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, FMEAs 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, 501

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for example mean time between failures (MTBF), and is generally performed in a part-level fashion (bottomup). 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 FMEAs 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. - Dtermine Failure Mode C.P. - Changes Proposed? C.A.R. - Corrective Action Required N.C.R. - No Change Required R.E. - Reliable Equipment 502

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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 503

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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. Thats 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 RPMs in the same analysis, but an RPM is not comparable to RPNs in another analysis. Because similar RPNs 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. 504

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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. SEVFollowing recommended corrective action. OCCFollowing recommended corrective action. DETFollowing recommended corrective action. RPNFollowing 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 RPNs. 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 Criteria No effect Negligible effect on Performance. Some users may notice. Slight effect on performance. Non vital faults will be noticed by many users. Minor effect on performance. User is slightly dissatisfied. Reduced performance with gradual performance degradation. User dissatisfied. Degraded performance, but safe and usable. User dissatisfied. Very poor performance. Very dissatisfied user. Inoperable but safe. Probable failure with hazardous effects. Compliance with regulation is unlikely. Unpredictable failure with hazardous effects almost certain. Non-compliant with regulations.

Effect None Very Slight Slight Minor Moderate Severe High Severity Very High Severity Extreme Severity Maximum Severity

Rank 1 2 3 4 5 6 7 8 9 10

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. 506

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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 Criteria Extremely Unlikely Remote Likelihood Very Low Likelihood Low Likelihood Moderately Low Likelihood Medium Likelihood Moderately High Likelihood Very High Severity Extreme Severity Maximum Severity 1 2 3 4 5 6 7 8 9 10 Less than 0.01 per thousand 0.1 per thousand rate of occurrence 0.5 per thousand rate of occurrence 1 per thousand rate of occurrence 2 per thousand rate of occurrence 5 per thousand rate of occurrence 10 per thousand rate of occurrence 20 per thousand rate of occurrence 50 per thousand rate of occurrence 100 per thousand rate of occurrence

Source Book of Quality and Reliability Management by Lalit Wankhede

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 Criteria Can be corrected prior to prototype/ Controls will almost certainly detect Can be corrected prior to design release/Very High probability of detection Likely to be corrected/High probability of detection Design controls are moderately effective Design controls have an even chance of working Design controls may miss the problem Design controls are likely to miss the problem Design controls have a poor chance of detection Unproven, unreliable design/poor chance for detection No design technique available/Controls will not detect

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

Rank 1 2 3 4 5 6 7 8 9 10

Source Book of Quality and Reliability Management by Lalit Wankhede

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 Consequence Failure whole Category Likelihood System Loss of hot water, more cold water input and gas

Component

Failure Mode

Effects on other Components

Detection Method

Compensating Provisions

Jammed open Pressure relief valve

Increased gas flow and thermostat operation

I - Safe

Reasonably probable

Observe at pressure relief valve

Shut off water supply, reseal or replace relief valve

Jammed closed

None

None

I - Safe

Probable

Manual testing

No conseq. unless combined with other failure modes Open hot water faucet to relieve pres., shut off gas; pressure relief valve compensates

Gas valve

Jammed open

Burner continues to operate, pressure relief valve opens

Water temp. and pressure increase; water turns to steam

III - Critical

Reasonably probable

Water at faucet too hot; pressure relief valve open (obs.)

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Jammed closed

Burner ceases to operate

System fails to produce hot water

I - Safe

Remote

Observe at faucet (cold water) Open hot water faucet to relieve pressure; pressure relief valve compensates

Thermostat

Fails to react to temp. rise

Burner continues to operate, pressure relief valve opens

Water temp. rises; water turns to steam

III - Critical

Remote

Water at faucet too hot

Fails to react to temp. drop

Burner fails to function

Water temperature too low

I - Safe

Remote

Observe at faucet (cold 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 #92020963BENG 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. 15. 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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