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.

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. 

While working at my current company I have been able to work on a PFMEA for a product that will be coming out for release. Luckily for me, this product was very similar to one we already produced, but required us to make some changes to the PFMEA to look at the risk involved in some of the new process steps. The first thing that we did was list all of the process steps that were different from the old manufacturing process and the new product manufacturing process. Once this was done, we went through each process step to review any possible risks that we thought were applicable to the new process steps. Once this was done, we compared the severities to the old product and tried to justify similar severities to processes that were similar to the processes already recorded. Any new processes would be analyzed and risks severities would be applied using the risk management plan and possible impact to product and patients if these failures occurred. A design verification was then done, which is a dry run or producing products for design verification testing. During this any risks that occurred that were not initially presented on the PFMEA were added and severities to these were also determined. We also used the statistics of how often the failures occurred in the design verification build to determine if the occurrence level was accurate or to give an initial occurrence rating for new processes. This was a large bulk of the risk analysis process that we have done up to know, and as the product continues to be developed and testing continues, the PFMEA will be updated to document any other risks or changes to severity and occurrences that we may find.

Working for a company that manufactures medical devices (more specifically, I deal with nonconforming components), some of the main documentation I deal with (when determining the Severity and Occurrence of these errors) are these DFEMAs, PFMEAs, and FMEAs. A lot of these are very comprehensive, going component by component for every piece within the assembly of the medical device. From a component interaction perspective, I would like to add that starting off with the dimensions the device relies on would be a great place to begin with risks. From there you can break down the material that is involved with the device and the risks that a compromise in this poses. Then you can worry about the interactions this component has with other materials within the assembly and determine what compromises there are to safety in this manner. You can also add whether or not temperature/environment plays a role in risk factors. Is there more than one person involved in using the device/implanting it? Should the material be packaged in a certain way in order to avoid damage during transportation? Unfortunately, I do not think there is any way around having a long and tedious process to creating an FMEA, but the more rigorous the process is, the safer the product is. Another important factor I'd like to mention in its design is readability. Emphasizing the importance of these risks in simple words and in a readable format such as an organized excel sheet with risks and occurrences in numeric form, allows anyone from any department to read the document and understand exactly how severe each risk is. From here, a reasonable response can be made to address this error.