Risk Analysis and Management. May 2011 ISO 14971

Transcription

1 Risk Analysis and Management Qsite May 2011 ISO

2 Agenda Definitions Risk Management Development Phases Process Hazards Evaluation Residual Risk 2

3 Why Do We Need Risk Analysis 1. Quantify the risk level of the device to the patient, to the user and to the device efficacy 2. Required by regulatory agencies We: List the Hazards Assess the associate risk regarding gthe safety of the patients and User Assess the associate risk regarding the device efficacy Compare them to a predefined dthresholdh Mitigate the risk to make sure that they are under this threshold 3

4 IEC rd Edition Requires Risk Management IEC rd Edition Mandatory Adoption Dates: Europe: June 1, 2012 Canada: June 1, 2012 USA: July 1, 2013 IEC rd Edition requires Risk Management process in accordance to ISO Clause 4.2 of the third edition states: A risk management process complying with ISO shall be performed. 4

5 Definition iti Harm: physical injury/damage to the health of people or to property and environment. Hazard: potential source of harm Risk: combination of the probability of occurrence of harm and the severity of that harm Mitigate Risk: 21 CFR 50: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during routine physical or psychological exam or test. Risk management: systematic application of management policies, i procedures and practices to the tasks of analyzing, evaluating and controlling risk. Residual Risk: Risk remaining after protective measures have been taken. 5

6 Risk Assessment The ISO 14971:2007 Standard does not specify acceptable risk levels. life-cycle all phases in the life of a medical device, from the initial conception to final decommissioning and disposal 6

7 Product Development Phases (MEDICAL DEVICES) Concept Feasibility Design Pilot Post Production Prelim. Risk Assessment Product Risk Management- On-going 7

8 Risk Management Risk Assessment Risk Analysis Intended d Purpose Identification Hazard Identification Risk Estimation Risk Evaluation Risk Acceptability Decision Risk Control Options analysis Implementation Residual Risk Evaluation Overall Risk Acceptance Preliminary Hazard Analysis Fault Tree Analysis Functional Analysis Tolerability of Risk Cost-Benefit Analysis Socio/Ethical Analysis FMECA HACCP HAZOP PAT Post-production Information Post-production experience Six Sigma Systemic Procedures SPC Identification of new Hazards CAPA Change Control & Feedback Loop Complaint Mgmt. 8

9 Hazard d/ri Risk Hazard Risk Potential source of harm Probability of the occurrence of harm and the severity of that harm. 9

10 Hazard d/ri Risk 10

11 Known Hazard 11

12 Risk ManagementProcess 12

13 Management responsibilities Define and document the policy for determining criteria for risk acceptability Review the suitability of the risk management process at planned intervals to ensure continuing effectiveness of the risk management process and document any decisions and actions taken 13

14 Risk Management Team Qualified personnel appropriate p knowledge and experience Risk management plan Scope, assignment of responsibilities, requirements of activities, criteria for risk acceptability, verification activities Matrix - which h combines probability bilit of harm and severity of harm, acceptability and risk mitigation 14

15 Initiate t Risk Analysis Process Start a Risk management File Identify a RA lead person Define hazards based on experience, similar preliminary device, preplanned plan Etc. Identify hazardous situations Risk evaluation 15

16 Identifying i Hazards Compile documentation on known and foreseeable hazards associated with the medical device in both normal and fault conditions. Extrapolate from similar preliminary devices Use preplanned hazards (will follow in this presentation) tti Identification of anticipated hazards in both normal and fault conditions 16

17 Whatever you do, don t plug it in 17

18 Estimation of Risk(s) () for each Hazardous Situation Identified hazardous situation, the associated risk(s) using available information or data. Quantitative categorization of probability of occurrence of harm or severity of harm Analysis (quantitative) of the probability of occurrence and dthe consequences 18

19 Risk Evaluation Use the criteria defined in the risk management plan Decide if risk reduction is required If risk reduction is needed follow the risk control process 19

20 Risk Control Follow risk control options in the priority order listed Design change (ECO) Protective measures in the medical device itself or in the manufacturing process Information for safety (like labeling change) Rik Risk control measures selected tdshall hllbe recorded dd in the Risk Management File Implementation of each risk control measure shall be verified 20

21 Safety Controls to Mitigate t Risk Design Change Process Labeling Standards and Compliance (Use of consensus standards to defend safety adequacy) 21

