Technical Sessions - ISO 9000

20th Annual International Conference on ISO 9000 & QMS
February 26-28, 2012
Hyatt Regency Grand Cypress, Orlando, Florida, USA

Keynote: Quality Success Stories from World Leaders

7:30 a.m. - 8:00 a.m. Continental Breakfast
8:00 a.m. - 8:15 a.m. Opening Remarks
Lorri Hunt & Jack West, Conference Co-Chairs

In his current role, Fowler reports directly to Alan Mulally, the company’s President and CEO. His responsibility is driving quality processes and discipline throughout the design and production of Ford vehicles. He is responsible for new model launches globally. Fowler directly influences the quality of Ford's newest model, current model, and future model vehicles. With more than 30 years experience in the automotive industry, Fowler has held key positions in the heart of the company’s business operations and began serving in leadership roles very early in his career. Prior to his quality and launch leadership role, Fowler served as Vice President, Advanced & Manufacturing Engineering, and Chief Operating Officer of Jaguar Land Rover.

9:00 a.m. - 9:45 a.m.
#A2: From Product Quality to Organization Quality: Managing for Success
Isaac Sheps, Ph.D., CEO, Carlsberg UK, Northampton, United Kingdom

Organizations face the need to address the needs and expectations of all their interested parties and not just their customers'. To do so, organizations have to move from Product Quality to Organization Quality. Successful organizations have realized that sustainable success is a result of an organization’s ability to achieve its objectives in the long term, with balanced consideration of the needs and expectations of all its interested parties, such as customers, investors, shareholders, employees, suppliers, partners, and society. To achieve this goal, organizations will have to develop one Integrated Management System having a common purpose.

10:15a.m. - 12:00 p.m.
#B1: Current Status and the Future of ISO 9000 Series Standards

Panelists

• Lorri Hunt, U.S. Delegation Leader to ISO/TC 176/SC2, President, Lorri Hunt & Associates, Inc., Kansas City, MO, USA
• John E. (Jack) West, Past Chair US TAG to TC 176, Silver Fox Advisor, The Woodlands, TX, USA
• Jose Dominguez, Mexican Delegate to ISO/TC 176, Managing Director, Plexus, Mexico, Mexico City, Mexico
• Peter Papakostantinu, Canadian Delegate to ISO/TC 176, President, Papa and Associates, Inc., Toronto, ON, Canada

ISO 9001 can be expected in 2012. The panel will review how the Technical Committee has analyzed data to form a basis for any recommendations for an update to the ISO 9001 standard, and will analyze the results of the Technical Committee’s review and updating of the eight Quality Management principles that can be expected to be a key input to any future changes to ISO 9001. The panel will discuss current information on ISO 9001 and the decision regarding common structure and text for all ISO Management System Standards. Decisions on this are expected to be made by the ISO Technical Management Board in February 2012. This interactive panel discussion will also answer questions from the audience. Questions can be pre-submitted at the International Conference on ISO9000|LinkedIn.

12:00 p.m. - 1:00 p.m. Networking Luncheon

1:00 p.m. - 1:35 p.m.
#C1: Keys for Effective Problem Solving
R. Dan Reid, Program Manager, Quality, AIAG, Southfield, MI, USA

Has the confidence in your supply chain grown because of the effectiveness of their problem solving? This material will discuss typical steps to prevent recurrence and the impact of problem complexity on this process and the role of leaders in making problem solving effective, such as following procedures already in place and using the solutions found for future processes. If the same problems occur year after year in your supply chain, this presentation will identify key actions to overcome this common challenge.

1:35 p.m. - 2:10 p.m.
#C2: Pyramid Audits
Tim O'Hanlon, Ph.D., Associate Partner, Atos Origin, Birmingham, United Kingdom

Within the in-patient wards, a common cause of disruption to patient flow within the system was the failure to discharge patients in a timely manner (30% by 11 a.m.) There were many reasons for this, and they were all known. Yet they remained out-of-control. Recognizing the failure of previous initiatives to sustain, the solution was worked from right to left. By asking “How do we sustain any future improvement?” before the improvement process started, management, staff, and clinicians identified one common approach to which there was unanimous buy-in….the pyramid audit.

