Control of Non Conforming Product Procedure

(QMS-ISPL-P-CNP)

 

 

 

 

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

06-06-2012

V01

N/A

D

The Company address information is removed from the Footer

3

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, Exit criteria

6   Responsibility

7   Procedure description

7.1       Identification of product non-conformities

7.2       Nature and reasons for non-conformance

7.3       Elimination of non-conformance

7.4       Records maintenance

7.5       Re-verification

7.6       Root cause analysis

7.7       Actions to deal with a non-conforming product

8   Quality system documents referred

9   Records

 

 

 

 

 

 

 

 

 

 

 


1       Purpose

To establish and maintain a procedure for controlling non-conforming product.

2       Objective

Non-conformity product procedure ensures that a software product, which does not conform to specific requirement identified and controlled to prevent its unintended use or delivery.

3       Scope

Control, responsibility and authority, as well as information for dealing with non-conformity product. It is applicable to all software development and projects undertaken by Inooga Solutions.

4       Terms and definitions

 

Abbreviations/Terms

Description

ISPL

Inooga Solutions Private Limited

QMS

Quality Management System

NC

Non Conformity

QA

Quality Assurance

SDD

Software Design Document

Non-conformity product

It is a program code or documentation, which does not currently conform to its requirements or has not yet been validated and demonstrated to meet its requirements.

Non- fulfillment of a requirement.

5       Entry criteria, Input, Activity, Output, Exit criteria

 

Sl.No

Entry Criteria

Input

Activity

Output

Exit Criteria

1

Product with non-conformities.

Review of records.

Internal Audits records.

Test Records.

Identification of non-conforming product.

Product with non-conformities is identified and controlled.

Completion of identification of non-conforming product.

2

Identification of non conforming product.

Test Records with identification.

Prevention of non conforming product from usage.

Corrective actions.

Initiate corrective and preventive actions.

 6       Responsibility

 

Sl.No

Activity

Responsibility

    1.              1.        

Identification of  product non-conformities

Project manager and QA representative

    2.              2.        

Control of product with non-conformities

Project manager, QA manager

    3.              3.        

Root cause analysis and initiate corrective and preventive actions

Project manager and  QA manager

7       Procedure description

7.1     Identification of product non-conformities

During reviews and testing of the work product, non-conformities are recorded in the review and test reports. Work product under review and testing are kept in separate directories to ensure their identification.

7.2     Nature and reasons for non-conformance

Nature and reasons for non-conformance are as follows:

Ø       Improper interpretation of customer defined requirements.

Ø       Ambiguity in requirements/inadequate explanation about requirements/undefined scope of requirements.

Ø       Ambiguity in analysis of requirements.

Ø       Improper authentication in analysis of requirements.

Ø       Improper traceability in requirements.

Ø       Improper design of the application.

Ø       Incompatibility with predefined naming and coding standards.

Ø       Improper configuration management.

Ø       Improper management and implementation of changes in design and coding.

Ø       Incompatibility with standard testing process and test case data.

Ø       Improper management of changes in the system integration and functionality verification.

Ø       Improper software development process.

Ø       Internal audit yields non-conformance.

Ø       Review yields non-conformance.

 

7.3     Elimination of non-conformance

The process of elimination of non-conformance involves the following:

 

Ø       Review the problem domain and statement of requirements.

Ø       Review the SRS document.

Ø       Review the SDD.

Ø       Identifying the correct explanations which are given in the above document along with the conformance criteria.

Ø       Reach to a conclusion by keeping in view the conformance criteria and prepare an action plan also considering the inputs from the team members while preparing the action plan.

Ø       Re-review the action plan to verify conformance.

7.4     Records maintenance

Record the details of dates, types, person, responsibility, causes, action taken to transform non-conformance onto conformances, concessions obtained and imposed, and customer approval. MR approves and maintains these records and produces them as and when required.  

7.5     Re-verification

Post- release non-conformance reported by customer is to be attended by marketing department in the company, the development conformity team converts the non-conformities to conformities and this is to be re-verified to demonstrate conformity to requirements by following the above mentioned procedural steps.

Non-conformance in the stages of analysis, design, coding, testing, integration and internal audits are to be participated by the various departments within the company and they are to be re-verified to demonstrate conformity.

7.6     Root cause analysis

Project manager and QA Manager analyze the records and carry out a root cause analysis. Based on the root cause of analysis, corrective actions and preventive actions are initiated as per corrective action and preventive action procedure.

7.7     Actions to deal with a non-conforming product

Ø       Corrective actions are taken to eliminate the detected non-conformity.

Ø       In order for a non-conforming product to be used or released under controlled conditions, the MR or the customer, whoever is applicable, authorizes or grants concession for the same. These concessions to non-conformities are documented.

Ø       Steps are taken to preclude its original intended use or application.

Ø       When a non-conforming product is corrected, it is subjected to re-verification to demonstrate conformity to the requirements.

Ø       When a non-conforming product is detected after delivery, or use has started, Inooga Solutions take appropriate action to the potential effects of non-conformity.

8       Quality system documents referred

Nil

9       Records

Nil