Re: Process Audit Approach vs. Clause Audit Approach
Not sure I agree, Andy. While I agree with you comments about the process approach, I also encourage people to fully audit the administrative or supporting processes, as well.
For example, core processes like Engineering and Production obviously should be fully audited. But, Calibration should as well.
If you don't, then calibration will only be audited by checking some gages while you are auditing something else. And, let's assume those gage records check out fine. Later, you check a few more, and so on. The activity (process) of Calibration never really gets audited, but it looked good when the interactions were checked. There could be problems with how the gages are calibrated, how MSA are done, even the basic metrollogy skills. These could hide under the surface, but would definitely come to light if the process itself is audited.
The same applies to other support processes, like Doc Control, and Internal Audits, etc.
I have a mental block over how and why elements would be audited...
In addition, I can't conceive why ...would you audit doc. control, or any one part of the standard? In my world, it's the interfaces between the processes where the problems lie, not in the pocess. So looking at the outputs/inputs etc is vital.
In addition, I can't conceive why ...would you audit doc. control, or any one part of the standard? In my world, it's the interfaces between the processes where the problems lie, not in the pocess. So looking at the outputs/inputs etc is vital.
For example, core processes like Engineering and Production obviously should be fully audited. But, Calibration should as well.
If you don't, then calibration will only be audited by checking some gages while you are auditing something else. And, let's assume those gage records check out fine. Later, you check a few more, and so on. The activity (process) of Calibration never really gets audited, but it looked good when the interactions were checked. There could be problems with how the gages are calibrated, how MSA are done, even the basic metrollogy skills. These could hide under the surface, but would definitely come to light if the process itself is audited.
The same applies to other support processes, like Doc Control, and Internal Audits, etc.


