CORRECTIVE AND PREVENTIVE ACTION. Co-X/QHS/SOP06

Transcription

1 CONVENTION & EXHIBITION (PUTRAJAYA) SDN. BHD. Co-X/QHS/SOP06 Revision No.: 03 Effective Date: 1 st November 2017 PREPARED BY REVIEWED BY APPROVED BY Name: Name: Name: Position: Position: Position:

2 REFERENCE NO. Co-X/QHS/SOP06 PAGE NO. Page 2 of 8 REVISION HISTORY Rev. No DCN No. Description of Changes Effective Date Initial Release 01/06/ / /17 Changes in Clause 5.4 (c) and 5.5 (b) from one (1) week to seven (7) working days. 1. Change company logo from PICC to Co-X. 2. Additional Clause 3.0 Definition. 3. Change format from bullet to numbering. 4. Revised process flow. 01/12/16 01/11/17

3 REFERENCE NO. Co-X/QHS/SOP06 PAGE NO. Page 3 of OBJECTIVE The objective of this procedure is to establish a system to control conditions at Co-X that are averse to quality, health, safety and environmental. This is achieved by finding / detecting the root cause of problems, and correcting the causes to prevent recurrence. The system established is also established to eliminate the causes of potential nonconformities in order to prevent their occurrence. 2.0 SCOPE This procedure applies to actions necessary to resolve system non-compliances, repetitive product non-conformities, customer s complaints, improvements identified as well as actions initiated to eliminate causes of potential nonconformities. 3.0 DEFINITION 3.1 Co-X : Convention & Exhibition (Putrajaya) Sdn. Bhd. 3.2 QHSE : Quality, Health, Safety & Environment 3.3 MR : Management Representative 3.4 NCAR : Non-conformance and Corrective Action Request 3.5 HOD : Head of Department 3.6 SWOT : Strengths, Weaknesses, Opportunities, Treats 3.7 MRM : Management Review Meeting 3.8 HSE : Health, Safety, Environment 3.9 HIRADC : Hazard Identification, Risk Assessment& Determining Control 3.10 CEO : Chief Executive Officer 3.11 COO : Chief Operating Officer 3.12 CAPA : Corrective Action, Preventive Action 4.0 RESPONSIBILITIES 4.1 The MR and / or internal auditors are responsible for: Raising NCAR as a result of audits, non-conformities, customer complaints or as directed by management Monitoring the Non-conformance and Corrective Action Request (NCAR) Register (Co-X/QHS/SOP06-R02) to ensure effective action is taken and NCAR is closed out. 4.2 The MR and respective HODs, including committee members, are responsible for: Identification of to the potential nonconformities, risk and opportunities of improvement Evaluating the need for action Planning and implementing control measure activities.

4 REFERENCE NO. Co-X/QHS/SOP06 PAGE NO. Page 4 of Monitor, review, verify and report of findings. 5.0 REFERENCE 5.1 ISO 9001:2015 Clause 10.2 Nonconformity and Corrective Action 5.2 ISO 14001:2015 Clause 10.2 Nonconformity and Corrective Action 5.3 OHSAS 18001:2007 Clause Nonconformity, Corrective Action and Preventive Action 5.4 Co-X/QHS/SOP02 Management of Change Procedure 5.5 Co-X/QHS/SOP03 Risk Management Procedure 5.6 Co-X/QHS/SOP11 HSE Risk Assessment Procedure

5 REFERENCE NO. Co-X/QHS/SOP06 PAGE NO. Page 5 of PROCEDURE 6.1 Identifying Needs for Preventive Action Committee which consist of all HODs and key personnel, shall identify risk and opportunities as results of assessment from: SWOT analysis Context of Organization Risk Assessment & Planning Register HIRADC Environmental Impact and Aspect Register When the potential non-conformity, risk and opportunity for improvement are identified, the committee members may suggest an appropriate control measure as preventive action The effectiveness of actions taken to address risks and opportunities shall be reviewed and presented during MRM Risk management and assessment as tools of preventive action are implemented in accordance to Risk Management (Co-X/QHS/SOP03) and HSE Risk Assessment (Co-X/QHS/SOP11) procedures. 6.2 Identifying Needs for Corrective Action The HOD and MR shall identify the process / service non-conformities by using appropriate sources of information, not limited to: Feedback from internal staff Audit Results (Internal & External) Customers Compliant / Feedback Outputs from the analysis of data Inputs from other different sources Supplier Non-conformities The trend of non-conformities Other foreseen potential problem from relevant records Whenever customer complaints, the MR immediately initiates countermeasure to rectify the abnormalities Having identified the needs, the concern HOD reviews the impact and seriousness of the identified nonconformities to determine whether the nonconformity requires Corrective Action When required, all the relevant records / data shall be utilized in the process of reviewing the non-conformities.

