Session 12: Failure Mode and Effects

Criticality Analysis (FMECA)

Failure Mode, Effect and Criticality Analysis (FMECA)
• Cause and Effect diagram is most powerful for identifying the causes of the problem
and describing its effects, defects or failures.
• Fails to describe the failure mode and other dimensions of failure mode such as trend
of failure, severity, risk, length of failure etc.
• A judicial knowledge on how and when failure mode should be required.
• FMEA + Criticality Analysis =FMECA

• Methodologies designed to identify potential failure modes for a process, to assess the
risk associated with those failure modes, to rank the issues in terms of importance and
to identify and carry out corrective actions to address the most serious concerns.
• Definition: A disciplined procedure for systematic evaluation of the impact of potential
failures and thereby determining a priority of possible actions that will reduce the
occurrence of such failures.
• A team approach led by a Process Owner.
Elements of FMECA (MIL-STD-1629) & Benefits
• Failure Mode: The way in which the component, subassembly, product, input,
or process could fail to perform its intended function.
• Failure Effect: The consequence (s) of a failure mode on the operation of an
item.
• Failure Criticality: Potential failures of a product or service are examined to
determine how severe the failure will be.

Benefits
• Allows us to identify areas of our process that most impact our customers
• Helps us identify how our process is most likely to fail
• Points to process failures that are most difficult to detect
Why FMECA & When to Conduct an FMECA
• Why
• Identifies and eliminates concerns early in the development of a process or design.
• Improve internal and external customer satisfaction.
• Focuses on prevention of bad product or service.
• FMECA may be a customer requirement (likely contractual)
• Estimate the risk associated with specific causes
• Prioritize the actions that should be taken to reduce risk.

• When
• Early in the process improvement investigation
• When new systems, products, and processes are being designed
• When existing designs or processes are being changed
• When carry-over designs are used in new applications
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Hierarchy in FMEA
• The degree of analysis is depend on the level at which FMEA is used.
• System FMEA: Used to analyze the entire system made up of various subsystems. Focus will be on
system related deficiencies such as system safety, system integration, interface between system
and subsystems, interactions between subsystems and environment etc. Usually undertaken prior
to the introduction of either a product or service.

• Design FMEA: Analyzes product design before release to production, with a focus on product
function. A component level analysis is carried out. Focus on design related deficiencies with
emphasis on ensuring safe and reliable product operations during the useful life of the component.

• Process FMEA: Used to analyze manufacturing and assembly processes after they are implemented.
Focus is on manufacturing related deficiencies with emphasis on ensuring the product is built to
design requirements in a safe manner, minimal downtime, scrap and rework etc.

• Service FMEA, Maintenance FMEA and Environment FMEA.

FMEA Procedure
1. For each process input determine the ways in which the input can go wrong (failure
mode).
2. For each failure mode, determine effects
• Select a severity level for each effect
3. Identify potential causes of each failure mode
• Select an occurrence level for each cause
4. List current controls for each cause
• Select a detection level for each cause
5. Calculate the Risk Priority Number (RPN)
• Give priority to high RPNs
6. Develop recommended actions and revise RPN.

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Severity, Occurrence, Detection and RPN
•• Severity
  (S): A numerical measure of how serious is the effect of the failure to the
customer. The degree of severity is measured on a scale of 1-10, where 10 is the most
severe.
• Occurrence (O): Frequency with which a given cause occurs and creates failure
modes (obtain from past data if possible). A measure of probability of occurrence of a
particular mode. The degree of occurrence is measured on a scale of 1 to 10, where
10 being highest probability of occurrence.
• Detection (D): The ability of the current control scheme to detect (then prevent) a
given cause (may be difficult to estimate early in process operations). The degree of
detection is measured on a scale of 1 to 10, where 10 being virtually no ability to
detect the fault.
• The larger the RPN, the higher the priority.

• The rating scales are based on MIL-STD-1629.

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Revision of RPN
•• Based
  on the RPN, suggest possible recommended actions to reduce S, O and D of
the failure modes.
• Severity can be generally reduced only through a design change whereas
occurrence may be reduced through design or process improvement.
• List the actions taken and revise the RPN (RRPN).
• Compute the risk (chance of implementing the action successfully) associated
with each action taken on a scale of 1-5 with 1 being the smallest risk.
• Compute a weighted RPN (WRPN).

• Higher the WRPN, the higher the priority associated with the failure mode and
the associated remedial action.
The FMECA Form

Identify failure modes and Determine and assess

Identify causes of the failure Prioritize
their effects actions
modes
and controls
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