Meet Our Opening Keynote Speakers…
Some of the Biggest Names in Quality Management Systems

Connie Conboy, Bayer Corporation (ret) & Chair of ANSI/ASQ ANAB	Joseph DeFeo, Juran Institute, Inc.	Robert Ottolini, General Motors	Alka Jarvis, Cisco Systems & Chair of US TAG to TC 176	Maj Gen Harold L. Mitchell, U.S. Air Force (ret)

TRACK 1

KEYNOTE:
Next Generation of Quality Management Systems

TRACK 2:

KEYNOTE:
Future of ISO 9001/QMS in a Global Economy

8:10 AM - 9:10 AM; Session #ISO011

Next Generation Quality Management Systems (QMS) - How a QMS can Foster Sustainment

Joseph DeFeo, President and CEO, Juran Institute, Inc., Southbury, CT, USA

Many organizations are not sure what to do with their Quality Management Systems or their quality function departments. Mr. DeFeo will present the questions you should be asking as well as some observations from other World Class companies to help you determine your company's future direction for its Quality Management System. Joe will also address the design elements of the future Quality Management System he calls Enterprise Assurance. This will cover the basic premises that are the key underlying principles for creating the Enterprise Assurance environment, steps to create an Enterprise Assurance System, the Enterprise Assurance System Elements, and how the future Quality Management Systems design will help organizations achieve new levels of breakthroughs in performance and sustaining results.

10:15 AM – 10:50 AM; Session #ISO021

Future Relevancy of ISO 9001 in Organizations with Global Presence

Alka Jarvis, Process & Excellence Leader, Cisco Systems, Palo Alto, CA, USA

This presentation discusses growing awareness that new concepts are required in ISO 9001 to ensure that it is the the top Quality Management Systems Standard to facilitate positive customer experience and spur growth. There are challenges that are faced by organizations such as acquisitions, innovations, outsourcing, expansion, political risks, and, most of all, competition. The global economy is rapidly changing. It is important for the Standards to remain relevant to meet the changing needs of these organizations with world-wide presence. There is a role for ISO 9001 in this changing atmosphere. However, enhancements are needed to ensure it remains relevant to address complex global business requirements.

9:10 AM - 9:50 AM; Session #ISO012

General Motors and Quality Standards: Drive for Customer Satisfaction

Robert Ottolini, Executive Director Global Quality Strategy, General Motors, Detroit, MI, USA

This presentation outlines GM's current quality strategy of satisfying the customer over the complete ownership experience. Mr. Ottolini will discuss how standards play a role in this strategy whether a specific component requirement, or a customer interface on a service call is involved. From initial program conception through the development, manufacturing, sales, and dealer interface, it is an absolute goal of GM to meet or exceed customer expectations. Standards play a key role in ensuring that this objective is met. GM, like many manufacturers, has been focused on internal quality metrics (i.e., warranty frequency, cost). Application of standards drive the discipline required. Not having any standards to meet these objectives results in divergence -- even with committed leaders. On the other hand, over-prescribed standards curtail some of the innovation required to move forward with an evolving strategy. Finally, this presentation will describe to how an organization deals with "walking this line" and manages to drive enterprise focus and accountability.

10:50 AM – 11:25 AM; Session #ISO022

7 Best-Kept Secrets of Great Quality Leaders

Connie Conboy, Retired Vice President of Corporate Quality and Business Excellence, Bayer Corporation; Board Chair of ANSI-ASQ National Accreditation Board; SherTrack, LLC, Bloomfield Hills, MI, US

A You have the tools and you know the rules and now it's time to learn the real secrets of success from a few of the great quality leaders of today! Of course, it's not as simple as it sounds. Connie Conboy will help you explore how to transform your quality process by uncovering the seven best-kept secrets of success used by the top quality leaders. She provides vivid examples of what actually works and, uncovers hidden gems from a few top corporate quality leaders' private play books. Connie's remarks are based on experiences from her role as Vice President of Corporate Quality and Business Excellence for Bayer Corporation and Board Chair of ANSI-ASQ National Accreditation Board.

11:25 AM - 12:00 PM; Session #ISO023

Quality Management Systems in a Government Organization

Maj. Gen. Harold L. Mitchell, U.S. Air Force, Washington, D.C., USA

Maj. Gen. Harold L. Mitchell is Deputy Inspector General of the Air Force, Office of the Secretary of the Air Force, Washington, D.C. He assists in the performance of all responsibilities of the Inspector General. The Inspector General provides inspection policy, and oversees the inspection and evaluation system for all Air Force nuclear and conventional forces; oversees counterintelligence operations and chairs the Air Force Intelligence Oversight Panel; investigates fraud, waste and abuse; oversees criminal investigations; and provides oversight of complaints resolution programs.

