Procedure for Non-Conforming Output

1. SCOPE

This procedure covers the detection of non-conforming products within XXX operations and taking the necessary corrective or preventive action to avoid unintended use or delivery.

2. PURPOSE

The purpose of this procedure is to ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Public Procurement and Disposal Act,2015
3.3 XXX Strategic Plan

4. TERMS & DEFINITIONS

4.1  D –  Director
4.2 MR –  Management Representative
4.3 NCP –  Non-conforming product
4.4 SOP  – Standard Operating Procedure
4.5 Non-Conformity – Non-fulfilment of requirement.

5. RESPONSIBILITY AND AUTHORITY

5.1 Director

  1. Appoint the disposal committee members.
  2. Authorize disposal of non-conforming products.
  3. Overall responsibility for determination of appropriate disposition method for non-conforming product.

5.2 Deputy Directors/ Centers Directors/ Departmental Heads /Stores Officer /Other Staff

  1. Responsible for control of the non-conforming products in their unit.

6. DETAILS OF PROCEDURE

6.1 Detection of Non Conformity

6.1.1 Non-conforming products are detected through any of the following activities:-

  • Protocol and manuscript review.
  • Inspection and testing.
  • Customer feedback and complaints handling.
  • Quality audits.
  • Procurement process.
  • Service delivery.

6.1.2 Identify/label and quarantine the non-conforming products.
6.1.3  XXX shall deal with non-conforming outputs in one or more of the following ways:

  1. Correction
  2. Segregation, containment, return or suspension of provision of products and services;
  3. Informing the customer;
  4. Obtaining authorization for acceptance under concession.

6.1.4 Where non-conformity is detected during processing, it is suspended until action is taken to eliminate the detected non-conformity.
6.1.5 Where non-conformity is detected in protocols and manuscripts, it is referred back for effecting of suggested corrections or rejected outright.
6.1.6 Where non-conformity is detected during handling/delivery further processing/delivery will be suspended until action is taken to eliminate the cause of the non-conformity.
6.1.7 Non-conforming products detected during quality audits or inspections are recorded on corrective action request forms as non-conformity.
6.1.8 Where a concession is allowed on supply or receipt of a product that does not certain specifications/characteristics a concession form is filled.
6.1.9 The relevant process owner shall review and investigate the non-conformance.

NOTE 1: All non-conformances shall be closed out without undue delay.

7. OBJECTIVES

To ensure that product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

8. RETAINED DOCUMENTED INFORMATION

8.1 Corrective Action Request Form QMS F001
8.2 Concession request form – QMS F012

9. ANNEXES

9.1 Process Flow Chart
9.2 Concession request form – QMS F012

process plan

 

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