2:10 p.m. - 2:45 p.m.
#C3: Auditing Top Management Without Losing Your Job
Kristin Case, P.E., Owner, CaseConsults,Tulsa, OK, USA

Auditing top management can be intimidating, stressful, and career-limiting, or it can be a valuable experience. Proven tools and techniques for auditing top management, both with and without interviewing, will be provided in this presentation. What if top management commitment is noticeably absent? How do you objectively record and share that information without jeopardizing your position or career? Unless senior leaders understand the relationship between a Management System, the organization’s objectives, and measures and its activities, commitment is unlikely. Techniques and examples will be presented to show your organization that the value of their Quality Management System is greater than the value of their ISO 9001 certificate.

1:00 p.m. - 1:35 p.m.
#D1: Role Ahead: The Innovation Manager
Jane Keathley, Director of Quality, Medical Automation Systems, Charlottesville, VA, USA

Anticipating the needs of tomorrow’s customers and identifying creative ideas to address them is essential for an organization’s long-term success. Turning those ideas into reality requires discipline, leadership, and management skills. The primary focus of Quality Management has gradually evolved from compliance and documentation to performance improvement and business excellence. A well-established environment of Continuous Improvement positions the organization for effectively developing a culture of innovation. The Quality Manager is positioned to take the lead. Transforming the Quality Manager's role for innovation management provides a promising professional future.

1:35 p.m. - 2:10 p.m.
#D2: Using the QMS to Improve Voice of the Workforce
Eugene Kirsch, Senior Associate, Booz Allen Hamilton, Rockville, MD, USA

Considering human resources, ISO 9001 expects management to maintain workforce competency to measure and direct the effectiveness of their actions and to initiate and maintain their awareness in their roles. The expectation is that management will be engaged in fostering workforce participation. Further, ISO 9004 includes career planning and participation in the development of new processes in its criteria for mature organizations. The expectation for addressing the voice of the workforce is part of a well-functioning QMS. The QMS provides the framework for improved Voice of the Workforce. This presentation addresses these mechanisms.

2:10 p.m. - 2:45 p.m.
#D3: From ISO 9001 to an Innovation Management System
Peter Merrill, President, Quest Management Systems, Kilbride, ON, Canada

An ISO 9000 Quality Management System can be used as the basis for an Innovation Management System (IMS) by using the ISO 9001 requirements with a deeper level of thinking and application. System thinking is imperative for successful change. For that reason, system thinking is essential for successful innovation. This presentation will focus on key elements of ISO 9001 and show you how to use the activities you conduct in each of those elements to develop Innovation Management. The session shows the sequence in which to engage the ISO 9001 elements as you move through an innovation project.

1:00 p.m. - 1:50 p.m.
#E1: Leadership: The Key to a Quality Culture
Keith Hamilton, Manager, North America Manufacturing and Education Center, Bridgestone, LaVergne, TN, USA

Bridgestone's Warren County, Tennessee, facility has created a culture of quality through its unique concept of "shared leadership." This presentation explores the concept of "The Warren Culture." The tire plant in Warren County was the first "green field" start up for Bridgestone outside of Japan. The concepts behind the start up of the plant and the unique culture created as a result will be discussed. Based on the military model of the "concept of team," the Plant created a culture where everyone is expected to take personal ownership for the quality of the product. Leadership is expected of everyone at every level. The Plant's culture overcomes the apparent conflict between "managers do things right" and "leaders do the right thing."

1:50 p.m. - 2:45 p.m.
#E2: Building and Maintaining a Culture to Support Quality
Judith Ann Pauley, Ph.D., CEO & Joseph F. Pauley, President, Process Communications, Inc., Potomac, MD, USA

Establishing positive relationships within teams has been a key to increasing staff morale and productivity. How can a leader identify the strengths of people, their preferred mode of communication, their learning style, and the most effective way to motivate them? Participants in this presentation will learn skills to build a profitable and sustainable culture, as well learning the indicators of miscommunication and intervention strategies against employee dissatisfaction. Companies that have implemented the lessons from this presentation have improved client satisfaction, productivity, profitability, and feel they have a “magic wand” to eliminate negative behaviors in their work culture.

2:45 p.m. - 3:00 p.m. Refreshment Break

3:00 p.m. - 3:35 p.m.
#F1: DHS/FEMA Voluntary Private Sector Preparedness (PS-Prep™) Accreditation Program
Ashley P. Moore, NSCP, MBCI, Senior Policy and Standardization Advisor Standards & Technology Branch National Integration Center, Department of Homeland Security, Washington, DC, USA

Organizations are challenged by disasters, and implementing the necessary disaster recovery capabilities in order to return to a state of normal operation is vital. Imagine finding your organization shut down by a disaster—a flood, tornado, terrorist attack, or even power outage. According the Small Business Administration 40 to 60 percent of small businesses without continuity plans never reopen their doors. ISO 9000 is the standard for a Quality Management System that aids PS-Prep™.

