Factory Acceptances Test / Site Acceptance Test checklist.

Machine Name: _________________________________ Machine ID: ________

Location  FAT (Prod Design Facility)  SAT (NHB3 Facility)

1.0 PURPOSE
1.1 The purpose of this checklist is to have a guideline to verify the design and installation
requirements for Factory Acceptance Test and/or Site Acceptance Test at Equipment
Manufacturer or HB3 Facility as correspond.
1.2 This checklist is for verification/testing support to be using during Engineering Study
Protocol when a Factory Acceptance Test and/or Site Acceptance Test activities.
1.3 Provide guidelines for successful completion of the design and verification requirements
to provide assurance that the equipment has been tested according to specifications,
operates properly, and will function and can be maintained as required.
2.0 REFERENCE DOCUMENTATION
Identification No. Description Revision
TJ-MVP-2019-0137 PV-1806636 MASTER VALIDATION PLAN DAYTON
PROJECT XCEL DEVICE.
PRC091372 Factory Acceptance Test for XCEL Bladeless Universal line A
TJ-VF-2013-0917 (IQ) INSTALLATION QUALIFICATION PROTOCOL 16

TJ-PROC-2004-0016 Procedimiento de Calibración de Equipo / Equipment

38
Calibration Procedure
TJ-PROC-2004-0084 Procedimiento de Validación / Validation Procedure 49

3.0 GENERAL ASSUMPTIONS

3.1 Execute each checklist according to the procedures specified in each section.
3.2 Identify instrumentation on equipment and inspect to verify proper calibration. Document
the calibration information.

3.3 Whenever the results of a given challenge do not meet the acceptance criteria established,
the results should be recorded using a Punch List and the issues shall be fixed before
moving the machines to HB3 Facility.
3.4 As part of this checklist there is a section to write a summary report that clearly explains
the verification activities performed and how it compares to the acceptance criteria in the
protocol.
4.0 PROCEDURE
4.1 All applicable checklists shall be completed. Checklists shall be filled out by hand at the
equipment manufactured site and/or HB3 Site and not electronically. The completed
checklists will be attached to the Engineering Study report with all required supporting
documentation per Machine tested.
4.2 Provide a summary at corresponded section.

Page 1 of 17
5.0 FAT/SAT CHECKLIST – EQUIPMENT IDENTIFICATION
Verify the equipment information on the following checklist.

Equipment Identification Result

Equipment Description Optiview Stopcock Press
Manufacturer Prod Design
Manufacturer ID
Serial #
[Specify if Nypro Healthcare owns the equipment
Equipment Owner
or which customer]

Acceptance criteria: Appropriate information is present, complete and properly documented.

Results: [ ] Pass [ ] Fail
Performed By: Date:
Verified By: Date:

Page 2 of 17
6.0 FAT/SAT CHECKLIST – EQUIPMENT DOCUMENTATION (PAGE 1 OF 2)
Verify the documentation package against the following documentation checklist.

Document Item File Name REVISION VERIFIED?

Machine Drawings
Equipment Requirement Specification
Facilities/Utilities Requirements
Electrical Documentation
Control Documentation
PLC Controls Software
Vision Sensors
Servo/Stepper Control Systems
Operator Interface/Message Display
Pneumatic Documentation
Maintenance Procedure (Draft)
Troubleshooting Guide Rev Edgar
Alignment, Set-Up Procedures Edgar
Spare Parts List
Cleaning Procedures Edgar
Operational Documentation
Sequence of Operation
Setup and Changeover Procedures
Manufacturer’s Manuals
Manufacturer’s Certification
Material Safety Data Sheets (MSDS)
Other.

Acceptance criteria: Appropriate documentation is present, complete and properly

documented.
Results: [ ]Pass [ ] Fail
Performed By: Date:
Verified By: Date:

Page 3 of 17
FAT/SAT CHECKLIST – SAFETY FEATURES (PAGE 1 OF 2)
Instructions: This form shall be completed by EH&S department Representative or assigned
Engineer to execute the Factory Acceptance Test or Site Acceptance Test. Evaluate each
checklist item for the equipment under verification and determine if the item is applicable. If the
checklist item is not applicable, check the N/A box for acceptance. If the checklist item is
applicable, evaluate it for the equipment under verification and determine if what is in place is
acceptable and check the corresponding box.

