TS 16949 Clause 8.5.2 Audit Nonconformance for not issuing internal CARs

S

Shawn

#1
Hello all,
My Issue: We have received 2 CARs during surv. audits for not issuing internal CARs for what we call "quality daily observations", which are findings by our quality inspectors that range from material being out of spec. to forms not being filled out correctly and everything in between. Now, if I were to issue an internal CAR for every daily observation it could be as many as 15 or more in one day, but typically around 5-10. I know the TS clause 8.5.2 states "...shall take action to eliminate the cause of nonconformities to prevent recurrence..." but what is the definition of "nonconformities" in that clause? Does it apply only to nonconformities against TS clauses or does it include CSRs, Internal requirements, etc. (I'm sure it applies to all of the above but I have to ask)? This is a struggle for me, I'm sure most of you have problems getting CARs replied to like I do, so I don't want to, and don't see it as constructive to, issue a CAR for each daily observation unless the finding would have caused our customer to receive nonconforming product. I hope I am making sense here and have included enough info for you.

Thanks to everyone who shares their wealth of knowledge so those of us coming up can benefit from it.

Shawn
 
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C

Craig H.

#2
Hi, Shawn

What is done with the "daily quality observations"? Are they documented? Is action taken?

If so, this might just be a matter of semantics.
 
#3
Yes, indeed you will overwhelm.........

your Corrective Action System by issuing so many. My thoughts are that the product issues should be dealt with through the non-conforming product process. Any issues of forms not being completed correctly should be a trigger to the internal audit system to go find out how widespread the issue is, how it affects data integrity or if it's because the form design is poor etc. etc.

Perhaps you're making it a little difficult to understand for your poor external auditor who can only react to this mis-understanding by 'dinging' you:lol:

It's inappropriate to issue CARs for all type of non-conformity - we need that 'extra' step of analyzing the data and trends here. Yes, once more I know I'm in danger of thinking outside of the box, but even (internal) audit findings shouldn't end up on a CAR - they should be recorded as a non-conformance and let management deal with them as a CAR.:mg:

Shawn - you may need to look at the intent of this system to see what it's accomplishing:yes:

Andy
 
S

Shawn

#4
Yes Craig, the daily obs are documented in a database that I've created where the quality auditors enter the findings/problems and assign them to the responsible department and operator if known. The database is set up where all the production supervisors, quality dept. personnel, etc. can access it and run standard reports that are set up (observations by date, date range, operator, etc.) or I can generate custom reports when requested. I summarize the info for management review. If the quality auditor believes the observation requires supervisor attention and actions taken there is a checkbox he clicks. The supervisors go into the database and enter a response to the observation (why it happend and what they did to correct the problem or if there were any actions taken with an operator like write up or suspension).

Andy, I agree with your thoughts but am struggling with how to design the system where it is value added, as easy as possible for the respondants, and that meets QMS requirements (or how the auditor(s) choose to look at things in the gray areas).

My thoughts were to document that a CAR will be issued when a non conformance against any direct TS or customer requirement is found. Also that non conformances (or defects?) that can be addressed through other change systems (process change requests, daily observation follow ups, etc) will not be required to have a CAR issued. BUT, the problem with that is the TS clause that requires a root cause determination be done for each non-conformance.

Any ideas will be appreciated, I can't pull much more hair out over this one.

Thanks
 
#5
I'm more confused than I was before.....

because you said 'Quality inspectors'. Are you doing internal quality system audits? Or Manufacturing Process audits or Product audits?:confused:

If they're doing internal quality audits, maybe you need to look at what they're finding. A form not filled out correctly is a superficial finding. If it's a manufacturing process audit, and the control plan/WI's are not being followed then issue an audit NC. If it's a product audit, issue a product NC.

Your description of what it is the 'auditor' (I'm not clear here whether there's confusion there over product inspection vs audit - being a kind of inspection) is finding makes me unhappy that they are auditing a 'system' rather than simple stuff, which is in danger of overloading your CAR process.

