Unique Situation - Preventive or Corrective Action?

[KenS]

Unique Situation, Preventive or Corrective

I know this has question has been visited in a number of threads, but I ran into one today....

On 10/8 Manufacturing drafted a work instruction on assembly of a PBN (a magic device in the product we produce). This was viewed as a Preventive action, it was not in response to a nonconformance but was drafted to document "tribal knowledge".

On 10/16 we get an e-mail from a customer that a PBN they received some 6 or 7 months ago was assembled wrong. The 10/8 draft of the WI was approved by the appropriate people today, and as a matter of fact was utilized (in part) to answer the customer's CAR.

SO, is the WI a preventive or corrective action?

 

[gpainter]

I vote PA

 

[Mike S.]

I wouldn't argue if you chose either one, it seems mainly an exercise in semantics. But if I had to vote I'd say corrective. The defect was already produced and you had not yet formally approved and instituted your new WI, but you did finalize it as part of the customer's CAR, which I'm guessing sped the approval and implementation process along.

 

[M Greenaway]

OK here we go !

What about this.........

Its both PA and CA (ahem).

If you have a QS or TS approval, or if you are a very good company otherwise, you may well perform an APQP process. During this process you would go through an FMEA cycle on the manufacturing process itself, at which point you may well identify the need for a Work Instruction to control your process. The whole APQP process may rightly be considered as preventive action, and you would retain records to demonstrate this. Alternatively if you are a 'bare bones' ISO9001 company you probably dont have such a formal process, relying more on instinct and intuition, nevertheless you would have taken preventive action by creating this document.

Then, simply because you quote this action in response to a complaint, and perhaps the complaint forced the issue to finalise the document, it is also a corrective action.

So its both IMHO.

 

[db]

Mike said:

it seems mainly an exercise in semantics

I agree, but I would call it a PA because they seem to be much harder to come by, and this allows us to show the system works. But, I even think that is crazy because we are doing (listing) things for the benefit of the registrar (an action I firmly disagree with).

The bottom line is the system is improved. I would worry more about the outcome of the action, rather that what list it should be categorized as.

 

[Bruce Wade]

How about:

The situation that led to the documentation of the work instruction is Preventive Action.

Application of the work instruction and testing to see if it addresses the nonconformance is Corrective Action. Corrective Action does not require you redouble efforts, only to take action commensurate with the significance of the nonconformance. If the nonconformance took several months to record, and effort was already in place to address the conditions that caused the nonconformance, you are not required to take additional action.

I would agree with Martin. The action answers, and should be recorded as both PA and CA...

 

[Bruce Wade]

Jim,

I was responding to the assertion found in the first post that:

On 10/8 Manufacturing drafted a work instruction on assembly of a PBN (a magic device in the product we produce). This was viewed as a Preventive action, it was not in response to a nonconformance but was drafted to document "tribal knowledge".

Ergo, my response the action addressed PA. Documenting "tribal knowledge" would be preventive, addressing the "Mack Truck" theory of succession planning...

 

[Marc]

Your opinions 16 years later? Has anything changed?

 

[gpainter]

WI's by nature are PA. However, since it was approved on 10/16 and presumably no one had been trained on it. I would vote that is a CA

 

[Ninja]

What is the difference between an orange?

Call it either one...doesn't matter...that's my vote...