Risk analysis 7.2.2.2

hello

can anyone elaborate me about the risk analysis in 7.2.2.2, which components we have to discussed in it.
In the current surveillance audit this NC is raised by our CB.

 

I believe this issue was raised due to the onset of the RBT (risk-based thinking) concept of the 2015 version of ISO 9001. Auditors are on the hunt for RBT evidences. Anyway, the intent of 7.2.2.2 is for an organization to review first whether manufacturing the required product is feasible or not. When evaluating for the manufacturing feasibility, risks are already determined if you have negative answers for feasibility questions like:

• can the product be manufactured to tolerances specified in the drawing?
• can we produce the product as per the required material?
• do we have the suitable equipment to manufacture the product?
• do we have the suitable measuring equipment to check conformance with engineering specifications?
• is there adequate capacity to produce the product?
• can we manufacture the product within the required production rate?;...

...and other critical questions that you need to consider to establish the manufacturing feasibility. Documenting the results of this evaluation including the decisions and actions for those questions with negative or unsatisfactory answers can demonstrate evidence that risks were analyzed.

 

Through my research there appear to be two main definitions of risk and risk based thinking, one involves the idea of 'enterprise risk' and the other is more based on the 'engineering risk' (there are a few YouTube videos that explain the overall concepts of risk). Please if you have time can you help me by taking my 5-10 min survey http://goo.gl/forms/lNp76KKSDUli8k6c2

I hope to share all these lessons learned in my final thesis - please let me know if your interested.

 

While I agree with you, this probably will be insufficient to cover "risk" analysis. It's one of the areas that they modified the TS standard but didn't update the aiag feasibility form. It's a non-value added finding in most cases. Basically you need to update your feasibility documents to cover risk how you define it. So we added a colum to the above questions yes, no, risk - high, med, low. Got us thru. Good luck.

 

ISO stands for International Organization for Standardization.