Failure mode and effects analysis A failure modes and effects analysis (FMEA) is a procedure in product development and

operations management for analysis of potential failure modes within a system for classification by the severity and likelihood of the failures. A successful FMEA activity helps a team to identify potential failure modes based on past experience with similar products or processes, enabling the team to design those failures out of the system with the minimum of effort and resource expenditure, thereby reducing development time and costs. It is widely used in manufacturing industries in various phases of the product life cycle and is now increasingly finding use in the service industry. Failure modes are any errors or defects in a process, design, or item, especially those that affect the customer, and can be potential or actual. Effects analysis refers to studying the consequences of those failures. Basic terms[1]

FMEA cycle. Failure The loss of an intended function of a device under stated conditions. Failure mode The manner by which a failure is observed; it generally describes the way the failure occurs. Failure effect Immediate consequences of a failure on operation, function or functionality, or status of some item Indenture levels An identifier for item complexity. Complexity increases as levels are closer to one. Local effect The failure effect as it applies to the item under analysis. Next higher level effect The failure effect as it applies at the next higher indenture level. End effect The failure effect at the highest indenture level or total system. Failure cause Defects in design, process, quality, or part application, which are the underlying cause of the failure or which initiate a process which leads to failure. Severity The consequences of a failure mode. Severity considers the worst potential consequence of a failure, determined by the degree of injury, property damage, or system damage that could ultimately occur. History Procedures for conducting FMECA were described in US Armed Forces Military Procedures document MIL-P-1629[2] (1949; revised in 1980 as MIL-STD-1629A).[3] By the early 1960s, contractors for the U.S. National Aeronautics and Space Administration (NASA) were using variations of FMECA or FMEA under a variety of names.[4][5] NASA programs using FMEA variants included Apollo, Viking, Voyager, Magellan, Galileo, and Skylab.[6][7][8] The civil aviation industry was an early adopter of FMEA, with the Society for Automotive Engineers publishing ARP926 in 1967.[9] During the 1970's, use of FMEA and related techniques spread to other industries. In 1971 NASA prepared a report for the U.S. Geological Survey recommending the use of FMEA in assessment of offshore petroleum exploration.[10] FMEA as application for

HACCP on the Apollo Space Program moved into the food industry in general.[11] In the late 1970s the Ford Motor Company introduced FMEA to the automotive industry for safety and regulatory consideration after the Pinto affair. They applied the same approach to processes (PFMEA) to consider potential process induced failures prior to launching production. Although initially developed by the military, FMEA methodology is now extensively used in a variety of industries including semiconductor processing, food service, plastics, software, and healthcare.[12][13] It is integrated into the Automotive Industry Action Group's (AIAG) Advanced Product Quality Planning (APQP) process to provide risk mitigation, in both product and process development phases. Each potential cause must be considered for its effect on the product or process and, based on the risk, actions are determined and risks revisited after actions are complete. Toyota has taken this one step further with its Design Review Based on Failure Mode (DRBFM) approach. The method is now supported by the American Society for Quality which provides detailed guides on applying the method.[14] [edit] Implementation In FMEA, failures are prioritized according to how serious their consequences are, how frequently they occur and how easily they can be detected. A FMEA also documents current knowledge and actions about the risks of failures for use in continuous improvement. FMEA is used during the design stage with an aim to avoid future failures (sometimes called DFMEA in that case). Later it is used for process control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service. The outcomes of an FMEA development are actions to prevent or reduce the severity or likelihood of failures, starting with the highest-priority ones. It may be used to evaluate risk management priorities for mitigating known threat vulnerabilities. FMEA helps select remedial actions that reduce cumulative impacts of life-cycle consequences (risks) from a systems failure (fault). It is used in many formal quality systems such as QS-9000 or ISO/TS 16949. [edit] Using FMEA when designing This article contains instructions, advice, or how-to content. The purpose of Wikipedia is to present facts, not to train. Please help improve this article either by rewriting the how-to content or by moving it to Wikiversity or Wikibooks. (August 2011) FMEA can provide an analytical approach, when dealing with potential failure modes and their associated causes. When considering possible failures in a design like safety, cost, performance, quality and reliability an engineer can get a lot of information about how to alter the development/manufacturing process, in order to avoid these failures. FMEA provides an easy tool to determine which risk has the greatest concern, and therefore an action is needed to prevent a problem before it arises. The development of these specifications will ensure the product will meet the defined requirements and customer needs. [edit] The pre-work The process for conducting an FMEA is straightforward. It is developed in three main phases, in which appropriate actions need to be defined. But before starting with an FMEA, it is important to complete some pre-work to confirm that robustness and past history are included in the analysis. A robustness analysis can be obtained from interface matrices, boundary diagrams, and parameter diagrams. Many failures are due to noise factors and shared interfaces with other parts and/or systems, because engineers tend to focus on what they control directly. To start it is necessary to describe the system and its function. A good understanding simplifies further analysis. This way an engineer can see which uses of the system are desirable and which are not. It is important to consider both intentional and unintentional uses. Unintentional uses are a form of hostile environment. Then, a block diagram of the system needs to be created. This diagram gives an overview of the major components or process steps and how they are related. These are called logical relations around which the FMEA can be developed. It is useful to create a coding system to identify the different system elements. The block diagram should always be included with the FMEA.

