Are two separate procedures required for Corrective action and preventive actions

[Sam4Quality]

Originally Posted by selena15

my explication of ISO requirement is that the mandatory is to get a procedure of CA & PA, but not necessary separate one! if it is written two time, it is just because the CA & PA are nitified in two separate chapter and of course in order to avoid any confusion, to have a procedure written is mentioned in the 2 chapter!

If that's the case then, no where in the entire standards does it say that there should be six separate mandatory procedures as a statement in itself. It has been interpreted based on the number of times the phrase "A procedure shall be maintained......" has been mentioned. So, then we have the liberty to actually make one document for all six mandatory procedures. True?

Then why only CA and PA to be included in one? Part of the Clause 4.2.1 Note1 of the ISO 9001:2008 version says "A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document."

So now its crystal clear. The standard does give us the liberty to include more than one procedures into a single document AND/OR have many documents for a single procedure. Period.

Originally Posted by bobdoering

Then determine if the processes are really similar enough to write into one procedure.

There is NO similarity between Corrective Actions and Preventive Actions. So there is no requirement for the determination of similarities for procedure purposes. The standard itself has clarified that.


Ciao.
______________________
Sincerely, SAM

"To achive the impossible, it is precisely the unthinkable that must be thought!"

[selena15]

Agreed Sam
ISO 9001:2008 had clarified it enough.

For just the discussion purposes...
Even before, we use to make also in one procédure the document control and the Forms in the same document
Lets say that normaly we can make together the document which go in the say spirit
isn't it ?

[Joe Cruse]

In Reply to Parent Post by Sam4Quality

There is NO similarity between Corrective Actions and Preventive Actions.

No similarity?????

[Jim Wynne]

In Reply to Parent Post by Sam4Quality

There is NO similarity between Corrective Actions and Preventive Actions.

Of course they're similar. They both deal with prevention of defects, one with recurrence and the other with preventing defects from happening to begin with.

In Reply to Parent Post by Sam4Quality

So there is no requirement for the determination of similarities for procedure purposes. The standard itself has clarified that.

I'm not speaking for Bob, but he didn't suggest that there was a requirement to gage similarities before combining process documentation. There is no requirement in the standard for using common sense, but some of us insist on doing it anyway.

[Sam4Quality]

Originally Posted by selena15

For just the discussion purposes...
Even before, we use to make also in one procédure the document control and the Forms in the same document
Lets say that normaly we can make together the document which go in the say spirit
isn't it ?

I believe so! However, I would like to know others comments, past experiences on this, especially concerning audits. Do auditors really raise a hue and cry if they dont see the six mandatory procedures as independent separate documents? Also, about other procedures?

Ciao.

__________________
Sincerely, SAM

"To achieve the impossible, it is precisely the unthinkable that must be thought!"

[Sam4Quality]

Originally Posted by Joe Cruse

No similarity?????

Originally Posted by Jim Wynne

Of course they're similar. They both deal with prevention of defects, one with recurrence and the other with preventing defects from happening to begin with.

Well, I think I used the incorrect word here . I meant to say they (CA & PA) were not the same, in keeping with my earlier post.

And yes, I do agree, they're similar.

Ciao.

______________________
Sincerely, SAM

"To achieve the impossible, it is precisely the unthinkable that must be thought!"

[JaneB]

In Reply to Parent Post by Jim Wynne

There is no requirement in the standard for using common sense, but some of us insist on doing it anyway.

Yes.

We just can't help ourselves or break the habit.

[jrugburn]

While both Corrective and Preventive Actions require a team based approach to solving an issue, be it current or one that may develop without assistance, a few points I have not yet read are as follows.

1. Timeframe for completion. Corrective Actions are a short term solution while Preventive Actions can last in excess of six months to complete, due to the extenuating circumstances.

2. Budget. Corrective Actions generally are closed with a minimal amount of capital required for closure. Preventive Actions have a large budget, in excess of several thousand dollars and sometimes require the sign off from upper level management for moving forward.

I am heading up a group effort within our facility to begin the use of CAPA to change the means with which we solve problems in the services and limited products we supply our customers, both internal and external.

Great site here, I am glad I joined up!!!

John