TRACK 3

Innovative Approach to Auditing

TRACK 4

Managing Risk with ISO 9000/QMS

1:00 PM - 1:35 PM; Session #ISO031

A Shot Across the Bow - Application of the Process Approach for Effective Internal Audits

Paul Palmes, Business Standards Architects, Inc., Prescott, WI, USA

Auditing for effectiveness is a requirement of ISO 9001:2008, yet most internal audits continue to audit only for compliance. "Auditing the Clauses" is only half of the story. Internal audits are often of little interest to top management. This presentation captures and explains the key elements within ISO 9001 that enable internal and third party auditors to conduct highly effective audits.

1:00 PM - 1:35 PM; Session #ISO041

Risk Management and Preventive Action

William Houser, President, Eagle Force, Inc., Spring, TX, USA

Corrective action can be a pain in the @#$! It takes a lot of time and energy and can be costly. Preventive action takes much less time and energy and is a higher payback. So why don’t we pursue preventive actions? The fact is, preventive actions will not come looking for you like corrective actions do. That is the primary reason that we are not generating many preventive actions. You will learn how to establish and operate an effective risk management process that will advance your organization toward a proactive preventive culture.

1:35 PM - 2:10 PM; Session #ISO032

Audit Risk: Find It, Manage It or Verify It

JP Russell, Managing Director, QualityWBT Center for Education, Lake Wylie, SC, USA

Audit Risk could mean risks associated with auditing, verifying risk treatments, or risks observed while conducting an audit. Risk is a massive topic and confusing to many of us. This session will discuss the application of risk as part of an audit program. It will look at ISO 19011 guidance and ASQ CQA Body of Knowledge for auditors. It will review how risk should be managed, how it can it be verified, and when can it be identified by auditors and audit program managers.

1:35 PM - 2:10 PM; Session #ISO042

Applying Risk Management Methods to Outsourcing and Supplier Controls

Richard Vincins, VP, Quality Assurance, Emergo Group, Austin, TX, USA

Outsourcing introduces risk! Some organizations outsource key activities such as design processes, customer service, and auditing that, if not controlled, can lead to variation in the supply chain and ultimately loss of revenue. In this session, you will learn about ways to implement, review, and manage a risk management process to assure the appropriate risk level is assigned to those outsourced activities and how to effectively manage those risks.

2:10 PM - 2:45 PM; Session #ISO033

eAuditing - The Next Frontier of Auditing

Shauna Wilson, President, Amazon Consulting, Inc., Corvallis, OR, USA

Traditionally, ISO 9000/QMS auditors have traveled to company sites to audit processes, but in today's world, auditors find that many of these "work from home" employees have also traveled to the site that day for the audit or are attending the audit via an online system. The concept of eAuditing raises doubt, but e-Auditing presents a host of benefits to companies that could help them solve their remote communication issues. eAuditing is a more efficient and cost saving method for conducting audits at distant sites, including supplier locations. In this session, attendees will learn about applicable environments, eAuditing fundamentals, and benefits derived from using online auditing methods.

2:10 PM - 2:45 PM; Session #ISO043

Using the QMS to Manage the Risk of Liability

Dr. William Stimson, Forensic Engineer, Charlottesville, VA, USA

Remember “The Ford-Firestone Litigation of 2001” or the “Toyota Litigation of 2010?” These companies faced lawsuits of hundreds of millions of dollars and product recall costs in the billions. From 2000-2010, the Department of Justice (DOJ) successfully prosecuted over 1300 liability cases therefore supporting that liability in operations should be addressed in any serious plan of risk management. Among the first things a forensic engineer will look for is systemic QMS nonconformance. Dr. Stimson will show you how ISO 9001 clauses can be implemented to reduce the risk of liability in operations.

TRACK 5

Implementing QMS at the Enterprise Level

TRACK 6

Successful Supply Chain Management

1:00 PM - 1:35 PM; Session #ISO051

Implementing ISO 9000 in a Mature Company

Ben Overwyk, Technical Service Engineer, Olin Brass, East Alton, IL, USA

This presentation will show how a 200-year-old company went from no Quality Management System to a certified ISO 9000 company in less than one year. Yes, buy-in was a significant challenge. We had processes and documentation that had not been updated for over 50 years! As you would expect, many employees were against the changes that ISO 9000 brought. Once they understood the primary goals were to improve product quality, customer satisfaction, and improve their quality of work, those changes were perceived as positive. A major accomplishment was imparting the fact that the Quality Management System was theirs and not just for management.

