Challenge, Change, & Innovation in PLM, Manufacturing, & Compliance

Challenge, Change, & Innovation in PLM, Manufacturing, & Compliance Brion Booth Manager - Enterprise Application Solutions Varian Medical Systems 1 |...
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Challenge, Change, & Innovation in PLM, Manufacturing, & Compliance Brion Booth Manager - Enterprise Application Solutions

Varian Medical Systems 1 | CORPORATE COMMUNICATION

Varian Saves Lives ! Varian Medical Systems: Focus on saving lives. Through collaboration with customers & partners, the people at Varian develop technology leading solutions for advancing cancer treatment, radio surgery, X-ray imaging, and security.

 Treat over 250,000 patients/day

Oncology Systems

 FY 2012 Revenues ~$2.6 B  5,800 employees  Manufacturing sites -NA, China, Europe  60 Sales/support offices globally Security and Inspection products

2 | CORPORATE COMMUNICATION

X-Ray & Imaging Systems

How did it all get started at Varian? PLM & manufacturing challenges & opportunities lead us to improve core engineering and manufacturing processes Reach RoHS Compliance

3 Basic Philosophies: • • •

What is my stuff ? How much does my stuff cost ? Where is my stuff ?3

3 | CORPORATE COMMUNICATION

• Lack of process compliance • Inadequate tools & infrastructure • Looming regulatory requirements • Big workload to become compliant

Engineering Change & BOM • Paper based and manual • Backlogs due to process inefficiencies • Inconsistencies across organizations • Manual configuration management

Mfg. Shop Floor • Paper based/manual processing error prone & abused. • Lack of integration between systems • Transaction timing • OLTP/UX in ERP not mfg focused

Mfg Process Control, & Compliance • Limited process enforcement • Regulatory data silo’d & not easily reported • Routers didn’t represent the build process – financial only.

Results in Ops

4 | CORPORATE COMMUNICATION 3/8/2004

5/3/2004

Date

Results in Pharma

9/6/2004

8/23/2004

8/9/2004

7/26/2004

7/12/2004

6/28/2004

6/14/2004

5/31/2004

5/17/2004

80.0%

4/19/2004

4/5/2004

3/22/2004

90 Day Avg

2/23/2004

2/9/2004

1/26/2004

1/12/2004

Results in Med Device

12/29/2003

12/15/2003

4 Wk Average Yields

Benchmarking … Sequence 130 - Final QA Yields

100.0% 95.0%

90.0%

85.0%

MES Deployed

75.0%

Business Transformation: Digital Product Collaboration PLM Outcomes: - Leverage and reuse product engineering data - Establish continuous data stream - Design  Manufacturing  Service

- 3D Model Material  EBOM  MBOM - Re-use of parts and information - Enable one global engineering platform - Capture Electronic E-BOM’s and parts - Building block for “virtual product” - Quicker access to product and process information - Global version/revision control Device Master Record (DMR): Drawing SAP Platform becomes the system of record

5 | CORPORATE COMMUNICATION

PLM Systems Landscape Integrated SAP Software was platform of choice for REACH RoHS and EC process ProE OrCAD

PDM

Mentor Graphics

PLM 7.01

Solid Works, AutoCAD

SPRC (RoHS) Drawings

Clear Case DX Designer CADSOFT Eagle

SAP DMS

CAD Apps PP

Drawings P-drive

MM

Data resides in SAP ERP (Material, BOM, Vendor, DIR etc)

SAP ERP /PLM

Altium



Simple application architecture, no additional cost for hardware, software and integration.



Included NetWeaver Business Client (NWBC) UX and logic services to streamline PLM process. Several new engineering screens, workflows, & interfaces 6 | CORPORATE COMMUNICATION

Business Transformation: Manufacturing Execution

Improve: Quality, First Pass Yield, Cycle Time, Error reduction, Avoidables, Data Availability, Analytics & Reporting, User Experience & Integration, SPC (Instantaneous)

7 | CORPORATE COMMUNICATION

Business Transformation: Manufacturing Integration & Intelligence (MII)

8 | CORPORATE COMMUNICATION

Business Transformation-Digital Product Collaboration From EBOM to Full Configuration Management EC4 ProE 3D Assembly Functional Requirements -15

Rev A

Compliance Documentation

Rev C Rev B

3D PDF Assembly ProE 3D Model

EC2

Rev A

-06

Highlights

PDF Drawing ProE Drawing

1. Establish a System of Record and also provide a structure for navigation and search across product information

Test Plan

Rev C Rev B

3D PDF Assembly SolidWorks 3D Model PDF Drawing SolidWorks Drawing

Rev A

-05

Functional Specification

Rev C

Rev B Schematic Board 3D Model OrCAD Schematic Board Layout Model

EC3

-10

Mechanical Part

Testing Plan

Rev C Rev B

Electrical Part

Components Compliancy Certificate

Software Part Document

-08

Rev A

Manufacturing Spec Sheet

Rev C Rev B

File EC

3. Foundation for full traceability

Functional Specification

Rev A

2. Foundation for Configuration Management

Eng Change

Firmware Binaries Functional Specification

9 | CORPORATE COMMUNICATION

-10

Rev A

Integration Testing

Rev C Rev B

PLM Benefits: Compliance, Revenue Protection, Cost Avoidance, Agility, Process Consistency, Protect EU Revenue

 ~30% of total Varian revenue in 2014 and thereafter Speed of design process  Increase component selection and alternate Optimize component spend  Leverage standard components and reuse Automate component data acquisition

 PartMiner interface with SAP, capture AML, data sheets & pricing

10 | CORPORATE COMMUNICATION

2012

2013

2014

2015

2016

Mfg Execution Benefits: Paperless Processing, Process Enforcement, Compliance & Analytics Real Time SPC:  Manual/automatic data collection - Any source  Process control  Event driven NC, Rwk, Notification  Workflow  MII - Automatic from AtP

Standard in ME:  Analysis on all things manufacturing  MII & BOBJ options available

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Device History Record • • Test Log:



Measurement data by SN ! Tools: Calibration Verification !

Created in real time – can view anytime. Ties together BOM levels/ops by SN Customized through MII & DHTMLX extensions

Serialization Components & Sub Assemblies !

12 | CORPORATE COMMUNICATION

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