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Failure Modes and Effects Analysis
An FMEA (Failure Mode and Effect Analysis) is a systematic method of identifying and preventing product and process problems before they occur. FMEAs are focused on preventing defects, 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 and processes can also yield substantial benefits.
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. What Is an FMEA? An FMEA (Failure Mode and Effect Analysis) is a systematic method of identifying and preventing product and process problems before they occur. FMEAs are focused on preventing defects, 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 and processes can also yield substantial benefits.
The objective of an FMEA is to look for all of the ways a process or product can fail. A product failure occurs when the product does not function as it should or when it malfunctions in some way. Even the simplest products have many opportunities for failure. For example, a drip coffeemaker—a relatively simple household appliance—could have several things fail that would render the coffeemaker inoperable. Here are some possible ways the coffeemaker can fail: The heating element does not heat water to sufficient temperature to brew coffee. The pump does not pump water into the filter basket. The coffeemaker does not turn on automatically by the clock. The clock stops working or runs too fast or too slow. Calcium deposits from impure water clog up the brewing process. There is either not enough or too much coffee used. There is a short in the electrical cord. Failures are not limited to problems with the product. Because failures also can occur when the user makes a mistake, those types of failures should also be included in the FMEA. Anything that can be done to ensure the product works correctly, regardless of how the user operates it, will move the product closer to 100 percent total customer satisfaction. Ways in which a product or process can fail are called failure modes. Each failure mode has a potential effect, and some effects are more likely to occur than others. In addition, each potential effect has a relative risk associated with it. The FMEA process is a way to identify the failures, effects, and risks within a process or product, and then eliminate or reduce them.
The History of FMEAs
The first formal FMEAs were conducted in the aerospace industry in the mid-1960s and were specifically focused on safety issues. Before long, FMEAs became a key tool for improving safety, especially in the chemical process industries. The goal with safety FMEAs was, and remains today, to prevent safety accidents and incidents from occurring. While engineers have always analyzed processes and products for potential failures, the FMEA process standardizes the approach and establishes a common language that can be used both within and between companies. It can also be used by nontechnical as well as technical employees of all levels. The automotive industry adapted the FMEA technique for use as a quality improvement tool. Learning from each failure is both costly and time consuming, and FMEA is a more systematic method of studying failure. As such, it is considered better to first conduct some thought experiments. Procedures for conducting FMECA were described in US Armed Forces Military Procedures document MIL-P-1629 (1949; revised in 1980 as MIL-STD-1629A). Later it was used for aerospace/rocket development to avoid errors in small sample sizes of costly rocket technology. An example of this is the Apollo Space program. It was also used as application for HACCP for the Apollo Space Program, and later the food industry in general. The primary push came during the 1960s, while developing the means to put a man on the moon and return him safely to earth. 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. 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.
and the Malcolm Baldrige National Quality Award. The result is a more robust process because the need for after-the-fact corrective action and late change crises are reduced or eliminated. ISO/TS 16949. While FMEAs can be effectively used alone. In this case. missing significant opportunities to improve the failure modes that are the biggest problems. Used in both the design and manufacturing processes. Without reliable product or process data the FMEA becomes a guessing game based on opinions rather than actual facts. a company will not get maximum benefit without systems to support conducting FMEAs and implementing improvements that are a result of the FMEAs. This is especially critical with a process FMEA. people working in the process could be introducing significant variation into it by operating it slightly differently each time the process is run. including ISO 9000.What is the Purpose of an FMEA? Preventing process and product problems before they occur is the purpose of Failure Mode and Effect Analysis (FMEA). it produces different results. the FMEA is aiming at a moving target because each time the process is run. There are many different models for quality systems. they substantially reduce costs by identifying product and process improvements early in the develop process when changes are relatively easy and inexpensive to make. . and the current quality systems that are already in place. The best model for a company depends on the type of business. The result may be that the FMEA team focuses on the wrong failure modes. Part of a Comprehensive Quality System A formal FMEA process should be a part of a comprehensive quality system. one element of a comprehensive quality system is effective use of data and information. Another example that supports the need for a comprehensive quality system is documentation of procedures. the requirements of the customers of the business. In the absence of documented procedures. For example.
Example 1 Ford required a manufacturer of automobile liquid-level floats to conduct both a design/product FMEA and a process FMEA. eliminating problems that had existed for years but were not high enough a priority to address until the FMEA. Example 3 A small printed circuit board manufacturer with thirty-five employees formed an FMEA team. After a brief FMEA training session. The Results The combined efforts of the teams resulted in a decrease in defectives to 0. While the manager was a team member. they were able to complete the FMEA in four two-hour sessions. The manufacturer saved $6. The team discovered that many of the failure modes were related to preventive maintenance of the soldering unit. although all were familiar with assembly to some extent. the team decided to collect data and information from other operators that were not on the team. Here are three real examples. The Results The highest-priority items were associated with the wave-soldering operation. The Results The team identified the biggest risk of failure and mistake-proofed the process to the point where there was no chance of it recurring. A cross-functional team was formed that included individuals from outside of the assembly department. Internal failures dropped to one-third of what they had been. The equipment uptime increased from 74 percent to 89 percent.FMEAs and Bottom-Line Results Effective use of FMEAs can have a positive impact on an organization's bottom line because of their preventive nature. not to lead the team. each tasked with a different aspect of the process/product.000 per month on engine teardowns. The manufacturer established three FMEA teams.2 part per million. Three team leaders were assigned and were responsible for ensuring the team's efforts were coordinated. Example 2 An aircraft engine manufacturer conducted an FMEA on its engine assembly operation. With that information. Productivity per labor hour increased by 22 percent. Customer complaints dropped from an average of two per year to none. his role was to keep notes. .
the team decreased solder defects on the complex boards they manufactured from an average of eleven per board to an average of one per board. ISO/TS 16949. . and FMEAs ISO 9000 is a family of standards for quality management systems. The team continues to work to further reduce the defects. After establishing and implementing a preventive maintenance program. ISO 9000.
While ISO/TS 16949:2002 is based on ISO 9001.When an organization achieves ISO 9000 certification. and uses systems capable of controlling processes that determine the acceptability of its product or services. defines the requirements of a comprehensive quality management system. that organization has developed. which combined the earlier standards of ISO 9001. it contains complementary automotive industry-specific requirements adding to the standard both a process orientation and a focus on the customer. and 9003. ISO/TS 16949:2002 takes ISO 9001 one step further with an emphasis on a process approach. 9002. ISO 9001:2000. Basic terms Failure . instituted.
Next higher level effect The Failure effect as it applies at the next higher indenture level." Failure mode "The manner by which a failure is observed. Failure cause Defects in design. Complexity increases as levels are closer to one. function or functionality. quality. determined by the degree of injury." Implementation . Severity "The consequences of a failure mode."The LOSS of an intended function of a device under stated conditions. Local effect The Failure effect as it applies to the item under analysis. or system damage that could ultimately occur. or part application. process. property damage. it generally describes the way the failure occurs. End effect The failure effect at the highest indenture level or total system. which are the underlying cause of the failure or which initiate a process which leads to failure." Failure effect Immediate consequences of a failure on operation. or status of some item Indenture levels An identifier for item complexity. Severity considers the worst potential consequence of a failure.
