RISK MANAGEMENT. Co-X/QHS/SOP03
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1 CONVENTION & EXHIBITION (PUTRAJAYA) SDN. BHD. Co-X/QHS/SOP03 Revision No.: 02 Effective Date: 1 st November 2017 PREPARED BY REVIEWED BY APPROVED BY Name: Name: Name: Position: Position: Position:
2 REFERENCE NO. Co-X/QHS/SOP03 PAGE NO. Page 2 of 8 REVISION HISTORY Rev. No DCN No. Description of Changes Effective Date Initial Release 01/06/ /17 1. Changed company logo from PICC to Co-X 2. Additional Clause 3.0 Definition 3. Changed format from bullet to numbering 4. Revised process flow 01/11/17
3 REFERENCE NO. Co-X/QHS/SOP03 PAGE NO. Page 3 of OBJECTIVE The purpose of this procedure is to identify risk from activities and processes performed in Co-X that may affect product and service in terms of quality and delivery. Risk identified are assessed and managed, and contingency planning is carried out to mitigate effect of disruptive incidents based on the assessed risk. (For risk management on occupational health & safety and environmental system, refer to HSE Risk Assessment (Co-X/QHS/SOP11) procedure) 2.0 SCOPE This procedure covers the identification and management of situations under which activities, processes or services may cause malfunction or deterioration in quality performance. 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 HOD : Head of Department 3.5 MRM : Management Review Meeting 4.0 RESPONSIBILITIES 4.1 MR is responsible to initiate the Risk Identification and Assessment. 4.2 ISO committee comprising HOD and headed by MR completes the Risk Identification and Assessment. 4.3 All personnel can identify risk and report to the committee. 5.0 REFERENCE 5.1 ISO 9001:2015 Clause 6.3 Action to address risk and opportunities 5.2 Co-X/FBO/GCP02 Contingency Plan
4 REFERENCE NO. Co-X/QHS/SOP03 PAGE NO. Page 4 of PROCEDURE 6.1 Risk Identification and Assessment (RIA) MR shall appoint a committee, represented by all HOD and key personnel, to perform the Risk Identification and Assessment (RIA) When establishing the RIA, consideration should be given to determine risks at Co-X operations which can have an impact on the product quality, overall quality management system and its interested parties. The committee may use previously established information and other sources to identify risk At a minimum, RIA shall be taken into account: Facility and equipment availability and maintenance Supplier performance and material availability Delivery of non-conforming product Availability of competent personnel. 6.2 RIA Methodology Identify risks. All personnel can identify risk occurring and report to the committee Collect information about these activities, process, products or services, in relation to the effect it can do overall quality management system Assess the risks which may result in product failure, looking at the type, intensity, length, frequency and occurrence to quality The method of assessment considers: Scope, nature & timing to ensure proactive assessment Classification of risks based on current control measures Consistent with personnel experience and capabilities Rank the severity of the established risks index. The criteria used in ranking are detailed in Risk Evaluation Criteria. 6.3 Risk Assessment and Control Measure The MR will chair the meeting, attended by the HOD, and review all the risk and opportunities identified. All actions addressed to each
5 REFERENCE NO. Co-X/QHS/SOP03 PAGE NO. Page 5 of 8 risk, person to carry out these actions and time frames for completion shall be agreed, and recorded in the minutes By referring to the Risk Evaluation Criteria (Table 1), the Risk Index Score can be obtained. The minimum Risk Index Score is 1 whereas the highest is The following table provide a guide to the level of risk and applicable control measures: Risk Level Significantly high & intolerable Significant risks Moderate risks Risk Index score Type of Control Measure Generally unacceptable. Stringent monitoring of work by HOD, MR and top management. Monitoring during work by HOD. Control measures in place before work commence. Worker informed or training given for identified risk. Preparation of Work Instruction to ensure limited product nonconformance & worker training. Trivial 1 4 General monitoring by relevant personnel Countermeasure are discussed and agreed on actions to be taken to prevent, reduce or transfer the risk. This may include production of contingency plans Upon completing the RIA, Risk Assessment & Planning Register (Co-X/QHS/SOP03-R01) is prepared, listing the all the risks associated to conformity of products and services. 6.4 Review of Risk Register and Actions Taken The committee shall review the Risk Assessment & Planning Register to determine (new or additional) control measures to manage each risks All risk control measures should ideally be implemented quickly once the RIA is completed.
6 REFERENCE NO. Co-X/QHS/SOP03 PAGE NO. Page 6 of Upon implementing the new risk control measures for a minimum 6 months or earlier as decided by MR, an assessment is carried to determine the effectiveness of the new control measures in place. Status of risk is recorded on Risk Assessment & Planning Register The Risk Assessment & Planning Register are reviewed and updated annually and thereafter the effectiveness of actions taken are presented to management during Management Review Meeting (MRM) Where appropriate the Risk Assessment & Planning Register communicated by providing relevant training to employees or other parties to ensure the effectiveness of risk management. 7.0 RECORDS 7.1 Co-X/QHS/SOP03-R01 Risk Assessment & Planning Register 8.0 APPENDIX / ATTACHMENT 8.1 Risk Evaluation Criteria [Table 1] 8.2 Process Flow
7 REFERENCE NO. Co-X/QHS/SOP03 PAGE NO. Page 7 of 8 Table 1 RISK EVALUATION CRITERIA Probability versus impact matrix Impact Probability Negligible Marginal Moderate Critical Catastrophic Almost Certain Likely Possible Unlikely Rare Probability and Impact Guide Score Probability Example Score Impact Consequences 1 Rare No case so far 1 Negligible No effect on and not noticeable by customer 2 Unlikely Once in several years 2 Marginal May require customer notification but very minimal effect on customer satisfaction 3 Possible Once a year 3 Moderate May concern customer but issues easily resolved 4 Likely Seen several times a year 4 Critical Serious noncompliance may result to customer complain 5 Almost Certain Seen several times a month 5 Catastrophic Serious impact to customer and may risk legal action
8 PROCESS FLOW REFERENCE NO. Co-X/QHS/SOP03 PAGE NO. Page 8 of 8 RESPONSIBILITY OUTLINE ACTION - MR - Committee 1 Determination of Risk associated to processes from respective department - MR together with a committee represented by all HOD and key personnel shall determine risks associated to processes at Co-X operations - MR - Committee 2 Assess risk - MR shall chair the meeting attended by committee and review all the risk and opportunities identified. - MR - Committee 3 Determination of controls - MR and committee shall determine control measures by development of objective, management program and operational control to manage each risks - Respective department HOD 4 Implement risk control measures - Respective department HOD shall implement the new risk control measuress for a minimum of 6 months or earlier. - MR 5 Monitor effectiveness of control measures - MR shall conduct an assessment to determine the effectiveness of the new control measures in place. - MR 6 - MR shall review the effectiveness of Review in MRM actions taken during Management Review Meeting.
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Risk Protocol for the Management of Risk Instr No Contact Brian Orpin Version 4.0 Email brian.orpin@nhs.net Issue Date 27/04/2015 Telephone 0131 314 5360 Review Date 27/04/2016 Status Issued Change Control