Product Realization Group - Ops A La · PDF file©Product Realization Group, Inc., 2010...

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©Product Realization Group, Inc., 2010 Product Realization Group Product Realization Certificate Program Overview August 20, 2010

Transcript of Product Realization Group - Ops A La · PDF file©Product Realization Group, Inc., 2010...

©Product Realization Group, Inc., 2010

Product Realization Group

Product Realization Certificate

Program Overview

August 20, 2010

©Product Realization Group, Inc., 2010

Agenda

• Introductions- Michael Gozzo, President, TBC Group- Walt Maclay, President, Voler Systems - Mike Keer, President, Product Realization Group - Tim Stein, President, Business Performance Associate- John Cooper, Sr. Reliability Engineer, Ops A La Carte

• PRG Certificate Introduction

• Module Summaries

• Submitted Questions

• Open Questions and Discussion

©Product Realization Group, Inc., 2010

Michael Gozzo Bio

Michael W. Gozzo is President and Founder of THE TOTAL BUSINESS CONSULTING GROUP, INC., a firm specializing in counseling and education of all levels of management in the areas of Supply Chain, Lean Manufacturing, Demand Flow Technology, Just-In-Time, Total Quality Control, Manufacturing Systems Implementation, Inventory Control and Production/Operations Management. Recent involvement with Silicon Valley leader’s in Supply Chain Management, Lean Manufacturing practices and ISO include Cisco, Infineon, Sunrise Telecom, PerkinElmer, Philips Semi-conductor and SanDisk. He has traveled to Germany to train operational personnel at Lufthansa Air Cargo. Mr. Gozzo has been associated with Lean practices: pull systems, quick change, 5-S, VMI, cell design and others.He has traveled and worked extensively in Canada, England, Hong Kong, Ireland, Scotland, Germany, Japan, Korea, Mexico, Indonesia, South Africa and Taiwan.He has an Executive Program Masters Degree from the University of New Haven, as well as a Bachelor of Science in Finance from the University of Connecticut. He is certified as CPIM & CSCP by the Association of Operations Management (APICS).

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Walt Maclay Bio

Graduated from Syracuse University with a BSEE, Walt Maclay worked as an engineer and engineering manager at several companies before starting Strawberry Tree Inc, in 1979. For 20 years Strawberry Tree designed, manufactured and sold data acquisitionequipment worldwide. In 1999, using the name Voler Systems, thecompany began doing consulting engineering for companies that need high quality electronic design and software. The company focuses on medical devices, but it does work in other fields as well.

Walt has been the President of Voler Systems and Strawberry TreeInc. since its start in 1979 and Chief Engineer of Voler Systems since 1999. He has directed over 250 engineering projects in the past 11 years. Walt is a senior member of the PRG, a senior member of IEEE, and has been active in several consultant organizations for manyyears.

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Michael Keer Bio

Michael Keer has over 20 years of High Technology leadership experience in Original Equipment Manufacturer (OEM) and ContractManufacturing (CM) environments. Mike maintains a strong focus on business systems, having spent three years as a Systems Integrator at SofTEQ, Inc., where he supported 15 PLM implementations and 5ERP Integrations including Expandable, Oracle, Syspro, and Intuitive. Prior to SofTEQ, Mike was Director of Operations at Paramit, where he developed interfaces with EPR and PLM systems while managing Document Control / IT Operations (100 PC’s, ERP, MES) supported by two custom programmers. He has experience developing systems requirements / selection documents and SOW’s, and is well versed in both Data Management systems as well as communications methods to optimize operational performance.

Mike received a B.S. in Industrial Engineering and Masters in Manufacturing Engineering from Northwestern University in Evanston, IL. He is an active Mentor for Stanford University’s Product Realization Network.

©Product Realization Group, Inc., 2010

John Cooper Bio

John has 25 years experience in high tech reliability, testing and management, in startup companies and companies such as Plantronics, Agilent and Leapfrog. He has worked in telecommunication products, networks, consumer electronics (including the toy industry), power equipment, and contract manufacturing. His experience includes overall product quality and reliability strategy, Design and Process FMEA, reliability testing, HALT and HASS, reliability modeling, manufacturing test, quality control, and compliance engineering. Areas of expertise include RF and wireless circuitry, microwave, power, batteries, motor controllers, user interface, audio and acousticproducts, toys, and control circuitry.

He has taught courses in Reliability Engineering, and has managed various reliability and test groups, as well as manufacturing groups. He is certified by ASQ for CRE, CQE and a licensed Professional Engineer.

©Product Realization Group, Inc., 2010

Tim Stein Bio

Tim founded Business Performance Associates, Inc., a consulting firm located in Cupertino, California in 1994. Over the past 16 years, he has consulted with over 90 companies. These clients span 18 market segments with the majority in FDA regulated industries. Tim’s major service areas include: implementing quality systems, software development life cycles, and computer system validation.

