DISTRIBUTOR PROCESS CHANGE REQUEST FORM
Affected Process:
Manufacture
Packing Pcs
Label
Packing Box
MATP
Other:_____
Date:
Created by:
Change ID:
DISTRIBUTOR INFORMATION
Supplier Name:
Street Address:
City/State/Zip:
Country:
Contact Person:
Title:
Phone #:
Email:
Communicated via:
Personal Visit:
Phone Call:
E-mail/Memo (attached)
PROCESS CHANGE INFORMATION
Request Category
Process Change Description:
Cleaning/Sterilization
Raw Material
Special Process
Packaging/Labeling
Finished Component
Semi-Finished
Component
Product Line(s) Affected:
Part Number(s):
Other:_________
Potential Impact on other DVL´s Product(s):
Process Change Validated?
YES
NO
If yes, what was the
date?
If No explain why:
Signature Distributor
Date:
PL´s ASSESSMENT OF PROCESS CHANGE
Required
Review
Yes No
Function
Implementation Notes
Date
Quality Engineering
QC Lab
Manufacturing
Product Development
Validation/Microbiology
Regulatory
Other: Supplier Quality
COMMENTS:
PROCESS CHANGE RESPONSE
Approved - Implementation Date:
Not Approved
Quality Manager Signature:
Place original document in Distributor´s File
Form: 039
Rev: N/C
Date: March 2014
Effective Date: March 2014
App by: MF
Page: 1