Purchasing Controls / Doc. Class
WIF / Document No.
SCF013 / Revision
N
Title
Supplier Proposal for Change / Effective Date
31-JUL-2017 / Page
1 of 3
Reference WI – Supplier Proposal for Change – Ann Arbor, 852642, for instructions.
For Internal TCVS use only, SPC number:To be completed by Supplier: Sections 1-5
Section 1: Supplier InformationSupplier Name: / Date:
Supplier Contact: / Telephone:
Supplier Signature: / Email:
Section 2: Category of the Proposed Change (check all that apply)
Source of Material / Method of Testing
Site of Manufacture / Contractor for Manufacturing Process
Composition of any Raw Material / Contractor for Testing
Manufacturing Process / Supplier ResponsibleDesign
Instructions for Use / Label/Packaging
Terumo CVS Design, Specification, Drawing, or Part / Other (provide detail):
Section 3: Detail of the Proposed Change (provide red-lined print if applicable)
Affected Terumo CVS Part Number(s) and Part Description(s):
Description of Proposed Change:
Reason for Requesting the Proposed Change:
List Affected Document(s):
Section 4: Proposed Effectivity / Implementation of Change
Lot Number: / Date: / Purchase Order: / Other (provide detail):
Additional Detail:
Section 5: Validation
Protocol and / or results attached (list attachments):
None completed (provide rationale):
Return completed form to:
Terumo Materials Management Representative or Supplier Quality Representative
Section 6: Approval SectionSPC number:
Terumo CVS Approvesthe Proposed Change Not Applicable
Terumo CVS Director, Materials (approve first)
______
Print / ______
Signature / ______
Date
Terumo CVS Supplier Quality Management (approve second)
______
Print / ______
Signature / ______
Date
Terumo CVS Approvesthe Proposed Change pending TCVS Internal Updates Not Applicable
Terumo CVS Director, Materials (approve first)
______
Print / ______
Signature / ______
Date
Terumo CVS Supplier Quality Management (approve second)
______
Print / ______
Signature / ______
Date
Supplier Signature (approve third) attesting that the proposed change will not be implemented until the pending updates are complete. Notification of the implemented change will be completed in section 7.
______
Print / ______
Signature / ______
Date
Terumo CVS Does Not Approvethe Proposed Change Not Applicable
Provide Rationale :
Terumo CVS Director, Materials (approve first)
______
Print / ______
Signature / ______
Date
Terumo CVS Supplier Quality Management (approve second)
______
Print / ______
Signature / ______
Date
Supplier Signature (approve third) attesting that the proposed change will not be implemented:
______
Print / ______
Signature / ______
Date
Section 7: Final Terumo CVS Approval Section for Changes Requiring ECR
(Section not applicable for other SPC dispositions)
SPC number:
Provide ECR Number :
Provide ECO/CC Number:
Terumo CVS Director, Materials(approve first)
______
Print / ______
Signature / ______
Date
Terumo CVS Supplier Quality Manager (approve second)
______
Print / ______
Signature / ______
Date
Terumo Cardiovascular Systems Corporation Confidential