3:35 p.m. - 4:10 p.m.
#F2: Transitioning from a FMEA to Total Risk Management System
Richard Vincins, Vice President, QA, Emergo Group, Pembroke Pines, FL, USA

Implementing risk assessment techniques into a quality system can assist companies in making risk-based decisions, and not just ad-hoc decisions. This presentation provides attendees methods for fully integrating their Risk Management process into the Quality Management System. This presentation focuses on how attendees can incorporate a Risk Management plan and risk analysis into their customer feedback system. The principles of Risk Management applied to product realization will allow organizations to provide best quality products and prevent costly liability issues.

4:10 p.m. - 4:45 p.m.
#F3: Developing a Business Continuity Management System for PS-PrepTM
Timothy J. Woodcome, Director, National Quality Assurance USA, Acton, MA, USA

3:00 p.m. - 3:35 p.m.
#G1: Value Added Management Reviews
Patricia George Anderson, Vice President, Quality/Safety/Environmental, Saab Barracuda, LLC, NC, USA

Management Reviews provide the cornerstone for the organization’s strategic planning. However, getting the Management Review simple, Lean, and data driven can be as much of a challenge as getting top management motivated. You start by streamlining the meeting, making it value-added, and provide data in a format that top management can use. With so many other meetings that management members attend, why should they be enthusiastic about this meeting? The key factor is showing them how this process is linked to others within the business system. Management Reviews need not be a complicated process. Initial planning and preparation is required, and execution will follow.

3:35 p.m. - 4:10 p.m.
#G2: Drive Out Fear: Applying Deming’s Point
Denise Robitaille, Vice-Chair of US TAG to ISO/TC 176, Kingston, MA, USA

Often, we cling to habits that perpetuate the climate of fear that will hinder an objective, factual approach to decision making, and Continual Improvement. Any intimidation or anxiety that persists can obstruct an organization’s goals, understandably showing Dr. Deming’s point as relevant today. How can we follow the principles acted upon by successful organizations, apply those principles to our organization, and take steps to build integration in order to sustain that success? Ms. Robitaille will take an unexpected look at the wisdom of one of Dr. Deming’s points to benefit your organization for the long term.

4:10 p.m. - 4:45 p.m.
#G3: Implementing ISO 9001 as a Business Management System
Linda D. Feres, Director of Quality Systems, INTUITIVE Research and Technology, Huntsville, AL, USA

3:00 p.m. - 3:35 p.m.
#H1: Challenges of Integrating Multiple Management Systems
Peter Papakostantinu, President, Papa & Associates, Inc., Markham, ON, Canada

With the proliferation of Management System Standards (e.g., Quality, Environmental and Health & Safety), organizations have been implementing multiple Management Systems with the goal of achieving third party registration. Interest has been shown to integrate multiple Management Systems to optimize resources and to reduce cost. Organizational challenges are: integration of multiple Management Systems without affecting performance, Continual Improvement, how to improve management efficiencies, and dealing with cultural incompatibility.

3:35 p.m. - 4:10 p.m.
#H2: Integrating Quality, Environmental, Health, and Safety
David McLean, P.Eng., Senior Consultant, DMA Technical Services, Inc., Chatham, ON, Canada

This presentation will explore the implementation of an Integrated Management System (IMS) at NEC to ensure that the corporation operated in compliance with ISO 9001, ISO 14001, and ANSI Z10 as a precursor to ISO 18001. Each of the NEC facilities is designed to accommodate a “quick change” of the work that is being conducted. To ensure this work is carried out in a safe and effective manner, NEC relies on the IMS. This presentation will explore some of the key IMS elements that comprise this system.

4:10 p.m. - 4:45 p.m.
#H3: Responsible Recycling - Using Integrated Management Systems for Handling Electronics Waste
Thea D. Dunmire, President, ENLAR Compliance Services, Inc., Largo, FL, USA

The handling and disposal of electronics waste is a significant challenge. Today’s wired society is creating a mountain of e-waste. No organization wants its name linked to the graphic pictures of environmental contamination associated with the mismanagement of e-waste in developing countries. Handling e-waste appropriately requires that organizations establish sound management practices. This presentation outlines the steps taken to recycle its e-waste through the use of integrated Management System processes, ISO 14001, OHSAS 18001, and the U.S. EPA R2 Practices.

