HI, I have a question regarding approved suppliers. I hope that someone can help.

We have an approved supplier register and supplier assessment procedure.

There is a section within the procedure which allows us to use 'non-approved suppliers' when absolutely necessary as a 'one off.'

Is this practice acceptable by the FDA?

My thoughts are that this is not acceptable after reading the FDA guidelines on Purchasing Controls.

I thank you in anticipation.

HI, I have a question regarding approved suppliers. I hope that someone can help.

We have an approved supplier register and supplier assessment procedure.

There is a section within the procedure which allows us to use 'non-approved suppliers' when absolutely necessary as a 'one off.'

Is this practice acceptable by the FDA?

My thoughts are that this is not acceptable after reading the FDA guidelines on Purchasing Controls.

I thank you in anticipation.I have a few questions since you may be restricting yourself unnecessarily.





What does your assessment procedure require before a supplier is approved?
What is are the FDA Guidelines you refer to?
This is the rule: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.From the FDA's Medical Device Quality Systems Manual: A Small Entity Compliance Guide (http://www.fda.gov/cdrh/dsma/gmpman.html) 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.Why not purchase material and perform an evaluation and based on the performance of the initial lot, the supplier may be added to your "approved supplier register". Your procedures can be revised to allow this.

Nice expedient solution, Al!

Thanks again for reminding folks about the FDA manual available for download (a zip file containing all chapters or download individual chapters one-at-a-time.)

Thankyou for your reply.
In answer to your questions.

1 What does your assessment procedure require before a supplier is approved?Our procedure requires a self assessment questionaire for the supplier. we then decide on their suitability. Supplier audit is then performed, they are then either approved or rejected.

2 What is are the FDA Guidelines you refer to? The 'guidelines' I refer to are the regulations in the title of this post.


The FDA manual is very useful. I keep losing the link, thanks! :agree1:

Thankyou for your reply.
In answer to your questions.

1 What does your assessment procedure require before a supplier is approved?Our procedure requires a self assessment questionaire for the supplier. we then decide on their suitability. Supplier audit is then performed, they are then either approved or rejected.

2 What is are the FDA Guidelines you refer to? The 'guidelines' I refer to are the regulations in the title of this post.


The FDA manual is very useful. I keep losing the link, thanks! :agree1:

Have the survey submitted from the supplier with the first lot or in lieu of it evaluate the first lot as I stated in post 2.
To be precise, that is the regulation and not a guideline. In the business we are in language and it's interpretation are very important.
Bookmark that link.

That wasn't very clear at all was it!:o

Firstly the regulations that that I was concerned with are in the title of the post.

I then read the guidelines to get some advice but was still not absolutely sure after reading them.

I still haven't managed to pin down my manager to get this procedure changed. It states that all suppliers must be audited every twelve months. They haven't done an external audit in the last five years or more:eek: :eek:

That wasn't very clear at all was it!:o

Firstly the regulations that that I was concerned with are in the title of the post.

I then read the guidelines to get some advice but was still not absolutely sure after reading them.

I still haven't managed to pin down my manager to get this procedure changed. It states that all suppliers must be audited every twelve months. They haven't done an external audit in the last five years or more:eek: :eek:Incoming inspection is a means of controlling a supplier. By whatever means you plan on controlling suppliers, your procedure must state it. You must say what you do and do what you say.

Hello everyone,

This wasn't what I was looking for but would like an opinion on what we have for supplier approvals. I changed this some time ago to meet what was going on. We make a FDA CL 1 device.


5.0 APPROVED VENDOR / SUPPLIER
Vendor / Supplier performance is the main criteria used to maintain approved status. A vendor audit or survey may be used for the initial or continued approval of new or existing Vendor/s or Supplier/s. In lieu of an audit or survey a Vendor / Supplier approval is based on performance as tracked through the receiving inspection history process. Management has the ultimate authority to approve or disapprove a specific Vendor / Supplier, regardless of past performance.
Note: Approval status of a Vendor / Supplier in no way constitutes acceptance of a supplied product or component.


Thanks
Don

Hello everyone,

This wasn't what I was looking for but would like an opinion on what we have for supplier approvals. I changed this some time ago to meet what was going on. We make a FDA CL 1 device.


5.0 APPROVED VENDOR / SUPPLIER
Vendor / Supplier performance is the main criteria used to maintain approved status. A vendor audit or survey may be used for the initial or continued approval of new or existing Vendor/s or Supplier/s. In lieu of an audit or survey a Vendor / Supplier approval is based on performance as tracked through the receiving inspection history process. Management has the ultimate authority to approve or disapprove a specific Vendor / Supplier, regardless of past performance.
Note: Approval status of a Vendor / Supplier in no way constitutes acceptance of a supplied product or component.


Thanks
DonWhat is your initial criteria for selecting a supplier in lieu of the survey?

5.0 APPROVED VENDOR
Vendor performance is the main criteria used to maintain approved vendors. A vendor survey may be used for the initial approval of new vendors. Management may in lieu of a survey give conditional approval. Vendor performance is tracked through the receiving inspection history process and Quality Assurance Management. Management has the ultimate authority to approve or disapprove a specific vendor, regardless of past performance.

This is the current approval statement.
The previous post was of an in-work SOP.
Is the underlined bold statement acceptable or would I need to expand on it.

Thanks
Don

5.0 APPROVED VENDOR
Vendor performance is the main criteria used to maintain approved vendors. A vendor survey may be used for the initial approval of new vendors. Management may in lieu of a survey give conditional approval.Vendor performance is tracked through the receiving inspection history process and Quality Assurance Management. Management has the ultimate authority to approve or disapprove a specific vendor, regardless of past performance.

This is the current approval statement.
The previous post was of an in-work SOP.
Is the underlined bold statement acceptable or would I need to expand on it.

Thanks
DonI appologize that I'm a little late with this response. But, I think the term "Management" is vague. Who in "Management" has this authority? The Purchasing Manager, the President, the Quality Manager or the Bean Counter Manager?