FMEA with 2 or 3 criteria? Standard applicable to the Medical Device industry

D

Dudes

#1
I am of the opinion that an FMEA should include parameters for severity, occurence probability and detection probability. However, ISO 14971 only refers to the first two. All examples are with severity and occurence.

Is there any other standard applicable to the medical device industry which refers to the 3 criteria? It would make it much easier to convince management that we should change and use the 3 criteria ;)
 
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R

Richard Pike

#2
Re: FMEA with 2 or 3 criteria?

I am of the opinion that an FMEA should include parameters for severity, occurence probability and detection probability. However, ISO 14971 only refers to the first two. All examples are with severity and occurence.

Is there any other standard applicable to the medical device industry which refers to the 3 criteria? It would make it much easier to convince management that we should change and use the 3 criteria ;)
Not that I know of specific to the medical industry.

AIAG recommend that BOTH should be evaluated SOD and SO

Previous versions kinda mixed up a little -- Occurrence of Cause with Detection of Failure Mode.

So if you thought it added value; you could use all three, but report on both SOD and SO.

Be careful tho - because as mentioned some standards consider - Occurrence to be Occurrence of the Failure Mode as opposed to other guidelines consider Occurrence as Occurance of the Cause of the Failure Mode.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
Re: FMEA with 2 or 3 criteria?

The medical device industry is mostly interested in simply identifying risks and mitigating them thru elimination. There are even those that are advocating away from the severity and occurence ratings as they are subjective at best and the 'number' that results is not a mathematically valuable number - it is directional at best. you might want to read "Analysis of risk: are current methods theoretically sound?" by Nataly Youssef and William Hyman, from the Product Development Insight column published in Medical Device & Diagnostic Industry, October 2009.

I tend to agree with the current thinking that we should simply identify and mitigate risks and not worry about the rankings or RPNs etc. Detectibility is a valuable assessment of measurement and inspection systems, but a true measurement systems assessment is more accurate not subjective and provides more information on how to improve poor systems.

The key is to do what works for you and your organization and what meets the intents - and in some cases the requirements - of your Customers, regulatory agency, certifying body and industry...
 
U

username

#4
Re: FMEA with 2 or 3 criteria?

For Use and Design FMEA, we use Occurrence and Severity, for Process FMEA (which is where you can detect the problem), we use three.

WE are convinced that in Use FMEA for ex: if teh User (physician) detects a problem, Quality-wise we failed!

(OF course I am assuming medical device here)
 
D

DrM2u

#5
I am of the opinion that an FMEA should include parameters for severity, occurence probability and detection probability. However, ISO 14971 only refers to the first two. All examples are with severity and occurence.

Is there any other standard applicable to the medical device industry which refers to the 3 criteria? It would make it much easier to convince management that we should change and use the 3 criteria ;)
The ISO 13485 clause 7.1 mentions ISO 14971 as a reference only and not a requirement. AIAG's FMEA manual is followed in the automotive industry but I also came across followers in other inductries like the medical devices. I am not aware of any specifications or requirements from FDA but I might be wrong.

Bottom line (FDA aside): there is no requirement to follow any standard for risk assessment, as others have indicated. As an organization you have to decide on and subscribe to the risk assessment tools and methods that best fit your needs and products. There is a lot of discussion in the Cove regarding the use and applicability of FMEA and FTA to risk analysis. Whatever method(s) you select, do it as a group/users consensus else it will fall by the way side soon.
 

Marcelo

Inactive Registered Visitor
#7
I am of the opinion that an FMEA should include parameters for severity, occurence probability and detection probability. However, ISO 14971 only refers to the first two. All examples are with severity and occurence.

Is there any other standard applicable to the medical device industry which refers to the 3 criteria? It would make it much easier to convince management that we should change and use the 3 criteria
Please note that FMEA does not equals risk management as defined by ISO 14971. FMEA is a tool which might be generally used for risk anaisysfor risk analysis, which one of the steps in the risk management process. For an example of used of techniques on the risks management processo, please take a lookat this post: Re: Seeking thoughts on using BOTH FTA (Fault Tree Analysis) and FMEA.

Also, although it´s generally not required by regulations that you use a standard (as they are generally voluntary), developing a risk management system by yourslef is a challenging task, so it´s still better to use ISO 14971 as it´s a consensus guideline.

There´s a lot of reasons on why ISO 14971 does not have detectability. The standards also mentions that detectability can be used if someone uses FMEA as a technique, but "only to the degree that detection will enable preventive measures in the context of this International Standard".

Please note that in fact this is already built in the risk management process but it´s not very clear (it would be classified as "information for safety", the third option of risk control", but note that you can only use this option IF you cannot use the first - inherit safety - and the second - protective measures - and justify it).
 
R

Richard Pike

#8
Bottom line (FDA aside): there is no requirement to follow any standard for risk assessment, as others have indicated. As an organization you have to decide on and subscribe to the risk assessment tools and methods that best fit your needs and products.
Yep - However be careful if there is a specific Customer Requirement which of course overrides the applicable standard / guideline.

And - be prepared to defend your decision / method against Auditors who perceive that the various guidelines are not "guidelines".
 
D

Dudes

#9
Thank you all for your helpful answers! :thanks:

To sum up:
- of course FMEA is only a part of the risk maagement process
- It is true that giving ratings is very difficult (and subjective). As I see it, the FMEA is here to help us think oft he possible problems and mitigate them before the problem arises...
- I'd like to avoid as much as possible to have 2 different ratings for use and design.
 
C

Charlotte Percy

#10
In my training from a previous employer, notified body, the statement was put forth that probability of detection doesn't belong in a design FMEA. ( As opposed to a manufacturing process FMEA)

The logic for this thinking is that the risk mitigation for unacceptable risk would likely be to put a warning in the IFUs, (which are likely not to be read) in order to increase the probability of detection and arrive at an acceptable RPN number.

What I have seen, which to me is logical and acceptable, is to have a detection number in the design FMEA which represents, "Can this problem be detected in-house in design verification and validation?" , rather than can this problem be detected by the end user.
 
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