owner will act as the liaison between Sanmina
and the supplier. The owner will issue the SCAR to the supplier,
receive the response back from the supplier, and enter the response
into the system. The Owner will assign either him/herself, the buyer, or
the appropriate SQE as the Team Lead.

4.9.6 The supplier is to provide feedback for Steps 1 through 6 of the 8D.
Once the internal owner has entered the information from the supplier,
the SCAR will be moved to the Evaluation step. The Evaluation and
Verification will be completed by the appropriate Sanmina internal
personnel as described in sections 4.3 and 4.4 above.

4.9.7 If the suppliers response is rejected, then the internal owner will work
with the supplier to update and resubmit the response.

5.0 RECORDS

5.1 Agile PQM CCN/CAR System

6.0 ASSOCIATED DOCUMENTS

6.1 QAP-07.4 Supplier Quality Management Practices

6.2 QAP-07.9 Customer Concern Notification Procedure

6.3 QAT-0002-C 8D Corrective Action – Concepts and Application.

6.4 QAF-0128-C CAPA Self Assessment Tool

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7.0 REVISION LOG

Writer/
Rev Date Description of Change
Reviser
Revised note after 1.1, 4.2.2 and 5.3.2 to define the actions
N 10-12-07 necessary when a supplier is determined to be the root cause T. Ayotte
and implement the requirements of AS 9100.
Revised 4.2.2 and 5.3.2 adding the method to be used to
O 03-13-08 T. Ayotte
determine root cause.
Revised 1.1, 4.2.2, 4.4.4, 4.6.3, 5.3.2, 5.5.4 and 5.7.3 to
P 02-19-09 clarify that there may be more than one root cause for a T. Ayotte
nonconformity in alignment with ISO 9001:2008.
Revised 4.1.1 and 5.1.1 to define the use of the standard
Q 09-15-09 CAR and PAR system versus the DAS and Medical CAR and T. Ayotte
PAR systems.
Revised 2.4, 4.2.2, 4.3.1, 5.3.2 and 5.4.1 to include details of
R 10-27-09 the due date extension process. Revised 2.5, 3.4 and 3.5.4 T. Ayotte
to include the CAR grading process.
Revised 4.2.2, 4.4.4, 4.6.3, 5.3.2, 5.5.4 and 5.7.3 to provide
S 06-23-10 T. Ayotte
additional guidance on CAR/PAR response and verification.
T 12-08-10 Revised 2.2 and 3.3.2 to align with AS 9100 rev C. T. Ayotte
Revised section 3.2.1 per (CAR 88537) to add additional
review requirements, added print screens throughout the A.Lam-
U 05-10-12
document; deleted list in 3.3.1 and combined PAR along with Finneke
CAR in 4.0.
Section 4.1.1 Update print screens, revise section 4.1.2 to
A. Lam-
include general guideline for response time and add
V 07-10-12 Finneke
exceptions to the rules for Evaluators.
Updated 3.5.2
Updated 3.5.2 to better define process step and 4.2.2 for K. Dudley
W 08-31-12
better clarification of Preventive Action
X 10-3-12 Revise Section 2.2 K. Dudley
Review and Revised Document, Change out to the new logo K. Dudley,
Y 6-24-13 and remove references to -SCI A.Lam-
Finneke
Z 12-9-13 Rewrite procedure to replace CCN System with Agile PQM K. Dudley

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Writer/
Rev Date Description of Change
Reviser
Add section 4.9.4 to clarify issuance of SCARs to internal
AA 06-20-14 K. Dudley
supplier per DCO QMSP000109.
Remove color coding by standard.
Update 3.2.5 and 4.1.3 to amend Evaluator and Verifier
AB 08-11-14 K. Dudley
criteria
Clarify section 4.9.4 per DCO QMSP000136
Update QAP to reflect new Verification/Effectiveness section
4.4.2. Detail additional requirements for Containment
AC 11-11-14 Section. Remove CAR Grading requirements and K. Dudley
Add requirements for Verification plan. Per DCO
QMSP000164
Significant rewrite in order to align with the Agile/CAPA
AD 1-16-15 K. Dudley
system. per DCO QMSP000182
Remove references to IT documents (no longer applicable).
Add 3.2.7, 4.1.2, 4.3.3.1 and 4.3.3.2 detailing 2nd level K. Dudley
AE 11-24-15
Evaluator requirements per DCO QMSP000259 and
CAR00113262 and CAR00113263
Updated PAR sections
A.Lam-
4.6.1- Remove section on 5 Why, 4.7.1- remove Root cause ,
AF 12-17-15 Finneke
4.7.3 and 4.8.4 remove references to the 8D steps 1-3. Per
K. Dudley
DCO QMSP000287
Update 3.2.10 to add reference to QAF-0128-C
Removed broken links.
Updated 4.3.3.2 to remove requirement for Corporate Quality
AG 08-18-16 K.Dudley
to submit NC responses to the third party auditor.
Add the concept of risk when considering Preventive Actions.
Per DCOQMSP000384
Update 2.5.3 to better define when request for extension
AH 09-14-16 must be documented with an attachment. Per K. Dudley
DCOQMSP000397
Added note to 4.1.2 & 4.3.3.2 requiring corporate EH&S act
AI 01-19-17 as second level evaluator for EHS related 3rd party audit K. Dudley
CARs per DCO QMSP000438
Review, revise and update section: 3.2.1 Add Reviewing,
4.2.2 added elements to include human factors, 4.4.2.1 edit
AJ 09-18-17 K. Dudley
and update various sections. per DCO QMSP000551

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