posted 31 May 2001 10:34 AM               

I seem to not be understanding my registrar. They do not think that I close-out my CPAR's in a reasonable amount of time. What constitutes a reasonable amount of time? Obviously that would vary from CPAR to CPAR. Some would take longer than others, right? Just curious if anybody has had a similar experience.

posted 31 May 2001 12:57 PM               

The registrar doesn't know the size of the hole, soil conditions, electrical wire hazards, gas lines, size of the shovel, etc. Without a proper diagnosis of the situation, to attach any fixed length of time is almost pointless. The exception in my mind is that if we don't fix the problem now, then doom will occurr (put your finger in the hole in the side of the boat now or it will sink)! Immediate responses like this also tend to treat masking symptoms and not root causes.

I think what the registrar is after here is to determine if your process is moving along reasonably or growing moss. Can you demonstrate that the time taken to close out CARs are by managements definition (inclusive of customer requirements) is reasonable? If you can, then the registrar is fishing without bait. If not, the registrar can press you on the effectiveness of your CA process and you will have to address this.

Best regards,

posted 31 May 2001 03:10 PM               

Nobody wants that. We cleaned up our act fast.

posted 04 June 2001 08:42 PM               

Got written up with a minor NCR during a surveillance audit because the health and safety committee had one recurring agenda item, and the auditor expressed the learned opinion that corrective action should have been taken to resolve these issues more expeditiously.
Sometimes it just isn't worth the effort debating the point.

You could always whip your fire hose out!

posted 04 June 2001 10:34 PM               

Generally, this is a finding when the auditor sees CPAR's that are open either for an extended period (judgment time...often more than thirty days) or past the due date (this is obvious) with no record of activity.

The key is often NO RECORD OF ACTIVITY. I'll be the first to admit that some CPAR's will take an extended length of time. Generally, I recommend designing the system such that a response is due in 30 days; if a longer period is required, I recommend writing the system such that a "progress report" demonstrating ongoing activity be submitted once a month. By demonstrating ongoing activity, the auditors I've dealt with readily accept the longer periods for an open CPAR.

Esentially, an open CPAR for an extended period is the cue that the corrective action system is being ignored and may become ineffective. The activity reports sell the system as a working system.

posted 07 June 2001 12:32 PM               

Auditors are ready to pounce when you either have no plan or you have one but are not following it.

Languishing corrective actions are common but not acceptable. That's what this is all about. It has nothing to do with the time it will take to implement the plan. Sometimes the plan will be to replace a piece of equipment "...in 1 year..." to which the auditor cannot complain *unless* the plan is obviously not being followed.

-> They didn't like the fact that some of our non-conforming
-> product had been on the hold shelf for several months.

I believe they probably had a legitimate 'gripe' but again, it depends upon how your system is set up and other mitigating factors (including your specific business, product and processes). In some companies a couple of months might not be a big deal - the system may be set up for a review of NC product every 6 months.

-> when they see this kind of situation they know that our
-> system is not effective and they start to dig a lot
-> deeper.

Unless you can explain why severa,. months is appropriate in context of your defined system.

-> Got written up with a minor NCR during a surveillance
-> audit because the health and safety committee had one
-> recurring agenda item

To me the key word is recurring. Is the problem recurring or is it a recurring agenda item? Either way there is an obvious problem with the system and/or its performance.

-> The key is often NO RECORD OF ACTIVITY.
-> By demonstrating ongoing activity, the auditors I've
-> dealt with readily accept the longer periods for an open
-> CPAR.

posted 07 June 2001 08:32 PM               

-> Got written up with a minor NCR during a surveillance
-> audit because the health and safety committee had one
-> recurring agenda item

To me the key word is recurring. Is the problem recurring or is it a recurring agenda item? Either way there is an obvious problem with the system and/or its performance.

YES. The recurring problem was the negotiation with an Under Seige Again government over their financial liability for bulldozing blue asbestos into an Earth wind break around a installation where 450 people worked.
Temporary controls were in place to control the hazard.