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TS 16949 - 8.5.2.4 - When are Corrective Actions required

S

stogsdill1

#1
Hello all!... and thanks again for being here. We have recently moved up to a TS16949 QMS and are approaching our readiness audit. Since the TS revision to our quality manual, I have been requesting corrective action for all automotive-related RGA,s... even the one-offs. Our engineering manager has proposed that rather than issuing CA for each RGA, we pareto these one-off rejects, and issue CA when we see a trend. While, from a resource perspective, I like the idea... it doesn't seem to fit the requirement. As I read it, it is product specific and the product is what shall be issued CA.

Can I get a sanity check?

Thank you!!
 
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C

CandidQuality

#2
Re: 8.5.2.4- are corrective actions required

If you stop and create a written system of what will be evaluated, when it will be evaluated, who will be responsible for the action, what are the triggers for the action, you can do well with that system. If you leave it to chance that someone will notice a random trend, and then their opinion of what is important differs from yours, you will spiral down the wrong path. Set a system in place, do not leave it up to an individual(or their unqualified replacement). Set up a yearly review of that system to ensure that it is still meeting the current needs of the company. Not just a check box, but some type of measurable data. Did your lack of action on a single incident result in an additional 20 errors of the same type before it was taken seriously enough to be an issue? What was the potential impact to your company? There should also be exceptions with some consensus. if that single error is with a new supplier with a potential to provide future business of 30% of your net next year, you might want to coddle it and pay special attention.

Bottom line. Create a system, review it annually (once stable) and be prepared to make exceptions above and beyond when needed.
 
S

stogsdill1

#3
Re: 8.5.2.4- are corrective actions required

Thanks Candid,

I get what you're saying about the bottom line, i.e...creating a system, reviewing in, making exceptions. However, my concern is that the spec seems to define said system as the corrective action procedure.

"The organization shall perform analysis and initiate corrective action to prevent recurrence".

A system such as a pareto, followed by CA if a trend is identified does not meet the spec as I read it.

I want to be wrong here, please convince me.:thanx:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
As I see it, 8.5.2.4 does not negate nor override 8.5.2 c) which gives the organization the latitude to determine if and when a corrective action is truly justified.

Not every nonconforming product requires a corrective action, not even a returned product from the customer. As we know, many times, at the completion of an alleged product failure analysis, the supplier can not replicate the failure. Sometimes, the problem is the customer and not the product.
 

Pjservan

Involved In Discussions
#5
There is wiggle room in 8.5.2.4. As long as you are able to show results of an analysis and a justification to not issue a Corrective Action you should be OK. Your process will basically determine if corrective action is needed on a case by case basis (you can define criteria around this) as well as a secondary review based on data collection over time.
 
O

outoftown

#6
I would be wary of using a pareto to generate CARs. There needs to some accounting for risk or impact of the RGA item to the customer, to you and to the end consumer. Cost may also be a factor.

Best way to handle this is to separate the line accumulations (normal industry accepted fallout, e.g. porosity issues in castings), that should be addressed as returns for credit in your contract and therefore not subject to a corrective action. Other RGAs can be eliminated from CARs because it may be for a return to stock from excess inventory from the customer.

In my audit trails, I look at RGAs vs CARs occasionally for a reality check, but most CARs come from four sources; customer complaints, internal audit findings, supplier corrective actions and internal issues other than from internal audits. If you want to include RGAs, I would ask the customer requesting the RGA if they want a corrective action also. After all, why go through the entire CAR process if the customer doesn't want to see it?

Note, that you are still obligated to do failure analysis on returned product.

-outoftown, TS auditor
 
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