Presented by ASQ S Audit Division Partnering with the Quality Management, Biomedical And

Presented by ASQ’s Audit Division partnering with the Quality Management, Biomedical and Design and Construction Divisions

Conference at a Glance

MONDAY OCTOBER 8 – WEDNESDAY, OCTOBER 10 - 8:00 a.m.- 5:00 p.m. Pre-Conference Tutorials
WEDNESDAY OCTOBER 10 - 1:00 p.m.-5:00 p.m. Registration and Book Store Open
THURSDAY OCTOBER 11
7:00 am – 5:00 pm Registration and Book Store
7:00 am – 8:00 am - Continental Breakfast
8:00 am – 9:30 am – Opening Remarks and Keynote Sipho Tjabadi, Quality General Manager, Eskom
Technical Sessions
9:45-10:30 a.m.
A1:Guide to International Audits and Traveling –BJ Johnson- (Beginner to intermediate)
B1: Governance & Audit Management – Business Model and Best Practice – Ehab A. Abbas - (Advanced and intermediate)
C1: Audit Sampling - Larry Whittington–( All)
D1: Strategic planning and execution using lean - Jd Marhevko Part 1 of 2 (Audience:An organizational leader at any level that is responsible for the planning, execution and attainment of goals and objectives)
E1: Become an International Auditor for $995 or less* - Brian Palmquist- (All)
F1: ISO 14971 A globally accepted approach to assuring device safety - Michael Barille – (All)
10:45-11:30 a.m.
A2: Managing Cultural Differences on International Audits - Richard A. Kish – (Beginner & Intermediate)
B2: Risk Based Auditing - Lance Coleman – ( Beginner to Intermediate)
C2: Improving Customer Satisfaction by Leveraging Data Parameters and/or Descriptive Statistics- Jeff Bostow – (All)
D2: Strategic planning and execution using lean - Jd Marhevko Part 2 of 2 (Audience: An organizational leader at any level that is responsible for the planning, execution and attainment of goals and objectives)
E2: Increasing Quality Standards for US Department of Transportation, Alternate Delivery Projects - J. Jeffrey Seiders, Jr. – (All)
F2: Globalization of Technology Transfers: Compliance Challenges - Emilie Chartier – (All)
12:00 – 1:30 p.m. – Lunch, Announcements and Keynote Dr. Marta Wilson, CEO Transformation Systems, Inc.
1:45-2:30 p.m.
A3: Beware theTowerofBabel - Naomi B. Whitehead - (Beginner)
B3: Risk is the Compass TM - Auditing on Risk and Organizational Objectives - Denis J. Devos - (Intermediate)
C3: Best Practices – Risk-Based Auditing in Supplier Quality Management - Angelo Scangas – (All)
D3: Planning and implementing an Integrated Management System - Jim Heaviland – (Beginner to Intermediate)
E3: Auditing a Construction Management Project - Robert Orkin – (Intermediate)
F3: Strategies for Auditing in the Global Pharmaceutical Regulatory Environment - Joseph Knight McKenna –(All)
2:45-3:30 p.m.
A4:Achieving World-Class Performance In A Multi-National/Multi Cultural Environment - JR McGee- (All)
B4: Working with and Auditing Partners Domestically and Globally? Use Technology to Improve Your Process – Christopher Quesnel – (All)
C4: Auditor Charm School: Practicing Skills from the CQA BOK - Cindy Bonafede and Jocelyn Phillips- (All)
D4: Applying the Tools of Quality to Define and Quantify the Business Case for Social Responsibility - Milton Krivokuca – (All)
E4: When Standards Collide - Auditing for Project Success - Benjamin Trujillo – (Intermediate)
F4: Agile Development and Risk Based Control of Complex Medical Device Systems - Dr. Byron Mattingly - (Intermediate)
3:45-4:30 p.m.
A5: Remote Auditing – How to do it Effectively - Lorri Williams - (Intermediate or advanced auditors)
B5: Supply Chain Management: Resourcing organization needs - J.P. Russell – (All)
C5: Auditing Beyond Compliance - Janet Bautista-Smith – (All)
D5: Creating Advantages Using the Perspective of the Customer - Sandy Miller – (Intermediate to Advanced)
E5: QA Issues in Bridge Construction: The Self-Anchored Suspension Span of the San Francisco – Oakland Bay Bridge - Chuck Kanapicki – (All)
F5: How We (unintentionally) Lose Their Objectivity in Decision Making - Darrel F. Untereker (All)

