Recover a Damaged CAPA (Corrective and Preventive Action) Project

[QE]

Team, I wanted to pick your thoughts on recovering a damaged CAPA project. May I get help an discussions on ow to recover a damaged CAPA project.

Damaged means...
1. Running Late.
2. Short of Resources.
3. Does not have a priority and a sense of urgency.

Thanks
QE...

 

[Raffy]

Hi QE,
It is very painful for a person managing a damaged CAPA project without the corresponding MANAGEMENT COMMITMENT and/or SUPPORT to accomplished the said project.
In recovering to Damaged CAPA, I will use all the resources that my company can give example, as of this date with all the technology, software applications, newer versions of OS. The fact that my system runs under Windows 98 and office 97 is the only tool that I have right now. So for a CAPA, I am using the excel to track and monitor our CAPA, to add some spice in tracking mdb database can be design and developed. And so far, it is okay for now but there are other software applications that can be used to develop CAPA, i.e. MySQL combined with Php, Perl, etc.
In this regard, wherever you are in life without the necessary resources, it is still good that you have tools to used and developed.
Raffy

 

[jkuil]

First of all, CAPA's need continuous monitoring of the progress to pervent them going into a damaged stage.
If a CAPA went into a damaged stage, then the first thing to investigate is, as Raffy said, the management support and commitment. The managament responsible for the area of the CAPA needs to define a revised action plan that is realistic based on available resources and the priorities based on the associated risk. If management is not held responsible for the plan, there will be no commitment nor support. Even if a plan is defined by the CAPA owner, appropiate management needs to approve so they can be held responsible for adherance to the plan and the required resources to do so. Likewise, management is responsible for the CAPA owner's commitment in adhering to the revised plan.
Commonly the QA department monitors the CAPA process to assure CAPA action items do not go overdue. Progress reports are provided to senior management.

 

[Ajit Basrur]

Great question, QE and equally great responses from Raffy and jkuil.

In addition, I would suggest to prepare a "Damage" Report to include % Damaged, Pareto of Damage criteria etc. and present to Sr Management.

Figures can help communicate better

 

[Bev D]

There are many ways to attempt to recover focus on CAPAs that are 'damaged'. One of the more effective ways is to first understand what is causing the 'damage' so we can truly correct and prevent recurrence. This is analogous to the difference bewteen reworking defective product and understanding the causal mechanism so one can take corrective action to prevent recurrence.

Why are CAPAs getting damaged? Is it truly a lack of management support? Could it be that the nonconformances that are the subject of these CAPAs have little to no impact on the organization? Are there just too many things to fix and the system is lacking prioritization of constrained resources? Just some things to think about.

 

[iamtroll]

I agree with Bev, often a CAPA program will get bogged down in the minutia and a good Pareto analysis will direct you to the critical few that then may be able to be managed by the resourses that are available to you. This analysis can also aid you in convincing upper management that there are a some CAPA issues that are mission critical to the organization and do deserve attention.

 

[Jim Wynne]

Team, I wanted to pick your thoughts on recovering a damaged CAPA project. May I get help an discussions on ow to recover a damaged CAPA project.

Damaged means...
1. Running Late.
2. Short of Resources.
3. Does not have a priority and a sense of urgency.

Thanks
QE...

Assuming that you've already tried cajolery and nagging, think about posting something in a conspicuous place that details the transgressions and responsible parties. If you can't do this for fear of being vaporized by an offended manager, there is probably nothing at all you can do to promote the process. Change will have to emanate from a higher level.