2012 audit conference brochure

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					                              21 Annual Audit
                                         St


                      Division Conference

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




             The Impact of Globalization on Quality
           QualityQualityyour company’s tagline
                           here!
October 11-12, 2012

Augusta Marriott at
 the Convention
     Center
  Augusta, GA




   www.asq.org/conferences/
      audit/index.html



                                 ASQ 21th Annual Audit Division Conference
                                                                    Preliminary Program
                    October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                                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 the Tower of Babel - 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)

                                        ASQ 21th Annual Audit Division Conference
                           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
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)




                                          ASQ 21th Annual Audit Division Conference
                             October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
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 the Globe - 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




                                      ASQ 21th Annual Audit Division Conference
                         October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                               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


                                         ASQ 21th Annual Audit Division Conference
                            October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
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.


                                        ASQ 21th Annual Audit Division Conference
                           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
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




                                        ASQ 21th Annual Audit Division Conference
                           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
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




                                        ASQ 21th Annual Audit Division Conference
                           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                                     Keynote Speakers
                       Sipho Tjabadi – Thursday Morning (October 11, 2012)

                       Implementing Quality in your organization? Either partner with Leadership or don’t even think of
                       starting

                       Mr. Tjabadi, Quality General Manager for Eskom, South Africa’s State Owned Electricity Enterprise, has
                       20 years of professional experience including market research, sales and management, and leads the Quality
                       Management Group, responsible for the Quality Management strategy, QMS development, Business
                       Improvement, Quality Assurance, Quality Control, Quality Improvement, Quality Planning, Quality Policy
                       development, Quality measurement, Internal Quality Audit program, and Quality IT system.

Implementing Quality in your organization? Either partner with Leadership or don’t even think of starting.

Ever wondered why many an organization is proud to hang a Quality certificate on its wall whilst nothing much that they do and
the experience of their customers doesn’t attest to the organization Quality status?

Whilst the reasons could be many and varied, one conclusion that can be drawn is that the organization was probably interested
primarily in securing the “paper” itself. This would mean that its heart, mind and spirit were never behind the exercise of
introducing Quality as a way of life or work into the organization.

Unfortunately the blame can only be placed at one door – the door of Leadership. Unfortunately too, I would suggest that the
Quality practitioner cannot be blameless. To all you committed, loyal, forward thinking, and competent Quality professionals – the
message is as follows:

“If you plan to or have been assigned to introduce or run a Quality program into your organization and you don’t have Leadership
as your partner, then don’t even bother.”

“Well how do I get Leadership behind me, or know that they are behind me?” You ask.

I am looking forward to exploring this topic with you.



                      Dr. Marta Wilson – Thursday Afternoon (October 11, 2012)

                      CEO of Transformation Systems, Inc




                        Today, globalization drives many of us to lead, work and collaborate in ways that are leaner, faster, better
                        and smarter. How do we do that? Dr. Marta Wilson, CEO of Transformation Systems, Inc. and author of
                        the books Leaders in Motion and Everybody’s Business will share insights on the moves you can make to
                        propel forward in the face of demanding realities. Discover what it means to take personal responsibility for
bold business goals, demonstrate unwavering resolve to produce the best organizational outcomes and create superb customer
results as a catalyst for transformation. In this session, Dr. Wilson will share how you can take risks to be more powerful and
advance to your next level of leadership effectiveness as you engage your total enterprise to boost quality, productivity and
profitability.

                                        ASQ 21th Annual Audit Division Conference
                           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                             Peter Shearstone – Friday Morning (October 12, 2012)

                             Re-engineering a Quality System for Profitability, Compliance and Global Success

                            Peter Shearstone, Division Vice President, Quality Assurance/Regulatory Affairs/Medical Affairs, Abbott
                            Diagnostics

                             Quality Management systems are critical for the success of any business. Establishing a sound structure,
                            resources and process ensures that the business is set for the long haul. This presentation will share the
                            key steps to take to reengineer a quality management system and to share what the result of this work
                            might be via metric improvements.

     Key takeaways for the audience will be:

1.    Novel approaches to reengineering the quality system
2.    The importance quality and business culture play in sustainability
3.    Simplification and harmonization of global quality systems
4.    Focusing on reducing errors through procedure structure
5.    Movement of the learning environment from “read and forget” to true competency
6.    Quality metric improvement and business profitability

     At the conclusion of the talk the audience shall have a comprehensive understanding of how quality system effectiveness is
     inextricably linked to business success.



                               Timothy H. McKay, P.E. – Friday Afternoon (October 12, 2012)

                               "How To Build Quality In Transportation"

                               Timothy McKay, Executive Vice President, Growth and Regional Development Dallas Area Rapid
                               Transit




     Timothy McKay graduated with a BSCE from Michigan Technological University began serving DART as a consultant in 1987.
     Mr. McKay directs the Growth and Regional Development Group which includes Commuter Rail, Capital Planning, Service
     Planning, Transit Oriented Development, Innovative Services, Construction Safety Program, Capital Quality Program, Rail
     Program Development, Environmental, System Integration and Safety Certification, and LRT Vehicle Design and Assembly.

     Notable and award winning projects include the 28 mile/20 station light rail Green Line expansion (the longest Light Rail
     Expansion in North America), the Platinum LEED rated DART Police Headquarters at Illinois Station (conversion of Monroe
     Shops, Register of Historic Places), and the 3 1/2 mile long TRE Beltline Grade Separation project which utilized composite
     railroad crossties.




                                             ASQ 21th Annual Audit Division Conference
                                October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                                  Technical Program
                                       THURSDAY OCTOBER 11, 2012 9:45-10:30


A1: Guide to International Audits and Traveling – BJ Johnson- (Beginner to intermediate)

This session will discuss planning and conducting international audits from the perspective of a female and contains good
information for anyone who will be traveling internationally. Topics include preparing for the audit and the country, how to
conduct the audit keeping in mind the country specific habits, how to handle areas that usually don’t work with women what
to take with you, both personally and for business along with some traveller safety all based on actual international travel
experience.

B1: Governance & Audit Management – Business Model and Best Practice – Ehab A. Abbas - (Advanced and
intermediate)

Based on a case study from the oilfield services industry, this presentation will provide the audience a best practice in
addressing some of the most pressing questions in governance and audit management that face multinational corporations
operating in diversified regulatory, cultural and operational environments; including.

1. Policies and procedures that work in one place or a given business context don’t necessarily fit everywhere else.
2. How to develop comprehensive activity-specific risk maps including cause and root cause analysis, and be able to relate
   individual policy clauses to specific risks so that the auditors are able to form an opinion on the comprehensiveness of the
   risk maps, the relevance and adequacy of the policies write up in addressing the specified risks and the degree of
   organizational compliance;
3. The role of technology in addressing the complexity of scale involved in managing global virtual audit teams, enabling pre
   and post audit activities (preparation and reporting) and in seamlessly integrating the audit function in the entire
   governance cycle.

C1: Audit Sampling - Larry Whittington – ( All)

Auditors know it may not be practical to examine all available evidence due to its volume and dispersal. In those cases, a
sample is selected to evaluate against the audit criteria and form the audit conclusion.

The risk is that the sample may not be representative of the total set of people, documents, practices, and records being
assessed. As a result, the audit conclusion may be different than if the auditor had examined the whole population. So, we
may over-audit by taking samples that are too large and waste time and resources. Or, we may under-audit by taking samples
that are too small and end up not detecting nonconformities.

This session will discuss selecting samples, sizes, and timeframes; conducting convenience, haphazard, judgmental,
systematic, and statistical sampling; and reporting sampling methods with disclaimers.
It is important to apply the appropriate use of sampling since it is closely related to the confidence that can be placed on the
audit conclusion.