Ideally. before and during ongoing operation of the process. quality and reliability – an engineer can get a lot of information about how to alter the development/manufacturing process. FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service. When considering possible failures in a design – like safety. failures are prioritized according to how serious their consequences are. The outcomes of an FMEA development are actions to prevent or reduce the severity or likelihood of failures. FMEA is used during the design stage with an aim to avoid future failures (sometimes called DFMEA in that case). in order to avoid these failures. A FMEA also documents current knowledge and actions about the risks of failures for use in continuous improvement. FMEA provides an easy tool to determine which risk has the greatest concern. 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. The FMEA Process Overview . how frequently they occur and how easily they can be detected. The development of these specifications will ensure the product will meet the defined requirements and customer needs. and therefore an action is needed to prevent a problem before it arises. Using FMEA when designing FMEA can provide an analytical approach.In FMEA. Later it is used for process control. It may be used to evaluate risk management priorities for mitigating known threat vulnerabilities. cost. performance. starting with the highest-priority ones. when dealing with potential failure modes and their associated causes.
Failures are not limited to problems with the product. a risk priority number (RPN) will be determined for each potential failure mode and effect. For example. Detection— The probability of the failure being detected before the impact of the effect is realized. low to high. Ways in which a product or process can fail are called failure modes. Occurrence— The probability or frequency of the failure occurring.000 for each failure mode) is used to rank the need for corrective actions to eliminate or reduce the potential failure modes. and some effects are more likely to occur than others. Each failure mode has a potential effect. Evaluating the Risk of Failure The relative risk of a failure and its effects is determined by three factors: Severity— The consequence of the failure should it occur. and then eliminate or reduce them. . FMEA Development FMEAs are developed in three distinct phases where actions can be determined. and risks within a process or product. The clock stops working or runs too fast or too slow. each potential failure mode and effect is rated in each of these three factors on a scale ranging from 1 to 10. although special attention should be given when the severity ranking is high (9 or 10) regardless of the RPN. Assessing the Risk Priority Number Using the data and knowledge of the process or product. a drip coffeemaker—a relatively simple household appliance—could have several things fail that would render the coffeemaker inoperable. Here are some possible ways the coffeemaker can fail: The heating element does not heat water to sufficient temperature to brew coffee. By multiplying the ranking for the three factors (severity × occurrence × detection). There is a short in the electrical cord. will move the product closer to 100 percent total customer satisfaction. The FMEA process is a way to identify the failures. Because failures also can occur when the user makes a mistake. The coffeemaker does not turn on automatically by the clock. Even the simplest products have many opportunities for failure. There is either not enough or too much coffee used. regardless of how the user operates it. 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. Those failure modes with the highest RPNs should be attended to first. those types of failures should also be included in the FMEA. each potential effect has a relative risk associated with it. In addition. effects.The objective of an FMEA is to look for all of the ways a process or product can fail. Anything that can be done to ensure the product works correctly. A product failure occurs when the product does not function as it should or when it malfunctions in some way. The risk priority number (which will range from 1 to 1. The pump does not pump water into the filter basket. Calcium deposits from impure water clog up the brewing process.
these actions reduce risk and increase the . Reviewing the probability or occurrence number in order of the highest severity and working downwards. Step 2 adds causes and Occurrences to each Failure Mode. RPN threshold values do not play an important role in action development. This is not preventing failure. occurrence. only in action evaluation when completed. As the Process FMEA progresses. Actions are not only determined based on RPN values. This is the detailed development section of the FMEA process. Step 1 is to determine all failure modes based on the functional requirements and their effects. Process Failure Mode and Effects and Analysis The second part of a collaborative FMEA deployment is the Process FMEA. detection) steps 1. 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. After each of these steps actions are developed. but in fact driving bad behavior of the design and process teams required to perform the FMEA. When completed. Please note that RPN's are calculated after three possible action opportunities have occurred. Risk Priority Numbers (RPN) are calculated. In past years. Process Failure Mode and Effects Analysis takes a product or service design and considers all the steps that are necessary to be successful. Each combination from steps 1 and 2 which are considered at risk requires the detection number to be selected. Next.3 as described above. 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. occurrence (criticality) and detection capability) is the topic of actions which are counter measures to the risk. 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. 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.2. each potential cause which has risk (measured with severity. The detection number represents the ability of planned tests and inspections at removing defects or excite failure modes to fail. design verification and inspection methods. setting an RPN would immediately be met with lower numbers without any real change or improvement.
But before starting with an FMEA. special or otherwise should be investigated and finding fed back to the product/service design team prior to design completion. in which appropriate actions need to be defined. which contains the important information about the system. These characteristics. . A good understanding simplifies further analysis. a worksheet needs to be created. Process FMEA is an integral part of the Lean Product Development process and APQP (Advanced Product Quality Planning). 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. Before starting the actual FMEA. It is useful to create a coding system to identify the different system elements. It is developed in three main phases. To start it is necessary to describe the system and its function. Unintentional uses are a form of hostile environment. A robustness analysis can be obtained from interface matrices. This collaboration can have benefits such as cost savings. it is important to complete some pre-work to confirm that robustness and past history are included in the analysis. a block diagram of the system needs to be created. and parameter diagrams. such as the revision date or the names of the components. personnel or as a result of a corrective action process The pre-work The process for conducting an FMEA is straightforward. because engineers tend to focus on what they control directly. On this worksheet all the items or functions of the subject should be listed in a logical manner. It is important to consider both intentional and unintentional uses. This provides and excellent opportunity for the product or service design to take full advantage of the knowledge of the process experts. Many failures are due to noise factors and shared interfaces with other parts and/or systems. These are called logical relations around which the FMEA can be developed. and increased use of Error Proofing required to avoid problems as opposed to detecting and sorting. Then. This way an engineer can see which uses of the system are desirable and which are not. This diagram gives an overview of the major components or process steps and how they are related. The block diagram should always be included with the FMEA.probability of success. 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. Design for Assembly and Manufacturing. boundary diagrams. based on the block diagram.
Examples of causes are: erroneous algorithms. A failure effect is defined as the result . again 1–10. This step is called the detailed development section of the FMEA process. Actions need to be determined if the occurrence is high (meaning > 4 for nonsafety failure modes and > 1 when the severity-number from step 1 is 1 or 0). Hereafter the ultimate effect of each failure mode needs to be considered. A failure mode is given an occurrence ranking (O). Occurrence also can be defined as %. we can give 1 to it. therefore each failure mode should be listed in technical terms and for function.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. A failure mode in one component can lead to a failure mode in another component. A failure cause is looked upon as a design weakness. corrosion or deformation. This can be done by looking at similar products or processes and the failure modes that have been documented for them. excessive voltage or improper operating conditions. Examples of failure modes are: Electrical short-circuiting. It is based on your product and customer specification. Again this should be in technical terms. Step 2: Severity Determine all failure modes based on the functional requirements and their effects. All the potential causes for a failure mode should be identified and documented. If a non-safety issue happened less than 1%.
Examples of failure effects are: degraded performance. if possible. analysis. noise or even injury to a user. This ranks the ability of planned tests and inspections to remove defects or detect failure modes in time. The proper inspection methods need to be chosen. . First. 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. actions are considered to change the design by eliminating the failure mode. monitoring and other techniques that can be or have been used on similar systems to detect failures. it is necessary to test their efficiency. or protecting the user from the effect. In this way it is convenient to write these effects down in terms of what the user might see or experience. In addition.of a failure mode on the function of the system as perceived by the user. From these controls an engineer can learn how likely it is for a failure to be identified or detected. If the sensitivity of an effect has a number 9 or 10. design verification is needed. A high detection number indicates that the chances are high that the failure will escape detection. Step 3: Detection When appropriate actions are determined. The assigned detection number measures the risk that the failure will escape detection. Hereafter one should identify testing. These numbers help an engineer to prioritize the failure modes and their effects. Each combination from the previous 2 steps receives a detection number (D). that the chances of detection are low. Each effect is given a severity number (S) from 1 (no danger) to 10 (critical). that prevent failure modes from occurring or which detect the failure before it reaches the customer. an engineer should look at the current controls of the system. or in other words.
