This Month's Theme is Recommended
Next month's theme will be severity risk
Every month in FMEA Corner, join Carl Carlson, a noted expert in the field of FMEAs and facilitation, as he addresses a different FMEA theme (based on his book Effective FMEAs) and also answers your questions.
Questions and answers are a great way to learn about FMEAs, for both experienced and less experienced FMEA practitioners. Please feel free to ask any question about any aspect of FMEAs. Send your questions to Carl.Carlson@EffectiveFMEAs.com, and your contact information will be kept anonymous. All questions will be answered, even if they are not included in the FMEA Corner.
recommended actions [rek-uh-men-did ak-shuhns, noun]
In an FMEA, "recommended actions" are the tasks recommended by the FMEA team that can be performed to reduce or eliminate the risk associated with a potential cause of failure. Recommended actions should consider the existing controls, the relative importance (prioritization) of the issue and the cost and effectiveness of the corrective action. There can be many recommended actions for each cause.
FMEA Tip of the Month
The FMEA team reviews each of the high severities and each of the high RPNs, and develops the recommended actions that, when executed, will reduce risk to an acceptable level. There is often more than one action needed to address risk associated with each of the failure modes and causes. The FMEA team should take care to recommend feasible and effective actions that will fully address the risk associated with each failure mode/cause. Whatever action the FMEA team believes needs to be done to address risk must show up in the recommended action column.
Which of the following are characteristics of well-written FMEA recommended actions? (Select all that apply.) [Show/Hide Answers]
1. The name of the person on the FMEA team who recommended the action.
(False. This information is not needed, as the FMEA recommended actions are team approved.)
2. The name of the person who is responsible for execution of the recommended action.
3. A brief description (no longer than three or four words in length) of what action is to be done.
(False. FMEA recommended actions should be described in sufficient detail to be fully understood even by someone who is not part of the FMEA team.)
4. The date the recommended action was first established.
(False. This information is not needed. The important date is when the action needs to be completed.)
5. The date the recommended action needs to be completed.
Scenario: An FMEA team is considering how to address a high severity and high occurrence issue. Some of the team members want to reduce the severity risk with action strategies such as fail-safe and early warning. Other team members want to significantly reduce the occurrence risk using a robust design strategy.
Problem: What is the best approach for this team? [Show/Hide Answer]
Answer: The first risk-prioritization task for any FMEA team is to adequately address all high-severity problems. If the team is using a severity scale of 1 to 10, this means addressing all 9s and 10s at minimum. The FMEA team must review and fully understand all the high-severity issues so as to address them in its recommended actions to ensure those issues do not occur within the life of the product or manufacturing process. The severity ranking can be reduced through actions strategies such as fail-safe; however, these strategies require a design change to ensure that the system responds to failure in a way that will cause minimal harm to other devices or danger to personnel.
If lowering the severity ranking is not possible or feasible, the FMEA team must confirm and verify that the occurrence and detection rankings are as low as possible (preferably 1), or must take all action necessary to achieve the lowest possible occurrence and detection rankings, and then obtain management’s concurrence and support before determining that no further action is required.
Scenario: The following is an excerpt from a power steering pump FMEA. Consider the recommended action "Review results of function test to confirm successful pressure and flow rates achieved."
Problem: Is this a good action to address the risk? Is it sufficient? What comments or critiques do you have? [Show/Hide Answer]
Answer: The action "Review results of function test to confirm successful
pressure and flow rates achieved" is inadequate to address the risk identified in this excerpt for three reasons:
First, it is late in the product development process. FMEAs should be completed during the window of opportunity to best impact the design before design freeze date.
Second, there is no action to improve the design. The FMEA team identified the cause as "Pressure relief incorrectly identified on the drawing," with severity 8 and RPN 280. This is relatively high risk and an action should have been recommended to specify pressure relief correctly.
Third, for high-risk issues there usually needs to be more than one action recommended. In this case, there could be an action to address the incorrect specification, and another action to improve the ability of the bench rig test to detect this problem.
I’ve always wanted to know about FMEAs
"If I had an hour to solve a
problem and my life depended on the solution, I would spend the first 55 minutes
determining the proper question to ask… for once I know the proper question, I
could solve the problem in less than five minutes." Albert Einstein
A HotWire reader submitted the following question to Carl Carlson. To submit your own question about any aspect of FMEA theory or application, e-mail Carl at Carl.Carlson@EffectiveFMEAs.com.
