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

[jfount]

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

[GStough]

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....

[Jim Wynne]

Originally Posted by jfount

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.

[Madfox]

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

[ScottK]

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.

[jfount]

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

[ScottK]

Originally Posted by jfount

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.

[John Nabors]

Originally Posted by Discordian

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