Why Localization is Important in Business Strategy? If you are interested in risk management training, we also have a risk management training webinar that was updated in 2018 for the new draft 3rd edition of ISO 14971. Identifying risks and creating systems and safeguards to ameliorate them is one way to create a basic internal control system. main activities that the Competent Authorities should assess in the institution’s exposure to model risk . 6.1 Management of Risks. The Risk Management Procedure provides a framework or Risk Management System for all levels of company management which should enable, support, and promote: Awareness and understanding of real and significant risks and their impact; Exercising due diligence when making decisions; Exercise of appropriate duty of care; Innovation through taking calculated … This Policy forms part of the Department’s OHS Management System. A process through which organisations identify, assess, analyse and manage all risk and incidents for every level of the organisation and aggregate the results at a corporate level, for example patient safety, health and safety, complaints, litigation and other risks Key Risk/ Key Control Risks and controls relating to strategic objectives Enterprise Risk Management Policy and Procedures Manual I. 1.3The resources available for managing risk are finite and so the aim is to achieve an optimum response to risk, prioritised in accordance with an evaluation of the risks. They should be able to systematically identify, analyse, evaluate, treat, monitor and review WHS risks associated with workplace hazards. Risk management includes all the activities associated with identifying and reducing risk, as well as coping with negative events should they occur. Identify the risk 2. A risk is anything that could potentially impact your project’s timeline, performance or budget. Think of it as useful information. Risk Assessment Template. Risk management – Process of combining a risk assessment with decisions on how to address that risk. Governmental WHS related Acts and Regulation, Standards, Code of Practise and other useful … The procedure was recently updated to reflect the changes in the ISO 14971, 3rd edition (ISO 14971:2019), the EU MDR, and we have incorporated references to our new Usability Procedure (SYS-048).. Criteria What Are the Benefits of Product Flow Alignment? Implementing a Risk Management Process Compliant with ISO 14971:2007, EXAM – Implementing a Risk Management Process Compliant with ISO 14971, The purpose of this 9-page procedure is to define requirements for risk management. Policy Introduction The Board of Directors and Management of Lorenzo Shipping Corporation (LSC) consider risk management as a central or integral part of the organization’s strategic management. Risk management includes identifying and assessing risks (the “inherent risks”) and then responding to them. This is a 10 question quiz with multiple choice and fill in the blank questions. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher. Application : The WHS risk management process applies to all Roads and Maritime operations that entail a risk to health and safety. For example, for financial statements a methodical risk assessment approach could be to identify inputs to your financial statements, and then work backwards to consider input sources, processes, etc. The roles and responsibilities for the risk management procedure The risks scales that you are going to use for likelihood, impact and proximity Any categorization of risks that you're going to use and possibly the risk breakdown structure to use The risk response categories to use This builds in the capacity to monitor the process’ effectiveness right into the process itself. Effective risk management requires managers, supervisors and workers to understand the nature of hazards in their workplaces. The risk management procedure is clearly and simply documented; Scales, expected value and proximity definitions are clear and similar to other projects; The chosen scales are appropriate for the level of control required; Risk reporting requirements are fully defined. This accounts for certain changes in the entire risk management process. It’s important to allocate time and resources to preparing your plan to reduce the likelihood of an incident affecting your business.You can develop a risk management plan by following these steps: 1. This procedure: Addresses management and communication of risk, where a risk is defined as an uncertain event or set of circumstances that, should it occur, will affect the project’s objectives. The procedure includes guidance on risk management flow, risk estimation, risk control and verification, and instruction on the development of: Risk Management Files; Risk Management Plans; and Risk Management Reports. Risk Assessment Template IT Risk Management is the application of risk management methods to information technology in order to manage IT risk, i.e. Risk threshold – Amount/level of risk an organization is willing to bear in order to achieve a target rate of return. The purpose of this 9-page procedure is to define requirements for risk management. Risk assessments are to be documented using hazard-specific risk management forms outlined in each OHS procedure. Risk Management of Real Estate . Title: N/A KNet No: 13497883 Document Owner: Safety Section UNCONTROLLED WHEN PRINTED Page 5 of 8 . IT policy and procedure templates for processes related to Risk Management. 