FMEA.pdf

CORE TOOL TRAINING:
1. APQP
2. FMEA
3. PPAP
& COMPETENCY ASSESSMENT
Presented by
ABDUL RASHID HM

Course objective
• Understanding the FMEA
• SOD and its calculation
• RPN & continous improvement
• Reviewing current issue

Failure Mode And Effects Analysis

History of FMEA
1993 - US Automotive incorporate
FMEA as part as QS-9000 compliant
1949 - Developed by US Military
(MIL - STD - 1629A)
1970 - Ford Motor Company to introduced
FMEA in their production process
1960 - Adopted to aerospace industry during
APPOLLO mission

Failure Mode & Effects Analysis
“Thinking is the hardest work there is
which is probably why so few engage in it”
Henry Ford

Failure Mode
Manner in which a product does not meet customer
requirements
Effects Analysis
Study of the effects of failure on fit for usefulness

WHAT IS FMEA
• An analytical methodology used
to ensure that potential
problems has been addressed
and considered throughout the
product and process
development (APQP)

IATF 16949
Continuous
Improvement
Problem
Prevention

Other Risk Assessment Techniques
◼ Hazard and Operability Study (HAZOP).
◼ Hazard Analysis Critical Control Points (HACCP)
◼ Aspect And Impact - ISO 14000
◼ Hazard Analysis - OHSAS 18000
◼ Fault Tree Analysis (FTA)
◼ Process Decision Program Chart (PDPC)

What are a FMEA’s goals
• To increase the quality of the design or process
by systematically eliminating its potential failure
modes
• Satisfy its customerS who can be:
– END USER
– OEM ASSEMBLY
– SUPPLY CHAIN MANUFACTURING
– REGULATORS

Benefit of FMEA
◼ Identifying and reducing potential
problem before they occur.
◼ Reducing the likelihood of
Customer Complaints
◼ Reducing the possibility of safety
failures
◼ Reducing the possibility of
reliability failure
◼ Reducing the likelihood of Product
Liability claims

When FMEA will be generated
◼ New design/process or new technology.
Scope: the complete design/process
◼ Modification to existing design (assumes there is
a FMEA for existing design)
Scope: focus on modification to design process,
possible interactions due to the interaction and
field history.
◼ Use of existing design/process in a new
environment, location or application.
Scope: the impact of the new environment or
location on the existing design.

TEAM EFFORT
All effected areas shall actively involve:
Shall be developed by multidisciplinary team such as:
 Design Engineer
 QC Engineer
 Maintenance Engineer
 Manufacturing Engineer
 Higher or lower assembly/ process
DFMEA should be catalyst to stimulate the interchange of ideas

Limitation of DFMEA
◼ Time consuming
◼ Tedious
◼ Lack of Resources
◼ “Before-the-event”
◼ No action is taken
◼ Not following the disciplines.
◼ Require high product knowledge
◼ FMEA team composition

4.4.1.2 Product Safety
15
The organization shall have documented processes for the
management of product-safety related products and
manufacturing processes, which shall include but not limited to
the following, where applicable:
a) Identification by the organization of statutory and
regulatory product-safety requirements
b) Customer notification of requirements in item a)
c) Special approval for design FMEA
d) Identification of product safety-related characteristics
e) Identification and controls of safety-related
characteristics of product and at the point of manufacture
f) Special approval of control plan and FMEAs
g) Reaction plan

6.1.2.1 Risk analysis
16
The organization shall include in its risk analysis at a minimum,
lesson learned from product recalls, product audits, field returns
and repairs, complaints, scraps and rework.
The organization shall retain documented information as
evidence of the results of risk analysis.

