7.1.4 Environment
In Week 15, we glossed quickly over “People as a resource”, due to the structure of ISO9001:2015, and we discussed how weird the layout is in this section. We also debated heavily the term “resource” and everyone was very passionate about the inclusion of people in the discussion. In Week 16, the standard was a little more straightforward as we discussed “infrastructure”. Infrastructure is clarified to describe things like buildings, equipment, information systems, etc. And this made our discussion much easier. (We still haven’t had the opportunity to really discuss people as a resource, because the standard doesn’t dive into the real “people” issues (like 7.1.6 Organizational knowledge, 7.2 Competence, 7.3 Awareness and 7.4 Communication) until later.
Here in Week 17, we really hit some quicksand, though. I think it’s very interesting that the introduction of the idea of “risk based thinking” in the standard has generated so much debate and even outrage at the thought of its auditability. But, this section has gone virtually undiscussed.
7.1.4 begins easily enough with “The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of its goods and services”. [Check – no problem]. However, the “NOTE” adds, not clarification in my opinion, but a perfectly fashioned rabbit hole when it says environment can include “physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics, and cleanliness).” Temperature, humidity, ergonomics, and cleanliness? Ok. Most organizations are pretty successful with this and it isn’t a common source of written nonconformances. But, I’ve participated in audits where the auditor has chosen to debate some of these areas and even has demanded that these parameters be identified on paper and monitored to ensure they are maintained. Either way, not an insurmountable task. But back up just a second to….whoa….social and psychological?! How does an auditor audit that? What does that audit checklist look like?
I’ve known auditors who would do the logical thing and simply address this area in an anecdotal way. S/he may interview a few folks and ask questions about training, communication, etc to assure compliance with the broader intent of the clause. But I also know other auditors who could exploit the language and (incorrectly) demand social and psychological surveys as objective evidence in these areas. This could sidetrack an audit for hours with debate, conjecture, etc. Some might even use this opportunity as a strategic sidebar to avoid delving into meatier issues, but I digress. With the often limited understanding of so much of the language between both the auditors and the “auditees”, dropping these words into the standard without more clarity is irresponsible. Any standard which is written should also provide enough detail to clearly understand compliance v noncompliance for each of the requirements. In my opinion, this section falls far short of that.
In the meantime, it is obviously critical that a suitable environment be maintained by an organization to achieve conformity of its products and services.
THIS WEEK’S HOMEWORK
Take a moment to think about this area of your quality management system. Does your current status address each of these areas? Are changes required to address each one? What changes will you make? What will your discussion be with your auditor when compliance to this clause comes along in your audit cycle?