7:30 a.m. - 8:00 a.m. Continental Breakfast
8:00 a.m. - 8:10 a.m. Opening Remarks

8:10 a.m. - 8:45 a.m.
#I1: The Quality Journey at Ford
Michael Hardie, Director of Global Quality and Productivity, Ford Motor Company, Ann Arbor, MI, USA; Jay Zhou, Ph.D., Corporate Executive Technical Leader for Quality, Ford Motor Company, Ann Arbor, MI, USA

Learn how Ford Motor Company utilized the practice of problem solving and the spirit of Continuous Improvement on its quality journey. This session will present the quality business case, the value stream, the standardization of processes, business plan reviews, operational excellence plans, and the results of Ford’s quality journey.

8:45 a.m. - 9:20 a.m.
#I2: Leadership GPS – Goals, People, and Systems
Shane Yount, Principal/Author, Competitive Solutions, Inc., Alpharetta, GA, USA

In this presentation, participants will receive a lively overview of the four key elements necessary to create and sustain a high performance mentality throughout an organization. There will be a strong focus on the role of leaders to create the non-negotiable strategies necessary to sustain success. This presentation will look at the real-world business challenges facing organizations today and give a specific implementation methodology to begin practicing. Attendees will learn how to drive business objectives down from the top management to the hourly employee, to drive measurable results.

9:20 a.m. - 9:55 a.m.
#I3: Technology Approaches to Quality Management
Joe Goodman, Director, Solutions Consulting, Sparta Systems, Holmdel, NJ, USA

As regulated industries become more globalized and companies continue to expand their operations through mergers and acquisitions, organizations face increasing pressure to comply with differing regulatory standards. This presentation will provide

organizations with a step-by-step approach to implementing and standardizing effective global change management. Successfully managing change across the organization can prove demanding. In this presentation, you will learn the specific steps needed for a successful change control initiative. Key recommendations for securing the necessary executive buy-in will be presented. You will hear a real-world example of a successful global change management initiative.

7:30 a.m. - 8:00 a.m. Continental Breakfast
8:00 a.m. - 8:10 a.m. Opening Remarks
8:10 a.m. - 8:45 a.m.
#J1: ISO 9001 in a Government Healthcare System; the Good, the Bad, and the Ugly
Robert Burney, MD, Director, Quality Improvement, Medical Services, U.S. Department of State, Washington, DC, USA

ISO 9001 in healthcare--how to do it and why you would want to. New demands are being placed on the healthcare industry, this time from politicians. The key message is "spend less money." Once we have a reason to improve, ISO 9001 provides the Management System to ensure this happens everywhere within an organization and you have metrics to demonstrate success. In 2007, MED achieved registration to ISO 9001 after a two-year journey. This presentation will detail the trials and tribulations of the ISO 9001 registration.

8:45 a.m. - 9:20 a.m.
#J2: QMS Utilization in Accountable Care Organizations
M. M. “Mickey” Christensen, MSME, P.E. Ret., President, TQM Systems, Baton Rouge, LA, USA

Developing an understanding that a Quality Management System is necessary for sustainability in Accountable Care Organizations. ACOs appear to be the wave of the future. A discussion of the application of a Quality Management System (QMS) based on ISO 9001 as it would apply to an ACO is included. With the Centers for Medicare and Medicaid Services [CMS] piloting ACOs, more people will need to understand how to support the sustainability of an ACO. Effective QMS will be needed to manage ACOs successfully.

9:20 a.m. - 9:55 a.m.
#J3: Case Study on a Medical Device QMS
Joseph J. Tsiakals, Senior VP, Quality & Regulatory, Baxa, Parker, CO, USA

Learn about the changes that are planned for ISO 13485:2003, that is intended to serve as the model for the Quality Management System for the design and manufacture of medical devices. The standard has been adopted in one form or another in many national and regional regulatory systems. The technical committee ISO TC 210, responsible for ISO 13485, has decided to revise it to bring it in line with the recent changes in ISO 9001. The anticipated changes will be discussed in light of how they should be incorporated into a QMS.

7:30 a.m. - 8:00 a.m. Continental Breakfast
8:00 a.m. - 8:10 a.m. Opening Remarks
8:10 a.m. - 8:45 a.m.