Before starting the actual FMEA, a worksheet needs to be created, which contains the important information about the system, such as the revision date or the names of the components. On this worksheet all the items or functions of the subject should be listed in a logical manner, based on the block diagram. Step 1: Occurrence In this step it is necessary to look at the cause of a failure mode and the number of times it occurs. This can be done by looking at similar products or processes and the failure modes that have been documented for them in the past. A failure cause is looked upon as a design weakness. All the potential causes for a failure mode should be identified and documented. Again this should be in technical terms. Examples of causes are: erroneous algorithms, excessive voltage or improper operating conditions. A failure mode is given an occurrence ranking (O), again 110. Actions need to be determined if the occurrence is high (meaning > 4 for non-safety failure modes and > 1 when the severity-number from step 1 is 1 or 0). This step is called the detailed development section of the FMEA process. Occurrence also can be defined as %. If a non-safety issue happened less than 1%, we can give 1 to it. It is based on your product and customer specification. Rating Meaning 1 No known occurrences on similar products or processes 2/3 Low (relatively few failures) 4/5/6 Moderate (occasional failures) 7/8 High (repeated failures) 9/10 Very high (failure is almost inevitable)
[15]

[edit] Step 2: Severity Determine all failure modes based on the functional requirements and their effects. Examples of failure modes are: Electrical short-circuiting, corrosion or deformation. A failure mode in one component can lead to a failure mode in another component, therefore each failure mode should be listed in technical terms and for function. Hereafter the ultimate effect of each failure mode needs to be considered. A failure effect is defined as the result of a failure mode on the function of the system as perceived by the user. In this way it is convenient to write these effects down in terms of what the user might see or experience. Examples of failure effects are: degraded performance, noise or even injury to a user. Each effect is given a severity number (S) from 1 (no danger) to 10 (critical). These numbers help an engineer to prioritize the failure modes and their effects. If the sensitivity of an effect has a number 9 or 10, actions are considered to change the design by eliminating the failure mode, if possible, or protecting the user from the effect. A severity rating of 9 or 10 is generally reserved for those effects which would cause injury to a user or otherwise result in litigation. Rating Meaning 1 No effect 2 Very minor (only noticed by discriminating customers) 3 Minor (affects very little of the system, noticed by average customer) 4/5/6 Moderate (most customers are annoyed) 7/8 High (causes a loss of primary function; customers are dissatisfied) Very high and hazardous (product becomes inoperative; customers angered; the failure may result unsafe operation and 9/10 possible injury)
[15]

[edit] Step 3: Detection When appropriate actions are determined, it is necessary to test their efficiency. In addition, design verification is needed. The proper inspection methods need to be chosen. First, an engineer should look at the current controls of the system, that prevent failure modes from occurring or which detect the failure before it reaches the customer. Hereafter one should identify testing, analysis, monitoring and other techniques that can be or have been used on similar systems to detect failures. From these controls an engineer can learn how likely it is for a failure to be identified or detected. Each combination from the previous 2 steps receives a detection number (D). This ranks the ability of planned tests and inspections to remove defects or detect failure modes

in time. The assigned detection number measures the risk that the failure will escape detection. A high detection number indicates that the chances are high that the failure will escape detection, or in other words, that the chances of detection are low. Rating Meaning 1 Certain - fault will be caught on test 2 Almost Certain 3 High 4/5/6 Moderate 7/8 Low 9/10 Fault will be passed to customer undetected
[15]

After these three basic steps, risk priority numbers (RPN) are calculated [edit] Risk priority number (RPN) RPN play an important part in the choice of an action against failure modes. They are threshold values in the evaluation of these actions. After ranking the severity, occurrence and detectability the RPN can be easily calculated by multiplying these three numbers: RPN = S O D This has to be done for the entire process and/or design. Once this is done it is easy to determine the areas of greatest concern. The failure modes that have the highest RPN should be given the highest priority for corrective action. This means it is not always the failure modes with the highest severity numbers that should be treated first. There could be less severe failures, but which occur more often and are less detectable. After these values are allocated, recommended actions with targets, responsibility and dates of implementation are noted. These actions can include specific inspection, testing or quality procedures, redesign (such as selection of new components), adding more redundancy and limiting environmental stresses or operating range. Once the actions have been implemented in the design/process, the new RPN should be checked, to confirm the improvements. These tests are often put in graphs, for easy visualization. Whenever a design or a process changes, an FMEA should be updated. A few logical but important thoughts come in mind:

Try to eliminate the failure mode (some failures are more preventable than others) Minimize the severity of the failure (severity of a failure cannot be changed) Reduce the occurrence of the failure mode Improve the detection

[edit] Timing of FMEA The FMEA should be updated whenever:

A new cycle begins (new product/process) Changes are made to the operating conditions A change is made in the design New regulations are instituted Customer feedback indicates a problem

[edit] Uses of FMEA

Development of system requirements that minimize the likelihood of failures.