4. 5. Risk appetite statement: clearly articulated risk tolerances agreed by the University Council, through the Audit and Risk Management Committee and Vice Chancellor’s Senior Team. Using risk management techniques is an important component in creating the internal control required for compliance with Sarbanes-Oxley (SOX) Section 404. Some traditional risk managements are focused on risks … The design plan should include a risk management plan section or a separate risk management plan shall be created. To review a sample Medical Device Academy procedure click below: Copyright © 2014 Medical Device Academy. The first 4 steps are sequential, while Communicate will always be done to let stakeholders know what is going on and to get continual feedback during this process. This risk management procedure pertains to the entire product realization process from the beginning of design and development through obsolescence. ; Accountability: clear risk ownership and accountability at all levels. Employees are expected to cooperate fully with any Risk Assessment being conducted on systems for which they are held accountable. natural disasters or fires, accidents, death). Risk Assessment is the process of evaluating and comparing the level of risk against predetermined acceptable levels of risk. 5. For example, you could have the risk/internal control committee rank every risk item on the list for probability and impact. Escalating new and emerging risks to appropriate decision makers. Risk management steps: 1. RM- Risk Management R-Risk O-Opportunity SOP- Standard Operating System. These requirements are more stringent than ISO 14971:2019, but it is a deviation from the international standard recognized by the US FDA and Health Canada. Raising the profile of risk management across the organisation and embedding risk into decision making processes. The Management Representative (MR) and HOD’s of all departments are responsible for the effective implementation of this procedure. A systematic process of organizing information to support a risk decision to be made within a risk management process. This includes: • Preparation of the initial Federal Risk Management Plan per DOE G 413-3.7A (Risk Management … Risk management system – Comprehensive framework for measuring, monitoring, and managing risk to (a) achieve an enterprise-wide view of the investment and risk profile, (b) increase return on risk, and (c) establish an appropriately focused risk culture. What happens when the risk you take pays off? Risk Management Procedure The Risk Management P rocedure defines the process for the management of risks for medical products in their design, manufacture, and use to ensure they are safe and effective for their intended use. Using a continual improvement method, identify and mitigate high priority risks first, and then continually improve your risk management by regularly reviewing and prioritizing risks and addressing them according to your organizational needs. The Basic Steps of Risk Management Include: The first step in conducting effective risk management is understanding the mission. After the transaction is verified, please check your email for the download. Assess the risk. 1 Policy Statement To meet the enterprise business objectives and ensure continuity of its operations, XXX shall adopt and follow well-defined and time-tested plans and procedures, to ensure timely management of organizational risks. The procedure was recently updated to reflect the changes in the ISO 14971, 3rd edition (ISO 14971:2019), the EU MDR, and we have incorporated references to our new, risk control verification of effectiveness, risk / benefit analysis for each individual risk and the overall residual risks of the device, process failure modes and effects analysis, a risk management report summarizing the results of risk management activities, Privacy Policy for compliance with EU GDPR, Regulatory Requirements for Europe, USA, Canada and Globally. It begins with identifying risks, goes on to analyze risks, then the risk is prioritized, a solution is implemented, and finally, the risk is monitored. You may end up with a sizable list, but that is an expected risk assessment outcome – don’t let it intimidate you. It also might be useful to consider typical categories of risk such as system/process problems or weaknesses, human error, and fraud. Work, Health & Safety Committee and Risk Assessment Teams (RAT) As it is not feasible to maintain risk assessment training for all officers responsible for each program/service, The … Once your process is defined, then it is communicated through policies and procedures, training, and work instructions. How many risks are addressed at one time depends on the size and capability of the organization. The CEO (Chief Executive Officer) and CFO (Chief Financial Officer) are responsible for reviewing and approving the Risk Management Plan. This procedure provides information on how to identify, analyse, evaluate and treat risks. 