Are Risks and Opportunities Required as Part of the Process Definition

[Mohammed]

Greetings,

I'd like to have your feedback if Risks and Opportunities are required to be part of the process definition; what I mean in process definition is the process card where the inputs, outputs, process owner, objectives, metrics etc. are recorded. The Point is that will help the owner to monitor the risks related to the process instead of skimming through a detailed risk register which could be for the whole organization. The same will support the reporting for the management during the QMS MR meetings.

I'd appreciate your inputs.

Thank you,

 

[Sidney Vianna]

This is exactly what is being discussed in the Informational - Is Identification of Risks and Opportunities required for QMS Processes? thread

 

[Mohammed]

This is exactly what is being discussed in the Informational - Is Identification of Risks and Opportunities required for QMS Processes? thread

Thank you, Sidney. I am aware of this informational thread- and I am in the favor of identifying risks for all QMS processes;any process is an input to the Risk Management approach. I am just concerned if I should record these within the process card for easing the reference.

 

[tony s]

I'd like to have your feedback if Risks and Opportunities are required to be part of the process definition; what I mean in process definition is the process card where the inputs, outputs, process owner, objectives, metrics etc. are recorded.

First, there's no requirement for "process definition" where you have to maintain documented information (in a card or even a manual) of the inputs, outputs, process owner, etc.
Second, It's up to the organization on how they will document their identified risks/opportunities. Refer to Annex A.4 of ISO 9001:2015, which specifies that:

Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement​

for formal methods for risk management or a documented risk management process. Organizations can​

decide whether or not to develop a more extensive risk management methodology than is required by​

this International Standard, e.g. through the application of other guidance or standards.​