Development of methods to design and test systems to ensure that the failures have been eliminated. Evaluation of the requirements of the customer to ensure that those do not give rise to potential failures. Identification of certain design characteristics that contribute to failures, and minimize or eliminate those effects. Tracking and managing potential risks in the design. This helps avoid the same failures in future projects. Ensuring that any failure that could occur will not injure the customer or seriously impact a system. To produce world class quality products

[edit] Advantages

Improve the quality, reliability and safety of a product/process Improve company image and competitiveness Increase user satisfaction Reduce system development timing and cost Collect information to reduce future failures, capture engineering knowledge Reduce the potential for warranty concerns Early identification and elimination of potential failure modes Emphasize problem prevention Minimize late changes and associated cost Catalyst for teamwork and idea exchange between functions Reduce the possibility of same kind of failure in future Reduce impact of profit margin company Reduce possible scrap in production

[edit] Limitations Since FMEA is effectively dependent on the members of the committee which examines product failures, it is limited by their experience of previous failures. If a failure mode cannot be identified, then external help is needed from consultants who are aware of the many different types of product failure. FMEA is thus part of a larger system of quality control, where documentation is vital to implementation. General texts and detailed publications are available in forensic engineering and failure analysis. It is a general requirement of many specific national and international standards that FMEA is used in evaluating product integrity. If used as a top-down tool, FMEA may only identify major failure modes in a system. Fault tree analysis (FTA) is better suited for "top-down" analysis. When used as a "bottom-up" tool FMEA can augment or complement FTA and identify many more causes and failure modes resulting in top-level symptoms. It is not able to discover complex failure modes involving multiple failures within a subsystem, or to report expected failure intervals of particular failure modes up to the upper level subsystem or system.[citation needed] Additionally, the multiplication of the severity, occurrence and detection rankings may result in rank reversals, where a less serious failure mode receives a higher RPN than a more serious failure mode.[16] The reason for this is that the rankings are ordinal scale numbers, and multiplication is not defined for ordinal numbers. The ordinal rankings only say that one ranking is better or worse than another, but not by how much. For instance, a ranking of "2" may not be twice as bad as a ranking of "1," or an "8" may not be twice as bad as a "4," but multiplication treats them as though they are. See Level of measurement for further discussion. [edit] Software Most FMEAs are created as a spreadsheet. Specialized FMEA software packages exist that offer some advantages over spreadsheets. [edit] Types of FMEA

Process: analysis of manufacturing and assembly processes Design: analysis of products prior to production Concept: analysis of systems or subsystems in the early design concept stages Equipment: analysis of machinery and equipment design before purchase

Service: analysis of service industry processes before they are released to impact the customer System: analysis of the global system functions Software: analysis of the software functions

Failure Mode and Effects Analysis (FMEA) is a systematic team driven approach that identifies potential failure modes in a system, product, or manufacturing / assembly operation caused by either design or manufacturing / assembly process deficiencies. It also identifies critical or significant design or process characteristics that require special controls to prevent or detect failure modes. FMEA is a tool used to prevent problems from occurring. History of FMEA FMEA has been around for a very long time. Before any documented format was developed, inventors and process experts would try to anticipate what could go wrong with a design or process before it was developed or tried. The trial and error and learning from each failure was both costly and time consuming. For example: Each individual iteration of an invention might fail without a thorough thought experiment by a group of engineers or inventors and take advantage of their collective knowledge to reduce the likelihood of failure.

FMEA Cause and Effect Diagram FMEA was formally introduced in the late 1940s with the introduction of the military standard 1629. Used for Aerospace / rocket development, the FMEA and the more detailed Failure Mode and Effects Criticality Analysis (FMECA) were helpful in avoiding errors on small sample sizes of costly rocket technology. The primary push for failure prevention came during the 1960s while developing the technology for placing a man on the moon. Ford Motor Company introduced FMEA to automotive in the late 1970s for safety and regulatory consideration after the disastrous "Pinto" affair. Ford Motor Company also used FMEA effectively for production improvement as well as design improvement. The current advancement of FMEA has come from the automotive sector as FMEAs are required for all Designs and Processes to assure the prevention of problems. Integrated into Advanced Product Quality Planning (APQP), FMEA in both Design and Process formats provide the primary risk mitigation tools in the prevention strategy. Each potential cause must be considered for its effect on the product or process and based on the risk, actions determined and risks revisited after actions are complete. Toyota has taken this one step further with its Design Review Based on Failure Modes (DRBFM) approach. DRBFM moves the user through the FMEA process by considering all intentional and incidental changes and their effects on the performance of a product or process. These changes drive potential

causes which require follow-up action to resolve the risk. Design reviews are the primary place to review progress and address these risks.

