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Develop FMEAs in alignment with AIAG FMEA reference manuals. Page 4. Changes in the FMEA Manual (4th Ed.) • Improved format, easier to. FMEA 4th Edition - Download as PDF File .pdf) or read online. AIAG PPAP Manual 4th Edition Forms (Including Control Plan). Uploaded by. befoa. FMEA Handbook (with Robustness Linkages). Failure Mode . This FMEA Handbook contains instructions for preparing an FMEA, and answers the What, In addition, on large systems a third or fourth level boundary diagram may be Type A – It was introduced in the previous edition of this handbook. Data are entered.
McDermott Raymond J. Mikulak Michael R. Beauregard Pro Raymond J. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use.
A specific and clear definition is even more important with process FMEAs because they can encompass so many different aspects of the process manufacturing chain, from the raw materials to components, to the actual manufacturing and assembly, to the shipping, and everything in between.
While each part of the chain plays an important role in the quality of a product, it may help to use a narrow definition of the process to ensure that the FMEA project is completed in a timely manner. Because large processes may be difficult to work on in their entirety, break them into subprocesses when possible and attend to them one at a time, or have several teams working at the same time on different subprocesses.
Date Completed: Team Members: Who will take minutes and maintain records? What is the scope of the FMEA? Attach the Scope Worksheet. YES NO 4. Are customers or suppliers involved? Boundaries of Freedom 5. What aspect of the FMEA is the team responsible for? What is the budget for the FMEA?
Implementation of Improvements 7. Does the project have a deadline? What is the procedure if the team needs to expand beyond these boundaries? How should the FMEA be communicated to others? The key question asked in design FMEAs is: How can the product fail? Part 1: Who is the customer? Scope defined by: Part 2: What are the product features and characteristics?
Part 3: What are the product benefits? Part 4: Study the entire product or only components or subassemblies? Part 5: Include consideration of raw material failures? Part 6: Include packaging, storage, and transit? Part 7: What are the operational process requirements and constraints? For example, a piece of automated assembly equipment may misfeed parts, resulting in products not being assembled correctly.
Or, in a chemical manufacturing process, temperature and mixing time could be sources of potential failures, resulting in an unusable product. With these five elements in mind, ask: How can process failure affect the product, processing efficiency, or safety? What process components are to be included in the investigation? What process support systems are to be included in the study? To what extent should input materials be studied?
What are the product material requirements and constraints? Should packaging, storage and transit be considered part of this study? Both types of FMEAs use severity, occurrence, and detection rankings, although the definitions of the ranking scale for each may be different.
The ranking scales presented in this book are suggestions and can be used as starting points to develop customized ranking scales specifically designed for a particular organization. Step 2 Brainstorm potential failure modes. Step 3 List potential effects of each failure mode. Step 4 Assign a severity ranking for each effect. Step 5 Assign an occurrence ranking for each failure mode. Step 7 Calculate the risk priority number for each effect. Step 8 Prioritize the failure modes for action.
Step 9 Take action to eliminate or reduce the high-risk failure modes. Step 10 Calculate the resulting RPN as the failure modes are reduced or eliminated. These steps are explained in detail following the FMEA worksheet section and are illustrated in a case study. This form captures all of the important information about the FMEA and serves as an excellent communication tool.
FMEA Date: Original Revised Page: FMEA Team: Team Leader: Others will adapt this form to meet their needs. The numbering system should enable cross-referencing to similar FMEAs as well as other improvement activities dealing with the same product or process. Copies of all FMEAs should be kept in a central location so they are easily accessible during audits or internal process and product reviews.
Step 1: Review the Process or Product The team should review a blueprint or engineering drawing of the product if they are considering a product FMEA or a detailed flowchart of the operation if they are conducting a process FMEA.
This will help ensure that everyone on the FMEA team has the same understanding of the product or process that is being worked on.
If a blueprint or flowchart is not available, the team will need to create one prior to starting the FMEA process. Information on creating a flowchart can be found in Appendix 1. With the blueprint or flowchart in hand, the team members should familiarize themselves with the product or process. For a product FMEA, they should physically see the product or a prototype of it.
For a process FMEA, the team should physically walk through the process exactly as the process flows. Step 2: Brainstorm Potential Failure Modes Once everyone on the team has an understanding of the process or product , team members can begin thinking about potential failure modes that could affect the manufacturing process or the product quality.
Team members should come to the brainstorming meeting with a list of their ideas. Because of the complexity of most manufactured products and manufacturing processes, it is best to conduct a series of brainstorming sessions, each focused on a different element i.
