Preventive Action (PA) and Corrective Action (CA) - One or Two Procedures?

[JaneB]

So many organizations do not give themselves credit for the good PA activities they have in place.

Stijloor.

You're right.

I just saw an organisation doing this brilliantly. They had a very sound risk asessment process in place. It's based around the risk management model in the Standard (4360 I think), with their risk assessment revisited and updated at defined internvals, & at least annually.

For each risk assessed at a certain level, they determine what mitigation or management strategies are needed (ie, preventive), and ensure they implement those, and/or revisit/revise as needed. Some of the measures they've put in place are similar to some of those on the PA Matrix you posted - eg, procedure XYZ, audit checks of ABC, etc. Best I've seen. And report all this through to the Board regularly, of course.

 

[qualitytoughnut - 2010]

Good points.

If you proactively initiate action to prevent a potential problem, call it a Preventive Action.

If you reactively initiate action to address (prevent) the reoccurrence of an existing problem, call it a Corrective Action.
Then move on. I think we are WAY overthinking this!

Good to hear from you again, Chuck!

Good point Jilling,and I too subscribe to same.ISO also says-To prevent occurance is PA.Yet quality personnels are using CAPA in one format!?Problem has 'occured',and half the form is dedicated to RCA,1/4th to CA;and then there is 1/4th for PA!!!While PA,by the defination,is inapplicable here.This is the anomaly I am talking about.Could you please shed light on this?

 

[Ashwani]

whats the fun of making 2 - procedures when a single is capable of handing both. beleive me i have worked with both old & new systems & the latter is much effective to control than the former one.u can use the diff. forms that too based on the process criticality like risk mgmt etc. but single procedure is great

 

[Helmut Jilling]

Good point Jilling,and I too subscribe to same.ISO also says-To prevent occurance is PA.Yet quality personnels are using CAPA in one format!?Problem has 'occured',and half the form is dedicated to RCA,1/4th to CA;and then there is 1/4th for PA!!!While PA,by the defination,is inapplicable here.This is the anomaly I am talking about.Could you please shed light on this?

Oh Boy...there are probably a thousand posts here on Elsmar about this topic. I recommend you search for Preventive Action and you will find much to read. If you are interested, you should search those.

A simple answer to your question, there are a few things that cause confusion.

• Originally in ISO 901, CA and PA was one section. The 1984 version separated them, and we have been arguing ever since.
• The Global 8D form has a step #7 which is titled "Preventive Action" from many years ago. That was actually intended as a "permanent action to the system level (documents, ctl plans, etc.). Should be renamed in my view.
• Since the steps are the same, only the stating point is different, they can be completed on the same form, and one procedure can do the job, but the procedure should be very clear these are similar but different actions. And the common form should have a check box to mark whether it is a CA or PA.
• Once the action is underway, it is no longer important whether it is CA or PA, the steps will be the same. It is the initial driver (proactive or reactive) that makes the difference.

Now, I will suggest, let's not start a new series of posts on this topic. Please read the many things already written, and then we can discuss if needed. There is much good discussion already on Elsmar.

 

[dmimore]

Hello! to everybody
In my company we are separating these two activities
this is to make it easy for the user and to properly distinct
the differences of the requirements of this standard.
Note:
In the old version of the standard we combined it into one

Thanks....More Power

 

[ETYSUN]

Dear All,

Note: I'm coming into this thread late and I have not read all postings. Forgive me if I've repeated previous discussion points.

I have the following inputs:

1. The CAPA process is a hub, therefore, there may be feeder processes that have satellite CA of their own;
2. Typically, companies have an issue of how to perform root cause or assignable cause investigation;
3. Also, companies have issues with the definition and scope of effectiveness checks; how they connect to audit management; how they trigger CAPA closure; etc.

Given the Items 1,2,3, the question of whether you have one or two or more CAPA procedures is too ambiguous. The answer may depend upon the size of your organization; the abilities of your ME/QE/R&DE population to perform investigations; and how tightly coupled your QSM processes are in practical terms.

If you are in an electronic CAPA system, it is easier to have one form. Prepopulated Drop down selectables can harmonize the process so that whether it is CA or PA, selection of drop down items to the electronic form directs the real issue to be more of what are your defect categories; your action types; your root cause codes; and closure task management criteria.

Best regards

 

[ChuckHughes]

To some extent I disagree with Helmut in citing the two systems as fundamentally the same. Prevention has a different and independent initiation. The intent is "avoid the first occurance". Correction is "to avoid the second occurance". The challenge in prevention is determining what is to be avoided. Unlike "corrective actions" which respond to physical stimulus (irate customer, inspection fall out, scrapped parts, etc), "preventive actions" need to be initiated cerebrally. By that I mean personnel charged with prevention must know when to do it. Most businesses have separate "preventive" programs that initiate some type of risk analysis and establish mitigation to reduce risk. Such programs as Safety or ISO 14000 have a requirement to assess risk and set controls in place. Prevention within the QMS should follow this pattern and some forum needs to be established that systematically assesses risk to processes, products or the entire business before the demons appear.

I advise my clients to establish a pattern within each planning meeting to define what is at risk in the execution and determine if the risk warrants some control/mitigation. Once stated as a risk, the execution of the plan can be monitored.

 

[Helmut Jilling]

To some extent I disagree with Helmut in citing the two systems as fundamentally the same. Prevention has a different and independent initiation. The intent is "avoid the first occurance". Correction is "to avoid the second occurance". The challenge in prevention is determining what is to be avoided. Unlike "corrective actions" which respond to physical stimulus (irate customer, inspection fall out, scrapped parts, etc), "preventive actions" need to be initiated cerebrally. By that I mean personnel charged with prevention must know when to do it. Most businesses have separate "preventive" programs that initiate some type of risk analysis and establish mitigation to reduce risk. Such programs as Safety or ISO 14000 have a requirement to assess risk and set controls in place. Prevention within the QMS should follow this pattern and some forum needs to be established that systematically assesses risk to processes, products or the entire business before the demons appear.

I advise my clients to establish a pattern within each planning meeting to define what is at risk in the execution and determine if the risk warrants some control/mitigation. Once stated as a risk, the execution of the plan can be monitored.

Hi Chuck, good to hear from you again. Hope you are well!

No disagreement at all, I think. I agree with all points you made, and strongly make the same case.

I meant the format - root cause, actions, verifications - between CA and PA are essentially the same. The trigger - proactive vs reactive - is definitely different.

Keep in touch.

 

[ChuckHughes]

Thanks Helmut

I get a little passionate about this one. There is little in the way of prevention and a lot of money spent on corrections.

These icons are neat.

Happy Easter and I will talk to you soon.

Chuck

 

[rcap1]

Hi to all, I am new to the forum, but I could not help myself get caught in the CA/PA debate since started in 2003 to current, there are many good suggestions, ideas and so forth.

I do have one thing to add, all process and documentation you create and implement, just remember to keep it simple (KISS Principle), the more documentation you create the harder is to maintain, implement and follow.

I vote for one CA/PA Procedure and one Form.

ps: Also the new ISO 9001:2008 Draft version does not specify CA/PA on how many procedures you need, its entirely up to your organisation needs.