From May of 2008 to May 2010, Tim was the Director of Software Validation and Quality Assurance at Genomic Health. There and at several other companies Tim provided leadership in designing a compliant software development life cycle and processes for the implementation and validation of purchased software.

Tim is the author of the highly regarded volume on computer system validation entitled: The Computer System Risk Management and Validation Lifecycle. Tim, a renowned speaker, has given 28 public presentations in the past nine years include webinars, speeches at national and local conventions, and local, national and international workshops and training sessions.

Tim is a Fellow of the American Society for Quality, and served on the leadership team of the Northern California Biomedical Discussion Group for seven years.

©Product Realization Group, Inc., 2010

Michael KeerPresident and CEO

Product Realization Group

Product Realization CertificateCourse Overview

©Product Realization Group, Inc., 2010

Course Objective

Learn how to effectively bring new products to market

Gain the tools for collaboration and team based development

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Business Challenges

©Product Realization Group, Inc., 2010

Impact to Businesses

SpreadsheetsEmails

Faxes

Cha

nges

BOMs

New Part Requests

Engineering

?

Manufacturing

• Product Revisions?

• Current BOM?

• New Part Signoffs?

• Contract Manufacturers tied into change control?

Product is not what customer wantsCosts are too highProduct is not manufacturable or supportableUnable to achieve compliance (ISO, FDA, RoHS, etc.)Missed business plan targets

©Product Realization Group, Inc., 2010

Course Benefits to Individuals

The Product Realization Certificate Program will teach individuals to:

1. Understand the Product Realization Process

2. Learn Current Best Practices

3. Find out how individual functions impacts others (up and downstream)

4. Gain Continuing Educational Units (CEU’s)

5. Increasing value to the organization

©Product Realization Group, Inc., 2010

Course Benefits to Businesses

The Product Realization Certificate Program will enable businesses to:

1. Minimize costs to bring products to market

2. Develop products that customers want

3. Make designs manufacturable from the start

4. Achieve regulatory compliance

5. Beat time-to-market window

6. Deploy a common methodology for developing products

©Product Realization Group, Inc., 2010

Course Target Audience

Companies that develop electronic high-tech products

• Design / Manufacturing Engineers & Managers

• Product Line Managers

• Document Control and PLM Administrators

• Quality and Compliance Engineers & Managers

• Purchasing / Supply Chain & Operations Management

• New Product Introduction Engineers & Mangers

©Product Realization Group, Inc., 2010

Module Start Dates

Module #1: Sept. 14th - Engineering Development

Module #2: Oct. 12th - Product Reliability

Module #3: Nov. 9th - Data Management and Collaboration

Module #4: Dec. 7th - Supply Chain Management

Module #5: Jan. 4th - Business Compliance

Final Exam: Feb. 1st - Certificate of Completion

©Product Realization Group, Inc., 2010

Course Location and Price

Location:

Krause Center for InnovationFoothill College 12345 El Monte RoadLos Altos Hills, CA 94022

Price is $995 and Includes:

• All Modules• Workbooks and Hand Outs• Final Exam• Certificate of Completion

©Product Realization Group, Inc., 2010

Course Contact Information

Contact:

Michael [email protected](831) 768-9501

©Product Realization Group, Inc., 2010

Module #1Engineering DevelopmentModule Overview

Walt Maclay, President Voler Systems

Module Objective

• To share best practices for developing great product designs. 

• Great product design practice involves • Great design skills• Great project management

• This course will focus on the project management as it applies to different disciplines, i.e. electrical and mechanical design.

• Industrial design and software are somewhat different – separate sections.

Module #1: Objective

Module Outline

• Design Process• Planning – scheduling and budgeting• Inputs – specifications, with examples• Design• Outputs – documentation, reviews, and  communication

• Verification testing• Validation testing• Transfer to manufacturing and tracking changes

Module#1: Outline

Module Outline continued

• Trade‐offs – time to market, cost, manufacturability, and quality

• Design Process for Industrial Design• Strategy• Conceptualization• Refinement• Design Definition

• Design Process for Software• Case Study – design of a device with electrical, mechanical, and software design

Module #1: Outline (continued)

Module Outcomes

• Gain an overall comprehension of solid product design practices for the following disciplines

• Mechanical 

• Electrical 

• Software 

• Gather common terminologies and how they are used

Module #1: Outcomes

Module Outcomes continued

• Learn common pitfalls that can slow or block design and development progress

• Learn how other groups should work with engineering

• Manufacturing

• Marketing

• Etc. 