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)

Part 1 of this 2 part session is a hands-on, high-level, walk through session of how to utilize Lean Six Sigma (LSS) tools at
the organizational level. The discussion takes the participants through a DMAIC process where they Define their key
objectives via the simplified use of a strategic planning/goal setting matrix. They then identify what their key Measures will
be and will draft samples pertinent to their business settings. During this session, participants will review LSS Analysis
tools that have been successfully applied across a variety of industry and service sectors. The course then discusses the act of
Improvement to enable the achievement of their defined objectives. Lastly, the concept of Control will be reviewed to
show participants some methods of how to review and ensure that executed improvements achieve and/or hold the gains that
were made.
                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
E1: Become an International Auditor for $995 or less* - Brian Palmquist- (All)
. *travel costs, cell phone/3G bills, software subscriptions not included!

At the last Audit Conference the presenter evaluated the four main tablet operating systems and the associated tablet
computers that might suit auditors. This presentation will briefly refresh and update those findings (technology changes
quickly), then move forward and examine how specific auditing concepts are (or are not) managed by available, inexpensive
hardware and software. The balance between expense and customization will be examined in light of to-day’s constrained
budgets. There will be specific focus on the emerging ability to audit offline in locations lacking connectivity, such as the
shop floor, the building construction site, or the mountain road or pipeline under construction, synchronizing with integrated
web-based enterprise systems when connections become available.

F1: ISO 14971 A globally accepted approach to assuring device safety - Michael Barille – (All)



                                       THURSDAY OCTOBER 11, 2012 10:45-11:30

A2: Managing Cultural Differences on International Audits - Richard A. Kish – (Beginner & Intermediate)

The session will present a "hands on" approach on how to manage cultural differences while conducting international audits
and includes advice from the firsthand experience of the speaker, who has conducted over 30 international audits in 10
different countries. (Belgium, England, Canada, Mexico, Spain, Korea, Japan, Sweden, Italy and Czech Republic) By
learning and understanding other cultures, auditors will be more accepted by the host country resulting in more successful
international audits.

B2: Risk Based Auditing - Lance Coleman – ( Beginner to Intermediate)

Risk Elimination. Risk Management. Risk Mitigation. This is the language of upper management that we as auditors from
any industry must learn, if we truly want to effect positive change throughout our environment.
During this presentation, the various phases of the audit process will be viewed through the lens of ISO 14971. Attendees
will learn how to define, recognize, and manage risk through their audit program. Case studies will be reviewed, as we
discuss how to incorporate risk management thought, language and techniques into our internal audit process. In short, this
presentation will show attendees how to transform an audit program from one that is compliance based and backward facing,
to one that is risk managing, continuous improvement driving and forward seeking.


C2: Improving Customer Satisfaction by Leveraging Data Parameters and/or Descriptive Statistics- Jeff Bostow –
(All)

This presentation provides a requisite tool kit for creating and displaying customer satisfaction data using data set parameters
and descriptive statistics. Data parameters and descriptive statistics specific to attribute (discrete) data will be defined along
with a step-by-step demonstration illustrating how to conduct accurate data analysis using nothing more than a scientific
calculator and a conference-provided note pad. The intent of this session is to model how this methodology scientifically
replicates the correct use of a basic statistical tool referred to as a “Frequency Distribution Chart” embraced by quality
professionals worldwide.

Beyond the use of this statistical tool, conferees will also examine how the displayed data can be used to leverage/enhance
customer satisfaction going forward by providing a basis for ongoing Plan-Do-Check-Act (PDCA) improvement cycles.




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
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)

Part 2 of this 2 part session is a continuation of the hands-on, high-level, walk through session of how to utilize Lean Six
Sigma (LSS) tools at the organizational level. The discussion takes the participants through a DMAIC process where they
Define their key objectives via the simplified use of a strategic planning/goal setting matrix. They then identify what their
key Measures will be and will draft samples pertinent to their business settings. During this session, participants will review
LSS Analysis tools that have been successfully applied across a variety of industry and service sectors. The course then
discusses the act of Improvement to enable the achievement of their defined objectives. Lastly, the concept of Control will
be reviewed to show participants some methods of how to review and ensure that executed improvements achieve and/or
hold the gains that were made.

E2: Increasing Quality Standards for US Department of Transportation, Alternate Delivery Projects - J. Jeffrey
Seiders, Jr. – (All)

The US Transportation Industry is going through an ambitious evolution of how projects are procured and delivered in the
United States today. With demands of our aging Infrastructure continuing to mount, the need to deliver projects more timely
with reduced public funding has led many states to utilize Alternate Delivery Methods. In my presentation, I will show when
responsibilities are shifted from the Public Owner (State, Toll Authority, etc.) to the Contractor (Design, Build) and
sometimes to the Concessionaire (Finance, Design, Build, Maintain, Operate), how this changes the quality roles project
participants’ play and the increased sophistication of quality systems and standards that these projects require.

F2: Globalization of Technology Transfers: Compliance Challenges - Emilie Chartier – (All)

Globalization affects many industries, including the pharmaceutical business. Thus, we are now faced with growing
challenges where cost reduction, constant quality and compliance are sometimes difficult to combine. This presentation will
focus on how tech-transfer projects can help achieve these new business goals, and how project management techniques are
closely related to the audit process. Using real life examples, the following aspects will be explored: How can we maintain
standard product quality throughout different companies and countries? What are the challenges when dealing with emerging
countries or companies with different quality policies? How do you evaluate the audit requirements versus cost and benefit?
Managing difficult relationship: what is the limit to the possible complexity?


                                        THURSDAY OCTOBER 11, 2012 1:45-2:30

A3: Beware the Tower of Babel - Naomi B. Whitehead - (Beginner)

Auditing in familiar places can be an “experience” so how much more complicated auditing in an unfamiliar location be?
Where to begin….

This presentation will focus on communication (methods), preparation and research of the location (specific facility) and
environment considerations (weather, travel restrictions). Discussion will include regulatory, environmental and local
requirements, methods to enhance pro-active communication and possible language barriers and awareness to cultural
customs so as not to offend inadvertently.

Tools and techniques to be included in the presentation are:
Preparation – check lists, passport, primary contacts, resource considerations, etc.
Reports – previous history
Schedule – time differences, various shifts, etc.
Conduct - attire / mannerisms / food




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
B3: Risk is the Compass TM - Auditing on Risk and Organizational Objectives - Denis J. Devos - (Intermediate)

Many auditors have been trained to follow a checklist and audit according to procedures. If procedures are weak, then audits
will be weak. This session will teach participants a preparation approach that ensures audit questions and findings are linked
to the characteristic risks of business processes and the objectives of the organization.

C3: Best Practices – Risk-Based Auditing in Supplier Quality Management - Angelo Scangas – (All)

Effectively managing supplier quality is a critical part of the business performance strategy for most organizations that rely
on hundreds of suppliers that spread across the world. Global organizations are making significant investments in systems
and processes to improve supplier quality, reduce lead time and increase transparency in their supply chain. Leading
organizations have adopted multiple approaches to improve supplier collaboration and visibility. It includes real-time quality
tracking, collaborative approach to automation of inspection and approval workflows, proactively implementing supplier
corrective actions, supplier audits, implementing supplier scorecards for performance monitoring etc. These approaches have
helped organizations significantly increase visibility into supplier quality and improve supplier responsibility.

D3: Planning and implementing an Integrated Management System - Jim Heaviland – (Beginner to Intermediate)

Implementing Techniques – Listen and learn as managers and leaders share their experiences of successfully implementing a
management or leadership technique that enabled their organization to stay competitive in a global economy.

