Developing a ISO/FDA Compliant Supplier Quality Assurance System - Medical Device

[Ironcountry]

Recently, I've received the assignment of developing a formal SQA system including Qualification, Rating, Corrective Action, Auditing, etc. (not necessarily in that order), basically cradle to grave. I've searched the forums here and have found some valuable information however would certainly appreciate further input/suggestions. My timeline is qualification guidelines by the end of 7/07 and the remainder by 1/08.
Thanks in advance!

 

[CarolX]

Ironcountry - sorry you have not received any input to your question -

Sorry I can not help.

Any takers?

 

[Phil Fields]

I would review both ISO 13485 and 21CFR Part 820. Once I have reviewed and understand both documents, I would define/document what your company is presently doing that complies with the two documents. Remember if you are in the Medical device industry, you must comply with Federal regulations.
I would have to assume that you are already doing most of what is required, you just need to pull it together to formalize the process.
I hope this helps,
Phil

 

[Ajit Basrur]

Recently, I've received the assignment of developing a formal SQA system including Qualification, Rating, Corrective Action, Auditing, etc. (not necessarily in that order), basically cradle to grave. I've searched the forums here and have found some valuable information however would certainly appreciate further input/suggestions. My timeline is qualification guidelines by the end of 7/07 and the remainder by 1/08. Thanks in advance!

Ironcountry,

When you refer yourself as manufacturer of Medical devices, is it that you do molding and final assembly of the finished device ? Who are your suppliers - resin suppliers etc ?

When you say that you are intending for ISO / FDA compliant Supplier Quality system, the basic things which you should target are -

1. Supplier Qualification - This should be proceduralised with audit checklist and criteria for qualifying the suppliers. The suppliers can be qualified by either audit or supplier self evaluation (based on the material which you receive). The suppliers after audit could be either Approved , rejected, or mconditionally approved. The conditionally approved suppliers should be introduced in your system after review and approval of the suggested changes. Also note that this phase can involve Customer dictated suppliers. The names of these suppliers should be mentioned in an approved supplier list.

2. The next phase would be signing documents like Non Disclosure Agreement, Commercial Agreement, Technical Agreement (highlighting apart from others, that the supplier should notify you of any process changes. This is of utmost importance for manufacture of medical devices) between your company and the supplier. Ensure that compliance of regulatory requirements are met through these documents.

3. Supplier rating - Come up with a supplier rating form based on Quality, Delivery, End customer compalints, cost competitiveness etc.

4. Supplier Decertification Process - Have a system for decertification of suppliers for issues like non compliance to agreements, repititive major defects, etc.

5. Recertification - In the event of DECERTIFICATION of any supplier, you may elect to re-start the CERTIFICATION process. The recertification process shall treat as this this is a new supplier and to review all corrective actions.

Pls let me know if you need additional info.

 

[RCW]

Recently, I've received the assignment of developing a formal SQA system including Qualification, Rating, Corrective Action, Auditing, etc. (not necessarily in that order), basically cradle to grave. I've searched the forums here and have found some valuable information however would certainly appreciate further input/suggestions. My timeline is qualification guidelines by the end of 7/07 and the remainder by 1/08.
Thanks in advance!

Ironcountry,

What exactly is the scope of the system you are to put into place? Is it solely to meet FDA requirements?

The reason I ask is that I started with an ISO 9001 system and tweaked that to comply with 21CFR820 (to meet FDA regulations). My system currently wouldn't meet ISO13485 standards though.

I'm suggesting that if it has not been done yet, you and your company (aka management) should define the focus of the system you want to put into place.

 

[Ironcountry]

First, thanks to CarolX for getting the ball rolling! and to Phil, Qualityalways and RCW for your contributions!

A little more detail that I failed to include in my haste:

1) My company is a producer of implants and implant instruments
2) materials are SS, Titanium, etc. and more recently machined medical grade plastic
3) There is a SQA system in place that includes Supplier Assessment, Supplier Self Assessment (Suppliers), skeleton rating system, etc.
4) There is an Approved Supplier List but is in need of paring down to a workable number, too many one time purchases have lumped those suppliers into the ASL. I'd like to consider breaking the list into categories; raw material, components, complete assemblies, services (not sure about this one, ie how to state). Any thoughts
5) We an ISO and FDA registered company.

Prior to my arrival, the SQA system was functional but performed by committee. Weaknesses --> Approved supplier list and qualification criteria, surveillance policy, rating system (probably the biggest challange), corrective action follow up, etc.

I'm wide open to suggestions and certainly appreciate the input.

 

[Conquer]

To combat the problem of having too many suppliers to evauluate we have grouped our suppliers into different levels. They are divided into Major and Minor suppliers that have different evaulation and reevaluation criteria. This ensures we focus our supplier auditing on the ones that really count. During our reevaluation process we also ensure that we check to make sure a supplier shouldn't be bumped up to Major from Minor.

 

[LGDeneault]

I have a COMPLETE set of Quality Documents that were recently audited by the FDA at QSIT Level II (Comprehensive).

 

[SilverHawk]

Like to share the copy with us here?

 

[Ironcountry]

Hello Everyone,
If someone is up to sharing some of their documentation, it would be appreciated. I'll do the same with the info. that I have.
Thanks