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Failure Mode &

Effect Analysis
(FMEA)
AIAG & VDA - 1st Edition

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VDA-FMEA
Excel Template

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History Of FMEA

✓ FMEA’s have been used as a risk identification and reduction tool for decades.
✓ Developed by the US Military in the late 1940’s.
✓ Used for almost 70 Year’s with relatively small evolutionary enhancements.
✓ In 2019,Substantial changes were introduced as AIAG & VDA “harmonized” their
difference for conducting FMEA’s

1949’s 1960’s 1970’s 1982’s 2019’s

Ford Auto
US Military NASA
Industry
AIAG AIAG&VDA

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What is FMEA?

Failure Mode and Effects Analysis FMEA is a structured too to,

✓ Identify failure modes for a process

✓ Estimate its effect and the risk associated with it

✓ Identify and Prioritize probable causes of failure

✓ Prioritize the failure modes based on the Action Priority

✓ Evaluate and develop control plan to contain the risk

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Is FMEA a Quality Tool?

✓ Yes,FMEA is a quality tool. This tool helps to minimize or eliminate


failures in product design/manufacturing process and improve
quality.

Why FMEA?

✓ To avoid product recall


✓ To avoid customer dissatisfaction
✓ To avoid loss of market share
✓ To avoid loss of reputation
✓ To avoid repair and rework cost
✓ To avoid legal action

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Key Changes in AIAG & VDA FMEA

✓ New 7 Step Approach (PS 2F RO R)


✓ Revised Severity, Occurrence and detection rating
✓ RPN replaced by AP
✓ New FMEA sheet in color with linkage
✓ PFD is integral part
✓ Use of 5T & 4M Approach
✓ Recommended Action replaced by Prevention & Detection Action
✓ Added Status of Action
✓ Added special characteristics to replace classification
✓ Added FMEA-MSR

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Benefits of FMEA

✓ On time delivery of the quality product to customers


✓ Higher accuracy in designing & manufacturing of products
✓ Better control pf verification and validation of design
✓ Less rework in the design phase
✓ No/Very low risk of product failure
✓ Less/No rework and repair
✓ Better customer satisfaction.

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APQP Phases Vs FMEA

Product Design & Process Design & Product &


APQP Plan and Define Feedback Assessment
Development Development Production
Phases Program & Corrective Action
Verification Verification Validation

Complete DFMEA
Complete DFMEA
Start FMEA planning Start DFMEA when analysis prior to
actions prior to
DFMEA in concept phase the design concept release of design
start of production
before product is well understood specifications for
tooling
development begins quotation
Information flow
Start again with
from DFMEA to
DFMEA and PFMEA
PFMEA
planning if there are
The DFMEA and
changes to an
PFMEA should be
existing design or
executed during the
process
same time period to Start PFMEA when
Complete PFMEA Complete PFMEA
allow optimization of the production
PFMEA both the product and concept is well
analysis prior to final actions prior to
process decisions PPAP
process designs understood

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7 Step Approach

Section 1 : System Analysis


• It covers the scope definition, project team
make-up and project planning aspects of • Used to identify and breakdown the • Analyzes each System Element
the study. system (design or process) into the identified in Step 2 in terms of its
• A clear definition of the scope, set by the system, subsystems and component intended function(s) and
management team, minimizes the
elements so that a comprehensive risk corresponding requirements.
probability of “scope creep."
• Project Planning is done following “Five
assessment can be conducted.
T’s” and should be covered in the FMEA • The Function Analysis leads to a
kickoff meeting. • This information is the basis for the next
comprehensive and relevant Failure
• The information from this step is the basis step
Analysis in Step 4.
for Step 2.

1.Planning and Preparation 2.Structure Analysis 3.Function Analysis

7.Result 4.Failure
6.Optimization 5.Risk Analysis
Documentation Analysis

• Marks the beginning of the


• In this step the level of risk next phase of the FMEA,
• In this step where plans are for each failure mode is Failure Analysis and Risk
• It is the final step where the evaluated in terms of Mitigation.
developed that reduce risk
results of the FMEA study Severity, Occurrence and • The purpose of the Failure
and increase customer
are fully documented in a Detection (S-O-D). Analysis Step is to identify
satisfaction by improving • Items are then assigned an failure modes, failure effects
report.
the design or process. Action Priority Level of High, and failures causes to
Medium or Low. establish the basis for risk
assessment.