An Integrated Management System (IMS) is not only an improved, more efficient management system; it becomes a
technique that enables an organization to stay competitive in a global economy. The IMS can be a combination of multiple
ISO, Association and Government Regulations that can include the global requirements for the industrial environment,
health, safety, security, and quality as well as the requirements governing the food, drug and cosmetic industry.

When combined the IMS begins to improve the management system through process simplification. There is a reduction, if
not elimination, of redundant requirements; there are improved efficiencies of employee time in areas such as training,
completion of daily processes, and there should be a reduction of loss time due to injuries, accidents, near misses and non-
compliance mitigation.

The implementation of the IMS takes time, commitment and an audit system that ensures appropriate system deployment and
adherence. This is, or needs to be, the commitment roll of senior management.
This presentation discusses the planning process for combining requirements of the various ISO Management Systems and of
Association and Government regulations. In addition, we’ll discuss the importance of an internal audit program to ensure
IMS compliance.

E3: Auditing a Construction Management Project - Robert Orkin – (Intermediate)

When planning and auditing a construction management project the auditor will have a different set of considerations than
when auditing a design project, a manufacturing project or an office.

This presentation will discuss some differences I have observed in the audit setup, checklist and process. Some similarities
will also be discussed.

I will discuss that the Lead auditor must understand the environment of a construction field office, and the background of the
typical construction management team. The influence of client preferences and contract specifications on how the team is
structured and how the job is handled play a significant role in what will be observed and what is acceptable. The checklist
cannot be adequately customized in advance so the Lead Auditor must be flexible and apply knowledge of the underlying
basis for the questions when interpreting the responses.

This presentation will include discussion and example items to support the topic. Audience discussion will be encouraged.




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
F3: Strategies for Auditing in the Global Pharmaceutical Regulatory Environment - Joseph Knight McKenna –(All)

Even though there has been significant advancement in harmonization of global pharmaceuticals regulations, unique local
requirements still exist for most countries. The risks of non-compliance with regulations increases with the more countries
products are marketed and the more locations clinical trials are performed. To reduce these risks, companies must be diligent
in their regulatory knowledge to ensure their processes are comprehensive for all regulatory agencies in which they do
business. Auditors in this environment must also have an extensive understanding of all regulations and guidances to be able
to provide meaningful audit reports to their employer or clients.

The presentation will look at both Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) and the
challenges that face an auditor in a multinational pharmaceutical organization. Strategies will be discussed that
pharmaceutical businesses and auditors can use to be successful in the global regulatory environment.

                                        THURSDAY OCTOBER 11, 2012 2:45-3:30

A4: Achieving World-Class Performance In A Multi-National/Multi Cultural Environment - JR McGee – (All)
Multi-national/multi-cultural teams offer significant challenges to management and leadership in today’s global work
environment. But few things are as satisfying to build or as powerful to work with as a world-class, high performance work
team that can change the world! This session will discuss how to accomplish the four key objectives that define a High
Performance Work Team and fully understand the subtleties and nuances of a multi-national/multi-cultural team
environment.

B4: Working With and Auditing Partners Domestically and Globally? Use Technology To Improve Your Process –
Christopher Quesnel – (All)

The Walt Disney Company has multiple theme parks spread out across the globe. Standards, audits and technology are a
crucial part of our global consistency. With most companies spread out domestically and globally it’s important to be able to
work effectively and efficiently with partners and team members across the globe.

I will cover how to build global consistency through effective standards and collaboration with a global team. Audits are an
imperative part of keeping global teams consistent. Technology is also an imperative part of working efficiently and
communicating domestically and globally. How can you put technology to work for you to improve your communication?


C4: Auditor Charm School: Practicing Skills from the CQA BOK - Cindy Bonafede and Jocelyn Phillips- (All)

This paper offers a skill-building game for auditor role-play in difficult audit situations that demand professional skills to
ensure successful conduct of the audit.

As defined in the body of knowledge (BOK) for Certified Quality Auditor (CQA), an audit is an independent, structured, and
documented evaluation of the adequacy and implementation of an activity to specified requirements. An auditor is a person
who is qualified and authorized to perform all or part of an audit.

What does it take to become a qualified auditor? What skills do you need? The BOK audit skills include theory/book
knowledge (certifications), and how to gather information, hold meetings, produce reports, and track findings to closure.
While skills to perform these tasks are certainly necessary, there are other skills that are key to the success of any audit:
people skills—how the auditor interacts with people with varying degrees of seniority and knowledge; communication
skills—how the auditor sends and receives information; listening skills—concentration and awareness; and management
skills—managing the session to achieve the desired outcome within the defined scope. We use the CQA BOK general
knowledge and skills as we step through the skill-building scenarios of the interactive “Auditor Charm School” game.




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
D4: Applying the Tools of Quality to Define and Quantify the Business Case for Social Responsibility - Milton
Krivokuca – (All)

Social responsibility is a significant element of the routine business process. From the small one person entrepreneurship to
the multi-national corporation, social responsibility is a necessary part of any successful business. Since the development of
ISO 26000, this topic continues to be addressed by white papers and various publications. Confusion exists for the business
case of social responsibility due the lack of a clear business case with quantifiable activities that reflect the organization’s
commitment to supporting social responsibility and a working definition of social responsibility which is specific to the
organization and its stakeholders. In this 45 minute presentation, the application of proven quality tools and methodologies
will be applied in a case study format to a fictional midsized organization in a midsized community to quantify and define
this organization’s commitment to social responsibility. The current information published related to social responsibility
successes contain numerous examples from large and multi-national corporations, but the success from a community
stakeholders perspective lies with the numerous small and mid0sized companies throughout the world.

E4: When Standards Collide - Auditing for Project Success - Benjamin Trujillo – (Intermediate)

 A nuclear design and construction project relies on many participants, each with a unique culture and manner of performing
business. Additionally, each project participant may have a quality management system (QMS) written to a quality standard
that does not match the standard required for the project. For example, a calibration service for measuring and test equipment
operates to an ISO 17025 compliant program, but the project dictates that suppliers have a program compliant to the
requirements of ASME NQA-1-2000. In such cases, the supplier’s QMS may not meet the requirements of the project
standard, and, the supplier may have a different understanding of what constitutes compliance to a quality standard.
Identifying and reconciling such gaps efficiently is required for project success.

This presentation will provide a case history of such an event, and highlight the role of the quality auditor in identifying gaps
and solutions to ensure that project work can be executed while satisfying the requirements of the project’s governing quality
standard. Elements of the ASQ Quality Auditor Body of Knowledge that will be addressed by this presentation include:
Purpose of audits, Audit criteria, and Audit preparation and planning.


F4: Agile Development and Risk Based Control of Complex Medical Device Systems - Dr. Byron Mattingly -
(Intermediate)

This session focuses on integrating risk management and control with agile and lean software development techniques to
drive robustness and reliability for the entire product lifecycle of complex medical device systems. Because such systems are
inherently non-linear, risk management must take into account how small events can have enormous consequences that can
happen quite suddenly, and often in unexpected ways. Special attention is given to applying the FDA’s draft guidance for
Mobile Medical Applications when validating and qualifying processes for the Apple iPad and Android based tablets.
                                         THURSDAY OCTOBER 11, 2012 3:45-4:30

A5: Remote Auditing – How to do it Effectively - Lorri Williams - (Intermediate or advanced auditors)

Content will cover the challenges of auditing global locations, remotely and via proxy, and obtaining objective evidence
when the auditee is in a different state, country, and time zone.
     Scheduling of audit times, making auditee’s aware of expectations
     Performing the audit
     The role of the audit guide in remote auditing
     The use of a proxy for hands-on activities
     Taking notes, capturing objective evidence and reporting out

    The above items present a variety of challenges to the novice and even the experienced auditor. The speaker will
    provide tips on how to perform an effective remote audit, and overcome many of the challenges today’s global operating
    environment presents us with.

