IDENTIFICATION AND MANAGEMENT OF NONCONFORMITIES

Similar documents
ACCREDITATION PROCESS FOR TESTING/ CALIBRATION/ MEDICAL LABORATORIES

ACCREDITATION REQUIREMENTS

Procedure for Corrective Action and Non-conformities

Document Ref.: Issue Date: CU/GOP/PA/06 10 th March, 2015 CHUKA UNIVERSITY GENERAL OPERATING PROCEDURE FOR PREVENTIVE ACTION CU/GOP/PA/06

Corrective and Preventive Action

GENERAL PRINCIPLES FOR THE ASSESSMENT OF MANAGEMENT SYSTEMS/ PRODUCT/PERSONS CERTIFICATION BODIES

IAF Guidance on the Application of ISO/IEC Guide 61:1996

Archived. DPC: Corrective Action. Quality Manual

National Accreditation Board for Certification Bodies. Accreditation Procedure. for. Energy Management Systems Certification Bodies

The CMMI Product Suite and International Standards

OSEAN Quality Criteria for Osteopathic Educational Providers

Supervision of Qualified Trust Service Providers (QTSPs)

CNAS-RL01. Rules for the Accreditation of Laboratories

POLICIES & PROCEDURES

Complaints, Feedback and Appeals Management

New Zealand electronic Prescription Service Access Prerequisites. Reference Guidelines for General Practices

IECEx OPERATIONAL DOCUMENT

SHEC CORPORATE MANAGEMENT SYSTEM STANDARD

Department of Defense INSTRUCTION. SUBJECT: Security and Policy Review of DoD Information for Public Release

EPEAT Requirements of PREs

AC291 Special Inspection Agencies ACCREDITATION CRITERIA FOR IBC SPECIAL INSPECTION AGENCIES AC291

DOD MANUAL DOD ENVIRONMENTAL LABORATORY ACCREDITATION PROGRAM (ELAP)

IAF MLA Document. Policies and Procedures for a MLA on the Level of Single Accreditation Bodies and on the Level of Regional Accreditation Groups

Frequently Asked Questions (FAQs) regarding ISO/IEC 17025:2017 and the transition of accreditation from the previous version of the Standard

Raad voor Accreditatie (Dutch Accreditation Council RvA) Specific Accreditation Protocol for Certification according to ISO/IEC 13485

CMDCAS Handbook Policies and Procedures for Sector Qualification under the Canadian Medical Devices Conformity Assessment System (CMDCAS)

YOUR PROPOSED NEW MECA

STANDARD OPERATING PROCEDURE

Appendix 5A. Organization Registration and Certification Manual. WORKING DRAFT-August 26, 2014

GENERAL INFORMATION BROCHURE FOR BLOOD BANKS/ BLOOD CENTRES AND TRANSFUSION SERVICES

Medicines Reconciliation: Standard Operating Procedure

TANZANIA CIVIL AVIATION AUTHORITY AERODROMES AND AIR NAVIGATION SERVICES. Foreword

Public Summary of KPMG PRI Certification Processes

Work of Internal Auditors

HSQF Scheme HUMAN SERVICES SCHEME PART 2 ADDITIONAL REQUIREMENTS FOR BODIES CERTIFYING HUMAN SERVICES IN QUEENSLAND. Issue 6, 21 November 2017

INCIDENT INVESTIGATION PROGRAM

IMO MEASURES TO ENHANCE MARITIME SECURITY

Procedures and Conditions of GLP Registration

POLICY. Asbestos removal OHSMS REQUIREMENTS FOR CLASS A ASBESTOS REMOVAL

PANAMA MARITIME AUTHORITY MERCHANT MARINE CIRCULAR MMC-359. Recognized Security Organizations (RSO s), Operators and Company Security Officer (CSO)

Observations of Implementing the Nuclear Promise for CAP

Request for Proposals (RFP) to Provide Auditing Services

PROGRAM REGULATIONS SCHOOL OF NURSING AND MIDWIFERY. Graduate Certificate in Nursing (Registered Nurse Re-entry) GradCertNur PROGRAM CODE: 4151

Donald Mancuso Deputy Inspector General Department of Defense

International Programs Security Handbook T-1

REPUBLIC OF THE PHILIPPINES DEPARTMENT OF TRANSPORTATION AND COMMUNICATIONS MARITIME INDUSTRY AUTHORITY

Maintain the Health, Hygiene, Safety and Security of the Working Environment

Marine Safety Center Technical Note

REQUIREMENTS FOR FACTORY INSPECTORS

Pars Oil & Gas Company HEALTH, SAFETY AND ENVIRONMENT PROCEDURE. HSE Anomaly Reporting Procedure DOCUMENT ID - PR-74-POGC-002 REVISION 0.

