questions about risk based implementaion of Production and process controls in medical devices
I work for a small medical device company and we are updating our PPCs (Production and Process Controls) as part of a risk based approach, that is focusing on processes whose output(s) are tied to high risk (based on ISO 14971 risk categories). I'm a recent BME graduate, very new to this, and I haven't been able to find good documentation about how does a good PPC implementation looks like. I read 21 CFR 820.70 Subpart G–Production and Process Controls but that wasn't really helpful. Our SOP and WI weren't helpful to me either, so I'll be updating those as well as part of this effort too.
Essentially I need to see how everything is tied up, from Manufacturing Procedures to Process FMEA to Process Controls. I'm having trouble understanding and defining what exactly constitutes a control? and is it the same as the method of detection for a given process output? What is a primary control vs secondary control?
Submitted July 01, 2017 at 10:01PM by BME_PPC
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