                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
B5: Supply Chain Management: Resourcing organization needs - J.P. Russell – (All)

In a world where organizations are focusing on their core competencies, supply chain management is much more than
procurement requesting bids and issuing purchase orders. This session will discuss the key supply chain management
processes identified by the ASQ Customer-Supplier Division book primer committee. It will also cover enterprise process
components, specifying requirements, selection of resources, communications, contracts and monitoring performance.

C5: Auditing Beyond Compliance - Janet Bautista-Smith- (All)

This presentation will show strategies and models in breaking free from the typical ‘police enforcer ogre’ image typically
associated with auditing. Easy to implement basic Lean and Six Sigma methodologies will show the added value of
identifying measurable continuous improvement opportunities during compliance audits without additional capital expense,
additional resource or extensive costly training.

These lessons learned are from actual experiences consisting of more than 25 years of hands-on quality management-to-date
in environments including manufacturing medical devices, military, aerospace, automotive as well as logistics experiences.
Presenter’s experience includes initiation of systems from ground-zero to maintenance mode of standards such as: ISO, AS,
TL, TS, CTPAT standards and FDA/GMP.

D5: Creating Advantages Using the Perspective of the Customer - Sandy Miller – (Intermediate to Advanced)

This workshop will focus on five principles of successfully running any program or company:
         1) Perception
         2) Cost
         3) Quality
         4) Schedule
         5) Teamwork

In today’s changing business environment, it is no longer enough for a Program Manager to meet the old trifecta of cost,
schedule and quality. Those are still important, but with Customers’ ever increasing options, and their growing demand to
“be in the know”, a good PM cannot win new business – or maintain existing contracts without going beyond what has
always worked in the past.
Program Managers tell me, “Our Customers are constantly getting smarter”. I don’t think so! Customers have always been
this smart – it was just that it was acceptable for us to omit details, keep them in the dark, and claim “proprietary” or
“company sensitive” for the things we didn’t want to share. Well, guess what. They’ve found out that other companies are
willing to share details and go that extra mile for them and now they’re beginning to expect the same thing from you.
In most cases, Customers are judging you on not only the cost, quality and schedule, but also the way they get treated when
they interact with you. It’s all about the perception they have when they interact with you, what your competitors think about
you, their friends who know you, etc. You must manage that perception along with the cost, quality and schedule of the
program.
Also, without teamwork we believe you will never be able to achieve the other four principles. The team drives Customer
perceptions and enables your program to successfully cut costs - cutting out the waste that lies in every process. It is also the
team which will manage the schedule of those waste-free processes and ensure that quality at the source becomes the norm




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
    E5: QA Issues in Bridge Construction: The Self-Anchored Suspension Span of the San Francisco – Oakland Bay
    Bridge - Chuck Kanapicki – (All)

    American Bridge/Fluor Enterprises, A Joint Venture, are the general contractors building the new signature span of the San
    Francisco – Oakland Bay Bridge, a self-anchored suspension bridge. The first of its kind in the world, the bridge faces
    numerous technical and logistical challenges. This presentation provides an update on the project and the quality assurance
    issues involved as well as discuss social responsibility and sustainable aspects of the project.

    When completed, the Self-Anchored Suspension span (SAS) will transform the bridge’s appearance with its unique,
    asymmetric design. With a main span length of 1,263 feet, the SAS will be the longest single-tower, self-anchored suspension
    bridge in the world. Motorists will be able to enjoy a dramatic view of the Bay Area’s landscape while driving under an
    angled canopy of suspension cables.

    The 2.2-mile East Span of the bridge includes two main sections: a Self -Anchored Suspension structure with a single 525-
    foot-tall steel tower and a 1.2-mile-long elevated Skyway viaduct, which descends gradually towards the Oakland shoreline.
    The roadways, configured as upper and lower decks on the original East Span, will be built as two parallel roadways with
    five lanes each. The new span will feature a cantilevered bicycle/pedestrian path on the eastbound (south) side and lighting
    designed to underscore its beauty. All elements of the SAS, including the tower, piers, color and lighting will emphasize an
    elegant, futuristic appearance.

    F5: How We (unintentionally) Lose Their Objectivity in Decision Making - Darrel F. Untereker - (All)

    In the world of science and business it is important that we remain objective while making decisions. A loss of objectivity
    can lead to poor decisions, which, in turn, can lead to failure of an effort, project, or even an entire enterprise if the stakes are
    high enough. Most of us believe that we are objective in our professional careers. In fact, most of us probably can’t imagine
    ourselves behaving in any way other than being objective. For technical people, objectivity is our stock and trade – almost a
    starting assumption we make in any endeavor. But what if we aren’t as objective as we believe, and what if the things that
    cause us to lose our objectivity are subtle, built into the fabric of all of us, and influence us in ways we do not suspect?
    Situations in which there is uncertainty are often the most pivotal decision making situations where we need to be at our best.
    Yet, as we will see, these are also the situations where we are most prone to compromising our objectivity. The result is
    often that we only have the illusion of making a decision, and we actually follow a predetermined default course of action.
    This talk discusses the characteristics of human behavior that predispose us to become victims of a loss of objectivity without
    knowing it. But more importantly, this talk also describes things we can do to avoid losing our objectivity.
0

                                               FRIDAY OCTOBER 12, 2012 9:45-10:30


    A6: Audit Consistency Around the World - Andy Hofmann - (All)

    It used to be that auditing was a more local endeavor. Suppliers, customers and registrars were local organizations that at
    worst were a few hours’ drive away. All that has changed with globalization, the internet and the drive for the best value for
    money. As auditors, it has meant more travel, a lot more travel. This is particularly true when a corporation has a desire to
    apply the same measurement criteria. They quickly find that there is too much variation in the interpretation of standard
    requirements. They revert to sending the same people around the world.

    As a person who flies more than 150,000 miles per year performing audits, the speaker will describe strategies to ensure
    consistent results. The example includes a strategy deployed to arrange an audit team to cover an organization operating
    around the globe. Mr. Hofmann will share what went well and what his company is still working on to improve.




                                            ASQ 21th Annual Audit Division Conference
                               October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
B6: How Should Organizations Evaluate Risk? - Ron Meier, Ph.D. – (All)

This session will provide participants with a practical approach and the tools for dealing with the expected and unexpected
events that impact organizational performance. These tools already exist in:
               Project Management

                 Quality Management

                 Risk Management


C6: Performance Metrics for Internal Quality Audit and Corrective Action - Duke Okes – (Intermediate-to-
Advanced)

How can we show the value of the audit process to senior management? By putting it in terms of results! This presentation
will discuss common metrics used for the internal audit and corrective action processes, which unfortunately are often based
on what’s easy to measure. An alternative would be to use value-oriented metrics that look at what the processes are
accomplishing relative to business performance, weighted by the costs of carrying them out.

