Module 8 - Risk Management.pdf

Medical devices — Application of risk management to medical devices (ISO 14971:2019) 1 Agenda  What is Risk ?  Types of Risk and Strategies for treating risks  Illustrations  Evolution of ISO 14971  Key Defin...

Medical devices — Application of risk management to medical devices (ISO 14971:2019) 1 Agenda  What is Risk ?  Types of Risk and Strategies for treating risks  Illustrations  Evolution of ISO 14971  Key Definitions  Risk Management  Risk Management Plan  Risk Analysis  Risk Evaluation  Risk Controls  Risk benefit Analysis  Overall Residual Risk Acceptability  Risk Management Report  Production & Post-Production Information  Risk Management File  Correspondence between ISO 14971:2007 to ISO 14971:2019 2 What is Risk ? We must understand what a Risk is before we can address Risk Management. Impact of uncertainty on targets — ISO 31000:2018 “Risk management — Guidelines” Uncertain event or condition that might affect your project if it occurs. — Project Management Combination of the probability of occurrence of harm and the severity of that harm — ISO 14971:2019 “Medical devices — Application of risk management to medical devices” 3 What is Risk conti… Risk Vs Issue A risk as an event that has not happened yet but has the probability. An issue as something that already has happened. Example In December 2019, for India Corona was a risk. But for china it was an issue. Now, Corona is an issue as well as risk for all the countries. So a risk can be identified based on history or studies 4 Types of Risks Positive Risk (Opportunity) An important point to consider here is that not all risks are negative. Positive risk consider as opportunity. Negative Risk (Threats) Negative risks consider as threats, it will affect the project badly. Example: Find out that the prices of machinery parts are lower than estimates. Find out that the prices of machinery parts are higher than estimates. So a risk can affect your project positively or negatively 5 Best strategies for treating the risk 6 Scenario 1 Probability :Low Consequence :Low 7 Scenario 2 Probability :High Consequence :Low 8 Scenario 3 Probability :Low Consequence :High 9 Scenario 4 Probability :High Consequence :High 10 Assessment 1 Risk Matrix Scenario 1 Probability : Low High Consequence : Low Risk : Low Scenario 2 Probability : High Risk : Medium Consequence : Low Probability of Occurrence Scenario 3 Probability : Low Risk : Medium Consequence : High Scenario 4 Probability : High Risk : High Consequence : High Low Low High Consequenc e 11 Assessment 2  Define strategies for below condition Probability Impact Strategy (-) Strategy (+) High High Avoid Exploit Low High Transfer Share High Low Mitigate Enhance Low Low Accept Accept  Difference between Contingency plan and Mitigate Mitigation helps to reduce the risk. Contingency plan means alternate option. 12 Evolution of ISO 14971 13 Key Definitions Risk Management Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk Risk Combination of the probability of occurrence of harm and the severity of that harm Harm Physical injury or damage to the health of people, or damage to property or the environment Hazard Potential source of harm Hazardous Situation Circumstance in which people, property or the environment are exposed to one or more hazard(s) Severity Measure of the possible consequences or impact of a hazard. Severity is one component of risk. 14 Key Definitions Systematic use of available information to identify hazards and to Risk Analysis estimate the risk Process used to assign values to the probability of occurrence of harm Risk Estimation and the severity of that harm. e.g.: Severity=2 ,Probability=5. Process of comparing the estimated risk against given risk criteria to Risk Evaluation determine the acceptability of the risk Risk Assessment Overall process comprising a risk analysis and a risk evaluation Process in which decisions are made and measures implemented by Risk Control Measures which risks are reduced to, or maintained within, specified levels. Residual Risk Risk remaining after risk control measures. 15 Risk Management Risk management is all about identifying, analysing, and responding to the risk Identify the risk factors This help manage uncertainty throughout the life of project. Assessment Analyze the risk Risk Management Evaluate the risk Risk Treat the risk Monitor the risk The main objective of risk management is to increase the probability and/or impact of positive events and decrease that of negative events. 