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...
Question:
How would you go about choosing (and justifying) a sampling number for manufacturing process validation?
Details:
...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!
...or advise in layman's terms...
Question:
How would you go about choosing (and justifying) a sampling number for manufacturing process validation?
Details:
- We've identified only one essential critical component: the fuse. It is easy to test via destructive testing. It either passes or fails.
- Batch sizes are variable, but they are always low-quantity (maximum 15).
- The validation plan is to:
- select random samples output from the manufacturing process
- conduct functional verification
- 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!