Module #1: Outcomes (continued)

©Product Realization Group, Inc., 2010

Module #1: Highlights

• The right way to design products.

• The wrong way to design products.

©Product Realization Group, Inc., 2010

Module #2Product ReliabilityModule Overview

John CooperReliability Engineer

Ops A La Carte

©Product Realization Group, Inc., 2010

Module #2: Objective

• To discuss the different reliability techniques used across the product life cycle from initial concept of design to finished product all the way to product end of life.

• To show you how to integrate these techniques together into a cohesive reliability program, including goals, plans, and metrics.

Module #2: Outline

• Overview/Introduction• Planning for Reliability

• Assessments• Goals• Reliability Plan

• Modeling & Predictions• Thermal Analysis• Derating Analysis

• FMEA

• HALT• Rel. Demo Tests• Accelerated Life Tests• HASS• Root Cause Analysis• Wrap-Up• Workshop Exercise

©Product Realization Group, Inc., 2010

Module #2 :Outcomes

• Learn how to assess your organization

• Learn how to set reliability goals and write a solid reliability plan

• Understand design techniques such as thermal and derating analysis, and fmea

• Understand testing techniques such as HALT, RDT, ALT, and HASS

• Develop skills in Root Cause Analysis

©Product Realization Group, Inc., 2010

Module #2: HighlightsPower of Design for Reliability

• Meet or exceed customer expectations for reliability by: • Assessing your capabilities• Setting a goal• Developing a plan• Executing the plan

It’s that simple!

A detailed evaluation of an organization’s approach and processes involved in creating reliable products. The assessment captures the current state and leads to an actionable reliability program plan.

• Initiate a Reliability Program• Determine next best steps• Reduce customer complaints • Select right tools• Improve reliability

Now

Goal

$ unreliability

$ Profits

Assessment Interviews

StatisticalData Analysis

Benchmarking

Gap Analysis

Program Plan

complaints

fieldfailures

satisfaction

marketshare

? Unknown Reliability ?

Reliability Program FlowModule #2: HighlightsReliability Program Flow

©Product Realization Group, Inc., 2010

Module #3Data Management and CollaborationModule Overview

Michael KeerPresident

Product Realization Group

©Product Realization Group, Inc., 2010

Module #3: Objective

This module will teach best practices for how businesses should structure product data as well as leverage data management systems to more effectively collaborate throughout the product lifecycle.

Best practices will be applied in a variety of real world situations to understand the impact of data and configuration management on the organization.

©Product Realization Group, Inc., 2010

Module #3: Outline

• Overview / Introduction• The Benckmark• Item Master

• Part Numbers• Attributes• Compliance• AVL vs. AML

• Bills of Materials• Single Level• Multi-Level• Configurations

• Change Management

• Data Management• Methods• Business Systems• Workflows• Integration• Compliance / Control

• Collaboration• Strategies• Methods• Tools

• Case Studies

©Product Realization Group, Inc., 2010

Module #3: Outcomes

The Data Management and Collaboration module will teach the student to:

1. Understand the function and makeup of the Item Master and Bill of Materials (BOM) and their role in the product definition process.

2. Utilize product benchmarking concepts while mentoring a common language for product definition and control.

3. Learn how to manage Engineering Change Orders (ECOs) across the organization and supply chain.

©Product Realization Group, Inc., 2010

Module #3: Outcomes (continued)

The Data Management and Collaboration module will teach the student to:

4. Learn the latest business systems strategies and tools including: Customer Relationship Management (CRM), Product Lifecycle Management (PLM), Enterprise Resource Planning (ERP) and more.

5. Understand current Collaboration strategies and practices.

6. Develop solutions to real world data management and collaboration case studies that are based on scalable and repeatable best practice concepts.

©Product Realization Group, Inc., 2010

Module #3: Course Highlights

Why is it important to manage data effectively

throughout the organization?

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Module #3: Course Highlights

Product RealizationAs envisioned by the designers……

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Module #3: Course Highlights

Product RealizationAs built to Documentation……

©Product Realization Group, Inc., 2010

Module #4 Supply Chain ManagementModule Overview

Michael GozzoPresident

TBC Group

©Product Realization Group, Inc., 2010

Module #4: Objective

Supply Chain Management:To describe the processes from the initial raw materials to the ultimate consumption of the finished product linking across supplier-user companies.

The functions within and outside a company that enable the value chain to make products and provide services to the customer.

