International Conference on Technology and Business Management March 26-28.

2012

FMEA for Manufacturing and Assembly Process

A. A. Nannikar
D. N. Raut
R. M. Chanmanwar
S. B. Kamble
amolnannikar@gmail.com
VJTI, Mumbai
D. B. Patil
datta.patil@siemens.com
Siemens Ltd., Mumbai
1. Introduction
FMEA is a systematic method of identifying and preventing system, product and process problems before they
occur. It is focused on preventing problems, enhancing safety, and increasing customer satisfaction. Ideally,
FMEA’s are conducted in the product design or process development stages, although conducting an FMEA on
existing products or processes may also yield benefits.
FMEA is a tool that allows us to:
 Prevent System, Product and Process problems before they occur.
 Reduce costs by identifying system, product and process improvements early in the development cycle.
 Create more robust processes.
 Prioritize actions that decrease risk of failure.
 Evaluate the system, design, and processes from a new vantage point.

FMEA is
Description
A procedure that examines each item in a system, considers how that item can fail and then determines how that
failure will affect (or cascade through) the system.

Acronyms
 FMEA: Failure Modes and Effects Analysis
 FMECA: Failure Modes and Effects and Criticality Analysis

2. Review of Literature
Failure Mode and Effects Analysis (FMEA) for ensuring that reliability is designed into typical semiconductor
manufacturing equipment (Mario Villacourt 1992). The FMEA is taken during the design phase of the
equipment life cycle to ensure that reliability requirements have been properly allocated and that a process for
continuous improvement exists. The guide provides information and examples regarding the proper use of
FMEA as it applies to semiconductor manufacturing equipment.
This Executive Summary is designed in a what, why, when, how format to allow the reader a relatively quick
overview of the main issues surrounding an FMEA which are contained in the main part of the Guidance
Document itself (IMCA 2002). FMEA does not attempt to give comprehensive answers to the frequently
answered questions (FAQs), which are addressed in the main document.

3. Purpose of FMEA
The purpose of performing an FMEA is to analyze the product's design characteristics relative to the planned
manufacturing process and experiment design to ensure that the resultant product meets customer needs and
expectations. When potential failure modes are identified, corrective action can be taken to eliminate them or to
continually reduce a potential occurrence. The FMEA also documents the rationale for the chosen
manufacturing process. It provides for an organized critical analysis of potential failure modes and the
associated causes for the system being defined. The technique uses occurrence and detection probabilities in
conjunction with severity criteria to develop a risk priority number (RPN) for ranking corrective action
considerations.
The FMEA can be performed as either a hardware or functional analysis. The hardware approach requires
parts identification from engineering drawings (schematics, bill of materials) and reliability performance data,
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for example mean time between failures (MTBF), and is generally performed in a part-level fashion (bottom-
up). However, it can be initiated at any level (component/assembly/subsystem) and progress in either direction
(up or down).
Typically, the functional approach is used when hardware items have not been uniquely identified or when
system complexity requires analysis from the system level downward (top-down). This normally occurs during
the design development stages of the equipment life cycle; however, any subsystem FMEA can be performed at
any time. Although FMEA analyses vary from hardware to software, and from components (i.e., integrated
circuits, bearings) to system (i.e., stepper, furnace), the goal is always the same: to design reliability into the
equipment.
Thus, a functional analysis to FMEA on a subassembly is appropriate to use as a case study for the purposes of
this guideline.

When to perform FMEA

 Equipment Life Cycle
The recommended method for performing an FMEA is dictated by the equipment life cycle. The early
stages of the equipment life cycle represent the region where the greatest impact on equipment
reliability can be made.
 Total Quality
FMEA is recommended along with Process Analysis Technique, Design of Experiments and Fault Tree
Analysis, as a part of quality assurance that a company should use systematically for total quality
control. All indicators from the total quality management perspective and from examination of the
equipment life cycle tell us that the FMEA works best when conducted early in the planning stages of
the design.