6 REFERENCE NO. Co-X/QHS/SOP06 PAGE NO. Page 6 of Issuance of NCAR & NCAR Register Each Non-conformance and Corrective Action Request (NCAR) (Co-X/QHS/SOP06-R01) raised is registered with serial number to Nonconformance and Corrective Action Request (NCAR) Register (Co- X/QHS/SOP06-R02) The identity and type/ nature of the nonconformity are to be detailed clearly on the report, including but not limited to the following: P = Problem. E = Evidence of the problem. R = Requirements in the standard or procedure. L = Location where the non-conformity was found In the event of the NCAR is attention to suppliers, NCAR shall be raised accordingly by the Purchaser or relevant personnel. 6.4 Root Cause Investigation The Person In Charge (PIC) shall investigate the root causes of the non-conformity. Root causes may be identified by determining why deficiencies arose. If applicable methods to identify causes may include brain storming or statistical process The responsible personnel (usually HOD or Manager) shall then evaluate the need for action. If action is required, then the responsible personnel determine and propose such action to eliminate the root cause of the problem. Two possible actions are necessary: Immediate Action to resolve or mitigate the problem. Mitigation action aims to prevent the problem from becoming bigger, and are taken immediately upon detecting of the problem Longer term corrective action is taken to prevent recurrence of the problem The identified root cause shall be document accordingly in the NCAR and a time frame of seven (7) working days is normally required to reply the Corrective Action.

7 REFERENCE NO. Co-X/QHS/SOP06 PAGE NO. Page 7 of Monitoring of NCAR The MR shall review the NCAR Register and should a Corrective Action be overdue, a reminder shall be sent to the relevant HOD requesting a response If no response is received within seven (7) working days of the reminder date, the matter shall be passed to the COO / CEO for further action. 6.6 Close Out NCAR Ideally a one (1) month period is given to close out the NCAR. A followup shall be taken to review the implementation and results of the actions taken If implemented effectiveness resulted for satisfactory, close the NCAR accordingly by updating the verification comment and initial for closing. Otherwise arrange for 2 nd verification until it is closed If the NCAR are not closed after the 2 nd verification, a new NCAR will be issued attached with the 1 st NCAR and forwarded to the Top Management for attention Records of NCAR activities and effectiveness are filed and maintained Where appropriate, follow up action to review, initiate and update relevant documents, including procedures and records such as Management of Change process or relevant risk registers The MR compiles a summary for the closed NCAR and submits for review and analysis during the MRM. 7.0 RECORDS 7.1 Co-X/QHS/SOP06-R01 Non-conformance and Corrective Action Request (NCAR) Form 7.2 Co-X/QHS/SOP06-R02 Non-conformance and Corrective Action Request (NCAR) Register 8.0 APPENDIX / ATTACHMENT 8.1 Process Flow

8 REFERENCE NO. Co-X/QHS/SOP06 PAGE NO. Page 8 of 8 PROCESS FLOW RESPONSIBILITY OUTLINE ACTION - HOD - Key personnel 1 Identify needs for CAPA, HOD or key personnel shall identify needs for CAPA. - Internal auditors 2 Issuance of NCAR and monitor NCAR / Internal auditors shall be responsible to issue NCAR to respective department. - Each NCAR raised shall be registered with serial number. - HODs 3 Investigate root cause - HOD shall investigate the root cause of non-conformity. - HODs - Responsible personnel 4 Take action - HOD shall evaluate the need for action. - Responsible personnel shall take action to eliminate the root cause 5 Monitor NCAR shall monitor NCAR Register. - Reminder shall be sent if not reply within 7 working days. - If no response within 7 working days from the reminder date, the matter shall be passed to COO/CEO - Internal auditors 6 Follow-up on action taken - Follow up shall be taken to review the implementation and results of action taken - Internal auditors 7 Effective? No - If implementation not effective, 2 nd verification shall be conducted. - Internal auditors 8 Close NCAR - Once implementation effective, the NCAR shall be closed out accordingly. 9 Review in MRM shall analyse and review during MRM