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

barb butrym

Quite Involved in Discussions
#11
The thing about preventive Action is that nearly everyone does it, but 99% don't document it well.

I have difficulty seeing how you can put that into an existing process. AND I use process flow diagrams ALL the time. Seems to me, if you can predict it, then its corrective action (poka-yoke) not preventive. I see that fitting nicely into a flow diagram, but preventive is yet another animal. Preventive is many things, your process engineering group does it all the time I bet. As do task teams and all good managers. AND the best to capture is the operator level stuff.

Some registars just tell you PA is a long term fix to correct the root cause, and CA the short term to fix the problem at hand. That if you do CA correctly, then PA is the result. I disagree, but depending on the registrar I am representing, I have to adjust that a bit.

As a consultant I approach it for the prevention of potential issues...a common sense approach that leads you onto the path toward Continuous Improvement.....which now will fit nicely into the '2000' revision, even though I have been doing it for years. CA still addresses root cause of issues at hand.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#12
Could we not say:

Corrective Action is a response to a negative event (an occurance),

while

Preventive Action is response to a predicted negative event (has not yet occurred)?

Or is this too simple a definition? I think the definition of Preventive Action has changed over the last 15 years. I learned it as 'things we do to prevent a negative event from happening again'. Now I understand it as I stated above.

Key to differences as I understand them:
Actual occurance of a negative event
-vs-
Predicted occurance of a negative event.

If I was told:
--> ...need to insert a (new) Corrective & Preventive
--> section into each of our processes.

I would point blank ask for an example of what that person has in mind. I would want to know just what their expectation was/is. C&P Section? What is that? What does (should) it contain? Will a system where FMEAs and Control Plans are utilized suffice?

I would, as I say, ask for an example to really pin down (and I personally would document) their requirement and expectations. Come to an agreement on the intent of their request (yeah, I know it's self evident, but I wouldn't let that stop me from discussing it). Then come to an understanding on issues such as implementation time, breadth of implementation (All products? Customer specific products?), and related issues. Develop a project plan and get them to approve it. Then, I guess, do it.

[This message has been edited by Marc Smith (edited 12-31-98).]
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#13
John,

I am in agreement with Dawn on the need not to place CA and PA into each flowchart. It seems to me that you would be better off creating one process to deal with any type of CA/PA issue that is referred to perhaps in each flowchart. Otherwise, redundancy will only increase the typing.

You mentioned the "what" that could go wrong and "what to do about it when it does". This sounds to me like contingency planning. As far as the differences of CA and PA, the group sums it up well. There were several postings about a month or so ago, can't remember where, but I will post where they are if I get the chance.

Welcome to the group...
 
J

John LeBlanc

#14
Thanks, everyone, especially for the quick responses. Let me clarify something. I misled you regarding the flow charts. While we have flow charts in each of our process documents, I didn't mean to imply that we were inserting corrective and preventive INTO the flow charts. That is not the case. Rather, we have been instructed to now include a new section of the process document that deals specifically with Corrective and Preventive.

My point was that I had been suggesting to the document authors that they utilize the flow chart as a "stepping off point" for creation of this new section of the process document. Looking at the flow chart, they were to determine what could go wrong, and what they would do to rectify that situation (thus, Corrective) and then they would give some thought to what should be done to ensure that this same problem would not happen again (thus, Preventive).
Does that clarify the confusion that I caused regarding the flow charts?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#15
Using a process flow chart is standard procedure for 8-D and other investigations. I've very 'pro' flow charts. See the 8-D pdf file in the pdf files directory.

I don't know how you'll solve this but please do keep us informed of what happens. I still think we are all at issue over preventive vs corrective. Seems to be a never ending topic subject.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#16
John,

Marc is right, CA vs. PA is an ongoing discussion. Barb raised a good point. Some registrars consider long-term fixes as preventive action (the registrar we have viewed it that way, my organization does not). From my perspective, CA is taken to remedy an "existing" problem. PA is taken to "prevent" problems from occurring. By definition, CA is taken to eliminate cause and prevent future occurrences of a nonconformance (although prevent is used here, it is not a preventive action as it is "an existing negative event").

Flowcharting is a great tool! Keep pushing that point with your document creators. But I feel that the responses you are building in your flowcharts are contingency plans and not CA. Remember, CA totally eliminates 'causes' making contingencies unnecessary (in theory anyway). There is nothing wrong with contingency planning as it provokes a response to an undesired result, and as you will find, most processes and systems will always produce some level of nonconformance. Contingency planning will hopefully control the level of nonconformance, CA will eliminate the cause of nonconformance.

I also think that Contingency Planning points to potential Preventive and Corrective Actions. For example, "if" this occurs "then" this is what we will do. If you know the "ifs", you may decide to plan to avoid the "ifs" (preventive actions). And if the "ifs" exist, you may plan to avoid them in the future (corrective action). Quite a tough read there, but I hope you get my point.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#17
Uh ohhhh. Contingency Planning rears its ugly head... We need a thread on Contingency Planning.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#19
I have my name on all too many 'starter' threads. I'll let someone else start it off - Let's just NOT add it to this thread. I'ld like to stay as 'on-topic' as we can.
 
J

John C

#20
The definition of Corrective action can be gleaned from clauses 4.14.2a and b where it refers to “nonconformities” identified from customer complaints, reports and records of investigations.

Preventive action is in 4.14.3a where ‘appropriate sources’ (shall) be used to detect...’potential’ causes of nonconformities.
This seems pretty straightforward to me but there might be some confusion regards sources of warning about potential nonconformities in 4.13.3a, eg; What sort of customer complaint indicates a “potential” nonconformity, rather than an actual one?

Well, one example would be where a customer has a problem, but it is not clear if it is our equipment that is failing. At this stage it is ‘potential’ and we would implement 4.14.3a looking for relevant evidence.

If our records gave a strong indication of potential causes, we would probably then flip over to 4.14.2b action to pin it down. (Note that in ISO 9002, corrective action includes investigation of possible causes which might, logically, be said to be only potential causes. In practise, it is better to make assumptions and act as if you know the problem is down to you, otherwise the argument as to who is at fault would go on for ever like the CO2 issue in the ecological summit in Rio, and no-one would do anything. Once again, the guys who wrote the original wording can be seen to have got the balance just right.)

In the general case, though, I believe that Corrective action is a response, just as it is laid out in the clause, but that Preventive action is an ongoing, positive and deliberate search for trouble, where you don’t have reason to suspect there is any. The only confusion in my mind about this is where do I put my ‘Continuous improvement’ process. Is it here in 4.14.3 or is it in 4.2.3 Quality planning?

Running towards the smoke with a bucket, is not ‘preventive’ action, even though I haven’t yet seen the fire. Niether is shutting the stable doors after one horse has bolted. That is correcting an existing defect to prevent the rest of them bolting.

rgds, John C
 
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