In search of better health K E M R I STANDARD OPERATING PROCEDURE CONTROL OF NON-CONFORMING PRODUCTS

Transcription

1 In search of better health K E M R I STANDARD OPERATING PROCEDURE CONTROL OF NON-CONFORMING PRODUCTS

2 REF NO: KEMRI/QMS/SOP/NCP/03 Version no 2 PAGE: 2 of 8 Controlled copy: Circulation authorized by the Management Representative.

3 REF NO: KEMRI/QMS/SOP/NCP/03 Version no 2 PAGE: 3 of 8 TABLE OF CONTENTS 1. SCOPE PURPOSE REFERENCE DOCUMENTS TERMS & DEFINITIONS RESPONSIBILITY AND AUTHORITY DETAILS OF PROCEDURE DETECTION OF NON CONFORMITY CORRECTIVE ACTION OBJECTIVES RETAINED DOCUMENTED INFORMATION ANNEXES... 6 PROCES FLOW CHART... 7

4 REF NO: KEMRI/QMS/SOP/NCP/03 Version no 2 PAGE: 4 of 8 1. SCOPE This procedure covers detection of non-conforming products within KEMRI 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 KEMRI Quality Manual, Public procurement and Disposal Act, KEMRI Strategic Plan TERMS & DEFINITIONS 4.1 KEMRI Kenya Medical Research Institute 4.2 DK Director KEMRI 4.3 MR Management Representative 4.4 NCP Non-conforming product 4.5 SOP Standard Operating Procedure 4.6 Non-Conformity Non-fulfilment of requirement. 5. RESPONSIBILITY AND AUTHORITY 5.1 Director KEMRI Appoint the disposal committee members Authorize disposal of non-conforming products Overall responsibility for determination of appropriate disposition method for non-conforming product. 5.2 DEPUTY DIRECTORS/CENTRE DIRECTORS/ DEPARTMENTAL HEADS /STORES OFFICER/OTHER STAFF Responsible for control of the non-conforming products in their unit.

5 REF NO: KEMRI/QMS/SOP/NCP/03 Version no 2 PAGE: 5 of 8 6. DETAILS OF PROCEDURE 6.1 DETECTION OF NON CONFORMITY 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 Identify/label and quarantine the non-conforming products KEMRI shall deal with non-conforming outputs in one or more of the following ways: a) Correction b) Segregation, containment, return or suspension of provision of products and services; c) Informing the customer; d) Obtaining authorization for acceptance under concession Where non conformity is detected during processing, it is suspended until action is taken to eliminate the detected non-conformity Where non-conformity is detected in protocols and manuscripts, it is referred back for effecting of suggested corrections or rejected outright 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 Non-conforming products detected during quality audits or inspections are recorded on corrective action request forms as non-conformity Where concession is allowed on supply or receipt of a product that does not certain specifications/characteristics a concession form is filled The relevant process owner shall review and investigate the non-conformance. NOTE 1: All non-conformances shall be closed out without undue delay.

6 REF NO: KEMRI/QMS/SOP/NCP/03 Version no 2 PAGE: 6 of 8 NOTE 2: Conformity to the requirements shall be verified when nonconforming outputs are corrected. 6.2 CORRECTIVE ACTION In the event of non-conformance, action is taken to eliminate the detected nonconformance Details of the corrective action procedure are described in Corrective Action procedure; KEMRI/QMS/SOP/CA/ 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 F Concession request form - QMS F ANNEXES 9.1 Process Flow Chart 9.2 Concession request form - QMS F015

7 REF NO: KEMRI/QMS/SOP/NCP/03 Version no 2 PAGE: 7 of 8 PROCES FLOW CHART PROCESS OPERATOR OPERATIONS / MGT MEETING PROCESS OWNER / HOD START NON CONFORMITY DETECTED DISCUSSED AT OPERATIONS MEETIG SUSPEND SERVICE PROCESS/ SEGREGATE GOODS DISCUSSED AT MANAGEMENT MEETING REVIEWS CORRECTIVE ACTION CORRECTIVE ACTION TAKEN

8 KENYA MEDICAL RESEACH INSTITUTE CONCESSION REQUEST FORM QMS - F015 To: Date: We are requesting for a concession to accept the following products with the characteristics listed below: Product Characteristics Required Actual Deviation If acceptable, please sign and stamp for customer s approval and send this form back to us immediately to facilitate dispatch of the products. Thank you. Yours faithfully, Customer s Approval: Date: Issuing officer Annex to KEMRI/QMS/SOP/NCP/03 Version 2