Observations vs. Preventive Actions discovered during Audits

[mshell]

I am in the process of issuing Corrective/Preventive Actions discovered during an audit and was wondering how other cove members manage observations made during audits. Our audit procedure says that we will issue CARs for nonconformances and PARs for observations. Is this common practice or is there an easier way to manage observations?

 

[Al Rosen]

I am in the process of issuing Corrective/Preventive Actions discovered during an audit and was wondering how other cove members manage observations made during audits. Our audit procedure says that we will issue CARs for nonconformances and PARs for observations. Is this common practice or is there an easier way to manage observations?

Mshell:

That's what I do. An observation is an opportunity for improvement.

 

[db]

I separate PARs from OFIs. This may be just a wording thing, but....

Preventive actions are designed to prevent a problem.

Opportunities for Improvements are when I want the auditee to look at something. It might not be related to a potential problem. It might be because I think clarification is in order, or perhaps there might be a more effective (efficient) way of doing things.

The bottom line is...Don't get wrapped up too much in language. Use language that you and your company can both deal with.

 

[The Taz!]

We've found that audit "recommendations", whether an improvement or preventive action are not acted on. We have taken the track of issuing a CAR or not issuing one. Heck, it's hard enought to get action on a CAR let alone a recommendation regardless of how good it is.

 

[db]

We've found that audit "recommendations", whether an improvement or preventive action are not acted on. We have taken the track of issuing a CAR or not issuing one. Heck, it's hard enought to get action on a CAR let alone a recommendation regardless of how good it is.

This is where my system breaks down. What I call the "Pain Theory". Until the pain of staying the same exceeds the pain of change, no progress will be made. PARs and OFIs do not carry pain, so they are ignored. CARs only carry discomfort, so you have to fight to get them resolved. And then, the resolution is normally far from adaquate.

If anyone knows how to break through this barrier. Please let us know!

 

[cncmarine]

I treat all Observations has warnings and therefore issue corrective actions.

OFI's are not the same as observations. In fact I believe that OFI's should not even be allowed.

It consulting.

 

[mshell]

Thanks for the feedback. I am going to keep using the PARs for observations for now. If I see that they are not working, I will have to continue to improve the process. Please keep the ideas coming .

 

[db]

I treat all Observations has warnings and therefore issue corrective actions.

OFI's are not the same as observations. In fact I believe that OFI's should not even be allowed.

It consulting.

We could be just mincing words here.

Warnings about what? There is either compliance, or not. If not, then correction or corrective action is required. If in compliance, then a corrective action is meaningless. There is nothing to correct.

I write observations (I use that term synomously with OFI) under four conditions.
1) The situation is compliant, but close. There is a good possiblity that a nonconformance will occur.
2) I believe there to be a nonconformance, but it is out of scope. I will also schedule a supplemental audit for the activity in about 30 days.
3) A nonconformance might exist, but for some reason, I cannot make the call. Maybe there is not enough time for me to complete the investigation. Once again, a supplemental audit would be scheduled.
4) I find something an issue where an improvement can be made. This is a simple case of a suggestion for better performance.

Now, about the consulting issue. Absolutely it is consulting. However, my audits are strictly internal, and as such my role is to determine if the system (QMS) works, and to find ways to "continually improve its effectiveness" (4.1).

Thank you for bring that up. My comments are only intended for internal auditing.

MShell, are we talking internal or external. Probably should have asked that first.

 

[The Taz!]

If anyone knows how to break through this barrier. Please let us know!

I actually issued one Major Noncon to the Top Mgr for not excercising his responsibility to 1) ensure that the CAR's are covered in Mgt Rev, and 2) not issuing CAR's to the offending Managers (All of them) for not addressing the issues without undue delay.

We'll see what happens at this month's Management Review. I have PLENTY of paper!

 

[db]

I actually issued one Major Noncon to the Top Mgr for not excercising his responsibility to 1) ensure that the CAR's are covered in Mgt Rev, and 2) not issuing CAR's to the offending Managers (All of them) for not addressing the issues without undue delay.

We'll see what happens at this month's Management Review. I have PLENTY of paper!

That's a scary way to do things (for internal auditors). Top Management will now have to "either put up or shut up". The registrar will also want to watch this closely (providing of course that your N/C is valid -- I have no doubts).