General Electric proprietary information

1.

GE Healthcare
Wipro GE Healthcare Private Limited JFWTC
(No 122,Phase II, Export Promotion Industrial Park, Whitefield Road, Bangalore)
welcomes
Mr Jeffrey Thibodeau
US FDA
National Center for Expertise of Medicines and Medical
Devices" of the Committee for Medical and Pharmaceutical
Control of the Ministry of Health of the Republic of Kazakhstan
Erzhan Isabaev and Aimara Beisekova
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
1
12/25/2022

2.

FOCUSED ON SOLUTIONS FOR DIAGNOSIS, TREATMENT, AND MONITORING
Imaging
BUSINESS LINES
Offerings
Ultrasound
Pharmaceutical
Diagnostics
• MR
• Women’s Health
• Monitoring
• PACS/RIS
• Contrast Media
• CT
• Cardiovascular
• VNA
• Molecular Imaging Agents
• MI
• General Radiology
• Anesthesia &
Respiratory
• X-Ray
• Point of Care
• Advanced
Visualization
• Pharma Trial Companion
Diagnostics
• Women’s Health
• Primary Care
• Image Guided
Therapies
Capabilities
Enterprise Digital
Solutions
Life Care
Solutions
• Diagnostic Cardiology
• Maternal & Infant
Care
• CVIT
• Acute Care
NINE COMMERCIAL REGIONS
ONE INTEGRATED SUPPLY CHAIN
GLOBAL SERVICES
GE HEALTHCARE PARTNERS
GE HEALTHCARE EQUIPMENT FINANCE
EDISONTM INTELLIGENCE PLATFORM
© 2020 General Electric Company - All rights reserved | Content approved for internal and external use. Updated March 30, 2020.
2
© 2020 General Electric Company - All rights reserved | Content approved for internal and external use.

3.

Quality Policy
Top executive management must review the
suitability, adequacy, and effectiveness of
the Quality Management System (GQM
5.5.4)…
at planned intervals and with
sufficient frequency
according to established procedures
to ensure that the QMS satisfies
external requirements and the
company’s own quality policy and
quality objectives
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
3
12/25/2022

4.

GE Healthcare Purpose
Improving lives in
moments that matter.
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
4
12/25/2022

5.

Monterrey Site Overview
485 employees
Total of 210K square feet
Started Operations: March 1998
Manufacturing activities:
• Bone Mass Densitometers (2016)
ISO13485:2016 Certified
ANVISA Brazil, MHLW Japan, KFDA, COFEPRIS México
Site Location
Apodaca, Nuevo León
México
2 hours drive from border to USA (Texas)
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
5
12/25/2022

6.

Monterrey - Site Overview
Working time on the site
• 3 shift operation (M-F)
– 1st Shift (6:00am – 2:00pm), (7:00am to 4:36pm)
– 2nd Shift (2:00pm to 11:00pm), (4:00pm to 12:00pm)
– 3rd Shift (11pm to 7:00am)
• Normal office hours 8am – 5pm
• Safety Rules on the site
• COVID restrictions: facemask optional
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
6
12/25/2022

7.

Organization
Structure
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
7
12/25/2022

8.

Organization Flow Down
GE Healthcare
Laila Gurney
Vice President & Chief
Quality Officer
GE Healthcare
Peter Arcduini
President & CEO
GE Healthcare
Jan Makela
President & CEO,
Healthcare Imaging
GE Healthcare
Xue Jie
President & CEO, MR
GE Healthcare
Tony Sikorski
MR Chief Operating Officer
GEHC Quality
Nicholas Threasher
Executive – MR Total
Quality Leader
GEHC Quality
Fernanda Novak**
Site Total Quality Leader
GEHC Supply Chain
Robert Wojdelko
Sr. Executive Manufacturing
GEHC Supply Chain
Rafael Doria*
Site Executive, Plant
Manager
*Management with Executive Responsibility
**Management Representative
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
8
12/25/2022

9.

*Site Executive
**Management Representative
Quality Organization
Supplier Quality
Reporting to Supplier
Management org
President & CEO, GE Healthcare
Peter Arduini
***Product Quality
Reporting to Monterrey
site operations
Chief Quality & Regulatory Officer
Laila Gurney
Plant Manager
*Rafael Doria
Product Quality
Eduardo Lopez
MR Total Quality Leader
Nicholas Threasher
Site Total Quality Leader
**Fernanda Novak
MR supplier Manager
Dan StPierre
Sr Sourcing Staff Manager
Supplier Quality Eng
Kimberly Spindler
Sourcing ManagerSupplier Quality Eng
Felix Hernandez
Supplier Quality
Lead Engineer
Oscar Perez
Lead Sourcing Specialist
Supplier Quality
Ivan Mendoza
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
Lead Sourcing Specialist
Miguel Pantoja
Lead Sourcing Specialist
Ely Daniel
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12/25/2022

10.

