Quality Revolution .... Evolution 
October 10 & 11, 2013  Tucson, Arizona

 

9:45 a.m.

10:45 a.m.

12:00 - 1:30 p.m.

1:45 p.m.

2:45 p.m.

Audit 
(Turquoise III)

A1: Exorcising the Seagull Syndrome

Lori Williams

(Beginner to Intermediate)

A2: How Delightful is Your Audit Program

Lance Coleman

(Beginner - Intermediate)

 Lunch, Announcements and

 

A4: Audit Interviews

Larry Whittington

(Beginner)

QMD
(Turquoise II)

B1: Quality Focused Organizational Change

Milton Krivokuca

(Intermediate)




 


DCD
(Turquoise I)


Special
(Turquoise I)

           

5:30 - 7:00 p.m    Audit Division/Quality Management Division Annual Business Meeting – All conference attendees are  invited to participate       * (Audit Division member password required.to access prior meeting minutes)  

7:00 - 10:00 p.m.  All Conference Attendees Thursday Evening Reception

FRIDAY OCTOBER 11

 

           
                       

9:45 a.m.

10:45 a.m.

12:00 – 1:30 p.m.

1:45 p.m.

2:45 p.m.

3:45 p.m.

 

Audit 
(Turquoise III)

Lunch, Announcements and

QMD
(Turquoise II)

B7: Evolution and Revolution in Decision Making

Grace L. Duffy, LSSMBB, CMQ/OE, CQA, CQIA

(All)

B8: Moving Quality Towards the Aesthetic

Kurt Stuke, DA, CMQ/OE, CQA, CQIA, CSSGB

(Beginner)


DCD
(Turquoise I)

C10: Executive Panel Discussion

Tim McKay, Wm Thomsen, Celia Gray, Darren James & other industry exec leaders

(All)

Special
(Turquoise I)

D6: The Many Faces of Auditing

Sandor G. Juhasz, CMQ/OE, CQA

(All)



Keynote JR McGee, Managing Partner and CEO of X-Stream Leadership Group

Compelling Quality for a World in Chaos

J.R. McGee’s experience includes 30+ years in services as an Aerospace Executive, Senior Program Manager, Engineer, and Systems Analyst. As internal and external principal consultant/subject matter expert for business management with the world’s largest aerospace firm, he directly impacted every functional aspect of operations. A certified Master Black Belt in LEAN Six Sigma, J.R. has been developing high performance organizations on a professional and personal level for his entire career. He’s been a program manager at “top gun” ranges worldwide, specializing in the training and development of high performance work teams with a specific focus on fighter pilots and special forces, as well as providing field engineering and operational support to intelligence and counter-terrorism operations. He holds a degree in Electronic Technology from Troy State University (European Div) and a degree in Business Management from the University of Maryland. He has also completed the Strategic Studies Program at Carnegie Mellon Business Institute, as well as the Strategic Leadership Program at the Goizueta Business School, Emory University. Today, J.R. is a professional faculty instructor at Drexel University, and he sits on the Executive Board for Drexel’s Nano-Technology Manufacturing Council. He is passionately committed to improving business strategy execution and developing world-class organizations of every description. J.R. also provides Executive Coaching, Leadership Development, and Business Process Improvement sessions for management teams worldwide. He and his wife have lived in 14 states and 4 countries, and he’s done business in 34 other countries to date.

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A1: Exorcising the Seagull Syndrome – Lori Williams- (Beginner to intermediate)

Content will cover moving away from the mentality of going to a site, auditing for compliance or effectiveness, writing a number of findings, and then fleeing the scene to let the site unbury themselves from the audit results.

  • Basic auditor mentality

  • Use of Subject Matter Experts

  • Complete the execution of the audit, non-partial, objective

  • Closing out the audit activities

  • Introduction of the consultation phase

The above concepts present a variety of challenges to the novice and even the experienced auditor. I will provide tips on how to perform an effective audit, and still help the site on methods to consider for improving processes as well as best practice sharing.

