Hi,

Is there any guidance on who/ what function should conduct the supplier audits.

I have worked with companies who use purchasing, others just quality. What's your views.

Thx

Hi,

Is there any guidance on who/ what function should conduct the supplier audits.

I have worked with companies who use purchasing, others just quality. What's your views.

ThxWelcome to the Cove, John. Supplier Evaluation should be a cross functional activity. Suppliers are both assets and liabilities. Narrow evaluations will always leave unknown risks which can not be managed nor mitigated. The trend I see these days is for supplier evaluation not only to include supplier's quality performance, but their financial health, environmental management practices, labor relations, data security, ethics and more.

A perfectly capable supplier, from a quality perspective, can bring you down if they are closed for a long time due to a labor dispute/strike. Depending on how mainstream your organization is, you might become "guilty by association" if your suppliers are found to use child labor or other non-accepted labor practices.

If a supplier gets slapped with a multi-million dollar fine, due to environmental violations, it is just a matter of time until you and your customers pay for that fine.

If your single source suppliers go bankrupt, you, as the customer will have to deal with the consequences of losing that supplier.

So, my answer to your question is: It should be a multi-functional team and a holistic approach, depending on the product/commodity/service being acquired.

Thanks for the reply.

We take 'most' of these areas into consideration before the site audit.

What happens if the our company does not have the resources to send multi-functional teams to send to each potential supplier? Would the FDA 'approve' the use of 1 person. If so would it need to be a person from the quality function.

Thx

Hi,

Is there any guidance on who/ what function should conduct the supplier audits.

I have worked with companies who use purchasing, others just quality. What's your views.

Thx


Many robust suppliers, particularly if they are already certified, probably do not need additional audits?

Take a look at this article: http://www.asqkitchener.org/articles/Changing_boundaries_of_Supplier_audits-paper.pdf

Just came across this Webinar :

http://www.tuvtraining.com/tuvnews/seminars/returnonauditing.cfm

Maybe it could help...

Thanks for the reply.

We take 'most' of these areas into consideration before the site audit.

What happens if the our company does not have the resources to send multi-functional teams to send to each potential supplier? Would the FDA 'approve' the use of 1 person. If so would it need to be a person from the quality function.

Thx

John, as far as the FDA, follow 21 CFR Part 820. Sec 820.50section (a) 1, 2, 3 define what is required for evaluation of suppliers. This does not define who needs to perform the evaluations, just that each manufacture shall establish and maintaine procedures.

I hope this helps,
Phil

Thanks for the reply.

We take 'most' of these areas into consideration before the site audit.

What happens if the our company does not have the resources to send multi-functional teams to send to each potential supplier? Would the FDA 'approve' the use of 1 person. If so would it need to be a person from the quality function.

ThxThere is no requirement to perform site audits.

Sec. 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.
From the QSR Manual (http://www.fda.gov/cdrh/qsr/10purch.html#purchasing_and_receiving_of_product)

Supplier Qualifications

A major factor in obtaining high quality components is the selection of suppliers. Although a manufacturer's knowledge of supplier operations may be limited and information about the operations difficult to obtain, the GMP requirement that a manufacturer is responsible for quality remains undiminished. To the maximum extent feasible, selection and qualification of suppliers by audits, performance analysis, etc., should be part of a quality system. If the manufacturer does not have the capability to test components for conformance to specifications, then supplier test data or outside lab results are acceptable provided that components are tested and inspected in a statistically valid manner to show their acceptability for use in the finished device. Any outside test results should be accompanied by relevant raw data used for the test so that judgments of authenticity may be made by the finished device manufacturer. Excluding a supplier whose components are unreliable from supplying components may help prevent problems with the final device and is certainly worthwhile as a cost reduction effort.

It is important to remember that raw components acquire cumulative value as they are processed through receiving, assembly, test, inspection, and as they ultimately become part of the finished device. If a component fails during assembly, or as part of the device, additional costs will be incurred for fault isolation, removal, replacement, inspection, testing, etc. When field failures occur, the ultimate cost of the component becomes even higher because its replacement requires travel, trouble-shooting, and retrofit. In addition, customer dissatisfaction, user injury, product liability action, medical device reporting, or regulatory action may result. Usually, the initial cost of a component is relatively insignificant compared to the later cost should the component prove to be defective or improper for the selected use. Many recalls occur because manufacturers fail to qualify components properly or to assure that a supplier's manufacturing methods and quality system are adequate.

Hi,

Is there any guidance on who/ what function should conduct the supplier audits.

I have worked with companies who use purchasing, others just quality. What's your views.

Thx

Many people are surprised to learn that no one has ever been able to establish a positive correlation between the results of audits of potential suppliers, and supplier performance. Doing a formal scored audit is a big waste of time and resources. Now, if you want to visit a potential supplier, and get a plant tour, and ask some business-oriented questions, such as looking into the company's EDI capabilities, then by all means do so. But you have to remember that even when the visitor is experienced in the type of work being done, supplier selection is often a crapshoot. The only really reliable indicator of the future performance of a supplier is past performance.

But you have to remember that even when the visitor is experienced in the type of work being done, supplier selection is often a crapshoot. The only really reliable indicator of the future performance of a supplier is past performance.So, Jim, if you had to qualify a new supplier which, by definition, you have no past performance with, how would you go about screening potential candidate suppliers and qualifying them?

So, Jim, if you had to qualify a new supplier which, by definition, you have no past performance with, how would you go about screening potential candidate suppliers and qualifying them?

By visiting, if necessary, and having a look around. I wouldn't send anyone who didn't have experience in the work being done, and I wouldn't traipse through the plant with a checklist. I have a lot of experience, and I've been fooled. I've seen plants where it appeared that everything was good, and you could eat off of the floor, and when it came time to provide product, they couldn't do anything right. Conversely, I've been in plants that scared the bejebus out of me that never did anything wrong.

It's also possible to take advantage of others' experience with a supplier; networking is a good way to find out who's doing what.

It's also possible to take advantage of others' experience with a supplier; networking is a good way to find out who's doing what.

I termed this the 'referral' method. To me it's one of the best method and incidentally, I obtained the bulk of my business by this method also.

supplier selection is often a crapshoot.By visiting, if necessary, and having a look around.On this one, we will have to disagree. Any new business relationship brings risks to both parties. From a customer perspective, the accepted methodology, as part of the due diligence which is required, is to assign competent personnel and resources to assess the prospective supplier's capabilities in supporting you, the customer.

While I agree with you that no prequalification supplier assessment (as thorough as it can be) represents a guarantee of future supplier's performance, I submit that it would be better than a "visit", finger-crossing, prayers and other less scientific methods. Actually, from the suppliers perspective, you might be giving them a wrong impression of your seriousness, as a customer, if the qualification process is too informal. The supplier might think that you are not a demanding and educated customer.

Obviously, I don't advocate comprehensive supplier evaluations for each and every occasion, but critical suppliers-to-be should have their risks clearly identified as early as possible. To me, it is just another aspect of the factual approach to decision making principle.