Académique Documents
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Culture Documents
Revision #: 04
Issue Date: 07 Jan 2016
Parent Document: TG-000081
Page 1 of 6 Nonconformance
Number
Page 2 of 6 Nonconformance
Number
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)
(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)
Page 3 of 6 Nonconformance
Number
1 1-Jan-2015
2 1-Jan-2015
3 1-Jan-2015
4 1-Jan-2015
5 1-Jan-2015
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:
Section A APPROVALS
Initiator
Other
Page 4 of 6 Nonconformance
Number
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
Page 5 of 6 Nonconformance
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.
Page 6 of 6 Nonconformance
Number
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
Initiator
Other