Control of Non Conforming Product Procedure
(QMS-ISPL-P-CNP)
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Version No |
V20 |
Prepared by
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Date |
30-01-2015 |
Name |
Suman |
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Signature |
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Date |
30-01-2015 |
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Copy No
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Approved by |
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Issued to
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Name |
Sai Prasad Koneru |
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Signature |
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Date |
30-01-2015 |
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Document Amendment Record
A- A- Added, M- Modified, D- Deleted
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Brief description of change |
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15-07-2002 |
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Initial Release |
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06-06-2012 |
V01 |
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D |
The Company address information is removed from the Footer |
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30-01-2015 |
V20 |
N/A |
N/A |
Reviewed
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Table of Contents
5 Entry criteria, Input, Activity, Output, Exit criteria
7.1 Identification of product non-conformities
7.2 Nature and reasons for non-conformance
7.3 Elimination of non-conformance
7.7 Actions to deal with a non-conforming product
8 Quality system documents referred
1 Purpose
To establish and maintain a procedure for controlling non-conforming product.
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.
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.
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Abbreviations/Terms |
Description |
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ISPL |
Inooga Solutions Private Limited |
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QMS |
Quality Management System |
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NC |
Non Conformity |
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QA |
Quality Assurance |
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SDD |
Software Design Document |
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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
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Sl.No |
Entry Criteria |
Input |
Activity |
Output |
Exit Criteria |
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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. |
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2 |
Identification of non conforming product. |
Test Records with identification. |
Prevention of non conforming product from usage. |
Corrective actions. |
Initiate corrective and preventive actions. |
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Sl.No |
Activity |
Responsibility |
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1. 1. |
Identification of product non-conformities |
Project manager and QA representative |
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2. 2. |
Control of product with non-conformities |
Project manager, QA manager |
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3. 3. |
Root cause analysis and initiate corrective and preventive actions |
Project manager and QA manager |
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.
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.
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.
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
Nil