Section 3 : Risk Analysis Section 2 : Failure Analysis & Risk Mitigation

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5T Approach

✓ inTent: What is and isn't included in the scope of this project and why is the FMEA being

undertaken?

✓ Timing: When will the FMEA be done? (includes when in the product/process

development cycle to conduct the study with deadlines for completing the FMEA).

✓ Team: Who will be on the core team and extended team and what are the members'

roles and responsibilities?

✓ Tasks: What work needs to be done by the team?

✓ Tools: What tools will the team use or will the team need to complete the project.

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Failure Chain Model

The concept of a “Failure Chain” helps to visualize failures as part of three links of a chain comprised of

the Failure Effect (FE), Failure Mode (FM) and Failure Cause (FC). In turn, this clarity will help assign

meaningful S-O-D Ratings.

1.Next Higher-Level Element

Failure Effect: What happens in the event


of a failure mode?

2.Focus Element

Failure Mode: Failure to perform an


intended function or met requirements

3.Next Lower-Level Element

Failure Cause: Why is the failure mode


happening?

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S-O-D Rating Table

Design-FMEAs and Process-FMEAs use the (familiar) S-O-D approach to evaluate risk.

✓ Severity (S) is an estimate of how serious the impact of the failure effect would be assuming that a

specific failure mode occurred. To determine the Severity, consider the impact the effect would

have on a customer, a customer's operation, your operation, your customer’s operation, and end-

user or the people working with the product or process.

✓ Occurrence (O) reflects the prediction of each Failure Cause Occurring based on the type of control

(behavioral, technical or best practice methodology). For Prevention Controls with multiple

Occurrence Ratings, use the rating that best reflects the robustness of the control.

✓ Detection (D) is used to depict the relative effectiveness of the system to either prevent a potential

failure mode or failure cause or to detect a failure mode or cause has occurred

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Prevention Vs Detection

The new AIAG-VDA FMEA process places greater emphasis on PREVENTION vs


DETECTION.
For a Design-FMEA, Detection Controls are the basis of the robustness of the
design. Prevention Controls describe how a potential cause that may result in a
Failure Mode will be mitigated while Detection Controls are intended to detect (not
mitigate) the potential existence of a Failure Cause or Failure Mode.
For a Process-FMEA, emphasis is placed on Prevention Controls (that eliminate
the Failure Cause or reduce its rate of occurrence) as well as Detection Controls
(that detect a Failure Cause or Failure Mode).

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AIAG & VDA FMEA SCORING

Failure Impact Severity


Severity (S) Rating (FE)

Safe Dangerous

Potential cause of
Occurrence (O) Failure Rating Value (FC)

Less Possibility/Never Happens Likely to happen

Detection or process
Detection (D) control method Rating
(FC or FM)
Defect can be detected and not pass No detection

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Action Priority (AP) Table
Action Priority Table is a risk matrix that can represent combinations of S-O, S-D and O-D, each resulting in
either a High, Medium or Low Action Priority.

AP High (H)
Action to improve prevention and/or
detection controls (or justification on why
current controls are adequate) MUST be
taken.

AP Medium (M)
Action to improve prevention and/or
detection controls (or justification on why
current controls are adequate) SHOULD
be taken.

AP Low (L)
Action to improve prevention and/or
detection controls COULD be taken.

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FMEA and COQ

✓ The payoff of an effective and efficient FMEA is a reduction of COQ

✓ FMEAs and Cost of Quality go hand-in-hand, While the immediate benefit of the

FMEA is mitigation of risk, it should translate into a reduction in the Cost of

Quality (COQ).

✓ FMEA comes under the Prevention & Appraisal Cost categories, An efficient

FMEA will see Failure costs will go down substantially more than the

corresponding increase in Prevention and Appraisal Costs.

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FMEA MSR’s

✓ Intended to help maintain a safe state or state of regulatory


compliance during customer operation.
✓ Introduced to ensure functional safety goals (as required by
ISO 26262) have been fully considered and are met.
✓ A significant focus of the analysis is to determine if the system or the
end user will detect a failure if one does occur.
✓ Used as a supplement to a DFMEA
✓ It uses the same seven-step process used for DFMEAs and PFMEAs.

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