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.

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.

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

jscholen said:

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

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Total agreement. If you cannot make your manufacturer validate the process, additional inspection, or say, verification, need to be in place.

jscholen said:

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.

Click to expand...

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?

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

Click to expand...

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.

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

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.

We have a supplier that extrudes for us, but they are a job shop with multiple machines used to extrude the same component. Each machine can very well have a completely different set of operating parameters. With many more clients then ourselves, it would be difficult to plan a production run on a single machine since they would possibly have the machine occupied for a longer period of time with another customers job.

Depending on the complexity and volume of your components, a in-line inspection process might be more cost effective then running a multi-machine validation effort IF your current production needs can support it...but I think that greater scrutiny will be placed on data capture to show objectively that the inspection is occurring and works adequately. It really depends on what your customer needs/wants and what they are willing to pay.

As more companies such as yourself get into the mix of supplying to medical device companies, they will need to be more adept to the needs to their customers(ie, medical device speak....it's music to my ears when a supplier ALREADY understands my need for V&V activities).

The specific things you can do ahead of time, regardless of customer inputs:
-Document the installation of each machine...i suggest you dig up the user manual and create a checklist that ensures you installed it according to manufacturers instruction. If the manufacturer installed it for you, they should have given you a signed statement of installation....this could be used as your IQ...just have your own internal document or form state you are accepting this as the IQ and have the right people approve it.

-OQ is tough, since your goal is to test the operational range of the specific tool doing the work. You could go through a gamut of possibilities, but you most likely(murphy's law) won't get all of them.

I would suggest you factor in a validation cost to your piece part price and sell the client on your ability to deliver them with a qualified part ready for FDA scrutiny.

I could be wrong on this, but the day is coming when medical device companies looking for suppliers won't even engage with you unless you already understand their needs and are factoring it in.

To your specific question of extrapolating out to multiple machines, I don't recommend this, but that's not to say it can be justified. You will have to show an objective way that the machines are equivalent in processing capability.

I have done cnc validation and know first hand FDA process validation expectations (and how widely varying they can be). My question to the group, do any of you really feel the time and human effort to accomplish this is really adding value or quality to the piece part compared to sample inspection of critical features?

If I was trying to totally eliminate all inspection I could see this. I "perform the ritual", but in my bones think it is of very little value.