Hi Folks,

I know there are already a million questions regarding CAPA.
I haven't been able to find a definitive answer on this specifically.

Does anyone have a list as to what should generate a CAPA?
We are using the risk based approach, but are also revamping our SOP and would like to cover as much as possible.

Example: Lack of Training
Inadequate SOP
Not following procedures?
OOS
Trend exceeded
Etc.

Any help would be appreciated.
Thanks in advance

Don't forget:
- Results of audits (both internal and external)
- Customer complaints (where applicable)
- Action items resulting from management review

I'm sure there are others, but these 3 are the first to come to mind at the moment....

Hi Folks,

I know there are already a million questions regarding CAPA.
I haven't been able to find a definitive answer on this specifically.

Does anyone have a list as to what should generate a CAPA?
We are using the risk based approach, but are also revamping our SOP and would like to cover as much as possible.

Example: Lack of Training
Inadequate SOP
Not following procedures?
OOS
Trend exceeded
Etc.

Any help would be appreciated.
Thanks in advance

The only thing that should generate formal corrective action is evidence of a failure of the system such that (A) unless the cause is corrected, the same problem is likely to recur and (B) the cost of fixing the problem is less than the cost of not fixing it. Of course, customer requirements might supersede the use of common sense.

Rather than generate CA's based upon a laundry list of specific occurances, my be belief is that is should be based upon severity.
In brief, that a CA is generated when you want to see notice of the occurance (and possible responses) get communicated laterally and vertically in an organization.

The Madfox

I don't know if I'd do a CAPA on "trend exceeded" if the parts are still spec. That's really an alert for the operator that the process is going out of control.

Is your CAPA system made up of two subsystems (PA and CA) or is it all in one?
I use two subsystems. The PA system is used more to identify opportunities for improvement and can be used by anyone in the company.
The CA system is for identifying nonconformities and the only people that can write CARs are QA/QC, Safety Committee, and Internal Auditors. The CAR requires "action to prevent recurrence" but does not automatically generate a PAR.

It's CA PA Trend exceeded is just a fancy way of saying there is a trend.
We do use risk analysis. Looking for what might generate a CAPA, and possibly categorizing

It's CA PA Trend exceeded is just a fancy way of saying there is a trend.
We do use risk analysis. Looking for what might generate a CAPA, and possibly categorizing

I catagorize my PAs as such:
Safety/Environmental
Housekeeping
Efficiency Improvement
Cost Savings
Product Quality
Other

Corrective actions are not really catagorized per se. All corrective actions are the result of a nonconformance. If it's an observation it goes on to a PA. I allow for "criticality" but I'm thinking of eliminating that.


I purposely leave it broad.

The CA system is for identifying nonconformities and the only people that can write CARs are QA/QC, Safety Committee, and Internal Auditors.

In my organization, anyone can write a CAR or PAR. 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 although that has not yet happened during my tenure here (2-1/2 yrs).

Regards -John

In my organization, anyone can write a CAR or PAR. 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 although that has not yet happened during my tenure here (2-1/2 yrs).

Regards -John

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

Here, if someone not on the list observes a nonconformance he/she can notify a QC inspector or safety committee member who can write it up. That alos provides some anonymity for someone who is afraid of being labeled a whistle blower.

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

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

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

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

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

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.........

"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.

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