Risk Controls in PFMEA

Quality Engineer

Starting to get Involved
In my PFMEA we have 3 kinds of risk controls:

1. Inherent safety by Contruction
2. Protective measure in manufacturing process
3. Information for Safety

I am confused that can we add Test method validation reports (TMVR). Process Qualification reports (PQR) and Operational Qualification report(OQR) as control under inherernt safety bu construction?

YES or NO?

If YES, what is the reason and logic behind this?
If NO, what is the reason of not entering it there? Can it be enter under other 2 categories (which I believe we can't but still asking :D)?

What else can be entered under "Inherent safety by construction controls"?
 

Onceuponatime

Starting to get Involved
I am confused that can we add Test method validation reports (TMVR). Process Qualification reports (PQR) and Operational Qualification report(OQR) as control under inherent safety by construction?

You seem to be confusing multiple things.

First of all, inherent safety by design implies the design itself prevents the hazardous situation. Refer table 6 in ISO24971.
for pFMEA context, inherent safety in manufacturing process implies that a particular hazard from the manufacturing process is removed and the hazard is not present in the medical device.

TMVs or Process validations serve to justify verification of effectiveness of process risk controls (irrespective of type of risk control).
Does this help?
 
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Quality Engineer

Starting to get Involved
I am confused that can we add Test method validation reports (TMVR). Process Qualification reports (PQR) and Operational Qualification report(OQR) as control under inherent safety by construction?

You seem to be confusing multiple things.

First of all, inherent safety by design implies the design itself prevents the hazardous situation. Refer table 6 in ISO24971.
for pFMEA context, inherent safety in manufacturing process implies that a particular hazard from the manufacturing process is removed and the hazard is not present in the medical device.

TMVs or Process validations serve to justify verification of effectiveness of process risk controls (irrespective of type of risk control).
Does this help?

so they should not be used?

What can I use under Inherent safety by construction?
The standard outlined by my industry says that Operator certification level should be added (I mean operator training work instructions). Other than this? I am trying to learn what documents should lie under this?
 

yodon

Leader
Super Moderator
The tests (against which TMVs are run) are the control. As @Onceuponatime said, the TMV is a verification that the control is effective (demonstrates that 'bad' is detected and 'good' is passed). Your PFMEA will assess a step and possibly identify one or more tests (controls) to mitigate passing of defective product.

The standard outlined by my industry says that Operator certification level should be added

Which standard says this? I've certainly seen operator certification as a control but, beyond postmarket surveillance, demonstrating effectiveness might be challenging. You'll want to keep those certs current.
 

Tidge

Trusted Information Resource
I'll provide a hard NO to the original question as asked:

In my PFMEA we have 3 kinds of risk controls:

1. Inherent safety by Contruction
2. Protective measure in manufacturing process
3. Information for Safety

I am confused that can we add Test method validation reports (TMVR). Process Qualification reports (PQR) and Operational Qualification report(OQR) as control under inherernt safety bu construction?

...
If NO, what is the reason of not entering it there? Can it be enter under other 2 categories (which I believe we can't but still asking :D)?

Neither Test Method Validation reports, Process Qualification reports, nor Operational qualification reports are INHERENT to any "construction".

The closest you can get (IMO) for listing IBD as a risk control for a "constructed" element of a process is something like using a 3rd-party certified fuse/circuit breaker because you won't need to test the fuses themselves because an external 3rd-party has already assessed that such a thing is a good risk control for over-currents. The key here is the use of independent 3rd-party assessments against consensus standards. Internal testing/validation almost never falls into this category. If there is no 3rd party assessment, then it is unlikely that IBD is an appropriate category for a risk control (blah blah blah modulo elimination of the hazard blah blah fishcakes)
 

Johnnymo62

Haste Makes Waste
Construction? Wouldn't it be design? Aren't the process fixtures, tools, etc. constructed to a design that you specify?
 

Quality Engineer

Starting to get Involved
The tests (against which TMVs are run) are the control. As @Onceuponatime said, the TMV is a verification that the control is effective (demonstrates that 'bad' is detected and 'good' is passed). Your PFMEA will assess a step and possibly identify one or more tests (controls) to mitigate passing of defective product.



Which standard says this? I've certainly seen operator certification as a control but, beyond postmarket surveillance, demonstrating effectiveness might be challenging. You'll want to keep those certs current.

From here I want to clear more things. I believe inspection processes are controls but they are added in PFMEA as a process with multiple failure modes like "e.g. Fail to detect a defect"?

So Inspection processes work as controls and have their own failure modes (mean risks)?
 

Quality Engineer

Starting to get Involved
The tests (against which TMVs are run) are the control. As @Onceuponatime said, the TMV is a verification that the control is effective (demonstrates that 'bad' is detected and 'good' is passed). Your PFMEA will assess a step and possibly identify one or more tests (controls) to mitigate passing of defective product.



Which standard says this? I've certainly seen operator certification as a control but, beyond postmarket surveillance, demonstrating effectiveness might be challenging. You'll want to keep those certs current.

I mentioned it poorly. Sorry, I mean to say industry SOP.
 

Tidge

Trusted Information Resource
From here I want to clear more things. I believe inspection processes are controls but they are added in PFMEA as a process with multiple failure modes like "e.g. Fail to detect a defect"?

So Inspection processes work as controls and have their own failure modes (mean risks)?

Typical failure modes relating to inspection involve handling; failure to detect a defect is not a new failure mode it is an ineffective control.

Handling failure modes involve consideration of contamination, breakage, exposure to ESD, etc.
 
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