17
Shall use multidisciplinary approach to establish, document and
implement processes to identify SC and shall include the
following:
a) Documentation of all SC in the drawing, risk analysis(such as
FMEA), control plan and Standard Work Instruction; SC are
identified with specific markings and are cascaded through
each of these documents,
b) Development of control and monitoring strategies for SC
c) Customer-specified approval, when required
d) Compliance with Customer specified definition or symbols or
the organization’s equivalent symbols, as defined in a symbol
conversion table. The table shall be submitted to customer,if
required.
8.3.3.3 Special characteristics

18
Shall include but not limited to the following, as applicable:
a) Design risk analysis (DFMEA)
b) Reliability study analysis
c) Product special characteristics
d) Results of product design error-proofing, such as DFSS, DFMA
and FTA
e) Product definition including 3D models, technical data,
product manufacturing information and GD&T
f) 2D drawings, product manufacturing information and GD&T
g) Product design review result
h) Service diagnostic guidelines and repair and serviceability
instructions
i) Service part requirements
j) Packaging and labelling requirements for shipping
8.3.5.1 Design and development outputs -
supplemental

19
Shall include but not limited to the following, as applicable:
a) Specification and drawing
b) Special characteristics for product and manufacturing process
c) Identification of process input variables that impact characteristics
d) Tooling and equipment for production and control, including capability
studies of equipment and processes
e) Manufacturing process flow
f) Capacity analysis
g) Manufacturing process FMEA
h) Maintenance plans and instruction
i) Control plan
j) Standard work and work instruction
k) Process approval acceptance criteria
l) Data for quality, reliability, maintainability and measurability
m) Results of error-proofing identification and verification as appropriate
n) Method of rapid detection, feedback and correction of
product/manufacturing nonconformities
8.3.5.2 Manufacturing process design outputs

20
Shall identify, document, and maintain a list of the process controls,
including inspection measuring, test, and error-proofing devices, that
includes the primary process control and the approved back-up of
alternate methods.
Shall document the process that manages the use of alternate control
methods. The organization shall include in this process, based on risk
analysis (such as FMEA), severity, and the internal approvals to be
obtained prior to production implementation of the alternate control
method.
Before shipping product that was inspected or tested using the
alternate method, if required, the organization shall obtain approval
from the customer(s). The organization shall maintain and periodically
review a list of approval alternate process control methods that are
referenced in the control plan.
8.5.6.1.1 Temporary change of process
controls

8.7 Control of nonconforming outputs
8.7.1.4 Control of rework product
Shall utilize risk analysis (such as FMEA) methodology to assess risk in the rework
process prior to a decision to rework the product. If required by customer, the
organization shall obtain approval from the customer prior to commencing
rework of the product.
Shall have a documented process for rework confirmation in accordance with the
control plan or other relevant documented information to verify compliance to
original specifications.
Instructions for disassembly or rework, including re-inspection and traceability
requirements, shall be accessible to and utilization by the appropriate personnel.
Shall retain documented information on the disposition o reworked product
including quantity, disposition, disposition date, and applicable traceability
information

8.7 Control of nonconforming outputs
8.7.1.5 Control of repaired product
Shall utilize risk analysis (such as FMEA) methodology to assess risk in the repaired
process prior to a decision to repaired the product. The organization shall obtain
approval from the customer before commencing repair of the product.
Shall have a documented process for repair conformation in accordance with the
control plan or other relevant documented information.
Instruction for disassembly or repair, including re-inspection and traceability
requirements, shall be accessible to and utilized by the appropriate personnel.
Shall obtain a documented customer authorization for concession for the product to
be repaired.
Shall retain documented information on the disposition of repaired product including
quantity, disposition, disposition date, and applicable traceability information.

