Preventive Action Procedure

Preventive Action Procedure

(QMS-ISPL-P-PAP)

Version No

V20

Prepared by

Date

30-01-2015

Name

Suman

Signature

Date

30-01-2015

Copy No

Approved by

Issued to

Name

Sai Prasad Koneru

Signature

Date

30-01-2015

Document Amendment Record

A- A- Added, M- Modified, D- Deleted

Sl.No	Date	Version No	Page No	Change Mode(A/M/D)	Brief description of change
1	15-07-2002	V01	N/A	A	Initial Release
2	28-10-2002	V02	N/A	A	Included Section 9 - Records
3	12-06-2003	V03	3	A	In Section 7.4, included the description of the preventive action tracker
3	12-06-2003	V03	3	A	In Section 9, included the reference of the preventive action tracker.
4	06-06-2012	V03	N/A	D	The Company address information is removed from the Footer
5	30-01-2015	V20	N/A	N/A	Reviewed and base lined

Table of Contents

1 Purpose

2 Objective

3 Scope

4 Terms and definitions

5 Entry Criteria, Input, Activity, Output and Exit Criteria

6 Responsibility

7 Procedure description

7.1 Identification of potential non-conformities

7.2 Determining the causes of non-conformities

7.3 Evaluating the need for preventive actions

7.4 Determining and implementing preventive actions

7.5 Records of preventive actions

7.6 Management review of preventive actions

8 Quality system documents referred

9 Records

1 Purpose

The purpose of preventive action procedure is to take action to eliminate the causes of potential non-conformities in order to prevent their occurrence.

2 Objective

The objective of this procedure is to have an established process for identifying the causes of potential non-conformities and initiate actions to prevent their occurrence.

3 Scope

Applicable to all activities covered in the QMS.

4 Terms and definitions

Abbreviations	Description
ISPL	Inooga Solutions Pvt.Ltd
QMS	Quality Management System
QA	Quality Assurance
MRP	Management Review Procedure
MR	Management Representative
CEO	Chief Executive Officer
CTO	Chief Technology Officer

5 Entry Criteria, Input, Activity, Output and Exit Criteria

Sl.No	Entry Criteria	Inputs	Activity	Outputs	Exit Criteria
1	Non conformities reported	Software Test Records, Audit Reports, Customer complaints	Identification of non conformities	Non conformities	Non conformities that need preventive action identified
2	Non conformities that need preventive action identified	Non conformities	Preventive action	Preventive actions	Completion of preventive action

6 Responsibility

Activity	Responsibility
Preventive action in projects and processes	Project manager or Project leader
Preventive action in functional areas	Functional head
Preventive action in QMS	MR
Review of initiation of the preventive actions	CEO/CTO

7 Procedure description

7.1 Identification of potential non-conformities

Potential non-conformities can occur with respect to product, process, quality management system and functional areas. These are identified by the following sources.

Category of Non-Conformity	Source of Information
Product non-conformities	Risk analysis, market analysis, customer needs and expectations
Process non-conformities	Metrics report trend analysis and process assessments
Quality management system non-conformities	Management reviews and internal audit reports
Functional area non-conformities	Functional area reports

The potential non-conformities are recorded and action is taken to prevent their occurrences.

7.2 Determining the causes of non-conformities

Category of Non-Conformity	Source of Information
Product non-conformities	Beginning of the project and at the completion of every milestone.
Process non-conformities	Beginning of the project and at the completion of every milestone.
Quality management system non-conformities	Management reviews and internal audits
Functional area non-conformities	Once in every quarter

The potential non-conformities are analyzed to determine the impact of the non-conformity on the product, process, quality management system or the functional area. Based on the impact of non-conformity actions to avoid the non-conformity are determined.

7.3 Evaluating the need for preventive actions

Based on the criticality of the potential non-conformity action is evaluated either by the concerned individual or a team to ensure that non–conformities do not occur. Some examples of preventive actions are creation of expert teams, identification of alternatives, acquisition of technology, etc.

7.4 Determining and implementing preventive actions

The preventive actions are determined and implemented consisting of

· A definition of the causes of non-conformities

· Elimination of causes of non-conformities

· Appropriate actions to avoid occurrence of non-conformities

· A preventive action tracker is maintained by MR/QA Manager to track the closure of the preventive actions taken during the course of the internal audits.

7.5 Records of preventive actions

Record of proposed preventive action and verification of effectiveness of the preventive action is maintained as per Preventive Action Record

7.6 Management review of preventive actions

Preventive actions are included for management review

8 Quality system documents referred

Management Review Procedure (QMS-ISPL-P-MRP).

9 Records

Sl.No	Required Record	Custodian	Retention Period	Record ID
1	Non Conformance Record	MR/QA Manager	N/A	QMS-ISPL-F-NCR
2	Preventive Action Tracker	MR/QA Manager	N/A	QMS-ISPL-R-PAT