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Thanks Nikki - It puts things more in context.
What I would say is that this is bit more serious than just recording the number of instances of rejections due to cleanliness. What would bother me here is that if either you or your customer misses this and get into patients, you could be looking at a recall or lawsuit that could put you out of business.
I'm not a materials scientist to understand specifics of the plastics but how often / what triggers a "clean". Is it time based? it is after end of a lot? How big is a lot?
I guess where I am going with this is there something you can do to do to make 'contamination' sources more predictive - What does each type of contamination correlate to?
What I would say is that this is bit more serious than just recording the number of instances of rejections due to cleanliness. What would bother me here is that if either you or your customer misses this and get into patients, you could be looking at a recall or lawsuit that could put you out of business.
I'm not a materials scientist to understand specifics of the plastics but how often / what triggers a "clean". Is it time based? it is after end of a lot? How big is a lot?
I guess where I am going with this is there something you can do to do to make 'contamination' sources more predictive - What does each type of contamination correlate to?