1. Presented to: [Date] By (Insert Name) Failure Mode and Effect Analysis (FMEA)

2. Agenda What is FMEA? History of FMEA Risk Priority Numbers Process steps of a FMEA Discussion/Questions

3. FMEA FMEA is a team effort All Stakeholders in the process should be involved from the beginning Purpose: FMEA describes the prospective analysis of a process to ensure that: – “All” that could potentially go wrong with a process has been recognized, and – Actions are taken to prevent or mitigate failures

4. Evolution 1960’s: NASA moon program engineers devised a method of forecasting problems. 1970’s: Method becomes known as FMEA and is adopted by various quality organizations. 1980’s: With increased emphasis on quality, method spreads to large corporations. 1990’s: Large corporations are, in turn, pressing suppliers to adopt the method. 2000’s: Method is being applied elsewhere such as HealthCare.

5. Key Definitions Customer: persons and organizations that are affected by the process. Failure: any malfunction, defect or error that causes the process to not perform its intended function(s) or meet requirements satisfactorily. Failure Mode: the appearance, manner or form in which the process failure manifests itself. (Short circuit or handling damage) Cause(s) of the Failure: Possible mechanism(s) and/or way(s) in which the failure mode can be produced. Effect(s) of the Failure: the experience the customer encounters as a result of the failure mode

6. HealthCare Process FMEA Steps 1.Select a high-risk process and assemble a team. 2.Diagram the process. 3.Brainstorm potential failure modes 4.Estimate the severity of the failure 5.Estimate the probability of occurrence 6.Estimate the probability of detection 7.Calculate the risk priority number 8.Prioritize failure modes 9.Identify contributing factors of failure modes 10.Redesign process 11.Analyze and test the new process 12.Implement and monitor the redesigned process

7. Risk Priority Number (RPN) RPN is a quantitative measure to evaluate and assess the failure mode The RPN is comprised of the following three criteria: – S = Severity or seriousness of the failure mode – O = Probability of the occurrence of the failure mode – D = Probability that a potential failure will be detected before it can have any consequences The ranking system for each criterion is typically based on a linear scale: – 1-10 ranking scale, 1-5 ranking scale depending on team preference – Low number corresponds to low risk – High number corresponds to high risk

8. Severity Rating Scale (1-10 Scale) RatingDescriptionDefinition 10Extremely DangerousFailure could injure the patient 9898 Very DangerousFailure could cause major or permanent injury 7DangerousFailure causes minor to moderate injury with a high degree of patient dissatisfaction 6565 Moderate DangerFailure cause minor injury with some customer dissatisfaction 4343 Low to Moderate DangerFailure causes very minor or no injury but annoys customers 2Slight DangerFailure causes no injury and customer is unaware 1No DangerFailure causes no injury and has no impact on system Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.

9. Occurrence Rating Scale (1-10 Scale) RatingDescriptionPotential Failure Rate 10Certain probabilityFailure occurs at least once a day; or, failure occurs almost every time 9Failure is almost inevitableFailure occurs predictably; or, failure occurs every 3 or 4 days 8787 Very high probabilityFailure occurs frequently; or. Failure occurs about once per week 6565 Moderately high probabilityFailure occurs about once per month 4343 Moderate probabilityFailure occurs occasionally; or, failure occurs once every 3 months 2Low probabilityFailure occurs rarely; or, failure occurs about once per year 1Remote probabilityFailure almost never occurs; no one remembers last failure Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.

10. Detection Rating Scale (1-10 Scale) RatingDescriptionDefinition 10No chance of detectionThere is no known mechanism for detecting the failure 9898 Very Remote/UnreliableThe failure can be detected only with thorough inspection and this is not feasible or cannot be readily done 7676 RemoteThe failure can be detected with manual inspection but no process is in place so that detection is left to chance 5Moderate chance of detetion There is a process for double-checks or inspection but it is not automated an/or is applied only to a sample and/or relies on vigilance 4343 HighThere is 100% inspection or review of the process but it is not automated 2Very HighThere is 100% inspection of the process and it is automoated 1Almost certainThere are automatic “shut-offs” or constraints that prevent failure Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.

11. Risk Priority Number (1-5 Scale) RatingSeverity (S)Occurrence (O)Detection (D) 1Failure did not reach pt.1 failure per year100% of the time 2Failure reached pt.1 failure per quarterAlmost always 3Failure requires monitoring 1 failure per month75% of the time 4Failure requires intervention 1 failure per week50% of the time 5Failure results in death1 failure per dayNot detectable Severity: Assessment of the seriousness of the effect Occurrence: Estimation of likelihood that a failure will occur. Detection: How likely will the failure be detected

12. Risk Priority Number (RPN) RPN = Severity Rank x Occurrence Rank x Detection Rank The highest RPN’s and Occurrence Ranking should be given the first consideration for corrective actions. As a general rule, special attention should be given when the severity ranking is high, regardless of the resultant RPN.

13. Process FMEA Worksheet

14. Column 1: Provide a brief description of the process step. Column 2: Describe a failure mode, i.e., the manner in which the process step could potentially fail. Column 3: Describe effects of the failure mode on customers. Column 4: Describe failure mechanism and possible causes – Failure mechanism is the way in which the failure mode occurs – Failure causes are conditions that could produce the failure mode Column 5: Describe current ways failure is prevented or detected. Columns 6,7,8,& 9: Risk Priority Number Column 10: List of recommended corrective actions

15. Summary FMEA allows NMH to gain a deeper knowledge of the process. It increases awareness of the strengths and weaknesses of the process for all involved parties. It provides a basis for continuous improvement. Experience indicates that it is more cost-effective not to perform a FMEA at all than to produce a vague, half-hearted one. – Time and commitment are required – Effective and appropriate follow through are required

16. DISCUSSION / QUESTIONS