CNAS-RC07. Rules for the Accreditation of Certification Bodies with Foreign Locations

LOCAL GOVERNMENT CODE OF ACCOUNTING PRACTICE & FINANCIAL REPORTING SUBMISSION RELATING TO THE DISCLOSURE OF

MANAGEMENT SYSTEM. Procedure. Performance of information review submitted by applicant and documents of laboratory

Australian Nursing and Midwifery Federation - NSW Branch

Corrective and Preventive Action Procedure

CORRECTIVE ACTION REQUEST

City Clerk's Division COUNCIL FOLLOW-UP NOTICE

SA 610 (REVISED) USING THE WORK OF INTERNAL AUDITORS. Contents

Incident/Injury Reporting & Investigation Program

Appendix C Request for Consideration of Plan Change Form Appendix D Controlled Copy Registration Transfer Form

1 LAWS of MINNESOTA 2014 Ch 250, s 3. CHAPTER 250--H.F.No BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

New South Wales Nurses and Midwives Association

The official manual of the Sheriff's Department of the County of Los Angeles is hereby established and is titled "Manual of Policy and Procedures.

Accreditation Procedure

Are You Ready for This? The New Uniform Grant Guidance 2 CFR 200

KAREN E. RUSHING. Audit of the Vendor Selection Process

Los Angeles County Community Prevention and Population Health Task Force Charter: Mission, Responsibilities & Membership

IOSA Program Manual (IPM) Operational Safety Audit. Effective September th Edition

Navigating the New Uniform Grant Guidance. Jack Reagan, Audit Partner Grant Thornton LLP. Grant Thornton. All rights reserved.

REPORT 2016/106. Audit of management of implementing partners at the International Trade Centre FINAL OVERALL RATING: PARTIALLY SATISFACTORY

Content Sheet 11-1: Overview of Norms and Accreditation

Tel.: +1 (514) ext Ref.: AN 12/51-07/74 7 December 2007

For Client Labs Purpose This document specifies the general requirements for the calibrations performed on Test and Measurement Equipment.

Revision 03. Preparation Approval Authorization Application date. Director of the Dept. of Certification & Inspection

APPENDIX N FEDERAL AUDIT CLAUSES

Standards for the Medical Laboratory

Video Lottery Operation Licensees Minority Business Participation

Waitemata DHB Paid Family Carer Policy for Home Based Support Services

Standard for Zoo Containment Facilities

Manual handling procedure ITFA14

POCKET GUIDE TO THE ACCREDITATION STANDARDS (ISO 15189:2014)

HOUSING AUTHORITY OF THE COUNTY OF LAKE, IL REQUEST FOR PROPOSAL FOR FINANCIAL CONSULTING SERVICE PROVIDER. CLOSING DATE: December 14, a.m.

Value Engineering Program Administration Manual (05/16/2018)

To Green Paper Modernising the Professional Qualifications Directive

supplementary criteria for GLP registration

REPORT 2016/111 INTERNAL AUDIT DIVISION. Audit of contingent-owned equipment in the United Nations Interim Force in Lebanon

Report of the Auditor General. At A Glance. October Photo Credit: Paul Buckingham

Effort Certifications

Research Audits PGR. Effective: 12/04/2013 Reviewed: 12/04/2015. Name of Associated Policy: Palmetto Health Administrative Research Review

Collaborative Agreement for CCGs and NHS England

Client Procedure Green Building Submissions [NOC-BP]

SUBCHAPTER 03M UNIFORM ADMINISTRATION OF STATE AWARDS OF FINANCIAL ASSISTANCE SECTION ORGANIZATION AND FUNCTION

Procedures and Conditions of Building Consent Authority Accreditation

2. This SA does not apply if the entity does not have an internal audit function. (Ref: Para. A2)

EFFECTIVE ROOT CAUSE ANALYSIS AND CORRECTIVE ACTION PROCESS

Calibration Certificate Analysis

SICLAR Questionnaire. Instructions

STANDARD ADMINISTRATIVE PROCEDURE

PROGRAM REGULATIONS SCHOOL OF NURSING AND MIDWIFERY GRADUATE CERTIFICATE IN NURSING LEADERSHIP AND MANAGEMENT. GCertNurs&Mgmt PROGRAM CODE: 4136

SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM

Transcription:

IDENTIFICATION AND MANAGEMENT OF NONCONFORMITIES Prepared by: Technical Manager Approved by: Chief Executive Officer Approval Date: 2016-07-20 Effective Date: 2013-12-12

