Document Title: IAB Tray With T-Handle Inspection Report Document Number: 03-251-01

Document Type: Templates/Forms (Non-Production) Revision: D

Page: 1 of 2

Part Name: IAB Tray with T-Handle QC Proc. No: 03-251 Rev:

Part No: 0335-00-0186-01 Rev: PO No:

Quantity: Vendor Batch No:

Vendor: Batch No:

Expiration Date: NCMR No:

Inspector Signature: Date: Date:

ANSI/ASQ Z1.4 INSPECTION LEVEL: NORMAL □

TIGHTENED □ REDUCED □
NO. CHARACTERISTICS DISPOSITION

7.2 General Inspection Sample Size: 100%

7.2.1 Approved Material Vendor List □ Accept □ Reject
7.2.2 Cartons undamaged □ Accept □ Reject
7.2.3 Vendor labels comply with the Labeling Requirements of the material specification. □ Accept □ Reject
7.2.4 Vendor should provide total lot quantity and purchase order number □ Accept □ Reject
7.2.5 Certificate of Compliance □ Accept □ Reject
7.2.6 Quantity of samples received matches the vendor paperwork for quantity shipped □ Accept □ Reject
7.3 Visual Inspection Sample Size: ANSI/ASQ Z1.4, Level I , 0.65% AQL Ac __ Re_____
Number Rejected Samples: ________
7.3.1 Packaging per material specification
7.3.2 Opaque white and have a smooth surface finish □ Accept □ Reject
Material must be free from excessive surface dirt, foreign matter, or other defects
7.3.3 □ Accept □ Reject
visible to the unaided eye
7.3.4 Embedded foreign particles □ Accept □ Reject
7.3.5 No sharp edges, cracks, holds, nicks, fractures, or scratches are allowed □ Accept □ Reject
7.3.6 Cavity identification numbers (2 cavity mold) □ Accept □ Reject
7.4 Dimensional/Functional Inspection
Sample Size: ANSI/ASQ Z1.4, Level S-4 , 0.65% AQL Ac __ Re____
Number Rejected Samples: ________

CONFIDENTIAL – UNAUTHORIZED DISTRIBUTION OUTSIDE OF DATASCOPE CORP IS PROHIBITED.

The reader is responsible for ensuring that they use only the current revision of this document for compliance purposes.
08-030-29 Rev C
Document Title: IAB Tray With T-Handle Inspection Report Document Number: 03-251-01
Document Type: Templates/Forms (Non-Production) Revision: D
Page: 2 of 2

7.4.1.1 Wall thickness 0.010 min (anything equal or greater than this is good) □ Accept □ Reject

7.4.1.2 Length 20.260±0.090 □ Accept □ Reject

7.4.1.3 Width 9.750±0.100 □ Accept □ Reject

7.4.2.1 T-Handle cavity (Section A-A) Go-No GO □ Accept □ Reject

7.4.2.2 Extra-corporeal tubing cavity (2x Section B-B) Go-No GO □ Accept □ Reject
7.4.2.3 Extra-corporeal tubing cavity (Section C-C) Go-No GO □ Accept □ Reject

7.4.2.4 Extra-corporeal tubing cavity (Section D-D) Go-No GO □ Accept □ Reject

7.4.2.5 Syringe cavity (Section E-E) Go-No GO □ Accept □ Reject

7.4.2.6 Catheter cavity (Detail G) Go-No GO □ Accept □ Reject

7.4.3 Height 1.100±0.200 □ Accept □ Reject

7.4.4 Label fit Pass fail □ Accept □ Reject

7.5 Lot Acceptance

7.5.1 Lot Disposition □ Accept □ Reject
Comments: N/A

QCRI Manager or Lead: _________________________________ Date: _______________________

CONFIDENTIAL – UNAUTHORIZED DISTRIBUTION OUTSIDE OF DATASCOPE CORP IS PROHIBITED.

The reader is responsible for ensuring that they use only the current revision of this document for compliance purposes.
08-030-29 Rev C