D6: The Benefits of Implementing a Lean ISO System - Enrique M. Bekerman – (All)

Many organizations have reported internal and external benefits from ISO 9001 implementation. Misconceptions still exist
regarding the requirements of ISO 9001 and related standards, making many small organizations shy away from an ISO
implementation initiative. This presentation shows how Lean concepts can be used to simplify the initiative, amplify the
benefits and effectiveness of ISO 9001:2008 implementation and provide maximum value to the organization.
Implementation of a Lean ISO system results in improved communications, particularly in diverse environments, enhanced
customer satisfaction and improved product quality while reducing costs and increasing profits. These benefits can be
obtained in any organization, large or small, whether in manufacturing, distribution, services, or government. The common
threads of Lean and ISO are discussed. The use of Lean tools in the development, maintenance and Continual Improvement
of the ISO QMS is discussed. Practical tips will be given on the deployment and integration of the two methodologies.

E6: Revision of FTA’s Quality Management System Guidelines - Rick Simon – (All)

Under contract to the Federal Transit Administration, Urban Engineers has revised the FTA’s Quality Management System
Guidelines. These Guidelines provide a resource for transit authorities and others undertaking capital projects. The FTA
requires grantees undertaking major capital programs to prepare a Project Management Plan (PMP) that includes a Quality
Plan. Even for those projects not considered major, a Quality Plan can be a useful tool for guiding activities to assure project
quality. These revised Guidelines provide a Grantee with assistance in establishing a Quality Management System for their
entire organization.


F6: Why a standard for usability? IEC 60601-1-6/62366: Usability & Human Factors Part 1 of 2 - Schmidt –
(Intermediate)

A background and overview of the IEC 60601‐1‐6 and 62366 Usability standards for medical devices. This two part session
addresses how the combined application of the IEC Usability Engineering Standards (IEC/EN 60601-1-6 in combination with
IEC/EN 62366) are required in order to demonstrate compliance with IEC/EN 60601-1 MEDICAL ELECTRICAL
EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (both the
2nd and 3rd Editions) as well as collateral standards in the 60601-1 series.

The participant will gain and understanding of how the usability engineering process is a critical element in controlling risks
associated with labeling, accompanying documents, training and alarms as well as the operator/device interface. They will
also learn how implementation of the Usability Engineering Process will assure the compliance of new devices and
understand how to retrospectively assess legacy devices.

                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                        FRIDAY OCTOBER 12, 2012 10:45-11:30

A7: Auditing in a Virtual World (Team, Tools, & Techniques) - Sheronda Jeffries – (All)

The workplace is evolving and global collaboration drives innovation, creativity and improved decision-making. Global
collaboration is critical due to the “new normal for technology”. Although the workplace is evolving into “anytime,
anywhere”, differences in time zones, holidays, communication styles and language must be accounted for. How does an
organization overcome the challenges of a globally diverse workforce and what is the impact of this globally diverse
workforce on audits?

As an implementer, quality auditor and trainer for a large, multi-national organization with global ISO 9001 Certification,
tips on building relationships and leveraging technology will be shared. The lessons learned and best-practice sharing will
include the tools and techniques used in planning, conducting and managing virtual audits and training auditors for a Fortune
500 telecommunications organization.

Learn more about the 3 T’s – Team, Tools and Techniques for “Auditing in the Virtual World”.

B7: Risk Management: Compliance vs. Cost - Anita Fauchier – (All)

In a heavily regulated industry such as the pharmaceutical industry, companies need to maintain compliance while sustaining
a profitable business model. Many small emerging companies as well as large organizations resort to outsourcing to drive
costs down. This poses complex challenges such as managing day to day activities and the ultimate risks associated with
products manufactured by third parties. Companies need to find a balance of cost and risk to ensure profits stay up and
compliance risk is low. Auditors are instrumental to help manage risks within the organization and can help companies avoid
unforeseen pitfalls.

The speaker will provide a case study of a small virtual company and the challenges with managing suppliers in order to
sustain the business and maintain compliance. The presentation will be helpful to auditors, managers and senior management
in identifying ways to communicate and manage risk within the organization. By knowing how to properly identify and
manage risks, companies can work to mitigate risks from a business and compliance perspective and ultimately, to the
customer.

C7: Efficient Quality: A SharePoint Success Story - Doug Wilson – (Intermediate)

Global teams, reduced quality budgets, and the significant amount of evidence required for audits has forced many
companies to embrace innovation in response to this challenge. The automation and modernization of quality and
management records is an emerging best practice, embraced by both Government and Commercial companies. This
presentation describes how an organization can leverage MS SharePoint in a number of ways that have proven to increase
efficiency, reduce costs, and improve the audit process. We will discuss the positive influence the auditing group can have in
pioneering techniques to virtualize measurements, automate audit corrective actions, and build a world class process
repository within the core functionality of SharePoint. The audience will be presented a case study that involved
participation from all levels of the organization as well as its customers. We will discuss the pros and cons, and offer
suggestions for how this technology may change in the near future. The presenter will describe how this approach has been
successful for both CMMI and ISO evaluations. The audience will learn how this technology can have a positive impact on
success without an army of consultants or expensive customization.




                                      ASQ 21th Annual Audit Division Conference
                         October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
D7: Using the Right Measure Right - Sandy Miller - (All)

This presentation will explore how organizations fail to understand how to use data to make effective decisions. Too many
organizations today are caught up in “helping” their metrics. We will look at how data can be over or under interpreted and
how real signals can be missed while we are busy acting on false signals.

Many organizations today fail to understand how to use data to make effective decisions. Too many times organizations get
caught up in “helping” their metrics. We will look at how data can be over or under interpreted and how real signals can be
missed while we are busy acting on false signals.
In fact, something I heard recently really summed it up nicely. Instead of using evidence based decision making, too many
companies are using decision based evidence making!
This workshop will focus on five principles of success company measures:
           1) Collecting the right data
           2) How to interpret the data right
           3) How to recognize a signal when you see it
           4) Data vs. context
           5) The psychology of decisions

“In God we trust; all others must bring data”. The old saw, attributed to Dr Deming and repeated on a daily basis across the
world, is taken as gospel in many companies. As Six Sigma practitioners we are supposed to be driven by data in everything
we do. Organizations and senior management teams seek to be ‘data driven’ or make ‘evidence based decisions’. This
presentation will show draw upon a host of real life examples to illustrate how even the most numerate of organizations fail
to understand how to use data to make effective decisions.
.

E7: : FTA Guidelines Revisions and how they Affect You - Rick Simon – (All)

Under contract to the Federal Transit Administration, Urban Engineers has revised the FTA’s Quality Management System
Guidelines. These Guidelines provide a resource for transit authorities and others undertaking capital projects. The FTA
requires grantees undertaking major capital programs to prepare a Project Management Plan (PMP) that includes a Quality
Plan. Even for those projects not considered major, a Quality Plan can be a useful tool for guiding activities to assure project
quality. These revised Guidelines provide a Grantee with assistance in establishing a Quality Management System for their
entire organization. Learn how these revisions affect you.


F7: Why a standard for usability? IEC 60601-1-6/62366: Usability & Human Factors Part 2 of 2 - Schmidt –
(Intermediate)

A background and overview of the IEC 60601‐1‐6 and 62366 Usability standards for medical devices. This two part session
addresses how the combined application of the IEC Usability Engineering Standards (IEC/EN 60601-1-6 in combination with
IEC/EN 62366) are required in order to demonstrate compliance with IEC/EN 60601-1 MEDICAL ELECTRICAL
EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (both the
2nd and 3rd Editions) as well as collateral standards in the 60601-1 series.

The participant will gain and understanding of how the usability engineering process is a critical element in controlling risks
associated with labeling, accompanying documents, training and alarms as well as the operator/device interface. They will
also learn how implementation of the Usability Engineering Process will assure the compliance of new devices and
understand how to retrospectively assess legacy devices.




