Lean SCAR Process and Form needed - ISO 13485 and FDA

[dutch meddev]

Dear all,

I work for a medical device company in the Netherlands which develops and markets mostly disposable accessories.
Unfortunately we face loads of non conformities caused by our suppliers.
We're in the process of developing a SCAR process and so I was wondering if someone could help me out with an example of a working form and process description.
We are looking for a way to implement a lean system that is compliant to ISO-13485 and FDA regulations, but on the other hand as user friendly as possible.
Please drop me a line if you could point me in the wright direction.

Thanks a million!

 

[Stijloor]

Dear all,

I work for a medical device company in the Netherlands which develops and markets mostly disposable accessories.
Unfortunately we face loads of non conformities caused by our suppliers.
We're in the process of developing a SCAR process and so I was wondering if someone could help me out with an example of a working form and process description.
We are looking for a way to implement a lean system that is compliant to ISO-13485 and FDA regulations, but on the other hand as user friendly as possible.
Please drop me a line if you could point me in the right direction.

Thanks a million!

Hallo beste Limburger...

You may want to do a search on (SCAR) supplier corrective action here at The Cove Forums.

For example, a search in the Post Attachment List on the term "SCAR" revealed this.

Not all apply obviously, but it may be a good start for you.

De hartelijke groeten.

Stijloor. (Ex-Brabander)

 

[Bob Bonville]

Dutch, if SCAR stands for Supplier Corrective Action Request, I just developed one. Send me an email to [email protected] and I will pass it on to you.

Bob

 

[Stijloor]

Dutch, if SCAR stands for Supplier Corrective Action Request, I just developed one. Send me an email to [email protected] and I will pass it on to you.

Bob

Bob,

Could your SCAR be shared with others at this Forum?
(That's the intent and purpose of The Cove.)

Stijloor.

 

[Bob Bonville]

I would be happy to if I knew how.

Bob

 

[Stijloor]

I would be happy to if I knew how.

Bob

Bob,

If you scroll down on your "post page", you'll see a button "Manage Attachments."

Fairly easy to follow...

Stijloor.

 

[John Broomfield]

Dear all,

I work for a medical device company in the Netherlands which develops and markets mostly disposable accessories.
Unfortunately we face loads of non conformities caused by our suppliers.
We're in the process of developing a SCAR process and so I was wondering if someone could help me out with an example of a working form and process description.
We are looking for a way to implement a lean system that is compliant to ISO-13485 and FDA regulations, but on the other hand as user friendly as possible.
Please drop me a line if you could point me in the wright direction.

Thanks a million!

Hopefully you are getting a grip of your supplier selection criteria too so you will make less use of your new SCAR form and process.?

 

[dutch meddev]

Hi John,

selection criteria are known, but we are in a position with very few suppliers and even less alternatives. This is the main cause of (multiple) non conformities per supplier. This means we sometimes have to support our suppliers in sorting out their process to garantee acceptable components.

 

[harry]

I would be happy to if I knew how.

Bob

Hi Bob,

Have a look at: How to Attach a File to a Post in a Thread