5:30-7:00 – p.m. Audit Division Annual Business Meeting – All conference attendees are invited to participate

7:00-10:00 – p.m. All Conference Attendees Thursday Evening Reception

FRIDAY OCTOBER 12
7:00 a.m. – 4:00 p.m. Registration and Book Store
7:00 a.m. – 8:00 a.m. - Continental Breakfast
8:00 a.m. – 9:30 a.m. – Opening Remarks and Keynote Peter E. Shearstone, Division Vice President, Quality Assurance/Regulatory Affairs/Medical Affairs, Abbott Diagnostics
9:45-10:30 a.m.
A6: Audit Consistency Around the World - Andy Hofmann -(All)
B6: How Should Organizations Evaluate Risk? - Ron Meier, Ph.D. – (All)
C6: Performance Metrics for Internal Quality Audit and Corrective Action - Duke Okes – (Intermediate-to-Advanced)
D6: The Benefits of Implementing a Lean ISO System - Enrique M. Bekerman – (All)
E6:Revision of FTA’s Quality Management System Guidelines - Rick Simon – (All)
F6: Why a standard for usability? IEC 60601-1-6/62366: Usability & Human Factors Part 1 of 2 - Schmidt – (Intermediate)
10:45-11:30 a.m.
A7: Auditing in a Virtual World (Team, Tools, & Techniques) - Sheronda Jeffries – (All)
B7: Risk Management: Compliance vs. Cost - Anita Fauchier – (All)
C7: Efficient Quality: A SharePoint Success Story - Doug Wilson – (Intermediate)
D7:Using the Right Measure Right - Sandy Miller - (All)
E7: Revision of FTA’s Quality Management System Guidelines - Rick Simon – (All)
F7: Why a standard for usability? IEC 60601-1-6/62366: Usability & Human Factors Part 2 of 2 - Schmidt – (Intermediate)
12:00 – 1:30 – p.m. Lunch, Announcements and Keynote Timothy H. McKay, P.E. Executive Vice President, Growth and Regional Development Dallas Area Rapid Transit
1:45-2:30 p.m.
A8: Auditing multinational organizations with ASRP (Advanced Surveillance and Recertification Procedures): An innovative approach in a global environment. - Alex Guzman - (Advanced)
B8: The Happiest place on Earth just got Happier! Are you ready to join the Happiness? – Bret Pfost – (All)
C8: Writing "Meaningful" Audit Findings - Richard Kish – (All)
D8:The Journey from a Site Based Supplier Quality System to a Global Supplier Quality System -Jeff Esselman– (Intermediate to Advanced)
E8: Public Construction Contracting from a Quality Perspective -(Part 1 of 2) Diane Gollhofer – (All)
F8: Globalizing Process Qualification & Validation for Medical Device - Naren S. Patel – (All)
2:45-3:30 p.m.
A9: Remote Audits – Using Technology for a Complete Audit Experience - Angela Hunnicutt – (All)
B9 TBA
C9: Auditing Under HIPAA Constraints A Mental Health Case Study- Bill Hackett – (Intermediate to advanced)
D9: Balancing Stability and Innovation - Ian Meggarrey – (Intermediate)
E9: Public Construction Contracting from a Quality Perspective (Part 2 of 2) - Diane Gollhofer – (All)
F9: Medical Device Alarm System Assessments - Richard Davis - (Intermediate)
3:45-4:30 p.m.
A10: Quality: A Tough “sell” in a Global Marketplace -Stephanie Peika & Daniel Cote– (All)
B10: Effectively use of Process Audit & Product Audit to improve suppliers’ performance in China’s automotive industry - Richard Feng – (All)
C10: The Expert Traveling Auditor: Addressing the Challenges of Conducting Audits around theGlobe - Mary Chris Easterly – (All)
D10: INTEGRITY in MANAGEMENT – What Would Your Parents Think? - Pat Fremont – (Beginner)
E10:Supplier Quality in a New Economy – Brad Ivey – (All)
F10: World Café – Supplier Performance Issues and Performance Ratings - Mark Lindsey– (All)