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                         FRIDAY OCTOBER 12, 2012 1:45-2:30

A8: Auditing multinational organizations with ASRP (Advanced Surveillance and Recertification Procedures): An
innovative approach in a global environment. - Alex Guzman - (Advanced)

This presentation shares the experience of a multinational company that moved from multiple ISO9001 certificates to a single
global ISO9001 certificate and further matured to be granted implementation of ASRP (Advanced Surveillance and
Recertification Procedures). ASRP is a program that can reduce certification costs with less external audits and without
jeopardizing the effectiveness of the QMS. This requires a mature QMS, a robust internal audit program and highly
competent internal auditors.
During this session attendees will learn about innovative ideas for ISO9001 certification in a global environment. * One
common Business Management System (BMS) certified to ISO9001 through a single registrar. * One team of self-managed
full-time auditors closely engaged with the organization businesses. * Account Management concept applied to the internal
audit function addressing global business needs. * Utilizing ASRP as a cost-effective tool for process improvements.

B8: The Happiest place on Earth just got Happier! Are you ready to join the Happiness? - Bret Pfost – (All)

The presentation will discuss the risks involved in re-launching a Theme Park and changing business goals. Why it is
important to stay focused on your goal and what tools can you utilize when your environment is changing and the whole
World has their eyes on your Business including the Stock Market.

We are changing as a Global World and how we adapt our behavior to those changes will either break/make your Business
happier/successful. We will look at the impacts of your Businesses on a domestic/ International level.


C8: Writing "Meaningful" Audit Findings - Richard Kish – (All)

The paper will present a hands on approach on how to write "Meaningful" Audit Findings and then to follow them through a
documented closeout.

Writing audit findings that management can understand will make them more committed to take immediate corrective action.
Findings also need to be detailed as to what part of the standard they violate, these will help to identify trends in the audit
findings. These serve as input the management review process. We don’t want to see are internal auditors identifying a
bunch of training findings if our customers are identifying significant design control issues.

D8: The Journey from a Site Based Supplier Quality System to a Global Supplier Quality System - Jeff Esselman –
(Intermediate to Advanced)

In moving to a global supply base, a process for ensuring proper supplier controls was put in place (Article Quality
Assessment – AQA). This was the top priority item and will be shared. Next an RFP (Request for Proposal) process was
implemented to ensure requirements are understood when seeking a supplier quotation. The third process implemented
was Supplier Feedback, which includes a Supplier Requirements Guidebook, Supplier Corrective Action Reports
(SCAR) process, and an Engineering Change Request (ECR) format. The last global process implemented was for
Supplier Evaluation and Approval. This includes requirements for segmenting our supply base into tiers and outlines the
management needed for each of these 4 different levels. The tiering is based upon criticality and spend level. A Global
Approved Supplier List (GASL) with tiering listed is now controlled. This has been a journey with lessons learned about
change management and global implementation along the way.




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
E8: Public Construction Contracting from a Quality Perspective - Diane Gollhofer –(Part 1 of 2) – (All)
Part 1 of this 2 part presentation will focus on the keys to building quality construction projects. It will cover the need for
active contractor and designer relationship building and team communications. A review of standard specification
components and requirements as well as proven quality control practices will be discussed. In addition, pointers will be
provided for capturing accurate and complete documentation. Participants who attend will take away practical applications
that include field office procedures and checklists that can be used as the backbone for successful quality construction
management.




F8: Globalizing Process Qualification & Validation for Medical Device - Naren S. Patel – (All)

    Objectives of this presentation are to:

             Assist manufacturers in understanding Quality Management System (QMS) requirements for process
              validation especially when they have operations worldwide.
             Harmonize Procedures so that everybody (all facilities worldwide) is on the same page when it comes to
              compliance.
             Provide techniques to minimize issues due to different cultures and beliefs.
             Demonstrate the benefits of performing of proper Validation.
                                        FRIDAY OCTOBER 12, 2012 2:45-3:30

A9: Remote Audits – Using Technology for a Complete Audit Experience - Angela Hunnicutt – (All)

Virtual teams are now commonplace. Schedules and budgets are so tight that audit teams cannot travel for face to face audit
interviews. How does an organization overcome the challenges of a globally diverse workforce to deliver a complete audit
experience?

As a quality auditor for a large, multi-national Fortune 500 telecommunications organization with global ISO 9001
Certification, tips on leveraging technology in first and third party audits to deliver a complete audit experience will be
shared. Lessons learned and best-practices from virtual audits of customer-facing processes directly impacting customer
satisfaction will be included.

Learn more about effectively using technology to deliver a complete audit experience.

B9: TBA

C9: Auditing Under HIPAA Constraints A Mental Health Case Study- Bill Hackett – (Intermediate to advanced)

Conducting an internal quality audit in an environment that is under the constraints of Health Insurance Portability and
Accountability Act, HIPAA, regulations and privacy laws can be difficult to perform and obtain adequate objective evidence
of customer needs and fulfilments, determining competence, corrective and preventive actions, and other ISO 9001
requirements. A case study will be presented of internal auditing practices in a mental health facility which adheres to both
ISO 9001 requirements and HIPAA.

D9: Balancing Stability and Innovation - Ian Meggarrey – (Intermediate)

You know the saying, “Look before you leap.” On the other hand, you’ve also heard, “He who hesitates is lost.” In any
industry that requires leading (even bleeding)-edge technology, it is critical to strike a balance between these two.

Where is that balance point? How is balance found? What happens when balance is lost? This interactive presentation
requires audience participation and will explore innovation versus stability, along with solutions for risk management that
will help balance the two.
                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
E9: Public Construction Contracting from a Quality Perspective - Diane Gollhofer - (Part 2 of 2) – (All)

Part 2 of this 2 part presentation will focus on the keys to building quality construction projects. It will cover the need for
active contractor and designer relationship building and team communications. A review of standard specification
components and requirements as well as proven quality control practices will be discussed. In addition, pointers will be
provided for capturing accurate and complete documentation. Participants who attend will take away practical applications
that include field office procedures and checklists that can be used as the backbone for successful quality construction
management.

F9: Medical Device Alarm System Assessments - Richard Davis - (Intermediate)

This presentation provides the background and overview of the IEC 60601‐1‐8:2006‐10, General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems, collateral standard’s approach
and associated requirements for medical device alarm systems. It is intended for individuals involved in design conformity
assessments to IEC 60601‐1:2010 third edition for legacy products that were developed and marketed prior to the
Standard’s introduction and adoption. It covers the key alarm topics of the standard: priority; visual, audible, limits, presets,
distributed system and required content of product’s accompanying documents. It provides a systematic methodology of
reviewing and evaluating the product and its design, labeling and risk management records to determine the measure of
conformity.



                                          FRIDAY OCTOBER 12, 2012              3:45-4:30

A10: Quality: A Tough “sell” in a Global Marketplace -Stephanie Peika & Daniel Cote– (All)

Because globalization is becoming a fact of life across industries, learning to audit in unfamiliar locations, with challenging
differences in business practices and culture, is becoming a foremost concern within most quality organizations. Therefore,
auditors must learn to “sell” themselves, their company and their quality goals when working in the global marketplace, in a
way that crosses all cultural barriers. This presentation therefore aims to help auditors apply sales strategies and techniques to
the audit process, to effectively reach audit and quality goals across the world. Auditors will learn presentation skills,
communication skills, and selling skills to help navigate these new international waters.

B10: Effectively use of Process Audit & Product Audit to improve suppliers’ performance in China’s automotive
industry - Richard Feng – (All)

This presentation, based on the experiences of an actual Chinese tier 1 supplier, will cover guidance on use of VDA6.3
Process Audit, identifying process risks (risk analysis - ‘Turtle model’), the audit process, assessment, scoring, classification
and final evaluation, VDA6.5 Product: to determine the product quality level from the customer’s perspective, combined use
of product and process audits to improve the organization’s performance, German OEMs’ specific requirement to the
supplier chain based on VDA6.3, e.g. Formel-Q from Volkswagen & DPA from Daimler, and a Grade A Program from VW
based on its Strategy 2018, case study.


