Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation

[ECHO]

I haven't spent much time working in manufacturing and I was hoping someone could help me understand a bit more about equipment qualification.

Having read a number of existing threads, I understand that per ISO 13485:2016 section 7.5.6, process validation is only required when "the resulting output cannot be or is not verified by subsequent monitoring or measurement".

1. If a MPI (Manufacturing Process Instructions) requires someone to cut a wire to length using a ruler/caliper (calibrated), does the ruler need an IQ/OQ?
My first thought is IQ would be covered by the calibration and the OQ would be required. I am thinking that the OQ will mainly be discussing rather the ruler is "appropriate" for this task. However, if the MPI later verifies the length of the wire using the same ruler, does this mean IQ/OQ can now be justified as not necessary?

2. How about fixtures that aid in the manufacturing process, like a microscope for soldering? or a clamp fixture that helps in the soldering process?

Again, I am pretty new to the regulations around manufacturing and please excuse me if these are simple questions. I am thankful for any help.

 

[Ronen E]

First, make a distinction between manufacturing (production) processes, and measurement/monitoring.
IQ, OQ, PQ, ISO 13485 s. 7.5.6 etc. apply to the former only.

Second, I recommend that you look at IQ and OQ (to the extent necessary) in a complete specific production step context, rather than in a single equipment item context. In your example, think how you will validate the soldering process, not the microscope or the clamp (they will come in as possible factors, through the soldering process risk analysis).

 

[Tidge]

Ronen E makes two excellent points. I will echo that (in the context of medical device manufacturing*) validation is for processes, not for measurement or monitoring equipment.

The methodology for using measurement equipment has to be appropriate: This is referred to as "test method validation". Only extremely rarely have I seen anyone question straightforward methodologies such as using a gradiated rule to measure linear distances, but for less obvious test methodolgies you can conform to accepted (industry) standards maintained by ASTM, etc. Equipment used in test methods needs to be calibrated and maintained. Potentially absurd examples: No one would question the use of a stopwatch to measure (appropriate intervals of) time, but if the stop watch is used to measure fluid flow, you can believe that there had better be a validated test method backing that up.

Specific to the question about a piece of manufacturing equipment that is supporting a process (such as a clamp used to assist hand-soldering): There are questions like: Is the tool always required, and if so what are the different adjustments of the tool? This would likely be worth exploring through OQ because it is variability you explicitly designed into the process. If the use of the tool is left up to the discretion of operators, then this sort of thing is probably best explored through the PQ challenging different operators and/or individual techniques.

As a one-time certified assembler of PCB and cable assemblies, I'd subject adjustable temperature soldering irons to the OQ, but simply identify the ancillary equipment allowed within the procedure and examine the variability due to trained operators and techniques to the PQ.

(*) NB: There is a slight difference in IQ/OQ/PQ terminology between pharma and medical device manufacturing process validation. All of this discussion is distinct from medical device design validation.

 

[ECHO]

Thank you very much for your help.

 

[LUFAN]

First, make a distinction between manufacturing (production) processes, and measurement/monitoring.
IQ, OQ, PQ, ISO 13485 s. 7.5.6 etc. apply to the former only.

Would sub-processes of injection molding be required for process validation? Obviously, the molding itself is a no brainer, but say the DI Water system used in the manufacturing process of a stamper which ultimately is used in the molding process?

 

[Ronen E]

DI Water system used in the manufacturing process of a stamper

Not sure what exactly you refer to. By "stamper", do you mean the injection moulding tool?
There is no explicit requirement to validate the production of production equipment (other than supplier qualification). You do need to look into the resultant production equipment itself, yes (typically in IQ).

 

[Divpara]

Ronen E makes two excellent points. I will echo that (in the context of medical device manufacturing*) validation is for processes, not for measurement or monitoring equipment.

The methodology for using measurement equipment has to be appropriate: This is referred to as "test method validation". Only extremely rarely have I seen anyone question straightforward methodologies such as using a gradiated rule to measure linear distances, but for less obvious test methodolgies you can conform to accepted (industry) standards maintained by ASTM, etc. Equipment used in test methods needs to be calibrated and maintained. Potentially absurd examples: No one would question the use of a stopwatch to measure (appropriate intervals of) time, but if the stop watch is used to measure fluid flow, you can believe that there had better be a validated test method backing that up.

Specific to the question about a piece of manufacturing equipment that is supporting a process (such as a clamp used to assist hand-soldering): There are questions like: Is the tool always required, and if so what are the different adjustments of the tool? This would likely be worth exploring through OQ because it is variability you explicitly designed into the process. If the use of the tool is left up to the discretion of operators, then this sort of thing is probably best explored through the PQ challenging different operators and/or individual techniques.

As a one-time certified assembler of PCB and cable assemblies, I'd subject adjustable temperature soldering irons to the OQ, but simply identify the ancillary equipment allowed within the procedure and examine the variability due to trained operators and techniques to the PQ.

(*) NB: There is a slight difference in IQ/OQ/PQ terminology between pharma and medical device manufacturing process validation. All of this discussion is distinct from medical device design validation.

It was good to read a detailed answer. Being new to manufacturing, I also struggle with equipment validation and sub-processes like software validation and don't know what should they really check in regard to SW in equipment.
Quality engineers in my plants do some SW validation as part of FAT and SAT where they do not challenge the system and very much depends upon vendor assessment. They feel it's good enough since the output samples are already verified. It is difficult for them to see SW as a separate entity and thinks that it is integrated into HW and if we are validating a system during process validation then there is no need to do extra work.
SW validation documentation is also integrated with process validation and every change is managed through change management.
I guess, my question is more about their thought process. I have been an SW developer myself and know very well, how the coding happens and how the developer thinks so my trust is very limited. How do I explain the importance of running thorough SW validation in equipment?

 

[indubioush]

Didn't you ask this question before? Software validation in Medical Equipment

Maybe continue on with that thread if you have further questions that did not get answered.