#K1: An Integrated Approach to Aviation, Space, & Defense Standards
L.L. (Buddy) Cressionnie, Senior Manager, Quality & Mission Success Processes, Lockheed Martin Aeronautics, Fort Worth, TX, USA
Alan Daniels, Quality Senior Manager, Boeing Commercial Airplanes, Seattle, WA, USA

The Aviation, Space, & Defense industry has revised its standards and developed guidance documents and best practices to help drive improvements in product conformity and on-time delivery throughout the supply chain. This presentation will include discussion of the various tools that the International Aerospace Quality Group (IAQG) has available to drive improvements into an integrated, systemic framework.

8:45 a.m. - 9:20 a.m.
#K2: What You Need to Know About AS9101 Audits
Gerald L. Antonucci, Ret., NASA, Melbourne, FL, USA

The “new and improved” AS9101 builds on ISO 19011 and ISO 17021. Auditing for effectiveness has always been an expectation of the customers, but the reality is that most auditors focused on process conformance with little regard to the process results. Customers have complained about “certified” suppliers that continually have poor performance issues. This presentation will provide: an overview of the structure of the AS9101 standard; use of the Process Effectiveness Assessment Report (PEAR); and the Objective Evidence Record.

9:20 a.m. - 9:55 a.m.
#K3: Transition to AS9100C Causing Quite a Stir!
Roger Ritterbeck, Aerospace Product Manager, QMI-SAI Global, Cleveland, OH, USA

Organizations certified to AS9100 are required to transition to the ‘C’ version of the standard by July 1, 2012, or lose their certification. The International Aerospace Quality Group has raised the bar on AS9100 certification. Previous audits have focused strictly on conformity. Now the focus is on conformity and this has left some suppliers blindsided. Learn what is causing this situation. Time is running out. It is imperative to learn what needs to be done so your certification does not lapse. Organizations not transitioned by July 1, 2012, will be required to ‘start over’ as a new certification.

10:15 a.m. - 10:50 a.m.
#L1: Implementing ISO 9001: As Easy As 1, √2, π
Kristin Case, P.E., Owner, CaseConsults

If you are planning to implement ISO 9001 or would like a holistic perspective from which to assess your system, this presentation is for you. If you are a complete ISO 9000 geek, the topic is clauses 4.1(a-b), 4.1(c-f), 5.4.1, 5.3, and 5.6 with examples of models for QMS effectiveness. Many organizations implement an ISO 9001-compliant system haphazardly. Then, year after year, the Quality Management System depletes resources away from the real business. In order for the benefits to outweigh the costs, the Quality Management System needs to be well designed. Learn how to sequence your QMS processes and align them your business objectives.

10:50 a.m. - 11:25 a.m.
#L2: A QMS Built to Do More with Less
Trisha L. Balazovic, Director of Quality and Sustainability, Compuware Corporation, Detroit, MI, USA

Compuware Corporation was mandated to obtain ISO 9001 certification eight years ago. The two people delegated to achieve this determined a way to create a global QMS without additional headcount. The two Quality Compliance Office staff members realized they would need experts from each department to get the QMS ready. Compuware’s Quality Planning was designed to allow the work to be completed in seven steps. A Charter defining the attributes, roles, and responsibilities of a Quality Lead Advisor (QLA) was created. In this presentation, the experiences encountered along the way will be described.

11:25 a.m. - 12:00 p.m.
#L3: Integrated Management Systems - Leading Strategies and Solutions
Wayne Pardy, HSEQ Manager, Quality Plus, Inc., St. John’s, NL, Canada; Terri Andrews, President, Quality Plus, Inc., St. John’s, NL, Canada

While many organizations create their Management Systems based on the requirements of their respective areas, integrating Management Systems provides the most effective solution to challenges these organizations face. The purpose of an integrated Management System is to provide a clear representation of all the features of Management System pieces, and how they impact each other. In this session, presenters weave together a practical integrated Management System roadmap.

10:15 a.m. - 10:50 a.m.
#M1: ISO 9001 in a Physician Group Healthcare System, the Good, the Bad, and the Ugly
Robert Burney, MD, Director, Quality Improvement, Medical Services, US Department of State, Washington, DC, USA

This talk will address the implementation of ISO 9001 in a 50 physician group that had as a Champion, Dr. Jim Levett, who is a cardiologist and chief medical officer of the clinic. Dr. Levett and Dr. Burney wrote the book “Using ISO 9001 in Healthcare.” Dr. Burney will discuss the issues and benefits of the use of ISO 9001 in a physicians group that is a for profit organization. Similar results were achieved in both government and private healthcare facilities.

