Failure Mode and Effect Analysis (FMEA

Presented to: [Date]

By (Insert Name)

• • • • •
What is FMEA? History of FMEA Risk Priority Numbers Process steps of a FMEA Discussion/Questions


FMEA is a team effort

• All Stakeholders in the process should be involved from the beginning • FMEA describes the prospective analysis of a process to ensure that: – “All” that could potentially go wrong with a process has been recognized,

– Actions are taken to prevent or mitigate failures

• • • • •
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.

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

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

10. Redesign process 11. Analyze and test the new process 12. Implement and monitor the redesigned process

Risk Priority Number (RPN)
• RPN is a quantitative measure to evaluate and assess the failure
– – –

• 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
– – –
1-10 ranking scale, 1-5 ranking scale depending on team preference Low number corresponds to low risk High number corresponds to high risk

Severity Rating Scale (1-10 Scale)
Rating 10 9 8 7 6 5 4 3 2 1 Description Extremely Dangerous Very Dangerous Definition Failure could injure the patient Failure could cause major or permanent injury

Dangerous Moderate Danger

Failure causes minor to moderate injury with a high degree of patient dissatisfaction Failure cause minor injury with some customer dissatisfaction

Low to Moderate Danger

Failure causes very minor or no injury but annoys customers

Slight Danger No Danger

Failure causes no injury and customer is unaware Failure causes no injury and has no impact on system

Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.

Occurrence Rating Scale (1-10 Scale)
Rating 10 9 Description Certain probability Failure is almost inevitable Potential Failure Rate Failure occurs at least once a day; or, failure occurs almost every time Failure occurs predictably; or, failure occurs every 3 or 4 days

8 7 6 5 4 3 2 1

Very high probability

Failure occurs frequently; or. Failure occurs about once per week

Moderately high probability

Failure occurs about once per month

Moderate probability

Failure occurs occasionally; or, failure occurs once every 3 months

Low probability Remote probability

Failure occurs rarely; or, failure occurs about once per year Failure almost never occurs; no one remembers last failure

Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.

Detection Rating Scale (1-10 Scale)
Rating 10 9 8 7 6 5 Description No chance of detection Very Remote/Unreliable Definition There is no known mechanism for detecting the failure The failure can be detected only with thorough inspection and this is not feasible or cannot be readily done The failure can be detected with manual inspection but no process is in place so that detection is left to chance 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 There is 100% inspection or review of the process but it is not automated There is 100% inspection of the process and it is automoated There are automatic “shut-offs” or constraints that prevent failure

Remote Moderate chance of detetion High

4 3 2 1

Very High Almost certain

Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.

Risk Priority Number (1-5 Scale)
1 2 3

Severity (S)
Failure did not reach pt. Failure reached pt. Failure requires monitoring Failure requires intervention Failure results in death

Occurrence (O)
1 failure per year 1 failure per quarter 1 failure per month

Detection (D)
100% of the time Almost always 75% of the time


1 failure per week

50% of the time


1 failure per day

Not 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

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.

Process FMEA Worksheet
Process Failure Mode and Effects Analysis Process: 1 Process Function/ Requirements 2 Potential Failure Mode 3 Potential Effect(s) of Failure Comments: 4 Potential Cause(s)/ Mechanism(s) of Failure 5 Current Process Controls 6 S 7 O 8 D 9 RPN 10 Recommended Corrective Action Sheet No.__of__

Process FMEA Worksheet
• • • • • • •
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

• • • •
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


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