Failure Mode and Effects Analysis

(FMEA)
Dr. Syed Amir Iqbal
 FLOW DIAGRAM
STEP

STORE
MOVE
OPER
#

INSP.
1

5
PFMEA’s
6
POTENTIAL FMEA Number 1
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of

Item 2 Process Responsibility 3 Prepared By 4

Model Year(s)/Vehicle(s) 5 Key Date 6 FMEA Date (Orig.) 7

7 Core Team 8

S C O D R. Action Results 22
Process Function Potential Failure Potential Effect(s) E L Potential Cause(s)/ C E P. Recommended Responsibility Actions S O D R.
Requirements Mode of Failure V A Mechanism(s) of C Current Process Control T N. Action(s) & Target Taken E C O P.
9 10 11 12 S Failure U 16 E 18 19 Completion Date 21 V C T N.
S 14 R C 20
13 15
17

• “PICTURE” OF PROCESS JOB

• SHOWS FLOW OF PROCESS
• FOUNDATION FOR PFMEA,
CONTROL PLANS, TOOL CONTROL
LAYOUTS, WORK STATION PLAN
LAYOUTS, ET.
• LISTS EACH OPERATION
• CURRENT CONTROLS
• ENHANCED CONTROLS FROM RECOMMENDED
ACTIONS
INST JOB
• KPC's, KCC's PER OPERATION: RUC
TION
• INSPECTION FREQUENCY S

• GAGE & CHECKING DEVICES

• REACTION PLANS FOR NON-
CONFORMING PRODUCT
PER OPERATION:
• INSPECTION FREQUENCY
• GAGE & CHECKING DEVICES
• REACTION PLANS OF NON-
CONFORMING PRODUCT
 WHAT IS A FMEA?
The Failure Mode and Effect Analysis (FMEA) is a Prevention
Technique used to define, identify and eliminate potential
problems from a system, subsystem, component or a process.
• Focus on Prevention
• An assessment of Risk
– Safety
– Regulatory
– Customer Satisfaction
– Program
• Coordinated/Documented team effort
• A method to determine the need and priority of actions
 FAILURE MODES AND EFFECTS
ANALYSIS HISTORY…

• Initially developed in the 1940’s

• Used extensively in NASA Apollo Program in 1960’s
• Carried to other industries by displaced Apollo engineers
• Adopted by Ford engineering in the 1980’s
• Adopted by Automotive Industries Action Group (AIAG)
• Incorporated into GM GVDP and PPAP
 UNDERSTANDING FAILURE MODE
RELATIONS

• Every problem is preceded by the error and the source of the error
(cause).
• The cause is that which produces an incorrect action (something done
poorly) or an omission of a required action (something not done).

All problems have three components:

1. Frequency of occurrence of the cause.
2. The ability to detect (the problem / effect or error).
3. Severity (how the problem / effect affects the customer).
 Value of FMEA's
• Aids in improving designs for products and
process
– Increased safety
– Enhances Customer Satisfaction
• Better Quality
• Higher Reliability
• Contributes to cost savings
– Decreases warranty costs
– Decreases waste, non-value added operations
 Types of FMEAs ?
System/Concept “S/CFMEA”- (Driven by System functions) A
system is a organized set of parts or subsystems to accomplish one
or more functions. System FMEAs are typically very early, before
specific hardware has been determined.

Design “DFMEA”- (Driven by part or component functions) A

Design / Part is a unit of physical hardware that is considered a
single replaceable part with respect to repair. Design FMEAs are
typically done later in the development process when specific
hardware has been determined.

Process “PFMEA”- (Driven by process functions & part

characteristics) A Process is a sequence of tasks that is
organized to produce a product or provide a service. A
Process FMEA can involve fabrication, assembly, transactions
or services.
7
 Types of FMEAs ?
System/Concept “S/CFMEA”- (Driven by System functions) A
system is a organized set of parts or subsystems to accomplish one
or more functions. System FMEAs are typically very early, before
specific hardware has been determined.

Design “DFMEA”- (Driven by part or component functions) A

Design / Part is a unit of physical hardware that is considered a
single replaceable part with respect to repair. Design FMEAs are
typically done later in the development process when specific
hardware has been determined.