Shall maintain manufacturing process capability or performance results as
specified by the customer’s part approval process requirements. The
organization shall verify that the process flow diagram, FMEA, and control
plan are implemented, including adherence to the following:
a) Measurement techniques
b) Sampling plans;
c) Acceptance criteria;
d) Records of actual measurement values and/or test results for variable
date
e) Reaction plan and escalation process when acceptance criteria are not
met.
9.1 MONITORING, MEASUREMENT, ANALYSIS & EVALUATION
9.1.1.1 Monitoring and measurement of manufacturing
process (cont’)
23

9.3 Management Review
24
9.3.2.1 Management review inputs - supplemental
a) Cost of poor quality (cost of internal and external nonconformance;
b) Measures of process effectiveness;
c) Measures of process efficiency;
d) Product performance;
e) Assessments of manufacturing feasibility made for changes to existing operations and for
new facilities or new product (see section 7.1.3.1);
f) Customer satisfaction (see ISO 9001, section 9.1.2);
g) Review of performance against maintenance objectives;
h) Warranty performance (where applicable);
i) Review of customer scorecards (where applicable);
j) Identification of potential field failures identified through risk analysis (such as FMEA);
k) Actual field failures and their impact on safety or the environment.

10.2 Nonconformity and Corrective Action
25
10.2.3 Problem Solving
a) Defined approaches for various types and scales of problems (e.g., new
product development, current manufacturing issues, field failures, audit
findings);
b) Containment, interim actions, and related activities necessary for
control of nonconforming outputs (see ISO 9001, Section 8.7);
c) Root cause analysis, methodology used, analysis, and results;
d) Implementation of systemic correction actions, including consideration
of the impact on similar processes and products;
e) Verification of the effectiveness of implemented corrective actions;
f) Reviewing and , where necessary, updating the appropriate
documented information (e.g., PFMEA, control plan)
Where the customer has specified presubscribed processes, tools, or
systems unless otherwise approved by the customer.

10.2 Nonconformity and Corrective Action
26
10.2.4 Error-proofing
He organization shall have a documented process to determine
the use of appropriate error-proofing methodologies. Details of
the method used shall be documented in the process risk
analysis (such as PFMEA) and test frequencies shall be
documented in the control plan.
The process shall include the testing of error-proofing devices
for failure or simulated failure. Records shall be maintained.
Challenge parts, when used, shall be identified, controlled,
verified, and calibrated where feasible. Error-proofing device
failures shall have a reaction plan.

Shall have a documented process for continual improvement. The
organization shall include in this process the following:
a) Identification of the methodology used, objectives, measurement,
effectiveness, and documented information;
b) A manufacturing process improvement action plan with emphasis on
the reduction of process variation and waste;
c) Risk analysis (such as FMEA).
NOTE Continual improvement is implemented once manufacturing
processes are statistically capable and stable or when product
characteristics are predictable and meet customer requirements.
10.3 Continual improvement
10.3.1 Contnual improvement - supplement
27

What are
the Functions,
Features or
Requirements ?
What can go wrong ?
- No Function
- Partial/ Over/
Degraded Function
- Intermittent
Function
- Unintended Function
What are
Effect (s) ?
How bad
is it ?
What are
the
Cause (s)
?
How often
does it
happen?
How can this
be prevented
and detected ?
How good is
this method
at detecting
it ?
What can be
done ?
- Design
Changes
- Process
Changes
- Special
Controls
- Changes to
Standards,
Procedures or
Guides

APQP Five Phase Process
Plan And Define Program
Product Design and Development
Process Design and Development
Product and Process Validation
Production
Feedback Assessment and Corrective Action
Pilot Launch
Concept
Initiation/Approval
Program
Approval
Prototype
Planning
DESIGN
FMEA
PROCESS
FMEA

Step and Approach of the FMEA
• Identify the team
• Define the Scope
i) System
ii) Subsystem FMEA
iii) Component FMEA
• Identify Functions,Requirements and Specification
• Identify Potential Failure Mode

Step and Approach of the FMEA
• Identify Potential Effects
• Identify Potential Causes
• Identify Controls
• Identifying and Assessing Risk
• Recommended Actions and Results
• Management Responsibility

Management Responsibility
• Management owns the FMEA process
• Ultimate responsibility of selecting and applying resources
• ensure effective risk management process including timing
• Direct support to team through on going reviews, eliminating
roadblocks and incorporating lesson learned

Reference Document
Potential Failure Mode and Effects Analysis (FMEA) –
4rd edition
Fourth edition

New Format for FMEA – 4th edition
• New format moves the Design or Process controls
“prevention” to the left of the Occurrence Ranking.
– To better show the relationship between prevention
controls to occurrence ranking.
• Column order can be modified and columns can be
added to the form depending on the organization
and customer.

