Corrective Action Filing and Traceability Techniques

gunnyshore

Starting to get Involved
I am looking for some feedback to help on our implementation of ISO 13485. Up to now the company has done very well but the Quality System has relied on the small group of people to do things with very little documentation. The company has started to grow so we need to get better at record keeping and traceability.

We have a paper based system, so I'd like to hear from you on:

How do you maintain CAPA documentation storage filing, and labeling?

How do I teach other people to understand and respect documentation rules such as how forward and backward traceability is critical?


thanks,
Jim

PS I've been a long time member of the Cove but have never posted before. I'm looking forward to replying to others!
 

Pancho

wikineer
Super Moderator
I am looking for some feedback to help on our implementation of ISO 13485. Up to now the company has done very well but the Quality System has relied on the small group of people to do things with very little documentation. The company has started to grow so we need to get better at record keeping and traceability.

We have a paper based system, so I'd like to hear from you on:

How do you maintain CAPA documentation storage filing, and labeling?

How do I teach other people to understand and respect documentation rules such as how forward and backward traceability is critical?


thanks,
Jim

PS I've been a long time member of the Cove but have never posted before. I'm looking forward to replying to others!

Hi Jim, and welcome to posting!

Regarding your first question, we use Bugzilla. It's open-source and much easier for keeping CAPA documentation than a paper based system.

On your second question, IMO it is most important that traceability is built right in the process, and not discretionary. This means that your documented procedures must spell out in minute detail how traceability is kept at every step of your production. If your process has traceability built in, then your teaching of traceability will be exactly the same training you need give your operators to do their regular work; not something tacked-on as an afterthought. Theodore Levitt said "discretion is the enemy of quality". Remove discretion from traceability.

Good luck!
Pancho
 

gunnyshore

Starting to get Involved
Hi Pancho -
Thanks for your feedback regarding my question.

I agree about not making it optional, I try to explain it as it's the same way we trace materials thru incoming to manufacturing and final. However, they don't understand the approach needs to be the same for Corrective Action.

The example I tried explaining was:
Field complaint, device does not work
Device returned, turned out to be a supplier item
We sent the unit back to the supplier and they took corrective action
We inspected the next couple of lots to make sure the fix was effective

....now, I tried to explain that the documentation needs to follow the same methodology and be traceable back to the first field complaint.

Do you or anyone else have any suggestions that work with their corrective action system?

thanks,
Jim
 
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