Appendix A_QG4.pdf

Special Notice

70T04026SN7573N001

Air Cargo Screening Qualification Test

Qualification Group Four Explosive Detection Systems

Appendix A: ACSQT White Paper Requirements & Templates

Date: ______________________________ Manufacturer: _______________________________

Model: _____________________________________

I. VENDOR INFORMATION

U.S. Business Foreign Business Foreign Government

Yes No

Yes No

What is the vendor’s legal business name?

What is the type of business entity?

Does the vendor have a (SAM.gov) Unique Entity Identifier (UEI) number?

If yes, what is the vendor’s UEI number?

What is the physical address the SAM.gov has on file for the vendor?

Is the vendor currently registered with the System for Award Management (SAM)?

If yes, what is the vendor’s Commercial and Government Entity (CAGE) code?

What is the vendor’s web address?

What is the vendor’s Point of Contact (POC) name for this submission?

What is the POC’s phone number?

What is the POC’s email address?

Provide city & state location(s) of the candidate device final point of production.

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine the vendor’s ability to meet Security Sensitive Information (SSI) vetting requirements and that the vendor is an established business.

Manufacturer: _______________________________ Date: ______________________________

II. DEVICE OVERVIEW AND TECHNICAL SPECIFICATION

Describe the candidate device to include a technical summary of the screening/detection technology.

What are the dimensions of the largest object (width x height x length) that can be screened by the candidate device in metric and English units?

What is the dimensional footprint and weight of the candidate device in metric and English units?

What are the following electrical requirements for the candidate device?

Voltage Alternating Current?

Hertz

Amperage

Yes No

How many views does the candidate device have?

Does the candidate device have dual-energy capabilities?

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the device meets the qualification group criteria and assess the candidate device general screening capabilities.

III. COMMERCIAL AVAILABILITY

Yes Yes No

Yes Yes No

Yes Yes No

Is the candidate device currently available for purchase?

If available for purchase, what is the production lead time for the candidate device?

What is the current production rate of the candidate device?

What is the current commercial pricing of the candidate device?

Is the candidate device rebranded?

If rebranded, who is the original Equipment Manufacturer (OEM)?

Is the candidate device product information available online?

If yes, what is the web address?

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the candidate device is commercially available and a Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the candidate device is commercially available and a representative unit can be made available for further evaluation upon acceptance into the ACSQT program.

IV. PERFORMANCE

Has the device been evaluated by the Transportation Security Laboratory?

If yes, list all approvals to regulatory detection standards, such as TSA checked baggage, TSA accessible property, European Civil Aviation Conference (ECAC) hold baggage, etc.?

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if device is certified for checked baggage inspection.

Yes No

V. SAFETY

General Safety

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the candidate device is safe and does not represent an ionizing radiation hazard. Note – compliance with the listed standards is required and evidence will be requested during later stages of the qualification process.

Yes No

Yes No

Yes No

Yes No

Yes No

Does the candidate device comply with any recognized industrial or commercial standards which ensure the device does not pose any safety hazards to an operator or to transient personnel?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with UL 61010-1?

Safety (Ionizing Radiation)

Does the device comply with any recognized government standards which limit external emissions of ionizing radiation with respect to human exposure?

If yes, can the vendor provide evidence the candidate device is compliant with FDA Title 21, CFR 1020.40?

Can the vendor provide evidence the device meets the certification requirements specified by FDA Title, 21, CFR 1010.2, and the labeling requirements specified by FDA Title, 21, CFR 1010.3?

Date: ______________________________ Manufacturer: _______________________________

VI. ELECTROMAGNETIC COMPATIBILITY (EMC)

EM Immunity

Yes No

Yes No

Yes No

Yes No

Yes No

Does the candidate device comply with any recognized industrial or commercial standards which ensure the normal operation of the device is not susceptible to electromagnetic disturbances typical of an air cargo screening environment?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with IEC 61326-1?

EM Emissions

Does the candidate device comply with any recognized government, industrial, or commercial standards which ensure the device does not emit conduc ted or radiated electromagnetic fields at a level which may disrupt the operation of electronic equipment in the vicinity of the devi ce?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with IEC 61326-1?

Radio Frequency Interference

Does the candidate device comply with any recognized industrial or commercial standards which ensure the device does not emit radiated RF electromagnetic fields at a level which may disrupt the operations of electronic equipment in the vicinity of the device?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with FCC Title 47, CFR Part 15?

Yes No

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the candidate device is immune to EM disturbances and does not emit EM fields that may affect the operation of equipment in the vicinity of the device. Note – compliance with the listed standards is required and evidence will be requested during later stages of the qualification process.

VII. QUALITY MANAGEMENT

Yes No

Yes No

Does the vendor comply with any recognized industrial or commercial quality management standards?

If yes, can the vendor provide third-party certification evidence of compliance with the most current version of ISO 9001.

Does the vendor agree to provide the TSA access to technical records, personnel, and facilities pertaining to manufacturing, processing, inspection, and testing to assure continued compliance with all performance specification requi rements?

Yes No

Evaluation considerations: The TRP will evaluate the vendor’s responses to ensure the product and services are consistent and continually improved upon.

VIII. CONFIGURATION MANAGEMENT

Yes No

Yes No

Yes No

Does the vendor identify, control, maintain status records, and conduct periodic audits of your product configuration baselines in accordance with ISO 10007 or an equivalent?

Does the vendor identify and cont rol each delivered system configuration using a unique vendor-assigned serial number?

Will the vendor be willing to provide a document package that fully defines the design baseline of your product upon request for TSA review as part of the qualification process?

An emulator is a standalone component of an EDS device that displays stored image data files. This will be required to verify some proposed changes to the detection system. Is an emulator available for the candidate system?

Yes No

Evaluation consideration: The TRP will evaluate the vendor’s responses to ensure the vendor utilizes a standardized configuration management process to identify and control the functional and physical characteristics of the device.

IX. SUPPORTING INFORMATION

Yes No

Yes No

Yes No

Has the system previously been tested at the Department of Homeland Security’s (DHS) Science and Technology Directorate’s (S&T) Transportation Security Laboratory (TSL)?

If yes, provide the dates of the test and the test POC.

Does the candidate device meet the Electronic Baggage Screening Program (EBSP) requirements for automated detection of explosives (rev 5.8) or EDS detection performance?

Has the system been qualified for use by another DHS program, or agency of the United States government?

Does the device have a completed User Manual? Yes No

No Does the device have a completed training package? Yes

Evaluation consideration: The TRP will evaluate the vendor’s responses to assess the candidate device’s level of test readiness.

X. ATTACHMENTS

Yes No

Yes No

Include candidate device specification sheet.

Include block diagram of candidate device major components.

Include letter from the DHS S&T TSL stating the device meets the EBSP requirements for automated detection of explosives and EDS detection performance.

Yes No

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