What should generate a CAPA (corrective action - preventive action)

[John Nabors - 2009]

that's great if it works for you.
Unfortunately I've had the opposite experience where people would feud via the CAR system.

Yup, I've seen exactly the same garbage in other organizations, particularly one specific defense contractor I once worked for. It was to the point where someone would write a CAR just so that the subsequent blamestorming would distract attention from their own deficiencies. Fortunately that sort of crap isn't tolerated where I now work.

Regards -John

 

[lrowe]

I am going through a complete retooling of the CAPA process /procedure with my new company now. I've been here a little over a month and what I found here was Deja Vu from my previous company when I first took over ISO responsibilities with them. In short - if you don't have a fairly well defined CA criteria, people will call just about anything they don’t like a cause for "Corrective Action". This leads to a system that becomes over whelming in a hurry and CA are open for a long time, since some of the problems won't necessarily have a root cause or effective action plans.

It's my contention that if you use the term "Corrective Action" this indicates a problem that is serious in either it's cost, your company's reputation, customer satisfaction, etc. As such, this means there will be substantial resources applied to fix the problem. Other problems that have less impact should be called something else, like an internal Non conformance, Supplier reject, customer complaint etc. These types of problems are processed differently, in other words appropriate actions that won't require the intensity of the resources for a "real" corrective action.

So in a nutshell, I like to define the situations that warrant a true corrective action and make sure that definition is not so vague that any problem is processed as a corrective action. This makes the system much more manageable and has passed audit muster several times.

Larry

 

[Tim Butler]

John,

That is a problem. If the QM and Management Team does not review these NCRs and the resulting ( CA/PA ) for:

1.) Accuracy - Internal Auditors should be well trained
2.) How and why it was found. If anyone can write a N/C ( CA/PA ), this could very well happen. Control who can write the N/C, allow anyone to issue a request to investigate the possible N/C.

If the procedure is that the QM and their (I.A.s ) Internal Auditors must investigate the NCR prior to issuance - this can prevent useless findings from being written and prevent the issue of employee bashing.

It is the QM and the Executive Management, that sets the tone and how N/Cs are written against the QMS. There are, in the majority of cases, good findings and I think it best, not to lose sight of the benfit from finding N/Cs and implementing ( CA/PA ) before the customers do. Provided they are valid.

I will agree that in some cases, there is a blame game that goes on and people use the N/C as a means of political ammo. This hurts the QMS and its' validity.

If this occurs during the Internal Audits by the internal auditors, it is up to the QM to prevent this. I have seen in somes cases where the QM didn't have the ability to prevent it and as a result, outsourced the I.A. to a third party to maintain objectivity.


Sincerely,
Tim

JFount,

My name is Tim Butler and I have 10 years of experience and have worked with 1000+ companies on their ISO programs: AS/ISO/EMS/CE/OHSAS/TL/RCMS/TS.

If you are looking for what should trigger a CAPA look to your companies' procedure and if there is a deviation in this procedure from what actually occurred, then a CAPA should be required. I would also make sure the procedure is lean - calling out only what is absolutely required to perform the specific task. Otherwise, you are requiring additional steps that could bog your QM system. If you need a checklist for any standard or anything else, please feel free to ask.

Sincerely,
Tim

 

[John Nabors - 2009]

Tim-

An earlier post places my second post in context-

...The CAR or PAR is reviewed by the managers of Quality, Production, Materials, Engineering and Maintenence. If the CAR is found to be inappropriate or spurious it is rescinded...

Regards -John

 

[justncredible]

A CA should address the outliers and sporadic change.

A PA should address the normal occurring process waste.

Pa goes with a pareto for known causes of waste or scrap.

CA goes with a system breakdown, a flier, a outlier, a non-conformance that does not fall into known waste related issues.

The PA will eliminate process variation, based on knowns. The CA is a remedy for a unknown. Cost of quality analysis should be studied for a PA, whereas a CA involves customer risk. So the CA should be a weighted, and customer risk driven action.

But, then I just make this stuff up as I go along.........

 

[Roland Cooke]

"The most important preventive action we ever took was to implement a Corrective Action system, just in the unlikely event that our up-until-now fully effective Preventive Action system let us down at any future point."


Joking aside, I really would recommend breaking out the CA system from the PA system. Don't even call it CAPA if you can get away with something that radical.

Anything that happens following a problem to stop it or something similar happening again is further corrective action.

There is an argument that lessons that can be applied to unrelated areas would be preventive actions. I do tend to subscribe to that theory, but from my perspective, I don't care what you call it as long as it gets done.


Most companies have a lot of Preventive Activity going on - they just don't recognise it as such. Action/alert levels on trending data, contingency planning, safeguards built in for larger / longer-term projects, etc etc.

Analysis (e.g. by Internal Audit) of why projects went bad, will usually indicate that the preventive action system wasn't effective.

 

[Phil Fields]

Is you company FDA regulated? If yes then follow 21 CFR Part 820 section 820.100 a (1). This section defines the areas that would trigger a CAPA