I'm at a company that is a contract manufacturer for a variety of industries. I accepted a position as Quality Engineer (six month contract) to help out with a class 3 medical device assembly project. The culture here is non-medical (my back ground = 20 years in the Medical Device industry). Part of my task is to review the customers and in-house top level documents prior to final PQ's and production launch. Documents include; Control Plan, Material Specification, pFMEA, Work Instructions and various other connected documents.
The Control Plan was for lack of better words.... crap. I have redlined the documents - but I'm getting push back from my employer... as they do not want to "rock the boat". Specifically I would like to get input on content requirements. These are the guidelines how I understand them to be...see attached guideline.
Your input is appreciated! Thanks
The Control Plan was for lack of better words.... crap. I have redlined the documents - but I'm getting push back from my employer... as they do not want to "rock the boat". Specifically I would like to get input on content requirements. These are the guidelines how I understand them to be...see attached guideline.
Your input is appreciated! Thanks
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I hope this helps.