Once this is done it is easy to determine the areas of greatest concern. Whenever a design or a process changes. These actions can include specific inspection. This means it is not always the failure modes with the highest severity numbers that should be treated first. Once the actions have been implemented in the design/process. These tests are often put in graphs. There could be less severe failures. recommended actions with targets. the new RPN should be checked. to confirm the improvements. They are threshold values in the evaluation of these actions. responsibility and dates of implementation are noted. After ranking the severity. redesign (such as selection of new components).After these three basic steps. but which occur more often and are less detectable. risk priority numbers (RPN) are calculated Risk Priority Number (RPN) RPN play an important part in the choice of an action against failure modes. After these values are allocated. 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. 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 Reduce the occurrence of the failure mode Improve the detection . testing or quality procedures. for easy visualization. adding more redundancy and limiting environmental stresses or operating range. The failure modes that have the highest RPN should be given the highest priority for corrective action. an FMEA should be updated.
This understanding simplifies the process of analysis by helping the engineer identify those product/process uses that fall within the intended function and which ones fall outside.FMEA Procedure The process for conducting an FMEA is straightforward. An understanding of the product or process under consideration is important to have clearly articulated. 1. It is important to consider both . Describe the product/process and its function. The basic steps are outlined below.
2. Examples of potential failure modes include: Corrosion Hydrogen embrittlement Electrical Short or Open Torque Fatigue Deformation Cracking . Prepared By. which can be costly and time consuming. 4. Complete the header on the FMEA Form worksheet: Product/System. Create a Block Diagram of the product or process. 3./Assy. and Revision Date. list them in a logical manner under their subsystem/assembly based on the block diagram. Modify these headings as needed. The block diagram should always be included with the FMEA form. This diagram shows major components or process steps as blocks connected together by lines that indicate how the components or steps are related. The diagram shows the logical relationships of components and establishes a structure around which the FMEA can be developed. Establish a Coding System to identify system elements.. Use the diagram prepared above to begin listing items or functions. Identify Failure Modes. process. etc. Component. A failure mode is defined as the manner in which a component.intentional and unintentional uses since product failure often ends in litigation. subsystem. Date. Design Lead. 5. If items are components. Revision (letter or number). system. A block diagram of the product/process should be developed. Subsys. could potentially fail to meet the design intent.
A failure cause is defined as a design weakness that may result in a failure. Enter the Probability factor. Failure modes should be listed for function of each component or process step. A failure effect is defined as the result of a failure mode on the function of the product/process as perceived by the customer. Describe the effects of those failure modes. At this point the failure mode should be identified whether or not the failure is likely to occur. Each failure should be listed in technical terms. A numerical weight should be assigned to each cause that indicates how likely that cause is (probability of the cause occuring). Examples of potential causes include: Improper torque applied Improper operating conditions Contamination Erroneous algorithms Improper alignment Excessive loading Excessive voltage 9. They should be described in terms of what the customer might see or experience should the identified failure mode occur. A failure mode in one component can serve as the cause of a failure mode in another component. Current Controls (design or process) are the mechanisms that prevent the cause of the failure mode from occurring or which detect the . Examples of failure effects include: Injury to the user Inoperability of the product or process Improper appearance of the product or process Odors Degraded performance Noise Establish a numerical ranking for the severity of the effect. Identify Current Controls (design or process). Identify the causes for each failure mode. The intent of the ranking is to help the analyst determine whether a failure would be a minor nuisance or a catastrophic occurrence to the customer. The causes should be listed in technical terms and not in terms of symptoms. This enables the engineer to prioritize the failures and address the real big issues first. A common industry standard scale uses 1 to represent no effect and 10 to indicate very severe with failure affecting system operation and safety without warning. For each failure mode identified the engineer should determine what the ultimate effect will be. Looking at similar products or processes and the failures that have been documented for them is an excellent starting point. 10. 7. 8.6. Keep in mind the internal as well as the external customer. A common industry standard scale uses 1 to represent not likely and 10 to indicate inevitable. The potential causes for each failure mode should be identified and documented.
Based on the Current Controls. The engineer should now identify testing. After these actions have been taken. monitoring. Determine Recommended Action(s) to address potential failures that have a high RPN. and inclusion of back-up systems or redundancy. Notice that RPN and criticality prioritize causes differently. Review Risk Priority Numbers (RPN). selection of different components or materials. analysis. FMEA Example A bank performed a process FMEA on their ATM system. “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. The FMEA should then be updated and plans made to address those failures to eliminate them from the product/process. The Risk Priority Number is a mathematical product of the numerical Severity.” The team should use their experience and judgment to determine appropriate priorities for action. Detection is an assessment of the likelihood that the Current Controls (design and process) will detect the Cause of the Failure Mode or the Failure Mode itself. These actions could include specific inspection. monitoring mechanisms. Assign Responsibility and a Target Completion Date for these actions. and Detection ratings: RPN = (Severity) x (Probability) x (Detection) The RPN is used to prioritize items than require additional quality planning or action. . de-rating. According to the RPN. Criticality does not include the detection rating. Indicate Actions Taken. testing or quality procedures. This makes responsibility clear-cut and facilitates tracking. limiting environmental stresses or operating range.failure before it reaches the Customer. After a new product or process has been in use previously undetected or unidentified failure modes may appear. Determine the likelihood of Detection. 15. consider the likelihood of Detection using the following table for guidance. Figure 1 shows part of it—the function “dispense cash” and a few of the failure modes for that function. performing preventative maintenance. thus preventing it from reaching the Customer. redesign of the item to avoid the failure mode. 13. so it rates highest the only cause with medium to high values for both severity and occurrence: “out of cash. Only the headings are shown for the rightmost (action) columns. Each of these controls should be assessed to determine how well it is expected to identify or detect failure modes. 14. Update the FMEA as the design or process changes. Are any further actions required? 16. re-assess the severity. The optional “Classification” column was not used. and other techniques that can or have been used on the same or similar products/processes to detect failures. the assessment changes or new information becomes known. 11. probability and detection and review the revised RPN's. Probability. 12.
the analysis team must: Rate the severity of each effect of failure.e. the likelihood of detecting the problem before it reaches the end user or customer). Rate the likelihood of prior detection for each cause of failure (i. are described next.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. Risk Priority Numbers and Criticality Analysis. Rate the likelihood of occurrence for each cause of failure. Risk Priority Numbers To use the Risk Priority Number (RPN) method to assess risk. The two most common methods. Calculate the RPN by obtaining the product of the three ratings: .
Identify the portion of the item’s unreliability that can be attributed to each potential failure mode. Criticality Analysis The MIL-STD-1629A document describes two types of criticality analysis: quantitative and qualitative. Item Criticality = SUM of Mode Criticalities To use the qualitative criticality analysis method to evaluate risk and prioritize corrective actions. Effects and Criticality Analysis (FMECA). the analysis team must: Rate the severity of the potential effects of failure. . This risk assessment method is commonly associated with Failure Mode and Effects Analysis (FMEA). Compare failure modes via a Criticality Matrix. These risk assessment methods are commonly associated with Failure Modes. Rate the likelihood of occurrence for each potential failure mode. the analysis team must: Define the reliability/unreliability for each item and use it to estimate the expected number of failures at a given operating time. Calculate the criticality for each potential failure mode by obtaining the product of 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. To use the quantitative criticality analysis method. which identifies severity on the horizontal axis and occurrence on the vertical axis. Rate the probability of loss (or severity) that will result from each failure mode that may occur.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.
