Is Validation of Plating Processes required and who is responsible?

[mmnelson553]

I work at an electroplating company and we plate quite a few components that are used in medical devices. I'm wondering when OQ/PQ is required. GHTF says that plating processes should be validated, but if we perform inspection after plating (using a sampling plan) and we test for CTQ outcomes such as plating adhesion and plating thickness, aren't we verifying the process each time we plate an order?

Secondly, I'm wondering who is responsible for determining if validation is required. We are providing the plating service for another company who is supplying the material to be plated and then they are using the parts with our plating in their medical device. If our customer says they want us to start plating a part for them, do we need to be performing a validation, or do we only need to do it if they request it from us?

 

[William55401]

Typically, medical device companies request component process validation of their suppliers as part of component purchasing controls. Mature component suppliers will have validation methods well defined for the med device customer to review outcomes. Less mature component suppliers will need help from the med device customer in developing their validation approaches.

Update. I am not experienced in plating process validation. I did look at the GHTF and see plating grouped in with molding. To me, the decision to validate is made based on the GHTF grouping.

 

[mmnelson553]

So what about the opposite where the med device customer is not mature and they send us a new product to plate. Are we just supposed to plate it and send it to them without doing any validation work? Or do we need to perform a formal validation running an OQ to low and high settings followed by a PQ with 3 runs at nominal settings? Do we just leave it up to them and relinquish responsibility for it? It seems like overkill to perform a validation for a battery contact being used in a medical device. It seems legitimate for a surgical implant, but then if we're sampling and performing inspection on every lot it doesn't really seem that useful either.

 

[John Broomfield]

Like welding, plating is a special process where the product cannot be fully verified without destroying the product. So, the design of a special process has to be validated.

Your customers, naturally will want to engage a plating company that has a suite of current validated plating processes that match their requirements. Before accepting their business you will review each customer's requirements to confirm your ability to fulfill their requirements.

If not currently able you may be able to change the customer for design and validation of the plating process they seek, or you may have to do this yourselves to prequalify for their PO.

Therefore we design each plating processes to result in a spec to control the critical variables and then we validate each spec by making and testing samples to destruction.

We may then be assured of quality by plating strictly in accordance with the validated plating spec.

 

[William55401]

Good response from the moderator. Here's my take. As a supplier, you need to do the right thing and look out for your customer as well as protect the compliance status of your firm. Question. Are you 13485 certified? (Some component suppliers are). As part of contract review, that is the time to educate the customer on validation requirements. These will come at a cost and your firm must price them accordingly to account for the time and effort.

 

[Jim Wynne]

Like welding, plating is a special process where the product cannot be fully verified without destroying the product. So, the design of a special process has to be validated.

Can you give an example of a plating requirement that can't be verified without destruction?

 

[John Broomfield]

Test coupons may be used to validate the plating process.

But testing the bond strength (of electroplated chromium for example) may require use of one of these quantitative test methods:


...of these, I understand, only the qualitative Heat/Quench test is nondestructive which may be insufficient for the customer's purpose.

From ASTM B571 − 2013

 

[Jim Wynne]

Test coupons may be used to validate the plating process.

But testing the bond strength (of electroplated chromium for example) may require use of one of these quantitative test methods:

View attachment 26926
...of these, I understand, only the qualitative Heat/Quench test is nondestructive which may be insufficient for the customer's purpose.

From ASTM B571 − 2013

Qualitative nondestructive testing is done all the time on plated parts. Occasionally a sacrifice is needed, as when doing a microsection for plating thickness, or a bend test, but destructive testing isn't the norm. Even if it's done it doesn't mean that plating always requires destructive testing. Whether or not validation is prudent depends on the circumstances.

 

[pziemlewicz]

Can you give an example of a plating requirement that can't be verified without destruction?

Validation is typically for corrosion resistance, via salt spray test. ASTM B117 is one of the applicable test methods.

 

[Jim Wynne]

Validation is typically for corrosion resistance, via salt spray test. ASTM B117 is one of the applicable test methods.

That's not validation, per se. It's just testing.