Critical Supplier will not allow us to audit Plant floor

#1
I need to perform a Supplier audit on a Critical Supplier and they are stating we can't visit or have a Plant Tour due to proprietary information, how do I assure compliance of processes by operators, plant cleanliness, warehousing etc. They will supply documents and are ISO:9001 certified. What would you do?
 
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optomist1

A Sea of Statistics
Super Moderator
#2
Hi donna0816,

I have zero experience in the FDA realm, yet what does your contract/PO/Spec provide for RE: access audits, etc?

Cheers Optomist1
 
#3
The contract was written when my company was R&D based only and it states they will allow audit, but not on plant floor; We are now working under a Quality aspice as we move closer to FDA submission. A quality agreement and revised contract has not been finalized for these different expectations. I need to have objective evidence that we as a company have done our due diligence and auditted them against their procedures. They are a FDA regulated company also.

In layman's language, they can give us standard operating procedures saying they do this and that, but I have no way of verifying all. An example would be calibration, they procedure can say their equipment must be calibrated yearly, but I have no insight to looking at the equipment and seeing the calibration stickers.

I appreciate the advice.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#4
how do I assure compliance of processes by operators, plant cleanliness, warehousing etc.
you as the customer cannot assure compliance of anything. The supplier does. Any second party audit should be designed to provide confidence to the customer that the supplier has a system in place and can address customer specific expectations. What is the historical performance of this supplier? Do you have specific concerns about them? If so, engage in a dialogue and go over these concerns. As for “enforcing” your right of access to their plant, that should have been discussed in the contractual arrangements phase.
 

BradM

Leader
Admin
#5
The contract was written when my company was R&D based only and it states they will allow audit, but not on plant floor; We are now working under a Quality aspice as we move closer to FDA submission. A quality agreement and revised contract has not been finalized for these different expectations. ....
Hello Donna!!

So if I understand your post, you don't have an agreed upon contract/ agreement with this supplier that you wish to audit? If that is accurate, I can see their hesitancy. Until there are confidentiality agreements and such in place, I might be nervous also.

Until that is in place, if this vendor supplies product/ service in the FDA industry, I am sure they have been audited already. You may can leverage that with the supplier until documents are in place.

Until you establish more of a relationship with this supplier, they will most likely stay fairly guarded.
 

Randy

Super Moderator
#6
Are they a sole source or can you get what you need elsewhere?

Proprietary is fluid, I've no idea how much "proprietary" stuff I've been exposed to, nor do I care and I'll guarantee you they ain't got anything more secret that what me and many other 3rd party guys as well as others here have had to circumnavigate doing the work we do. Their claim of "proprietary" most likely is nothing more that "we want your money, we just don't want you".
 
#7
you as the customer cannot assure compliance of anything. The supplier does. Any second party audit should be designed to provide confidence to the customer that the supplier has a system in place and can address customer specific expectations. What is the historical performance of this supplier? Do you have specific concerns about them? If so, engage in a dialogue and go over these concerns. As for “enforcing” your right of access to their plant, that should have been discussed in the contractual arrangements phase.
**********
I can assure they are following their procedures by observation of the operator. Perhaps the operator is skipping steps of the procedure. I have no insight to this part of auditing. We conduct our external supplier audit as the FDA would preform a routine GMP audit. They always asked for a Plant/Warehouse/Lab tour and take notes as they go along. The FDA will then start asking for documentation. I have been the host and runner for FDA inspections. There are a few concerns with this venfor and a discussion is planned.. The supplier was established while we were in R&D stages years back and now as we head towards submission they need to be scrutnized under adherace to the their QMS.[/QUOTE]
 

Miner

Forum Moderator
Leader
Admin
#8
See if your supplier would allow an on-floor audit if your company would agree to sign an Non-disclosure agreement (NDA) with them. That may ease their concerns.
 

Enghabashy

Quite Involved in Discussions
#9
*We can make 2nd party audit if there’s a requirement ; regulatory clause in directive ; CSRs ; the new suppliers regarding IATF 16949 requirements & if there critical issues stated in contract /orders conditions –

** the scope should concern & focus on the relevant business in-between & our orders tracing ‘ without matching any other Info./ other irrelevant shipments;---the confidentially rules ; data & Info. privacy; restrictions should be stated as well ;

***the 2nd party audit of our suppliers didn’t mean that a more controlling of products / material shipped , the preparation made before the formal visit can hide many major issues which could be existed ,

**** we can make effective planned audit ; raising positive points & excellent reports which make the supplier has a strong formal evidence of his excellence for other relevant stakeholders “ maybe competitor also “ ; this type of issues could give him clearance from innocent; against any critical points ;any issues happened in future- in market

*****many critical evidences needed for a compliance could be conditional stated in the orders ‘ rather than performing supplier audit
 

William55401

Quite Involved in Discussions
#10
This is all about balance of controls. Audit is just one tool. Can you dial up your incoming assurance activities? Have they been effective so far? Your supplier controls procedures should allow for the no audit scenario. Don't over think this. No access to proprietary technology is a common occurrence.
 
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