21st annual audit division conference - northern … 21th annual audit division conference october...

ASQ 21th Annual Audit Division Conference

October 11-12, 2012 at the Augusta Marriott at the Convention Center, Augusta, GA

21St Annual Audit

Division Conference

The Impact of Globalization on Quality

QualityQualityyour company’s tagline

here!

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 11-12, 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

Technical Sessions

9:45-10:30

A1: Guide to International Audit 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: Laboratory Supplier Qualification with Limited Resources - Renee Forsberg – (Intermediate)

10:45-11:30

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 – Lunch, Announcements and Keynote Dr. Marta Wilson, CEO Transformation Systems, Inc.

1:45-2:30

A3: Managing Diversity and Cultural Differences - 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

A4: Achieving World-Class Performance In A Multi-National/Multi Cultural Environment - JR McGee

B4: Designing a Risk Based Supplier Auditing Program - Andrew Hendricks – (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)

http://asq.org/conferences/audit/2012/sessions/e4.html

http://asq.org/conferences/audit/2012/sessions/f4.html



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

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

FRIDAY OCTOBER 12

7 :00 am – 4:00 pm Registration and Book Store

7:00 am – 8:00 am - Continental Breakfast

8:00 am – 9:30 am – Opening Remarks and Keynote Peter E. Shearstone, Division Vice President, Quality

Assurance/Regulatory Affairs/Medical Affairs, Abbott Diagnostics

9:45-10:30

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: Using the Right Measure Right - Sandy Miller - (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

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

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 – Lunch, Announcements and Keynote Timothy H. McKay, P.E. Executive Vice President, Growth and

Regional Development Dallas Area Rapid Transit

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)

B8: TBA

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

D8: 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 - Diane Gollhofer – All (Part 1 of 2)

F8: Medical Device Alarm System Assessments - Richard Davis - (Intermediate)

3:45-4:30

A5: Remote Auditing - Lorri Williams - (Intermediate or advanced auditors)

B5: Supply Chain Management: Resourcing organization needs - J.P. Russell – (All)

C5: Outsourcing the Audit Function: A Strategic Framework - Andrew Hendricks – (All)

D5: The Benefits of Implementing a Lean ISO System - Enrique M. Bekerman – (All)

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)

http://asq.org/conferences/audit/2012/sessions/f8.html



2:45-3:30

A9: 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)


F9: ISO 14971 A globally accepted approach to assuring device safety - Michael Barille

3:45-4:30

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

B10: TBA

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: Focusing software risk management audits where they can most impact safety - Stan Hamilton

4:45-6:00 pm – Closing Reception - All Conference Attendees

SATURDAY OCTOBER 13

8:00 – On-Site Certification Exams

11:00 am – Golf Outing

http://asq.org/conferences/audit/at-a-glance.html



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.


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


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.


CEU: 1.6

Writing Exceptional Audit Reports (TUT02)

Presented by: Mary Chris Easterly


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


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


This highly interactive session uses a lecture, discussion and team format. It is case driven using a variety of examples from

many different organizations as well as using their own initiatives. The entire session is managed as a large planning process.

This approach to session delivery has proven to be highly effective in imparting the session knowledge to the participants. Not

only do they learn the process of developing Strategic Quality Plans, they actually experience applying it to “real” quality

issues and the development of strategies to better plan these. The outcome is measurable, as session participants will be able to

take these strategies back into their own work place environments and begin executing them immediately.



Price: $695.00

RUs: 1.6

Human Error Prevention (TUT04)

Presented by: Ben Marguglio

8:00 a.m. – 5:00 p.m. (Tuesday and- Wednesday)

In addition to discovery and invention, human error prevention can be the greatest contributor to improved productivity, safety

and quality. This seminar provides the most current developments in human error prevention.

This seminar is designed for anyone whose objective is to improve productivity, safety and quality. The principles and practices

of human error prevention are universally applicable regardless of the type of industrial, commercial or governmental

enterprise, and regardless of the type of function performed within the enterprise.

Handouts include:

· Copy of the visual aids

· Compilation of recommended behaviors to prevent human error

· Case study and exercise materials

· Certificate of Completion, with Continuing Education Units

Price: $695.00

RUs: 1.6

Wednesday October 10, 2012

Q-Ture (Future) Leader Workshop (TUT05)

Presented by: J.P. Russell

8:00 a.m. – 5:00 p.m. (Wednesday)

This one day workshop is focused on professional development of future quality and improvement professionals. Students will

participate in a series of lectures and workshops that will include guest speakers sharing their insight and tips on how to

succeed. We are looking for conference attendees that want to contribute to the body of knowledge or advance the profession.