Acceptance Criteria: If the item is applicable and is not acceptable, document in Punch list and
determine the required corrective actions before considering this check list as passed.

Item Acceptance Criteria Result

All hazardous points in the machine, like point
of operation, ingoing nip points, rotating parts, [ ]Pass [ ] Fail
flying chips and sparks, are they cover by [ ]Not Applicable
guarding?
Guarding
Is the guarding safe enough that not [ ]Pass [ ] Fail
represents a risk for the operator? [ ]Not Applicable
Are the guards properly labeled? [ ]Pass [ ] Fail
[ ]Not Applicable
An interlock system is required in addition to [ ]Pass [ ] Fail
the safety guarding? [ ]Not Applicable
In case that machine requires two start
[ ]Pass [ ] Fail
Interlocks operation buttons, an anti-tie down control is in
[ ]Not Applicable
place?
If light curtains are installed, all unsafe area is [ ]Pass [ ] Fail
cover? [ ]Not Applicable
Are the energized parts of the machine
[ ]Pass [ ] Fail
covered?
[ ]Not Applicable
Is the machine/equipment has installed the
following labels in Spanish language according [ ]Pass [ ] Fail
Electrical to the Mexican norm: rate voltage, electrical [ ]Not Applicable
safety risk, arc flash hazard, etc?
Is the electrical installation (wiring, plugs, [ ]Pass [ ] Fail
contacts) in good condition? [ ]Not Applicable
Is the static electricity generated by the
[ ]Pass [ ] Fail
process properly eliminated by any mean
[ ]Not Applicable
(Ionizer, ground, etc)?

Acceptance criteria: Appropriate safety measures are in place.

Results: [ ]Pass [ ] Fail
Performed By: Date:
Verified By: Date:

Page 4 of 17
FAT/SAT CHECKLIST – SAFETY FEATURES (PAGE 2 OF 2)

Item Acceptance Criteria Result

Verify that no hot areas on the equipment can be [ ]Pass [ ] Fail
Thermal safety
reached and they are properly tagged. [ ]Not Applicable
Mechanical Verify that no moving parts are exposed and that [ ]Pass [ ] Fail
Safety crush risk is isolated and properly tagged. [ ]Not Applicable
Verify that risk of chemical damage, if present, is [ ]Pass [ ] Fail
properly isolated and tagged. [ ]Not Applicable
Is the chemical used in the chemical approved list? [ ]Pass [ ] Fail
Chemical Safety
[ ]Not Applicable
Is MSDS available in Spanish? [ ]Pass [ ] Fail
[ ]Not Applicable
Verify that no risk of explosion is present or it is [ ]Pass [ ] Fail
Explosion Risk
isolated and properly tagged. [ ]Not Applicable
Verify that the equipment does not have a direct [ ]Pass [ ] Fail
Environmental environmental impact. [ ]Not Applicable
Exhaust Are the fumes, vapors or gases under control? [ ]Pass [ ] Fail
[ ]Not Applicable
Ergonomics Verify the operation to be ergonomically acceptable [ ]Pass [ ] Fail
Review per current Nypro procedures. [ ]Not Applicable
Personal Will be determined upon the activities performed on [ ]Pass [ ] Fail
Protective the new or modify process. [ ]Not Applicable
Equipment (PPE)
Decibel Verify that the noise level is below 85 dBA [ ]Pass [ ] Fail
Inspection [ ]Not Applicable
Lock out / tag out procedure and devices shall be in
[ ]Pass [ ] Fail
Lock out/Tag out place and available for application upon equipment
[ ]Not Applicable
maintenance.
E-Stop. Emergency Stop at proper reach and proper [ ]Pass [ ] Fail
Emergency Stop
labeled? [ ]Not Applicable
Measure the Room Illumination, where the process
will be installing or modify. Reference Point 7 of [ ]Pass [ ] Fail
Illumination NOM-025-STPS-2008. [ ]Not Applicable
Result:________________LUX.
Non Ionizing Verify that the equipment does not have a direct [ ]Pass [ ] Fail
Radiation impact to the employee. [ ]Not Applicable
Verify that the equipment or process does not have
Waste water [ ]Pass [ ] Fail
a discharge of waste water that can make an impact
Discharge [ ]Not Applicable
to the environment.
Will pressure vessels be installed in the new or [ ]Pass [ ] Fail
Pressure Vessels
modify process or equipment. [ ]Not Applicable
Observations:

Acceptance criteria: Appropriate safety measures are in place.