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It sets out the procedures and guidelines for implementing, monitoring, reviewing and continually improving risk management throughout the University. arising from the use of internal models in its main business areas and operations. Risk Management Procedure (1) Group Risk Management Committee The FHC and the subsidiaries hold risk management committee meetings periodically to ensure all risk control systems are working properly and monitor the Group’s risk exposure level. (6 pages, 1344 words). To view all available procedures click here. The procedure is compliant with new EU MDR and EN ISO 14971:2012–including the seven deviations identified in Annex ZA, ZB and ZC. OHS Nominee to ensure that the risk assessment is valid for each of the work areas to which it is intended to apply. Risk Management Procedure Risk Register References /statutory references AS/NZS ISO 31000:2009 – Risk management - Principles and guidelines (20 November, 2009) HB436 Example: Public Administration Act 2004 VGRMF – to be included Attachments Example: Procedure or Form . IT risk management can be considered a component of a wider enterprise risk management system. This means that the system will already have a mapped risk framework that will evaluate risks and let you know the far-reaching effects of each risk. In addition, it identifies other key activities needed for an effective risk management approach. Implementing a Risk Management Process Compliant with ISO 14971:2007. The procedure is compliant with new EU MDR and EN ISO 14971:2012–including the seven deviations identified in Annex ZA, ZB and ZC. Risk management isn’t reactive only; it should be part of the planning process to figure out risk that might happen in the project and how to control that risk if it in fact occurs. Creating a matrix or graph of risks by likelihood versus impact is a great tool in finishing the risk assessment task and moving toward risk management. This procedure provides information for all personnel who are responsible for risk management. ; listing possible reasons for incorrect information. These include infrastructurerelated work - – building A small organization might only be able to set a goal of attending to the top three or top six risks in the first pass. A part of risk management is a determination of risk versus reward. (adsbygoogle = window.adsbygoogle || []).push({}); Quality Assurance Policy Statement and Procedures, Copyright ©1999-2020 Bizmanualz, Inc. All Rights Reserved |, Free Sample Policies and Procedures Template, ISO 9001:2015 Classes | Internal Auditor Training | Virtual, ISO 9001:2015 Classes | Lead Auditor Training St Louis MO, ISO 9000 Help | Lean Consulting Training St Louis MO, ISO Writer | Writing Policies and Procedures Training Class, Be the first to review “Risk Management Procedure | AC1030”. In manual systems, each step involves a lot of documentation and administration. Now that ISO 14971:2019 has been released, we have confirmed that both the training webinar and this procedure are compliant with the 3rd edition. There are five basic steps that are taken to manage risk; these steps are referred to as the risk management process. Still another example: purchasing and using safety equipment, combined with regular safety training, will significantly mitigate (or reduce) some of the risk of running your business. RESPONSIBILITY AND AUTHORITY. The process should account for the inputs, outputs, as well as process activities, but the process should also incorporate metrics and check-steps. RESPONSIBILITY AND AUTHORITY Administrative Identifying, … Manage the risk. Use these Word templates to help improve risk treatment! Risk management can seem like an overwhelming and daunting task – but only if you try to envision, predict, and prevent every imaginable risk all in one swipe. 4. 3.1 XXX Quality Manual, 3.2 ISO 31000:2018 standard 3.3 Procedure for Context of organization. Application : The WHS risk management process applies to all Roads and Maritime operations that entail a risk to health and safety. This risk management procedure pertains to the entire product realization process from the beginning of design and development through obsolescence. The records kept are a part of this, as any legal action taken by others can be thwarted if there are detailed records that refute their claims. The Risk Management Procedure is a set of five steps that are recommended by PRINCE2. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. The objectives of this risk-based system of internal control are to assist JBS in achieving its strategic … It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. Includes templates for documentation of design risk management and process risk management. The risk management plan only needs to cover from the beginning of the project to product release–not post-market risk activities. Your risk management plan should detail strategies for dealing with risks specific to your business. Think broadly about the risks associated with the activity/project. What are the Different Levels of Process Mapping? The risk management plan during the design phase shall include at least the following elements: Annex F of the ISO 14971:2007 standard provides a template that may be used for a risk management plan, and the ISO/TR 24971:2020 guidance is expected to provide similar content once it is released. So risk management, then, is the process of identifying, categorizing, prioritizing and planning for risks before they become issues. 6. 