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So we have a business unit that makes very small batch (typically 1-2 pieces) custom orders, and the process is primarily manual assembly. We were going to add what is essentially a new feature offering to the product line (note that this process is already previously in place at a sister site- we are following the same work instructions, but we are now also manufacturing it).
There was an engineer assigned to implement this new product offering, and he is no longer with the company, but he gave me the meat and potatoes of his "qualification" activities, which he essentially called a "process VERIFICATION report". In it, he essentially has the new product offering styles built and then inspected per the routine production inspection requirements established at our sister site. Note that we would be doing 100% manual inspection to the same inspection criteria when we go to full production.
I know that if this were an automated process we would typically do process VALIDATION. But since it's not, and we will be doing future 100% inspection of production products anyways, is this "process VERIFICATION report" necessary? Should something else be done instead?
This is med device industry if it makes a difference.
There was an engineer assigned to implement this new product offering, and he is no longer with the company, but he gave me the meat and potatoes of his "qualification" activities, which he essentially called a "process VERIFICATION report". In it, he essentially has the new product offering styles built and then inspected per the routine production inspection requirements established at our sister site. Note that we would be doing 100% manual inspection to the same inspection criteria when we go to full production.
I know that if this were an automated process we would typically do process VALIDATION. But since it's not, and we will be doing future 100% inspection of production products anyways, is this "process VERIFICATION report" necessary? Should something else be done instead?
This is med device industry if it makes a difference.