Process “PFMEA”- (Driven by process functions & part

characteristics) A Process is a sequence of tasks that is
organized to produce a product or provide a service. A
Process FMEA can involve fabrication, assembly, transactions
or services.
8
 IMPORTANCE OF PFMEA's
• Systematic Method to Analyze a Process
• The Process Potential FMEA:
– Identifies potential product related process failure modes
– Assesses the potential customer effects of the failures
– Identifies the potential manufacturing or assembly process
causes and identifies process variables on which to focus
controls for occurrence reduction or detection of the failure
conditions
– Develops a ranked list of potential failure modes, thus
establishing a priority system for corrective action considerations
– Documents the results of the manufacturing or assembly
process
 PFMEA
Three Parts:
– Process Flow Diagram (PFD)
– Process Failure Mode and Effects Analysis (PFMEA)
– Process Control Plan (PCP)
 PFMEA's
• Focus is on potential process –related Failures and their
causes.
– Main drive is to understand the process through the identification of
as many potential failures as possible.
• e.g. Incorrect material used
• PFMEA typically assumes that the design is sound.
• Development of Recommended Actions is targeted at
eliminating the Root Cause of the potential failures
Information Flow
OVERVIEW OF THE FMEA PROCESS
• Define the scope of the study.
– Scope Definition Worksheet
• Select the FMEA team.
• Team Start-Up.
– Team Start-Up Worksheet.
• Review Design Intent / Process Function and the
process (PFMEA) or product (DFMEA) to be studied.
– MRD
– Process: Flowchart or Traveler
– Product: Blueprint or Schematic
OVERVIEW OF THE FMEA PROCESS
• Identify all failure modes & the corresponding effects.
• Rate the relative risk of each failure mode and effect.
– Severity
• Identify all potential causes
• Rate the relative risk of each cause.
– Occurrence
• Identify all current design/process controls to prevent/detect the failure mode.
• Rate the relative risk of all controls.
– Detection/Prevention
• Prioritize for action.
– Calculate the RPN (risk priority number).
– Use the Pareto Principle.
• Take action.
• Calculate the resulting RPN.
 The FMEA Team Roles
Champion
Champion //Sponsor
Sponsor
Provides resources & support
Provides resources & support
Attends
Attendssome
somemeetings
meetings
Promotes
Promotes teamefforts
team efforts
Shares
Shares authority / powerwith
authority / power withteam
team
Kicks
Kicksoff
offteam
team
Implements
Implementsrecommendations
recommendations

FMEA
FMEACore
CoreTeam
Team Facilitator
Team Leader 44––66Members “Watchdog“ of the process
“Watchdog” of the project Members
Good leadership skills Keeps team on track
Expertise
ExpertiseininProduct
Product//Process
Process FMEA Process expertise
Respected & relaxed Cross
Leads but doesn’t dominate Crossfunctional
functional Encourages / develops team dynami
Honest
HonestCommunication
Communication Communicates assertively
Maintains full team participation Active
Typically lead engineer Activeparticipation
participation Ensures everyone participates
Positive
Positiveattitude
attitude
Respects
Respects otheropinions
other opinions
Participates
Participatesininteam
teamdecisions
decisions

Recorder
Recorder
Keeps documentation of teams efforts
Keeps documentation of teams efforts
FMEA
FMEAchart
chartkeeper
keeper
Coordinates
Coordinates meetingrooms/time
meeting rooms/time
Distributes
Distributesmeeting
meetingrooms
rooms&&agendas
agendas
15
 A
Process
Flow
for
FMEA
 Timing
• One of the most important factors for the
successful implementation of an FMEA
program is timeliness.
• It is meant to be a “before-the-event” action,
not an “after-the-fact” exercise.
• Actions resulting from an FMEA can reduce or
eliminate the chance of implementing a change
that would create an even larger concern.
 PFMEA Scope Worksheet
• Product: Date:
• Scope Defined by:
Part 1: What process components are to be included in the
investigation?
Part 2: Who is the customer?
Part 3: What process support systems are to be included in the study?
Part 4: To what extent should input materials be studied during the
investigation?
Part 5: What are the product/process requirements & constraints?
Part 6: Should packaging, storage, and transit be considered part of this
study?
 PFMEA - Assumptions

• The design is valid

• Failures can but will not necessarily occur

• All incoming product is to design specifications

• Design failures are covered as part of the
design FMEA.
PFMEA – Process Steps
PFMEA - Benefits
 Process FMEA
• It is initiated by a member from the Operations
or Engineering.
• Representatives from Design, Assembly,
Manufacturing,
• Materials, Quality, Service and the Area
Responsible for the next assembly should be
involved.
• The Process FMEA assumes the product/process
as designed will meet the design intent.
 Design Intent and Process Function

Defines the function of the product or the

process
– Name of item or system
– Function of item per design intent
 Potential Failures
D) Manner in which a component, subsystem
or system could fail to meet design intent
(P) Manner in which the process could fail to
meet the process requirements and/or design
intent
• Using this definition a failure does not need to
be readily detectable by a customer to still be
considered a failure.
 Types of Questions to Ask
• How can the process/part fail to meet
specifications/requirements?
• Regardless of the engineering /requirement
specs., what would the customer consider
objectionable?
• When this operation is being done, what could
go wrong? Or, what tends to go wrong?
 Potential Effects

Determine the effects of potential failures.