FMEA Methodology Robustness analysis from Interface Matrices, Boundary Diagrams and Parameter Diagrams are extremely helpful prior to FMEA development. Noise factors and interfaces with other parts and/or systems are where a large number of failures can be found as design engineers typically focus on what they control directly. Shared interfaces are an area where many failures occur today. FMEA Development FMEAs are developed in three distinct phases where actions can be determined. It is also imperative to do pre-work ahead of the FMEA to assure that the Robustness and past history are included in your analysis.

Step 1 is to determine all failure modes based on the functional requirements and their effects. If the severity of the effect is a 9 or 10 (meaning safety or regulatory in nature) actions are considered to change the design or process by eliminating the Failure Mode if possible or protecting the customer from the effect. Step 2 adds causes and Occurrences to each Failure Mode. This is the detailed development section of the FMEA process. Reviewing the probability or occurrence number in order of the highest severity and working downwards, actions are determined if the occurrence is high (> 4 for non safety and regardless of occurrence >1 when the severity is 9 or 10) Step 3 considers testing, design verification and inspection methods. Each combination from steps 1 and 2 which are considered at risk requires the detection number to be selected. The detection number represents the ability of planned tests and inspections at removing defects or excite failure modes to fail.

After each of these steps actions are developed. Next, Risk Priority Numbers (RPN) are calculated. Please note that RPN's are calculated after three possible action opportunities have occurred. Actions are not only determined based on RPN values. RPN threshold values do not play an important role in action development, only in action evaluation when completed.

Selecting an arbitrary RPN to fall below is both ineffective at driving change and foolhardy if the order of the improvement is not controlled (severity, occurrence, detection) steps 1,2,3 as described above. In past years, setting an RPN would immediately be met with lower numbers without any real change or improvement. This is not preventing failure, but in fact driving bad behavior of the design and process teams required to perform the FMEA. Process Failure Mode and Effects and Analysis The second part of a collaborative FMEA deployment is the Process FMEA. Process Failure Mode and Effects Analysis takes a product or service design and considers all the steps that are necessary to be successful. Each step is considered as to its impact on the product or service to be provided with the idea that each step may inhibit or cause the product/service to fail. As the Process FMEA progresses, each potential cause which has risk (measured with severity, occurrence (criticality) and detection capability) is the topic of actions which are counter measures to the risk. When completed, these actions reduce risk and increase the probability of success. Process FMEA is an integral part of the Lean Product Development process and APQP (Advanced Product Quality Planning). Process and Design FMEA are linked and should be used in coordination of timing and collaboration in feedback. The proper time to do a Process FMEA is just after the Design FMEA has indicated certain Special Characteristics which are at risk that are likely related to a process or delivery step. These characteristics, special or otherwise should be investigated and finding fed back to the product/service design team prior to design completion. This provides and excellent opportunity for the product or service design to take full advantage of the knowledge of the process experts. This collaboration can have benefits such as cost savings, Design for Assembly and Manufacturing, and increased use of Error Proofing required to avoid problems as opposed to detecting and sorting. Process FMEA can be prompted by one of several events:

New Design Special Characteristics New Product Design Drawing or Design record Process Changes due to Lean events or Six Sigma Projects Process Changes due to upgrades in machinery, personnel or as a result of a corrective action process

Human Factors Operator error is never an acceptable cause of failure. Operators can make errors, but operator error alone is not actionable and therefore more detail is needed to get closer to a root cause. Human factors provide some thought into where the root cause may be found for the purpose of preventing or error proofing that cause. Learn more about the impact of human factors. Fourth Edition FMEA Manual Changes AIAG has recently released the Fourth Edition FMEA manual. To read an executive summary of the changes to the new manual, visit our Fourth Edition FMEA page. To learn how Q-1 can help your organization implement the new FMEA standards, call us today at (248) 280-4800. FMEA Exercise Can you determine the order of need for change in the following three examples:

FMEA and the Control Plan

Severity (5), Occurrence (4), Detection (2) = 40 Severity (9), Occurrence (2), Detection (2) = 36 Severity (8), Occurrence (1), Detection (8) = 64

The correct order for action is #2, #1, #3. To find out why, please contact us or sign up for our value driven training on FMEA. FMEA in selecting Special Characteristics FMEA is used to refine special characteristics that the design community may be concerned about as these characteristics may affect performance. These characteristics are translated into dimensions or features and provided for the Process design activity to error proof and/or develop mitigation plans to reduce risk of poor performance. The timing for this is critical to get the best benefit. Advanced Product Quality Planning (APQP) provides the concurrent and collaborative structure to accomplish this effectively. Eventually, process capability and evidence of proper Process Controls found in a control plan are required. Benefits of FMEA

Improves the quality, reliability, and safety of products / services / machinery and processes Improves company image and competitiveness Increases customer satisfaction Reduces product development timing and cost / support integrated product development Documents and tracks action taken to reduce risk Reduces potential for Warranty concerns Integrates with Design for Manufacturing & Assembly techniques

Applications for FMEA

Process - analyze manufacturing and assembly processes. Design - analyze products before they are released for production. Concept - analyze systems or subsystems in the early design concept stages. Equipment - analyze machinery and equipment design before they are purchased. Service - analyze service industry processes before they are released to impact the customer.

