Statistically Valid Audit Sample for Management System Audits?

K

kiwisfly

#1
Is there such a thing as a statistically valid audit sample in management system audits? A general question really, just wanting to get some views on this.

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Sidney Vianna

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#2
Re: Statistically valid audit sample

Is there such a thing as a statistically valid audit sample in management system audits? A general question really, just wanting to get some views on this.

Cheers,
No, there is no such a thing. ISO 19011 refers to this:
The audit evidence is based on samples of the available information. Therefore there is an element of uncertainty in auditing, and those acting upon the audit conclusions should be aware of this uncertainty.
A competent auditor knows s/he must base the audit conclusions on a REPRESENTATIVE sample of the process(es), activities and/or systems, and should not reach underlying conclusions based on a very limited sample.

One of the primary reasons for the fact that the number of audit days (audit length) is affected by the size of the organization is to allow for the need of a representative sample to be collected.
 
K

kiwisfly

#3
Thanks, I'm just reading through a draft of 19011:2010 and para C.5.3 talks about statistical sampling. It states "If there is a need to use statistical sampling methods the following apply:....."

I can see how it might apply in a product audit (inspection) but what about management system audits, any possible need for statistical sampling?? Anyone know what the authors had in mind here?

Cheers,
 

Sidney Vianna

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#4
Anyone know what the authors had in mind here?

Cheers,
I don't, but I can speculate that since ISO 19011 is being revised to allow for discipline-specific guidance (see annex A of the draft you have), some management systems and discipline conformity assessment pieces, e.g., for GHG Inventory (ISO 14064), EnMS (ISO 50001), etc... might become more rigorous in terms of sample size and confidence level on the sample.
 
T

treesei

#5
The US FDA's guidance QSIT (Quality System Inspection Techniques has a sampling plan (95% confidence and 99% confidence respectively) for the review of device history records. Would it be relevant?
 
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