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 .
the commonality of both forms simplifies the task. A brief discussion of the traditional FMEA and the reason for the simplification comes later in the chapter. This is intentional. Note that the simplified FMEA format is very similar to that used for the simplified QFD. as presented in the prior chapter. A simplified FMEA (failure modes and effects analysis) will reduce this likelihood. the simplified FMEA will be less complex than the FMEA taught in most Six Sigma classes. A simplified FMEA will generate savings largely through cost avoidance and it is usually used in the Define or Improve steps of the DMAIC process.Simplified FMEA Overview What we will learn in this chapter is that on any project there can be collateral damage to areas outside the project. Since many of the same people will be involved in both the QFD and the FMEA. . As was true for simplified QFDs. since the goal is to use both on every new product or change.
Just as in the simplified QFD. The proper group of participants will vary per project. Accounting and Software Development The introduction of a new software package or a different accounting procedure sometimes causes unexpected problems for those affected. You need input on what possible negative effects could occur. Sales and Marketing A change in a sales or marketing strategy can affect other products or cause aggressive response by a competitor. A simplified FMEA is a method to review things that can go wrong even if a proposed project. In doing a simplified FMEA. Receivables How receivables are handled can affect future sales. A simplified FMEA will reduce unforeseen problems and trauma.) The emphasis in a simplified FMEA is to identify affected components or issues downstream or tangentially related processes in which issues may arise because of the project. (They should have been covered in regular project reviews. customers. especially in regard to any effects that the project may have on things not directly related to the project. These people could be machine operators. Often a project generates so much support and enthusiasm that it lacks a healthy amount of skeptics. the critical step is getting everyone together who has anything to do with the project. A simplified FMEA is one way to make sure that all the possible ramifications are understood and addressed. especially those having to deal with the effects of the project. it is assumed that all inherent components of the direct project will be done correctly. A simplified FMEA will help to understand concerns of both customers and internal salespeople and identify approaches that minimize future sales risks while reducing overdue receivables. or even suppliers. it often saves a lot of cost and embarrassment. Insurance The balance between profits and servicing customers on insurance claims is dynamic. or change. task. or modification is completed as expected.Applications: Simplified FMEA Manufacturing Before implementing any new design. A simplified FMEA helps keep people attuned to risks associated with any actions under consideration. do a simplified FMEA. Simplified FMEA Instructions . Everyone is working on the details of getting the project going and little effort is spent on looking at ramifications beyond the specific task! The simplified FMEA form is a way of giving a project a critical look before it is implemented. process. An FMEA converts qualitative concerns into specific actions.
The left side of the simplified FMEA form (see Figure 4-1) is a list of things that could possibly go wrong. The first task of the meeting is to generate this list of concerns. or even employee problems. "3" is a medium concern. "4" means it addresses the concern well. assuming that the project is completed as planned. Below each solution and opposite the concern. After these ratings are complete. "3" means it addresses the concern satisfactorily. "4" is a very important concern. negative effects on existing similar products. Figure 4-1: Simplified FMEA example and form Across the top of the simplified FMEA is a list of solutions already in place to address the concerns or additional solutions that have been identified in the meeting. "1" is a matter for discussion to see if it is an issue. beneath the solution item and opposite the concern. Enter this value in the upper half of the block. "1" means it addresses the concern very little. environmental concerns. each response item is to be rated on how well it addresses the concern: "5" means it addresses the concern completely. "0" or a blank means it does not affect the concern. "2" means it addresses the concern somewhat. These will be rated in importance: "5" is a safety or critical concern. safety issues. On this list could be unforeseen issues on other parts of the process. "2" is a minor concern. A negative number means the solution actually makes the concern worse. multiply each rating times the concern value on .
so a barrier physically isolating the area around the magnets was not an option. The machine operator had to be free to access all areas of the machine. . which allowed it to rub against the product at one specific location on the machine. On following up with the pacemaker manufacturer. with the highest value being the #1 consideration for implementation. This solution was especially attractive because it would be inexpensive and easy to do. Below is the simplified FMEA as derived in the meeting. Powerful magnets would be mounted just outboard of the machine at the problem area. since all the parts were readily available and would be easy to install on the machine for a test. They didn't want to commit to what level of shielding would suffice to protect the operator and were afraid of any resultant liability. it was discovered that even representatives of the manufacturer were not sure how the powerful magnets would affect the device. operators. the concern that one operator had a heart pacemaker was a complete surprise. The cost of rebuilding the machine was very high. Most of the concerns that surfaced had doable and effective solutions. no one had any idea of how the magnets would affect the pacemaker. like reassigning the operator to another machine. This wear caused the tooling to have too much play. however. However. As in the simplified QFD. and it would solve the problem completely! The initial engineering study found no "show-stoppers" in regard to installing the magnets. near the tooling. these summations are only a point of reference. and quality technicians were invited to a meeting to do the simplified FMEA. But a requirement of the Six Sigma process was to first do a simplified FMEA to see if this could cause other issues. CASE STUDY: A POTENTIALLY LIFE-SAVING SIMPLIFIED FMEA A high-speed production machine was experiencing wear. maintenance people. Add all the values in the lower half of the boxes in each column and enter the sum in the Totals row indicated near the bottom of the form. An engineer came up with what seemed like an ingenious solution. Bench tests with actual magnets and tooling indicated that it would work extremely well.the left. Other options were discussed. fore-men. that they had serious reservations. a group of production engineers. So. Enter this product in the lower half of each box. so the manufacturing plant wanted other options of solving this problem. These are then prioritized. Everyone was anxious to implement this project. It is appropriate to reexamine the concerns and ratings. These magnets would hold open the tooling as it went by. They did say. eliminating the chance of the tooling rubbing against the product. causing quality issues. but all of those options raised issues (such as union issues on the reassignment).
seldom is a simplified FMEA done without uncovering some issue that was previously unknown. Although this example is more dramatic than most. However. process. and many people. or service should participate in the simplified FMEA. current design controls. cost. the option of using magnets was abandoned. Both the traditional and simplified FMEAs trigger consideration of collateral damage. Much effort goes into making sure the specific details of a project. because there seemed to be no way to eliminate the possible risk to the operator with the pacemaker! No other low-cost solution was identified. Most of these issues can be resolved and it's easier to resolve them up front than afterwards! In this case study. This traditional FMEA requires multiple forms. because collateral damage can occur on all levels of project or change. A traditional FMEA requires the people doing the form to identify each potential failure event and then the failure mode. the severity. and likelihood of the action succeeding. the machine was rebuilt. the frequency. the impact. The machine had to be rebuilt despite the high cost. areas not inherently tied to the project are often ignored. and removing the magnets.At that point. Traditional FMEAs As mentioned earlier. Everyone affected by the proposed project. Revisit the results of the simplified FMEA several times to make sure that they truly reflect the group's intent. since the simplified FMEA takes far less time. Obviously the author prefers the simplified FMEA. A simplified FMEA emphasizes identifying concerns in other affected areas and prioritizing potential solutions to these concerns. the consequences. Is the extra time and effort worth it? As with the traditional QFD. A simplified FMEA is usually used in the Define or Improve steps of DMAIC. Without the simplified FMEA. dealing with the effects. the potential cause. the simplified FMEA is less complex than the traditional FMEA normally taught in Six Sigma. the simplified FMEA prevented the risk. or service are correct. it can be used on every project or change. with some real risk that the operator could have been hurt or even lost his life. much time. However. and embarrassment of installing the magnets. process. so one of the two should be used. the project would have been implemented. This would probably have been the outcome in any case. . risk priority. the likelihood of detection. the recommended action. perhaps it is worthwhile on very complex and large programs. This gives the simplified FMEA a real advantage. which is unlikely to happen with a traditional FMEA.
