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FMEA Reviews and Brainstorming

pi29
 pi29
(@patricia)
Trusted Member Registered

Hi Everyone, 

FMEA documents can be very lengthy and tedious to review. Often times I find it difficult to start. I attended an FMEA training last year where they recommended to gather all the key members of the team, the process engineer, R&D engineer, regulatory, etc and start off by just writing down all the risks you can think off at each process step and for each design requirement. From there it's better to go column by column and then once all the steps and failure modes are listed, to assign severities etc.

I always wonder what the best way to review these documents is and would like to hear your take on gathering the team and holding these review meetings. If you have experience with these, do you like to start the document ahead of time and come to the meeting with most of the FMEA filled out? Do you prefer to start filling it out with the entire time. How do you go about keeping everyone engaged? 

Additionally, what are some steps you take to ensure you are capturing all risks possible. 

Let me know your thoughts! 

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Topic starter Posted : 14/11/2020 3:09 pm
pn266
(@266)
Trusted Member Registered

Brainstorming is a fantastic method to quickly generate a list of potential risks, however sometimes a brainstorming session seems to hit a limit. I have found from my own experience that introducing the actual product to a brainstorming session can help visualize potential risks and further expand the list. Additionally, inviting a user or expert to the session can provide additional risks since that person knows the typical user tendencies and common mistakes with that product. I would typically encourage my team to initially brainstorm independently and then have a meeting to collaborate and compare our independent lists. After we feel this list has hit a limit, I would consult an end user and ask them if they have additional suggestions.

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Posted : 15/11/2020 6:19 pm
ashabazz
(@ashabazz)
Active Member Registered
Posted by: @patricia

Hi Everyone, 

FMEA documents can be very lengthy and tedious to review. Often times I find it difficult to start. I attended an FMEA training last year where they recommended to gather all the key members of the team, the process engineer, R&D engineer, regulatory, etc and start off by just writing down all the risks you can think off at each process step and for each design requirement. From there it's better to go column by column and then once all the steps and failure modes are listed, to assign severities etc.

I always wonder what the best way to review these documents is and would like to hear your take on gathering the team and holding these review meetings. If you have experience with these, do you like to start the document ahead of time and come to the meeting with most of the FMEA filled out? Do you prefer to start filling it out with the entire time. How do you go about keeping everyone engaged? 

Additionally, what are some steps you take to ensure you are capturing all risks possible. 

Let me know your thoughts! 

I'm somewhat of a step slightly above an entry-level engineer in the medical device industry. For context, I graduated in 2016 with a BS in Biomedical Engineering, worked at a start-up laparoscopic surgery medical device company for 3 years, and am currently working for a company that develops hydrophilic coatings for medical devices commonly used in the neurological and cardiovascular spaces.

  • "...do you like to start the document ahead of time and come to the meeting with most of the FMEA filled out?"
    • At the company, I work for now it's slightly easier to do it this way. My department consists of engineers that all have a select amount of projects (customers) that we develop coating formulations and processes for. We take those projects from inception all the way through validation and commercialization. Part of commercialization is completing an FMEA with our coating services business unit and quality teams. Due to our busy schedules, the engineers usually come prepared with the FMEA filled out from the engineering/developmental perspective. From there, the coating services department and quality department add risks, specific to their department's interaction with the coating process, to the FMEA. In this sense, the FMEA is generally pretty quick. It acts more as a process FMEA that references a company-wide process FMEA for general coating.
  •  "How do you go about keeping everyone engaged?"
    • For longer FMEAs that are generated from scratch, I suggest breaking it up into separate days. Allocated a week or a little less, 1 hour a day, to address the risks. Doing your homework beforehand always expedites the process that way when you meet with the different departments in your organization is really all about identifying the severity, occurrence, etc. Getting your organization to provide food/lunch is always a great way to engage as well. 
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Posted : 17/06/2021 3:27 pm
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