• Effects of the failure mode on the customer
(internal or external)
 Severity Ranking
• Rating of 1 to 10 with 10 being the most
severe impact.
– Use a scale.
– Use the same scale throughout.
• To assign this rating, must assume the failure
mode has occurred.
• Assign severity rating for every possible effect.
– May have to estimate rating.
 Process Severity Evaluation Criteria
Effect Severity of effect Ranking
Hazardous, without warning May endanger personnel. Involves non-compliance with 10
gov’t. regulation without warning.
Hazardous, with warning Same as above only with warning 9
Very High Major disruption to production line; 100% of 8
product scrapped
High Minor disruption to production line; customer 7
dissatisfied
Moderate Product operable; not cosmetically satisfactory 6
Low 100% of product may have to be reworked; some 5
customer dissatisfaction
Very Low Fit/finish defects noticed by most customers 4
Minor Same as above, but, defect noticed by average 3
customer
Very Minor Same as above, but, defect noticed only by the 2
discriminating customer
None No effect 1
 Classification
This column may be used to classify any special
product characteristics (e.g., critical, key, major,
significant) for components, subsystems, or
systems that may require additional design or
process controls.
 Potential Causes
What are the potential causes of the failure mode?
A cause and effect (fishbone) diagram may be
helpful here.

(D) An indication of a design weakness resulting in

the failure mode
(P) How the failure could occur
– Typical failure causes: Improper torque, Inadequate
gating, inadequate or no lubrication, part mis-located
 Occurrence Ranking
• How often will each cause occur?
– Ignore the severity of the effect and any possibility
that it will be detected.
– Rating on a 1 to 10 scale with 10 being the most
frequent.
• Define root causes of each failure mode
• Use data where possible
– Customer complaints.
– Defect analysis.
Occurrence Evaluation Criteria
 Current Controls
• What are the current design or process
controls to prevent or detect the potential
failure mode?
• Prevention of cause of failure mode or
reduction in occurrence.
• Detection of cause of failure mode leading to
Corrective Actions
 Detection / Prevention Rating
• The assessment of the ability of the
“design/process controls” to identify a
potential cause or design weakness before the
component or system is released for
production/shipped to the customer.
• Rate the Detection from 1 to 10 with 10 being
no chance of detecting the failure mode or its
effect(s).
 DETECTION (D) Evaluation Criteria
Detection Criteria: Likelihood of DETECTION by Design Control Ranking
Absolute Design Control will not and/or can not detect a potential 10
Uncertainty cause/mechanism and subsequent failure mode; or there is no Design
Control
Very Remote Very remote chance the Design Control will detect a potential 9
cause/mechanism and subsequent failure mode.
Remote Remote chance the Design Control will detect a potential 8
cause/mechanism and subsequent failure mode.
Very Low Very low chance the Design Control will detect a potential 7
cause/mechanism and subsequent failure mode.
Low Low chance the Design Control will detect a potential 6
cause/mechanism and subsequent failure mode.
Moderate Moderate chance the Design Control will detect a potential 5
cause/mechanism and subsequent failure mode.
Moderately Moderately high chance the Design Control will detect a potential 4
High cause/mechanism and subsequent failure mode.
High High chance the Design Control will detect a potential 3
cause/mechanism and subsequent failure mode.
Very High Very high chance the Design Control will detect a potential 2
cause/mechanism and subsequent failure mode.
Almost Design Control will almost certainly detect a potential 1
Certain cause/mechanism and subsequent failure mode.
Process Detection Evaluation Criteria
 Risk Assessment
Severity
• The impact(s) of failure
Occurrence
• The likelihood of a failure occurrence from an
identified cause under current controls
Detection
• How detectable is the failure at any point?
 Risk Priority Number (RPN)
• Severity
1 10
none hazardous
• Occurrence
1 10
remote very high frequency
• Detection
1 10
very detectable extremely undetectable
RPN = S X O X D
Why do we need to calculate the RPN’s?

By giving every Failure Mode a RPN rating, we

can now prioritize which failure modes to
address now and which failure modes we
address later.
 REDUCING THE POTENTIAL RISK:
First line of defense -
– Eliminate causes of failure so that it does not
OCCUR - Implement prevention techniques
Second line of defense -
– Reduce probability of OCCURRENCE
Third line of defense -
– Improve DETECTION of the failure
 Priority for Action
• Involve Management to assign resources
(human/financial) for action items to reduce the RPN.
• Create a What, Who, How and When Matrix in order to
monitor action items.
• The FMEA Team Leader will check the status of the FMEA
follow-up and schedule review meetings as necessary.
• Re-calculate the RPN as action items are completed and
validated. Calculate savings ($$$) if possible based on the
reduction of the potential risk.
FMEA IS A “LIVING” DOCUMENT!!!
 Disagreements on Ratings?
• Use data where possible.
• Try to come to consensus.
• If consensus fails:
– Team may elect to defer to one of its members.
– Average individual ratings.
– Only average if ratings are close (spread of 2 or 3
points maximum).
– Get the process expert involved.
 FMEA – Reduce Future Liability
• FMEA can be a legal document
• Courts can take a favorable view of the liability
if proper FMEA was conducted and risks were
analyzed/acted upon
• Punitive damages can be eliminated and/or
reduced
 FMEA Pitfalls – A review
• Cross-functionality of the Team
• Leadership of the Team
• Scope Definition
• Data Availability
• NO Customer Involvement
• Meeting Management problems
• S,O,D criteria decisions (too long!)
• No supplier involvement
• Committed resources
• Management Commitment & Support
 In Conclusion
• FMEA does take time and effort
• It does reduce the risk to your customer
• It does reduce the risk to you
• It does save time to product launch
• It does help with Continuous Improvement