Validation for Ultrasonic Cleaner

[Quality_Goblin]

Hi All,

We had a third party auditor do our internal audit, and he marked us for not having our ultrasonic cleaner that is used in our finishing department validated. He said this was in nonconformance to AS9100D, 8.5.1.2

Customers have not requested this before, and to my knowledge, as long as the parts are sent to them clean, that's all that matters, unless there is a certain spec they are requesting. So, we are unsure how to go about getting a realistic validation on a small ultrasonic cleaner that we use to get oil and debris off small parts. I saw another post asking something similar and the responses said to do a foil test. Is that right? Just a simple foil test to show that the cleaner is working effectively? Does that mean we do not need to find a third party company to either come in and test the cleaner, or send parts to?

 

[Cristiann]

When classified as a special process, the underlying rationale is that the effectiveness of the cleaning process cannot be fully verified by monitoring or measurement. Regarding the foil test, if it clearly demonstrates sufficient cleaning results, it may be considered a viable method. However, as a precautionary measure, you could periodically clean selected parts using your standard process and send them to a laboratory or institute for verification of cleanliness.

 

[Big Jim]

That is not a special process because you can tell by visual inspection that the parts are clean or not. This is not an appropriate nonconformance.

 

[Quality_Goblin]

That is not a special process because you can tell by visual inspection that the parts are clean or not. This is not an appropriate nonconformance.

Thank you Big Jim! We feel the same way.

 

[jmech]

It sounds like the only requirement from your customers is that the parts not have visible oil spots or debris. If this is the case, then I'd agree with Big Jim that visual inspection is all you need and validation is not required (or logical).

The auditor might be used to customers that have more detailed/specific requirements for cleanliness (that can only be verified by testing) and might assume that your customers have the similar requirements. However, he needs to consider your customers' requirements and whether you are meeting them, not impose additional requirements due to his bias.