What does it contain?

An FMEA covering the complete system (which may include FMEAs of various subsystem manufacturers)
should encompass those FMEAs by a review and an analysis of the interfaces between the subsystems. An
FMEA should contain a practical test programme and the results from those tests.

Who carries out an FMEA?

An FMEA team should be well knowledge of the each system. They are specialist having discipline in each
system required in design process. For example, machinery systems, electrical systems, DP control systems and
other control systems.

4. Process Improvement
FMEA is done in any equipment. In this process, to identify the possible failure modes and find the effect of this
failure to the equipment. To prevent this failure, possible changes in design and improvement can be made. This
identification of potential failure mode leads to a recommendation of effective reliability program.
Mainly failure mode can be set according to the FMEA’s Risk Priority Number (RPN) system. A concentrated
effort can be placed on the higher RPN items based on the Pareto analysis obtained from the analysis. As the
equipment proceeds through the life cycle phases, the FMEA analysis becomes more detailed and should be
continued. The FMEA consist of following steps:
 FMEA Prerequisites
 Functional Block Diagram
 Failure mode analysis and preparation of work sheets
 Team Review
 Corrective action

R.R. - Review Requirements

R.F.D. - Review FRACAS Data
G.S.D. - Get System Description
F.B.D. - Functional Block Diagram
D.F.M. - Détermine Failure Mode
C.P. - Changes Proposed?
C.A.R. - Corrective Action Required
N.C.R. - No Change Required
R.E. - Reliable Equipment
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Figure 1 Steps of FMEA

5. FMEA Processes
FMEA Pre-requisites
 Review specifications such as the statement of work (SOW) and the system requirement document
(SRD).
 Collect all available information that describes the subassembly to be analyzed. Systems engineering
can provide system configuration
 Compile information on earlier/similar designs from in-house/customer users such as data flow
diagrams and reliability performance data from the company's failure reporting, analysis and corrective
action system (FRACAS).

The above information should provide enough design detail to organize the equipment configuration to the
level required for analysis.

Functional Block Diagram

This diagram shows how different parts are interact to each other to verify the critical path. It is easy to
understand relations of the parts.
The recommended way to analyze the system is to break it down to different levels (i.e., system, subsystem,
subassemblies, and field replaceable units). Review schematics and other engineering drawings of the system
being analyzed to show how different subsystems, assemblies or parts interface with one another by their critical

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support systems such as power, plumbing, actuation signals, data flow, etc. to understand the normal functional
flow requirements.

Failure Mode Analysis and Preparation of Work Sheets

 Determine the Potential Failure Mode
Answer of asking simply question determines the failure. That’s the simple question is “What can go
wrong?”
 Subassembly examples of failure modes
 Assembly examples of failure modes
 Manufacturing/Process examples of failure modes
 Component examples of failure modes

