Processes and risks

Answer:

A process is a series of actions or steps taken in order to achieve a particular outcome. You need to observe activities performed within your company and determine what are the separate entities that produce required outcomes. For example production process has an input which is working order, production plan or similar and as an outcome of the process you have a final product. Other examples of processes are sales process, design and development, purchasing, transport, etc. For more information, see: ISO 9001: The importance of the process approach https://advisera.com/9001academy/blog/2015/12/01/iso-9001-the-importance-of-the-process-approach/

Risks in the processes are in most cases related to events that can result in process failing to deliver the expected outcome. For example, what events can result with process delivering nonconforming products. These events are then assessed in therms of their probability of occurrence and severity of consequences to determine whether they need to be addressed. For more information, see: 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/