Results: [ ]Pass [ ] Fail
Performed By: Date:
Verified By: Date:

Page 5 of 17
7.0 FAT/SAT CHECKLIST – CALIBRATION
Verify the calibration information on the following checklist.

Measuring and test devices used or referenced during FAT/SAT

Instructions: Complete the following table in order to verify that all test gages,
instruments, and equipment used or referenced during the execution of this FAT/SAT have
been calibrated and that each instrument is within its calibration period.
Acceptance Criteria: Each test gage, instrument, or equipment used or referenced during
the execution of the FAT/SAT must be calibrated using standards traceable to the NIST or
equivalent and must be within its calibration period during use.
Measuring Calibration Due Verified
Description Pass or Fail
Device ID Date Date By / Date
[ ]Pass [ ]
Fail
[ ]Pass [ ]
Fail
[ ]Pass [ ]
Fail

System Instruments Calibration Verification

Instructions: Complete the following table in order to verify that all gages, instruments, and
equipment included in the scope of the FAT/SAT have been calibrated and that each instrument is
within its calibration period. This table shall establish what calibrations are required and at what
interval they must be performed.
Acceptance Criteria: Each gage, instrument, or equipment included in the scope of the FAT/SAT
shall be be calibrated using standards traceable to the NIST or equivalent and must be within its
calibration period.
Measuring Calibration Due Verified
Description Pass or Fail
Device ID Date Date By / Date
[ ]Pass [ ]
Fail
[ ]Pass [ ]
Fail
[ ]Pass [ ]
Fail

Results: [ ]Pass [ ] Fail

Reviewed By: Date:

Page 6 of 17
8.0 FAT/SAT CHECKLIST – UTILITIES VERIFICATION
Identify and document the utilities/facilities requirements for the equipment and compare
to the installed services.

Complete columns (Utility) and (Specification) for Engineering Study Reference. Columns
(Actual Value) and (Pass/Fail) are to be completed as part of the FAT/SAT checklist
execution. (Add Utility verification as needed)
Utility Specification Actual Value Result -Pass/Fail
Main Voltage [ ]Pass [ ]Fail
Amperage
Record Fuse Amp Rating as the [ ]Pass [ ]Fail
Actual Value
Phase [ ]Pass [ ]Fail
Air Pressure [ ]Pass [ ]Fail

Acceptance criteria: The utilities are within specification.

Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

Page 7 of 17
9.0 FAT/SAT CHECKLIST – EQUIPMENT SETUP
Verify the proper location of the equipment following the table below.

Verification Result
Installation Requirement
Method Pass or Fail?
Visually verify that the equipment has not
damages, rust, oil/grease, dust or any
contamination that can cause any malfunction in Visual [ ]Pass [ ]Fail
the testing cycle or contaminate production floor.
Clean and sanitize as needed.
Visually verify that all major components are
according to manufacturer model. All major model
Visual [ ]Pass [ ]Fail
components must match with those described in
manufacturer’s Documentation.
Verify equipment and components to be correctly
Level
mounted, leveled & secure (Ref. Manufacturer’s [ ]Pass [ ]Fail
instrument
Documentation).
Verify that the interlocks and grading of the
Visual [ ]Pass [ ]Fail
equipment are installed and properly connected.
Verify the proper location of the equipment per the
Visual [ ]Pass [ ]Fail
manufacturing floor plan
Are lubricants or other chemical agents required
for equipment operation? If so, Is
Lubricant/Chemical Agent approved for use by Visual [ ]Pass [ ]Fail
EH&S? and, does a MSDS exists for the chemical
agent and is it filed per site-specific procedure?

Acceptance criteria: Equipment meets the above requirements.

Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

Page 8 of 17
10.0 FAT/SAT CHECKLIST – TOOLING LIST
Verify the proper tooling for the machine and record it following the table below.

Tool Description Quantity Serial/Model

Included (Yes/No)
Printer
Scale
Gage

Page 9 of 17
11.0 FAT/SAT CHECKLIST – PARAMETERS.
Critical Process Parameters
Review all possible process parameters and identify those process parameters that can influence
product quality.

Parameter
Parameter to Test. Rational
Limits
Weld Amplitude 85%-100%

Non-Critical Parameters (Controlled and Disturbance)

Enlist operational parameters that could be adjusted but does not have significative influence to
the process because an adequate control or because it was demonstrated that has a negligible
impact on product quality.
Include references for procedures used to monitor and control variables or rational in case some
variables were considered disturbance.

Controlled or
Parameter Control Method or Rational
Disturbance Variable
Trigger Force 40 lb Daily Checklist TR232XXC
Sensing Start Position 3.52 In Daily Checklist TR232XXC

Acceptance criteria: Equipment meets the above requirements.

Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

Page 10 of 17
Process Outputs.
In the table below identify any control mechanisms for any specific process output.
Controls may include ongoing inspection (destructive and non-destructive testing for welds),
statistical process controls, audit etc.

Process Output Specification Limits Control Method

Pull Test 40 N – 60 N See Control Plan Method P232XXC
Lubricant Dispensing 5 gr - 8 gr See Control Plan Method P232XXC

Page 11 of 17
 Acceptance criteria: Equipment meets the above requirements.
Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

12.0 FAT/SAT CHECKLIST – EQUIPMENT OPERATION AND TEST CASES

Operate all the equipment functions and verify the equipment as a whole is functioning
as intended. Test all functions that are critical to device operation and parameter
control.

Note: All pieces used to Test function enlisted in this section shall be disposed to Scrap.

Safety Functions

Function / Test Case Expected

Actual Output Result Pass / Fail
(Procedure) Output
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail

Acceptance criteria: Equipment meets the above requirements.

Page 12 of 17
Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

System Enable
Function / Test Case Expected
Actual Output Result Pass / Fail
(Procedure) Output
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail

Acceptance criteria: Equipment operates as intended.

Results: [ ]Pass [ ]Fail

Page 13 of 17
Performed By: Date:
Verified By: Date:

Manual Motions
Function / Test Case Expected
Actual Output Result Pass / Fail
(Procedure) Output
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail

Acceptance criteria: Equipment operates as intended.

Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

Page 14 of 17
Normal Operation

Function / Test Case Expected

Actual Output Result Pass / Fail
(Procedure) Output
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail

Acceptance criteria: Equipment operates as intended.

Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

Page 15 of 17
Auto Cycle Verification

Function / Test Case Expected

Actual Output Result Pass / Fail
(Procedure) Output
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail
[ ]Pass [ ]Fail

Acceptance criteria: Equipment operates as intended.

Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

Page 16 of 17
13.0 FAT/SAT CHECKLIST – PRODUCT CONTACT
Identify all parts of the equipment (tooling, nests, fixtures, etc) that come into direct
contact with product, and analyze if the contact is acceptable.
Complete columns 1 for protocol approval. Columns 2-3 are to be completed as part of
the protocol execution. If an answer is Yes, document in the deviation section of closure
report and determine the required corrective actions.

List any Parts of the Could equipment part Could equipment part
Equipment that Could contaminate product? damage product?
Contact the Product (Yes/No) (Yes/No)
Stainless Steel Nest [ ]Yes [ ]No [ ]Yes [ ]No
Titanium Horn [ ]Yes [ ]No [ ]Yes [ ]No
Anodized Aluminum Insert [ ]Yes [ ]No [ ]Yes [ ]No
Delrin Rod [ ]Yes [ ]No [ ]Yes [ ]No
PVC Luer Lock [ ]Yes [ ]No [ ]Yes [ ]No
Stainless Steel Dispensing [ ]Yes [ ]No [ ]Yes [ ]No
Tip

Acceptance criteria: The product should not be contaminated or damaged in contact with the
equipment.
Results: [ ]Pass [ ]Fail
Performed By: Date:
Verified By: Date:

Page 17 of 17