Risk-based approach example

Should it be the risks associated with the individual process as they relate to customer satisfaction only, or more general?

Answer:

Start by considering the definition of risk in ISO 9000. Risk: effect of uncertainty on an expected result.

What I normally do is to look for each process, and list all expected results wanted from that process. For example, imagine a process called “To buy raw-materials”. What expected results do we want from this process? For example:

Raw-materials delivered without quality problems;
Raw-materials always available;
Raw-materials delivered on time;
Raw-materials with a good price;
No obsolete raw materials in the warehouse;
Raw-materials traceable;
Trustable suppliers.
Then, for each expected result do a brainstorm with your team about what can go wrong, what can deviate your company from these expected results.

For example, “Raw-materials delivered with quality problems” is a risk. Imagine that your company considers that it is an important risk. What will you do? Work with your current suppliers to improve their performance? Change suppliers? Implement a quality control plan at reception of raw-materials?

Remember, the risk-based approach came to substitute preventive actions. If a company has no quality management system, there are more important risks that deserve action.

The following material will provide you information about the risk-based 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/
Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
ISO 9001:2015 Risk Management Toolkit - https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Very helpful
Many Thanks