Clause 8.5.2 ISO 9001: 2008

Hello Friends,:


In ISO 9001:2008 Clause 8.5.2 states that corrective actions shall be appropriate to the effects of the nonconformities encountered. I have even read articles that talk about ranking the nonconformities based on severity to decide if it needs a corrective action.

Q1) Is this approach right? or Should we do corrective action requests for every single NC or for only those that need special attention? Please reply.


Q2) Clause 8.5.2 e) states that 'Records of the results of action taken'. Can someone please explain this and provide an example on how to keep records of results of action taken. What kind of forms to use. Are there any templates available for such forms? Please reply.

 

First you analyze the risk before doing the level of corrective action.

From the previous thread of Elmar Cove I have seen a non-conformance spreadsheet whereby the risk is analyzed and ranked according to severity. Those that were ranked as red and orange have to undergo a formalized corrective action. The rest are either quick fix or opportunity for improvement.

 

Nothing will destroy the credibility of your system quicker than requiring a formal corrective action for every issue. Some things are "fix and move on." You just need to define your criteria. We use a dollar value - if they can fix for less than $500, get it done.

And as others have stated, records can be anything you want. For formal corrective actions, there are all kinds of forms. For other corrections a simple note in the file may suffice. Good luck.

 

I wrote the process such that we DO create a Corrective Action for every internal audit nonconformance.

I have enough difficulty getting the responsible players to do their homework that I prefer it all to be managed in one sandbox. We average about ...checking...17 CARs a year doing this, which includes customer product returns that are our fault, internal audit nonconformances, and external audit nonconformances. Works for us, and the system has credibility, but your mileage may vary. Remember, we're a small outfit.

 

I believe Clause 8.5.2c gives us some elbow room to decide whether to push through with CA or just correction. It says "evaluate the need for action to ensure that nonconformities do not recur".

 

Thank you for the reply. I was not able to find that thread of Elmar Cove you are talking about. Can you please send me the link or upload that spreadsheet?

 

WOW!

 

AWESOME.

 

There is no "right" approach, but my advice is that corrective action for every single NC is a TERRIBLE idea. Unless you've got a perfect (or really simple) system, the overhead will cripple you.

Instead, develop criteria appropriate for you. You can, for example, just document an impact assessment with criteria such as:
- to what degree does the NC affect safety?
- to what degree does the NC affect business/customer goodwill?
- to what degree does the NC affect other products, or products already distributed?
- what, in the worst case, would happen if the NC is not addressed immediately?
- is there a history of similar NCs?

...then decide whether CA is appropriate or not, and document the decision. You're likely to find that many NCs do not require initiating the corrective action process...

Or, you could use a formal NC grading system like the one proposed by the GHTF:
http://www.imdrf.org/docs/ghtf/fina...sg3-n19-2012-nonconformity-grading-121102.pdf

Likely corrective actions will involve changes, which should be handled according to your change control process. The change records output from this process are "records of action taken".

As far as records of results, you just need to establish some criteria. For example, audit the process in 6-months from the change, and see if the NC still exists. The documentation of such an audit would be a record of the CA results.

 

" normzone said: ↑
I wrote the process such that we DO create a Corrective Action for every internal audit nonconformance."

>>>>>Is this because you were taught to do it that way in (Lead) Auditor course? If so, it's because the teachings are based on external audit practices, not what's practical or pertinent to internal audits! Sure, raise a NC, but, as with product, there some be some analysis and a disposition...rework, repair, scrap or very similar! In other words, fixit.

Then when the same types of NC become recurrent, a CAR can be issued to the process owner...(maybe out of management review, if held more than once or twice a year) and things would be fixed appropriately.<<<<<

I must confess to never having taken the Lead Auditor course, so we can eliminate that as a reason.

No, this just serves the purpose of roping reluctant players into doing the homework they try to avoid, and having the majority of my "follow up on that pledge that employee X made" in as few locations as possible. As long as I don't add frivolous issues to the CAR records there are no complaints.

AND THE COVE IS BACK! Talk about a bright spot in a rainy day....(San Diego, though, we'll take the rain gladly )

 

As suggested in other post - the FMEA is a good tool to start with - you could modified and also place priorities to determine which non conformance requires additional attention and which ones are solved immediately.

Furthermore, you quote ISO 901 : 2008.... start thinking 9001:2015 and begin the to incorporate Risk assessment and Preventive action while using the FMEA.

For further reading on risk assessment and a great documents to help you fill out the FMEA (page 12 of Risk Management Storyboard) follow the link and open up section 7.3.2 - http://www.sae.org/servlets/registr...HGeneral&PAGE=getSCMHBOOK&vgenNum=224&scmhs=1