|Authorization Code:||SAI/ QMS/MP/004|
|Title:||PROCEDURE FOR CONTROLLING NON-CONFORMITIES|
|Revision No. :||00|
|Created by:||MANAGEMENT REPRESENTATIVE|
|Date of version:||1st MAY 2015|
|Copy No.||Distributed to||Date||Signature||Returned|
|Date||Version||Created by||Description of change|
Table of Contents
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.
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.
3.1. ISO 9001:2008 – Quality Management Systems Requirements
3.2. EEI Quality Manual
3.3. Procedure for preventive and corrective actions
4.0. ABBREVIATIONS / DEFINITIONS
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.
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
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.
6.1 Reporting and consideration of non-conformities
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.
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
Director QA shall verify and separate non-conforming product from conforming products.
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.
Non-conforming raw materials and the final products are labeled with a sign reading NON-CONFORMING PRODUCTS, and they are stored separately
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
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.
The Committee for non-conforming product reviews the non-conforming product in order to determine the method for dealing with the non-conforming product.
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
Product recall, the process of retrieving non-conforming product from consumers, shall occur as a result of quality concerns.
Product withdrawal, the process of removing the product from the market, shall occur quality issues or product defect.
6.5 Management Representative shall
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
Receive reports from the Registrars on action taken
6.6 Registrar shall
Receive audit report from MR
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
Receive reports from the process owner on action taken
6.7 Process owner shall
Write to staff within his/her jurisdiction informing them of nonconformities identified in their areas of operation
Investigate the cause of the nonconformities and take the necessary corrective action
Write a report on the action taken to correct nonconformities
6.8 Managing Records kept on basis of this document
|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|
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:|
|Dealing with Non-Conforming Product|
|Corrective action (Yes/No):|
Appendix 2 – Registry of Non-conformities
Registry of Non-Conformities
|No.||Name of Product||Date||Description of Non-Conformity||Non-Conforming
|Recall or Withdrawal