Report No.

DOC-TFIQ-Report-001 Revision: A
Title: Tooling and Fixtures Installation Qualification (TFIQ) Report - Ring Bending Page 1 of 6

TOOLING AND FIXTURES INSTALLATION QUALIFICATION (TFIQ) REPORT

1. General Information

Equipment Name: Equipment Part Number

Ring Bending Fixture  193211026 (Mold)
 193211028 (Mold)
 193211030 (Mold)
 193211032 (Mold)
 193211034 (Mold)
 193211036 (Mold)
Equipment Unique Identifier(s) and ID Number(s) Product / Project:
 392470 (Bending Fixture - 26 mm) Ring
 392475 (Bending Fixture - 28 mm)
 392476 (Bending Fixture - 30 mm)
 392477 (Bending Fixture - 32 mm)
 392478 (Bending Fixture - 34 mm)
 392463 (Bending Fixture - 36 mm)
Equipment Description:
The equipment consists of fixtures and molds designed to perform the bending of annuloplasty rings according to the required
dimensional specifications.

2. Measurement Instruments
Is a measurement instrument required to complete verification of the equipment? Yes No
LAST
INSTRUMENT CALIBRATION INSTRUMENT CALIBRATION CALIBRATION
MEASUREMENT INSTRUMENT REQUIRED CALIBRATION
ASSET ID # RANGE RESOLUTION TOLERANCE DUE DATE
DATE
Mylar Template [Asset ID] N/A N/A N/A N/A N/A
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Title: Tooling and Fixtures Installation Qualification (TFIQ) Report - Ring Bending Page 2 of 6

3. General Requirements

INITIALS /
DESCRIPTION ACCEPTANCE CRITERIA RESULTS PASS/FAIL
DATE
CAD Model / Drawing If required, CAD model CAD Model / Drawing required?
or drawing represents Yes No
equipment and is CAD Model / Drawing #: [Enter]
released or concurrently Revision: [Enter]
approved with TFIQ. If
Pass [Initials/Date]
equipment is managed
by a supplier, the
supplier drawing is
attached to TFIQ.

Identification Part number and/or Complete Incomplete

unique ID number(s) as
indicated in section 1 is Pass [Initials/Date]
engraved or affixed.

Product Contact Assessed per EQL Submission Required? Yes No

Assessment GSOP7.2.006. EQL Number: [Enter]
If EQL submission is EQL Approved: Yes No N/A
Pass [Initials/Date]
required, testing is
approved and EQL
number is provided.
Calibration Assessed per site- Calibration Required? Yes No
Assessment specific procedure. Calibration Range: 0 – 180 degress
If calibration is required, Instrument Resolution: 1 degree
equipment meets Calibration Tolerance: +/- 2 degrees Pass [Initials/Date]
calibration requirements. Meets Calibration Requirements:
Yes No N/A
Report No. DOC-TFIQ-Report-001 Revision: A
Title: Tooling and Fixtures Installation Qualification (TFIQ) Report - Ring Bending Page 3 of 6

INITIALS /
DESCRIPTION ACCEPTANCE CRITERIA RESULTS PASS/FAIL
DATE
Preventative Assessed per the PM Required? Yes No
Maintenance applicable site PM Number: [Enter]
Assessment preventive maintenance
Pass [Initials/Date]
procedure.
If PM is required, PM
number is listed.
Cleaning If cleaning is required, Cleaning Required?
Requirements the routine cleaning Yes No
requirements are If “Yes”, identify the procedure where the
defined. cleaning requirements are defined:
Pass [Initials/Date]
If equipment is managed DOC#1
by a supplier, the
cleaning procedure is
attached to TFIQ.
Storage Determine if a storage Storage Container Required?
Requirements container is required to Yes No
prevent damage to the
form/fit/function of the
Pass [Initials/Date]
equipment or to provide
identification.

If a storage container is Container Material Complies with

required, the container GSOP7.2.006?
materials are compliant Yes No N/A
with requirements for
Pass [Initials/Date]
controlled environments
and GSOP7.2.006 as
applicable.

Assembly Status The assembly status of Complete Incomplete N/A

the equipment is Assembly performed during use Pass [Initials/Date]
documented.
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Title: Tooling and Fixtures Installation Qualification (TFIQ) Report - Ring Bending Page 4 of 6

4. Dimensional / Functional Requirements

Are there any dimensional and/or functional requirements for the equipment that are considered critical to form, fit, or function
of the associated device to be evaluated in this section? Yes No

INITIALS /
DESCRIPTION EXPECTED RESULTS ACTUAL RESULTS PASS/FAIL
DATE
Ring bending The ring must be bent Meets Pass [Initials/Date]
without gaps between
plates.

5. First Article Inspection

Are there any dimensional requirements for the parts produced from the equipment that require a first article inspection?
Yes No
Assessed per First Article Inspection Procedure: Not applicable because inspections are performed during each process using
the Mylar template.
Dimensional requirements for the equipment that are considered critical to form, fit, or function of the associated device are
verified in Section 4 of this TFIQ.

6. Signature Identification Table

NAME DEPARTMENT INITIALS SIGNATURE AND DATE
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Title: Tooling and Fixtures Installation Qualification (TFIQ) Report - Ring Bending Page 5 of 6

7. Conclusion

The equipment meets all requirements and acceptance criteria and is suitable for its intended use. This equipment is approved and
released for use in the next validation activity and/or production as defined in the process validation procedure.

8. Approvals

<This signature page is only to be used for documenting external approvals or for business units that do not utilize the Ignite PLM
system. For all other instances, delete this signature page and approve the document electronically in Ignite.>

<Name, Title>, Document Owner Date

 Report No. DOC-TFIQ-Report-001 Revision: A
Title: Tooling and Fixtures Installation Qualification (TFIQ) Report - Ring Bending Page 6 of 6

Approved by:

<Name, Title>, R&D, Manufacturing and/or Packaging Date

Engineering as applicable

<Name, Title>, Quality and/or Supplier Quality Engineering Date

as applicable

<Name, Title>, Other (e.g. External Approver) Date

9. Revision History
REV SHORT DESCRIPTION

A Initial release