I wasn't sure the level of detail required for parts of requirements 8.5.2 and 8.5.3 - Corrective and Preventative action. When it says that "A documented procedure shall be established for.... (b) determining the cause of nonconformities" can that be as simple as stating "A member of management or the quality department is responsible for determining the cause of the nonconformity"

That is very general but does describe what happens now.

I wasn't sure the level of detail required for parts of requirements 8.5.2 and 8.5.3 - Corrective and Preventative action. When it says that "A documented procedure shall be established for.... (b) determining the cause of nonconformities" can that be as simple as stating "A member of management or the quality department is responsible for determining the cause of the nonconformity"

That is very general but does describe what happens now.

I think that might be too little information regarding 8.5.2, and 8.5.3.

I would define what documents you would be using, the time frame of when a response is due (CA), what steps are taken if the time frame isn't met, and define the CA and PA systems.

In my opinion, the who, what, when, where, why, and how, would be the definitive procedure.

I wasn't sure the level of detail required for parts of requirements 8.5.2 and 8.5.3 - Corrective and Preventative action. When it says that "A documented procedure shall be established for.... (b) determining the cause of nonconformities" can that be as simple as stating "A member of management or the quality department is responsible for determining the cause of the nonconformity"

That is very general but does describe what happens now.


In the procedure, you would be limiting your options if a member of management or quality is responsible to determine the cause. You can give a little more flexibility in the procedure if you flowchart the process of corrective or preventive action, describe how the request is given to management, and explain that management will coordinate the efforts to find cause. Then management can give someone (Or a team) in engineering, quality, production or the office the task to find the cause. Management could be responsible for approving the cause and solution and returning it to the proper authority. Quality could be responsible for verifying the effectiveness.

Personally, I like giving management the responsiblity to manage their part of the corrective action process. Often, they are not close enough to the process where the cause ends up to be. This also gives quality a chance to train more people on the ways to find root cause, and make these workers better contributors to the company.

--QG

Very helpful input. Thanks!

I wasn't sure the level of detail required for parts of requirements 8.5.2 and 8.5.3 - Corrective and Preventative action. When it says that "A documented procedure shall be established for.... (b) determining the cause of nonconformities" can that be as simple as stating "A member of management or the quality department is responsible for determining the cause of the nonconformity"

That is very general but does describe what happens now.


As an auditor, I would be less concerned with the level of detail in the procedure. I am more interested in whether there is a clear understanding of the required steps and responsibilities. I am also more interested in how well they are being executed - are the CARs themselves well investigated and developed.