Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discussion

We are a little stuck in our work with iso 9001 concerning 4.14. All help is greatfully accepted.

What exactly are you stuck on?
do you have any kind of corrective or preventive action system?
How are problems reported and fixed? How about what you do after finding and dispositioning nonconforming product? is there a next step researching a cause? investigating/tracking how often the problem occurs or if it reoccurs, similiar problems in the same place?
Do you have a supplier corrective action system?

I'd love to help, but help me out with a few more details.

[Kevin Mader]

Johan,

I wrote something about a week ago in the QS9000 forum under the topic of Continuous Improvement Techniques that may help you out. I am assuming that you are having difficulty understanding the element and not having difficulty deploying CA & PA. Give that a look for greater detail and for a crude case example. Otherwise, here is a thought or two.

Corrective Action: Actions taken to eliminate the root cause of an existing nonconformance and to prevent its reoccurrence.

Preventive Action: Actions taken to eliminate a 'potential root cause' to a potential problem that has not occurred.

The element (4.14) requires that you identify areas for both within your organization. The CA portion deals with items such as customer complaints received, nonconformances uncovered as part of internal quality audits, or received incoming materials not meeting specifications for example. These problems exist in the here and now and require corrective action to prevent their reoccurrence. What do you do to correct the issues and how do you document what you did? Did it work (close the loop)? Do you review this as part of Management Review?

Preventive Action is a more difficult idea to grasp for most (maybe because we tend to put out fires rather than prevent them) and can be accomplished in various ways. I like to think of it this way. If a process or system is in a state of statistical control, does a problem exist? Sometimes but not always. There is natural variation in any process or system, but their output may not meet our desired expectations. A process not meeting our expectations may need refining, bu not necessarily correcting. We often think something 'must' be wrong when we don't get the results we hoped for. There is a significant difference in a process not meeting expectations and a process not producing to specification. This misunderstanding of system output usually leads to a landslide of issuing Corrective Action for every problem encountered. Does your organization make defective products occasionally? Mine does. Should I create a Corrective Action Report for each defective product especially if some level of defects is to be expected (the system will never produce zero defects)? No. Doing so would bog down the CA process and creates another set of problems (missing CA reports, CA reports not filled correctly, duplicate CAR for the same problem). Not all problems are Corrective Action opportunities. Some are Preventive Action opportunities. This example is more typical of a Continuous Improvement process with Preventive Action ties. Give thought to which situation you have and take actions commensurate with risks encountered. I hope this helped.

[Chaku]

So can i have use 1 Corrective and Preventive Action Report form or i need to separate them?

[harry]

In Reply to Parent Post by Chaku

So can i have use 1 Corrective and Preventive Action Report form or i need to separate them?

Welcome to the Cove.

Both are acceptable. Choose the method that you or your organization is comfortable with. From my experience, problems often arise due to the poor design of the form or people not knowing how to use it properly rather than whether it can be combined.

[Don Winton]

Kevin,

You have covered the aspects very well. I generally use this when describing the difference between CA and PA.

Corrective Action: Putting out a house fire after it has started.

Preventive Action: Observing conditions that may start a house fire and removing them from the system.

Regards,
Don

[John Broomfield]

In Reply to Parent Post by Don Winton

Kevin,

You have covered the aspects very well. I generally use this when describing the difference between CA and PA.

Corrective Action: Putting out a house fire after it has started.

Preventive Action: Observing conditions that may start a house fire and removing them from the system.

Regards,
Don

Don,

Beautifully stated, thank you.

Preventive Action should come before Corrective Action.

The term CAPA has caused untold confusion and wasted time.

It should be PACA so everyone seeks drivers of preventive action other than things that have already gone wrong.

If the airline industry had stuck with CAPA they would still be trying to improve air safety by digging black boxes out of the ground. Thankfully their preventive action is largely driven by data analysis and near-miss reports.

John

[Jim Wynne]

In Reply to Parent Post by John Broomfield

If the airline industry had stuck with CAPA they would still be trying to improve air safety by digging black boxes out of the ground. Thankfully their preventive action is largely driven by data analysis and near-miss reports.

John

Is a near-miss a nonconforming condition?