Future organizational leaders must find ways to equip, enable, and empower themselves so they are able to fulfill their

commitments and advance the profession.

Price: $595.00

CEU: 0.65

An Introduction to Lean Concepts (TUT06)

Presented by: Enrique M. Bekerman and Miriam Chart

8:00 a.m. – 5:00 p.m. (Wednesday)

This one day hands-on workshop is designed to teach the basic Lean Manufacturing concepts to a varied audience including

executives, managers, and operators. The Workshop alternates classroom learning with a realistic factory simulation taking

participants through several rounds starting from a traditional manufacturing environment and progressing to a Lean Enterprise

environment while simulating waste elimination and improved work flow at customer’s demand. Facilitators keep track of

financial and quality metrics from round to round to demonstrate the bottom line and customer satisfaction impact.

Price: $595.00

RUs: 0.8



Supplier Auditing: A one-day basic level seminar (TUT07)

Presented by: Dennis R. Arter

8:00 a.m. – 5:00 p.m. (Wednesday)

This seminar is designed for management, professional and technical personnel who want to improve customer-supplier

relations. No previous knowledge of auditing or management systems is required (or assumed). The instruction applies to any

quality system (ISO 9001, FDA, military, automotive, etc.), as well as environmental and safety systems. Buyers and

purchasing agents will find the information quite beneficial. Those preparing for the CQA exam will enjoy the review. It is

lecture-only - the compressed time does not allow for small group workshops.

Price: $595.00

RUs: 0.8

Governance Management – Theory, Business Model and Best Practice (TUT08)

Presented by: Ehab Abbas

8:00 a.m. – 5:00 p.m. (Wednesday)

A one-day tutorial that presents an innovative approach to managing the entire governance cycle starting with policy

formulation and endorsement; publishing and collecting feedback; auditing, reporting and statistical intelligence.

By the end of the tutorial, the audience will have learned new and powerful insights, and expanded their understating in the

following areas.

a. An innovative approach that integrates the concepts of value-creation, governance, auditing, company valuation and

strategic management in one holistic business model.

b. A Best-practice in distinguishing and yet integrating and aligning, corporate and operational risk maps and policies.

c. The role of policies in influencing organizational behaviors and shaping the organizational corporate culture – pitfalls

and recommendations.

d. How to put in place a best-in-class governance management system – process, organization and technology

Price: $595.00

RUs: 0.8

Auditing for Risk Considering Risks and Controls (TUT09)

Presented by: Denis J. Devos

8:00 a.m. – 5:00 p.m. (Wednesday)

Many reference books and texts have been written about how to conduct a successful audit. These books and training sessions

always talk about considering risks during a quality audit, but stop short of offering a template to assist in audit planning and

preparation. Our session will introduce auditors to a new auditing tool which includes Process Risks and their corresponding

enablers, or process controls. Many auditors find themselves unable to perform a QMS audit beyond written procedures and

checklists. Hands-on workshops will teach simple techniques to help auditors use risk as a compass for charting their course

through a challenging audit.

Price: $595.00

RUs: 0.8



Keynote Speakers

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:

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.

http://asq.org/conferences/audit/speakers.html



Technical Program

THURSDAY OCTOBER 11, 2012 9:45-10:30

A1: Guide to International Audit 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: Laboratory Supplier Qualification with Limited Resources - Renee Forsberg – (Intermediate)

Viracor-IBT is a small clinical laboratory that utilizes many reagents and kits from external suppliers. Viracor-IBT’s test

menu services both physician/hospital/reference laboratory clients regulated under the Clinical Laboratory Improvement

Amendments (42 CFR 493) and Pharmaceutical/Biopharmaceutical clients regulated under 21 CFR Parts 210 and 820. The

requirements related to supplier qualification in this mixed regulatory environment are not in complete alignment. As a small

company, Viracor-IBT had limited resources to develop and implement a supplier qualification program with a strict

requirement to conduct on-site audits, particularly when many suppliers are located outside of the continental United States.

Viracor-IBT developed a program for supplier qualification to meet the applicable regulatory requirements, company

standards, and client requirements. The primary goal was to provide confidence that the laboratory utilizes quality materials

to ensure that clients and patients can depend upon the accuracy of our test results.

