Process FMEA
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
I've never done a FMEA before and I would like to try a process FMEA for a process we are re-evaluating. Is this an appropriate time to use this tool and what advice do you have for me?
22 Replies
Daniel Zrymiak 169
Joined 04/18/2018 - 448 Posts
I found two resources which you might find helpful

https://www.aapm.org/meetings/2013SS/documents/FMEAPresentation.pdf

https://www.fda.gov/downloads/Drugs/Guidances/ucm073511.pdf

Let me know how these work for you. 
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
I just downloaded them, Daniel Zrymiak‍. I will let you know.
Michael Kirchner 159
Joined 04/18/2018 - 17 Posts
Amanda Foster, you can also check out this webinar:

Practical Application of FMEA

Released: July, 2009

Introduce yourself to the application of failure modes and effects analysis (FMEA) in healthcare to improve efficiency, patient safety, and effective implementation of process improvements.

Presenter: Keith Poole, CQA, CQE, CSQE, CSSBB, CMQ/OE, Corporate Manager Lean Six Sigma, Sisters of St. Francis Health Services
============
From ASQ's
Healthcare Quality in Focus
A Series of Free Online Webinars for ASQ Members

Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
Michael Kirchner‍, excellent! I will check that out as well.
John Vandenbemden 518
Joined 04/29/2018 - 15 Posts
Amanda
There is some great references for creating and utilizing FMEAs
  • SAE J1739 is a standard which followed the Mil-Std-1629 when the military standards were dissolved
  • The automotive sector utilizes the FMEA as one of their core tools and has a reference manual that can be purchased through AIAG
  • Six Sigma professionals also utilize the FMEA tool and the ASQ Six Sigma Black Belt Handbook and ASQ Six Sigma Green Belt Handbook along with many other references covers the essential parts of this tool.
  • ASQ Tool Box pages does include some of the basic forms used and some references.  I believe this is still contained within ASQ.Org
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
John Vandenbemden‍, thank you. I will see what I can get my hands on. I have seen FMEAs done. We work on projects that require them from time ti time, and I have seen them as part of the ITEA presentations. This will be my first time working through one myself. I think there's a lot of potential for great data through this type of analysis of the process. I am just praying I get it right so that I can convince senior management that it is the right course for us in this setting!
Gretchen Peterson 157
Joined 04/18/2018 - 43 Posts
Hi Amanda Foster‍, just sharing an article from Quality Progress that might help you: http://asq.org/data/subscriptions/qp/2006/0906/qp0906mccain.html

And, I think that John Vandenbemden‍ may have been referring to this template in his response to you: http://asq.org/learn-about-quality/data-collection-analysis-tools/overview/asq-fmea-template.xls

Good luck!
Gretchen
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
Excellent! Thank you Gretchen Peterson‍. Now that the ISO 9001:2015 surveillance audit is in the review mirror for me (another great success!), I am diving into this in earnest!
Tom Miner 5527
Joined 01/18/2019 - 1 Posts

Hi,
I am new to this group and hope to gain some information on the AIAG's FMEA. My company recently switches from the traditional PFMEA to AIAG FMEA. There was a fundamental change in AIAG FMEA where occurrence is defined as occurrence of the cause of the failure instead of the traditional occurrence of the defect. 

I want to know how people go about to obtain occurrence rate for occurrence of the cause. Occurrence of the defect can be obtained from scrap rate, process capability since these data available in most quality system.  I am at a lost about how to obtain the occurrence of the cause of the defect. 
I would appreciate any discussion on this topic. 

Many thanks
 
Jd Marhevko 70
Joined 03/06/2018 - 4 Posts
Amanda, I am an SME on Core Tools for the Automotive and Quality Divisions of ASQ. FMEA is a part of the core tool series. Would be happy to do a 1 hour webex overview with you. if you are interested, please respond to my professional e-mail at Jd.Marhevko@Frontier.com. I can also give you some thoughts on management persuasion on the value and criticality of the tool. 
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
Fantastic! I will be in touch Jd Marhevko‍!
Michael Mackley 6279
Joined 03/11/2019 - 5 Posts
Hi Amanda,

My company used to force a PFEMA every time we made a new part and was slowly working towards implementing a new PFEMA for every time there was a standard work revision.  he book I used to reference was a book from AIAG which went over both Process and Design FEMAs. I thought this was highly helpful in my endeavors maybe it will help you out as well.
https://www.aiag.org/store/publications/details?ProductCode=FMEA-4
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
Thank you, Michael Mackley‍. 
Kenneth Myers 3743
Joined 10/05/2018 - 5 Posts
Amanda,

While FMEA has a long-standing history of use, there are some challenges in the way it's used to manage design, process, and product use risk.

One of the challenges is in the way a Risk Priority Number (RPN) is calculated and used to manage risk across many areas of opportunity. 

I suggest you give the article from Dr. D. Wheeler a look via the link below to insure you understand the risk associated with this measure:

http://www.spcpress.com/pdf/DJW230.pdf

Regards,

Ken Myers
 
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
Kenneth Myers‍ thank you, I downloaded that PDF and will read it in a minute. I had a long and wonderful conversation with Jd Marhevko‍ who helped explain some of the issues with RPN. She also explained some of the impending changes to the AIAG recommendations. 

I love myASQ for the tremendous access to world class Quality professionals willing to share their knowledge and experience with those of us just learning the ropes!
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
Kenneth Myers‍ that was a very helpful article. The penultimate paragraph is particularly helpful. I think I will follow the suggestions made and use SOD codes rather than RPN. It makes a lot of sense to me and I think my team will understand this better as well. Thank you again for sharing this!
Dan Burrows 250
Joined 04/21/2018 - 392 Posts
Amanda Foster‍ , 
Process FMEA is an excellent tool for re-evaluating a process.
I recommend:
- Make sure you capture the current issues (Things Gone Wrong) with the process so that you can focus on improving those
- Make sure you capture what is good (Things Gone Right) with the process so that you keep that.  These will score as low RPNs, but you still want to capture what you are doing right and how you did it right.
- Then add the things that you are re-evaluating or changing.
- Use a cross-functional team so that you have a good range of experience from different viewpoints.
- I usually work Design and Process FMEA together since there are things about the Design that must be held in the Process and things about the Process that can help guide a more producible product and better running Process, so for your process re-evaluation maybe it should also be fair game to do a bit of Design FMEA or design re-evaluation too.

Good Luck,
Dan
 
Amanda Foster 1083
Joined 05/07/2018 - 637 Posts
Thanks Dan Burrows‍. I really appreciate the good advice!
Atousa Pourfard 4062
Joined 10/24/2018 - 6 Posts
Hello Amanda Foster , Thank you for this beautiful question. I'm beside you to read answers posted by your experienced friends and I'm learning.
Regarding  Practical Application of FMEA PDF document posted by Michael Kirchner is so helpful for me, as I'm dealing with issues in Healthcare in my night shift work. I have a question: What is the relation between occurrence and detection? For me, both are the same, if something is occurred and we know that is occurred, it means we have detected a risk. Vice versa, if a risk is detected it means something is occurred. So occurrence and detection are the same. So why we use both in FMEA and why they may have different scales for them? 
Duke Okes 1670
Joined 06/01/2018 - 72 Posts
There are definitely things that might occur but are not detected.  Wrong medicine administered, but didn't have an adverse impact (in that specific patient, but could have in another).  Patient falls and is not detected because they got back up and didn't mention it.

Think of Detection as a failsafe for when Prevention fails.  If we detect soon enough we may be able to counteract before impact is severe.