Are two separate procedures required for Corrective action and preventive actions

[Jim Wynne]

In Reply to Parent Post by 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

Welcome to the Cove, John

I see that you're associated with the Indiana University Cyclotron Facility, which is interesting in terms of your application of the subject matter here. Let me disabuse you of a few misconceptions. We deal mostly with the definitions of CA and PA that are used in international standards such as ISO 9001. CA is defined as "fixing" a process after some nonconformity has occurred, while PA is "proactive," and is intended to prevent nonconformities. The definitions are a bit ambiguous, because CA includes a prevention component--we're supposed to fix the immediate problem ("correction") and prevent it from happening again.

Thus your idea that CA is short-term and PA is long-term doesn't fit. In fact, CA may take considerably longer to complete than a given instance of PA because there may be a period of elapsed time necessary to verify the effectiveness of the CA.

It will be interesting to hear about your implementation, so I hope you will continue to join in the discussions here.

[Bob the QE]

In Reply to Parent Post by 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

Not all CA/PA are necessarily team based approaches. If, I as a process owner I can make the CA without any effect on other parts of the organization I do not a team to do it. I find this approach at time to be cumbersome and waisted time. Like when a customer demands of us to use the 8D form as they understand it to be intended and completed as such to solve simple CA's. This is usually an auto QMS based system asking us (a non-auto based QMS) to complete the CA.

Your organization must feel that these definitions or requirements are needed.
and as such these two requirements identified here are only relevant to your QMS, correct? I am not aware of these being detailed out in AS9100 or ISO9001 as some form of requirement, however, they may be identified somewhere else in other standards that I am not aware of. We do not have such details in our CA/PA processes.

And welcome aboard.

[jrugburn]

Corrective actions CAN be closed and shown as effective in a shorter timeframe than the closure of a Preventive action, which often times requires a loarge amount of capital and outside sources to aid in the completion of said PA.

At least this is how I have approached it in my limited 20 years of manufacturing under the ISO umbrella.

Example......A corrective action to a vendor who is not supplying the customer heat numbers for incoming raw materials. Issue a CA to said vendor outlining the need for this information and hopefully the CA can be closed in a matter of weeks.

A preventive action for the continued dropping of raw materials into an autoclave. Look into why the parts are dropping. Solutions to eliminate dropping. Select a solution, have a ganrty fabricated and implement equipment....timeline maybe two months.

Hell, either way you slice it, you are solving problems and preventing reoccurances.

John

[Jim Wynne]

In Reply to Parent Post by jrugburn

Corrective actions CAN be closed and shown as effective in a shorter timeframe than the closure of a Preventive action, which often times requires a loarge amount of capital and outside sources to aid in the completion of said PA.

At least this is how I have approached it in my limited 20 years of manufacturing under the ISO umbrella.

Example......A corrective action to a vendor who is not supplying the customer heat numbers for incoming raw materials. Issue a CA to said vendor outlining the need for this information and hopefully the CA can be closed in a matter of weeks.

A preventive action for the continued dropping of raw materials into an autoclave. Look into why the parts are dropping. Solutions to eliminate dropping. Select a solution, have a ganrty fabricated and implement equipment....timeline maybe two months.

Hell, either way you slice it, you are solving problems and preventing reoccurances.

John

I mostly agree, but was just pointing out the fact that PA=longer and more expensive as a defining term doesn't always hold true. Also, your example of PA, that of preventing materials from being dropped, is an example of CA, using the ISO definition--you're correcting an existing problem. If, when the process had been designed, some insightful person had anticipated the likelihood of material being dropped and installed the necessary controls, it would be PA.

[RJFisher]

In Reply to Parent Post by Jim Wynne

I mostly agree, but was just pointing out the fact that PA=longer and more expensive as a defining term doesn't always hold true. Also, your example of PA, that of preventing materials from being dropped, is an example of CA, using the ISO definition--you're correcting an existing problem. If, when the process had been designed, some insightful person had anticipated the likelihood of material being dropped and installed the necessary controls, it would be PA.

I agree with Jim on this one... In fact, my company prefers to spend as little money as possible, and sometimes the best PAs have been the least expensive to implement.

On the issue of one or two procedures, my company has one procedure document for both CA and PA procedures, as well as one procedure for both Document and Record Control procedures. Thus, we've got 4 documents for the 6 ISO required procedures.

Just my

[JaneB]

Good to hear from you John, and some interesting points.

I assume you're talking specifically of what's the case in your organisation.

My view and experience is rather different. I don't go for the CA = short and cheap, PA = long and expensive at all. In fact, my view is that it depends (as always) on the particular issue, context, importance, risk etc. And common sense would appear to suggest that it's often cheaper to prevent a problem from arising in the first place than to have to fix one after it happened.

I've seen PAs that cost very little and took a very short time to do. And I've seen some CAs that cost many, many tens of thousands to fix and many, many months to complete.

[howste]

In Reply to Parent Post by jrugburn

At least this is how I have approached it in my limited 20 years of manufacturing under the ISO umbrella.

I find it interesting that you've been working under the "ISO umbrella" for 20 years, and apparently haven't understood the ISO definitions for the terms corrective action and preventive action. The way you are using the terms, you're actually describing correction and corrective action:

In Reply to Parent Post by ISO 9000

3.6.4 preventive action
action to eliminate the cause of a potential nonconformity (3.6.2) or other undesirable potential situation
NOTE 1 There can be more than one cause for a potential nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action (3.6.5) is taken to prevent recurrence.

3.6.5 corrective action
action to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation
NOTE 1 There can be more than one cause for a nonconformity.
NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action (3.6.4) is taken to prevent occurrence.
NOTE 3 There is a distinction between correction (3.6.6) and corrective action.

3.6.6 correction
action to eliminate a detected nonconformity (3.6.2)
NOTE 1 A correction can be made in conjunction with a corrective action (3.6.5).
NOTE 2 A correction can be, for example, rework (3.6.7) or regrade (3.6.8).