This article originally appeared in a href=”https://www.qualitydigest.com/”>Quality Digestunder the title “How to Get More Out of Your FMEAs”
How to Get More Out of Your FMEA, Part II
by Richard Harpster, President of Harpco Systems
Organizations that use FMEAs can normally be categorized in one of five implementation stages. Organizations that achieve measurable monetary benefits operate in stages four or five. Unfortunately, most organizations remain in stages one through three, with most in stage one.
Poor FMEA Understanding: Stage One
Typically the organization in stage one uses FMEAs because it has to meet a paper requirement for a customer or quality standard. Personnel perform the FMEA right before it is due to be turned in to the customer, usually too late in the process to be useful.
Quite often, the wrong people perform the FMEA. The quality department ends up developing the documents rather than making design engineers responsible for design FMEAs and operating personnel responsible for process FMEAs.
Management does not understand the FMEA, and a lot of confusion and disagreement exists as to how to fill out the FMEA form. Debate occurs when individuals attempt to develop the ratings for occurrence and detection numbers. Because accurate feedback systems don’t yet exist to base the ratings on, they’re based on inaccurate guesses. Using inaccurate ratings , the organization calculates erroneous RPNs and identifies an RPN level at which recommended actions are needed. If the number of recommended actions required based on this level is too high, the organization “adjusts” the ratings to bring the RPNs down below the trigger level, which reduces the number of recommended actions. Obviously, this makes the entire FMEA process meaningless.
As a result, the organization fulfills its paper requirement, but the value of the FMEA is greatly diminished. Problems still remain unsolved at a high cost to the organization. The individuals performing the FMEAs believe they are doing them correctly because the customer or auditor is accepting them. Eventually, everyone sees the FMEA process not as a tool but as something that has to be done.
Learning Proper FMEA Techniques: Stage Two
Management ensures that the personnel who will perform and use the FMEA data are trained in the proper technique. They realize that the people who perform design FMEAs must be experts in the product and the people who perform the process FMEAs must be experts in the process. Rather than being confused by the FMEA terminology, they realize they have used the FMEA methodology before but never called it FMEA. They also learn that although they have used the methodology, they have not used it rigorously enough to achieve its full benefits.
In stage two, everyone involved gains an understanding of what the ratings and class column mean and how to use them to prioritize what must be worked on first. They understand that the class column is the most important factor and not the RPN. Management also realized that they don’t have systems in place that will give them data to accurately determine the failure probability occurrence ratings, detection ratings and class. Using the limited objective data they have, they know they will have to use their knowledge of the product and process to arrive at the ratings. Due to the lack of an objective basis, they know that it is a waste of time to argue for long periods about the ratings.
When leaving this stage, those who have been using FMEAs believe they can be a powerful tool. Unfortunately, the people who perform FMEAs doubt whether management will provide the time and resources necessary to support their successful implementation. They also question how they will explain the new approach to their auditor or customer, who may still be at stage one in their understanding of the FMEA implementation process.
Building a Proper FMEA: Stage Three
The organization begins to use FMEAs correctly on a targeted product. Early on there is excitement that the FMEAs are finally going to be done correctly. As the implementation continues, worry starts to set in as the FMEA uncovers and documents the complexity of the product and process being analyzed. Everyone knew the complexity existed but had never seen it documented. The FMEA grows from the 5 or 10 pages that used to be normal to 100 or more pages. The organization must overcome its fear of the increased length and complexity of the complete FMEA if FMEAs are to be used successfully.
As the FMEA process continues, many problems may be uncovered that must be solved if the company is to become as good as it can be. There may not be enough resources to solve all of these problems and still meet the launch deadline.
Knowing this, people begin to proclaim that FMEAs will never work. They believe that all the hard work has been a waste of time. What good is it to know what is wrong and not be able to correct it? Life was a lot easier when all the problems were not documented. If organizations don’t overcome this obstacle they may slip back into stage one.