FMEA use in Medical

Failure Mode and Effects Analysis is being deployed in many more industries than just Automotive and Aerospace. Medical device and drug delivery has added FMEA as a means to understand the risks not considered by individual design and process personnel. FMEA allows a team of persons to review the design at key points in product development and make comments and changes to the design of the product or process well in advance of actually experiencing the failure. The Food and Drug Administration (FDA) has recognized FMEA as a design verification method for Drugs and Medical Devices. (21 CFR 820) and typically wishes to review the effort put into the FMEA activity during scheduled reviews. Hospitals also have begun to use FMEA to prevent the possibility of process errors and mistakes leading to incorrect surgery or medication administration. This use is driven from the Joint Commission of Accreditation of Health Care Organizations (JCAHO). Q-1 has many years of experience with process driven FMEA and has trained and facilitated FMEAs for Medical Device design, drug delivery systems and hospitals wishing to prevent failure in its processes. Contact us to see how we could help you as well. FMEA in Machinery Development The reliability and maintenance of machinery is critical to many manufacturers as down time for maintenance or repair must be kept to an absolute minimum. FMEA is a tool which assists the designers and builders of tooling and equipment to determine when to improve reliability of components and where to use common parts. All R&M activities must consider the cost of ownership or total Life Cycle Costs (LCC) which must be determined well in advance of building the equipment. FMEA is an integral part of this LCC determination. Q-1 has trained and facilitated many machinery and equipment FMEAs to assist in lowering LCC and preventing costly down and excessive repair time.

FMEA Working Model FMEA in Aerospace and Defense Failure Mode and Effects Analysis has always been a part of the Aerospace industry since its first use in rocketry. FMEA continues to be an integral part of the development of Aircraft, Missile systems, Radar, Communications, Electronics and other key interfacing technologies. New innovations in this prevention technology have increased its

effectiveness. Technical Kickoff (TKO) combines many tools including robustness considerations into the process yielding more detailed results and leads to improved designs and processes. Q-1 is firmly committed to the use and innovation of FMEA. We are not only a major part and input into future FMEA process, we invent processes like LEAN FMEA to help our customers use the process more efficiently. We have developed faster and more thorough techniques which provide an excellent FMEA output, while achieving the superior output faster. Please contact us to find out how we can make your FMEA experiences more valuable. "Green" FMEA FMEA can also be used to assess the environmental impact of a product or process. The "Green" FMEA can identify where corrective and preventive actions can be taken to mitigate the environmental burden of a product. To learn more about "Green" FMEA, contact us today at (248) 280-4800. You can also download one of our Green FMEA reference cards below. Free Failure Mode and Effects Analysis Downloads Q-1 has a selection of FREE FMEA reference cards available for download. Now available are reference cards explaining Design FMEA and Process FMEA methodology as well as reference cards explaining the different severity, detection, and occurrence rankings. Click on a link below to begin your free download:

Design FMEA Methodology reference card Design FMEA reference card Process FMEA Methodology reference card Process FMEA reference card FMEA for Health Care reference card Green FMEA reference card

FMEA Online Training

We now offer an electronic version of our FMEA training course. This course is offered on the World Wide Web for the low price of $89.00 USD. The FMEA course is Web-Based, which allows users to access their course(s) anywhere that has an internet connection, anytime. Our FMEA course has been updated to include the changes to the AIAG Fourth Edition FMEA manual. Learn more about Q-1's FMEA Online Training course.
FMEA is a systematic analysis of potential failure modes aimed at preventing failures. This is intended to be a preventative action process carried out before implementing new or changes in products or processes. An effective FMEA identifies corrective actions required to prevent failures from reaching the customer and to assure the highest possible yield, quality and reliability. In semiconductor device design and manufacturing, it is common to perform different types of FMEA. These can be divided into two primary categories: product related and process related. These are often called Design FMEA and Process FMEA and they are often further subdivided to focus on specific areas of product or process development. The main purpose of an FMEA is: To identify possible failure modes that could occur in the design or manufacturing of a product.

To identify corrective actions that could reduce or eliminate the potential for failures to occur.

To provide documentation of the process. To quantify the risk level associated with each potential failure mode.

An FMEA is a two-phase process. First the potential failure modes and corrective actions are identified. Then after the corrective actions are implemented, the product or process is re-evaluated to determine if the result is acceptable. This is best accomplished with a cross-functional team with members from all affected work groups (e.g. Marketing, Engineering, Manufacturing, Test, QRA, etc.) Benefits of FMEA An FMEA provides benefits to both the manufacturer and the customer. Some of these benefits include:

Assists in determining the best possible design and development options to provide high reliability and manufacturability potential. Assists in considering the possible failure modes and their effect on the reliability and manufacturability of the product. Provides a well-documented record of improvements from corrective actions implemented. Provides information useful in developing test programs and in-line monitoring criteria. Provides historical information useful in analyzing potential product failures during the manufacturing process. Provide new ideas for improvements in similar designs or processes.