3:05 PM - 3:40 PM; Session #ISO061

The New Automotive Supplier Management Process

Ralph (Dan) Reid, Program Manager, Quality, AIAG, Southfield, MI, USA

Leadership of automakers and their suppliers indicated to AIAG that management of tier two and below suppliers is considered insufficient. The automakers and tier one suppliers have insufficient resources for supplier development after the great recession of 2009. AIAG initiated a project to address this concern. The Project Team scope was to develop a Tier One Supplier Management process for improving supplier performance to mitigate risk of poor product quality from the supply chain. Using a common supplier management process across the industry will result in more effective supplier evaluation, and selection. Deliverables from this project will be presented in this session.

1:35 PM - 2:10 PM; Session #ISO052

Developing an ISO 9000 Compliant QMS in a Variation-Rich Manufacturing Setting

Rick Homman, General Manager, Owl's Head Alloys, Bowling Green, KY, USA

The presentation will chronicle the inherent challenges faced while building and documenting a QMS based on procedures, practices, repeatability, and predictability while dealing with key process input variables and key process output variables that are historically uncontrolled (the scrap industry) or appear to be uncontrollable.

3:40 PM - 4:15 PM; Session #ISO062

QMS for Manufacturing: Increasing Brand Reputation Through High Quality Products

Mohan Ponnudurai, Industry Solution Director, Sparta Systems, Holmdel, NJ, USA

Today manufacturers operate in a global environment for production, sourcing, sales, and dispersed supply chains with enormous challenges from both consumers and regulatory agencies. Managing suppliers in various geographical regions requires central harmonized and standardized processes. Inadequate suppliers cannot only be costly from a pure financial sense but also may cause irreparable harm with respect to brand. What is ideal is to extend your ‘four walls’ to allow your suppliers, partners, and collaborators to use your Quality Management System to optimize quality, and to reduce cost and risk. Thus improving the bottom line.

2:10 PM - 2:45 PM; Session #ISO053

Obtaining Multiple QMS Certifications

Monroe Ratchford, President, LEAPS Consulting, LLC, Dumfries, VA, USA

Would having multiple QMS standards certifications make your company more competitive, highlight your passions, and quantify your strengths? Would expertise in information security and technology management be attractive to your customer’s privacy, account numbers, or cyberspace fears? Customers keep raising the bar and not only want a well-managed quality company, but one that has specific expertise critical to their success. Having multiple certifications may be the solution to this challenge. This presentation explores: the business advantage of having multiple certifications; making multiple certifications implementation easy; and shares some lessons learned. The presentation will tell you the story of how a Federal Agency took on certification to ISO 9001, ISO 20000, and ISO 27000 simultaneously and succeeded.

TRACK 7

Best Practices in Risk Management

TRACK 8

Road to Improved Certification & Communication

3:05 PM - 3:40 PM; Session #ISO071

Risk Management and Its Impact on Quality Management Systems

Morgan Palmer, Product Marketing Analyst, EtQ, Farmingdale, NY, USA

Who doesn’t want consumer confidence in their company’s products and services? Who wouldn’t love a positive return on investment for their shareholders? These achievements depend on identifying, handling, and managing risk across your supply chain. There is a growing trend in the industry to create a holistic approach to Risk Management, utilizing both proactive and reactive risk factors. To this end, Risk Management can be applied to all aspects of the enterprise and risk can influence quality at many different levels.

3:05 PM - 3:40 PM; Session #ISO081

Actions to Improve Accredited Certification to ISO 9001

Randy Dougherty, Chairman and President, International Accreditation Forum (IAF), Milwaukee, WI, USA

ISO 9001:2000 was published with a three-year period for companies with an accredited certification to complete the transition. When the transition progressed slowrt than expected, key individuals within ISO/TC 176 and at IAF formed the ISO 9000 Advisory Group (IAG) to try to answer this question. The IAG, jointly chartered by ISO/TC 176 and the IAF Technical Committee, constructed a cause and effect diagram of all possible threats to the credibility of third-party certification. They then attempted to identify potential solutions working with appropriate bodies: ISO, ISO/CASCO, and IAF. This presentation will briefly explain what has been achieved.

3:40 PM - 4:15 PM; Session #ISO072

Risk-Based Auditing in Supplier Quality Management - Best Practices

Speaker to be announced.

