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

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The Impact of Globalization on Quality

QualityQualityyour company’s tagline

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

Construction Divisions

Augusta Marriott at the Convention

Center Augusta, GA

October 11October 11October 11October 11----12, 201212, 201212, 201212, 2012

www.asq.org/conferences/

audit/index.html

Preliminary Program


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

“A” sessions are in Estes A

“B” sessions are in Estes B

“C” sessions are in Lamar A

“D” sessions are in Lamar B/C

“E” sessions are in Cummings

“F” sessions are in Oglethorpe A/B

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 Barile – (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 - 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: Developing an Effective Control of Work Transfers - Bill Hackett – (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)


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 Timothy H. McKay, P.E. Executive Vice President, Growth and Regional Development Dallas Area Rapid Transit

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 (Part 1 of 2)- Rick Simon – (All) F6: Why a standard for usability? IEC 60601-1-6/62366: Usability & Human Factors Part 1 of 2 – Mike 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 (Part 2 of 2) - Rick Simon – (All) F7: Why a standard for usability? IEC 60601-1-6/62366: Usability & Human Factors Part 2 of 2 – Mike Schmidt – (Intermediate) 12:00 – 1:30 – p.m. Lunch, Announcements and Keynote Peter E. Shearstone, Division Vice President, Quality Assurance/Regulatory Affairs/Medical Affairs, Abbott Diagnostics

2:45-3:30 p.m.

A4: Achieving World-Class Performance In A Multi-National/Multi Cultural Environment - JR McGee- (All) B4: Working with and Auditing Partners Domestically and Globally? Use Technology to Improve Your Process – Christopher Quesnel – (All) C4: Auditor Charm School: Practicing Skills from the CQA BOK - Cindy Bonafede and Jocelyn Phillips- (All) D4: Applying the Tools of Quality to Define and Quantify the Business Case for Social Responsibility - Milton Krivokuca – (All)

E4: When Standards Collide - Auditing for Project Success - Benjamin Trujillo – (Intermediate) F4: Agile Development and Risk Based Control of Complex Medical Device Systems - Dr. Byron Mattingly - (Intermediate)

3:45-4:30 p.m.

A5: Remote Auditing – How to do it Effectively - Lorri Williams - (Intermediate or advanced auditors) B5: Supply Chain Management: Resourcing organization needs - J.P. Russell – (All) C5: Auditing Beyond Compliance - Janet Bautista-Smith – (All) D5: Creating Advantages Using the Perspective of the Customer - Sandy Miller – (Intermediate to Advanced) E5: QA Issues in Bridge Construction: The Self-Anchored Suspension Span of the San Francisco – Oakland Bay Bridge - Chuck Kanapicki – (All) F5: World Café – Supplier Performance Issues and Performance Ratings– Mark Lindsey (All)


1:45-2:30 p.m.

A8: Auditing multinational organizations with ASRP (Advanced Surveillance and Recertification Procedures): An innovative approach in a global environment. - Alex Guzman - (Advanced) B8: The Happiest place on Earth just got Happier! Are you ready to join the Happiness? – Bret Pfost – (All) C8: Writing "Meaningful" Audit Findings - Richard Kish – (All) D8: The Journey from a Site Based Supplier Quality System to a Global Supplier Quality System - Jeff Esselman – (Intermediate to Advanced) E8: Public Construction Contracting from a Quality Perspective -(Part 1 of 2) Diane Gollhofer – (All) F8: Globalizing Process Qualification & Validation for Medical Device - Naren S. Patel – (All)

2:45-3:30 p.m. A9: Remote Audits – Using Technology for a Complete Audit Experience - Angela Hunnicutt – (All) B9: Auditor Professional Development, Open Forum Discussion – Peter Gauthier – (All) 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: TBA 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: Navigating a Strategy in Operations – Heather McCain – (All) E10: Managing Global Supplier Quality – Brad Ivey – (All) F10: The Implementation of ISO 14971 in Medical Device Regulation in the US and Europe – Mike Schmidt – (All)

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

SATURDAY OCTOBER 13 8:00 a.m. – On-Site Certification Exams

11:00 am – Golf Outing


Pre-Conference Tutorials

Monday – Wednesday October 8 – 10, 2012

Certified Manager of Quality and Organizational Excellence Exam Refresher (Course ID #6161) Presented by: Russell T. Westcott 8:00 a.m. – 5:00 p.m. (Monday, Tuesday, and Wednesday)

This course is designed to help participants become familiar with the breadth of the body of knowledge and identify areas for more in-depth study. During the course, participants will have the opportunity to practice and discuss both multiple-choice and constructed response questions. The Certified Manager of Quality/Organizational Excellence Handbook 3rd Edition (edited by the instructor) will be provided to all course attendees prior to the course start date. Participants are expected to complete pre-work reading and a sample exam before class. Homework will be assigned the first two nights of the class. It is highly recommended that participants register by August 31, 2012 to allow time for book shipment and pre-work. Don’t forget to register early and bring your book to class.

