Definition of a Critical Process

  • Thread starter Hindenberg Grnd Crew
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Hindenberg Grnd Crew

#1
Our notified body is asking for a list of critical process and those who provide those processes. I understand (or at least think I do) things such as sterilization is critical. Where do I stop? Our product is made up from many different parts from many suppliers with a majority of processing done in house. Do I include manufacturing of critical parts as a critical process or is that a stand alone, categorized as a critical supplier? Any help would be appreciated.
 
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normzone

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#2
I'm bumping this thread before it moves off the front page - do any of our medical folks have a suggestion for [Hindenberg Grnd Crew] ? ( GREAT user name... )
 

Ronen E

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#4
Our Medical customers typically refer to these as Special Processes. They are referring to things like weld, solder, heat treat, passivate, sterilize etc.
"Special Processes" (such as those listed) are those that require Process Validation because their outputs can't practically be verified (tested / inspected etc.) in the product. This is different from Critical Processes.

I can speculate on the right definition for "Critical Processes", but why not ask the NB what is their criterion, and be sure?
 

Sidney Vianna

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#5
Any help would be appreciated.
In the Guidance for Notified Bodies auditing suppliers to medical device manufacturers document a critical supplier is defined as

2.2 Critical supplier
A critical supplier is a supplier delivering materials, components, or services that may influence the safety and performance of the device [2].

Note: In the context of the audit of medical device manufacturers, a critical supplier is a supplier of a product or service, the failure of which to meet specified requirements could cause unreasonable risk to the patient, clinician or others, or could cause a significantdegradation in performance. This can include suppliers of services, which are needed for compliance with QMS or regulatory requirements, e.g. internal audit contractors or Authorised Representatives.
 

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mihzago

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#6
is the question about production processes or the QMS processes? (I understand that one is subset of the other)

For production processes, I've seen a definition of critical applied to any process, a failure of which (e.g. device defect caused during production) can result in an unacceptable risk to a user. So, as others have mentioned this frequently includes sterilization, welding, some forms of final test, etc.


For QMS processes, I'm a little more vague because there is no definition of a "critical process", but I've heard auditors frequently refer to them. For example, during an ISO audit I was asked if my external consultant performing my internal audit is considered to be a "critical supplier" (another use of "critical" without formal definition). When I asked why he would be considered a critical supplier, I was told that he is involved in a "critical process", namely an Internal Audit.

So, I presume, that critical means any QMS process for which a procedure is required by the standard.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
could cause unreasonable risk to the patient, clinician or others, or could cause a significant degradation in performance.
I just love it :sarcasm:

It's as clear as mud. What's reasonable and unreasonable risk? I know the "reasonable person" concept in the USA, but we're discussing EU regulations here. Besides, in risk management terms we normally refer to acceptable and unacceptable, which is a bit different. Similarly, what is significant and insignificant degradation?

If the definition of Critical Suppliers can include Authorised Representatives, I guess it can include just about any supplier except those that supply the most device-unrelated goods and services. In my opinion that misses the whole point, because the point (I would imagine) is to FOCUS on those suppliers and processes that actually make a huge difference. If one tries to focus on everything, one ends up focusing on nothing.
 

Charlotte Percy

Starting to get Involved
#8
Here is a short and sweet definition of a critical subcontractor
Critical subcontractors performing processes the results of which can not be verified by the Certification Holder
and/or
Critical contractors to which relevant processes have been outsourced (Typically outsourced manufacture of finished or nearly finished devices)
 

Pads38

Trusted Information Resource
#9
For a practical answer;
I used to work in the high-risk field of Active Implants.

Our only 'critical process' was sterilisation, and so our only 'Critical Suppliers' (who were listed on our NB certification) were our sterilisation sub-contractors.
 
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