Failure Mode and Effect Analysis (FMEA)

Presented to:

[Date]

By (Insert Name)
 Agenda

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

 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.
 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. 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
 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
 Severity Rating Scale (1-10 Scale)
Rating Description Definition
10 Extremely Dangerous Failure could injure the patient

9 Very Dangerous Failure could cause major or permanent injury

8

7 Dangerous Failure causes minor to moderate injury with a high degree of patient
dissatisfaction
6 Moderate Danger Failure cause minor injury with some customer dissatisfaction
5

4 Low to Moderate Danger Failure causes very minor or no injury but annoys customers
3

2 Slight Danger Failure causes no injury and customer is unaware

1 No Danger 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 Description Potential Failure Rate

10 Certain probability Failure occurs at least once a day; or, failure occurs almost every time

9 Failure is almost inevitable Failure occurs predictably; or, failure occurs every 3 or 4 days

8 Very high probability Failure occurs frequently; or. Failure occurs about once per week
7

6 Moderately high probability Failure occurs about once per month

5

4 Moderate probability Failure occurs occasionally; or, failure occurs once every 3 months
3

2 Low probability Failure occurs rarely; or, failure occurs about once per year

1 Remote probability 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 Description Definition
10 No chance of detection There is no known mechanism for detecting the failure

9 Very Remote/Unreliable The failure can be detected only with thorough inspection and this is
8 not feasible or cannot be readily done

7 Remote The failure can be detected with manual inspection but no process is in
6 place so that detection is left to chance

5 Moderate chance of There is a process for double-checks or inspection but it is not

detetion automated an/or is applied only to a sample and/or relies on vigilance

4 High There is 100% inspection or review of the process but it is not

3 automated

2 Very High There is 100% inspection of the process and it is automoated

1 Almost certain There are automatic “shut-offs” or constraints that prevent failure

Adapted from: The Basics of FMEA, Productivity, Inc. Copyright 1996 Resource Engineering, Inc.
 Risk Priority Number (1-5 Scale)
Rating Severity (S) Occurrence (O) Detection (D)
1 Failure did not reach pt. 1 failure per year 100% of the time

2 Failure reached pt. 1 failure per quarter Almost always

3 Failure requires 1 failure per month 75% of the time

monitoring

4 Failure requires 1 failure per week 50% of the time

intervention

5 Failure results in death 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 Sheet No.__of__
Process: Comments:

1 2 3 4 5 6 7 8 9 10
Process Potential Potential Effect(s) Potential Cause(s)/ Current Process Recommended
Function/ Failure of Failure Mechanism(s) Controls Corrective
Requirements Mode of Failure S O D RPN Action
 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
 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
DISCUSSION / QUESTIONS