Supplier Qualification

[Cliff]

Hi,

I am looking for suggestions on performing supplier qualification.

We have an SOP and a web site to track our suppliers and their qualification.

What I am looking for are suggestions on how to self-qualify a supplier that is not submitting the requested documents.

For instance, review FDA warning letters, review the suppliers site...

Also, if you have a recent publication you can suggest, I'd be happy to see that too.

If anyone has suggestions, please reply. If you have an SOP you'd like to contribute, please add it here so it can uploaded for all to use.

[L106]

Our hospital's Compliance Officer asked me to come up with such a procedure/policy just a few months ago. If I do this correctly, I will attach two documents I came up with. (They are pretty "basic", but at least it's a "starting point".

Donna

Annual Review of Blood Supplier 012009 BBT.doc

Annual Blood Supplier Review Form 012009 BBT.doc

[RR1]

Hi Cliff,

I would have thought you could use historical data/ info. ( if you have been using something for a long time without problems- might be evidence). Also your suggestions of any FDA warning letters sounds good . How about writing a list of questions for the supplier, with tick boxes for them to complete and return for your assessment ?

Also, can they supply you with evidence of compliance to any ISO regs?- especially important for calibration labs to be ISO 17025 certified ( for pipettes/ thermometers etc) , I think these labs are also deemed to be suppliers.

In the UK we would be looking at the product being additionally CE marked.

Sorry- but I don't have this in any of my SOPs yet- just something else that now needs to be written and improved on!

I presume you would only need to perform SQ for just key equipment/ reagents/ products that are critical to your functions?

[JHH1999]

It appears everyone is on the same path. Of course the CFR does not specifically tell you what should be in a supplier qualification program, but that you must have one.

The basic principles in our procedure includes:

1. Assess the supplier to determine if critical or non-critical. If non-critical document rationale. If critical evaluate as below.

2. Send the supplier a questionaire with basic questions about their operation including ISO certification

3. Evaluate the questionaire and search for FDA warning letters, need for a site audit, etc

4. Track the suppliers performance by documenting any problems and resolution in the suppliers file

5. Periodically review suppliers file for performance issues to determine continued approval

This has worked for us so far. By tracking supplier performance we have needed to discontinue using a couple of suppliers that continued to give us problems. Mostly because their corrective actions were insufficient.