The Reliability Analysis Centre (RAC) has developed a document designed solely to address
component failure mechanisms and failure mode distributions for numerous part types including
semiconductors, mechanical and electromechanical components.
 Determine the Potential Effects of the Failure Mode
The potential effects for each failure mode need to be identified both locally (subassembly) and
globally (system). Customer satisfaction is key in determining the effect of failure mode. Safety
criticality is also determined at this time based on Environmental Safety and Health (ES & H) levels.
Based on this information, a severity ranking is used to determine the criticality of the failure mode on
the subassembly to the end effect.
 Determine the Potential Cause of the Failure
Most probable causes associated with potential failure modes. As a minimum, examine its relation to:
 Preventive maintenance operation
 Failure to operate at a prescribed time
 Intermittent Operation
 Degraded output or operational capability
 Design causes
 Determine Current Controls/Fault Detection
Many organizations have design criteria that help prevent the causes of failure modes through their
design guidelines. Checking of drawings prior to release, and prescribed design reviews are paramount
to determining compliance with design guidelines.
Detection methods are - Local hardware concurrent with operation, downstream or at a higher level,
Built-in test (BIT), Application software exception handling, Time-out, Visual methods, Alarms.
After the detection by previous method, determining the recovery method is another part. Recovery
methods are- Retry, Re-load and retry, Alternate path or redundancy, Degraded, Repair and restart.
 Determining the Risk Priority Number (RPN)
RPN is the indicator for the determining proper corrective action on the failure modes. It is calculated
by multiplying the severity, occurrence and detection ranking levels resulting in a scale from 1 to 1000.
RPN = Severity × Occurrence × Detection
The small RPN is always better than the high RPN. A Pareto analysis is based on the RPN. In this all
the possible failure modes, effects and causes are determined. High RPN is gives idea for corrective
action on failure mode.
The engineering team generates the RPN and focused to the solution of failure modes. After finding
solution, improvements can be made.
Rating Scale Example:
If Severity = 10, indicates that the effect is very serious and is “worse” than Severity = 1.
If Occurrence = 10, indicates that the likelihood of occurrence is very high and is “worse” than
Occurrence = 1.
If Detection = 10, indicates that the failure is not likely to be detected before it reaches the end user is
worse than Detection =1.
An RPM is comparable to other RPM’s in the same analysis, but an RPM is not comparable to RPN’s
in another analysis. Because similar RPN’s can result in several different ways and represents different
types of risk.
 Preparation of FMEA Worksheets
Action takes tasks recommended for the purpose of reducing any or all of the rankings. Only design
revision can be bringing about the revision in the severity ranking.
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 Actions
 All critical or significant characteristics must have recommended actions associated
with them
 Recommended actions should be focused on design, and directed toward mitigating
the cause of failure, or eliminating the failure mode
 If recommended actions cannot mitigate or eliminate the potential for failure,
recommended actions must force characteristics to be forwarded to process FMEA
for process mitigation
 All recommended actions must have a person assigned responsibility for completion
of the action
 Responsibility should be a name, not a title
 Person listed as responsible for an action must also be listed as a team member
 There must be a completion date accompanying each recommended action
 Unless the failure mode has been eliminated, severity should not change
 Occurrence may or may not be lowered based upon the results of actions
 Detection may or may not be lowered based upon the results of actions
 If severity, occurrence or detection ratings are not improved, additional
recommended actions must to be defined.
 Worksheet

Table 1 Work Sheet of FMEA

Source Book of “Quality and Reliability Management” by Lalit Wankhede

 Description
Item/Function – Name or concise statement of function performed by the equipment.
Potential Failure Mode - A answer of asking simply question determines the failure.
Potential Local Effect(s) of Failure – subassembly consideration.
SEV – Severity ranking.
Class - A safety critical failure mode.
Potential Cause(s)/ Mechanism(s) of Failure - Most probable causes associated with
potential failure modes.
Occur - Occurrence ranking based on the probability of failure.
Current Design Controls - methods of prevention and detection.
Detect - Detection ranking based on the probability of detection.
RPN - Risk Priority Number.
Recommended Actions – Action recommended to reduce the possibility of occurrence of the
failure mode, reduce the severity (based on a design change) if failure mode occurs, or
improve the detection capability should the failure mode occur.
Response and Target Complete Date - This area lists the person responsible for evaluation
of the recommended actions. Besides ownership, it provides for accountability by assigning a
completion date.
Actions Taken – Following completion of a recommended action, the FMEA provides for
closure of the potential failure mode.
SEV—Following recommended corrective action.
OCC—Following recommended corrective action.
DET—Following recommended corrective action.
RPN—Following recommended corrective action.

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6. Team Review
The engineering team suggested comments and review the worksheet to consider the failure modes based upon
RPN’s. Engineering team determines potential problems, identify possible changes in design, data fill in the
worksheet etc. are updated. The worksheets need to reflect the changes until final design of equipment. When
the design is finalized, the worksheets are then distributed to the users, design engineering, technical support and
manufacturing. The worksheets may also provide information to other engineering areas.
Team members for FMEA
 Process engineer
 Manufacturing supervisor
 Operators
 Quality
 Safety
 Product engineer
 Customers
 Suppliers

7. Corrective Action
Design Engineering
Design engineering uses the completed FMEA worksheets to identify and correct potential design related
problems. This is where the FMEA becomes the basis for continuous improvement.

