ISO 9001:2015 Human Factors

Most people that know anything about management systems understand that human factors have to be accounted for. You can’t simply write a procedure or implement a control and then assume that it will be adhered to. People are not like that. People can be lazy, selfish, tired, distracted, hacked off … all of which can reduce the chance that a procedure, no matter how correct and communicated, may not be followed all of the time.

In general terms that means that a system manager should try so far as is possible to make the RIGHT thing to do also the EASIEST thing to do, as this dramatically increases the chances of conformance. Things that can’t be made easy (some things just are complicated) probably need a high level of monitoring (to account for the medium/high risk of nonconformance through poor understanding, laziness, short cuts or whatever).

At the time of writing, most of us are at the “theoretical” stage of understanding how ISO 9001:2015 will work. That is, we can see how it looks, but we don’t really know the levels that the certification bodies will operate at in terms of what they will and won’t accept. That process (which tends to work by custom and practice, osmosis even) will take some time to reveal itself. That said, I’ve noticed a couple of curious things that have not previously appeared in the standard that COULD have a significant impact – and the things I’m going to write about are very much hidden in the detail …

Controls to Prevent “Human Error”

How often is “human error” used as the Corrective Action Get Out Of Jail Free Card? Quite often, in my experience. Well, given the specific reference in Clause 8.5.1g, the options for organisations to use that excuse should be limited. Controls should seek to include actions to PREVENT HUMAN ERROR. Therefore, if human error is the cause of the nonconformity, then that Process Control requirement is not met. It will be interesting to see how that is audited (if it gets audited at all). At this stage I can’t help thinking that the standard might have been better if the aim to prevent human error was also included in the Nonconformity and corrective action clause too. It is very easy to overlook …

The “Social” and “Psychological” Work Environment

Good Lord! The requirements of clause 7.1.4 require that the organisation in terms of its work environment considers the following issues … (and I must to quote)

“Social (e.g non-discriminatory, calm and non-confrontational; and

Psychological (e.g. stress-reducing, burnout prevention, emotionally protective)”

Are they desirable attributes of an effective workplace? Well, yes they are, with the concept I have no problem. What I am looking forward to with a mixture of anticipation, trepidation and amusement is how they will be applied. Let’s think this through. How on earth will a QMS auditor interpret that? Quite aside from the fact that you are highly unlikely to witness highly charged and stressful events actually DURING the audit (because people are told to bite their tongues for a day) this could have significant legal implications for the company in countries where the employment laws deem stress, bullying, discrimination and so on to be unlawful. Are QMS sufficiently well versed in Employment Law so as to be legally correct in the call they make? In my experience they aren’t. Certification Bodies had better get their lawyers on standby.

I think this requirement, no matter how noble in its intent, is practically unenforceable. My guess is that this will actually be ignored.

Let’s see how these things move on. Time to get out the popcorn and plump up a cushion …


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