Session 3
Process Failure Mode And Effects Analysis
(PFMEA)

Item (Process) / Function / Requirements
• Process Step/ Function can be separated into two (or
more) columns or combined into a single column.
• Enter the item function (DFMEA) or process step
(PFMEA) being analyzed.
• Should be consistent with Block diagram (DFMEA) and
process flow diagram (PFMEA)
• To ensure traceability to drawing, control plan, WI, etc

Process Chart Symbols
Operation
Transport
Delay
Inspection
Decision

Establish the process Function/ Requirements
Component Insertion
Process Function/ Requirements
Insert LED of different colours on to PC Board
with the right polarity and in the right sequence
Soldering of components Solder the component leads to PC Board using
soldering iron
Trim Leads Cut the component leads to shorter length
Burn in Stabilize the LED and eliminate infant
Process Steps

Process Function Analysis
Process Flow
RAW MATERIAL
PROCESS STEPS
PROCESS STEPS
FINAL PRODUCT
PACKAGING
Product / Process Characteristic
• Part Condition (Product)
• Hole Position (Product)
• Label Position (Product)
• Part handling (Process)
• Part assembly (Process)
Process Specification/ Tolerance
• Part must be clean and free from
debris
• Hole size 20 dim
• Blank size 40’’ x 30”
•Operator must use due care
•Operator must place at right position

Establish Potential Failure Mode
• Defined as the manner in which the process could
potentially fail to meet the process requirements.
• Assumption that the incoming parts/material(s),
design of product are correct for PFMEA.
• Should be described in technical terms, not as a
symptom only.

Potential Failure Mode
Typical failures modes could be but are not limited to:
• Bent
• Cracked
• Handling damage
• Surface too rough
• Burred
• Deformed
• Miss-labeled
• Hole too deep

Process Step/ Function (PFMEA)
Process Requirements Potential Failure Mode
Four Screws Fewer than four screws
Specified screws Wrong screw used (larger diameter)
Assembly sequence : First screw in right front hole Screw placed in any other hole
Screws fully seated Screw not fully
seated
Screws torqued to dynamic torque specification Screw torqued too high
Screw torqued too low
Item Step/ Function : Operation 20: Attach seat cushion to
track using torque gun

Establish Potential Failure Mode (PFMEA)
Process Function / Requirements Potential Failure Mode
Component Insertion
Insert LED of different colours on to PC Board
with the right polarity and in the right sequence
1. Wrong colour LED used
2. Wrong polarity
3. Wrong sequence
Soldering of components
Solder the component leads to PC Board using
soldering iron
1. Cold Solder Joint
2. Not enough solder
Trim Leads
Cut the component leads to shorter length
1. Lead length too long
2. Burrs on lead
Burn in
Stabilize the LED and eliminate infant
1. Electrical Overstress

Potential Effect(s) of Failure
• Brainstorming the “Potential effect of failure” -
How does the failure effect the customer.
• Describe the effects of the failure in terms of
what the customer might notice or experience.
• State clearly if the failure mode could impact
safety or cause noncompliance to regulations.

Potential Effect(s) of Failure
Example failures effects for next operation:
• Line shutdown
• Stop shipment
• Yard hold
• 100% product scrap
• Decreased line speed
• Added manpower to maintain required line rate

Example of Effects (DFMEA)
• Failure Mode : Vehicle does not stop
• Effects:
– Vehicle control impaired: Regulatory non compliance Loose seat
cushion due to subsequent fracture of screw and noise.
– Manufacturing : Sort and rework due to affected portion
• Failure Mode : Screw torque too low
• Effects:
– Loose seat cushion due to gradual loosening of screw and noise.

