Qualification Test Risk Based Approach Evaluation

Project and/or Protocol #

Item

Test

Document
1 Verification

Drawing
2 Verification
Calibration
3 Verification

Criticality Level
L/M/H

Rational
Documentation verification does not affect the
product quality or change based on qualification
step, and don't change based on equipment
location.

Verification Level
FAT SAT IQ OQ PQ/PV CPV

Drawings verification does not affect the product

quality or equipment location, but could change
based on qualification step. Final installation
should be verified against the applicable
drawings.
M

Major
4 Components Inst.

5 Change parts

There is no critical instruments,

O
Major components verification test does not
affect the product quality, change based on
qualification step, and don't change based on
equipment location. However, as part of the
installation it is recommended confirm that the
major components were installed correctly if any
major component was disassembled as part of
the shipping process.
M
Change parts verification test does not affect the
product quality, change based on qualification
step, and don't change based on equipment
location.
M

Software verification test does not affect the

product quality, change based on qualification
step, and don't change based on equipment
location. However, as part of the installation it is
recommended confirm that the software name
and version tested during the FAT still the same. M

6 Software Inst.

N/A O

N/A

N/A

N/A

Rational / Assumptions
If there are no changes in
documents after FAT, If there are
changes then the test must be
verified in the IQ

N/A A

N/A

N/A

N/A

Verification of critical drawings

during FAT and any critical drawing
affected during the installation will
be verified during the IQ. Red lined
drawings shall approved by B+L
project engineer and handled under
applicable QCR.

N/A O

N/A

N/A

N/A

Critical instruments only, if any.

N/A O

N/A

N/A

N/A

Executed during FAT confirmed

during IQ, if there any change.

N/A O

N/A

N/A

N/A

Executed during FAT confirmed

during IQ, if there any change.

N/A A

N/A

N/A

N/A

Executed during FAT confirmed

during IQ, if there any change.

7 Hardware Inst.

8 I/O Checks

Back-Up and
9 Restore

10 EMI /FRI

11 Screen Verification

Security Access /
12 Edit Conf.

Loss
13 Communication

Hardware verification test does not affect the

product quality, change based on qualification
step, and don't change based on equipment
location. However, as part of the installation it is
recommended confirm that the hardware were
installed correctly if any hardware was
disassembled as part of the shipping process.
I/O verification test does not affect the product
quality, change based on qualification step, and
don't change based on equipment location.
However, as part of the installation it is
recommended confirm that the I/O wiring were
installed correctly, if any I/O wiring was
disassembled as part of the shipping process.
Back-up and Restore verification test does not
affect the product quality, change based on
qualification step, and don't change based on
equipment location. Additional verification is
required only if software change.
EMI/RFI verification test does not affect the
product quality, change based on qualification
step, and don't change based on equipment
location. Additional verification is required only if
software change.

N/A O

N/A

N/A O

N/A N/A M

Screen verification test does not affect the

product quality, change based on qualification
step, and don't change based on equipment
location. Additional verification is required only if
changes occurs between FAT and SAT.
M
Security Access / Edit Conf. verification test does
not affect the product quality, change based on
qualification step, and don't change based on
equipment location. Additional verification is
required only if changes occurs between FAT
and SAT.
M
Loss Communication verification test does not
affect the product quality, change based on
qualification step, and don't change based on
equipment location. Additional verification is
required only if changes occurs between FAT
and SAT.
M

N/A

N/A N/A O

N/A N/A O

N/A N/A O

N/A N/A O

N/A

Executed during FAT confirmed

during IQ, if there any change.

N/A

N/A

Executed during FAT and check in

the IQ only if I/Os were
disconnected during the shipment.

N/A

N/A

To cover additional changes

N/A

If there are no changes in hardware

after FAT

N/A

If there are no changes in

documents after FAT, If there are
changes then the test must be
verified in the OQ

N/A

If there are no changes in

documents after FAT, If there are
changes then the test must be
verified in the OQ

N/A

If there are no changes in

documents after FAT, If there are
changes then the test must be
verified in the OQ

N/A

N/A

N/A

N/A

N/A

14 Power Failure

15 Reject Challenge

Operational runs
Verification /
16 Water runs

Performance
17 Verification

Power Failure verification test does not affect the

product quality, change based on qualification
step, and don't change based on equipment
location. Additional verification is required only if
changes occurs between FAT and SAT.
M
Reject Challenge verification test does not affect
the product quality, change based on qualification
step, and don't change based on equipment
location. However, failures in the rejection
functionalities could result in customers
misinformation and regulatory issues. It is
recommended confirm that the rejection
functionality is working properly before proceed
with operational and performance test.
M

Operational runs Verification / Water runs

verification tests do not affect the product quality
or change based on qualification step, but could
change based on equipment location. This test is
important to confirm that the machine comply
with the boundaries specifications (smaller,
biggest and max. speed).
M

Performance Verification test do not affect the

product quality or change based on qualification
step, but could change based on equipment
location. This test is important to confirm that the
machine comply with the B+L requirements.
M

N/A N/A O

N/A N/A O

N/A N/A M

N/A N/A N/A

N/A

N/A

N/A

N/A

If there are no changes in

documents after FAT, If there are
changes then the test must be
verified in the OQ

N/A

If there are no changes in

documents after FAT, If there are
changes then the test must be
verified in the OQ

N/A

All sizes worst case will be testing

during FAT; If FAT runs are
acceptable only water runs (Mock
OQ) will be performed prior
proceed with the OQ of smallest
size and biggest size at max speed.
(*1)

N/A

If FATand OQ runs are acceptable

proceed with 3 first lot of the most
common configuration at nominal
speed concurrent with production.

Definitions:
Test Criticality: Based on test sensitivity on the qualification process, test impact in the product quality, or test impact due to installation and final location.
L: Low Risk, the success of the test is essential for the business but have no impact in the patient safety, product quality, and/or data integrity.
M: Medium risk, the success of the test is essential for the business and significant for patient safety, product quality, and/or data integrity. Leverage of this test in the
qualification protocols should be justified.
H: High risk, the success of the test is essential for the patient safety, product quality, and/or data integrity. Leverage of this test in the qualification protocols must be
justified.
M: Mandatory; the requirements must be tested during this step. Leverage of the test shall be approved.
A: Abbreviated, the requirement could be verified during this step. This test could be leverage if no additional changes has been made to the system/equipment.
O: Optional, the requirement could be verified during this step. This test could be leverage if no additional changes has been made to the system/equipment.

Notes:
Add any note to justify decisions

Performed By /Date:
Validation Engineer:
Approved By / Date:
Project Engineering
Manager:
Operation/Manufacturing
Manager:

QA/ Validation Manager