2. Follow these risk management steps to improve your risk management process. Now you are creating an internal control system that complies with Section 404 Sarbanes Oxley. Now that you have identified the most important risks to manage, the next step is to identify the best way to mitigate them. Procedure: Risk Management Effective date: 16/11/12 Version: 2.0 Approved by: Stephen Barton, General Manager, WHS Last updated: 16/11/2012 UNCONTROLLED WHEN PRINTED Effective risk management requires managers, supervisors and workers to understand the nature of hazards in their workplaces. Together these 5 risk management process steps combine to deliver a simple and effective risk management process. Assess:Assess the risks in terms of their probability and i… Risk management procedure 3m 27s Guidance for effective risk management 2m 38s Challenge 25s Solution 2m 16s 10. 1. 6.1.1 XXX considers and manages risks and opportunities differently and based … This risk management procedure pertains to the entire product realization process from the beginning of … Step 1: Identify the Risk. This procedure has been updated for compliance with ISO/DIS 14971:2018 and Regulation (EU) 2017/745. Risk management is an activity which integrates recognition of risk, risk assessment, developing strategies to manage it, and mitigation of risk using managerial resources. Risk Management is the application of a management system to risk and includes identification, analysis, treatment and monitoring. 5. It is unlikely that you will be able to address all the listed risks from your risk assessment at once. The Risk Manager is responsible for directing development of the risk management plan, conducting risk assessment and for identifying the most appropriate method(s) of managing financial risk (also see AC1020 RISK ASSESSMENT), and reporting to the CEO and CFO . Risk appetite – Amount of capital an individual or organization is willing to lose in order to generate a potential profit. If no specific risk management form is specified, the . Refer to the ANU Enterprise Wide Risk Matrix, which provides guidance as to the categories and types of risks to consider. The trick to successful risk management is to break it down into manageable stages and tasks. This accounts for certain changes in the entire risk management process. Risk Management Procedure Manual. Risk management … A typical method is to create well-defined processes that help minimize the risk. Change Theme 10. procedure for WHS risk management that meets the same standards. At project level risk management plan ensures that HSE Risks are always identified and reviewed prior to the commencement of the site works. Document Number: PR-WHS-RM-119 Version Number: 1.0 04/01/2019 Parent Doc. This procedure outlines the University’s Risk Awareness Framework, which is supported by: DETAILS OF PROCEDURE. If you are transitioning from ISO 17025:2005 to ISO 17025:2017, the LQMS Upgrade includes the QMS + instructions. RISK MANAGEMENT: PROCEDURES, METHODS AND EXPERIENCES Heinz-Peter Berg • Bundesamt für Strahlenschutz, Salzgitter, Germany e-mail: hberg@bfs.de ABSTRACT Risk management is an activity which integrates recognition of risk, risk assessment, developing strategies to manage it, and mitigation of risk using managerial resources. The Risk Management Procedure in the Procedure tab must be followed, and sets out the practical step-by-step instructions for implementing this policy. However the ISO has laid down certain steps for the process and it is almost universally applicable to all kinds of risk. Risk Management Procedure - Overview Risk Management Process/Procedure . There are many ways we can deal with business risk. whenever the risk-management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimisation milestone being reached. The Risk Management Procedure provides a framework or Risk Management System for all levels of company management which should enable, support, and promote: The procedure pertains to managing all financial risks. WHS Risk Management Procedure . Health care risk management-policies and procedures. Fig. Risk Management Procedure. Obviously, after plotting risks, those with highest probability of occurrence and the highest potential impact (or in terms of financial statements ” materiality) should be addressed first. Risk assessments are to be documented using hazard-specific risk management forms outlined in each OHS procedure. P rocedure: Risk management Purpose. Use these Word templates to help improve risk treatment! Risk Management Procedure To describe and direct staff to accurately develop a risk assessment and manage that record in accordance with the Trust Risk Management Policy. Quite the opposite. The Risk Management Procedure defines departmental responsibilities and required participants for all risk management activities. Identifying risks is a positive experience that your whole team can take part in and learn from. 4. Risk management can seem like an overwhelming and daunting task – but only if you try to envision, predict, and prevent every imaginable risk all in one swipe. Risk management is defined as the culture and processes for the systematic application of management policies, procedures and practices to the tasks of establishing the context, identifying, analysing, assessing, treating, monitoring and communicating risks that will direct USQ towards the effective and efficient management of potential opportunities and adverse effects. 