Technical Support
From the FMEA worksheets, the engineering team can suggest a statistically based preventive maintenance
schedule based on the frequency and type of failure. A spares provisioning list can also be generated from the
worksheet.

Manufacturing
From the FMEA worksheets, the team could suggest a process be changed to optimize installations, acceptance
testing, etc. This is done because the sensitivities of the design are known and documented. The selection of
suppliers can be optimized as well. FMEA can be a way to communicate design deficiencies in the
manufacturing of the equipment.

8. Ranking Criteria for FMEA

Severity Ranking Criteria
Calculating the severity levels provides for a classification ranking that encompasses safety, production
continuity, scrap loss, etc. It determines how affect the potential failure mode to the customers. Only applies to
the effect and is assigned with regard to any other rating.

Table 2 Severity Ranking Criteria

Effect Rank Criteria
None 1 No effect
Very Slight 2 Negligible effect on Performance. Some users may notice.
Slight 3 Slight effect on performance. Non vital faults will be noticed by many users.
Minor 4 Minor effect on performance. User is slightly dissatisfied.
Moderate 5 Reduced performance with gradual performance degradation. User dissatisfied.
Severe 6 Degraded performance, but safe and usable. User dissatisfied.
High Severity 7 Very poor performance. Very dissatisfied user.
Very High Severity 8 Inoperable but safe.
Extreme Severity 9 Probable failure with hazardous effects. Compliance with regulation is unlikely.
Maximum Severity 10 Unpredictable failure with hazardous effects almost certain. Non-compliant with regulations.
Source Book of “Quality and Reliability Management” by Lalit Wankhede.

 Environmental, Safety and Health Severity Code

The Environmental Safety and Health (ES&H) severity code is a qualitative means of representing the
worst case incident that could result from an equipment or process failure or for lack of a contingency
plan for such an incident.
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Occurrence Ranking Criteria

The probability that a failure will occur during the expected life of the system can be described in potential
occurrences per unit time.

Table 3 Occurrence Ranking Criteria

Occurrence Rank
Extremely Unlikely
Remote Likelihood
Very Low Likelihood
Low Likelihood
Moderately Low Likelihood
Medium Likelihood
Moderately High Likelihood
Very High Severity
Extreme Severity
Maximum Severity
Source Book of “Quality and Reliability Management” by Lalit Wankhede
Criteria
1 Less than 0.01 per thousand
2 0.1 per thousand rate of occurrence
3 0.5 per thousand rate of occurrence
4 1 per thousand rate of occurrence
5 2 per thousand rate of occurrence
6 5 per thousand rate of occurrence
7 10 per thousand rate of occurrence
8 20 per thousand rate of occurrence
9 50 per thousand rate of occurrence
10 100 per thousand rate of occurrence

Detection Ranking Criteria

This section provides a ranking based on an assessment of the probability that the failure mode will be detected
given the controls that are in place. The probability of detection is ranked in reverse order.

Table 4 Detection Ranking Criteria

Detection
Extremely Likely
Very High Likelihood
High Likelihood
Moderately High Likelihood
Medium Likelihood
Moderately Low Likelihood
Low Likelihood
Very Low Likelihood
Very Low Likelihood
Extremely Unlikely
Source Book of “Quality and Reliability Management” by Lalit Wankhede
Rank Criteria
1 Can be corrected prior to prototype/ Controls will almost certainly detect
2 Can be corrected prior to design release/Very High probability of detection
3 Likely to be corrected/High probability of detection
4 Design controls are moderately effective
5 Design controls have an even chance of working
6 Design controls may miss the problem
7 Design controls are likely to miss the problem
8 Design controls have a poor chance of detection
9 Unproven, unreliable design/poor chance for detection
10 No design technique available/Controls will not detect

9. Case Study
Perform FMEA on a Pressure Cooker

Figure 2 Pressure Cooker

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Pressure Cooker Safety Features

 Safety valve relieves pressure before it reaches dangerous levels.
 Thermostat opens circuit through heating coil when the temperature rises above 250° C.