16 1. Risk Management Plan The risk management activities coincide with the product development and design control process. Table: Risk management deliverables by project phase 17 2. Risk analysis STEPS: Intended use and identification of characteristics related to the safety of the medical device Identification of hazards Estimation of hazardous situation 18 3. Estimation Of Risks Probability Estimation is based on: Use of relevant historical data Use of experimental data Production data Post production information Use of expert judgment Severity levels will be justified based on the clinical experience. 19 4. Risk Evaluation Risk Evaluation can be determined based on : State of the Art technology (Following good practices) Comparing with previous devices already in use Evaluate the clinical data , especially for new technology. Risk Acceptability matrix 20 5. Risk Control Measures When risk reduction is required, risk control activities shall be performed. Risk control options Examples of RCM’S 21 6. Risk Benefit Analysis (RBA) After you identify Risk Controls and evaluate residual risks, it is still possible that you will have some risks that are still in the unacceptable level. In these cases, it might make sense to conduct and document a risk / benefit analysis (RBA). The RBA must be documented and provided objective evidence and rationale for why the medical benefits outweigh the unacceptable risks. If you are able to do so, the RBA is a special provision for moving forward with unacceptable risks. Benefit Estimation is mainly done in two ways: The clinical performance of the device during its clinical use, Clinical outcomes from that performance. 22 7. Overall Residual Risk Evaluation After all risk control measures have been implemented and verified, the manufacturer shall decide if the overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan. If the overall residual risk is not judged acceptable using the criteria established in the risk management plan, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk. If this evidence supports the conclusion that the medical benefits outweigh the overall residual risk, then the overall residual risk can be judged acceptable. Otherwise, the overall residual risk remains unacceptable. 23 7. Production and Post Production Information The manufacturer shall establish, document and maintain a system to collect and review information about the medical device or similar devices in the production and the post-production phases. The collected information shall be evaluated for: If previously unrecognized hazards or hazardous situations are present or If the estimated risk(s) arising from a hazardous situation is/are no longer acceptable. 24 8. Risk Management Report Summarize all your risk management activities The RM plan has been implemented or not. Explanation of overall risk acceptability of entire device. Discuss your plans for evaluating risks in production and post production. 25 9.Risk Management File The Risk Management File(RMF) is the place where you keep your Risk Management activities, documentation and records. The risk management file can be in any form or type of medium. The risk management file need not physically contain all the records and other documents; however, it should contain at least references or pointers to all required documentation. 26 Correspondence between ISO 14971:2007 and ISO 14971:2019 Annexes Annex C - Moved to ISO/TR 24971 as Annex A Annex D - As Annex C in ISO 14971 Annex E - Combined with Annex C Annex F - Moved to ISO/TR 24971 under clause 4.4 Annex G - Moved to ISO/TR 24971 as Annex B Annex H - Moved to ISO/TR 24971 as Annex H Annex I – Deleted Annex J – Moved to ISO/TR 24971 as Annex D 27 Fundamental Risk Concepts  A hazard cannot cause a harm until sequence of events lead to a hazardous situation.  Depending on the complexity of the medical device, a hazard can lead to multiple hazardous situations, and each hazardous situation can lead to multiple harms.  The probability of occurrence of harm (P) can be composed of separate P1 and P2 values. 28 Risk Vs RPN Risk Risk is only a combination of Severity & Occurrence. Risk does not take into consideration the Detection capability associated with your process. This perspective is taken more often in DFMEA’s as opposed to PFMEA’s because in a DFMEA there’s really no such thing as “Detection” and oftentimes the detection of a failure mode is merged into the Occurrence factor. Risk Priority Number (RPN) The ability to prioritize improvements based on risk or RPN is one of the major benefits of the FMEA because it allows you to analyze all failure modes on a common scale, etc 29 Linking Hazard to Harm Examples 30 Thank You Contact [email protected] [email protected] www.tataelxsi.com Confidentiality Notice This document and all information contained herein is the sole property of Tata Elxsi Limited and shall not be reproduced or disclosed to a third party without the express written consent of Tata Elxsi Limited. 31