An example is shown in Figure 7. For each process step shown in the first level. optimal process settings. The process decision program chart. Understanding process failure modes allows us to define mitigation strategies to minimize the impact or occurrence of failures. where failure cannot be economically prevented. also known by its acronym PDPC. a strategy can be developed to minimize the occurrence of the failure and contain the damage. Forcing the team to anticipate problems before they occur helps them uncover issues or solutions that would otherwise be ignored.6: Example PDPC. These mitigation strategies may result in new process steps. they are unlikely to be used on every program or change. which is the value of the simplified FMEA. this process allows team .The cost of doing a simplified FMEA will be more than offset by the costs avoided on the project's potential negative effects on other areas.6. In some cases. Countermeasures provide the contingencies for each problem. potential problems (what-ifs) are identified in the second level. is a tool for identifying problems that can occur in a project or process and developing contingencies (either a solution or work-around) to deal with each problem. but may be justified on extremely large and complex programs. it can be evaluated for its failure modes. Figure 7. The intent of the analysis is to confront problems which otherwise might not have been addressed. or process control strategies to prevent failure. Cause and effect diagrams used in the analyze stage are again useful for brainstorming the potential causes of failures. Additionally. Traditional FMEAs are more complex. This brainstorming activity will provide necessary input to process decision program charts and failure modes and effects analysis. The PDPC has the same general format as a tree diagram. Evaluating Process Failure Modes Once the process flow is established. However.
or an education program to inform workers of the need for change. Of course. suppose the anticipated problem is resistance to change among the process personnel. and likelihood of detection are determined. the next step is to think of a measure to counteract this problem. The methodology can be applied to products or processes. note each of these and prioritize the solution(s) using the methods discussed earlier. Failure mode 2: Item numbers not correctly defined in database. While some solutions will focus on . although the application to processes is most useful in the improve stage of DMAIC. The likelihood of occurrence and likelihood of detection are based on historical data. Prevention methods can achieve satisfactory results. and criticality analysis. particularly in service processes. Effect of failure mode 1: Wrong product shipped. For instance. where available. The FMEA process (described in detail in Part 3) begins by defining the functions for each process step. It is used to determine high risk functions or product features based on the impact of a failure and the likelihood that a failure could occur without detection. Reducing the risk often demands a reduction in the rate of occurrence. also known by its acronym FMEA or failure modes. These failure modes must be addressed. detection method. the failure modes and their effect are identified. particularly in reducing the rate of occurrence of human errors. Failure modes and effects analysis. PREVENTION OF HUMAN ERRORS It is useful to categorize process failures according to their origin. with increased cost of quality. You can then weigh the costs and benefit of each alternative in order to decide on your course of action. Effect of failure mode 2: Wrong product items shipped. without feeling like they are being unduly negative. the failure modes and their effects for the above function include: Failure mode 1: Product ID mistyped. likelihood of occurrence. rather than in the heat of the project when you suddenly discover an unanticipated problem. Many failures are due to human error. it is much easier to make these decisions in the calm of the planning room. The results of the FMEA will indicate activities prone to failure. Once the potential problems are identified. generally by posing the questions What could go wrong? or What could the customer dislike? For example. The severity. the process step Enter the Product ID number for each purchased item has the function Links to the product database to identify the item numbers necessary for shipment of the products being purchased. When more than one countermeasure is available. For example. Improvements in detection are stopgap measures. For each function. either through elimination or a mitigation strategy. effects. The possible counteractive measures include an incentive program to boost morale. is a more detailed approach to the problem. such as through the process optimization techniques described earlier. and a resulting risk factor (RPN: risk priority number) calculated. or likely to cause serious consequences if they do fail.members to discuss points that they may find troublesome.
automation. For example. and even 100% inspection is not 100% accurate. easily accessible to the clerk.individuals' performance. Bar code readers are simple devices used in many industries to prevent product numbers. There are three main categories of human errors: inadvertent errors. Inadvertent errors may be otherwise termed mistakes. Automation is a common way to minimize the occurrence of inadvertent errors by removing the human element. might help reduce data entry errors. An engaged and empowered work force is perhaps the best prevention. they usually involve only a single disgruntled worker and are extremely rare in practice. most failures resulting from human error will be prevented by process or system-level solutions. the part and the fixture used to secure the part could incorporate a pin with a mating slot so the part will not fit correctly into the fixture unless it is properly aligned. and isolated to a few workers. To prevent holes from being drilled in the wrong place on a production part. Fortunately. is one of the lean tools for preventing errors. usually confined to single characteristic or class of characteristics (for example. cracks). Foolproofing. modern hypodermic needles have now been designed to prevent the needle from being used more than once to avoid possible instances of cross-contamination between patients. Training is perhaps the most common method of reducing technique errors and can be combined with visual aids and documentation at the process level for easy access by the work force. For example. There is no predictable pattern to an inadvertent error. Willful errors are deliberate attempts to sabotage the process. Implementation and Verification . customer information. and willful errors. Another approach that has proven helpful is an ergonomic approach of improving the work environment. so errors can still be undetected. Technique errors can be minimized using the same methods as for inadvertent errors (fool proofing. and ergonomics) or through training. Inadvertent errors can be prevented in a number of ways. A fundamental change is incorporated to the design of the part or the process to prevent the error from occurring. Willful errors are characteristically nonrandom and difficult to detect. and often due to poor training. Technique errors are related to the process procedure. with little or no advance knowledge that a failure is coming. Inadvertent errors are typically characterized by a low incidence rate. Technique errors are characterized as being unintentional. Only 100% inspection can hope to detect these types of errors. technique errors. also called poka yoke. a simpler keyboard. or product data from being incorrectly typed into a database.
Process personnel. Nonetheless. and provide the necessary support to ensure its proper implementation. These updates allow the vision of the solution to be formed over time by the stakeholders. the project team must work closely with process personnel to communicate proper action and understanding of the process conditions. especially with regard to process failures. increasing the likelihood of buy-in to the solution. reasons for problems at this point is due to lack of communication. where in-depth training can be conducted. Hypothesis tests on the difference in means may be used to compare the process before and after implementation of the solution. must be cognizant of the authority vested in the project team in implementing the solution. to implement the specific solution beginning at a specific date and time. at this point the procedures may still be somewhat in flux until the solution has been deployed. Until this training takes place. even when the solution is evident. and their immediate management.Once the improvement methodology and new process levels have been determined. Previous chapters have discussed the need for regular updates with the stakeholder groups to avoid surprises at the improve stage. stakeholders will understand the need for a solution in the define stage. must be presented in a clear and orderly fashion to the stakeholder groups. appreciate the extent of the problem in the measure stage. yet still overlooked. As discussed in. caution and diligence must be exercised at this point. . they can be implemented. The process personnel must be provided with clear instructions on their new procedures. The sponsor must convey the specific authority to the project team. One of the most obvious. Depending on the extent of the solution. properly communicated through the organizational hierarchy. each step of the solution. Through proper communication. Exercising rigor during the improve stage brings clarity to the solution for each of the stakeholder groups. Starting with the project sponsor. with a contingency plan in the event of failure. generally using control charts. Statistical analysis of these conditions. The goal is to quickly establish the merits of the solution so that the project team can move to the control stage. and realize its complexity through the analyze stage. Even in the simplest of improvements. This state of transition requires oversight by the project team and/or process personnel (under the direction of the team) to ensure the process output meets the expectations of the authorized solution. in-depth training of all personnel could be premature until the process and its procedures have been stabilized. the project team must focus on proper communication to ensure support through the implementation of the solution. is needed to verify the results. statistical control of the process is necessary if project success is to be measured. While the control stage includes detailed training on the new process procedures.