22 Residual Risk Residual risk shall be evaluated using the criteria defined in the risk management plan If the residual risk is not judged acceptable using these criteria, further risk control measures shall be applied For residual risks that are judged d acceptable, decide which residual risks to disclose and document 22

23 Open Issues If the residual risk is not judged acceptable, decide which one is safety related Decide which residual risk and judged accepted and which not Record all the data and hand it over for management decision 23

24 Risk Management Process Risk management process is part of the design Risk analysis, risk evaluation and risk control are commonly recognized as essential ilparts of frikm Risk Management. Risk Management continues on into the post-production phase 24

25 Qualitative ti Analyses Examples of qualitative severity level Examples of qualitative i probability bili levels l 25

26 Risk Analysis Techniques * FMEA - Failure Mode and Effects Analysis FTA - Fault Tree Analysis FMECA - Failure Modes Effects & Criticality Analysis HACCP - Hazard Analysis Critical Control Points Combination Methods Tools & Approaches 26

27 Risk Analysis Techniques FMEA Failure Mode and Effects Analysis (FMEA) The consequences of an individual fault mode are systematically identified and evaluated. It is an inductive technique using the question What happens if...?. Components are analyzed one at a time, thus generally looking at a single-fault condition. This is done in a bottom-up mode. 27

28 Risk Analysis Techniques - FTA Fault Tree Analysis (FTA) Analyzing hazards identified by other techniques and starts from a postulated undesired consequence, also called a top event. In a deductive manner, starting with the top event, the possible causes or fault modes of the next lower functional system level causing the undesired consequence are identified. Following stepwise identification of undesirable system operation to successively lower system levels will lead to the desired system level, which is usually either the component fault mode or the lowest level at which risk control measures can be applied. This will reveal the combinations most likely to lead to the postulated consequence. The results are represented pictorially in the form of a tree of fault modes. At each level l in the tree, combinations of fault modes are described with logical operators (AND, OR, etc.). The fault modes identified in the tree can be events that are associated with hardware faults, human errors, or any other pertinent event, which leads to the undesired event. They are not limited to the single-fault condition. 28

29 Definitions and Analysis s Method (FMEA) F (Frequency of occurrence): The expected frequency of the failure occurrence. S (Degree of Severity): The severity of the failure effect on the user. D (Degree of Detection): The possibility of detecting the failure/problem by the physician/user before it causes any harm. RPN (Risk Priority Number of criticality): The problem-solving priority order = F x S x D. Quantitative indication for recommended preventing/monitoring action, the higher the number, the more serious the risk hence the required preventive action. 29

30 Analysis 3 Level The method is by addressing the potential failures, ranking the answers between 1 and 3 and calculating the RPN: F (Frequency of occurrence): What is the likelihood of the failure/hazard occurrence? 1 indicates RARE 2 indicates VERY LOW 3 indicates LOW 30

31 Degree of fseverity S (degree of Severity): How sever is the effect of the failure on the user/patient? 1 indicates MINOR, i.e. a defect that neither affects product performance nor patient injury 2 indicate PERFORMANCE, i.e. a defect that affects product performance but will not cause patient injury. 3 indicates CRITICAL, i.e. a defect that may cause patient injury. 31

32 Degree of fdetection ti D (degree of Detection): Can a failure be detected by the user (physician) before the hazard occurs? 1 indicates CERTAIN for failure detection possibility before hazard occurrence 2 indicates POSSIBLE for failure detection possibility before hazard occurrence 3 indicate NOT POSSIBLE for failure detection possibility before hazard occurrence. 32

33 RPN The RPN is equal to: F x S x D. This number provides for a relative priority of the failure item. The higher the number, the more serious the failure mode is considered. Based on these critical numbers, preventive/corrective actions are being designed. NOTE: RPN>=12 is considered unacceptable by the company and more severe action should be taken to reduce this hazard. 33

34 Integrating g Risk Assessment e into the Quality System Defining Risks as a result of field reports Post market surveillance Risk analysis techniques to evaluate MDRs and corrections and removals Integrate risk management into the CAPA program 34

35 Case Study Use sample device for Risk analysis and management file 35

36 Summary Lesson Learned in safety risk management Evolving standards, d raising i the bar for safety adequacy Using safety risk management to improve design 36

37 Questions? 37