Defining The Problem - Fmea

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 8

Very Dangerous

Failure could cause major or permanent injury

7

Dangerous

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

6 5

Moderate Danger

Failure cause minor injury with some customer dissatisfaction

4 3

Low to Moderate Danger

Failure causes very minor or no injury but annoys customers

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 7

Very high probability

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

6 5

Moderately high probability

Failure occurs about once per month

4 3

Moderate probability

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

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 8

Very Remote/Unreliable

The failure can be detected only with thorough inspection and this is not feasible or cannot be readily done

7 6

Remote

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

5

Moderate 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

4 3

High

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

1 failure per month

75% of the time

4

Failure requires intervention

1 failure per week

50% of the time

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 Process: 1 Process Function/ Requirements

Sheet No.__of__ Comments:

2 Potential Failure Mode

3 Potential Effect(s) of Failure

4 Potential Cause(s)/ Mechanism(s) of Failure

5 Current Process Controls

6

7

8

9

S

O

D

RPN

10 Recommended Corrective 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 provides a basis for continuous improvement.

It increases awareness of the strengths and weaknesses of the process for all involved parties. 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