Hello Everyone,

Am new here, lots of good information available for us Quality folk.

I have a question in regards to how some of you handle internal audit results and issuing CAPA's. During our internal audits we find that we are making quite a few recommendations for improvement due to one thing or another being on the verge of being an issue, but not quite. I was wondering how other companies handle this issue. We issue a CAR if we determine it is a system or major issue, but do not have any place to address the recommendations. Do you issue a CAR for these as well in your companies or do you handle them separately?

We are overlooking a lot of good improvement opportunities by not addressing these recommendations. I hate to run two systems (I am the CAPA manager as well as the Lead Auditor and am already pulling my hair out :mad: with one system). Would like to know how others handle this.

Thanks!
Laura

Welcome to the cove

You have a Corrective and Preventative Action system, why not a C, P, OFI(opportunity of improvement) system

Hello Everyone,

Am new here, lots of good information available for us Quality folk.

I have a question in regards to how some of you handle internal audit results and issuing CAPA's. During our internal audits we find that we are making quite a few recommendations for improvement due to one thing or another being on the verge of being an issue, but not quite. I was wondering how other companies handle this issue. We issue a CAR if we determine it is a system or major issue, but do not have any place to address the recommendations. Do you issue a CAR for these as well in your companies or do you handle them separately?

We are overlooking a lot of good improvement opportunities by not addressing these recommendations. I hate to run two systems (I am the CAPA manager as well as the Lead Auditor and am already pulling my hair out :mad: with one system). Would like to know how others handle this.

Thanks!
Laura

Welcome, Laura! :bigwave: We're glad you're here! :cool:

I, too, wear these two hats (in addition to several others!), and feel your pain. For major NCs found in our internal audits, we issue CARs to the process owner(s). For minor NCs, we issue an NC report. Depending on the situation, we may do a follow-up audit to ensure that things were taken care of as stated in the CAR and/or NC report and that those steps taken have proven effective.

I hope this helps...

We have a similar situation where I work. The way I handle it is as follows:
- for audit nonconformances, we issue a corrective action
- for minor observations, if we feel our recommendations or something else should be done that could help prevent a future nonconformance we will issue a preventive action
- for all other observations we do nothing, managers can read about them in the audit summary and we leave it up to them whether they take action or not.

Good luck.

Thanks to Gidget & Howard for your replys :D

The issue we have here is getting the process owners to just answer their CAPA's in a timely fashion and getting them to take the program seriously (like no one here has EVER had to deal with that). This is why I don't really want to put 2 systems into play. On the other hand, if we put an OFI system into place they may not see it as a slap as they do the CAPA program (culture here needs a major overhaul). The issue I am having is not wanting to make an OFI system "look" like a CAPA. I want to make it look like an improvement request, but I also want the process owners to take it seriously.

We also have a CI database in place that addresses very large CI projects. This is relatively new too. Just do not want to overwhelm everyone.

Laura

I understand your problem, I would suggest that before you add to your system get the culture improved.

Maybe you can connect the OFI to some sort of carrot!

Hello Laura!
Well, part of what Howard says is true - you've got to have the right (improvement oriented) management culture in place.

I'm going to add that it's possibly also a reflection on something to do with the way audits are managed. In my experience, internal audits aren't actually done in the spirit or practices of improvement. They often replicate the methods of external audits.

For example planning them rarely involves any management input and the scope and purpose of the audit, as a result, isn't to look for improvements. Under such circumstances, and although well intentioned, calling an audit finding an 'Opportunity for Improvement' or anything else, for that matter, doesn't make it one, in managements' minds.

The audits must be set up to go through a process very similar to any recognizable improvement process (like 6 Sigma) before the findings will be treated as such. And, as Howard says, gotta have the culture too - but you can change what you do, first, and lead the cultural thing!

Howard's on the right track...except I've issued OFIs and IF the manager decides to act on it it is a Preventive Action. The carrot is that each area has an annual goal for preventive actions and the OFI is a convenient source for this. (I also include FMEA resutls, Lean activities, SPC etc. in the Preventive action system...)