Module #4: Outline

• Introduction• Power of the supply

chain

• Fundamental Concepts• Strategy situations• Qualifying &

Winning• Four competitive

attributes

• Management Basics• Performance

measures• Operating

environments

• Managing for Improvements

• System • Case Study/Panel

©Product Realization Group, Inc., 2010

Module #4: Outcomes

• Learn what is competitive advantage

• How to minimize sub-optimization in the supply chain

• How to determine non-value added practices

• Understand tools – value stream mapping, constraint management, CRM & SRM

• Identify what performance measurements are needed

©Product Realization Group, Inc., 2010

Module #4: HighlightsPower of Supply Chain Management (SCM)

• It is the POTENTIALPOTENTIAL to include the customer as a partner in supplying the goods or services. There are several advantages:• Improve the information flow

• Reduces uncertainty and respective costs

• Integrates the product development with other functions• Shows that each function impacts others

Module #4: Highlights ESCALATOR EFFECT

Launch

DEVELOPMENT  STAGES

COST

Cost of changes multipliesBy 10 with each step

10 100 1000 10,000

Module #4: HighlightsSupply and Value Chains

Supplier Producer Distributor Customer

Physical Goods Flow

Flow of Information and Money

Support Functions

MarketingDesignOperationsPurchasing

Value Chain

©Product Realization Group, Inc., 2010

Module #5Business ComplianceModule Overview

Tim Stein, PhDPresident

Business Performance Associates

©Product Realization Group, Inc., 2010

Module #5: Objectives

• Understand the purposes for regulations and standards

• High-level knowledge of the ISO 9001 Quality System standard and the certification process

• Awareness of the scope of regulations with which companies need to comply

Module #5: Outline

IntroductionsStudentsReasons for standards & regulations

ISO 9001ObjectivesOverview of standard requirementsHow to achieve certification

• Medical Device Regulations and Standards• FDA• International

• Software engineering standards

• Overview of additional standards • Student presentations

©Product Realization Group, Inc., 2010

©Product Realization Group, Inc., 2010

Module #5: Outcomes

• Greater appreciation for the value of regulations

• An understanding of ISO 9001 with focus on product realization (international wisdom)

• Awareness of regulations and standards as a starting point for compliance• When they apply• What they involve

©Product Realization Group, Inc., 2010

Module #5: HighlightsWhy Compliance Is Important

• Excelling at product realization requires that a number of integrated processes are effective

• International quality standards exist to promote appropriate process development and improvement (e.g., ISO 9001)

©Product Realization Group, Inc., 2010

Module #5: HighlightsWhy Compliance Is Important

• Government regulations • Quality systems• Product and work place safety• Environmental protection• Control of information• Accuracy in label claims

• Customer expectations for compliance with voluntary standards

Module #5: HighlightsISO 9001 - Process-based QMS

©Product Realization Group, Inc., 2010

Module #5: HighlightsMedical Device

• Regulations and standards • FDA: Quality System Regulations • ISO 13485: Medical devices — Quality

management systems — System requirements for regulatory purposes

• Medical Device Directive (EU) • IEC 60601-1: Medical Electrical Equipment,

Part 1: General Requirements for Safety• IEC 62304: Medical Device Software • In Vitro Diagnostics Directive (EU)

©Product Realization Group, Inc., 2010

Module #5: HighlightsParticipant Presentations

• Student reports on a regulation / standard with which their company complies • Examples:

• HIPAA• OSHA• ISO 14000• RoHS, Restriction of Hazardous Substances

Directive • SOX• Technology specific regulations / standards

Submitted Questions

1. Are students eligible for continuing educational credits (CEU’s)?

2. Where is the program going from here?

3. What happens if I miss a class?

4. What is the most important advice for designers?

5. Will you cover medical device design?

6. How can I use this course material to exceed customer’s expectations for reliability?

7. Why is documenting the product structure important?

8. What is the value gained from electronic data management systems?

Submitted Questions

9. How does the Supply Chain Management Module demonstrate integration from Design thru Customer?

10. Will I learn the tradeoffs of onshore vs. offshore manufacturing?

11. How will taking the business compliance module benefit my company?

Submitted Questions

Audience Questions

Course Modules / Instructors

Walt [email protected] ext 101

Mark [email protected](408) 378-9980 x109

Mike [email protected](408) 472-3889

John [email protected]

Engineering Development

Engineering Development

PRC-01

InstructorsModuleNumber

PRC-01

ProductReliability

PRC-02

ProductReliability

PRC-02

Course Modules / Instructors

Michael [email protected](408) 427-4645

Bob [email protected](408) 782-5673

Michael [email protected](831) 768-9501

Tim Stein, [email protected](408) 366-0848

Data ManagementAnd Collaboration

Data ManagementAnd Collaboration

PRC-03

InstructorsModuleNumber

PRC-03

Supply ChainManagement

PRC-04

Business Compliance

PRC-05

©Product Realization Group, Inc., 2010

Product Realization Group

Product Realization Certificate

Program Overview

August 20, 2010