Professional Documents
Culture Documents
(PCN) Training
CONFIDENTIAL – for internal use only © 2014 CareFusion Corporation or one of its subsidiaries. All rights reserved.
1
Training Goals/Objectives
Phase II
of PCN
Submission Process
Phase I of PCN Process
• PCN submission tool 2014
introduced to suppliers
2013
Field Recalls
• an unapproved supplier
change was implemented
without CareFusion’s
Consent Decree knowledge 2012
• CFN received an FDA Consent
Decree
• Identified gap in Supplier Change
Notification process
2007
Current Goals -
All CareFusion suppliers submitting
PCNs through process
Expectations
• No Deviations are allowed in the production, or testing of materials or components,
unless prior documented approval is granted by CareFusion
• Verbal changes are not acceptable
• Do not assume that any changes are minor
• Min. 90 Day Advance Notification from implementation date when possible
• Min. 180 Day Advance Notification for all End of Life PCNs when possible
*Failure to obtain written approval from CareFusion for any change will result in Supplier
obligation for all costs to correct problems resulting from the unapproved changes
© 2014 CareFusion Corporation or one of its subsidiaries. All rights reserved. 5
What Supplier changes require a PCN?
Manufacturing
Packaging,
Plant
Labeling or End of Life
Environmental
Storage
Conditions
Manufacturing
Process, Design and/or Materials Supply
Equipment and Specification Base
Tooling
Supplier
Manufacturing
Product Name or Name/Company
Facility Site
Identification Ownership
Location
Change
Product/Process changes including, but not limited to this list, require a PCN submission
© 2014 CareFusion Corporation or one of its subsidiaries. All rights reserved. 6
Supplier PCN Submission Website
How you submit PCNs to
CareFusion
3. Reference the
Supplier PCN
Training Deck (if
needed)
4.Click here to
access PCN Web
CONFIDENTIAL – for internal use only 8
© 2014 CareFusion Corporation or one of its subsidiaries. All rights reserved.
Submission Form
Supplier PCN Submission Form Overview
Disclaimer: The receipt of a PCN by CareFusion does not signify acceptance of the proposed
product or process change 9
© 2014 CareFusion Corporation or one of its subsidiaries. All rights reserved.
You submit the PCN – now what?
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© 2014 CareFusion Corporation or one of its subsidiaries. All rights reserved.
Q&A
For status inquiries or questions relating to your PCNs,
please contact: GMB-CFN-SupplierPCN@carefusion.com