Documenting an FMEA This preventative action process provides a methodical approach to study the cause and effect of potential failures. The form below (Fig. 1) is used to document the process.

Product or Process: FMEA Team Members: Process/Product Description or Purpose Potential Potential S Failure Effect(s) of Modes Failure E V C L

FMEA Type:

FMEA Date: Rev __ / Rev Date:

Potential Causes/ Mechanisms

O C C

Current Design/ Process Control Prevention Detection

D E T

R P N

Recommended Actions

Who When

Actions Taken

S E V

O C C

D E T

R P N

A Of Failures S S

Fig. 1: Typical FMEA Form The Process/Product Description or Purpose should be clearly defined. This may be broken down into sub-processes with each being considered separately. Potential Failure Modes lists the different ways the process might fail to meet the process requirements or design intent. The Potential Effect(s) of Failure is how the customer perceives the failure. The "customer" includes subsequent design or manufacturing operations and/or the end customer. Each of the Failure Modes and Effects is assigned a Severity (SEV) value and Classification (CLASS). How a failure could occur should be described in terms of something that can be corrected or controlled and listed under Potential Causes/Mechanisms of Failures. The probability that a given cause or mechanism that might occur is assigned a numeric value in OCC. Current Design/Process Control Prevention/Detection describes any controls that can prevent or detect each of the failure mechanisms. The probability that each control will effectively detect the failure is assigned a numeric value in DET. The Risk Priority Number (RPN) is the product of Severity, Occurrence and Detection. These are assessed and engineering judgment is used to determine if the risk is acceptable. Recommended Actions are developed to reduce the RPN with priority given to the highest RPN values and customer defined specific characteristics. Once the actions are implemented, the Severity, Occurrence and Detection values are reassessed, and a new RPN is calculated. This process continues until the risk level is acceptable. An FMEA is a living document that should be reviewed and updated periodically. Any change in design, process or use of the product should be updated in the FMEA.

Failure Modes and Effects Analysis (FMEA) and Failure Modes, Effects and Criticality Analysis (FMECA)
An Overview of Basic Concepts Failure Mode and Effects Analysis (FMEA) and Failure Modes, Effects and Criticality Analysis (FMECA) are methodologies designed to identify potential failure modes for a product or 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. Although the purpose, terminology and other details can vary according to type (e.g. Process FMEA - PFMEA, Design FMEA - DFMEA, System FMEA, Product FMEA, FMECA, etc.), the basic methodology is similar for all. This document presents a brief general overview of FMEA / FMECA analysis techniques and requirements. FMEA / FMECA Overview In general, Failure Modes, Effects and Criticality Analysis (FMEA / FMECA) requires the identification of the following basic information: Item(s) Function(s) Failure(s) Effect(s) of Failure Cause(s) of Failure Current Control(s) Recommended Action(s) Plus other relevant details

Most analyses of this type also include some method to assess the risk associated with the issues identified during the analysis and to prioritize corrective actions. Two common methods include: Risk Priority Numbers (RPNs) Criticality Analysis (FMEA with Criticality Analysis = FMECA)

Published Standards and Guidelines There are a number of published guidelines and standards for the requirements and recommended reporting format of failure mode and effects analyses. Some of the main published standards for this type of analysis include SAE J1739, AIAG FMEA-3 and MIL-STD-1629A. In addition, many industries and companies have developed their own procedures to meet the specific requirements of their products/processes. Figure 1 shows a sample Process FMEA (PFMEA) in the Automotive Industry Action Group (AIAG) FMEA-3 format. Click to enlarge the image. Basic Analysis Procedure for FMEA or FMECA The basic steps for performing an Failure Mode and Effects Analysis (FMEA) or Failure Modes, Effects and Criticality Analysis (FMECA) include:

Assemble the team. Establish the ground rules. Gather and review relevant information. Identify the item(s) or process(es) to be analyzed. Identify the function(s), failure(s), effect(s), cause(s) and control(s) for each item or Evaluate the risk associated with the issues identified by the analysis. Prioritize and assign corrective actions. Perform corrective actions and re-evaluate risk. Distribute, review and update the analysis, as appropriate.

process to be analyzed.

Risk Evaluation Methods A typical failure modes and effects analysis incorporates some method to evaluate the risk associated with the potential problems identified through the analysis. The two most common methods, Risk Priority Numbers and Criticality Analysis, are described next. Risk Priority Numbers To use the Risk Priority Number (RPN) method to assess risk, the analysis team must: Rate the severity of each effect of failure. Rate the likelihood of occurrence for each cause of failure. Rate the likelihood of prior detection for each cause of failure (i.e. the likelihood of Calculate the RPN by obtaining the product of the three ratings: RPN = Severity x Occurrence x Detection The RPN can then be used to compare issues within the analysis and to prioritize problems for corrective action. This risk assessment method is commonly associated with Failure Mode and Effects Analysis (FMEA). Criticality Analysis The MIL-STD-1629A document describes two types of criticality analysis: quantitative and qualitative. To use the quantitative criticality analysis method, the analysis team must: Define the reliability/unreliability for each item and use it to estimate the expected Identify the portion of the items unreliability that can be attributed to each potential

detecting the problem before it reaches the end user or customer).

number of failures at a given operating time. failure mode.