Table of Contents Page 1. PURPOSE AND SCOPE... 3 2. RESPONSIBILITY... 3 3. DEFINITIONS... 3 4. ACTIVITY DESCRIPTION... 3 4.1 Identification of Nonconformities... 3 4.2 Registration of Nonconformities... 3 4.3 Implementation of Corrective Action... 4 4.4 Monitoring the Effectiveness of Corrective Action... 4 5. PREVENTIVE ACTION... 4 6. CONTINUAL IMPROVEMENT... 4 7. REFERENCES... 5 APPENDIX AMENDMENT RECORD... 6 Page 2 of 6

1. PURPOSE AND SCOPE This document outlines the procedure of identifying and managing nonconformities in order to ensure that root causes of nonconformities are thoroughly investigated and effectively resolved to eliminate their recurrence. This procedure covers all nonconformities which have a bearing on the SADCAS quality management system. 2. RESPONSIBILITY All SADCAS personnel are responsible for the identification of nonconformities, and implementation of corrective actions within their scope of operation. The Quality Manager shall be responsible for closing nonconformities. Nonconformities raised during internal audits shall be closed by the auditor who performed the audit. 3. DEFINITITIONS 3.1 Nonconformity is the non-fulfillment of a requirement of ISO/IEC 17011 and SADCAS quality management system. 3.2 Improvements are actions taken to improve the effectiveness of SADCAS quality management system. 3.3 Continual improvement is the use of repeated activities to increase the ability to meet requirements. 3.4 Preventive Action an initiative to remove the reason for a potential nonconformity or potentially undesirable situation. 4. ACTIVITY DESCRIPTION 4.1 Identification of Nonconformities Nonconformities can be identified by SADCAS personnel or SADCAS clients through the customer feedback system. SADCAS personnel can identify nonconformities while performing routine work or during internal audits. 4.2 Registration of Nonconformities 4.2.1 All nonconformities identified by SADCAS personnel shall be documented in SADCAS F 42 Nonconformity, Corrective Action and Clearance Report and shall be referred to the Quality Manager who shall assign responsibility for handling the nonconformity. Page 3 of 6

4.3 Implementation of Corrective Actions 4.3.1 Upon assignment of the responsibility for handling the nonconformity identified from routine work, the responsible person shall investigate the cause of nonconformity and implement corrective actions that address the root cause and prevent recurrence. Records of all investigations and corrective action(s) taken shall be recorded. 4.3.2 Upon assignment of the responsibility for handling nonconformity(ies) identified from internal audits, the person responsible shall propose corrective action and improvements in consultation with the Quality Manager. The proposed corrective action shall be implemented within 4 months. Once implemented, the responsible person shall advise the Quality Manager accordingly. 4.4 Monitoring the Effectiveness of Corrective Actions The Quality Manager shall review all corrective actions implemented, for effectiveness, verify and close out the nonconformity raised during routine work. A follow up audit shall be carried out by an auditor to verify the effectiveness of corrective actions implemented to address nonconformities raised during internal audits. Auditors close out nonconformities raised during internal audits once corrective action has been implemented. The Quality Manager shall report on nonconformities, corrective actions and status of preventive actions at the management review meeting. 5. PREVENTIVE ACTION SADCAS staff members hold regular meetings (management, technical and operational) which provide fora where possible areas in which nonconformities can occur are identified. When such areas are identified, measures are taken to prevent recurrence of the nonconformity. The system described in this procedure provides a platform for the implementation of corrective actions that prevent recurrence of nonconformities. 6. CONTINUAL IMPROVEMENT Continual improvement in SADCAS is achieved through internal audits, management reviews, customer feedback, corrective action on nonconformities, training and continuous professional development, + supervision and monitoring of assessors etc. Page 4 of 6

7. REFERENCES SADCAS PM 01 Sections 4.4 and 4.5 SADCAS AP 06 Internal Audits SADCAS AP 07 Management Review SADCAS AP 08 Customer Feedback Handling Procedure SADCAS F 42 Nonconformity, Corrective Action and Clearance Report Page 5 of 6

APPENDIX - AMENDMENT RECORD Revision status Change Page No. Clause Description of change Approved by Effective Date Issue 1 - - - CEO 2009-09-04 Issue 1 1 - Footer Reformatted cover as per new format. CEO 2013-12-12 2 - Contents Added Appendix Amendment Record All - All pages Deleted Issue No. 1 and substituted with Issue No. 2 Issue 2 4 4.3.2 3 rd line: Deleted 3 months and substituted with 4 months. CEO CEO CEO 2016-07-20 Page 6 of 6