1 002 supplier vendor quality audit

Standard Operating Procedure SOP No.
Supplier/Vendor Quality Audit 1.002

DCR No.: 05023

Effective: 01-05-2006

Supersedes: 01-05-2006

Revision No.: 0

Revision Date: 01-05-2006

Page No.: 1 of 3

1 Purpose

1.1 To establish a standard procedure for vendor/supplier qualification.

2 Scope

2.1 This procedure may apply to Therma's existing vendors/suppliers and can be utilized to pre-qualify a new vendor/supplier.

3 Responsibility

3.1 Quality Assurance (QA) Manager is responsible for developing and editing supplier quality audit questionnaire (FN 1.002.1).

3.2 QA Manager shall perform supplier quality audit.

4 Procedures

4.1 Operations Manager or Project Manager shall request the QA Manager to initiate a supplier quality audit for existing or new suppliers.

4.1.1 The operations manager or project manager request form (FN 1.002.3) must be filled and submitted to the QA Manager prior to initiating the supplier quality audit.

4.2 A supplier quality audit may be initiated for an existing or new supplier/vendor with prior notification to the QA Manager or Project Manager.

4.3 The QA Manager shall deliver the Supplier Quality Audit Questionnaire (FN 1.002.1) to the vendors/suppliers. The due date for the completion of the questionnaire shall be indicated.

4.4 The QA Manager shall follow up with vendors/suppliers if the questionnaire has not been sent back to Therma by the due date.

4.5 The QA Manager shall evaluate vendors' questionnaire:

4.5.1 Ensure that all questions listed in the questionnaire are complete.

4.5.2 Review vendors' policies, procedures, and program if they are requested.

4.5.3 Determine any deficiencies that the supplier/vendor has.

4.5.4 Rate for supplier/vendor qualification.

4.6 The rating has two (2) levels: qualified and unqualified. Each level is described below.

4.6.1 Qualified Supplier/Vendor: This rating is given to a supplier who has no or minor deficiencies for the most recent audit. The supplier shall have no more than two (2) Customer Service issues with Therma. Therma can procure the referenced equipment and/or components from this supplier without exception.

4.6.2 Unqualified: This rating is given to a supplier who has major deficiencies for the most recent audit. Therma cannot procure the referenced equipment and/or components from this Supplier until the Supplier corrects the major deficiencies.

4.7 Major Deficiency - Any deficiency in the supplier's facility, equipment, procedures, or personnel that could prevent the supplier from consistently manufacturing the referenced equipment and/or components to meet Therma requirements and specifications.

4.8 Minor Deficiency - Any deficiency that is not considered major. This deficiency should be addressed by the supplier to enhance its ability to manufacture the referenced equipment and/or components to meet Therma requirements and specifications.

4.9 After completion of vendor/supplier evaluation, the QA Manager shall develop a supplier/vendor audit summary report (FN 1.002.2), which shall include audit date, audit due date, actual completion date by vendor/supplier, evaluation start & end dates, supplier's rating, and comments.

4.10 The Operations Manager or Project Manager and the QA Manager will determine if a site inspection for a vendor/supplier is required.

5 Review and Approval

5.1 The QA Manager shall send a copy of the supplier/vendor audit report to the Operations Manager and Project Manager for their reference.