Identification of certain design characteristics that contribute to failures. public. not just manufacturing processes or product design. private. It can be used to improve support processes. This helps avoid the same failures in future projects. .FMEAs can be used to improve the safety of the process of manufacturing a product as well as to improve the safety performance of the product itself. This combination of user knowledge and outsider observations provides a comprehensive analysis of the hazards. or governmental organizations. Manufacturing safety FMEAs should be conducted by a team of people who operate the equipment. Ensuring that any failure that could occur will not injure the customer or seriously impact a system.Uses of FMEA Development of system requirements that minimize the likelihood of failures. The FMEA process was developed to anticipate and eliminate safety problems before they occurred. Consequently. FMEA is not just a tool for the manufacturing or engineering department. Development of methods to design and test systems to ensure that the failures have been eliminated. A discussion of some of the support processes where FMEA might be useful follows. along with others who are not involved in operating the equipment. Tracking and managing potential risks in the design. profit and not-for-profit. FMEAs provide a structure and a common language that can be used by teams in manufacturing and service. To produce world class quality products When and Where to Use FMEAs The FMEA process is widely applicable in a variety of settings beyond the product design and manufacturing processes focused on in this book. and minimize or eliminate those effects. Evaluation of the requirements of the customer to ensure that those do not give rise to potential failures. Safety FMEAs were first developed as a tool to identify and correct safety hazards.
while others are financial busts. FMEAs can be helpful in determining financial strategies and assessing credit or investment risks. an FMEA that studies the things that could go wrong with customer credit and how credit failures would affect the company would provide a structure for a credit plan that will reduce financial risk.FMEAs conducted on products to determine their safety are critical in today's litigious society. It can also be used to preplan reaction and response to potentially damaging product recalls or disasters. As with a product or design FMEA. computer systems and the software that drives them are used in air transportation. If these possibilities can be uncovered during an FMEA. Human Resources With organizational restructuring (downsizing. Companies have an obligation to assure their customers that their products are safe and fit for use. computer glitches can happen because of hardware or systems issues. and banking. It is not unusual for a product to be incorrectly used or to be used for an unintended purpose. Practically everything that we do is governed by software. From the simplest local area network (LAN) to multi-million-dollar telecommunications systems. It is helpful to involve consumers or eventual users of the product in such an FMEA. so they can be eliminated or reduced. Accounting/Finance With some modifications to the ranking scales for severity. medicine.S. right-sizing). Software Design The effects of software are all around us. FMEAs force a structured analysis of problems and glitches that might happen. and other members of the FMEA team should observe how it is used. Problems created by software bugs or incorrect programs can range from nuisances to potentially fatal disasters. For example. and detection. firms annually. safety provisions must be built in to the products. before extending substantial credit to a potential customer with a shaky credit history. use of FMEAs can help make both the design and installation of information systems more robust. Some promotional campaigns are wildly successful. Marketing Billions of dollars are spent on marketing and advertising by U. occurrence. it is not sufficient that product instructions spell out safe operating procedures. An FMEA can be used as a bridge between the plan and the actual restructuring. An FMEA conducted prior to an advertising or marketing launch can help businesses avoid costly and sometimes embarrassing mistakes. An FMEA can be used to identify offensive or misleading advertising copy. Information Systems/Technology Even without software problems. For example. the human resources field is faced with developing and executing plans for new organizational structures that are significantly different from the classic pyramid structures we are all familiar with. Changes on paper that appear to be workable can turn into disasters. Software quality assurance is critical in many of these instances. They should be asked to use the product. In many cases. a software design quality FMEA can identify problems before they occur. Plans . safeguards can be built in to the product design. to name a few applications.
Table 10. A firm that develops CAD software used an FMEA to uncover bugs in the system prior to release for beta testing.1: Other Uses for FMEAs Function Safety Examples A plastics molder conducted an FMEA on a new piece of molding equipment to ensure that the safety devices on it worked and that emergency stop buttons were properly placed. an FMEA can be conducted to anticipate problems with different purchase options. An HR department led an FMEA that involved senior managers from all departments during an organizational restructuring. This information can be used to improve purchasing decisions as well as to develop installation plans once the equipment is purchased. saving time and money while improving morale. the marketing department incorporated an FMEA into the design process to reduce the potential of offending potential customers and miscommunicating vital information about the company. A finance department performed an FMEA on its annual budget to make sure it was realistic and accounted for potential emergency expenses. a purchasing group used an FMEA to select a new piece of manufacturing equipment.can be designed to address the potential problems and crises can be avoided. Purchasing Prior to purchasing a major piece of equipment. During the development of a new corporate brochure. Working with the process-engineering department. The information systems department conducted an FMEA to determine the security of sensitive data. Accounting/finance Software design Information systems/technology Marketing Human resources Purchasing .
Equipment .analyze manufacturing and assembly processes.analyze service industry processes before they are released to impact the customer. process capability and evidence of proper Process Controls found in a control plan are required.analyze products before they are released for production. Medical device and drug delivery has added FMEA as a means to understand the risks not considered by individual design and process personnel. 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. Benefits of FMEA Improves the quality. The timing for this is critical to get the best benefit. . Eventually. The Food and Drug Administration (FDA) has recognized FMEA as a design verification method for Drugs and Medical Devices. 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. 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 machinery and equipment design before they are purchased. Concept . Design . Advanced Product Quality Planning (APQP) provides the concurrent and collaborative structure to accomplish this effectively. FMEA use in Medical Failure Mode and Effects Analysis is being deployed in many more industries than just Automotive and Aerospace.analyze systems or subsystems in the early design concept stages. (21 CFR §820) and typically wishes to review the effort put into the FMEA activity during scheduled reviews. Service . reliability.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.