C10: The Expert Traveling Auditor: Addressing the Challenges of Conducting Audits around the Globe - Mary Chris
Easterly – (All)

Auditor proficiency is imperative to conducting a successful audit, but coordinating the numerous details associated with
auditing globally can also impact audit performance. How does an auditor communicate effectively with audit hosts and
audit team members around the globe? What organizational tools can an auditor use to smooth the path of audit preparation?
How can an auditor minimize travel challenges within or outside the United States? An auditor with resources can remove
potential barriers associated auditing worldwide and can focus on conducting an audit that provides value to the organization.

D10: INTEGRITY in MANAGEMENT – What Would Your Parents Think? - Pat Fremont – (Beginner)
                                        ASQ 21th Annual Audit Division Conference
                           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
In today’s fast paced business world, sometimes important ideals such as integrity and civility, are forgotten by individuals
and by company management. All you have to do is pick up a newspaper or read an article on the internet and you’ll see
where a person’s integrity has gone away. Integrity is almost a dying thing, a thing of the past. Bottom line at all costs,
drives too many managers. This is a disturbing trend that has become more apparent as time goes forward and the symptoms
have worsened as the economy started moving downward. Webster’s definition of integrity is simply: “adherence to a code
of especially moral and ethical values.” And the key to establishing and maintaining respect in your company is to ensure
that integrity is present in everyone who works in your organization – especially management. The connection between
integrity and business ethics is simple: both concepts involve honesty, character, truthfulness and a strict morale code. This
presentation will focus on the large amount of research that has been conducted about characteristics of successful leaders,
and integrity tops the list of these key characteristics.
Expected take-a-ways: 10 to-do points on improving integrity/civility, to get these declining behaviors moving in an upward
trend.



E10: Supplier Quality in a New Economy – Brad Ivey – (All)

This presentation will share information about a shrinking supplier base, strengthening supplier relationships and how the
economic strain takes a toll on quality. The presentation will also include a supplier scorecard and reverse scorecard
overview.

F10: World Café – Supplier Performance Issues and Performance Ratings - Mark Lindsey– (All)
This workshop will be conducted as a “World Café” setting where Attendees will be able to create generative dialog on
supplier issues. Part of this workshop will consist of the Attendees working in groups at each table to create an Affinity
Diagram to determine what their primary performance issues are with their suppliers. Each group will share their Affinity
Diagram with the other groups.

This workshop will also provide strategies and tactics on how to:
    • Establish Supplier Rating Systems based on key performance attributes (i.e. Quality, Responsiveness to Issues,
        Delivery, Technical Capability, Price Competitiveness, and other key service attributes). This includes developing
        Supplier Benchmarking Systems and how to use it for SWOT Analysis.
    • Evaluate and award orders to existing suppliers based on past performance (best predictor for future performance)
        and pricing.
    • How to share the Costs of Poor Quality (COPQ) with the responsible suppliers and when warranted with internal
        suppliers/departments (i.e. Engineering and Purchasing).
     How to collaborate with the key stakeholders (internal and external) to identify and pursue opportunities for
        improvement.




                                       ASQ 21th Annual Audit Division Conference
                          October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
          A Celebration of Quality Around the World




                                     Thursday Evening

                                        7:00-10:00 p.m.

       Please join us as we celebrate quality around the world.

Taste foods from around the globe, enjoy music, dancing, visiting with
                old friends and meeting new friends.




                        ASQ 21th Annual Audit Division Conference
           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
              On-Site Certification Exams

                    ASQ will offer 5 certification exams

                         Saturday, October 13, 2012

                  Application Deadline: August 31, 2012.

                      All exams will start at 8:00 am.

                               Register Online

        Certified Manager of Quality/Organizational Excellence

                          Certified Quality Auditor

                         Certified Quality Engineer

                 Certified Quality Improvement Associate

                       Certified Biomedical Auditor




             ASQ 21th Annual Audit Division Conference
October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                                            Golf Outing

                  Join us for a day of golf at the River Golf Club
   Set along the banks of the Savannah River, The River Golf Club has established itself as one of the best course designs in the
 Southeast since it's opening in 1998. Conveniently located across from downtown Augusta, GA in North Augusta, SC, the club
 has continued to enhance its reputation with club improvements even after being named a top five new course nationally by Golf
                                                             Digest.

                                                           Course Details
The River Golf Club course combines a fantastic layout with a
spectacular setting to create a golfers' paradise. Designed by
internationally acclaimed golf course architect Jim Fazio, The River
Golf Club offers a unique setting which includes large Mini-Verde
Bermuda grass greens, numerous lakes, wetlands and dramatic
bunkers.

The course was elected as one of the top five new courses nationally
in 1999 by Golf Digest. It also has hosted US Open qualifying in
2002 and was Hooters tour championship site in 1999 and 2000.

Designed with true golfers in mind of all levels, The River Golf Club
offers five sets of tees, a challenging but fair layout, and all the
amenities to ensure a memorable golf experience. For more details
about the River Club go to The River Golf Club home page.

                                                           Outing Details

When: Saturday after the 21st Audit Conference, October 13, 2012

Fee: $90.00 which includes:

*   Transportation to and from the Golf Course
*   One (1) hour golf lessons with club professional from 11:30 - 12:30
*   Box lunch prior to start of play
*   1 PM shotgun start
*   Range balls
*   Green and cart fee
*   Cookout after play
*   Prizes for longest drive and closest to pin as well as some others
*   Participation gift

There is a $25.00 Club Rental and you must reserve in advance and specify right or left handed.

Beverage carts will be available on the course for purchase of drinks/snacks

Participants will have to purchase their own balls, etc.

The maximum number of players is 28, so make your reservation early!
                                         ASQ 21th Annual Audit Division Conference
                            October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                                             Location




                                                          Welcome!
                                         American Society for Quality – Audit Division

                                                         October 8-14, 2012

                                       Special Group room rate of $134.00++ per night each

                        A limited number are available at the Government Rate of $84.00++ per night each

                                                       Call 866-316-5958
                                                       Or register online:
                                            Reference the : ASQ – Audit Division rate

Marriott Augusta at the Convention Center Amenities:

Coffee maker, hair dryer, iron with ironing board, complimentary high speed internet, refrigerator, flat screen HD television,
outdoor pool and indoor pool with whirlpool, fitness center, full service restaurant, Augustino’s, lounge, room service, Starbucks
coffee shop in the lobby.

Airport Shuttle:

The Augusta Marriott at the Convention Center offers complimentary shuttle to and from the Augusta Regional Airport. Air
Service is provided by Delta, American Airlines (direct flights to/from Dallas) & US Air. The airport is just a short fifteen (15)
minute ride from the hotel. Guests should call the hotel at 706-722-8900 to arrange for pick up and departure.

Parking:
Covered, gated parking will be available at $7.00 per night for guests at the Augusta Marriott at the Convention Center.

                                                    Food and Beverage Outlets

                                                            Augustino’s
                            Full service, award winning restaurant serving breakfast, lunch and dinner.
                                                       Augustino’s Lounge
                                   Serving cocktails and a light fare menus for lunch and dinner.
                                                      Starbucks Coffee Shop
                                      Serving breakfast pastries and snacks in the main lobby.
                                                              Quizno’s
                                  Sub Shop located on the first floor of the Marriott Suites tower.


