terça-feira, junho 29, 2021

Corrective actions versus continual improvement in ISO 9001

When do you use clause 10.2 and when do you use clause 10.3 when talking about improvement in ISO 9001:2015?

Let's look at this:


We have a standard way of doing things. 
We follow that standard, and we check the results. And we decide how to act. 
When everything is "as usual" we decide to keep the standard. The standard is useful. (Top SDCA cycle in the figure)

When a non-conformity (NC) happens, we treat the NC. After confirming that it was closed we ask,  should we improve? 

If the answer is no, we keep the standard, but when the answer is yes we start the improvement cycle, the PDCA cycle. (Bottom PDCA cycle) 

We plan an experiment about changing the way how things are done. 
We do the experiment. 
We check the results, and we decide how to act. 
If the results are not NOK we will continue in the PDCA cycle trying a new experiment. 

If the results are OK we can leave the PDCA cycle and return to the SDCA cycle where we update our standard. 

This event-based improvement is initiated by an NC it is about clause 10.2 and behind that is clause 8.7. This is the everyday level that I mentioned here.

However, even if our decision after a negative event is to not improve, periodically we should prepare a performance report, we should monitor and measure (clause 9.1.1) and we should analyze and evaluate (clause 9.1.3). And again, we ask, should we improve?

If the answer is yes, we are starting a calendar-based improvement. This is about clause 10.3 continual improvement. Typically, performance reports are about quality objectives and process performance. 

If this topic interests you perhaps this free webinar may be useful. 

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