When to validate ?

Location: Europe

The company I worked for in the past was a sub-contractor global player with close to 100 reputable customers from around the world.

On the first run - which we called the sample prototype run - we needed to validate a product on one of our surface mount and assembly lines the same way you described. These products ended up being tested in many destructive and non-destructive manners, some of them, ultimately coming back to be used as golden and silver samples in production areas before serial production started. If these products were to be moved to be built on a different line, they needed re-validation by contract as the quality of the products could not be guaranteed with documents.

I remember clearly that some automotive, medical and military customers needed something similar to what you mentioned - installation, operational and/or performance qualification. In our case, it was to prove that our quality management/assurance is at the highest level required for their products and that the production processes will consistently achieve the right (if not best) quality results. In some cases where products had similar designs, some customers would approve of using one product's qualification for the other one too. Other customers needed qualifications even if there was one passive component difference. The key will be always communication.

Some customers were granted access to our AOI and SPI databases, allowing them to look whenever they wanted. They also imposed strict first-pass yield requirements on their own product runs, which were not justified, but what can we do as suppliers...

Why would they deem it necessary to perform OQ and PQ on equipment? Differences in machine capabilities, calibrations, and testing capabilities can leave you as a supplier uncovered in cases of customer claims, which ultimately can cost a lot. The validation will ensure you are legally protected against any future mass recalls or product defects related to their design. Add to that, your customer is someone else's supplier too, so they will need to provide the said documentation further to prove their products come from a state-of-the-art manufacturing facility and their products are of the highest quality possible built in a tightly controlled environment.

Hope this helps, although I assume you are US-based.

Best regards, Tom

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FDA requires validation when a process cannot be fully verified by inspection and test, but SPI and AOI provide 100% inspection, ensuring process control. Your approach, using a golden board for first article verification, aligns with aerospace and industrial standards and has satisfied auditors. However, some interpret FDA guidelines conservatively, requiring full OQ/PQ for each slope job to ensure compliance with stringent medical device validation expectations.

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Location - EU

From my experience if they wanted proof to validate each piece of equipment all we have done is provided proof from the calibration process that the equipment was operating within the manufactures defined spec/limits. SPI & AOI machines & golden boards never cut the mustard with our customers.

Eg UIC equipment can generally fail some levels of calibration but still produce product to meet IPC level 3 without issue.

Generally speaking when we have had to prove each piece of kit is fully working as it should to customers we plan in a shut down window to have the equipment suppliers run the cals & provide the documentation to state its all as should along with screen shots of any data as some customers have requested this also. Naturally this can impact production so if you run without shut down or planned periods to do this then you can always pass the costs onto them.

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