Special Price: $795.00 CEUs: 1.9 Certified Biomedical Auditor Exam Preparation (Course ID #6163) Presented by: Mark Moyer 8:00 a.m. – 5:00 p.m. (Monday, Tuesday and Wednesday) Thinking about or planning to take the Certified Bio-medical Auditor (CBA) exam? Need a review and preparation course? Don't miss the Certified Biomedical Auditor exam prep course. Each day will focus on a separate section of the exam Body of Knowledge.

Day 1 - Auditing Fundamentals, Auditing and Inspection Processes Day 2 - Biomedical Quality Management System Requirements Day 3 - Technical Biomedical Knowledge, Quality Tools and Techniques

Special Price: $795.00 CEUs: 2.4

Tuesday-Wednesday October 9-10, 2012 Certified Quality Auditor Exam Refresher (Course # 6121) Presented by: Nancy Boudreau and Sandra Storli 8:00 a.m. – 5:00 p.m. (Tuesday and Wednesday) The ASQ Audit Division will conduct an exam refresher to help experienced auditors become better prepared for the CQA exam. The basis for the exam is the CQA Body of Knowledge and class discussion will include an overview of the CQA BoK offering participants a better understanding of the basic principles and applications that will appear on the exam. All course participants will receive the course text The ASQ Auditing Handbook, Third Edition, which can also be taken into the exam and used as a reference. Special Price: $695.00 CEU: 1.6


Writing Exceptional Audit Reports (TUT02) Presented by: Mary Chris Easterly 8:00 a.m. – 5:00 p.m. (Tuesday and Wednesday) This workshop will cover the crucial elements of an exceptional audit report: a summary of the processes and systems reviewed; positive feedback; and observations of gaps in compliance with requirements. We will address how to write unambiguous observations to facilitate identification of the root cause and appropriate corrective actions by the auditee. To involve participants and help them learn to write exceptional audit reports, groups of attendees will review examples of poorly written observations, then apply concepts learned to improve the observations and present them to all attendees. Price: $695.00 RUs: 1.6 Failure Modes and Effects Analysis (FMEA) (COURSE #6162) Presented by: David M. Little 8:00 a.m. – 5:00 p.m. (Tuesday and Wednesday) This course is designed to provide the student with working knowledge of the FMEA process as it is applied to product, process, or system. References will be made to ISO 9001, AS9100, and TS 16949 standards. Failure Modes and Effects Analysis is a critical step in the development of new product or in the modifications of existing products. This systematic approach parallels, formalizes and documents the metal disciplines that an engineer normally goes through in any design process to identify risk. Discussions on FMEA history, methods, types, responsibilities, documentation, implementation and software will be reviewed and presented. Price: $695.00 RUs: 1.6


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.


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:

Novel approaches to reengineering the quality system

The importance quality and business culture play in sustainability

Simplification and harmonization of global quality systems

Focusing on reducing errors through procedure structure

Movement of the learning environment from “read and forget” to true competency

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.


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.


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 Barile – (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.


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?


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


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: Developing an Effective Control of Work Transfers - Bill Hackett – (Beginner to Intermediate)

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.

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.


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.

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.


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.

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

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: 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.

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.

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 – Mike 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.

FRIDAY OCTOBER 12, 2012 10:45-11:30

A7: Auditing in a Virtual World (Team, Tools, & Te chniques) - 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.

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 – Mike 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.

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.

