Continuous Improvement Log vs. Formal CAPA System

M

Maven

#1
Hello All:

Our QA department is considering starting a continuous improvement "log", upstream from our formal CAPA system. The reason for this is to:

1) more quickly identify opportunities for improvement
2) sort and group entries to identify trends and possible weaknesses in our process
3) funnel high occurrence/high risk items into a formal corrective or preventative action

Does anyone have any experience using a log in this way, while still using a formal CAPA system? My fear is that this could become too much double entry and create confusion. On the other hand, it is a quick way to show what work has and is being done for continuous improvement purposes. Thank you in advance for your comments.
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
We have a 3 tiered system:

1. small continual improvements made quickly and locally
2. improvement projects that are chartered outside of the formal correction action sytem
3. a formal corrective action system

We have an "ideas program" where any one can enter ideas for continual improvement. Some of these become projects. many are simply a recording of the problem adn the action taken as the work is done quickly (true Kaizen)

Projects are launched within a product grouping or functional area based on an assessment of what work needs to be done to meet our goals in employee engagement, Quality, Delivery and Cost. most of these projects come from regular review of our metrics, some from the ideas program and some from formal corrective actions.

When a project comes from a formal corrective action, the corrective action is typically 'closed to a project' to avoid duplicate entry. same with a project that comes form the idea program. we do not allow duplicate entries of work.

it works for us...
 
M

Maven

#3
Thanks, Bev. It sounds like you have something that works well for you. I think we may be headed in a similar direction.

One follow-up question: do you ever have an issue from an audit standpoint if you close out the corrective action (pointing it to a project) without somehow showing effectiveness? Just a thought. Our problem is that we have some medical devices we do, but most are not. Thus, we have two different sets of requirements (one more rigorous than the other).

Thanks again for the comment.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
well our 'projects' typically have much more oversight and 'effectiveness' at understandign causal mechanism, implementing robust solutions and solid control plans. our auditors have had no problem follwing the trail to determine effectiveness.

A couple of controls we have in place:
when we close a corrective action to a project, the containment and our correction is often documented in the formal CA system and project documentation picks up from there. (we actually close corrective actions for complex time consuming problems because our project process is much more rigorous and has much better technical and busienss oversight than our CA process which is adminstered by QA. (not a judgment call just a choice of how each system will be managed). The CA is also closed to a project for problems that will take more than 60 days to resolve....even tho QA often follows up for an effectiveness audit.

the other thing we do is that if have a serious regulatory (USDA) problem we will keep it in the formal system although we use our project process to resolve it. All documentation of the project is then stored as a quality record within the formal system...
 
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