Reader: I am hoping you can help me. I have been using PFMEAs for nearly 20 years with the majority of that time in the automotive industry. I never received formal PFMEA training but felt that I learned quite a bit from others I worked with who had received formal training. During a recent ISO9001 audit, the auditor wrote a non-conformance for not including a Review of Effectiveness of our PFMEAS. I had never heard of completing a Review of Effectiveness before and always assumed that by completing recommended actions and rescoring we were effectively reviewing our PFMEA. With that being said, my question is how do I complete a Review of Effectiveness? I greatly appreciate your time and thank you in advance for your help!
Carl: Great question. There are very specific quality objectives for FMEAs, and these quality objectives are the core of an effective FMEA audit process. Below is an excerpt from my book, describing the FMEA quality audit procedure.
The FMEA quality audit procedure is an essential part of ensuring good quality FMEAs. FMEA quality audits are in-person audits of completed (or nearly completed) FMEAs, done with the FMEA facilitator and the FMEA core team present. The audit can be done on a pre-scheduled or random basis. Someone, who is skilled and experienced with the content and quality of good FMEAs, performs the audit, from either management or an FMEA subject matter expert. Here is the procedure.
Each of the ten FMEA Quality Objectives has a corresponding "How to audit" recommendation. In a nutshell, an FMEA subject matter expert or management person reviews the FMEA results with the FMEA team against each of the FMEA Quality Objectives, one by one, using the "How to audit" recommendation. Each quality objective is evaluated for how well it is achieved. This evaluation can be done on a yes/no basis or a variable evaluation, such as high, medium or low. The estimated time is one hour for this audit, about 5 minutes per FMEA Quality Objective. The results of the audit provide valuable feedback to improve future FMEAs. The focus is on improving the FMEA process, not on the person or team doing the FMEA. The auditor is looking for specific process-related issues that underlie deficiencies in achieving the quality objectives, such as lack of training, procedure, facilitation skills, standards, resources, support, etc. Action items from the FMEA quality audit should be documented and pursued to improve the overall FMEA process. Do not expect to achieve all ten FMEA quality objectives instantly. Rather, work to maintain steady improvement.
I've written an article that outlines the FMEA quality objectives and explains how to audit the effectiveness of FMEAs. It can be found at: https://www.weibull.com/hotwire/issue137/hottopics137.htm
Incidentally, I’ll be presenting the difference between high-quality and poor-quality FMEAs, including case studies and an effective audit process, in a tutorial at the upcoming Applied Reliability Symposium (ARS) in Indianapolis.
Let me know if this answers your question.
About the Author
Carl S. Carlson is a consultant and instructor in the areas of FMEA, reliability program planning and other reliability engineering disciplines. He has 35 years of experience in reliability testing, engineering and management positions, and is currently supporting clients from a wide variety of industries, including clients of HBM Prenscia. Previously, he worked at General Motors, most recently senior manager for the Advanced Reliability Group. His responsibilities included FMEAs for North American operations, developing and implementing advanced reliability methods and managing teams of reliability engineers. Previous to General Motors, he worked as a Research and Development Engineer for Litton Systems, Inertial Navigation Division. Mr. Carlson co-chaired the cross-industry team that developed the commercial FMEA standard (SAE J1739, 2002 version), participated in the development of SAE JA 1000/1 Reliability Program Standard Implementation Guide, served for five years as Vice Chair for the SAE's G-11 Reliability Division and was a four-year member of the Reliability and Maintainability Symposium (RAMS) Advisory Board. He holds a B.S. in Mechanical Engineering from the University of Michigan and completed the 2-course Reliability Engineering sequence from the University of Maryland's Masters in Reliability Engineering program. He is a Senior Member of ASQ and a Certified Reliability Engineer.
Selected material for FMEA Corner articles is excerpted from the book Effective FMEAs, published by John Wiley & Sons, ©2012. Information about the book Effective FMEAs, along with useful FMEA aids, links and checklists can be found on www.effectivefmeas.com. Carl Carlson can be reached at email@example.com.