Assessing risks

Answer:

First, what is a risk? A risk is a deviation from the expected due to uncertainty. The expected are desired results, are the outcomes of the QMS.

Second, ISO 9001 mentions risks at three levels (clause 5.1.2b – risks about products and services. Clause 4.4.1f – risks about process outcomes. Clause 6.1.1 – risks about QMS overall results)

For example, yesterday I was working with a company describing the process where materials are ordered, received and prepared for production. We described the process as is. Then the Production Manager said that he would like to make a change in the process to minimize the risk of a supplier delayed a delivery and no one at the warehouse contacts him and Planning does not know that there is a problem of materials missing. This is a typical case about Clause 4.4.1f. For example, during context evaluation an organization can identify a trend for more competition, or more non-technical barriers when exporting beca use of a rise in protectionism. So, the organization can consider that trend as a risk or an opportunity. For example, analyzing all complaints from the previous year an organization can relate reasons for complaints with risks with products and services. After determining risks and opportunities organizations have to decide which need to be addressed and improve the system to eliminate or reduce those risks or take advantage of which opportunities.

The following material will provide you information risks and opportunities:

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/