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Evaluation of Supplier Risk for FSVP - Feedback

FSVP Foreign Supplier Importer Supplier Risk FSMA

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#1 apcraig

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Posted 23 May 2017 - 07:04 PM

Dear Colleagues,

 

I am a Preventive Controls Qualified Individual and I work for a company that qualifies as an importer subjected to the FSMA Foreign Supplier Verification Program (FSVP).

 

FSVP requires importers to evaluate the risk associated with each foreign supplier based on several verification activities, such as (a) evaluation of the suppliers' procedures, processes and practices (SOP's etc), (b) evaluation of supplier's hazard analysis, and © evaluation of the supplier's performance history based on audits, sample testing, etc. 

 

While we keep records of the verification activities above, I wanted to compile all this information into one Form, to be completed every year for each supplier. I wanted something simple to help us justify why (a) the supplier should or should not be listed on our "list of approved suppliers", and (b) which verification activities should be intensified, if any. Please find attached the Form. 

 

I would really appreciate it if you could provide me with feedback on how this form could be improved to satisfy the FDA's requirements for FSVP rule. 

 

Thank you!

 

 


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#2 apcraig

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Posted 23 May 2017 - 07:14 PM

Please find attached. 

Attached Files


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#3 sirgumby

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Posted 23 May 2017 - 10:50 PM

I am putting together a FSVP approval manual for us. We are a small company with as you can guess a small budget. I have asked upper mgmt. for fund for a consultant to help put together a program and of course their response is what did we send you to FSMA training for. Does anyone have a blank FSVP manual that asked the right questions that will qualify for the FDA audit? The supplier risk evaluation will help, Thx apcraig.


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#4 Charles.C

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Posted 24 May 2017 - 04:37 AM

I am putting together a FSVP approval manual for us. We are a small company with as you can guess a small budget. I have asked upper mgmt. for fund for a consultant to help put together a program and of course their response is what did we send you to FSMA training for. Does anyone have a blank FSVP manual that asked the right questions that will qualify for the FDA audit? The supplier risk evaluation will help, Thx apcraig.

 

Hi sirgumby,

 

Not quite sure what you mean by a blank manual ?.

 

Maybe try the first attachment in this post -

 

http://www.ifsqn.com...rd/#entry113320


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Kind Regards,

 

Charles.C


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#5 sirgumby

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Posted 24 May 2017 - 02:15 PM

Thank you Charles.C for the advice. I used a poor choice in words saying blank manual. I will be tasked with implementing the FSVP for our company. What I'm looking for is wording to use that will suffice the FDA should they ever audit. Formatting the documents is a learning curve I have not yet mastered. I understand the language I just don't know how to write it yet. I thought being a small company we had until March 19,2018. But after digging into the rule realized our supplier from China is not a small company. Which then put our deadline May 30, 2017. So I,m scrambling to get something together, luckily we only have a few products to asses the hazards. I always appreciate the advice from this community.

 

Thank you


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#6 Sandra-M

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Posted 28 September 2017 - 11:39 PM

Hi SirGumby, 

 

I wanted to reach out, since like you, I'm a PCQI for a small company and trying to create and FSVP all on my own. 

Were you successful in creating a FSVP manual or template?

If so, would you be willing to share it?

 

I'm creating one and wanting to see if I'm going in the right direction.

I have not been able to find anyone's FSVPs posted on line for comparison.

I don't know if my FSVP is too general or too detailed... I just don't feel it is ready yet... so it would be nice to see some comparisons from the industry. 

I'm lucky in that our suppliers are small so we have til march 2018 to finalize our FSVP. 

 

If you or anyone else out there can help.. it would be great!

 

Thanks in advance! 

Sandra


Edited by Charles.C, 30 September 2017 - 01:14 AM.
name edited

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#7 Charles.C

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Posted 29 September 2017 - 02:30 AM

Hi Charles.C, 

 

I wanted to reach out, since like you, I'm a PCQI for a small company and trying to create and FSVP all on my own. 

Were you successful in creating a FSVP manual or template?

If so, would you be willing to share it?

 

I'm creating one and wanting to see if I'm going in the right direction.

I have not been able to find anyone's FSVPs posted on line for comparison.

I don't know if my FSVP is too general or too detailed... I just don't feel it is ready yet... so it would be nice to see some comparisons from the industry. 

I'm lucky in that our suppliers are small so we have til march 2018 to finalize our FSVP. 

 

If you or anyone else out there can help.. it would be great!

 

Thanks in advance! 

Sandra

 

Hi Sandra,

 

Thks for post but actually I'm not in USA or a PCQI so (thankfully) not directly involved in what as an observer seems to be a FDA mess. Maybe you meant to address apcraig ?

 

Afai can see, Ch5 of the manual linked in Post4 specifically addresses yr query except in one crucial aspect, there seem to be  zero  worked examples to illustrate the text but i assume such examples were included in the paid-for PCQI training Course ? Yes ?

 

The example in Post2, i guess, attempts to answer yr query but so far despite 90+ downloads not a single comment !

 

Hopefully yr post will generate further constructive input.  Maybe you could consider posting yr own current draft to spur comments ?


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Kind Regards,

 

Charles.C


#8 Sandra-M

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Posted 29 September 2017 - 04:15 PM

Thanks Charles, 

Yes, I did mean to address my question to SirGumby ... 

 

I took both the PCQI and the FSVP course... I know the content in concept, but like Sir Gumby, wanted to see what formats people created for their FSVP.

I'm in the middle of re-writing ours... "version 2" and had hoped someone who is happy with theirs might want to share and help me or someone else out... 

 

Fingers crossed :-) 

 

Sandra


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#9 sirgumby

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Posted 29 September 2017 - 05:24 PM

Hi Sandra,

 

Here is the start of what I will be using, Not all of this was created by myself I have search the net looking for help. So I thank all the industry that has helped me. Good Luck and let me know if this helps.

 

Dennis

 

Attached File  FSVP 1 Assessment.docx   25.67KB   18 downloads

Attached File  FSVP 2 Compliance Status Review.docx   20.26KB   15 downloads

Attached File  FSVP 3 Hazard Analysis.docx   20.63KB   18 downloads

Attached File  FSVP 4 Supplier Registry.docx   19.61KB   15 downloads

Attached File  FSVP 5 Customer Complaint.docx   19.03KB   11 downloads

Attached File  FSVP 6 Monitoring.docx   19.74KB   11 downloads

Attached File  FSVP 7 Verification.docx   21.11KB   15 downloads

Attached File  FSVP SOP 2017.docx   22.07KB   15 downloads


Edited by Charles.C, 30 September 2017 - 01:06 AM.
slightly reformatted

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#10 Sandra-M

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Posted 29 September 2017 - 05:41 PM

HI Dennis, 

Yes this is very helpful!  It does help to see how others formatted their forms.  I like that your FSVP SOP is 2 pages. I thought I mine was a little too robust. 

Thank you again for sharing .. and for the others who shared their forms with you. 

 

Have a great week-end.

Sandra


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#11 sirgumby

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Posted 29 September 2017 - 07:23 PM

Sandra,

 

I'm glad to help.

Speaking of FSVP I have just returned from Europe auditing a few suppliers. One thing I will be adding in the program is that suppliers need to designate a qualified individual to oversee the products that will ship to US. Also adding they will comply to FSMA FSP under cGMP's 117.126.

 

Good luck.

 

Dennis 


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