And even R & R studies...

Since Internal Audits are part of the #ISO9001 requirement in section 9 #Measuring and #monitoring which implies (periodic) verification/calibration (or both) of auditors, should there be checks for #linearity #bias and #stability ?

 

That is an interesting question. If an MSA on auditors is warranted, which is arguable, I would suggest the appropriate approach would be an attribute agreement analysis (i.e., can auditors agree within and between each other on whether something is or is not a nonconformance), and a classification assessment on whether they can agree on what section of the standard was violated.

 

I agree with Miner. As we all know, the evaluation of audit inputs is subjective and yet it makes sense to try to "normalize" auditor recognition of issues based on type, and nuances large and small. The results is, of course up to the organization's expectations. It can feel like voodoo to go through this process. I did it as an NDT inspector "reading" UT signal of a brazed fitting's seal on an oscilloscope display. During qualification with the Level III NDT Examiner I would demonstrate a determination of solder coverage that was similar to that which the organization (or its representative, the Level III Examiner who was in turn qualified as such) had determined. If we differed, we were trained and retrained to "tune us in" until we were consistent. That seems unsound, but that is what qualitative assessment is about.

I saw the same sort of approach when auditing the training and qualification program within a perfume company. They trained to identify the "notes" in a scent, such as a hint of Vanilla, and the general proportions. It seemed wholly unscientific, and as such was fascinating because for them, it worked.

 

That would bring a whole, new level of complexity because you would introduce the possibility that an inspector was physically incapable of detecting these notes. Tasting the "notes" in flavors is big in wine, spirits and beer, but many people cannot distinguish these notes. I can tell a difference between two different scotches, but not the specific notes that make them different. Color is another area. I worked for a short time in a tennis ball factory where rolls of felt had to be matched by color. As a male, I could not distinguish color differences between rolls that female inspectors could tell at a glance. Yes, the ability to detect color shades is an XX trait. Smell and taste can be degraded by medications as well.

 

I had a similar experience of the "taste test team" at a very significant confectionary manufacturer in the UK. Everyone detects salt/sweet in different ways and they had a standardized test/calibration for that. Taste team members could not participate if they had a head cold or other illness(es). Also smokers couldn't participate.

 

Certainly there is physiological variation in ability to detect and identify scents. And it is true that medical conditions and/or medications can impact it, just as with the ability to detect and identify color. Just as not everyone is well suited to audit and color blindness would have disqualified me from Dye Penetrant inspection while in the Navy, not everyone should work in design of perfumes.