                                        ASQ 21th Annual Audit Division Conference
                           October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                                                   Registration Information
The
       Conference Dates
       The conference will be held on Thursday and Friday, October 11 & 12, 2012
       Pre-Conference Tutorials are offered October 8, 9, & 10, 2012

       Conference Cost
       Conference Registration*Early Bird Conference Rate of $795 is effective on or before July 29, 2012.
       Regular rate of $895 is effective on or after July 30, 2012.

        Group Rate (GROUP OF 10 or MORE):
       Separate registration form must be completed for each attendee in the group. Registration forms must be submitted the “same
       day” for the entire group.
       Hotel arrangement, travel and pre-conference tutorials are NOT included in the conference fee

       Suggested Dress Attire for the Conference: Business Casual

       Registration Substitution and Cancellation Policy

       We understand that occasionally things do happen that prevent you from attending a program for which you have registered. If
       you find that you cannot attend the 21st Annual ASQ Audit Division Conference, here’s what you can do:

         Send a substitute: Substitutions can be made at any time (even onsite!)
         Cancel: Cancellations can be made any time prior to the conference. Requests for cancellations will be handled as follows:
        1 week out from the event:                         100% Penalty (Full Forfeiture of Funds)
        2 weeks out from the event:                         75% Penalty
        3 weeks out from the event:                         50% Penalty
        4 weeks out from the event:                         25% Penalty

       Note: Registrants who fail to attend without providing notification of their inability to attend are responsible for the entire
      conference fee.

      ASQ Audit Division reserves the right to cancel, reschedule any event, or to change speakers. Please be advised that ASQ Audit
      Division or ASQ Headquarters is not responsible for any airfare penalties, or hotel charges that may be incurred due to sold out,
      cancelled, or rescheduled events.

      Payment Options
       At this time, we can accept online orders using a credit card (Visa, Mastercard, or American Express) for payment. If you prefer
       to call ASQ at 800-248-1946 or 414-272-8575, have your credit card ready. To speed registration, complete the registration
       form before calling. You may also print out and mail your completed online registration to:

       Event Management/Customer Care
       PO Box 3005
       Milwaukee, WI 53201-3005.

       Or you can print out and fax your completed order form with credit card number (MC/VISA/AMEX only) to 414-272-1734
       Attn: Customer Care.


                                               ASQ 21th Annual Audit Division Conference
                                  October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                      Please Print Clearly or Type                                        Conference Tutorials – Subject to Change

________________ ____________________________                                Three Day
ASQ Member #      First name for conference badge                            Monday – Wednesday October 8 – 10, 2012 (8:00 a.m.
                                                                             – 5:00 p.m. daily)
________________________________________                                     Advanced Lead Auditor Class (TUT01) CEUs: 2.5                  $1695.00
Name (Last)      (First)            (Middle)
                                                                             Certified Manager of Quality and Organizational                $ 795.00
_____________________________________________                                Excellence Exam Refresher (Course #6161) CEUs: 1.9
Company Name
                                                                             Certified Biomedical Auditor Exam Preparation                  $ 795.00
_____________________________________________                                (Course #6163) CEUs: 2.4
Title
                                                                             Two Day
_____________________________________________                                Tuesday - Wednesday October 9 – 10, 2012 (8:00 a.m.
Address                                                                      – 5:00 p.m. daily)

_____________________________________________                                Writing Exceptional Audit Reports (TUT02) CEUs:                $ 695.00
City/State/Province                                                          1.6

_____________________________________________                                Strategic Quality Planning (TUT03) CEUs: 1.6                   $ 695.00
Zip/Postal Code/Country
                                                                             Human Error Prevention (TUT04) CEUs: 1.6                       $ 695.00
_____________________________________________
Phone/Fax                                                                    Certified Quality Auditor Certification Preparation            $ 695.00
                                                                             (Course #6121) CEUs: 1.6
_____________________________________________
Email/Country                                                                Failure Modes and Effects Analysis (FMEA) (Course              $ 695.00
                                                                             #6162) CEUs: 1.6
_____________________________________________
Guest/Spouse Name (First, Last)                                              One Day                                                        $ 595.00
Register on site. Additional fees required.                                  Wednesday October 11, 2012 (8:00 a.m. – 5:00 p.m.)

                                                                             Q-Ture (Future) Leader Workshop (TUT05) CEUs:                  $ 595.00
T-shirt Size: (circle one) S M L XL 2XL                                      .65

Conference Registration = $895                                               An Introduction to Lean Concepts (TUT06) CEUs: .8              $ 595.00

Early Bird on or before July 29, 2012 = $795                                 Supplier Auditing: A one-day basic level seminar               $ 595.00
                                                                             (TUT07) CEUs: .8
Group Discount = $805.50 for 10 or more attendees from
the same company registering at the same time                                Governance Management – Theory, Business Model                 $ 595.00
                                                                             and Best Practice (TUT08) CEU: .8
Early Bird Group Discount = $715.50
                                                                             Auditing for Risk Considering Risks and Controls               $ 595.00
(Registration fee includes breakfast, lunch and breaks for                   (TUT09) CEUs: .8
both days, admission to our Thursday night opening
reception, including heavy h ors d'oeuvres and Friday night                 Please circle the sessions you wish to attend. Although you are not obligated
closing reception, including light h ors d'oeuvres)                         to these choices, this will provide an expected group size to the conference
                                                                            organizers. You will receive confirmation of your registration separate from
Attend the Golf event? $90                                                  your receipt.

                                                                                                 Thursday October 11, 2012
Special Needs                                                                     9:45- 10:30 a.m.    A1 B1 C1 D1 E1 F1
 Do you have any special needs, disabilities, and/or dietary restrictions
                                                                                  10:45 - 11:30 a.m.     A2    B2 C2 D2 E2 F2
 that we may address to make your participation more enjoyable?
                                                                                  1:45 - 2:30 p.m.       A3    B3 C3 D3        E3 F3

                                                                                  2:45 - 3:30 p.m.       A4    B4 C4 D4 E4 F4

                                                                                  3:45 - 4:30 p.m.       A5    B5 B5      D5 E5 F5
Is it okay to release your email to the conference exhibitors/sponsors?
                                (Yes or No)
                                                                                                  Friday October 12, 2012
                                                                                  9:45 – 10:30 a.m.   A6    B6 C6 D6 E6 F6

a.    Yes, it is ok to release my information to the conference                   10:45-11:30 a.m.       A7     B7 C7     D7 E7 F7


                                             ASQ 21th Annual Audit Division Conference
                                October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
     exhibitors/sponsors (SVY1)                                           1:45 - 2:30 p.m.     A8    B8 C8 D8 E8 F8

b.   Yes, I’m attending the Audit Division Annual Business Meeting        2:45 - 3:30 p.m.     A9    B9 C9 D9 E9 F9
      (SVY7)
                                                                          3:45 – 4:30 p.m.     A10 B10 C10 D10 E10 F10
c.   Yes, I’m attending the opening reception (SVY8)

                                                                     Grand total (Tutorials and Conference) _______________
                       Payment Information

___ Check enclosed (make payable to ASQ)
Check # ________________________________

___ Please charge my credit card
      ___ AMEX ___ MC __ _ Visa

Credit Card # ____________________________________
Expiration Date:__________________________________

Card holder Name (print): _______________________

Card holder Signature:

______________________________________




                                           ASQ 21th Annual Audit Division Conference
                              October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA
                  2012 Platinum Sponsors




                       2012 Gold Sponsors




                      2012 Silver Sponsors




                          2012 Supporters




             ASQ 21th Annual Audit Division Conference
October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA

				
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