Failure Mode Effets

Analysis (FMEA)

Joven Botin Bilbao, MAN

Chief Nursing Officer- Al Hayat National Hospital
Corporate Accreditation and Clinical Educator–Al Inma Medical
Services
Learning Objectives

By the end of this module participants should be able to:

• Identify the definition of Failure Mode And Effects
Analysis (FMEA)
• Describe how to apply FMEA in the procedure of design,
process, and project.
• Identify the terminology of failure mode, effect and cause,
severity, occurrence, detection, and current controls.
• Select the appropriate methods and strategies to apply Failure
Mode And Effects Analysis (FMEA) in the hospital nurse unit.
• Develop a completed FMEA using Risk Priority Numbers (RPNs)
in the hospital nurse unit.
What Is an FMEA?

• A structured approach to:

–Identify the ways in which a product or process can fail
–Estimate the risk associated with specific causes
–Prioritize the actions that should be taken to reduce the
risk
• A Process FMEA will:
–Capture the entire process and the key inputs
–Identify ways the product or process can fail because of
these key inputs
–Facilitate the documentation of a plan to prevent those
failures
Applications For FMEA

 Design:
Used to analyze product designs before they are released to production.
A DFMEA should always be completed well in advance of a prototype
build. Focuses on product function.
 Process:
Used to analyze manufacturing, assembly, or any other processes.
Focuses on process inputs. This is the topic for this module.
 Project:
Documents and addresses failures that could happen during a major
program
KEY SOURCE MATERIAL FOR AN FMEA

Process Map

FMEA
The FMEA Form - The Analysis Section

Process Potential Potential S O D R Action

Potential Current Section
Step/ Failure Failure E C E P
Causes Controls
The FMEA Form
Input Mode Effects V C T N 
The Analysis Section
What is the 0 0 0 0
How can
Effect on the this be If risk is too
Outputs?
0 0
found?
0 0 high, what
What can can be
go wrong 0
What are 0 0 0
done?
with the the
0 0 0 0
Process Potential
Step? 0 Causes? 0 0 0

What is
the How How often is the How well can Estimated
Process serious is cause likely to we detect a risk is “Sev” x
Step such an occur and result cause before it “Occ” x “Det”
Effect? in a Failure creates a
Mode? Failure Mode
and Effect?
 Definition Of Terms – Failure Mode

Failure Mode: The way in which a specific process input fails

 If it is not detected and either corrected or removed, it may
cause a negative “Effect” to occur
 Can be associated with a defect (in discrete manufacturing)
or a process input variable that goes outside of specification
 Anything that an operator can see that’s wrong is considered a Failure
Mode
 Note 1: Just because a dimension is out of spec (a Failure Mode), it
does not imply with 100% certainty that the product will not function
(an effect)
 Note 2: Just because the process is improperly setup (a failure
cause), it does not imply with 100% certainty that the dimension will
be out of spec (a Failure Mode)
 Definition Of Terms – Effect And Cause

 Effect: The adverse impact on customer requirements.

Generally has an external customer focus, but can also include
downstream processes.
–A product or process that does not perform satisfactorily to
design
 Cause: Whatever causes the Failure Mode to occur.
How a specific part of the process (operation or component) can
cause a Failure Mode.
–A worn spindle (cause) may cause a dimension to be out of
tolerance (mode) which may cause the part to not fit (effect)
 Definition Of Terms –
Severity, Occurrence, And Detection

 Severity: An assessment of how serious the Failure Effect (due

to the Failure Mode) is to the customer
 Occurrence: An assessment of the likelihood that a particular
Cause will happen and result in the Failure Mode
 Detection: An assessment of the likelihood that the current
controls will detect the Cause of the Failure Mode or the Failure
Mode itself, should it occur, thus preventing the Failure Effect
from reaching your customer. The customer in this case could
be the next operation, subsequent operations, or the end user
 Definition Of Terms – Current Controls

 Current Controls: Systematized methods/devices in place to

prevent or detect failure Modes or Causes (before causing
effects)
 Prevention-based controls may include Mistake Proofing,
automated controls, setup verifications, Preventive
Maintenance, and Control Charts
 Detection-based controls may include audits, checklists,
inspection, laboratory testing, and Control Charts
 Rating Definitions Typical Scales

Severity
Severity Occurrence
Occurrence Detection
Detection
Rating
High 10 Hazardous without warning Very high and almost Cannot detect
inevitable

Loss of primary function High repeated failures Low chance of

detection

Loss of secondary function Moderate failures Moderate chance of

detection

Minor effect Occasional failures Good chance of

detection

No effect Failure unlikely Almost certain

detection
Low 1

Note : Determine if your company has rating scales and rules.

