How to Validate the Automated Processes (CNC Lathe and Milling)?

#1
Hello everyone in the community. I am Mechanical Engineer and hired by medical devices manufacturing company as a Validation officer.

I am a beginner in Validation field so I don't know much about it and so far I have only been doing Machinery Qualification. Most of the processes/operations are manual i.e. machines are utilized and operated by worker to get the job done. For these machine I have mostly done Installation qualifications and training of workers. While I am moving toward the automated process i.e. CNC Machining on Lathe and Milling machines I am completely blank here shall we validate these or just verify the output?
If validation needs to be done then shall we proceed and if verification is employed how shall I go about it? Your help is much appreciated. @bobdoering your help would be much appreciated.

Regards
Sohail
 
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Tidge

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#2
I encourage a review of this historical document: Classic GHTF Guidance

I'm going to jump past the part of the discussion about motivating the validation (e.g. risk controls) and its power (e.g. sample sizes) and jump right to the main course: challenging the allowed range(s) of the process. Once a process is established, there will be an allowed range of settings for certain 'variables'... this could be speed settings, orientation of raw materials, flow of cutting fluid, whatever. These operator controlled settings (even if the operator is a computer!) are challenged 'at the extremes' to make sure that process outputs are conforming to specifications over the entire range of allowed settings. That is: the allowed/expected variation in the process doesn't lead to non-conforming outputs. This is referred to as an Operation Qualification (in medical device manufacturing, pharma uses a different definition).

The variability from raw materials and different operators is challenged during a Process Qualification (again, this is the definition used in medical device manufacturing, pharma uses a different definition).
 

normhowe

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#3
Tidge's advice is spot-on from my experience. One challenge that we've seen is the number of parameters and their extremes that need to be tested if you just charge ahead without thinking. The best strategy is to characterize your process well during design so that you have a clear understanding of how those parameters interact with each other. For instance, if you know that three parameters always follow each other, and you have a good theory for why, then you might be able to run only two test conditions. The caveat, as ever, is to document your reasoning well.
 
#4
Dear @Tidge Thanks a lot for your reply. I went through the document you mentioned and according to that Numeric control (NC) cutting processes "may be verifiable, but for business purposes, validation can be chosen" and I fully understand that but Computer Numeric Control Processes are different from NC then how can we go about validating CNC cutting processes? Can you refer to me a template or something that gives more guidance for validating these CNC cutting processes? Thanks in Advance
 
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Tidge

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#5
Your walking between worlds: Non-product Software (NPS) validation and Process validation.

Briefly: The process validation doesn't care if it is controlled by a human or computer, up until the point at which "variability due to operators" comes into play (PQ). The nature of the OQ challenges is essentially the same. The NPS validation needs assurance that the NPS system is in a state of control over the intended life of the software. For "embedded" software that "comes with the machine" and isn't going to be changed, there isn't much more onus on the Medical Device manufacturer beyond what would be covered in the IQ. (e.g. document the version of the firmware).
 
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