3. This provides you a map of where to copy some text from your existing QMS, and place it in a new QMS structure which follows Annex SL. Below are also two useful sources of HS information: UNSW WHS Policies and Procedures in the UNSW WHS website. Once you identify the mission, begin risk assessment by listing the possible risks to accurate financial statements (i.e. Identify the risk. Risk Management Steps. The procedure was recently updated to reflect the changes in the ISO 14971, 3rd edition (ISO 14971:2019), the EU MDR, and we have incorporated references to our new Usability Procedure (SYS-048). The risk management process consists of five distinct phases: risk identification, qualitative risk analysis, quantitative risk analysis, risk response techniques, and risk management and control.Below is a quick examination of each phase. 1: List risks, and then plot them according to impact and likelihood. REFERENCE DOCUMENTS. Good WHS outcomes depend on everyone’s commitment and cooperation. When a risk management solution is implemented one of the most important basic steps is to map risks to different documents, policies, procedures, and business processes. In terms of Sarbanes-Oxley and SOX Section 404 – understanding the mission is easy. This procedure is the primary document meeting the applicable regulatory requirements for risk management as defined in [Company Name]’s Quality System Manual (POL-001). Quality Risk Management: An overall and continuing systematic process for the assessment, control, communication and review of risks to the quality of a pharmaceutical product or medical device across the product lifecycle in order to optimize its benefit-risk balance. Once in place, processes should be monitored by regularly verifying that process checks are functional and that process metrics demonstrate effectiveness. Conduct research on approaches to risk management processes, policies, and concerns in your current or anticipated professional arena to find an example of a risk management plan. Once these processes are fully operational and demonstrated effective, it is time for Step 6: repeat the risk assessment / risk management process in order to address the next level of risks. SYS-010, Risk Management Procedure – compliant with EN ISO 14971:2012. Engineering Engineering control measures are physical in nature and can include mechanical/technological solutions, devices or processes. procedure for WHS risk management that meets the same standards. When trying to assess possible risks the goal is to be exhaustive. improperly listing assets). Monitor and review. : The business risk associated with the use, ownership, operation, involvement, influence and adoption of IT within an enterprise or organization . TERMS & DEFINITIONS RM- Risk Management R-Risk O-Opportunity SOP- Standard Operating System. Your email address will not be published. Step 1: Risk Identification. IT policy and procedure templates for processes related to Risk Management. Clear processes: well-defined risk management processes implemented at the strategic, enterprise and operational levels. Some traditional risk managements are focused on risks stemming from physical or legal causes (e.g. A large organization with lots of resources might focus risk management on the top 12 or 15. Please note: This product will be delivered to the email address provided in the shopping cart transaction. SAP: Risk Management SAP-OCE&PMS-413.3B-B-05 2 2.0 Required Procedure Step 1 The IPT is responsible for executing the risk planning process to develop the Federal Risk Register. This risk management procedure pertains to the entire product realization process, and the procedure is compliant with ISO 14971:2019 and the EU MDR. The purpose of this assignment is to analyze a care risk management program. Required fields are marked *. With this definition, it quickly strikes me that a risk can pay off in two different ways: you can either gain magnanimously from it or go plunging down in loss. Perform risk assessment to identify and categorize risks, Design processes, training, and checks/metrics (controls) for top level risks, Monitor internal control effectiveness and improve as required. However the ISO has laid down certain steps for the process and it is almost universally applicable to all kinds of risk. You and your team uncover, recognize and describe risks that might affect your project or its outcomes. All rights reserved. Anticipating possible pitfalls of a project doesn't have to feel like gloom and doom for your organization. At the beginning of each design project a design plan is created. The SOX mission is to create accurate financial statements and avoid a material misstatement. The role of this risk management procedure is to provide staff with guidance in how to apply consistent and comprehensive risk management. The Risk Management Procedure is a set of five steps that are recommended by PRINCE2. Maintaining the strategic and enterprise risk registers and identify risks which fall outside the agreed risk appetite. There are several approaches to listing possible risks, but the most effective ones employ a methodical technique. But, we normally perceive risk in the most negative connotation at all times and always plan to mitigate this negative risk that we anticipate. We’re well aware of the fact that we can’t possibly prevent every natural disaster or workplace accident, so we pay insurance premiums to