Effectively managing supplier quality is a critical part of an organization’s business performance strategy. 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. This presentation will focus on the incorporation of Supplier Quality Management (SQM) principles into the Supplier Auditing Process. It will also discuss how to use these SQM principles to more effectively conduct virtual and on-site audits.

TRACK 9

Panel: ISO 9001 & ISO 14001: The Revisions as a Partnership

TRACK 10

ISO 9000 Speed Networking

4:15 PM – 5:00 PM

Panel Lead: Lorri Hunt, Kansas City, MO, USA; Panel Members:

Jack West, Susan Briggs, and Jose Dominguez

ISO 9001 and ISO 14001 are two of the most widely used standards. This session provides an excellent opportunity to hear the most current information on ISO 9001 and ISO 14001 by North American experts participating in both revision processes. At the time of the conference, it can be anticipated that ISO 9001 will be entering the Committee Draft (CD) stage and ISO 14001 will be at Working Draft3 or CD1. Both of these stages are based on progress of the working group. The panel will discuss how the U. S. Technical Advisory Groups and INLAC work to develop consensus positions among the experts working on these management systems standards. Both standards are required to use a new mandated structure and a significant amount of identical text. You will learn the challenges and benefits associated with implementing such a structure. 

5:00 PM - 6:00 PM

Brian Clark, IT/QA Manager, Engines, Inc., Jonesboro, AR, USA

Space is limited. Please sign up in advance!
Come and join us for this fun session! Each participant is given three minutes to get to know another participant. At the end of this interval, participants are rotated to meet each other over a series of short “interviews.” You’ll be amazed at the results from a short discussion with someone you’ve never met before. The technique has resulted in new clients, projects, jobs, and friendships. Amazing connections have started at speed networking sessions!

TRACK 11

Implementing ISO 9000/QMS in Healthcare

TRACK 12

Improving Healthcare Using ISO 9000/QMS Tools & Techniques

8:10 AM - 8:45 AM; Session #ISO111

The ABC's of ISO 9000/QMS Communication and Training as Applied in Healthcare

Dr. Wanda Umber, Chief, Strategic Planning & Learning Reseach, Department of VA Cooperative Studies Program, Albuquereque, NM, USA;
Co-Presenters: Kimberly Moore, and Susan Rogers

The Veterans Administration continues to grow and the ISO 9000/QMS Consultation Division was created to provide a sustainable framework consistent with the ISO 9001 principles and to support the creation of effective and repeatable processes for use throughout Veteran Healthcare. This session will provide guidance on how to develop training and communication solutions for that purpose.

8:10 AM - 8:45 AM; Session #ISO121

9001:2008 and CMS Conditions of Participation Requirements

Charli Hoialmen, President, Diversified Management Systems, Clarkesville, GA, USA

This presentation will demonstrate how to develop one overriding business management system for healthcare organizations that addresses multiple requirements by the effective integration of existing business operating systems, such as ISO 9001:2008 and CMS Conditions of Participation that promote accountability, cost reduction, and improvement of healthcare delivery. Charli will discuss the process of integration of multiple standards as well as the benefits of system integration

8:45 AM - 9:20 AM; Session #ISO112

Implementing a QMS as a Lean Initiative in Healthcare

Gary J. Wade, QA Manager, Institute for Transfusion Medicine, Pittsburgh, PA, USA

This case study illustrates a company’s goal and efforts to Lean out its QMS implementation. It achieved the goal of eliminating manual processes, reducing printing from 120,000 pages per year to zero, and improving speed of delivery by 75%. This was done in the first phase of the QMS-error management process. This presentation will discuss details that are used and the lessons learned.

8:45 AM - 9:20 AM; Session #ISO122

Impacting a Clinical Trial's Success Using ISO 9000, cGMPs, Baldrige, and the ICH Guidelines

Dr. Julia Vertrees, Assoc. Director-QA, Department of Veterans Affairs, Albuquerque, NM, USA; Co-Presenters: Mike Sather, Jan Hickey, Stanley Johnson, Kathy Boardman, Cindy Colling, Shirley Madrid, Mark Jones, and Stuart Warren

The Department of VA Cooperative Studies Program (CSP) Clinical Research Pharmacy Coordinating Center is responsible for supplies used in multicenter clinical trials. Clinical supplies are the core of drug and device trials that ensure patient safety. The integrity of the supplies and process control must guarantee the results of the trial, whether positive or negative. This session demonstrates how quality standards and guidelines apply to all processes associated with the clinical supply chain

9:20 AM - 9:55 AM; Session #ISO113

The Evolution of a Healthcare Organization's Journey: Implementing ISO 9001 in a Multi-Medical Center Organization

Cynthia Due, Acting Director, Veterans Healthcare Administration, Washington, DC, USA

Veterans Healthcare Administration (VHA) Sterile Processing Services (SPS) are responsible for sterilizing reusable medical equipment. VHA's ISO Consultation Division is charged with implementing educational resources for deployment of the ISO 9001 System. The focus of the presentation will be: why Implement ISO 9001:2008 in SPS Services; comprehensive training for internal consultants; maintaining the Quality Management System; performing internal audits; and incorporating a Reliability Management System (PRISM).