10:50 a.m. - 11:25 a.m.
#M2: Data Analysis and Corrective Action in Healthcare: Bridging the Gulf Between Managers and Clinicians
Tim O'Hanlon, Ph.D., Associate Partner, Atos Origin, Birmingham, United Kingdom

Balancing the need for patient safety, quality, and experience, with the financial constraints can drive a serious wedge between managers and their clinicians. Clinicians are skilled care providers but do not always have the skills or time to define and resolve system problems. This is the domain of the managers. However, the success of any managerial breakthrough is dependent on the clinicians. This presentation allows participants to review the data that convinced clinicians to change their work practices and behaviors.

11:25 a.m. - 12:00 p.m.
#M3: Nurse Driven Catheter Associated Urinary Tract Infection Improvement
Jeannine Konzier, B.S. Nursing, M.E., Director Quality and Infection Prevention, Magee-Womens Hospital of UPMC, Pittsburgh, PA, USA

The attendees will learn about implementing a nurse driven protocol to lower infection rates and improve patient safety. Konzier will describe current process for identification of hospital-acquired catheter associated urinary tract infections and describe methodology for tracking daily catheters. Current practices for documentation in electronic health records will be discussed. Konzier will review how new technology can assist the health care worker, and share best practice on nurse-led indwelling urinary catheter removal protocols.

10:15 a.m. - 10:50 a.m.
#N1: Navigating Self Assessment to the Lowest Risk
Susan Moore, Compliance Assessments Lead, Lockheed Martin Missiles and Fire Control,
Arlington, TX, USA

Risk mitigation is important to senior management. This presentation will share “Out of the Box” tools that can be used to mitigate risk using a self-assessment program. You’ll leave this presentation with tools that can improve the bottom line by reducing escapes, enhancing communication, creating awareness, and improving customer/registrar satisfaction throughout the organization. Insight will be shared on how this proactive approach has improved the performance in a $5B organization.

10:50 a.m. - 11:25 a.m.
#N2: The Aviation, Space, and Defense Industry Controlled Certification Program – Lessons Shared
Sidney Vianna, Director, DNV Business Assurance, Long Beach, Canada, USA

Management system standards depend on conformity assessment. Sidney will present some salient points developed by International Aerospace Quality Group (IAQG) Industry Controlled Other Party (ICOP) Certification Scheme to improve the confidence in QMS Certificates, from the registrant’s customer’s perspective. Oversight of Accreditation Bodies (ABs), Certification Bodies (CBs), Auditor Authentication Bodies and Training Providers, as well as aerospace auditors, holds all parties accountable to the intent of AS91X0. The Online Aerospace Supplier Information System (OASIS) database provides real-time access to critical information such as supplier certification status, auditor authentication status, access to audit data and more. The OASIS website triggers feedback to both ABs and CBs when a stakeholder has concerns about the performance of a registrar or a certified supplier. Feedback promotes accountability by ABs and CBs.

1:00 p.m. – 1:35 p.m.
#O1: Electronic Document Repository and Control
Barry W. Knight, Quality Manager, Naval Surface Warfare Center (NSWC), Crane, IN, USA

Are you spending too much time searching for records or looking for a place to store them? If you are in this situation, attend this presentation. Barry Knight will demonstrate how electronic repositories are much easier to manage and control by using electronic software versus the old style filing and space eating hard copy repositories. He will specifically provide you a unique way to transform hard copy document repository and control into a totally electronic controlled repository (database) while demonstrating cost avoidance and, therefore, reducing the need for space.

1:35 p.m. - 2:10 p.m.
#O2: Implementing an Electronic Support System to Assist in the Maintenance of Your ISO QMS
Ricky Lee Glover, Senior Performance Consultant, Clancey Perfromance Consulting, Lenexa, KS, USA

Many organizations use Electronic Performance Support Systems (EPSS) for their ISO 9001 Quality Management Systems, but these systems do not always yield the expected success. This session will provide participants a demonstration of an Electronic Performance Support System that was specifically designed to maintain ISO 9001 compliant Quality Management Systems. The demonstration will focus on how the EPSS assists the Management Representatives with documenting their ISO 9001 QMS. It will also review case studies related to small and medium size organizations that have successfully used an EPSS for maintaining their QMS.

