QuEST GLOBAL MANUFACTURING PRIVATE LIMITED
UNIT-III
QUALITY SYSTEM PROCEDURE
[ISO 9001: 2008, ISO/TS 29001: 2010 & API SPEC Q1, 8TH EDITION]
PREVENTIVE ACTION REPORT
AMENDMENT HISTORY
Issue / Issue / Rev.
Sl. No. Description of the change
Rev No. Date
A New System Procedure developed as per the ISO 9001:
1 01/00 02 Sep 2013/- 2008, API Spec Q1 8th Edition and ISO TS 29001: 2010
requirements.
1.0 PURPOSE
The purpose of this procedure is to outline the process to ensure that a detailed process is utilized to identify
and systematically resolve potential problems.
2.0 SCOPE
This procedure applies to all personnel performing processes that have a direct impact on product quality and
the ability of the company to provide our customer’s product that meets all requirements.
This procedure is applicable to all the following systems and standards
- ISO 9001: 2008
- ISO / TS 29001: 2010
- API Spec Q1, 8th edition
It applies to all processes which have an influence on product quality.
3.0 RESPONSIBILITY
Management representative
All concerned process owners
Prepared by Management Representative
Date 02 Sep 2013 Edition No. 01 Rev. No. 00 Page No.
Signature
Approved by Vice President O&G
Date 02 Sep 2013 Date 02 Sep 2013 Date -- 1 of 5
Signature
QuEST GLOBAL MANUFACTURING PRIVATE LIMITED
UNIT-III
QUALITY SYSTEM PROCEDURE
[ISO 9001: 2008, ISO/TS 29001: 2010 & API SPEC Q1, 8TH EDITION]
PREVENTIVE ACTION REPORT
5.0 KEY PROCESS INDICATORS
Preventive Action Report
6.0 RECORDS
Sl.No Record Title Format No. Retention Retention Indexing
Period Responsibility Method
01. Preventive O&G / 5 Years Senior Manager
Computer /
Maintenance MNT / F 08 - Maintenance
File
Check Sheet
02. Monthly O&G / 5 Years Senior Manager
Schedule for MNT / F 09 - Maintenance Computer /
Preventive File
Maintenance
03. Action Plan for O&G / 5 Years Senior Manager
Preventive MNT / F 12 - Maintenance Computer /
Maintenance File
Observations
04. Preventive O&G / 5 Years Senior Manager
Maintenance MNT / F 13 - Maintenance Computer /
Check List and File
Record
05. Preventive O&G / MR / 5 Years MR
Computer /
Action Report F 07
File
7.0 PROCESS FLOW CHART
Prepared by Management Representative
Date 02 Sep 2013 Edition No. 01 Rev. No. 00 Page No.
Signature
Approved by Vice President O&G
Date 02 Sep 2013 Date 02 Sep 2013 Date -- 2 of 5
Signature
QuEST GLOBAL MANUFACTURING PRIVATE LIMITED
UNIT-III
QUALITY SYSTEM PROCEDURE
[ISO 9001: 2008, ISO/TS 29001: 2010 & API SPEC Q1, 8TH EDITION]
PREVENTIVE ACTION REPORT
Vice President
MR
Engineer – QA / All Process Owners
8.0 PROCEDURE
The Management determines action, to eliminate the causes to potential nonconformities in order to
prevent their occurrence.
Preventive Actions are appropriate to the effects of the potential problems.
The preventive action requires the following:
Determining potential nonconformities and their causes.
Evaluating the need for action to prevent occurrence of nonconformities.
Determining and implementing action needed.
Records of the results of action taken.
Reviewing of preventive action taken.
Management Representative ensures that Preventive Action is effective.
Records of Preventive Actions taken are maintained and retained for 5 years.
8.1 AREAS OF RESPONSIBILITY
1. The management and all employee of the respective location are responsible for introducing
preventive action in the company
2. All employees in departments, who influence product quality are obliged to:
a. Identify and eliminate potential non conformities
Prepared by Management Representative
Date 02 Sep 2013 Edition No. 01 Rev. No. 00 Page No.
Signature
Approved by Vice President O&G
Date 02 Sep 2013 Date 02 Sep 2013 Date -- 3 of 5
Signature
QuEST GLOBAL MANUFACTURING PRIVATE LIMITED
UNIT-III
QUALITY SYSTEM PROCEDURE
[ISO 9001: 2008, ISO/TS 29001: 2010 & API SPEC Q1, 8TH EDITION]
PREVENTIVE ACTION REPORT
b. Introduce effective corrective measures and show that these are effective
8.2 SOURCE OF INFORMATION
1. It is necessary for appropriate sources of information to be checked so that potential cause of
discrepancy can be recognised, analysed and eliminated.
Such sources are:
o Quality data from processes
o Data and trends from goods inwards inspection
o Data on scrap material
o Data on rework
o Results of intermediatary and final inspection and checking
o Results of system and process audits
2. The Asst. Manager - QA will either carry out these checks him or organise and assess them.
3. The results of the problem solving methodology are documented appropriately
9.0 API - QMS SPECIFIC REQUIREMENTS
1. A documented control feature is available for taking corrective and preventive actions
(Corrective & Preventive actions)
2. As for field non conformities (Product non conformity that has been detected after delivery or
use has started) the method of initiating Corrective & Preventive actions is described in the
procedure
3. Effectiveness review of action taken is a part of the Corrective & Preventive action process,
however to strengthen this activity Quarterly Customer complaint audit and Management
Review Meeting once in a year are carried out.
4. Response time for containment action would be forwarded in 3 - 5 working days &
submission of Corrective & Preventive action in 14 working days.
5. The mechanism followed for the process of evaluation, release or acceptance of
Prepared by Management Representative
Date 02 Sep 2013 Edition No. 01 Rev. No. 00 Page No.
Signature
Approved by Vice President O&G
Date 02 Sep 2013 Date 02 Sep 2013 Date -- 4 of 5
Signature
QuEST GLOBAL MANUFACTURING PRIVATE LIMITED
UNIT-III
QUALITY SYSTEM PROCEDURE
[ISO 9001: 2008, ISO/TS 29001: 2010 & API SPEC Q1, 8TH EDITION]
PREVENTIVE ACTION REPORT
nonconforming product at QuEST GLOBAL MANUFACTURING PRIVATE LIMITED is
described as follows which may include one or more of the following:
I. accepting products that do not satisfy manufacturing acceptance criteria
II. accepting products that do not satisfy the original design acceptance criteria
III. As for field non conformities (Product non conformity that has been detected after
delivery or use has started) the method of initiating Preventive actions is described in
this QSP - 06.
IV. QuEST GLOBAL MANUFACTURING PRIVATE LIMITED also declares through this QSP
that it shall notify its customer’s duly in writing or through an acceptable
communication mode that in the event of a product which does not conform to
design acceptance criteria has been delivered
Prepared by Management Representative
Date 02 Sep 2013 Edition No. 01 Rev. No. 00 Page No.
Signature
Approved by Vice President O&G
Date 02 Sep 2013 Date 02 Sep 2013 Date -- 5 of 5
Signature