Using a FMEA’s Outputs: Stage Four
Management realizes that the length of a FMEA cannot be predetermined. The complexity of the product and process being analyzed determines the FMEA’s length. Management understands that all of the problems uncovered in the FMEA can’t be solved in one product launch. They understand that the product will be launched with known problems and that they will have to make objective decisions as to what to work on during this launch and what must be delayed. When a problem occurs in an area that management decided not to work on, it is handled without emotion. This is possible because the FMEA identified that it might happen and management chose not to work on it so that other problems could be prevented.
Once the organization launches the product, management creates a long-term plan to improve the design and manufacturing systems. This plan minimizes the times the company must make difficult decisions when doing FMEAs in the future.
Full FMEA Implementation and Integration: Stage Five
The organization has implemented new design and manufacturing systems to answer the majority of the problems identified in the FMEAs. Systems now exist to provide data to accurately set occurrence and detection ratings. Due to the accuracy of the new ratings, predictions about field failures and process yields can be made. The class column can now be accurately determined and actions required for improvement prioritized.
Design engineers review design FMEAs before making design changes. If a change must be made, operating personnel review the process FMEA and control plan to determine the impact the change will have on the process.
When a problem occurs, the appropriate personnel consult the FMEAs. If the FMEA inadequately addressed the problem, engineers make changes to the design and manufacturing system to ensure that all possible steps have been taken to prevent a similar problem in the future.
The organization uses the FMEAs as training tools because they contain the collective knowledge of the company’s experts.
FMEA Acceptance: Conclusion
The FMEA process can be a powerful tool when properly used. As with any tool, before it can be used well it must be understood. Once organizations fully understand and commit to the FMEA process, they may be pleasantly surprised with the money they save and the product and process improvements that result.
Part I of this paper covers some FMEA basics: How to Get More Out of Your FMEA, Part I
About The Author
Richard HarpsterRichard Harpster is president of Harpco Systems, which he founded in 1987. Harpco Systems specializes in providing software, training, and consulting for risked-based product lifecycle management (RBPLM®). During the past 30 years, Harpster has helped hundreds of companies implement improved risk-based design and manufacturing systems in a wide variety of industries. He is a recognized expert in the application of FMEAs and has invented several new concepts, including the linking of design FMEAs to process FMEAs in 1990, which became an automotive industry standard 18 years later. His latest inventions in the field of RBPLM® include Requirements Risk Assessment (RRA®), Usage Risk Assessment (URA™), Multiple Integrated Cause Analysis (MICA™) and Rapid Integrated Problem Solving (RIPS®). He has published several papers on the topic of RBPLM®.
“Harpco breaks down the barriers and corrects the pitfalls so companies can reap the full benefits of FMEA. Classroom training not only properly teaches FMEA, but participants actually build their business’s FMEA as they go and are often blown away by how much work got accomplished. Harpco Systems has become known as the Modern FMEA for a reason. Its structured, simplified and sustainable.”
“We used QPlus to achieve Q1 and ISO 16949 successfully at the Ford Motor Co. Monroe BAO Plant. The software promoted linked documentation that prevented issues at internal and external audits. Assured the quality documents at the operations production level had all relevant and concurrent information that was reviewed in the program files. QPlus allowed the program members to create a baseline “Hot End Exhaust” database that produced linked documentation from the DFMEA to the production visual aids the operators used to perform correctly.”
“Harpco’s training is first rate and helps develop new ways of thinking about the importance of creating proper specifications early. Separately, I’ve seen firsthand the effectiveness of using their approach in problem solving, helping to advance problems that had reached a stall using traditional methods.”
“We were very fortunate to work with Rich Harpster and his team as we improved our DFMEA process at Calsonic. There is no better teacher, coach, implementer than Rich when it comes to creating a knowledge base for engineers to use in creating part specs to assure that products meet the customer’s requirements. Rich teaches the basics, then he accelerates the FMEA process so that requirements and specs are related in a database that can be continually updated.”
“I would like to thank Harpco Systems for the help, advice and frankly the education in how to design, develop, source and manufacture new to world products.”