Focusing on the elements one at a time will result in a more thorough list of potential failure modes. It is not unusual to generate dozens of ideas from the brainstorming process. In fact, that is the objective! Once the brainstorming is complete, the ideas should be organized by grouping them into like categories. Your team must decide the best categories for grouping, as there are many different ways to group failure modes.
You can group them by the type of failure e. Grouping the failures will make the FMEA process easier to work through.
Without the grouping step, the team may invest a lot of energy jumping from one aspect of the product to a completely different aspect of the product and then back again.
An easy way to work through the grouping process is to put all of the failure modes onto self-stick notes and post them on a wall so they are easy to see and move around as they are being grouped.
The grouping also gives the team a chance to consider whether some failure modes should be combined, because they are the same or very similar to each other.
When the failure modes have been grouped and combined, if appropriate, they should be transferred onto the FMEA sheet. Note that there are usually several failure modes for each component. Step 3: For some of the failure modes, there may be only one effect, while for other modes there may be several effects. This step must be thorough because this information will feed into the assignment of risk rankings for each of the failures.
It is helpful to think of this step as an if-then process: If the failure occurs, then what are the consequences? Steps 4—6: Kevin M. It is important to establish clear and concise descriptions for the points on each of the scales, so that all team members have the same understanding of the rankings.
The scales should be established before the team begins the ranking process. The more descriptive the team is when defining the ranking scale, the easier it should be to reach consensus during the ranking process. No discernible effect.
Degradation of primary function vehicle operable, but at reduced level of performance. Loss of primary function vehicle inoperable, does not affect safe vehicle operation. No effect 2 1 Appearance or Audible Noise, vehicle operable, item does not conform and noticed by discriminating customers No discemible effect. Slight inconvenience to process, operation, or operator A portion of the production run may have to be reworked in-station before it is processed.
A portion of the production run may have to be reworked off line and accepted. Line shutdown or stop ship. A portion of the production run may have to be scrapped. Deviation from primary process including decreased line speed or added manpower. May endanger operator machine or assembly with warning.
May endanger operator machine or assembly without warning. Frequent failures associated with similar designs or in design simulation and testing. Occasional failures associated with similar designs or in design simulation and testing. Isolated failures associated with similar designs or in design simulation and testing.
Only isolated failures associated with almost identical design or in design simulation and testing. No observed failures associated with almost identical design or in design simulation and testing.
This system should be customized by the organization for use with all FMEAs. See Appendix 4 for examples of custom ranking scales. The value of having one common set of ranking scales throughout an organization is that the rankings and the resulting risk priority numbers between FMEAs have a relationship to each other.
Even if the ranking system is clear and concise, there still may be disagreement about the ranking for a particular item. In these cases, the techniques described in Appendix 3 may help the group reach consensus. Step 4: Assign a Severity Ranking for Each Effect The severity ranking is an estimation of how serious the effects would be if a given failure did occur. In some cases it is clear, because of past experience, how serious the problem would be.
Post Design Freeze and prior to launch Not likely to detect at any stage 10 No current design control; Cannot detect or is not analyzed. No detection opportunity Rank Criteria: Product validation reliability testing, development or validation tests prior to design freeze using degradation testing e.
Failure Mode or Error Cause detection in-station by operator through the use of variable gauging or by automated controls in-station that will detect discrepant part and notify operator light, buzzer, etc. Gauging performed on setup and first-piece check for set-up causes only. Problem Detection at Source Criteria: Likelihood of Detection by Process Control No current process control; Cannot detect or is not analyzed. Error Cause detection in-station by automated controls that will detect error and prevent discrepant part from being made.
It is the effect, not the failure, which is rated. Therefore, each effect should be given its own severity ranking, even if there are several effects for a single failure mode. Step 5: The team can make a better estimate of how likely a failure mode is to occur and at what frequency by knowing the potential cause of failure.
Once the potential causes have been identified for all of the failure modes, an occurrence ranking can be assigned even if failure data do not exist.
Step 6: We start this step by identifying current controls that may detect a failure or effect of a failure. First, the current controls should be listed for all of the failure modes, or the effects of the failures, and then the detection rankings assigned. Step 7: This number alone is meaningless because each FMEA has a different number of failure modes and effects.