4:45-6:00 p.m. – Closing Reception - All Conference Attendees

SATURDAY OCTOBER 13

8:00 a.m. – On-Site Certification Exams

11:00 am – Golf Outing

Pre-Conference Tutorials

Monday – Wednesday October 8 – 10, 2012
Advanced Lead Auditor Class (TUT01)
Presented by: Stat-a-Matrix
8:00 a.m. – 5:00 p.m. (Monday, Tuesday, and Wednesday)
The Oriel STAT A MATRIX Advanced Lead Auditor Training course has been designed to give you the skills and knowledge needed to exponentially raise your ability to determine if your organization’s business management system is properly contributing to the company’s bottom line.
Presented primarily through hands-on workshops and exercises, the methods taught in this course will bring your audit program to the next level, no matter what standard you are currently auditing to.
Special Price: $1695.00
CEUs: 2.5
Certified Manager of Quality and Organizational Excellence Exam Refresher (Course ID #6161)
Presented by: Russell T. Westcott
8:00 a.m. – 5:00 p.m. (Monday, Tuesday, and Wednesday)
This course is designed to help participants become familiar with the breadth of the body of knowledge and identify areas for more in-depth study. During the course, participants will have the opportunity to practice and discuss both multiple-choice and constructed response questions. The Certified Manager of Quality/Organizational Excellence Handbook 3rd Edition (edited by the instructor) will be provided to all course attendees prior to the course start date. Participants are expected to complete pre-work reading and a sample exam before class. Homework will be assigned the first two nights of the class. It is highly recommended that participants register by August 31, 2012 to allow time for book shipment and pre-work. Don’t forget to register early and bring your book to class.
Special Price: $795.00
CEUs: 1.9
Certified Biomedical Auditor Exam Preparation (Course ID #6163)
Presented by: Mark Moyer
8:00 a.m. – 5:00 p.m. (Monday, Tuesday and Wednesday)
Thinking about or planning to take the Certified Bio-medical Auditor (CBA) exam? Need a review and preparation course? Don't miss the Certified Biomedical Auditor exam prep course. Each day will focus on a separate section of the exam Body of Knowledge.
Day 1 - Auditing Fundamentals, Auditing and Inspection Processes
Day 2 - Biomedical Quality Management System Requirements
Day 3 - Technical Biomedical Knowledge, Quality Tools and Techniques
Special Price: $795.00
CEUs: 2.4
Tuesday-Wednesday October 9-10, 2012
Certified Quality Auditor Exam Refresher (Course # 6121)
Presented by: Nancy Boudreau and Sandra Storli
8:00 a.m. – 5:00 p.m. (Tuesday and Wednesday)
The ASQ Audit Division will conduct an exam refresher to help experienced auditors become better prepared for the CQA exam. The basis for the exam is the CQA Body of Knowledge and class discussion will include an overview of the CQA BoK offering participants a better understanding of the basic principles and applications that will appear on the exam. All course participants will receive the course text The ASQ Auditing Handbook, Third Edition, which can also be taken into the exam and used as a reference.
Special Price: $695.00
CEU: 1.6
Writing Exceptional Audit Reports (TUT02)
Presented by: Mary Chris Easterly
8:00 a.m. – 5:00 p.m. (Tuesday and Wednesday)
This workshop will cover the crucial elements of an exceptional audit report: a summary of the processes and systems reviewed; positive feedback; and observations of gaps in compliance with requirements. We will address how to write unambiguous observations to facilitate identification of the root cause and appropriate corrective actions by the auditee. To involve participants and help them learn to write exceptional audit reports, groups of attendees will review examples of poorly written observations, then apply concepts learned to improve the observations and present them to all attendees.
Price: $695.00
RUs: 1.6
Failure Modes and Effects Analysis (FMEA) (COURSE #6162)
Presented by: David M. Little
8:00 a.m. – 5:00 p.m. (Tuesday and Wednesday)
This course is designed to provide the student with working knowledge of the FMEA process as it is applied to product, process, or system. References will be made to ISO 9001, AS9100, and TS 16949 standards. Failure Modes and Effects Analysis is a critical step in the development of new product or in the modifications of existing products. This systematic approach parallels, formalizes and documents the metal disciplines that an engineer normally goes through in any design process to identify risk. Discussions on FMEA history, methods, types, responsibilities, documentation, implementation and software will be reviewed and presented.
Price: $695.00
RUs: 1.6
Strategic Quality Planning (TUT03)
Presented by Michael Stanleigh
8:00 a.m. – 5:00 p.m. (Tuesday and Wednesday)
This highly interactive session uses a lecture, discussion and team format. It is case driven using a variety of examples from many different organizations as well as using their own initiatives. The entire session is managed as a large planning process. This approach to session delivery has proven to be highly effective in imparting the session knowledge to the participants. Not only do they learn the process of developing Strategic Quality Plans, they actually experience applying it to “real” quality issues and the development of strategies to better plan these. The outcome is measurable, as session participants will be able to take these strategies back into their own work place environments and begin executing them immediately.
