Global Nonconformance (NC) Form: Page 1 of 6

Document #: TG-F000039
Revision #: 04
Issue Date: 07 Jan 2016
Parent Document: TG-000081
Page 1 of 6 Nonconformance
Number
GLOBAL NONCONFORMANCE (NC) FORM
For Use by Affiliates of Teleflex

This document contains proprietary information. It may not be reproduced without prior written approval.
>>THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT<<
Revision #: 04
Number
Section A: Identification and Containment
Date NC Issued: 1-Jan-2015 Due Date for Closure (Target<30days): 1-Jan-2015
Nonconforming Function: Functional Manager:
Date Nonconformance Identified: 1-Jan-2015 Teleflex Facility: Select One
How NC Identified: Select One If Other, please specify:
Where NC Identified: Select One If Other, please specify:
What is the NC Identified:

Dimensional Defect Select One If Other, please specify:
Documentation Defect Select One If Other, please specify:
Functional Defect Select One If Other, please specify:
Labeling Defect Select One If Other, please specify:
Packaging Defect Select One If Other, please specify:
Sterility Defect Select One If Other, please specify:
Service Error Select One If Other, please specify:
Visual Defect Select One If Other, please specify:
NC Description:
(Full description of identified NC. Attach all relevant data as evidence. For product-related NCs, the following must be included: product
description; part number; lot number; and quantity affected in Table below. If NC is not product related the below table is non-applicable)
Product Description Part Number Lot / Serial Number Quantity Affected
Evaluate and Identify Scope of Nonconformance:
(For product related NCs, an evaluation of all finished goods, other inventory stock, work in progress, Teleflex warehouse / distribution
centers should be reviewed to identify if any other lots / batches are affected and recorded in the table below. If NC is not product related
the below table is non-applicable)
Product Description Part Number Lot / Serial Number Quantity Affected

Revision #: 04
Number
Containment Actions include: (if not required, provide rationale)
Action # Action Assigned to: Completion Date:
1 1-Jan-2015
2 1-Jan-2015
3 1-Jan-2015
4 1-Jan-2015
5 1-Jan-2015
Product Ship Hold Reference

(if affected product has left manufacturing site) No.:
If no product ship hold is performed an appropriate rationale must be provided:
Has a Risk Review been performed? (If a Product / Patient risk, risk review always required)
Yes If Yes, insert Risk Review Result:
No If No, provide rationale:
Event investigation Form (EIF)

Has product affected by this nonconformance been commercially distributed?
Yes No If yes, enter EIF Reference:
Section A APPROVALS
Role / Title Print Name Signature Date
Initiator
Functional Manager / Designee
Quality Manager / Designee
Other

Revision #: 04
Number
Section B: Disposition and Correction Plan Approval
Return to Vendor / Supplier Return to another Teleflex site Other (please specify):
Discard / Destroy (Scrap) Rework (e.g. Sort, Re-inspect) Use as Is (UAI)
Rationale must be provided for UAI:
Correction Plan:
Proposed
Action # Action Assigned to:
Completion Date:
1 1-Jan-2015
2 1-Jan-2015
3 1-Jan-2015
4 1-Jan-2015
5 1-Jan-2015
Section B APPROVALS
Initiator
Other

Revision #: 04
Number
Section C: Investigation
Investigation results and Root Cause analysis: (Note: 5 Why analysis and / or fishbone diagram may be helpful.)
Summary / Conclusion
1) The piercing blade comes in two types (Refer photo). The blunt tip likely to cause leak at rubber valve.
2) Length of piercing too deep (13mm to 14mm), shorten the piercing length by adding stopper at the piercing knife.
NC Root Cause Category
Man Select One If Other, please specify:

Method Select One If Other, please specify:
Material Select One If Other, please specify:
Machine (Equip & Software) Other If Other, please specify: two types rubber valve of piercing blade
Environmental Controls Select One If Other, please specify:
Other Select One If Other, please specify:
Root Cause Description:

The piercing blade comes in two types (Refer photo). The blunt tip likely to cause leak at rubber valve.
Section D: Nonconforming CAPA Consideration
Is Corrective and / or Preventive Action Required?

Yes If Yes, insert CAPA Request No.:
No If No, provide rationale: No CAPA request required as the products have not been shipped out. Furthermore,
the internal sorting had been done and verification by QA showed no failure after sorting.

Revision #: 04
Number
Section E: Final Disposition and Closure
Disposition Complete (appropriate evidence attached):

Return to Vendor / Supplier Qty: Return #:
Return to another Teleflex site Qty: Return #:
Discard / Destroy (Scrap) Qty: Evidence attached:
Rework (e.g. Sort, Re-inspect) Qty: Rework results attached:
Use as Is (UAI) Qty: Rationale must be provided for UAI:
Other Qty: If other, please specify:
If disposition differs in any way from section B explain and provide rationale:
Correction Plan Complete (appropriate evidence attached)
Reference
Action # Action Completed by: Completion Date: materials /
attachments
1 1-Jan-2015
2 1-Jan-2015
3 1-Jan-2015
4 1-Jan-2015
5 1-Jan-2015
Section C, D & E APPROVALS
Initiator
Other


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Document #: TG-F000039

GLOBAL NONCONFORMANCE (NC) FORM

For Use by Affiliates of Teleflex

Section A: Identification and Containment

Date NC Issued: 1-Jan-2015 Due Date for Closure (Target<30days): 1-Jan-2015

Nonconforming Function: Functional Manager:

Date Nonconformance Identified: 1-Jan-2015 Teleflex Facility: Select One

How NC Identified: Select One If Other, please specify:

Where NC Identified: Select One If Other, please specify:

What is the NC Identified:

Product Description Part Number Lot / Serial Number Quantity Affected

Evaluate and Identify Scope of Nonconformance:

Product Description Part Number Lot / Serial Number Quantity Affected

For Use by Affiliates of Teleflex

Containment Actions include: (if not required, provide rationale)

Action # Action Assigned to: Completion Date:

Product Ship Hold Reference

Event investigation Form (EIF)

Role / Title Print Name Signature Date

Functional Manager / Designee

Quality Manager / Designee

For Use by Affiliates of Teleflex

Section B: Disposition and Correction Plan Approval

Role / Title Print Name Signature Date

Functional Manager / Designee

Quality Manager / Designee

For Use by Affiliates of Teleflex

NC Root Cause Category

Man Select One If Other, please specify:

Root Cause Description:

Section D: Nonconforming CAPA Consideration

Is Corrective and / or Preventive Action Required?

For Use by Affiliates of Teleflex

Section E: Final Disposition and Closure

Disposition Complete (appropriate evidence attached):

Correction Plan Complete (appropriate evidence attached)

Section C, D & E APPROVALS

Role / Title Print Name Signature Date

Functional Manager / Designee

Quality Manager / Designee

For Use by Affiliates of Teleflex

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