However, it can serve as a gauge to compare the revised total RPN once the recommended actions have been instituted. Step 8: Prioritize the Failure Modes for Action The failure modes can now be prioritized by ranking them in order, from the highest risk priority number to the lowest. A Pareto diagram see Figure 8. The team must now decide which items to work on. Those below the cutoff are left alone for the time being.
For example, an organization may decide that any RPN above creates an unacceptable risk. This decision sets the cutoff RPN at Take Action to Eliminate or Reduce the High-Risk Failure Modes Using an organized problem-solving process, identify and implement actions to eliminate or reduce the high-risk failure modes. Ideally, the failure modes should be eliminated completely. For example, gasoline companies, car manufacturers, and pump manufacturers worked together during the phase-out of leaded fuel to eliminate the potential failure mode of putting leaded fuel into a car that runs on unleaded fuel.
This was accomplished by making the gas tank opening too small for the leaded gas nozzle. When a failure mode has been eliminated completely, the new risk priority number approaches zero because the occurrence ranking becomes one. While elimination of failure modes altogether is ideal, it may not be achievable in all cases. When this happens, it helps to refer back to the severity, occurrence, and detection rankings that the team assigned to each item.
Think of ways to reduce the rankings on one, two, or all three of the scales. Often, the easiest approach for making a process or product improvement is to increase the detectability of the failure, thus lowering the detection ranking. For example, a coffeemaker might have a tone that sounds every ten minutes to remind you that it is turned on and that you need to turn it off before you leave the house, or a computer manufacturer may include a piece of software that notifies the user that there is low disk space.
However, these are Band-Aid approaches that often are costly and do not actually improve the quality of the product. Increasing failure detectability will simply make it easier to detect failures once they occur.
Reducing the severity is important, especially in situations that can lead to injuries. For example, a company that manufactures weed wackers might limit the speed of the machine, reducing the severity of a potential personal injury. However, the richest opportunity for improvement lies in reducing the likelihood of occurrence of the failure. After all, if it is highly unlikely that a failure will occur, there is less need for detection measures.
Step Calculate the Resulting RPN as the Failure Modes Are Reduced Once action has been taken to improve the product or process, new rankings for severity, occurrence, and detection should be determined, and a resulting RPN calculated. For the failure modes where action was taken, there should be a significant reduction in the RPN.
If not, that means action did not reduce the severity, likelihood of occurrence, or detectability.
In addition, the total RPNs of the before-and-after product or process can be compared and contrasted. It is up to the FMEA team and the company to decide on how far the team should go with improvements. There will always be the potential for failure modes to occur. The question the company must ask is how much relative risk the team is willing to take. That answer will depend on the industry and the seriousness of failure.
For example, in the nuclear industry, there is little margin for error; they cannot risk a disaster occurring. In other industries, it may be acceptable to take higher risks. The company developed a new extinguisher for home use. It wanted to make sure the extinguisher would be effective and would not cause any problems when used. The consequences of a faulty extinguisher could be life-threatening.
A team of five employees was formed to work through the FMEA process. The team included a design engineer who helped develop the extinguisher, the second-shift manufacturing supervisor, the first-shift quality technician, the downloading manager, and the sales and marketing manager.
The deadline for project completion was April 15, at which time another team would be formed to conduct a process FMEA. Case Study Step 1: Review the Process All team members were given a blueprint of the fire extinguisher to review. The design engineer brought a prototype extinguisher to the first meeting and demonstrated how it worked.
He also handed out a product specification sheet. For example, the product manager demonstrated how the extinguisher worked, highlighting the differences in operation between the new and existing models. One participant asked if this extinguisher would work the same for left- and right-handed people as do the existing models. Another wanted to know the benefits of the rounder shape of the canister.
The most logical breakdown was into the key components of the extinguisher: The chemical agent in the extinguisher was excluded because another team had included it in an FMEA about six months earlier. The team then brainstormed all of the potential failures for each of those components.
For example, with the hose, potential failures were cracks, holes, and blockages.
With the canister, one potential failure was that the canister could be dented, and another was that the label might not be properly glued. While there was some disagreement about the likelihood that a certain effect would occur, the team agreed to include all possible effects. Members reasoned that if it was highly unlikely that the failure and effect would occur, then the item would probably get a low RPN anyway. The team listed each potential effect next to the failure. If members felt that several different effects were possible, and anticipated that each might have a different ranking in at least one of the three ranking categories, they listed them in a separate row.
Shane T. Tyler J. Chase L. March 5 K. Are all affected areas represented? Are different levels and types of knowledge represented on the team? NO Boundaries of Freedom 5. April Do team members have specific time constraints? Review with steering committee 9. In most cases, members agreed on the severity ranking, although in a couple of instances they had heated discussions before reaching consensus.
