Request for Formal CA - To Issue or Not to Issue

CarolX

Trusted Information Resource
to issue or not

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

Super Moderator
Trusted Information Resource
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?
 
A

Al Dyer

System Type

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.:ca:
 

CarolX

Trusted Information Resource
lemme try again

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:frust:

LOL. Thanks!!!

CarolX
 
E

energy

How about?

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.:rolleyes: :ko: :smokin:
 

E Wall

Just Me!
Trusted Information Resource
This is what we use

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

Trusted Information Resource
Re: How about?

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

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..... :bonk: Life goes on!

Carol
 
A

Al Dyer

E-Wall,

If a permanent corrective action is needed I would think that a corrective action has been initiated. No?

Hard to tell from the submitted snipet, I don't know what your MDR is, I guess it depends on your entire procedure/work instructions.

Just fishing for info!


Carol,

Example

A formal corrective action is issued when:

- A request for C.A. is submitted by the customer (Int. & Ext.)
- Ongoing scrap rate is above targeted scrap rate
- Process is below targeted capability goals (Cpk/Ppk)

For a small problem many companies opt to use a "Heads Up" issued to the production floor and temporarily increase spot inspections. The heads up keeps the operator in the loop and hopefully increases the chance of finding additional defects, if they exhist.
 

E Wall

Just Me!
Trusted Information Resource
Temporary VS Permanant

Al (and Carol too really): Temporary Corrective Action - We are human and even though you may have a good procedure in place...folks tend to get away from all the details if/when they rely on their memories rather than the provided reference documentation. If this is the reason bad product got out the door (rather than insufficient process) to us that calls for temporary corrective action measures. To us this is short term additional inspection requirements, monitoring of product or process by a third party to ensure process (currently in place) is followed all the time, etc...

Permanant Corrective Action - When we actually change the process, equipment, requirements, documentation, etc...

MDR for us is a Material Discrepancy Report. This is used internally only and how we track all material nonconformity issues regarless of Corrective Action (temp or perm) or just BS Customer Returns (product tests fine - but close to the 1 yr mark sitting in their warehouse...you know the political/scratch-my-back sales game).

A RCA is only generated for permanant Corrective Actions and is ultimately the call of the QA Manager although the information is reviewed by Engineers, Material Mgmt, and Mfg folks along with QA and the input reviewed by the QA Manger. Issues taken up with Plant Mgr if there are dissagreements on how it should be handled (very rarely needed).

Carol: Hard and fast guidelines for us is the 'rule-of-thumb' as I have stated in this post. Basically, if the root cause is training (aka - human error) issue rather than a failure of the process or equipment, we don't write it up as a corrective action.

Also, here is another snippet:
1.1 The purpose of this document is to ensure that timely and effective corrective or preventive action is taken to prevent, reduce, or eliminate non-conformances which degrade the quality and value of the product.

1.2 Request for Corrective/Preventive Action may be initiated as a result of nonconformities relating to process and product, audit findings, improvement teams, management review meetings, or review of standard quality records.
 
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