DOCUMENT

NO.:
QP-001

REVISION
NO.:
N/A

EFFECTIVE
DATE:

PAGE NO.:
1 OF 59

Rev. No.

Page No.

DOCUMENT TITLE

CORRECTIVE AND
PREVENTIVE
ACTION (CAPA)
PROCEDURE
Revision History

Originator

Date

DOCUMENT
NO.:
QP-001

REVISION
NO.:
N/A

EFFECTIVE
DATE:

PAGE NO.:
1 OF 59

DOCUMENT TITLE

CORRECTIVE AND
PREVENTIVE
ACTION (CAPA)
PROCEDURE

1.0

PURPOSE
1.1 This procedure describes the methods for initiating corrective
action to resolve quality problems
1.2 This procedure also explains the process for analyzing quality
problems so that recurrence of nonconformance or potential
nonconformance can be prevented thru initiating preventive
actions

2.0

SCOPE
2.1 This procedure shall be applied to work performed by the
company and its subcontractor/vendor.
2.2 Any written or oral expression of dissatisfaction by customers
related to the quality, reliability, or performance of any
products or service offered by M-4 CMSI will be subjected to
investigation for root cause and required corrective and
preventive action shall be implemented.

3.0

REFERENCES
3.1 ISO 9001
3.2 CES-12
Actions
3.3 CES-13
3.4 CES-14

2008 Section 12 & 13

Non-conformance
-

and

Corrective

Preventive Actions
Quality System Audits

4.0

RESPONSIBILITIES
4.1 The General Manager (Technical) shall be responsible for
documentation,
investigation
and
follow-up
customer
complaints and report of product, process, or service
nonconformities in the company, and/or at vendor
subcontractor.

5.0

PROCEDURE
5.1 GENERAL
5.1.1.1
Corrective and preventive action may
become necessary due to:
Recurring non-conformances
Internal quality audit findings
Customer Complaints
Procedure / Process improvement
5.1.1.2
Corrective and preventive action may be
initiated by any one at any level.

DOCUMENT
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QP-001

REVISION
NO.:
N/A

EFFECTIVE
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DOCUMENT TITLE

CORRECTIVE AND
PREVENTIVE
ACTION (CAPA)
PROCEDURE
5.1.1.3
The
procedure/Process
Improvement
Request (Form: QA/010) form shall be used to
identify problems in quality system, or to request
changes, or improvements to the quality system.
5.1.1.4
Nonconformance Report shall be used to
identify and report quality problems on the
product and process.
5.1.1.5
The General Manager (Technical) shall
receive data from all corrective and preventive
action systems, and analyze this with the
concerned to resolve the same and initiate
process improvements.
5.1.1.6
This
analysis
includes
on
data
nonconformities,
time
require
to
process
nonconformities, trend analysis, and excessive
delays in resolving nonconformities.
5.1.1.7
The objective of the analysis is to establish
confidence in the system and product quality.
5.1.1.8
The implementation of all corrective and
preventive action shall be verified by the QA/QC
Manager.

5.2

PROCEDURE / PROCESS IMPROVEMENT REQUEST (PIR)

5.2.1 The Procedure / Process Improvement Request (Form:
CES/QA/010) shall be used to record the deficiency
observed on a process or procedure and proposal from
the originator on the required improvements.
5.2.2 The process improvements request can also be result of
either an internal or external audit. In this case, the
General Manager (Technical) shall process the required
corrective action.
5.2.3 The process improvement request shall be discussed in
the management review meeting and necessary
decisions are taken for process improvement.
5.2.4 The required changes to the procedure and processes
shall be recorded and revised procedures shall be issued
to all concerned.

5.3

NONCONFORMANCE REPORTS
5.3.1 Non-conformance reports contain the nature of the
nonconformity and its possible cause.
5.3.2 For recurring type of non-conformances, the General
Manager (Technical) analyses the root cause of the
nonconformity, including analysis of the product or

DOCUMENT
NO.:
QP-001

REVISION
NO.:
N/A

EFFECTIVE
DATE:

PAGE NO.:
1 OF 59

DOCUMENT TITLE

CORRECTIVE AND
PREVENTIVE
ACTION (CAPA)
PROCEDURE

service specifications, process, operations, inspection

record, etc.
5.3.3 Non-conformances from customer complaints are also
reviewed for the type and nature of nonconformity.
5.3.4 The analysis considers frequency of occurrence as well
as the relationship of cause and effect.
5.3.5 The required corrective and preventive actions are
reviewed in the management review meeting.

6.0

5.4

CORRECTIVE ACTION
5.4.1 Necessary corrective action (Form: CES/QA/008) shall be
implemented to eliminate the cause of a recurring nonconformity.
5.4.2 The General Manager (Technical) shall arrange for the
follow-up of the corrective action.
5.4.3 On implementing the corrective action, its effectiveness
shall be monitored.
5.4.4 If any reoccurrences of the non-conformity is observed
after implementing the corrective action, further
investigations shall be carried out. These shall be
discussed in special review meeting and the required
corrective action shall be implemented.
5.4.5 Any changes required to the procedures or processes
shall be documented and necessary implementation
shall be verified.

5.5

PREVENTIVE ACTION
5.5.1 Preventive action shall be discussed and implemented
to eliminate the potential cause of a recurring nonconformity.
5.5.2 The required changes on the process, product
specification or to the quality system shall be made to
prevent such non-conformities.
5.5.3 The preventive action taken shall be suitable to the
magnitude of the problem.
5.5.4 The analysis of preventive action taken shall be
reviewed in the subsequent management review
meeting.

QUALITY FORMS AND RECORDS

6.1 Form: CES/QA/002
Non-conformance Report (NCR)
6.2 Form: CES/QA/008
Corrective Action Request
6.3 Form: CES/QA/010
Procedure
/
Process
Improvement Request (PIR)

DOCUMENT
NO.:
QP-001

REVISION
NO.:
N/A

EFFECTIVE
DATE:

PAGE NO.:
1 OF 59

DOCUMENT TITLE

CORRECTIVE AND
PREVENTIVE
ACTION (CAPA)
PROCEDURE

SIGNATURE
PREPARED BY:

REVIEWED BY:

APPROVED BY:

DA