Failure Mode and Effects Analysis FMEA

1. Failure Mode and Effects Analysis (FMEA)

2. Aims To understand how to use Failure Mode and Effects Analysis (FMEA) To learn the steps involved in the FMEA Process To use FMEA to plan improvement efforts The aim of today�s session is to allow you to understand how to use FMEA, learning steps involved in the process and then using FMEA to action plan for improvement to your systems and processes.The aim of today�s session is to allow you to understand how to use FMEA, learning steps involved in the process and then using FMEA to action plan for improvement to your systems and processes.

3. What is FMEA? A Systematic, pro-active method for evaluating a product or process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. (Institute of Healthcare Improvement, 2004) So what is FMEA? FMEA was developed outside of healthcare and is now being used in healthcare to assess risk of failure and harm in processes. It is a ���..(read from quote) In other words FMEA allows us to examine our current system or practice and proactively identify areas for improvement. It allows us to put improvements into practice to reduce the risk of harm to both patients and staff.So what is FMEA? FMEA was developed outside of healthcare and is now being used in healthcare to assess risk of failure and harm in processes. It is a ���..(read from quote) In other words FMEA allows us to examine our current system or practice and proactively identify areas for improvement. It allows us to put improvements into practice to reduce the risk of harm to both patients and staff.

4. FMEA Why? Methodology that facilitates process improvement Focuses on prevention Improves safety It facilitates the Improvement Process by identifying possible failures and then allows improvements to be made. It is a proactive approach by focusing in prevention rather than reaction to adverse events after failures have occurred therefore improving safety for all. It facilitates the Improvement Process by identifying possible failures and then allows improvements to be made. It is a proactive approach by focusing in prevention rather than reaction to adverse events after failures have occurred therefore improving safety for all.

5. FMEA When? New process being designed New equipment developed or purchased Existing process being designed or redesigned To monitor and track improvement over time So when can we use FMEA� It is particularly useful in evaluating a new process prior to implementation. Read from slideSo when can we use FMEA� It is particularly useful in evaluating a new process prior to implementation. Read from slide

6. FMEA includes review of: Steps in the process Failure modes (What could go wrong?) Failure causes (Why would the failure happen?) Failure effects (What would be the consequences of each failure?)

7. What is a Failure Mode? A Failure Mode is: The way in which the component, product, or process could fail to perform its intended function Things that could go wrong So before we go on to look at each step in the process this explains in a little bit more detail as to what exactly is a failure mode�. As the slide states it is the way in which the system, process or product or piece of equipment could fail to perform its intended function. Simply the things that could go wrong! So before we go on to look at each step in the process this explains in a little bit more detail as to what exactly is a failure mode�. As the slide states it is the way in which the system, process or product or piece of equipment could fail to perform its intended function. Simply the things that could go wrong!

8. FMEA Process Step 1 - Select a process to evaluate Step 2 - Recruit a multidisciplinary Team Step 3 - Have the team meet to list all the steps in the process Step 1 � FMEA works best on processes that do not have too many subprocesses. For example instead of looking at FMEA for medicines mgt for the whole hospital we can break this down to look at FMEA for perhaps ordering, dispensing and administration processes. Step 2 � Be sure to include everyone � all relevant stakeholders in the process, however all may not need to be present for all the analysis Step 3 � Remember to number each step of the process being specific as possible, flow charting can be helpful to outline the steps iun the process. Step 1 � FMEA works best on processes that do not have too many subprocesses. For example instead of looking at FMEA for medicines mgt for the whole hospital we can break this down to look at FMEA for perhaps ordering, dispensing and administration processes. Step 2 � Be sure to include everyone � all relevant stakeholders in the process, however all may not need to be present for all the analysis Step 3 � Remember to number each step of the process being specific as possible, flow charting can be helpful to outline the steps iun the process.

9. FMEA Process Step 4 Have the team list failure modes and causes Step 5 For each failure mode have the team assign a numeric value (Risk Priority Number (RPN)) for likelihood of occurrence, likelihood of detection and severity. Step 4 � for each step in the process list all possible failure modes, anything that could go wrong. For each failure mode list the possible causes.Step 4 � for each step in the process list all possible failure modes, anything that could go wrong. For each failure mode list the possible causes.

10. Step 5 continued Likelihood of occurrence � How likely is it that the failure mode will occur? Likelihood of detection � If this failure mode occurs, how likely is it that the failure will be detected? Severity: if this failure mode occurs how likely is it that harm will occur? Assign score between 1 and 10, where 1 = very unlikely 10 = Very likely

11. FMEA Process Step 6 - Evaluate the results - Identify the failure modes with the top 10 highest RPNs. Step 7 - Use RPNs to plan improvement efforts Step 6 To calculate the RPN for each failure mode multiply the three scores obtained. The lowest score will be 1 and the highest 1000 Top 10 highest RPNs, these are the ones to be considered first as improvement opportunities. To calculate the RPN for the entire process, simply add up all of the individual RPNs fpr each failure mode. Step 7 � failure modes with the high RPNs are probably the most important parts of the process on which to focus improvements. Failure modes with low RPNs are not likely to affect the overall process very much. Step 6 To calculate the RPN for each failure mode multiply the three scores obtained. The lowest score will be 1 and the highest 1000 Top 10 highest RPNs, these are the ones to be considered first as improvement opportunities. To calculate the RPN for the entire process, simply add up all of the individual RPNs fpr each failure mode. Step 7 � failure modes with the high RPNs are probably the most important parts of the process on which to focus improvements. Failure modes with low RPNs are not likely to affect the overall process very much.

12. Key Elements and Benefits Review of process with all stakeholders �Safe� environment Identification of improvement opportunities Assessment of changes prior to testing Measurement to quantify improvement FMEA allows you to review your system or process with all the relevant stakeholders contributing to the process. As previously stated through a proactive approach a safety is enhanced for patients and staff. It allows you to predict potential harm, assessing changes to establish if they will make improvements to the process Through the assignment of RPNs we can quantify improvements by showing the reduction in numerical value of each RPN, for each failure mode therefore showing an overall reduction to the total RPN. This demonstrates that the process has lead to an improvement.FMEA allows you to review your system or process with all the relevant stakeholders contributing to the process. As previously stated through a proactive approach a safety is enhanced for patients and staff. It allows you to predict potential harm, assessing changes to establish if they will make improvements to the process Through the assignment of RPNs we can quantify improvements by showing the reduction in numerical value of each RPN, for each failure mode therefore showing an overall reduction to the total RPN. This demonstrates that the process has lead to an improvement.

13. http://www.ihi.org/ihi/workspace/tools/fame/

14. USE OF FMEA IN SPSP MEDICATION PROCESSES: DRUG ORDERING DRUG ADMINISTRATION DISPENSING e.g. RENAL DRUG ADMINISTRATION PROCESSES INSULIN DISPENSING SYSTEM