If you fail to plan…

ISO 9001:2015 Clause 6 – Planning 

This is by no means a new concept, but there are some new requirements. Deming introduced the Plan-Do-Check-Act mantra back in the 50s and explained that he based his work on Shewart’s ‘Plan-Do-Study-Act’ cycle. Believe it or not, Deming claims to have used the work of Francis Bacon (1620) as a reference. So we’re not talking about the ‘flavour of the month’ here!

As hinted about in previous posts, get ready for some risk language in these clauses. We see it in the requirement to, “… determine the risks and opportunities that need to be addressed…”  to make sure our system in its Context (4.1) can produce the goods and services that our customers (and interested parties) are looking for.

We see a requirement manage risks so that we “…enhance desirable effects, prevent or reduce undesired effects and achieve improvement…” (6.1.1). Of course these plans have to be followed by action.  “A plan without action is just a speech” – Obama. Regardless of our political affiliations, we can all see the truth in this statement.

This section goes on to require that we weave these actions into our processes and assess how well our risk management activities are working. This needs to be reviewed during management review, too (9.3.2 e). No surprise there! And as with our current version, actions have to match the effect (or level of risk in this case).  It’s never possible to eliminate all risk, but we can avoid it, mitigate it and decide on what level of risk we are willing to accept.

The section on Quality objectives (6.2) has no real surprises, except that we are now required (as in ISO 14001 and ISO/CD 45001) to create an action plan to achieve our objectives that takes into consideration, “…what will be done, what resources will be required, who will be responsible (already in EMS and OHS requirements), when it will be completed and how the results will be evaluated…”. This will give us a better chance of hitting quality objectives, for sure. More work, perhaps, but a great big payoff.

The last section is new, but many of us have something in place now for managing change. We can always use a tune up in this area, for sure. I’ve seen Pareto’s law in effect here – 80% of our problems come from 20% of our orders – the ones with changes.

Managing change will be a value-adding exercise when we see the big costs associated with fixing problems. And change always introduces risk, no matter what the situation. We’ll have to, “…determine the needs and opportunities for change to maintain and improve the performance of the quality management system…” And when we do make changes we “…shall be carried out in a planned manner …” considering all the elements of the system and its processes (4.4).

So there you have it – something old (existing requirements), something new (risk/change management), something borrowed (action plans to meet objectives) and something blue (blue skies). Sounds like a match made in heaven!

Next: Clause 7 – Support