Rate the probability of loss (or severity) that will result from each failure mode that Calculate the criticality for each potential failure mode by obtaining the product of

may occur. the three factors: Mode Criticality = Expected Failures x Mode Ratio of Unreliability x Probability of Loss Calculate the criticality for each item by obtaining the sum of the criticalities for each

failure mode that has been identified for the item. Item Criticality = SUM of Mode Criticalities To use the qualitative criticality analysis method to evaluate risk and prioritize corrective actions, the analysis team must: Rate the severity of the potential effects of failure. Rate the likelihood of occurrence for each potential failure mode. Compare failure modes via a Criticality Matrix, which identifies severity on the

horizontal axis and occurrence on the vertical axis. These risk assessment methods are commonly associated with Failure Modes, Effects and Criticality Analysis (FMECA). Applications and Benefits for FMEA and FMECA The Failure Modes, Effects and Criticality Analysis (FMEA / FMECA) procedure is a tool that has been adapted in many different ways for many different purposes. It can contribute to improved designs for products and processes, resulting in higher reliability, better quality, increased safety, enhanced customer satisfaction and reduced costs. The tool can also be used to establish and optimize maintenance plans for repairable systems and/or contribute to control plans and other quality assurance procedures. It provides a knowledge base of failure mode and corrective action information that can be used as a resource in future troubleshooting efforts and as a training tool for new engineers. In addition, an FMEA or FMECA is often required to comply with safety and quality requirements, such as ISO 9001, QS 9000, ISO/TS 16949, Six Sigma, FDA Good Manufacturing Practices (GMPs), Process Safety Management Act (PSM), etc. You can use something as simple as a paper form or an Excel spreadsheet to record your FMEA / FMECA analyses. However, if you want to establish consistency among your organization's FMEAs, build a "knowledge base" of lessons learned from past FMEAs, generate other types of reports for FMEA data (e.g. Top 10 Failure Modes by RPN, Actions by Due Date, etc.) and/or track the progress and completion of recommended actions, you may want to use a software tool, such as ReliaSoft's Xfmea, to facilitate analysis, data management and reporting for your failure modes and effects analyses. More information on applications and benefits...

References
The following resources provide additional information on FMEA / FMECA. Web Resources
SAE International: The Society for Automotive Engineers provides the ability to AIAG: The Automotive Industry Action Group provides the ability to purchase the

purchase the J1739 and ARP5580 standards, as well as the AIR4845 document. AIAG FMEA Third Edition (FMEA-3) guidelines.

IEC: The International Electrotechnical Commission provides the ability to purchase Reliability-Related Military Handbooks and Standards on weibull.com: This site

the IEC 60812 standard. provides access to US Department of Defense standards and handbooks in PDF format, including the MIL-STD-1629A standard for Failure Modes, Effects and Criticality Analysis (FMECA) analysis. FMEA Info Center: This site provides information on books, publications, standards, software, consultants and other resources related to Failure Mode and Effects Analysis (FMEA). It also provides an online discussion list. NASA STI Special Bibliography for FMEA: NASA's Scientific and Technical Information (STI) program provides a "sampler bibliography" that contains abstracts for documents related to Failure Mode and Effects Analysis ( FMEA) and Failure Modes, Effects and Criticality Analysis (FMECA) in the NASA STI Database.

Printed Resources
Automotive Industry Action Group (AIAG), Potential Failure Mode and Effects Automotive Industry Action Group (AIAG), Advanced Product Quality Planning and International Electrotechnical Commission (IEC), Analysis Techniques for System Kececioglu, Dimitri, Reliability Engineering Handbook Volume 2. Prentice-Hall Inc., McDermott, Robin E., Raymond J. Mikulak and Michael R. Beauregard, The Basics of Stamatis, D.H., Failure Mode and Effect Analysis: FMEA from Theory to Execution. Society of Automotive Engineers (SAE), Aerospace Recommended Practice ARP5580:

Analysis (FMEA Third Edition or Fourth Edition), July, 2001 or June, 2008. Control Plan (APQP First Edition or Second Edition), June, 1994 or July 2008. Reliability: Procedure for Failure Mode and Effects Analysis (FMEA), July 1985. Englewood Cliffs, New Jersey, 1991. Pages 473-506. FMEA. Productivity Inc., United States, 1996. American Society for Quality (ASQ), Milwaukee, Wisconsin, 1995. Recommended Failure Modes and Effects Analysis (FMEA) Practices for Non-Automobile Applications, June 2000. Society of Automotive Engineers (SAE), Surface Vehicle Recommended Practice J1739: (R) Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA), and Potential Failure Mode and Effects Analysis for Machinery (Machinery FMEA), June 2000.

US Department of Defense, MIL-STD-1629A: Procedures for Performing a Failure

Mode Effects and Criticality Analysis, Cancelled in November, 1984.

Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. Failure modes means the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that affect the customer, and can be potential or actual. Effects analysis refers to studying the consequences of those failures. Failures are prioritized according to how serious their consequences are, how frequently they occur and how easily they can be detected. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones. Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement. FMEA is used during design to prevent failures. Later its used for control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service. Begun in the 1940s by the U.S. military, FMEA was further developed by the aerospace and automotive industries. Several industries maintain formal FMEA standards. What follows is an overview and reference. Before undertaking an FMEA process, learn more about standards and specific methods in your organization and industry through other references and training. When to Use FMEA

When a process, product or service is being designed or redesigned, after quality function deployment. When an existing process, product or service is being applied in a new way. Before developing control plans for a new or modified process. When improvement goals are planned for an existing process, product or service. When analyzing failures of an existing process, product or service. Periodically throughout the life of the process, product or service

FMEA Procedure

(Again, this is a general procedure. Specific details may vary with standards of your organization or industry.) 1. Assemble a cross-functional team of people with diverse knowledge about the process, product or service and customer needs. Functions often included are: design, manufacturing, quality, testing, reliability, maintenance, purchasing (and suppliers), sales, marketing (and customers) and customer service. Identify the scope of the FMEA. Is it for concept, system, design, process or service? What are the boundaries? How detailed should we be? Use flowcharts to identify the scope and to make sure every team member understands it in detail. (From here on, well use the word scope to mean the system, design, process or service that is the subject of your FMEA.) Fill in the identifying information at the top of your FMEA form. Figure 1 shows a typical format. The remaining steps ask for information that will go into the columns of the form.

2.
3.

Figure 1 FMEA Example (click image to enlarge) 4. 5. 6. 7. Identify the functions of your scope. Ask, What is the purpose of this system, design, process or service? What do our customers expect it to do? Name it with a verb followed by a noun. Usually you will break the scope into separate subsystems, items, parts, assemblies or process steps and identify the function of each. For each function, identify all the ways failure could happen. These are potential failure modes. If necessary, go back and rewrite the function with more detail to be sure the failure modes show a loss of that function. For each failure mode, identify all the consequences on the system, related systems, process, related processes, product, service, customer or regulations. These are potential effects of failure. Ask, What does the customer experience because of this failure? What happens when this failure occurs? Determine how serious each effect is. This is the severity rating, or S. Severity is usually rated on a scale from 1 to 10, where 1 is insignificant and 10 is catastrophic. If a failure mode has more than one effect, write on the FMEA table only the highest severity rating for that failure mode. For each failure mode, determine all the potential root causes. Use tools classified as cause analysis tool, as well as the best knowledge and experience of the team. List all possible causes for each failure mode on the FMEA form. For each cause, determine the occurrence rating, or O. This rating estimates the probability of failure occurring for that reason during the lifetime of your scope. Occurrence is usually rated on a scale from 1 to 10, where 1 is extremely unlikely and 10 is inevitable. On the FMEA table, list the occurrence rating for each cause. For each cause, identify current process controls. These are tests, procedures or mechanisms that you now have in place to keep failures from reaching the customer. These controls might prevent the cause from happening, reduce the likelihood that it will happen or detect failure after the cause has already happened but before the customer is affected. For each control, determine the detection rating, or D. This rating estimates how well the controls can detect either the cause or its failure mode after they have happened but before the customer is affected. Detection is usually rated on a scale from 1 to 10, where 1 means the control is absolutely certain to detect the problem and 10 means the control is certain not to detect the problem (or no control exists). On the FMEA table, list the detection rating for each cause. (Optional for most industries) Is this failure mode associated with a critical characteristic? (Critical characteristics are measurements or indicators that reflect safety or compliance with government regulations and need special controls.) If so, a column labeled Classification receives a Y or N to show whether special controls are needed. Usually, critical characteristics have a severity of 9 or 10 and occurrence and detection ratings above 3. Calculate the risk priority number, or RPN, which equals S O D. Also calculate Criticality by multiplying severity by occurrence, S O. These numbers provide guidance for ranking potential failures in the order they should be addressed. Identify recommended actions. These actions may be design or process changes to lower severity or occurrence. They may be additional controls to improve detection. Also note who is responsible for the actions and target completion dates. As actions are completed, note results and the date on the FMEA form. Also, note new S, O or D ratings and new RPNs.

8.
9. 10. 11.

12.

13. 14. 15.

FMEA Example

A bank performed a process FMEA on their ATM system. Figure 1 shows part of itthe function dispense cash and a few of the failure modes for that function. The optional Classification column was not used. Only the headings are shown for the rightmost (action) columns. Notice that RPN and criticality prioritize causes differently. According to the RPN, machine jams and heavy computer network traffic are the first and second highest risks. One high value for severity or occurrence times a detection rating of 10 generates a high RPN. Criticality does not include the detection rating, so it rates highest the only cause with medium to high values for both severity and occurrence: out of cash. The team should use their experience and judgment to determine appropriate priorities for action.

Excerpted from Nancy R. Tagues The Quality Toolbox, Second Edition, ASQ Quality Press, 2004, pages 236-240.