Q-1 is firmly committed to the use and innovation of FMEA. FMEA continues to be an integral part of the development of Aircraft. New innovations in this prevention technology have increased its’ effectiveness. 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. Communications. We are not only a major part and input into future FMEA process. FMEA is an integral part of this LCC determination. Technical Kickoff (TKO) combines many tools including robustness considerations into the process yielding more detailed results and leads to improved designs and processes. Missile systems. Radar. Contact us to see how we could help you as well. we invent processes like LEAN FMEA to help our . 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. Q-1 has trained and facilitated many machinery and equipment FMEAs to assist in lowering LCC and preventing costly down and excessive repair time. This use is driven from the Joint Commission of Accreditation of Health Care Organizations (JCAHO).Hospitals also have begun to use FMEA to prevent the possibility of process errors and mistakes leading to incorrect surgery or medication administration. drug delivery systems and hospitals wishing to prevent failure in its’ processes. 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. Q-1 has many years of experience with process driven FMEA and has trained and facilitated FMEAs for Medical Device design. 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. Electronics and other key interfacing technologies.
where a less serious failure mode receives a higher RPN than a more serious failure mode." but . If used as a top-down tool. Fault tree analysis (FTA) is better suited for "top-down" analysis. occurrence and detection rankings may result in rank reversals. General texts and detailed publications are available in forensic engineering and failure analysis. 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. but not by how much. or to report expected failure intervals of particular failure modes up to the upper level subsystem or system. Advantages Improve the quality.customers use the process more efficiently. Additionally. For instance. then external help is needed from consultants who are aware of the many different types of product failure. it is limited by their experience of previous 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 Limitations Since FMEA is effectively dependent on the members of the committee which examines product failures. FMEA is thus part of a larger system of quality control. Please contact us to find out how we can make your FMEA experiences more valuable. The ordinal rankings only say that one ranking is better or worse than another. It is not able to discover complex failure modes involving multiple failures within a subsystem. where documentation is vital to implementation. It is a general requirement of many specific national and international standards that FMEA is used in evaluating product integrity. the multiplication of the severity. If a failure mode cannot be identified. and multiplication is not defined for ordinal numbers. We have developed faster and more thorough techniques which provide an excellent FMEA output. a ranking of "2" may not be twice as bad as a ranking of "1. while achieving the superior output faster. FMEA may only identify major failure modes in a system. 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. The reason for this is that the rankings are ordinal scale numbers." or an "8" may not be twice as bad as a "4.
" The team boundaries were to complete the FMEA. the second-shift manufacturing supervisor. The team included a design engineer who helped develop the extinguisher. The company developed a new extinguisher for home use. Another wanted to know the benefits of the rounder shape of the canister. The team also used the FMEA Team Start-Up Worksheet (see Figure 9. Software Most FMEAs are created as a spreadsheet. FMEA Case Study Overview This example of a design/product FMEA involves a manufacturer of fire extinguishers. Specialized FMEA software packages exist that offer some advantages over spreadsheets. The design engineer brought a prototype extinguisher to the first meeting and demonstrated how it worked. A team of five employees was formed to work through the FMEA process. and the members decided to name their team the "Fire Extinguisher FMEA Team.000 budget and could request help from within the company to tap into outside team members' expertise. One participant asked if this extinguisher would work the same for left. the purchasing manager. The team was given a $5. He also handed out a product specification sheet. The design engineer was appointed the team leader. The consequences of a faulty extinguisher could be life-threatening. and several good questions were asked and answered regarding the similarities to existing models.and right-handed people as do the existing models. at which time another team would be formed to conduct a process FMEA. The deadline for project completion was April 15. and the sales and marketing manager.1) as a checklist to make sure they understood their boundaries of freedom and the scope of the project. the first-shift quality technician. .multiplication treats them as though they are. Case Study Step 1: Review the Process All team members were given a blueprint of the fire extinguisher to review. Everyone on the team was given an opportunity to operate the extinguisher. highlighting the differences in operation between the new and existing models. the product manager demonstrated how the extinguisher worked. It wanted to make sure the extinguisher would be effective and would not cause any problems when used. See Level of measurement for further discussion. including making improvements. For example.
potential failures were cracks. holes. rather than dealing with the entire product at once. . The chemical agent in the extinguisher was excluded because another team had included it in an FMEA about six months earlier. Case Study Step 2: Brainstorm Potential Failure Modes As suggested in the step-by-step FMEA guidelines. They listed the potential failures on the FMEA Analysis Worksheet and grouped them by component (see Figure 9.2). with the hose. and blockages. The most logical breakdown was into the key components of the extinguisher: the hose.Figure 9. With the canister. the canister.1: FMEA Team Start-Up Worksheet. and another was that the label might not be properly glued. and the valve mechanism. one potential failure was that the canister could be dented. the charge gauge. The team then brainstormed all of the potential failures for each of those components. the team broke analysis of the product design into manageable chunks. For example.
In one of those cases. the team could not agree on a ranking and had to hold a vote. and the team agreed on potential effects for each of the failure modes. Case Study Step 3: List Potential Effects of Each Failure Mode Each failure mode was discussed. and anticipated that each might have a different ranking in at least one of the three ranking categories. and the final ranking was an average of all of the votes. In most cases. but it also helped them target their improvement efforts once they had decided on the items they needed to improve. Case Study Step 6: Assign a Detection Ranking for Each Failure Mode and/or Effect The Fire Extinguisher FMEA Team listed all controls currently in place for each of the potential causes of failure or the effect of the failure and then assigned a detection ranking for each item. Case Study Step 4: Assign a Severity Ranking for Each Effect Because a failure can have several different effects. Members reasoned that if it was highly unlikely that the failure and effect would occur. and each effect can have a different level of severity associated with it. The team noted that there were significant differences . If members felt that several different effects were possible. the team agreed to include all possible effects. the team identified the potential causes of failure associated with each failure mode. although in a couple of instances they had heated discussions before reaching consensus. Each member voted the score they felt the item should get. they listed them in a separate row. the team gave each effect its own severity ranking. then the item would probably get a low RPN anyway. members agreed on the severity ranking.Figure 9. The team listed each potential effect next to the failure. Not only did this information help members determine the likelihood of the failure occurring.2: FMEA Analysis Worksheet. While there was some disagreement about the likelihood that a certain effect would occur. Case Study Step 5: Assign an Occurrence Ranking for Each Failure Mode The team began this step by collecting data on failures with similar fire extinguishers. Case Study Step 7: Calculate the Risk Priority Number for Each Failure Mode The RPN was calculated for each potential failure mode by multiplying the severity times the occurrence times the detection ranking. For the failure modes where no data existed.
but this did not surprise the team because members knew that severity is the most difficult ranking to impact. The highest score was 810 points. and all members responsible for an action item gave a report. Pleased with the results. The team decided it would work on any item that had an RPN of 200 or higher. The eight areas addressed were at or below the target of 200 points. team members prepared their final report for management CASE STUDY – FMEA REQUIREMENT The requirement was to evaluate the potential risks associated with the design of a cash handling mechanism to provide confidence that the specified performance could be achieved. . Case Study Step 9: Take Action to Eliminate or Reduce the High-Risk Failure Modes Each of the high-risk failure modes was discussed. With the criteria of an RPN of 200 or higher. to give the team time to reevaluate the severity. There were only a couple of cases where severity was reduced. In others. and determine what other work needed to be done before the product introduction date. Case Study Step 8: Prioritize the Failure Modes for Action One of the team members created a Pareto diagram of the failure modes so that it would be easy to distinguish visually between the items. In some cases they were able to significantly reduce the occurrence ranking by using mistake-proofing techniques. The team's efforts resulted in more than 60 percent reduction in the resulting RPN from the original FMEA total RPN for all items. The target was to have all of the action complete within six weeks. Two hundred was set as the cutoff point because it encompassed over half of all of the potential failure modes. Case Study Step 10: Calculate the Resulting RPN as the Failure Modes Are Reduced or Eliminated After completing the corrective action. All commitments were met. occurrence. they improved the detection rankings. there were eight items they would need to attend to. and the team was able to conduct its reevaluationFMEA at that same meeting. the team met. The team rationalized that an improvement in more than half of the failure modes would be a significant step in the right direction. and the team determined what action would be taken to reduce the risk. assigning responsibility and a target completion date for each failure mode. which made it easy to distinguish between the items that required action and those that could be left as is. and the lowest was 48 points. and detection of each item.among the rankings.
