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