2:10 p.m. - 2:45 p.m.
#O3: Use Visuals to Get Management Buy-In
Jackie Bower, Sr. Manager, Corporate Quality Services, Jeppesen, Englewood, CO, USA

As a quality professional, if you have ever had someone see you coming down the hall and turn in a different direction, not understand the important findings you are trying to share, or feel like you are speaking a different language, learn how simple visuals can help others understand ISO 9000. Based on the experiences of a global company, this presentation will share lessons learned by a team of quality specialists in eight different countries. All activities discussed are customizable and tailored to fit any business model. Learn how to connect the “dots” between Quality Management Standards.

1:00 p.m. – 2:45 p.m.
#P1: Utilizing Business Operating Systems to Reform Healthcare System
Charli Hoialmen, President, Diversified Management Systems, Clarksville, GA, USA; Craig Meyer, President, The Quality Network, LLC, Dunlap, TN, USA

This workshop is designed to get attendees to understand the value of applying the ISO 9001:2008 criteria and disciplines to healthcare (delivery, pharma, DME, etc.); to have them offer improvement suggestions to their management regarding healthcare issues; to expand their knowledge of issues concerning the improvement of local healthcare and provide potential solutions; and to offer healthcare delivery system-wide improvement suggestions. This workshop will demonstrate how healthcare organizations can realize solid improvement in care provision and cost reduction through the development and implementation of a business Management System based on ISO 9001:2008 principles. It will also present a new model for healthcare that expands these ideas and demonstrates what a quality healthcare system could accomplish by promoting accountability, cost reduction, and improvement of healthcare delivery while utilizing existing business operating systems such as ISO 9001:2008 and Malcolm Baldrige.

1:00 p.m. – 2:45 p.m.
#Q1: Leading a Culture of Performance Improvement
Craig L. Williams, Vice President of Quality, Aerospace Group, Eaton Corp., Jackson, MI, USA

This workshop considers the premise that as an organization improves its Quality Management System to Six Sigma levels and beyond, behavior analysis may be used as a determinant of risk to processes. The organization must use this analysis to determine which systems are at risk and at what time failures are likely to occur. The session will explore the idea that it is when the QMS goes “off-standard,” there is a greater tendency to fail. Based on this thesis, the organization can consider the behaviors that lead to putting the systems at risk and develop adequate plans for Containment, Control, and Communication (the 3 Cs) to mitigate these risks.

2:45 p.m. - 3:00 p.m. Refreshment Break

3:00 p.m. - 3:35 p.m.
#R1: Successful Integration and Registration of Three Management Systems at a National Laboratory
Steve Alvanas, Quality Programs Manager, Oak Ridge National Laboratory, Oakridge, TN, USA

This presentation provides an overview of the journey that Oak Ridge National Laboratory (ORNL) has taken to become one of the few National Laboratories to successfully integrate quality, environmental, and safety Management System registrations. Details will be provided on the process followed to ensure success. This will include efforts to integrate internal audits, management reviews, documents, records, and other related criteria. There will be a discussion on the selection of the registrar. Lessons learned will be provided to describe positive and negative aspects of the efforts.

3:35 p.m. - 4:10 p.m.
#R2: QMS Based on ISO 9001 Improves Government Agency
Rosy Aguilar, VP of Transportation Projects and Programs, Secretria de Comunicaciones y Transportes (Mexico), Mexico City, Mexico

The agency issues driver, pilot, and rail licenses to transport general cargo, specialized materials, and tourists, and additionally, it ensures drivers and pilots are medically capable and free from alcohol or drugs. Communication among other involved organizations, like those related to public health and safety is important to help improve the procedures. Combining two procedures into one, resulted in less paper work. Clarifying requirements from the beginning reduces waste. QMS helps this government agency improve the way things work, better infrastructure, payments on time to vendors, reduced cycle times, etc.

