Starting to get Involved
So, we are a contract Manufacturer, plastic injection molding, who have been running millions of shots for our customer. Now our customer has turned ownership of the tool over to us and I'm at a loss as to how to document Validation. The tooling is very old and has been at our shop for years. If there was an initial validation run, no documentation exists that I'm aware of... So, I'm looking for anyone who has experienced this, and how does one go about documenting Process Validation? Lot inspection / testing has been part of the process for years but, I don't have any hard data to do a statistical analysis... I have number of shots run (in the millions) but don't have any idea of scrap, etc. Sure hope someone has an answer for me... My idea was just a note to file stating that because the tool has been in production for years without any design changes, and the parts all pass inspection, therefore they are in a "validated state". ???