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: Auditor Professional Development, Open Forum Discussion – Peter Gauthier – (All) The forum is intended to foster a discussion on the direction the Audit Division should take concerning strengthening the audit profession and the performance of auditors. There is a perfective of some that auditing is not a profession, that auditors are individuals from various technical expertise that have been minted with a certificate based upon limited training. The Audit Division is looking for guidance of whether it should endorse and potentially sponsor the requirements for and the development of specific expectations for the formal training and development of auditors as do other professions. For example, engineers, accountants, or nurses. The discussion will be facilitated by Audit Division Executive Board Members. The Audit Division did sponsor a Focus Group to study this topic in the spring of 2009. A proposal was made by the Focus Group for the establishment of formal education requirements with corresponding certification recognitions in 2011. Key points the Audit Division Executive Committee would like to explore include, is there a problem with auditor competence to be addressed, is auditing a profession, is the preparation and training of auditor adequately robust, does the performance of auditors meet its potential and does it meet business’s needs.

C9: Auditing Under HIPAA Constraints A Mental Healt h 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.

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: TBA

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: Navigating a Strategy in Operations – Heather McCain – (All)

Garmin’s Olathe Operations uses the Hoshin X-Matrix to develop key objectives and then transform them into initiatives and tactical actions. The use of a goal-setting matrix has helped the team focus on what is important and track what has been accomplished. Learn firsthand the success Garmin has had using this methodology.

E10: Managing Global Supplier Quality – 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: The Implementation of ISO 14971 in Medical Device Regulation in the US and Europe – Mike Schmidt - (All)


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.


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


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!


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.


Registration Information

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



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.


Please Print Clearly or Type

________________ ____________________________ ASQ Member # First name for conference badge ________________________________________ Name (Last) (First) (Middle) _____________________________________________ Company Name _____________________________________________ Title _____________________________________________ Address _____________________________________________ City/State/Province _____________________________________________ Zip/Postal Code/Country _____________________________________________ Phone/Fax _____________________________________________ Email/Country _____________________________________________ Guest/Spouse Name (First, Last) Register on site. Additional fees required. T-shirt Size: (circle one) S M L XL 2XL Conference Registration = $895 Early Bird on or before July 29, 2012 = $795 Group Discount = $805.50 for 10 or more attendees from the same company registering at the same time Early Bird Group Discount = $715.50 (Registration fee includes breakfast, lunch and breaks for both days, admission to our Thursday night opening reception, including heavy hors d'oeuvres and Friday night closing reception, including light hors d'oeuvres) Attend the Golf event? $90

Special Needs

Do you have any special needs, disabilities, and/or dietary restrictions

that we may address to make your participation more enjoyable?

Is it okay to release your email to the conference exhibitors/sponsors? (Yes or No)

a. Yes, it is ok to release my information to the conference

Conference Tutorials – Subject to Change

Three Day Monday – Wednesday October 8 – 10, 2012 (8:00 a.m. – 5:00 p.m. daily)

Certified Manager of Quality and Organizational Excellence Exam Refresher (Course #6161) CEUs: 1.9

$ 795.00

Certified Biomedical Auditor Exam Preparation (Course #6163) CEUs: 2.4

$ 795.00

Two Day Tuesday - Wednesday October 9 – 10, 2012 (8:00 a.m. – 5:00 p.m. daily)

Writing Exceptional Audit Reports (TUT02) CEUs: 1.6

$ 695.00

Certified Quality Auditor Certification Preparation (Course #6121) CEUs: 1.6

$ 695.00

Failure Modes and Effects Analysis (FMEA) (Course #6162) CEUs: 1.6

$ 695.00

Please circle the sessions you wish to attend. Although

you are not obligated to these choices, this will provide

an expected group size to the conference organizers.

You will receive confirmation of your registration

separate from your receipt.

Thursday October 11, 2012 9:45- 10:30 a.m. A1 B1 C1 D1 E1 F1 10:45 - 11:30 a.m. A2 B2 C2 D2 E2 F2 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 C5 D5 E5 F5

Friday October 12, 2012

9:45 – 10:30 a.m. A6 B6 C6 D6 E6 F6 10:45-11:30 a.m. A7 B7 C7 D7 E7 F7

1:45 - 2:30 p.m. A8 B8 C8 D8 E8 F8 2:45 - 3:30 p.m. A9 B9 C9 D9 E9 F9 3:45 – 4:30 p.m. A10 B10 C10 D10 E10 F10

Grand total (Tutorials and Conference) _______________


exhibitors/sponsors (SVY1)

b. Yes, I’m attending the Audit Division Annual Business Meeting (SVY7)

c. Yes, I’m attending the opening reception (SVY8)

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: ______________________________________


2012 Platinum Sponsors

2012 Silver Sponsors

2012 Supporters

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