4:10 p.m. - 4:45 p.m.
#R3: A Case Study in Public Administration: Myths and Realities
Maria Dolores Maldonado, Chief Department of Special Vinculations, National Council of Science and Technology, Mexico City, Mexico

How many times have we asked whether the implementation of a Quality Management System (QMS) is suitable for an organization? This presentation will review the QMS implementation in a Mexican government agency. It will review how the integration of a QMS with Public Administration Quality Tools may help to organize the agency. Learn what happened to this government agency responsible for financing technological activities. This is a case study about "what should have happened,” as opposed to the reality of "what really happened

3:00 p.m. - 3:35 p.m.
#S1: Using Cost of Quality to Improve Business Results
Susanne Donovan, Director of Quality Systems, CRC Industries, Warminster, PA, USA

Who doesn’t want to reduce the cost of failures? This presentation explains the basics of Cost of Quality (COQ) and how it can be used as a key measure for improving business results. The different categories of traditional COQ programs, appraisal, prevention, internal, and external failure, will be defined and a modified approach will be suggested. It will cover the basic steps to starting a COQ program, including how to overcome the barriers. It will also explain how Lean & Six Sigma and COQ are complementary.

3:35 p.m. - 4:10 p.m.
#S2: A Dynamic Approach to Corrective & Preventive Action Using the CIPi-Xp Theory
Miriam Boudreaux, RABQSA QMS, ISMS Auditor, CQE, CQM, President, Mireaux Management Solutions, Houston, TX, USA

It is no longer practical to use forms and tools that do not accommodate our fast pace and Do-it-NOW requirements. If we are to improve, we need to get everyone’s ideas for improvement. Although that seems hard, the hardest is to ensure that management takes every opportunity submitted seriously and follows through. So everyone has to work effectively and efficiently. The CIPi-Xp theory incorporates Just-In-Time, Lean, ISO Concepts, and technology in order to achieve Continual Improvement. The CIPi-Xp Theory is based on two ISO principles: Involvement of People and Continual Improvement. In this presentation, you will learn the CIPi-Xp theory through a CIP online application.

4:10 p.m. - 5:10 p.m.
#S3: Integrating Lean and ISO 9001:2008: A Hands-On Factory Simulation
Enrique M. Bekerman, President, Quality Manufacturing Assoc., LLC, Coral Springs, FL, USA
Myriam Ochart, President, O-CHART Management Consultants, Inc., Parkland, FL, USA

This presentation will examine the benefits of maximizing value by integrating Lean concepts into an ISO 9001:2008 system. The presentation starts with an introduction to basic Lean and ISO 9001:2008 concepts and their individual benefits to the organization. The synergy between both methodologies is explored. The presentation alternates classroom learning with a realistic factory simulation. It takes participants from a traditional manufacturing to a Lean Enterprise environment. Along the way, participants will learn how simple Lean methods are used to reduce total lead time, while reducing cost, and increasing profits.

3:00 p.m. - 3:35 p.m.
#T1: The Added Value of ISO 9001 to an Existing Food Safety Management System
Patrick Bele, Food Business Development Manager, Bureau Veritas Certification, N.A., Houston, TX, USA

ISO 9001 certification adds value. Examples of added value include identifying customer expectations beyond food safety, measuring customer satisfaction, and driving Continuous Improvement. The recent surge in food safety certification in North America has caused many to question the relevance of ISO 9001 certification in the food industry. Retailers are now demanding food safety certifications, so ISO 9001 certifications may be considered burdensome. However, food safety & Quality Management Systems can be integrated smoothly. Learn how this integration can be achieved effectively.

3:35 p.m. - 4:10 p.m.
#T2: Food Safety Recall Case Studies - Lessons Learned in System Management
Cathy Crawford, VP, HACCP Consulting Group, LLC, Barksdale, LA, USA; Angelo G. Scangas, President, Quality Support Group, Inc., Peabody, MA, USA

Many recalls offer valuable lessons. Learn how to proactively reduce the chances of having a recall and increase your ability to recover from one by evaluating these public events. There is no single solution to eliminating hazards and recalls, but there are strategies that should be implemented to mitigate those risks. And those strategies are applicable across multiple industries. Lessons learned from case studies of food related recalls emphasize the importance of integrated verification systems. Case studies will provide lessons in Risk Management.

4:10 p.m. - 4:45 p.m.
#T3: How to Sustain Successful Six Sigma Programs
Jeffrey A. Robinson, Ph.D., Vice President, Accelerated Quality Improvement., Peoria, AZ, USA

Improvement programs using Six Sigma are usually not easy to start and often harder to maintain. If important elements are not recognized, the effort can stall, languish, or even fail. This discussion will review prescriptive guidelines for establishing and maintaining these programs with success, as well as a review of some common problems that may develop over time.

4:45 p.m. - 5:00 p.m. Closing Remarks
Lorri Hunt & Jack West, Conference Co-Chairs