Risk management and the process approach

Answer:
When I work with organizations in determining their risks, I use three perspectives:
I consider ISO 9001:2015 clause 4.4.1 – what can go wrong in each process
I consider ISO 9001:2015 clause 5.1.2b) – what can go wrong with products and/or services
I consider ISO 9001:2015 clause 6.1a) – what can go wrong with our intended QMS results, QMS objectives.

“Some managers even ask if quality objectives are the same as the performance objectives.”

Answer:
Yes, one can say that quality objectives are performance objectives.

“Can one process be used to meet several objectives.”

Answer:
Yes, one process can be instrumental to meet more than one objective. I like to make the relationship between objectives and processes very clear. That is why I recommend using a matrix like this one:

This way one can find that currently there is no process in place that can help the organization to meet Objective A, and that Processes 1 and 3 do not contribute to any quality objective.

“What is the main difference between process approach and risk management many people ask me.”

Answer:
The matrix above is a representation of the process approach. The intended results of an organization will be met through processes. There are no random results. If we don’t like current performance, we should act upon what we do, one or more of our processes. That is why in Quality there is the saying: Don’t blame the product (the result), blame the process (behind it). Risk management is about determining risks, evaluating them, deciding if some of them are significant, and act to reduce, control or eliminate those significant risks.

The following material will provide you information about risks and the process approach:
- ISO 9001 – How to address risks and opportunities in ISO 9001 - https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
- Free webinar – The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/
- free online training ISO 9001:2015 Internal Auditor Course – https://advisera.com/training/iso-9001-internal-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ (deeply based on the process approach)