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Manufacturing Process Validation Destructive Testing Sampling Plan Advice

Mark Meer

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#1
Forgive me, I've been browsing the threads in this forum and the statistics are overwhelming! Perhaps someone can point me to the appropriate thread?
...or advise in layman's terms... :eek:

Question:
How would you go about choosing (and justifying) a sampling number for manufacturing process validation?

Details:
  1. We've identified only one essential critical component: the fuse. It is easy to test via destructive testing. It either passes or fails.
  2. Batch sizes are variable, but they are always low-quantity (maximum 15).
  3. The validation plan is to:
    1. select random samples output from the manufacturing process
    2. conduct functional verification
    3. conduct destructive testing on the critical component

...I'm struggling with how to choose and justify how many samples are needed... Presumably this decision rests on selecting a confidence level of some sort? Is there a generally acceptable value for process validation activities?

Any advice (or links to threads) much appreciated!
 
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