Example of Effects (PFMEA)
• Requirements : Screws torque to dynamic torque specification
• Failure Mode : Screw torque too high
• Effects:
– Loose seat cushion due to subsequent fracture of screw and noise.
• Failure Mode : Screw torque too low
• Effects:
– Loose seat cushion due to gradual loosening of screw and noise.

Evaluate Severity (s)
• Evaluate severity of the effect of the failure (seriousness of the effect) from
customer stand point.
• Severity is an assessment of the seriousness of the potential failure mode’s effect
on the product. A ranking of 10 is most severe, and 1 is no effect.
• Severity should be estimated using Severity Table
• A reduction in severity ranking index can be affected through design change or
redesign the process.
• It not recommended to modify criteria for ranking values of 9 - 10.
• Failure modes with rank of severity 1 should not be analyzed further.

Evaluate Severity Ranking (Customer Effects)
• Safety/ regulatory requirements
– Failure mode affects safety / government regulation without warning (10)
– Failure mode affects safety / government regulation with warning (9)
• Loss or degradation of primary function
– Loss of primary function (8)
– Degradation of primary function (7)
• Loss of degradation of secondary function
– Loss of secondary function (6)
– Degradation of secondary function performance(5)
• Annoyance
– Appearance or audible noise, vehicle operable, items does not conform and noticed by most customer (> 75%) (4)
– Appearance or audible noise, vehicle operable, items does not conform and noticed by many customer ( 50%) (3)
– Appearance or audible noise, vehicle operable, items does not conform and noticed by many customer ( < 25%)(2)
• No discernible effect (1)

Evaluate Severity Ranking (Manufacturing Effects)
• Safety/ regulatory requirements
– Endanger operator without warning (10)
– Endanger operator with warning (9)
• Major Disruption
– 100% of product have to be scrapped. Line shutdown (8)
• Significant Disruption
– A portion of the production run may have to be scrapped. Deviation from primary process including decreased line speed or added manpower (7)
• Moderate Disruption
– 100% of production run may have to be reworked off line and accepted (6)
– A portion of the production run may have to be reworked off line (5)
– 100% of production run may have to be reworked in station before it is processed (4)
– A portion of the production run may have to be reworked in-station before it is processed. (3)
• Minor Disruption
– Slight inconvenience to process, operation or operator (2)
• No discernible effect (1)

Classification
• Used to classify any special product characteristic or manufacturing process
parameter that can affect:
– safety
– compliance with regulations
– fit
– function
– performance
• Identified by customer or selected by the organization
• use symbol provided by customer (if any) S
S

Classification
• Where a special characteristic is identified with a
severity of 9 or 10 in the PFMEA, the design
responsible engineer should be notified since this
may effect the engineering documents.

Potential Cause(s) of Failure
• Is defined as how failure could occur
• Brainstorm “Potential cause of failure “. To determine
the root causes and which can be controlled.
• Technique such as cause and effect diagram, Relation
diagram and 5 why may be used to identify root cause.
• Identifying “wrong” root cause can lead to the
implementation of the followed action

• To the extent possible, identify and document
every potential cause for each failure mode.
• The team should assume that the incoming
part/ material are correct

Failure to operate
Material Cracked
(overstress)
Material too thin
(inadequate design)
First level
cause
Second level
cause
Failure Mode

Process Failure Cause Example
• Improper torque
• Improper weld
• Inaccurate gauging
• Improper heat treatment
• Inadequate gating/venting
• Chip on tool
• Broken tool
• Improper machine setup
• Improper programming

Potential Failure Cause
• Use specific word
– (e.g. operator fails to install seal)
• Should not used ambiguous phrases
– (e.g. operator error, machine malfunction)
Important !