I'm not sure making it easy for the respondants is the correct goal here, either. Sure they need to 'get' the finding and maybe they aren't involved in the audit process (it sounds like they aren't) so designing a system for them isn't the issue - the reporting of value added audit results is.........:yes:

I have the feeling that any action that needs to be taken is painful....otherwise they would have fixed it anyways and making it easy is delaying the action even more. No pain...etc:lol:

Sorry if I appear not to 'get it' but to give guidance I gotta be happy that we're not trying to fix the symptom rather than the cause.:agree1:

Andy
 
S

Shawn

#6
Sorry Andy for not giving quite enough information and causing confusion. The QMS and manufacturing processes are audited by me, I conduct the internal process audits, and I don't have a concern with issuing CARs from these audit findings because they are findings where the TS requirements aren't met. I'm still in the learning curve so I like to be able to put my finger on a clause to support the finding. You are correct, a goal for the design of the process/system shouldn't be to "make it easy". But, I have found that the less complicated I can make something I get a much better and faster response. "Making it easy" was a bad choice of words.

Where my delima lies though is the product auditor's findings which are the inputs to the dailly observation database I mentioned. The product auditors audit/inspect product, audit forms and test data that production fills out/supplies, they assist in diagnosing problems, etc. and input these findings/non-conformances. These are non-conformances by definition, whether it be an out of spec part or a hold tag missing a piece of information like a date. Everyone will make mistakes, so in my mind there has to be some acceptable amount of these types of findings. Like I said before, I don't want to issue a CAR for every i that isn't dotted, that isn't the intent of TS or the CAR system. But, as long as we document these findings TS says that a root cause analysis has to be conducted and corrective action taken. So I guess my question is how could that be accomplished without putting every small finding through the formal CAR process? These findings aren't just tossed aside. We do use the information as inputs to quality planning meetings, management review, the CAR process, etc. and the employees are also informed of this information in many different ways. The information is used, but not in a neat little package all of the time like auditors want to see.

And, paragraph 5 of your last reply is very.......insightful......

I hope I was able to explain things better here.

Thanks again
 
Last edited by a moderator:

Sidney Vianna

Post Responsibly
Leader
Admin
#7
between b and d

I believe the answer to your dilemma lies with the careful and analytical reading of 8.5.2.c) evaluating the need for action to ensure that nonconformities do not recur.
Even the standard allows for consideration that you might NOT take any action in case of a non-conformity.
While we should strive for perfection, it is understood that mistakes will happen and to trigger corrective actions for issues that can NOT be prevented from recurring is nonsensical. Actually, by definition no true corrective action could be deployed.
Once again, it seems, based on your description that you need to appeal of the external auditor's finding and try to reason with the registrar.
On the other hand, I hope that the database you use to keep track of these "non-conformities" allow you to identify trends so, and when justified, both preventive and corrective actions can be triggered.
 
#8
Now I get it, I think...........

So, Shawn, why not simply keep a 'tally sheet' of the situations encountered, such as forms incorrectly filled out, etc., use a product non-conformance process for any product problems and then, present the tally results??

I have done something similar when organizing product audits. I will admit that we never got into form filling stuff, but if you find it, keep an eye on it.

The tally will show when a CAR - or better still - an internal audit might be useful to evaluate the extent of the issue. That way you are making better use of the quality management system and the TS requirements, if you want a 'story' to tell your registrar..........:agree1:

Whadya say?:bigwave:

Andy
 
S

Shawn

#9
Sidney, your correct about 8.5.2.c, and that is exactly what I keep falling back on but I guess I'm struggling with how to apply that in a way where everyone understands what is trying to be accomplished (if that makes any sense). Although, 8.5.2.c doesn't dismiss 8.5.2.b determining the causes of nonconformities. My auditor is stuck on 8D and 5 why root cause tools and I don't see any value added to applying an 8D method to find out why an operator forgot to fill in a date on a tag (not a real good example but you get the point). And yes, we use the information to look for trends and as inputs to the CAR process, managemtent review, quality planning meetings, etc.

Andy, this is exactly what I have been kicking around in my head. Summarizing the data and issuing CARs for the top 3, or 5, or 10 per quarter and/or increasing the frequency of the internal audits for the processes. I'm just trying to decide on the best way to define/document the "system" that will not leave any questions in our auditor's mind and will also be value added to the company and make a positive impact to our quality system. I guess I have just been fishing here to try and get ideas that will help me get off dead center on this issue.


Thanks again to everyone for the replies, I've been reading these posts for several years and very much appreciate the knowledge, ideas, and points of view that are shared.
 
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