In some companies, rating a “10” on severity may have legal consequences.
 Risk Priority Number (RPN)

 A key output of an FMEA is the “Risk Priority Number”

 The RPN is a calculated number based on information you
provide regarding:
 The likelihood of potential causes of Failure Modes
 The seriousness of the resulting effects
 The current ability of the process to detect the causes of the
Failure Modes before they cause an effect to reach a customer
 It is calculated as the product of three (3) ratings, each one
related to the severity, frequency, and detect ability

RPN = Severity x Occurrence x Detection

Regardless of RPN, high severity scores should be given special attention.
 Risk Priority Numbers (2)

 The Risk Priority Number need not be limited to

Severity, Occurrence, and Detection.
Some examples:
 Add an “Impact” score to estimate the overall impact of the
Failure Mode on the process (10 = high, 1 = low)
 Add an “EHS” rating to a project FMEA to incorporate
possible environmental impact (10 = high, 1 = low)
 Add an “EOC” or Ease Of Completion (10 = easy, 1= hard) to
help prioritize/focus projects
 Comments On Detection Scores

Low Det Score High Det Score

Virtually Virtually
certain no
Prevention Prevention

Cause Failure Mode Effect

(Defect)

 High detection scores imply that we will not easily catch the existence of a Failure Cause
until after the resulting Failure Mode creates a Failure Effect. Usually, this means that
we detect the effect at the end of the line or, even worse, our customer finds it.
 A very low detection score generally implies that you catch the cause before it creates
the Failure Mode.
 FMEA Model

Cause
Cause Mode
Mode Effect
Effect

Faculty inverter Agitator too slow Extractable too high

High particle Pits Internal opens on
count printed circuit in
clean room
Temp controller Temp too high of Conversion rate too
out calibration low
Drill not properly Hole not drilled Part will not
sharpened assemble straight
Part not clamped Hole not drilled Part will not
square in fixture assemble straight
Drill not properly Hole not drilled Part will not
sharpened assemble to proper
diameter
Linking Failure Modes To Effects Note:
The Last Three (3) Examples On Prior Slide

Failure Mode 1 Effect 1

Failure Mode 2 Effect 2

Effect 1
Failure Mode 1
Effect 2

Failure Mode 1
Effect 1
Failure Mode 2

Note that the relationship between the Failure Mode

and the Effect is not always 1-to-1.
 A Second Look At The Analysis Section
File: FMEA_Form.XLS
Process/Product - FMEA
Failure Modes and Effects Analysis

Process or
Product Prepared by: Page ____ of ____
Name:
Responsible: FMEA Date (Orig) ______________ (Rev) _____________

Key S O D R
Potential Failure Potential Failure
Process Step Process E Potential Causes C Current Controls E P
Mode Effects
Input V C T N

FM occur?

cause or FM?
Sev x Occ x Det
to the customer?

How well can you detect

How often does cause or
How Severe is the effect
What is the What is the In what ways What is the impact What causes the What are the existing
process step Key does the Key on the Key Output Key Input to go controls and procedures
Process Input go wrong? Variables (Customer wrong? (inspection and test) that
Input? Requirements) or prevent either the cause
internal or the Failure Mode?
requirements? Should include an SOP
number.

0
The FMEA Form
The Action Section

Analysis S O R
R Actions D
Section Actions E
P Responsibility Taken C E P
Recommended
 N V C T N
What are the actions for Who is What are the
Original RPN

Revised SEV

Revised OCC

Revised DET

Revised RPN
reducing the Severity or Responsible completed actions
Occurrence, or for the taken with the
improving Detection? recommended recalculated RPN?
Should have actions action? Be sure to include
only on high RPNs or completion
easy fixes. month/year.
 9 Strategies To Complete An FMEA

1. For each Process Input, determine the ways in which the Process
Step can go wrong (Failure Modes)
2. For each Failure Mode associated with the inputs, determine
Effects
3. Identify potential Causes of each Failure Mode
4. List the Current Controls for each Cause
5. Assign Severity, Occurrence, and Detection ratings to each Cause
6. Calculate RPN
7. Determine Recommended Actions to reduce High RPNs
8. Take appropriate actions and document
9. Recalculate RPNs
Getting Started

 Utilize Process Maps, C&E Diagrams, C&E Matrices, data collection,

warranty analysis, testing, and other pertinent information
 Select people from functions both upstream and downstream from the
process under analysis
– Engineering
– Manufacturing
– Maintenance
– Tooling
– Quality Assurance
– Marketing
– Suppliers
– Health, Safety, and Environment (HSE)
 Practical Tips for FMEA

 Do not try FMEA alone, it is a group activity

 FMEA, done right, may be a time consuming process
 Activities are required for completion, it is not just a paperwork
activity
 The team will likely need training and coaching
 Prepare properly for meetings
 Summarize often
 Make sure voting is independent (suggest anonymous ballots)
 Negotiate issues
Summary
 Failure modes and effects analysis (FMEA) is a step-by-step
approach for identifying all possible failures in a design, a
manufacturing or assembly process, or a product or
service.
 A key output of an FMEA is the “Risk Priority Number.”
You