9:20 AM - 9:55 AM; Session #ISO123

ISO 9001 Supports Accountable Care Organization Operations

Mickey Christensen, President, TQM Systems, Baton Rouge, LA, USA

This presentation will show how an Accountable Care Organization (ACO) can benefit by implementing an ISO 9001 management system. By doing so, the processes necessary for an ACO become easier to manage. The payoff for ACO's will be in managing efficiently while providing quality care. The measures to be reported to CMS will impact the reimbursements as well as "bonuses" for exceeding goals of quality and cost.

TRACK 13

Application of Newly Revised QMS in Aviation, Space, & Defense

TRACK 14

AS9100 Audits and Self-Assessment

8:10 AM - 8:45 AM; Session #ISO131

AS9100: An Innovative Approach for Aviation, Space, and Defense QMS

Alan Daniels, Process and Systems Manager, The Boeing Company, Lake Stevens, WA, USA;
Co-Presenter: L.L. Buddy Cressionnie

This presentation will focus on the aerospace standards for Quality Management System that have been promoted and implemented by the major aviation, space, and defense companies across the world. Emphasis will be on unique characteristics of these standards. The flagship standards for the International Aerospace Quality Group (IAQG) AS9100, AS9110, and AS9120 are currently being revised and current efforts will be shared.

10:15 AM - 10:50 AM; Session #ISO141

Launch Into the Future with a New Vision of Self-Assessment

Susan Moore, Compass/Self-Assessment Lead, Lockheed Martin Corporation, Arlington, TX, USA

The best way Lockheed Martin can secure its future is to stay focused and deliver value to its customers. This is not only true for Lockheed Martin, but any other corporation. Lockheed Martin has taken a proactive position and focused on a robust self-assessment process as a futuristic improvement missile. By sharing its process, any organization can direct their workforce toward a proactive approach to identify and avoid future risks. Its self-assessment program instills process ownership from the general manufacturing workforce to the highest level of management. It focuses on preventive action. Success stories and templates will be shared during the presentation.

8:45 AM - 9:20 AM; Session #ISO132

AS9100 Rev. C & the Supply Chain: Lessons Learned Implementing the New Revision in Small Companies

Doug Anton, Founder of AEM Consulting Group, Inc., Ashland, OR, USA;
Co-Presenter: Carole Anton

This presentation is a brief review of aerospace industry dynamics behind the Rev. C changes to AS9100 and the additional impact of AS9101. This revision means much more than changes to the standard. It showcases the heightened expectations of the prime aerospace companies to cull the supply base and dramatically improve quality, delivery, lead-time, and cost.

10:50 AM - 11:25 AM; Session #ISO142

Aerospace Expectations, Beyond Transition

Roger Ritterbeck, Aerospace Product Manager, Bureau Veritas, Cuyahoga Falls, OH, USA

Industry expectations of the suppliers are to deliver quality product, on-time. To accomplish this objective, systems must be process based and performance driven. Surveillance audits to the AS91XX:2009 standards will get tougher. If the indicators are customer requirements that are not met, then the expectation is it is a major nonconformance. The intent is to focus on poor performance of the organization. The section defines parameters when the organization’s certification is suspended. Failure by the organization to demonstrate effective corrective action on repeat nonconformities, the lack of actual performance data, or lack of operational control shall warrant suspension. The “show stopper” is going to be corrective actions that address repeat nonconformities. Many industry representatives have said "AS9100 certification should be tough to achieve and even tougher to maintain."

9:20 AM - 9:55 AM; Session #ISO133

Risk-Based Auditing as a Requirement of AS9100

Dr. Catherine Martin, Audits & Surveillance, Raytheon, Fullerton, CA, USA

This presentation is about developing a risk-based quality audit process to streamline the audit process and reduce costs. A new requirement in AS9100C is to implement a risk management process applicable to product and organization. Risk-based audits represent a trend in business and financial audits. With shrinking resources and increased customer pressure, quality professionals must streamline processes to reduce costs for compliance and risk management.