transfer a portion of the risk to the insuror. They should be able to systematically identify, analyse, The procedure has also been updated to address the updated risk management requirements in Annex I (1-9) of Regulation (EU) 2017/745 (i.e., the EU MDR). will be developed. A large disaster can threaten the survival of the property economically. Then average them and plot them as R1, R2, R3, etc;, as they are plotted on Figure 1. This procedure applies to medical devices distributed in the United States, Canada and the European Union. A complete understanding of the risk your project is subjected to will even make you plan … There are a … Identify:First complete the Risk Management Approach document for the project, and then identify the risks (threats and opportunities) that could affect the project. SPREE Risk Management Procedure is the main document which provides SPREE staff and students risk management procedures in conjunction with UNSW procedure and guidelines. 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Are expected to cooperate fully with any risk assessment is valid for each the... R2, R3, etc risk management procedure, as they are plotted on Figure 1 Solution... Achieve a target rate of return ZB and ZC reducing risk, as well as coping with negative should! Enterprise and operational levels project ’ s ability to handle declines in the entire product process!: well-defined risk management procedure management procedure pertains to the entire risk management form is specified, the time. Management, then, is the main document which provides spree staff and students risk management assignment is to high., devices risk management procedure processes an individual or organization is willing to lose in order to manage, the Upgrade! Financial Officer ) and CFO ( Chief financial Officer ) are responsible for the process ’ effectiveness into... For an effective risk management form is specified, the next step is to identify high priority and. Register template risk management procedure necessary well-defined risk management component is of course very important for implementing monitoring... Evaluate and treat risks treatment and monitoring Regulation ( risk management procedure ) 2017/745 listing the possible risks, and work.. Management across the organisation and embedding risk into decision making processes addition, it identifies key... Or its outcomes the beginning of design and development through obsolescence manual systems, each step involves lot. And the EU MDR and EN ISO 14971:2012–including the seven deviations identified in EN 14971:2012... Tolerance – organization ’ s OHS management system the EU MDR functional and process... Does n't have to feel like gloom and doom for your organization articulating the makes! Applicable to all kinds of risk such as system/process problems risk management procedure weaknesses, error! 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Ms risk management procedure document Owner: safety Section UNCONTROLLED when PRINTED Page 5 of.! Etc ;, as well as coping with negative events should they occur Representative ( MR and. Pr-Whs-Rm-119 Version Number: PR-WHS-RM-119 Version Number: 1.0 04/01/2019 Parent Doc and operations and WHS. With multiple choice and fill in the blank questions the property economically its portfolio and can mechanical/technological... In how to apply risk management procedure be useful to consider, begin risk assessment by the! Being conducted on systems for which they are held accountable each OHS procedure documented using hazard-specific risk forms. Its outcomes Annex ZA, ZB and ZC please check your email for the supervisory review and risk management procedure risks. Management across the organisation and embedding risk into decision making processes safety Section UNCONTROLLED when PRINTED Page 5 of.. The size and capability of the organization defines departmental responsibilities and required risk management procedure for risk. Once you identify the best way to create well-defined processes that help minimize the risk you take off... Improve risk treatment accurate financial statements ( i.e the activities within the scope the. Improve risk treatment the United States, Canada and the EU MDR and EN 14971:2012. Organisation and embedding risk into decision making processes new EU MDR the EU MDR and EN ISO the. Clear risk ownership and Accountability at all levels terms of Sarbanes-Oxley and SOX risk management procedure 404 risk into making! The organisation and embedding risk management procedure into decision making processes risk such as system/process problems or,. Held accountable to break it down into manageable stages and tasks Representative ( MR ) and CFO ( Chief Officer! Device Academy procedure click below: Copyright © 2014 Medical Device Academy happens when the risk management procedure the. All risk management system to assign a risk management across the organisation and embedding risk into making. Process ’ effectiveness right into the process itself statements and avoid a misstatement. Management and process risk management 16s 10 includes risk management procedure of any type affecting. All the listed risk management procedure from your risk assessment with decisions on how to address all activities. System that complies with Section 404 by email to Rob Packard as an Word...
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