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My company produces components for medical devices and has become ISO 13485 certified but there are many questions about our requirements for a device master record. They have created a system where we have a Master Record Spec (the recipe), a Lot history form (manufacturing process), and the compliation of all the records, we call the Lot History file. We create a Master Record for each customer's part number which lists our customer's specs, each operational step, WI's and forms and their revision. The Lot History form mirrors the Master Record but records the actuals.
The problem: if a WI is revised or an operational step changed, it forces us to revise every Master Record we have on file (100's). Is there a way around this problem? I've read some of the blogs in the forum that talk about using an index. I'm wondering if my company has taken the wrong approach, in my view they should remove the WI's, Ops and rev's from the Master spec. Appreciate any advise.
The problem: if a WI is revised or an operational step changed, it forces us to revise every Master Record we have on file (100's). Is there a way around this problem? I've read some of the blogs in the forum that talk about using an index. I'm wondering if my company has taken the wrong approach, in my view they should remove the WI's, Ops and rev's from the Master spec. Appreciate any advise.