Request for Formal CA - To Issue or Not to Issue

[CarolX]

Hello All,

I am looking for some opinions from all you fine folks here. What do you use as a guideline and/or requirement for establishing a formal corrective action request? I mean, like the grey areas. For example, a customer rejects 2 pieces out of a 1000 part order, and the parts are a penny apiece. Not an effective use of resources to issue a CAR for this.

Any thoughts?

Carol X

[SteelMaiden]

Carol,

I think that you could probably very easily justify not performing corrective action according to 8.5.2.c evaluating the need for action....

What I would do is investigate, (albeit breifly) and document why we decided that the risk involved was insignificant compared to trying to correct the problem. But, if you have 2 bad parts in every 1000 you send, you might rethink your position.

I hope that is what you were looking for?

Carol,

Are we talking ISO, ISO/TS, or QS?

At the least it has to be to the "degree appropriate" and commensurate with "risk". For me the first step would be to review the FMEA to determine degree and risk.

I would probably lean towards a corrective action that might say the root cause is undeterminable and that the C/A will be closed in 6 Mo. (?) if the situation does not re-occur. If it does happen again then there is a definate problem that needs to be resolved.

I guess I'm paranoid of PPM's hovering around 2000.

Carol,

I copied portions of this thread --> http://Elsmar.com/Forums/showthread.php?t=3188 to address exactly what you are posting about.

[CarolX]

Thanks for the responses...but what I am trying to develope, and hope to get some input from all by example, what is the threshold you use to initiate a corrective action. Is it based on the percentage of a "lot" rejected, or based on a dollar amount? My current procuedure was written very vague (intentionally on my part to give me latitued(sp)), but now the big cheese wants some more definitive guidelines.

From Steelmaiden

I think that you could probably very easily justify not performing corrective action according to 8.5.2.c evaluating the need for action....

see above...thanks for the input, already doing it this.

From Al

Are we talking ISO, ISO/TS, or QS?

ISO9002-1994

I guess I'm paranoid of PPM's hovering around 2000.

PPM-Not an issue here

Energy,

Thanks my friend...not quite what I was looking for. I guess I am just trying to do some benchmarking. Just gonna do some more of this

LOL. Thanks!!!

CarolX

If the cost of those original 2 pcs exceeds your production rate of $100 ($50 per hr for your salary and $50 per hour for all the company benefits, write it up. If not, file it somewhere and monitor for repetition.

[E Wall]

4.7 Corrective Action
4.7.1 If permanent corrective action is required to prevent future occurrences of the issue which prompted the MDR, the QA Auditor shall include the RCA # assigned from entry into the Corporate RCA Database.
4.7.1.1 If a Plant process is involved, refer to CWI-14-QAD-0001.

Hope it helps, Eileen

[CarolX]

Originally posted by energy
If the cost of those original 2 pcs exceeds your production rate of $100 ($50 per hr for your salary and $50 per hour for all the company benefits, write it up. If not, file it somewhere and monitor for repetition.

Energy - you are killin' me......$50/hour...I am DEFINITLY gettinig way under paid!!!!!

Eileen,

4.7.1 If permanent corrective action is required to prevent future occurrences of the issue which prompted the MDR, the QA Auditor shall include the RCA # assigned from entry into the Corporate RCA Database.

Not unlike my procedure....enough to satisfy the requirements, but vague enough to let you manage it properly.

And that's my quandry...the boss wants hard, fast guidelines, i.e. a detailed set of instruction on when exactly to initiate a documented corrective action.....which I fear will back us into a corners, but..... Life goes on!

Carol