Price: $695.00
RUs: 1.6
Human Error Prevention (TUT04)
Presented by: Ben Marguglio
8:00 a.m. – 5:00 p.m. (Tuesday and- Wednesday)
In addition to discovery and invention, human error prevention can be the greatest contributor to improved productivity, safety and quality. This seminar provides the most current developments in human error prevention.
This seminar is designed for anyone whose objective is to improve productivity, safety and quality. The principles and practices of human error prevention are universally applicable regardless of the type of industrial, commercial or governmental enterprise, and regardless of the type of function performed within the enterprise.
Handouts include:
·Copy of the visual aids
·Compilation of recommended behaviors to prevent human error
·Case study and exercise materials
·Certificate of Completion, with Continuing Education Units
Price: $695.00
RUs: 1.6
Wednesday October 10, 2012
Q-Ture (Future) Leader Workshop (TUT05)
Presented by: J.P. Russell
8:00 a.m. – 5:00 p.m. (Wednesday)
This one day workshop is focused on professional development of future quality and improvement professionals. Students will participate in a series of lectures and workshops that will include guest speakers sharing their insight and tips on how to succeed. We are looking for conference attendees that want to contribute to the body of knowledge or advance the profession. Future organizational leaders must find ways to equip, enable, and empower themselves so they are able to fulfill their commitments and advance the profession.
Price: $595.00
CEU: 0.65
An Introduction to Lean Concepts (TUT06)
Presented by: Enrique M. Bekerman and Miriam Chart
8:00 a.m. – 5:00 p.m. (Wednesday)
This one day hands-on workshop is designed to teach the basic Lean Manufacturing concepts to a varied audience including executives, managers, and operators. The Workshop alternates classroom learning with a realistic factory simulation taking participants through several rounds starting from a traditional manufacturing environment and progressing to a Lean Enterprise environment while simulating waste elimination and improved work flow at customer’s demand. Facilitators keep track of financial and quality metrics from round to round to demonstrate the bottom line and customer satisfaction impact.
Price: $595.00
RUs: 0.8
Supplier Auditing: A one-day basic level seminar (TUT07)
Presented by: Dennis R. Arter
8:00 a.m. – 5:00 p.m. (Wednesday)
This seminar is designed for management, professional and technical personnel who want to improve customer-supplier relations. No previous knowledge of auditing or management systems is required (or assumed). The instruction applies to any quality system (ISO 9001, FDA, military, automotive, etc.), as well as environmental and safety systems. Buyers and purchasing agents will find the information quite beneficial. Those preparing for the CQA exam will enjoy the review. It is lecture-only - the compressed time does not allow for small group workshops.
Price: $595.00
RUs: 0.8
Governance Management – Theory, Business Model and Best Practice (TUT08)
Presented by: Ehab Abbas
8:00 a.m. – 5:00 p.m. (Wednesday)
A one-day tutorial that presents an innovative approach to managing the entire governance cycle starting with policy formulation and endorsement; publishing and collecting feedback; auditing, reporting and statistical intelligence.By the end of the tutorial, the audience will have learned new and powerful insights, and expanded their understating in the following areas.
·  An innovative approach that integrates the concepts of value-creation, governance, auditing, company valuation and strategic management in one holistic business model.
·  A Best-practice in distinguishing and yet integrating and aligning, corporate and operational risk maps and policies.
·  The role of policies in influencing organizational behaviors and shaping the organizational corporate culture – pitfalls and recommendations.
·  How to put in place a best-in-class governance management system – process, organization and technology
Price: $595.00
RUs: 0.8
Auditing for Risk Considering Risks and Controls (TUT09)
Presented by: Denis J. Devos
8:00 a.m. – 5:00 p.m. (Wednesday)
Many reference books and texts have been written about how to conduct a successful audit. These books and training sessions always talk about considering risks during a quality audit, but stop short of offering a template to assist in audit planning and preparation. Our session will introduce auditors to a new auditing tool which includes Process Risks and their corresponding enablers, or process controls. Many auditors find themselves unable to perform a QMS audit beyond written procedures and checklists. Hands-on workshops will teach simple techniques to help auditors use risk as a compass for charting their course through a challenging audit.
Price: $595.00
RUs: 0.8

Keynote Speakers