SAI-QMS-MP-004

Controlling Non-conformitites

Authorization Code: SAI/ QMS/MP/004
Title: PROCEDURE FOR CONTROLLING NON-CONFORMITIES
Area: CORPORATE
Version No.: 01
Revision No. : 00
Created by: MANAGEMENT REPRESENTATIVE
Approved by: CHANCELLOR
Date of version: 1st MAY 2015
Signature:

Distribution List

Copy No. Distributed to Date Signature Returned
Date Signature

 

Change History

Date Version Created by Description of change
       
       
       
       

 

Table of Contents

  1. PURPOSE
  2. SCOPE
  3. REFERENCES
  4. ABBREVIATIONS / DEFINITIONS
  5. RESPONSIBILITIES
  6. METHOD
  7. APPENDICES

 

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1.0. PURPOSE

To describe all activities related to identifying and managing non-conforming product in order to prevent its unwanted use and to define responsibilities and authorities related to treatment of non-conforming product.


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2.0. SCOPE

This procedure is applied to all processes and/or areas (parts of organization) within the QMS (Quality Management System).

Users of this document are members of top management of SAI, as well as the owner of processes in which the non-conformity occurred.


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3.0. REFERENCES

3.1. ISO 9001:2008 – Quality Management Systems Requirements

3.2. EEI Quality Manual

3.3. Procedure for preventive and corrective actions


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4.0. ABBREVIATIONS / DEFINITIONS

4.1. Non-Conformity

Product or part of a process that does not meet statutory requirements

4.2. Corrective Measure

Action taken to eliminate root cause of nonconformity

4.3. Management Representative

Member of the management who has overall responsibility over the establishment, implementation and maintenance of the ISO 9001, IWA 2, as pertaining to Higher Education Requirements Quality Management System.

4.4. Registrar

The person appointed by the Council under Statute XI to be Registrar of the Institute

4.5. Process Owner

The person heading an administrative section, School or Directorate

4.6. MR

Management Representative

 

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5.0. PRINCIPAL RESPONSIBILITY

The MR shall be responsible for the implementation of this procedure according to ISO 9001, IWA 2, Quality Management Systems, as pertaining to Higher Education Requirements.

 

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6.0. METHOD

6.1 Reporting and consideration of non-conformities

6.1.1

Every employee or customer who notices a non-conformity must report it directly, by letter of complaint or through suggestion boxes. The non-conformity is recorded in the Record of non-conformed product SAI/QMS/MP/004/1 by the Director QA.

6.1.2

The report is considered by Director QA, who gives guidelines for isolation of the non-conformed product. If Director QA cannot independently resolve the incurred non-conformity, he notifies MR.

 

6.2 Separation, marking and storage of non-conforming products

6.2.1

Director QA shall verify and separate non-conforming product from conforming products.

6.2.2

Responsible for separation, marking and storage of non-conforming products in order to prevent misuse and unauthorized use shall be HoD or Process owner in which the non-conformity is discovered. An employee in the work place where the non-conformity is discovered marks the non-conforming product.

6.2.3

Non-conforming raw materials and the final products are labeled with a sign reading NON-CONFORMING PRODUCTS, and they are stored separately

6.2.4

After solving the nonconformity and performing all activities mentioned above, Director QA shall enter data about the non-conformity in the Registry of Non-Conformities.

6.3 Handling non-conforming product

6.3.1

Top management of SAI selects members of the Committee for non-conforming products depending on the process in which the non-conformity has occurred or was discovered.

6.3.2

The Committee for non-conforming product reviews the non-conforming product in order to determine the method for dealing with the non-conforming product.

6.3.3

The Team for non-conforming product decides which method for resolving non-conforming product will be used and it is recorded in the Non-conforming product record by the team leader.

 

6.4 Recall and withdrawal of non-conforming product

6.4.1

Product recall, the process of retrieving non-conforming product from consumers, shall occur as a result of quality concerns.

6.4.2

Product withdrawal, the process of removing the product from the market, shall occur quality issues or product defect.

 

6.5       Management Representative shall

6.5.1

Receive audit reports of non-conformities from the Director QA and subsequently release them to the Registrars responsible for Administration, Academics and Planning to take action on nonconformities identified

6.5.2

Receive reports from the Registrars on action taken

 

6.6 Registrar shall

6.6.1

Receive audit report from MR

6.6.2

Write memos to the process owners indicating areas under their jurisdictions in which nonconformities have been identified and request for their action in having these corrected

6.6.3

Receive reports from the process owner on action taken

 

6.7 Process owner shall

6.7.1

Write to staff within his/her jurisdiction informing them of nonconformities identified in their areas of operation

6.7.2

Investigate the cause of the nonconformities and take the necessary corrective action

6.7.3

Write a report on the action taken to correct nonconformities

 

6.8 Managing Records kept on basis of this document

 

Record name Code Responsibility
Retention Time Location Responsibility
Non-conforming Product Record EEI/QMS/MP/004/1 2 years Office of Director QA MR
Registry of Non-conformities EEI/QMS/MP/004/2 2 years Office of Director QA MR

 

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7.0 APPENDICES

Appendix 1 – Non-conforming Product Record

Non-conforming Product Record

Identification of Non-Conforming Product
Product name: Product ID: Quantity of Non-Conforming Product:
Source or Name of person who reported the non-conformity: Date:
Description of Non-Conformity:
Recall/Withdrawal of Non-Conforming Product:
Quantity of product sent to buyer(measuring unit): Quantity of recalled/withdrawn product(measuring unit): % of recalled/withdrawn product:
Referring document:
Dealing with Non-Conforming Product
Corrective action (Yes/No):

 

_________________________

[signature]

[name]

[job title]

 

Appendix 2 – Registry of Non-conformities

Registry of Non-Conformities

No. Name of Product Date Description of Non-Conformity Non-Conforming

Record No.

Recall or Withdrawal

(Yes/No)

Corrective

Action

(Yes/No)

Note
               
               
               
               
               
               

_________________________

[signature]

[name]

[job title]