Vendor (Supplier) Responsibility - Re: Quality Audits

OccamMan

Starting to get Involved
#1
Our company, ISO 9001 certified, designs and manufactures some critical subsystems which are sold to an FDA-regulated OEM. The ultimate device is FDA Class II, but can cause significant harm if things go wrong.

We're currently in the process of working through a business agreement with the OEM. OEM wants to be able to perform a quality audit on us at any time. We'd like to limit it to, say, once a year to avoid the distraction. I can understand the reason for their position, and I can understand the reason for ours. We need a way to get closer on this.

So, I guess that I have two questions here:

1. What access to us is the OEM obligated to have in order to satisfy FDA?
2. Any suggestions on fair contractual language around this issue, perhaps allowing them to audit any time they have a documented reason to do so?

Thanks!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove :bigwave:

The FDA's expectations of them are not that specific:

? 820.50
Purchasing controls.
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with ? 820.40.
At the end of the day, it's a matter of who-needs-who-more-than-the-other. If you want them badly, I say just go with it. I guess that their main interest is to be able to do unannounced visits, to see how you really operate, day-to-day; following the PIP scandal and its aftershocks. If you're mostly compliant, you have nothing to worry about - at worst, they will cite you for a few things, which you can actually use to improve yourself. Anyway, don't imagine the worse - they won't knock on your door every other week. Conducting an audit and following up is a lot of work. Most chances are they won't do it more than once a calendar year, unless they have a good documented reason. Maybe have a note in the contract that this clause is to be revisited and revised as necessary after, say, 3 years.

Cheers,
Ronen.
 
Last edited:
L

Laura Halper

#4
I've been remiss in logging on to the Cove recently, so I'm a little late to this party. But here's another approach to consider.

I have seen situations where the contract manufacturer wrote into the Quality Agreement that there would be a charge for more than one audit per year, and also a charge for audits extending for more than one day, unless the additional audits were "for cause".

The customer was not happy about having to pay if the audit ran 2 days, but they did sign they Agreement. This arrangement made it easier for the CM to accept long or frequent customer audits, and also made the customer focus on what was important and necessary to audit.

Laura
 
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