When is the Best Time to Initiate PFMEA?

[Milas]

Hi

When is it the ideal time to start an PFMEA for medical devices, i.e. after building initial samples, and if so how many? or prior to starting a trial run ?

Any feedback would be appreciated

Thanks

 

[shimonv]

PFMEA is gradually built up during development (initial/draft versions), and matured towards the completion of design transfer. Afterwords it is managed and updated as the product evolves and customer feedback is obtained.

I don't know to say that there is an "ideal" time to do it, but generally speaking - after building initial units (doesn't matter how many) is a good time to work on it.
Some small businesses start with DFMEA and PFMEA together and later on separate them when the PFMEA begins to get volume of it own.

Shimon

 

[Bev D]

It depends on why you are doing PFMEA. If it is only to ‘check the box’ that you did it, you should wait until the process is done. No sense wasting time on a process that will probably change.

If you are doing it for the reason it was intended then you start as soon as you begin developing the process(es). FMEA is intended to be a fluid mechanism to help you design and improve your process. It isn’t about filling out a form or documenting your process after the fact. It is a guide to help you ask and answer with data the critical questions for developing an effective process….

 

[John C. Abnet]

PFMEA is gradually built up during development (initial/draft versions), and matured towards the completion of design transfer. Afterwords it is managed and updated as the product evolves and customer feedback is obtained.

I don't know to say that there is an "ideal" time to do it, but generally speaking - after building initial units (doesn't matter how many) is a good time to work on it.
Some small businesses start with DFMEA and PFMEA together and later on separate them when the PFMEA begins to get volume of it own.

Shimon

To the other good council you have received, I would add a consideration of any equipment being prepared.

For example, if your organization is having equipment manufactured/prepared , then ensuring the development/use of FMEA during that equipment development can prevent a lot of frustration later (e.g. putting a burden of failure mode prevention on an operator or "detection " methods instead of something that could have been built in to the equipment ....or ensuring the equipment does not have features/aspects that actually contribute to/cause a failure.)

Hope this helps.
Be well.

 

[Tidge]

In medical device manufacturing, with a necessary requirement to reduce risks, there are IMO two natural reasons to "do the (manufacturing) PFMEA" beyond simply improving process outcomes (which ought to also be important!)

(1) If part of the manufacturing process is necessary to reduce/control risks in the device-as-designed, the PFMEA should be started ASAP. Some classic examples include sterilization or calibration. The PFMEA ought to demonstrate that the previously identified necessary risk controls are working at the necessary level.

(2) Once the process is semi-established (it could just be planned, or it could be more mature) the PFMEA ought to be used to demonstrate that you aren't introducing risk into the device-as-manufactured. Some classic examples are making sure finished devices are free of manufacturing materials (e.g. mold-release).

 

[somashekar]

Hi

When is it the ideal time to start an PFMEA for medical devices, i.e. after building initial samples, and if so how many? or prior to starting a trial run ?

Any feedback would be appreciated

Thanks

The production / manufacturing interface which happens in the design reviews is the time when the planning for the pFMEA gets into motion. At this phase a lot of previous pFMEA learnings are shared and the existing risks and controls / new risks are identified that will become the inputs for the pFMEA.

 

[Bev D]

I posted a brief summary of how FMEA is an integral part of quality improvement in a recent thread. I also posted in the resources section here. If you are serious about FMEA you might find this helpful. If you are only looking to fill out the form and get it over with, don't bother.

 

[Milas]

I posted a brief summary of how FMEA is an integral part of quality improvement in a recent thread. I also posted in the resources section here. If you are serious about FMEA you might find this helpful. If you are only looking to fill out the form and get it over with, don't bother.

I posted a brief summary of how FMEA is an integral part of quality improvement in a recent thread. I also posted in the resources section here. If you are serious about FMEA you might find this helpful. If you are only looking to fill out the form and get it over with, don't bother.

Hi Bev

Thank you for link, but unfortunately, there is no information behind it. Please can you try to send the link again.

 

[Milas]

@all, thank you for your feedback and comments, which are proving to very helpful. Just wanted to ask whether anyone would be grateful to share a DFMEA template and a SOP which documents how to complete the Template.

Thank you in advance.

 

[Bev D]

There is an orange button in the upper right hand corner that has “download”. Click on this button and it will give you the attachmnet