11:25 AM - 12:00 PM; Session #ISO143

Round Table Discussion for Aviation, Space, & Defense

Since AS9100/9110/9120:2009 standards were launched in 2011, many in the ASD supply chain have struggled to make the transition or maintain compliance.  Experts will discuss “lessons learned” and strategies necessary for successful and sustainable quality system implementation. Please submit your questions in advance.

TRACK 15

ISO 9000/QMS Best Practices

.TRACK 16

Using ISO 9000/QMS for Competitive Advantage

10:15 AM - 10:50 AM; Session #ISO151

QMS Quick Self-Assessment - What a Good QMS Looks Like

Colin Gray, President, Cavendish Scott, Inc., Denver, CO, USA

Often management believes they have a solid management system. Frequently they don't. A tool is needed to give a simple and quick review of the QMS. This requires answering the question, "What does a good QMS look like?" The idea is to define a good QMS with limited number categories that focus on best practices. The ideal QMS and the self- assessment tool are presented so that you can bring back and start using.

10:15 AM - 10:50 AM; Session #ISO161

Maximizing the Effectiveness of Voice of the Customer with Social Media Tools

Victor Canada, Operational Excellence Consultant, ASQ 1521, Prairieville, LA, USA

Communication and training come up in discussions among professionals seeking to solve problems and improve effectiveness in their organizations. Voice of the Customer, Root Cause Analysis, Employee Engagement, project management, and continuous improvement efforts rely on communication and training. Social Media and online collaboration technologies provide new and innovative methods for maximizing effectiveness.

10:50 AM - 11:25 AM; Session #ISO152

Keys to Creating Accountability in a Quality Management System

Cynthia Juncosa, Director, Lean Compliance Partners, Miami, FL, USA

An effective Quality Management System (QMS) is dependent on the accountability of every employee. Employees may view the QMS as punitive, with reprisals for mistakes, or missteps. This attitude towards the QMS may make it difficult to get employees to admit to errors and correct them. It is possible to cultivate a positive attitude towards the QMS. The culture becomes results-oriented, and open to improvements. Participants will be taken through the stepping stones to creating a culture of accountability.

10:50 AM - 11:25 AM; Session #ISO162

Impacting Manufacturing Performance and Product Quality Through Good Data Collection

Peter Guilfoyle, VP, Marketing, Northwest Analytics, Inc., Portland, OR, USA

To become a top performer, manufacturers need to extend beyond their current quality analytics to Enterprise Manufacturing Intelligence (EMI). EMI allows everyone in the organization to gain a deeper understanding of quality through five functions: Aggregation, Contextualization, Analysis, Visualization, and Propagation. The presentation uses real-world user profiles to demonstrate best practices for data collection.

11:25 AM - 12:00 PM; Session #ISO153

Keeping it Real: Audit Findings & Best Practices in Document & Record Management

Raj Joshi, Product Manager – Entropy Software, British Standards Institution (BSI), Reston, VA, USA

Organizations may be driven to action more by pain than by gain. BSI has analyzed years of data. Document & record management are a high percentage of major findings. These findings are quality concerns that are reflected in downstream effects like regulatory discipline and decreased customer satisfaction. Without effective document & record controls as a core component of their Quality Management Systems, organizations can easily fall prey to quality issues. Without an organization-wide approach to managing documentation companies leave themselves vulnerable. BSI will cite case studies of challenges faced by the clients, the actions taken to address these situations, and the results achieved.

11:25 AM - 12:00 PM; Session #ISO163

Your Best Foundation - How Your ISO 9001:2008 can Fast-Track You to CMMI Level 3

Hilary Benoit, Director of Quality, W R Systems, Ltd., Herndon, VA, USA

As a mid-size company doing business with the Federal Government, WR Systems, Ltd. found that both ISO 9001:2008 and Capability Maturity Model-Integration (CMMI) were required as differentiators in the government world. This is case study of how WR Systems, Ltd. started from scratch to build a highly-successful QMS, compliant with both ISO 9000 and CMMI, using limited resources.

TRACK 17

Innovative Use of Multi-Standard QMS in Healthcare

TRACK 18

QMS Successes in Service and Government

1:00 PM - 1:35 PM; Session #ISO171

Potential Revamp of Healthcare System

Mickey Christensen, President, TQM Systems, Baton Rouge, LA, USA;
Co-Presenter: Charli Hoialmen

Healthcare in the USA is currently a broken system. Several people who worked in healthcare developed a proposal to revamp the healthcare system. This proposal would affect all those who are involved in the provision of care and payments for the care provided. The idea is to focus on the patient/doctor relationship and have the patient participate in more of the decision making. The proposal would impact at least DME, insurance, pharmaceuticals, government, hospitals, doctors, labs, home care, and patients.