Rafael Doria Ortiz (223061...
GE HEALTHCARE
Plant Manager
Organizational Structure
GE MEDICAL SYSTEMS MONTERREY MEXICO
Rafael Doria Ortiz (22...
HC IMG-Magnetic Resonance
Executive Plant Manager
Andres Zermeño (212319279)
Eduardo Lopez Garza (21234...
Fernando Cardosa Aguilar (...
Hector Guadiana Manjarrez ...
Heidie Valdez (220041588)
JAIME RODRIGUEZ MARTINEZ
(...
Andres Zermeño (212319...
Eduardo Lopez Garza (2...
Fernando Cardosa Aguil...
Hector Guadiana Manjar...
Heidie Valdez (2200415...
JAIME RODRIGUEZ MARTIN...
HC IMG-Magnetic Resonance
HC IMG-Magnetic Resonance
HC IMG-Magnetic Resonance
HC IMG-Magnetic Resonance
HC IMG-Magnetic Resonance
HC IMG-Magnetic Resonance
GERENTE DE EHS
GERENTE DE CALIDAD DE PROD...
Manufacturing Engineering ...
Sr Manufacturing Manager -...
GERENTE DE MATERIALES
Lean Leader
Jorge Cazares Salazar (220...
Rogelio Bejar (223046358)
Alejandro De la Garza Mena...
Dante Ruiz Villarreal (212...
Damian Arturo Serna (212…
Fernanda Novak (212035465)
Jorge Cazares Salazar ...
Rogelio Bejar (2230463...
Alejandro De la Garza ...
Dante Ruiz Villarreal ...
Fernanda Novak (212035...
HC IMG-Magnetic Resonance
HC HR-Latin America
HC FIN-Global Supply Chain
HC IMG-Magnetic Resonance
HC QUAL-Global Quality Reg...
Sr Manufacturing Manager -...
Sr HR Staff Manager - HR B...
Sr Finance Manager - Manuf...
Sr Manufacturing Manager -...
GERENTE DE ASEGURAMIENTO
D...
Vacant
HC IMG-Magnetic Resonance
GERENTE DE MANTENIMIENTO
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
10
12/25/2022

11.

Products

12.

Monterrey Site Products
2014
2007
1999
Xray Hangers
and Bridges
2001
New BuildingMR Cabinets,
PET collimators
and Pen Panels
HDv MR
Patient Tables
introduction
2011
XRMb
Gradient Coil
transfer and
750w/GEM
MR
components
2017
Introduction of
TRM Gradient
HRMw
and RF Coils
2016 Gradient Coil,
transfer,
Introduction of Lunar Bone Pen Wall and
PET MR Densitometers RF former
Transfer
Components
2020
2018
Introduction
of BRM2
Gradient
Coils
2019
Ceased
production of
Refurbished
Lunar Systems
Additive
manufacturing
for MR
components
2021
2022
XR Fixed Rad
table & Cabinet
Signa Hero
Detachable Table
2022
Mobile XR
Base & thorax
1998
First
operation XR
and VH
Systems
2015
2002
2000
XR Cabinets,
Odetta
Table, AMX
Assemblies
and XR Tube
Housings
BRM
Gradient
Coils and
formers
2010
P500 Table full
assembly and
XRMw
Gradient Coil
transfers
VRMw 3T
Gradient Coil
introduction
and BRM LLD
Gradient Coil
transfer
2017
Lunar
Refurbished
systems and
service
components
transfer.
2019
TLF
Operations for
MX100-400,
500, HRT and
Performix
famility tubes
transfer out to
India
2020
2021
Introduction
of Motus
Detachable
table for
Premier
System
Voyager
detachable
table
© 2020 General Electric Company - All rights reserved | Content approved for internal and external use.
2021
Atlantis
Gradient Coil
IRMW
Gradient Coil

13.

BMD (Lunar) Products
Site Scope
Manufacturing activities:
GE Medical Systems Monterrey
México S.A. de C.V.
Prodigy Series
(iDXA and Prodigy product families)
Legal Manufacturer
GE Medical Systems Ultrasound and
Primary Care Diagnostic
iDXA
Est production
volumes
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
13
12/25/2022

14.

EHS Overview

15.

Monterrey Plant Layout
Safety glasses, shoes and face
mask required
Personal Protective Equipment
Requirements
Safety glasses, shoes and
ear protection, face mask
required
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
15
12/25/2022

16.

Evacuation
In the event of a plant evacuation, a sound and visual alarm will be activated as
part of the system to evacuate.
• Go to the nearest exit - know your primary and secondary exit routes
• Assemble in a designated
area outside (Guards area # 1 and #2)
• Follow direction of evacuation team
• Wait for all clear
GENERAL ELECTRIC PROPRIETARY INFORMATION
This document contains trade secrets and confidential or financial information of General Electric Company
exempt from disclosure under the FREEDOM OF INFORMATION ACT (FOIA) 5 USC Sect 522(b)(4)
16
12/25/2022