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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
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CNC Machine Validation Requirement


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Related Topic Tags
cnc machining, validation requirements, validation of machines equipment processes design etc.
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  Post Number #1  
Old 23rd January 2009, 10:29 AM
Ironcountry

 
 
Total Posts: 55
Question CNC Machine Validation Requirement

There is some debate over whether CNC machining operations require validation, whether results are fully verifiable. The sticking point is what does fully verifiable really mean and whether sampling plans verifying only key characteristics are adequate. A recent warning letter issued to a medical device manufacturer included a violation specific to CNC machining and failure to validate also stating that every device must be inspected in lieu of validation.
Input requested.

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  Post Number #2  
Old 23rd January 2009, 10:39 AM
achorste's Avatar
achorste

 
 
Total Posts: 200
Re: CNC Machine Validation Requirement

The Machines will need Installation Qualification at least.

The way we do it here is with IQ & OQ:

IQ - the normal stuff - utilities, training, maintenance plans etc etc

OQ - Verify functionality on the next batch scheduled for the machine.

Mind you we validate the manufacturing process for each product range as well.
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  Post Number #3  
Old 26th January 2009, 10:25 AM
jscholen

 
 
Total Posts: 93
Re: CNC Machine Validation Requirement

CNC's must be validated. Typical IQ/OQ/PQ methodology does not need to apply to every custom program. IQ/OQ is what you need to do once and maybe some revalidation of IQ/OQ as needed.

From their on, you will write custom programs for each specific cutting operation which then need to be PQ'ed. You could basically call this a component qualification, so your main objective is to prove repeatability through multiple set-ups and breakdowns of your tooling (what your machine would expect to see in a typically manufacturing environment).

We had a parallel situation in which our component manufacturer could not validate the process, so we had to inspect each component 100%. We instituted a CNC Inspection Machine that we programmed. So, we had to do the IQ/OQ and then PQ the custom inspection program to show that it was repeatable.

Jeff
  Post Number #4  
Old 22nd December 2009, 09:32 PM
vinh_lex - 2010

 
 
Total Posts: 9
Re: CNC Machine Validation Requirement

Quote:
In Reply to Parent Post by jscholen View Post

We had a parallel situation in which our component manufacturer could not validate the process, so we had to inspect each component 100%. We instituted a CNC Inspection Machine that we programmed. So, we had to do the IQ/OQ and then PQ the custom inspection program to show that it was repeatable.
Jeff
Total agreement. If you cannot make your manufacturer validate the process, additional inspection, or say, verification, need to be in place.

Quote:
In Reply to Parent Post by jscholen View Post

CNC's must be validated. Typical IQ/OQ/PQ methodology does not need to apply to every custom program. IQ/OQ is what you need to do once and maybe some revalidation of IQ/OQ as needed.
Not sure if you can need only 1 OQ for all products. Key process parameters need to be established at this point, so you you need to take product type into account, and revalidate when there's changes in your product portfolio

Can you share a sample package of a complete Validation case when you need only 1 OQ for all?
  Post Number #5  
Old 23rd December 2009, 09:31 AM
jscholen

 
 
Total Posts: 93
Re: CNC Machine Validation Requirement

Quote:
Not sure if you can need only 1 OQ for all products. Key process parameters need to be established at this point, so you you need to take product type into account, and revalidate when there's changes in your product portfolio
Agreed.

Since my comment was done so long ago, I suspect that I was referring too a CNC machine that may do the same operation(cutting) for multiple custom cutting programs.

Example: If you use a CNC mill and you typically use cutting tools ranging in size from 1mm to 25mm, then for the OQ, I would establish the precision of the mill for the 1mm, 12mm and 25mm cutting bits(with the justification that the precision of other "in between" sizes can be extrapolated) . I would run several custom cutting programs at the extremes of the table, low and high end of the cutting speed and feed speed and then measure the results to show where the mills limitations lie.

An example of multiple OQ would be a packaging line with multiple size boxes. Although you could theoretically establish a range of box sizes to run in one OQ, I suspect that it would be very difficult to try and capture the multitude of box configurations in one OQ, hence I would recommend a custom OQ for each product or product line.
  Post Number #6  
Old 23rd December 2009, 12:01 PM
JaxQC

 
 
Total Posts: 210
Re: CNC Machine Validation Requirement

One other train of thought. Yes look at the operating range youíre looking at (smallest/biggest) but also break it out by the variables (X axis, Y axis & Z axis). ie What can you hold / how good is the machine in each of the directions? A second item in addition to the axisís is the interpolation or change from one axis to the other (X-Y, X-Z, Y-Z Ö). How smooth / precise is the transition from one direction to antother.
  Post Number #7  
Old 22nd January 2010, 01:06 PM
alex.Kennedy

 
 
Total Posts: 53
Re: CNC Machine Validation Requirement

Validation applies to all the parameters that you are going to use. It also applies to the maintenance, calibration and predictive analysis of your CNC machines. The regulators are getting tough with companies that are treating validation very casually.
There are currently several devices being recalled some of which are implanted, the overall costs are enormous.
Validation starts at the intended use (User Requirements Specification) continuous through design to the (Design Qualification) then to the IQ/OQ/PQ. Without the URS in place your IQ/OQ/PQ have no relevance.

Alex Kennedy
  Post Number #8  
Old 11th February 2010, 01:29 PM
PoorDad

 
 
Total Posts: 2
Re: CNC Machine Validation Requirement

Applying this to a job-shop medical device manufacturer...

Considering that we run a variety of products through our lathes and mills, what is the proper way per the FDA to setup our IQ/OQ/PQ?

I need to understand whether the FDA will expect that every combination of axes and every cubic inch of usable working envelope have been included in the validation. What about variety of materials? Types of cuts made in the machine? If we have multiple machines of the same brand and type, can some of this work blanket the lot of them?


Thanks in advance.
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