This is a collection of Provision, Procedure, and Forms for Purchasing controls in a form consistent with the FDA QSR.
With the globalization of supply chains, Purchasing controls has come to be strictly required.

List of Forms
The following forms are included with your purchase.
・MD-QMS-F601 List of Suppliers and Potential Suppliers
・MD-QMS-F602 Supplier evaluation and re-evaluation records
・MD-QMS-F603 Supplier Audit Record
・MD-QMS-F604 Inspection and Testing Record Sheet
・MD-QMS-F605 Rejected Purchased Item Disposal Form
・MD-QMS-F606 Purchased Item Change Impact Assessment Form
・MD-QMS-K6 Purchasing controls Provision
・MD-QMS-S601 Purchasing Control Procedure
・MD-QMS-S602 Procedure for verification of purchased goods

Table of Contents

Provision

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Ensure quality of purchased products
5 Supplier Management Classification
5.1 Establishment of Supplier Management Classification
5.2 Degree of control by supplier category
6 Information gathering, audit, evaluation, and selection of potential new suppliers ・Contracts
6.1 Gather information on potential new suppliers
6.2 Audit of potential new suppliers
6.3 Evaluation of potential new suppliers
6.4 Assessment Results
6.4.1 Overall Judgment Result
6.4.2 Itemized Evaluation Results
6.5 Selection of new suppliers
6.6 contracts with suppliers
7 procurement
7.1 Communicate purchasing information to suppliers
7.2 Purchase Product Orders
7.3 Verification of purchased products
8 Sending SCAR
9 Supplier Management
9.1 Reevaluation of suppliers
9.2 Audit of suppliers
9.3 Manage purchases from registered mills
9.3.1 Manufacturer’s QMS
9.3.2 Method of periodic verification of the manufacturer, etc. concerned
9.3.3 Manufacturing and quality control for manufacturers
10 Collection of data on suppliers
11 Creation and storage of records
12 Criteria for determining corrective and preventive action requests
13 reference
14 by-laws

Procedure

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 List of suppliers and potential suppliers
5.1 New potential suppliers are included in the “List of Suppliers and Potential Suppliers” (MD-QMS-F601).
5.2 Updated “List of Suppliers and Potential Suppliers” (MD-QMS-F601)
6 Information gathering, audit, evaluation, selection, and contracting of potential new suppliers
6.1 New potential suppliers are included in the “List of Suppliers and Potential Suppliers” (MD-QMS-F601).
6.2 Gathering information on potential suppliers
6.3 Audit of potential suppliers
6.4 Evaluation of potential suppliers
6.5 Selection of suppliers
6.6 contracts with suppliers
7 procurement
7.1 Communicate purchasing information to suppliers
7.2 Purchase product orders
7.3 Verification of purchased products
8 Supplier Management
8.1 Monitoring supplier performance
8.2 Periodic verification of QMS of registered manufacturing sites
8.3 Periodic re-evaluation of suppliers
8.4 Audit of suppliers
9 SCAR
10 Measures to be taken in response to information provided by suppliers
11 Record keeping
12 Data analysis on suppliers
13 Corrective and preventive action requests
14 form
15 reference
16 by-laws