Hi all,

I have been searching all over for anything on this subject but have not found anything relatively close.

We have a new potential customer, that after auditing our company, says we are deficient in the supplier selection process in that we do not qualify suppliers that our customers say we have to use. We do monitor and evaluate them like all the rest of our suppliers.

Does anyone have any suggestions or feedback on what we might add to our procedure that would "qualify" customer-specified suppliers for our approved supplier list?

Any advice is appreciated!
Viki

But, I think the qualification is the requirement. “What qualifies that company to be your vendor?” “Ummm….. because the customer mandates it?” That is the only qualification that is necessary.

How do you qualify your regular vendors? That could be a start.

Well, here's what our current procedure says:

2) After the selection of a new supplier, a Supplier Authorization Form (SAF) (PURC600) will need to be completed by the requisitioner and turned into accounting in order for the supplier to be added into our system.
•It will be the responsibility of the requisitioner and/or purchasing department to supply supporting documentation to support the approval of the supplier such as:
a. CUSTOMER – Customer Drawing, Customer Print, Customer Supplier List, e- mail to/from customer confirming required supplier will be used.
b. HISTORY - Catalog, Brochure, Specification Sheet, resume’, certificate of professional certification, certificate of professional association membership, etc
c. ISO / QS / AS / A2LA - Copy of Certification
d. SURVEY – Quality Systems Survey

We also have incorporated an on-site audit as another way to qualify the supplier when needed, e.g. critical suppliers such as a sterilization house, etc.

I guess the question would be, who is responsible if that vendor's component fails or was non-conforming. If you are on the hook, I'd say you are responsible to validate the supplier. (Or you'd want to anyway.)

Yes, we are responsible and do our "diligence" by requesting samples when possible, perform first articles, do incoming receiving with customer-approved inpection plans, etc.

I am just confused as to what more we can do or document in the initial stages that shows our customer-specified supplier is "qualified" to be on our approved supplier list.:confused: :frust:

Viki,

7.4.1 (820)and the following:
7.4 Purchasing
7.4.1Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4). 7.4 Purchasing
7.4.1 Purchasing process
The organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.

The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.

Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4). 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.
No significant differences.
7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate

a) requirements for approval of product, procedures, processes, and equipment,

b) requirements for qualification of personnel, and

c) quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

To the extent required for traceability given in 7.5.3.2, the organization shall maintain relevant purchasing information, i.e. documents (see 4.2.3) and records (see 4.2.4).
820.50 Purchasing controls
(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 Sec. 820.40. The intent of both documents is consistent.

ISO/DIS 13485:2003 contains a requirement associated with the organization ensuring the adequacy of purchasing requirements prior to communicating them to the supplier.

The QS Reg contains a requirement that the organization obtain, where possible the agreement of the supplier to notify the organization of changes to the product or service so that the organization can assess the potential effect on the quality of the medical device.
7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information. 7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

Records of the verification shall be maintained (see 4.2.4).
820.80 Receiving, in-process, and finished device acceptance
(b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product.
Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented. ISO/DIS 13485:2003 contains requirements related to the scenario where the organization seeks to verify purchased product at the supplier’s location.

Yes, we are responsible and do our "diligence" by requesting samples when possible, perform first articles, do incoming receiving with customer-approved inpection plans, etc.

I am just confused as to what more we can do or document in the initial stages that shows our customer-specified supplier is "qualified" to be on our approved supplier list.:confused: :frust:

You add something to your documentation that says that customer-directed sources are automatically qualified.

You add something to your documentation that says that customer-directed sources are automatically qualified.

I agree with Jim. Infact, this is a common practice in the construction industry where they are termed as nominated contractors or suppliers - meaning you have to engage them or purchase from them because they are nominated or required by the customer - usually specialist trades like lifts and escalators (customer requirement) but you do have the obligation to manage and control their work and performance.

:topic: Jim, did you noticed your 'Silver Star' (for karma exceeding 15,000)? This is the first time it appears in the forum and you had the honor of being the first to receive it.

Congratulations Jim :agree1:

Harry - you are very observant ;)

In my procedure, I have clearly mentioned that Customer appointed suppliers will not be audited; however if the suppliers fail in our quarterly performance review for quality and delivery, the supplier issue would be escalated to the customer for their comments on retaining the said suppliers.

Thanks to all for your replies. I think I have a good idea of what to add to our procedure for this type of situation and to elaborate briefly on the requirements. We'll see if the "customer" agrees with it.:agree:

Thanks, again.
Viki

:topic: Jim, did you noticed your 'Silver Star' (for karma exceeding 15,000)? This is the first time it appears in the forum and you had the honor of being the first to receive it.

I hadn't noticed until you brought it up. It relieves some of the clutter up there. :D

:topic: Jim, did you noticed your 'Silver Star' (for karma exceeding 15,000)? This is the first time it appears in the forum and you had the honor of being the first to receive it.

Well deserved! :applause:

Stijloor.

Well deserved! :applause:

Stijloor.

Thanks, Stijloor, but let's not stray away from the topic. :D