1:00 PM - 1:35 PM; Session #ISO181

The Application of ISO 9001: 2008 in a Service Related Industry

Thomas Johnston, Corporate Manager Quality Assurance, Norton Lilly International, Essington, PA, USA

The ISO 9001:2008 Standard was written in such a way that its focus is primarily directed towards the manufacturing sector. The phrasing of the written standards as well as the classes that are offered by various registrars are largely designed for companies that manufacture a "product." This speaker has written the processes and procedures for three different service related companies and helped them obtain their certifications to ISO standards.

1:35 PM - 2:10 PM; Session #ISO172

The Six-Source Model for QMS Success: Creating a Reliable Patient Safety Culture

David Maxfield, VP of Research, VitalSmarts, Provo, UT, USA

CDC reports in the U.S. two million people get hospital-acquired infections (HAI) annually and 90,000 die. An effective way to combat HAIs is to ensure healthcare professionals wash their hands. The national average hand hygiene compliance rate remains below 60%. Spectrum Health System implemented hand hygiene initiatives. Despite these, Spectrum did not improve its compliance rates until implementing the Influencer Model. It organizes influence strategies into six sources that both motivate and enable people to change.

1:35 PM - 2:10 PM; Session #ISO182

Using ISO 9001 QMS to Sustain Operational Results: "Department of Defense Case Study"

Lynda Fox, President/Senior Consultant, Objectives International, Inc., San Diego, CA, USA

This presentation will provide a case study on how a Department of Defense facility successfully used the ISO 9001 Quality Management System (QMS) to achieve improvements in its daily operations, its overall customer satisfaction, and in the delivery of core business services, and repairs for buildings, equipment and hospital systems on Navy and Marine Corps installations.

2:10 PM - 2:45 PM; Session #ISO173

The New Pilot and Navigator in Healthcare: Patient Safety Organizations and QMS

Douglas Dotan, Executive Director, PSO Services Group, LLC, Bellaire, TX, USA; Co-Presenters: Michael Dowling, and Graciela Perez

The Patient Safety and Quality Improvement Act (PSQIA) encourages healthcare organizations to share quality and patient safety information. To implement the PSQIA, the HHS issued the PSQI Final Rule. They authorized the creation of Patient Safety Organizations (PSOs) to improve quality and safety. The Institute of Medicine suggests that PSOs are the ‘best way' to share knowledge between healthcare organizations. The HIMSS Electronic Health Record Association committed to work with PSOs as part of Meaningful Use. Hospitals will need a QMS to accomplish this task.

2:10 PM - 2:45 PM; Session #ISO183

Implementing a QMS in a Forensic Laboratory

Denise Robitaille, President, Robitaille Associates, Southborough, MA, USA

Most criminal labs are required to achieve accreditation to ISO 17025. The forensics community is new to the concept of Quality Management Systems. Their existing structures contained robust provisions for inspection, reports, and traceability. However, additional requirements relating to lab management review, qualifications of suppliers, process control, corrective action, etc., were missing. They face challenges. This presentation will describe those challenges and some of the lessons you might take away from their successes.

TRACK 19

Innovative New Methods in Quality Management

TRACK 20

QMS Case Studies & Applications

1:00 PM - 1:35 PM; Session #ISO191

Benefits of Waste Reduction Through QMS Implementation

Baskar Kotte, CEO, Quality Systems, Enhancement, Inc., Roswell, GA, USA

Many QMS practitioners still face difficulties in realizing the benefits of waste reduction through QMS implementation. This session clarifies several key terms used in implementing QMS and explains key concepts such as Process Approach, Plan Do Check Act, and emphasizes the effective use of Eight Quality Management Principles applied to Waste Reduction. The attendees will be made aware of the types of challenges encountered in achieving waste reduction. 

3:05 PM - 3:40 PM; Session #ISO201

Cyclic Interactive Auditor Training for Enhanced Retention and Performance

Mary-Anne Cobill, Quality System & Supplier Specialist, Lighting and Imaging Schott North America, Southbridge, MA, USA

Typically auditor training is dry by nature and can lead to inattention due to the inability to process large amounts of information at once and the perception of the information sounding repetitious. This is true when the training consists of reviewing the "text" of standards or any case of "reading" necessary material. It is known that learning is a function of position in that the first and last information in a session is best retained while information occurring in "the middle" is often lost. Therefore, it makes sense to break the audit training into cycles to facilitate more first and last position information opportunities. It is important to assess training retention and aptitude on an individual basis to ensure the effectiveness.