Scope of FMEA for Pressure Cooker

 Resolution - The analysis will be restricted to the four major subsystems (electrical system, safety
valve, thermostat, and pressure gage).
 Focus – Safety

Block Diagram of Pressure Cooker

Figure 3 Block Diagram Pressure Cooker

Table 5 FMEA is shown in Table

Effects on Effects on
Failure Consequence Failure Detection Compensating
Component other whole
Mode Category Likelihood Method Provisions
Components System

Loss of hot
Increased gas Shut off water
water, more Observe at
flow and Reasonably supply, reseal or
Jammed cold water I - Safe pressure
thermostat probable replace relief
open input and relief valve
Pressure operation valve
gas
relief valve

No conseq.
Jammed Manual unless combined
None None I - Safe Probable
closed testing with other
failure modes

Water at Open hot water

Burner Water temp.
faucet too faucet to relieve
continues to and pressure
Jammed Reasonably hot; pres., shut off
Gas valve operate, increase; III - Critical
open probable pressure gas; pressure
pressure relief water turns
relief valve relief valve
valve opens to steam
open (obs.) compensates

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Observe at
System fails
Jammed Burner ceases faucet
to produce I - Safe Remote
closed to operate (cold
hot water
water)

Open hot water

Burner
Fails to Water temp. faucet to relieve
continues to Water at
react to rises; water pressure;
operate, III - Critical Remote faucet too
temp. turns to pressure relief
pressure relief hot
Thermostat rise steam valve
valve opens
compensates

Fails to Observe at
Water
react to Burner fails to faucet
temperature I - Safe Remote
temp. function (cold
too low
drop water)

10. Conclusion
The failure modes included in the FMEA are the failures anticipated at the design stage. As such, they could be
compared with Failure Reporting, Analysis and Corrective Action System (FRACAS) results once actual
failures are observed during test, production and operation. Take appropriate steps to avoid either possibility.

11. References
1. B.G. Dale and P. Shaw, “Failure Mode and Effects Analysis in the U.K. Motor Industry: A State-of-Art
Study,” Quality and Reliability Engineering International, Vol. 6, 184, 1990.
2. Mario Villacourt, “Failure Mode and Effects Analysis (FMEA)”, Technology Transfer #92020963B-
ENG SEMATECH September 30, 1992.
3. Texas Instruments Inc. Semiconductor Group, “FMEA Process,” June 1991 Ciraolo, Michael,
“Software Factories: Japan,” Tech Monitoring by SRI International, April 1991, pp. 1–5.
4. Matzumura, K., “Improving Equipment Design Through TPM,” The Second Annual Total Productive
Maintenance Conference: TPM Achieving World Class Equipment Management, 1991.
5. Lalit Wankhede “Quality and reliability management”.
6. BSI Standard, BS 5760-5:1991: 'Reliability of Systems, Equipment and Components', Part 5: 'Guide to
Failure Modes, Effects and Criticality Analysis (FMEA and FMECA).
7. IEC Standard, IEC 60812: 'Analysis Techniques for System Reliability – Procedure for Failure Mode
and Effects Analysis (FMEA)’.
8. CEI/IEC812 – Analysis techniques for system reliability - Procedure for failure modes and effects
analysis (FMEA).
9. IMO MSC Resolution 36(63) Annex 4 – Procedures for Failure Mode and Effects Analysis (HSC
Code).
10. Analysis techniques for system reliability - Procedure for failure modes and effects analysis (FMEA) -
CEI/IEC 812:1985.

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