If there was no way of sensing that a failure mode had occurred this was rated at 10 and conversely. prioritisation and reduction. The product of these three ratings gave an overall "Risk Priority Rating" for that failure mode. We chose to use the Failure Modes and Effects Analysis method as a well-proven approach to risk identification. Severity Rating (SR) The severity ratings of failure modes were defined in terms of the perceived impact that the risk would have if it were realised.BACKGROUND Handling bank notes and other "documents of value" in automatic mechanisms gives rise to a particular set of potential problems. By dividing the mechanism into sections bounded by risk "hot spots". the "Detection Rating" and the "Occurrence Rating". for each failure mode. We needed to provide a way of systematically documenting and analysing the main risks in the mechanism design and to show how these risks could be minimised or. The lifecycle of documents through the machine was plotted so that none of the major risk contributors would be missed. at least. managed. These ratings range from 10 (most severe consequences) to 1 (least severe). Detection Rating (DR) The probability of detecting that a certain failure mode has occurred was then defined. SOLUTION The mechanism consisted fundamentally of a series of banknote transport and storage systems and was used to validate and store customer deposits. Each of these segments was addressed in turn by listing all of its possible failure modes and then. if a failure mode was almost certain to be detected this was rated at 1. it was possible to define a set of segments that would undergo evaluation. . recording the "Severity Rating".
000 documents were processed per week.Occurrence Rating (OR) The potential occurrence rating was defined in terms of the time that the system may run between fault occurrences and from that we could deduce the number of documents between occurrences of the particular fault. on average. SR = Severity Rating DR = Detection Rating OR = Occurrence Rating RPR = Risk Priority Rating Where RPR = SR*DR*OR. around 15. . The assumption made here was that. Section Failure Modes The following table gives an example of some of the failure modes identified in a section that includes a mechanism for separating notes.
but the most common FMEAs are Design-FMEAs (DFMEAs) and Process-FMEAs (PFMEAs). and safety hazards to name a few. and create safety hazards. Design-FMEAs uncover potential failures associated with the product that could cause product malfunctions. reduce process reliability. Regardless of the reason for implementing FMEAs. Process-FMEAs ideally should be conducted prior to starting up a new process. Some companies implement FMEAs to meet customer requirements. most people will agree that when FMEAs are used correctly they can uncover potential problems before the problems get out to the customer and lead the way to a more robust process or product. to increase the probability of detection so that it would be possible to take remedial action whilst in operation. cause customer dissatisfaction.from the preliminary design to when the product goes into production. reduce the probability of occurrence or. Return to top . Sometimes FMEAs are used as a proactive tool to reduce the potential for problems.This process was repeated for all failure modes and for all sections of the machine giving a complete picture of the risks associated with the mechanism design. shortened product life. FAQ: Why do companies use FMEAs? There are a number of reasons why companies use FMEAs. Sometimes FMEAs are initiated because of a specific problem. but are conducted on existing processes as well. CONCLUSION Using a technique such as Failure Modes and Effects Analysis allowed us to systematically identify the risks in a mechanism design. This process was used as a very effective tool for verifying if the proposed layout and design of the mechanism adequately coped with the failure modes that would predictably occur during machine operation. Return to top How can FMEAs help companies improve quality and productivity? FMEAs can be used in many different ways. quantify those risks with relative ratings and recommend design changes to increase the probability of product success. Design-FMEAs should be used throughout the design process . Process FMEAs uncover potential failures that can impact product quality. Those failure modes with the highest Risk Priority Ratings were given the most immediate attention and design changes were identified to either.
Members of the FMEA team have not been properly trained in the use of FMEAs and become frustrated with the process. Each potential failure mode will have at least one. medical device manufacturing. potential causes of the failure. if not several potential effects or consequences of the failure. ideally each who has a slightly different view of the product or process under investigation. possibly overlooking significant but obscure failure modes. also on a scale of 1 to 10 where 10 is the greatest likelihood of occurrence. The FMEA team gets bogged down with the minute details of the design or process. an FMEA is a listing of all potential failures and their corresponding effects of the product or process under investigation. and current controls to prevent the failure from occurring or to detect the failure once it does occur. aerospace. If an FMEA has over 200 potential failures it is a good sign that the product or process under investigation should be broken into subunits. The variety of perspectives that a team can bring to an FMEA is what makes them so powerful. Rushing through the generation of potential failure modes in a hurry to move on to the next step of the FMEA. Listing practically the same effect for every failure mode and not being more specific (for example "customer will be unhappy"). The design or process expert is either not included on the FMEA team or is allowed to dominate the FMEA team. 8. Return to top How are FMEAs conducted? FMEAs are typically conducted by small team of people. Stopping once the RPNs are calculated and not taking action on the highest risk failures. 3. but rather individual components of the car. Return to top What are some mistakes companies make when they use FMEAs? Here are the top ten reasons why FMEAs fail: 1. Such FMEAs are typically generated to satisfy customer requirements. Auditors are quick to pick up on FMEAs that are developed by one person. and control combination to get the risk priority number (RPN) for that combination. Any one person will not be able to develop as comprehensive and valuable am FMEA as a team of people can generate. each with its own FMEA. 9. Not reevaluating the RPNs once improvements have been made to assess the impact of the improvements. The combinations with the highest RPNs are the potential failures that you need to focus your improvement efforts on. Not customizing the three rating scales with company specific examples so that they are meaningful to your company. losing sight of the overall objective. cause. 6. effect. The potential effects of the failure are rated on a scale of 1 to 10 where 10 is the most severe consequence. 2. 5. The severity. but are seen as having little value to the company. For example.How does an FMEA work? Basically. and chemical processing. FMEAs are a means to achieving better quality product and that's why they are now required by OEMs and industry standards in diverse industries such as automotive. One person is assigned to do the FMEA alone. The ability to detect the failure prior to it occurring is also rated on a scale of 1 to 10 where 10 is the least likely chance of controlling or detecting the failure. 4. 7. and detection ratings are multiplied together for each potential failure. . It is not unusual for an FMEA to list 50 to 200 different potential failures. occurrence. automotive companies don't conduct FMEAs on the entire car. The potential causes of the failure are rated in terms of the chance of the cause occurring.
and eager to put what they have learned to use on an FMEA team. FMEA training is available through seminars but this approach can be expensive when you need to train several people. What is the best way to teach people how to conduct FMEAs? There is a basic methodology and terminology for conducting FMEAs that all people on an FMEA team should understand. While the FMEA process may seem relatively simple and straight forward. While the FMEA process is best worked through using post-it notes and flipcharts. The FMEA Investigator is cost-effective because you pay one price and can train everyone at your site without additional per user costs. Click here to download a free FMEA Excel Template. Once employees have completed the training they will be ready. willing. but there is no guarantee that if you give FMEA team members books that they will actually have the time to sit down and read them. they will be ready to start their first FMEA project. it helps to have an FMEA worksheet template in Microsoft Excel® for documenting the process. . The best way to train FMEA team members is with the FMEA Investigator computer-based training program.How can my company get started using FMEAs? The first step in using FMEAs is learning how to use them. the process can become unwieldy for the first-time user. Having this knowledge prior to participating on an FMEA team will enable the team to work efficiently and effectively. The FMEA Investigator is a solid training program. There are also books available on FMEA. Once a team of people have gone through FMEA training. Make sure that the project is well-defined so that the team doesn't get off on a tangent.
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