Each member voted the score they felt the item should get, and the final ranking was an average of all of the votes. Assign an Occurrence Ranking for Each Failure Mode The team began this step by collecting data on failures with similar fire extinguishers.
For the failure modes where no data existed, the team identified the potential causes of failure associated with each failure mode. Case Study Step 6: 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. The team noted that there were significant differences among the rankings, which made it easy to distinguish between the items that required action and those that could be left as is.
The highest score was points, and the lowest was 48 points. The team decided it would work on any item that had an RPN of or higher. Two hundred was set as the cutoff point because it encompassed over half of all of the potential failure modes. The team rationalized that an improvement in more than half of the failure modes would be a significant step in the right direction.
With the criteria of an RPN of or higher, there were eight items they would need to attend to. Case Study Step 9: Case Study Step Calculate the Resulting RPN as the Failure Modes Are Reduced or Eliminated After completing the corrective action, the team met, and all members responsible for an action item gave a report.
All commitments were met, and the team was able to conduct its reevaluation FMEA at that same meeting. The eight areas addressed were at or below the target of points. FMEAs provide a structure and a common language that can be used by teams in manufacturing and service, profit and not-for-profit, private, public, or governmental organizations. FMEA is not just a tool for the manufacturing or engineering department. It can be used to improve support processes, not just manufacturing processes or product design.
A discussion of some of the support processes where FMEA might be useful follows. Safety FMEAs were first developed as a tool to identify and correct safety hazards. The FMEA process was developed to anticipate and eliminate safety problems before they occurred.
Consequently, 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. Manufacturing safety FMEAs should be conducted by a team of people who operate the equipment, along with others who are not involved in operating the equipment. In many cases, it is not sufficient that product instructions spell out safe operating procedures; safety provisions must be built in to the products.
It is helpful to involve consumers or eventual users of the product in such an FMEA. They should be asked to use the product, and other members of the FMEA team should observe how it is used.
It is not unusual for a product to be incorrectly used or to be used for an unintended purpose. If these possibilities can be uncovered during an FMEA, safeguards can be built in to the product design.
For example, before extending substantial credit to a potential customer with a shaky credit history, 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. Software Design The effects of software are all around us. Practically everything that we do is governed by software.
Software quality assurance is critical in many of these instances. For example, computer systems and the software that drives them are used in air transportation, medicine, and banking, to name a few applications. From the simplest local area network LAN to multi-million-dollar telecommunications systems, use of FMEAs can help make both the design and installation of information systems more robust. Some promotional campaigns are wildly successful, while others are financial busts. 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. It can also be used to preplan reaction and response to potentially damaging product recalls or disasters.
Human Resources With organizational restructuring downsizing, right-sizing , 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. An FMEA can be used as a bridge between the plan and the actual restructuring. FMEAs force a structured analysis of problems and glitches that might happen. Plans can be designed to address the potential problems and crises can be avoided, saving time and money while improving morale. downloading Prior to downloading a major piece of equipment, an FMEA can be conducted to anticipate problems with different download options.
This information can be used to improve downloading decisions as well as to develop installation plans once the equipment is downloadd. Human resources An HR department led an FMEA that involved senior managers from all departments during an organizational restructuring. downloading Working with the process-engineering department, a downloading group used an FMEA to select a new piece of manufacturing equipment. Appendix 1 Creating a Process Flowchart Flowcharts are to manufacturing processes what road maps are to drivers.
They provide a detailed view of the process, and increase understanding of how the process flows. With a process flowchart, teams can identify repetitive steps, bottlenecks, and inefficiencies in the process.
The best way to create a flowchart is to walk through the process as if you were the thing being processed or created. The process steps should be followed sequentially, and notes should be taken during the walk-through.
Avoid shortcuts while going through the process, as you may miss critical steps. Once the walk-through is complete, each step should be listed on a self-stick note. It helps to have several people do this, as each will contribute ideas that others missed. The steps should then be grouped and organized according to their order in the process. For complicated processes with several steps and substeps, it helps to create a top-down flowchart, where each of the major steps in the process are listed in order of flow across the top of the chart, and the substeps are listed underneath each major step see Figures A1.
Once the steps are identified and put in order, symbols are assigned to each step. At this point, missed steps become more obvious and can be added as needed. With all the steps in place, arrows connecting the symbols are added to show the direction of the process flow.
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