1:35 PM - 2:10 PM; Session #ISO192

Innovative Management Review

Beth Leonard, Corporate QA Director, DMI, Bethesda, MD, USA

Often organizations adapt a quick and infrequent management review process, attempting to hold a single, annual management review to meet the requirements of ISO 9001:2008. This can be lengthy, cumbersome, and reactive. An effective management review process can be established by scheduling more frequent action team meetings. A well thought out schedule provides the ability to be proactive, capture valuable metrics, and understand trends impacting day-to-day responsibilities. A strong management review process will drive continual improvement and reduce inefficiencies. The presentation will include a case study.

3:40 PM - 4:15 PM; Session #ISO202

Achieving High Quality in Data Visualization

Michael Scofield, Assistant Professor, Loma Linda University, Loma Linda, CA, USA

This presentation discusses the difference between raw data and information. It explores the data-to-information life cycle and the potential points of failure. It covers the analysis and graphic tools and techniques which information is expressed. It reviews the importance of context (historical, lateral, etc.) in moving raw data towards information. It discusses survey graphical techniques and case studies that illustrate the importance of context in understanding the consequence of a data point. It explores simple mathematical and graphic techniques for putting raw metrics into more meaningful context. Included is a "rogue's gallery" of charts that are misleading, ambiguous, or simply impossible to read and interpret and shows how they could be improved.

2:10 PM - 2:45 PM; Session #ISO193

Windows-Based Document Management for Improving Quality Management Systems

Matthew Meigs, PR Manager, M-Files Corporation, Dallas, TX, USA

Document management and control are critical components of quality operations. Good manufacturing practice, FDA regulations, and ISO 9000/QMS requirements require that companies manage file versions, control employee access, facilitate training initiatives, and implement appropriate change control procedures for all documents. To succeed in this environment, organizations require a comprehensive solution tightly integrated with Windows that can manage and control document access and revisions across the enterprise. You will learn how to use windows-based document management.

TRACK 21

Improving Customer Satisfaction Through QMS

3:05 PM - 3:40 PM; Session #ISO211

Selective Implementation of ISO Standards can Promote Continual Improvement

Dr. Milton Krivokuca, Program Coordinator, California State University, Dominguez Hills, CA, USA

Successful implementation of an ISO 9001 Quality Management System reflects the maturity of an organization’s process management system. Changes in the global community drive the need for sector specific ISO standards, such as ISO 14001, 26000, and 50001. Certifications in addition to ISO 9001 are not necessary; however, specific elements within sector standards may be applicable to ISO 9001 certified organizations. The environment, social responsibility, and energy management are just three issues affecting most organizations. Adopting elements from sector specific standards into existing ISO 9001 programs provides opportunities for continual improvement.

3:40 PM - 4:15 PM; Session #ISO212

What Is ISO 9000 from the Customer Standpoint?

Marta McCann, Manager, Business Development & Process, ABS Quality Evaluations, Hackensack, NJ, USA

This presentation focuses on developing and implementing an ISO 9001 system for improving customer communication and satisfaction. In an organization, ISO 9000 is a way to strengthen the overall operation through a systematic approach. It can also be a new way of producing and servicing your clients and receiving a good return. ISO 9000 provides a high level of structure throughout all facets of an organization. Implementing ISO 9000 is a way of thinking if you were the customer, what type of product/service you would want to receive from your supplier or provider. ISO 9000 starts from the top by believing in the quality service that is needed to bring a positive culture to a company. 

TRACK 23

END KEYNOTE - How to Communicate with Impact & Authority ... High Impact Techniques that Work

This final keynote is a “must attend”. Whether you apply the ideas for business or personal use, this program will influence your daily choices on your life path to success.

Dr. James Melton is the author of several best-selling books, and has an eight-part series on his work titled, Reaching New Heights of Excellence, produced by Public Television.

4:15 PM – 5:00 PM; Session #ISO231

Dr. James Melton, Speaker / Author, Yucca Valley, CA, USA

"The single most important ingredient to command leadership and the respect of your peers is the ability to convey your ideas in an intelligent, clear, concise fashion." This presentation is designed for the busy professional who is ready for a no-nonsense approach to enhancing the teaching and learning experience. Presentation highlights include: preparation; voice power; audience response; professional image; handling resistant people; visual aids; style and delivery; humor with impact; confidence enhancement; consistent, dynamic delivery. Through this presentation, you will learn to deliver excellent material with impact and authority and put the spark back in your communications.