The key focus should ALWAYS be on the process but in many areas of our responsibility we use temporary work force and our work instructions etc are our key training and guidence documents so I would always expect them to be checked all be it in more detail in some areas than others.
If the process was deemed to be "crappy" as you put it, I would then want to see the WIs etc and if they reflected a "crappy" process then an need for improvement would be raised if the process was different to the documentation I would want to know why?
WIs, SOPs etc are not always how things should be done and do not always reflect the best process and if you find a good process that doesn't match the documentation you would also raise a finding as to why?
It can be then become a chicken and egg situation, which came first? The process or the documentation....................
Chrissie x
The question was about 4.2.3 and 4.2.4, which are about control of documents and control of records, respectively. Expanding on Stijloor's point, If you've verified in previous audits that the controls are adequate--there's no evidence of violation of the either of the two clauses--you should be able to focus on other things. Keep in mind that the two clauses don't address the
efficacy of the documentation, just the control of it.
You should use the process documentation to guide you through a process audit, and if you see that the process isn't operating in accordance with the documentation, you've discovered something that bears further investigation. That has nothing specifically to do with 4.2.3. and 4.2.4, however.
ETA: There should be something in "the organization's" own documentation that reflects the requirements of 4.2.3 and 4.2.4, and if there is a violation, the nonconformity should be written against your own requirements, not the requirements of the standard.