Occurrence (o)
• Occurrence is the likelihood that a specific cause of failure will occur.
• Estimate the likelihood of occurrence of a potential failure cause on a
1 to 10 scale.
• The “Incident per items/vehicles” is used to indicate the number of
failures that are anticipated during the process execution.
• If statistical are not available, subjective assessment can be made by
using the word descriptions in the left hand of the table.

Current Process Controls
• Controls that can either prevent to the extent
possible, the cause or detect the failure mode or
cause of failure.
• The format has two separate columns for
prevention and Detection control.
• If a one-column form is used, place “P” and “D”
before of after each control listed.

Prevention (P) : Prevent the cause/ mechanism of
failure or the failure mode from occurring, or reduce
their rate of occurrence.
Detection (D): detect the cause/ mechanism of
failure or failure mode and lead to corrective
action.

Example of Process Controls:
• Visual Inspection
• Statistical Process Control (SPC)
• Mistake Proofing
• Preventive maintenance
• First piece set-up
• Lot sampling
• Functional test

Evaluate Detection Criteria
• Detection assesses the probability that the proposed process controls
will detect the failure mode.
• A ranking of 10 is equivalent to not detecting, and 1 is equal to
detecting defects that passed the current process control.
• In order to achieve lower ranking, process control has to be improved
• Refer to Detection Evaluation Criteria Table
• The team should agree on an evaluation criteria and ranking system

Evaluate Detection Criteria (Summary)
• No current process control; cannot detect or not checked - 10
• Failure mode is not easily detect - 9
• Detection post processing through visual/ audible - 8
• Detection post processing through visual/ audible through attribute gauging - 7
• Detection post processing through visual/ audible through variable gauging/ in-station
through attribute- 6
• In-station detection use of variable gauging/ automated control in-station (buzzer, light,
etc), 1st setup - 5
• Detection (Failure) post processing by automated control ( Detect and lock part) - 4
• Detection (Failure) in-station by automated control (Detect and lock part) -3
• Error (Cause) detection in station - 2
• Defect cannot be made - poka yoke by product/process design-1

Risk Priority Number (RPN)
• RPN is a product of multiplying severity, occurrence and detection
ratings.
(S) x (O) x (D) = RPN
• The use of RPN threshold is NOT a recommended practice for
determining the need for actions.
• Such threshold may promote the wrong behavior avoids addressing
the real problem that underlies the cause of failure mode and merely
keeps the RPN below the threshold.

Risk Priority Number (RPN)
• Team to decide how to prioritize their reduction
efforts. Recommendation:
– The initial focus should be oriented towards failure
modes with 9 – 10 severity ranking.
– For failure modes with severities of 8 or below the
team should consider causes having the highest
occurrence or detection ranking.
– The highest RPN without looking on threshold.

Action Taken
Severity
Design and process
revision can only reduce
in severity ranking
Detection
Mistake proofing is preferred
method to accomplish in
reduction in the detection
ranking.
Occurrence
A reduction can be effected by removing or
controlling one or more causes of the failure mode

Recommended Action (s)
Actions such as, but not limited to:
• Revised Design Geometry and/ or tolerance
• Revised Material Specification
• Design of Experiments
• Revised Test Plan
• Increase frequency of inspection
• Install poka yoke device

Responsibility
• Person or group
• Must involve process owner
• To enter the following
– the name of individual responsible
– target for completion date.

Action taken and completion date
• To verify the action taken
• To evaluate the effectiveness and recalculate the RPN
• Action is effective if RPN is reduced
• To enter the following:
– brief description on action taken
– effective date after the action has been implemented.

FOLLOW UP ACTIONS
• The process-responsible is responsible for
ensuring that all actions recommended have
been implemented or adequately addressed.
• FMEA is a living document and should always
reflect the latest design/process level

PFMEA Linkages
Work Instructions
PFMEA
Change in detection
Change in occurence
Change in severity
Control Plan
Design Change Other Action
or
or
or
or

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