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Internal audit random sampling methodology

James

Involved In Discussions
#1
Hello forum dwellers

I'm setting an audit schedule with a 10% sample rate (so 10% of product will be checked monthly to see if it meets product audit criterion drawn from section 7 or 13485).

I wondered if using and citing a web-based tool that would help me achieve a more 'random' sample for my 10% would be ok, and how it may be perceived by my external auditor.. any thoughts? I was planning to use this: Research Randomizer

Depending on the conformance rate we may look to increase or decrease the sample size

Thanks

James
 
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William55401

Quite Involved in Discussions
#2
Quick reply / question. What is your statistical rationale? How do you know 10% is appropriate? Suggest you look at 8.1 General from the 13485 standard. Said differently, how would you defend your 10% to an auditor? Is it written down?

One more. Consider looking at the FDA's QSIT manual when it comes to sampling records. Also, when I read your question, you are talking about auditing product (and not records). If you are preforming true product acceptance sampling and you want a defendable sampling plan, C = 0 is a good starting point. I encourage you to search the cove on this topic.

Hope this helps. Have fun. Enjoy the ride!
 
Last edited:

Mike S.

Happy to be Alive
Trusted Information Resource
#3
The random number generator tool you suggest is fine to help you decide which parts to select to create a sample from a population in random fashion.
 
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