Supplier qualification efforts at Viracor-IBT had been insufficient from a historical perspective. A robust assay validation

and QC program, which the laboratory used as a mechanism to qualify materials, along with supplier “past performance”

criteria, became inadequate. Over the years as the laboratory grew, testing volume increased, and the use of high-priced kits

and reagents became routine, the company determined that the risk of purchasing testing materials without a formal supplier

qualification program was too great. A cross-functional team was selected encompassing regulatory and quality assurance,

laboratory management and procurement to develop a program that met identified regulatory requirements and was

realistically scaled for the size of business and available resources.

The objective of this presentation is to describe the cross-functional team’s efforts in developing this program (share the

journey), and provide an example of tools that can be utilized to qualify suppliers based upon a business risk-analysis process

and detailed supplier survey-focused effort that minimizes on-site supplier audits. It is not suggested that this program

accommodates the needs of all companies/industries. It is intended to provide an example of a simplified process that

adequately manages risk for a small clinical laboratory-based business.


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: Managing Diversity and Cultural Differences - 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: 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.

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

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: Designing a Risk Based Supplier Auditing Program - Andrew Hendricks – (All)

Many firms find themselves in one of two positions regarding supplier auditing – they have either relatively underdeveloped

supplier auditing programs or indiscriminate programs that overburden their limited resources. This is further complicated

by the increasing reach of globalized supply chains. The purpose of this presentation is to present best practices for

implementing a risked based supplier auditing program to better allocate firm resources. This interactive presentation is

geared toward the decision makers and decision influencers responsible for planning supplier auditing activities.

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 - 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

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: Outsourcing the Audit Function: A Strategic Framework - Andrew Hendricks – (All)

The purpose of this presentation is to examine the challenges management faces when determining if they should outsource

the auditing function to a 3rd

party. There is no “right” answer to this question so the purpose of the presentation is to discuss

the potential pros and cons of outsourcing and provide a framework that can be applied to each unique business situation to

help identify the best strategic decision. This interactive presentation is geared toward the decision makers and decision

influencers responsible for planning internal/supplier audit activities. The second half of the presentation is dedicated to a

discussion of best practices and available tools that can be utilized to maximize the value from an outsourced audit -- from

the firm/auditor selection process all the way to CAPA closeout activities.

D5: 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.

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.

6:0

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.

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: 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.

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.

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.

D7: 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.

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

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.

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: TBA (Bret Pfost)

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: 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.


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: 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 2:45-3:30

A9: 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 (Bret Pfost)



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.


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: ISO 14971 A globally accepted approach to assuring device safety - Michael Barille

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: Richard Feng

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)



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: Focusing software risk management audits where they can most impact safety - Stan Hamilton

On-Site Certification Exams

ASQ will offer 5 certification exams

Saturday, October 13, 2012

Application Deadline: ??

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

http://prdweb.asq.org/certification/control/manager-of-quality/index

http://prdweb.asq.org/certification/control/quality-auditor/index

http://prdweb.asq.org/certification/control/quality-engineer/index

http://prdweb.asq.org/certification/control/quality-improvement-associate/index

http://prdweb.asq.org/certification/control/biomedical-auditor/index



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 it's 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 21

st 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.

http://www.rivergolfclub.com/



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 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, 2012-06-23

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.

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:

________________________________________

Conference Tutorials – Subject to Change

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

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

Monday – Tuesday October 9 – 10, 2012 (8:00 a.m. – 5:00 p.m. daily)

Writing Exceptional Audit Reports (TUT02) CEUs:

1.6

$ 695.00

Strategic Quality Planning (TUT03) CEUs: 1.6 $ 695.00

Human Error Prevention (TUT04) 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

Wednesday October 11, 2012 (8:00 a.m. – 5:00 p.m.) $ 595.00

Q-Ture (Future) Leader Workshop (TUT05) CEUs:

.65

$ 595.00

An Introduction to Lean Concepts (TUT06) CEUs: .8 $ 595.00

Supplier Auditing: A one-day basic level seminar

(TUT07) CEUs: .8

$ 595.00

Governance Management – Theory, Business Model

and Best Practice (TUT08) CEU: .8

$ 595.00

Auditing for Risk Considering Risks and Controls

(TUT09) CEUs: .8

$ 595.00

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 B5 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) ___________________

2012 Platinum Sponsors



2012 Gold Sponsors

2012 Silver Sponsors

2012 Supporters

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