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A2:How Delightful is Your Audit Program - Lance Coleman – (Beginner - Intermediate)

Learn why your internal audit program should be an integral part of how your organization sustains positive results and how to make that happen if it is not. The 4 evolutionary stages of audit program development will be discussed in detail as this session teaches attendees how to develop an internal audit program from one that is backward facing, reactionary and solely compliance based to one that is also forward seeking, continuous improvement driving and results sustaining. The Kano model of customer satisfaction will be used as the framework to explore this new 21st century audit paradigm, as we move through the four phases of audit program evolution. These phases are 1) compliance seeking, 2) compliance maintenance, 3) risk managing and continuously improving and 4) achieving delightful results. We will also discuss who will be the auditor of the future, and what skills they will need.

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Keynote John Knappenberger, President and CEO of ANSI-ASQ National Accreditation Board November 2007 – Present

In 2007 John became president and CEO of the ANSI-ASQ National Accreditation Board in Milwaukee, WI. This US accreditation body for management systems, test laboratories, calibration laboratories, referenced material producers, inspection bodies, proficiency test providers, forensic test laboratories and forensic inspection agencies.

In 1995, he served as Vice President of Administration of Dura in Southfield, Michigan, a Tier 1 supplier to GM, BMW and many other major automotive OEM's. He was responsible for Purchasing, and Information Technology.

Prior to joining Dura, Mr. Knappenberger was Director of Quality for Carrier Corporation's North American Operations, manufacturers of heating and air conditioning systems, from February 1992 till 1995.

From 1985 to 1991, Mr. Knappenberger was employed by TRW, a supplier of components to the automotive industry, beginning as Director of Quality in 1985 for the Steering and Suspension Division and becoming Vice President, Quality for the Automotive Sector in 1990.

He brings broad experience of the automotive industry and insights and assistance in development and marketing of new technologies in North America and other markets.

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A3: Writing Effective Opportunities for Improvement Statements (OFIs) - Workshop - Denis J. Devos, P.Eng – (Basic)

Every auditor has been trained how to write effective nonconformance statements. However, it is far less common that auditors are trained to write effective Opportunities for Improvement statements. During this hands-on workshop, participants will learn a simple and effective format for OFIs and have an opportunity to contrast their content and tone with similar nonconformance statements.

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A4: Audit Interviews - Larry Whittington – (Beginner)

Audit interviews are one of four ways to gather information during an audit, the others being to review documents, observe operations, and examine records. Auditors have to conduct effective interviews to perform a successful audit. During interviews, we gather information about processes that may not be described in a documented procedure or instruction. We find out what is really happening and confirm our audit findings.

This session will begin with a reminder of why we conduct audits and review the six major audit activities. Auditor responsibilities will be covered next, followed by why audit interviews are so important, and what it means for auditors to be fair during an interview.

A 3-dimensional audit approach will then be addressed for judging conformity and effectiveness, along with the basic steps of an audit interview, including use of an audit checklist. Next will be a discussion of the different types of questions to be asked in an interview, with sample questions provided for your use. Since auditors take notes during interviews, the session will also cover good note taking practices.

The confidence people have in the audit results will be influenced by the competence of the auditor. The session discusses those competencies, especially the communication skills needed for audit interviews. The presenter will describe why nonconformities happen, how people may react to nonconformities found during your interviews, and how you can deal with their possible reactions and delaying tactics.

It is important to remember the four primary sources of evidence so you ask the right questions to judge conformity to requirements. The DORS and LOCS acronyms will be introduced as helpful memory aids. The session will conclude with a review of the six audit principles upon which the audit guidance in ISO 19011:2011 is based, plus a summary of the benefits of monitoring systems through audits.

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B1: Quality Focused Organizational Change –Milton Krivokuca - (Intermediate)

This presentation provides an advanced application of the basic PDSA improvement methodology to accommodate organizations requiring rapid improvements to existing processes. The theory, tools, and techniques of this rapid improvement model are aligned with the current revitalized interest in Total Quality management (TQM). This model can be adopted by any organization desiring to utilize the basic TQM concepts and meet the rapidly changing market demands and changing demographics of the workforce.

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B2: Steering A Lean Steering Committee - Jd Marhevko – (All)

This is an interactive session on how to develop, manage, and implement an effective quality or lean steering committee. Attendees will actively participate in the development of the key components of a steering committee process. Several successful examples across various business types will be shared. Attendees will walk away with a model that they can apply to their own organizations.

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B3: Align Strategy and VOC (Session 1 of 2) – Robin Lawton – (All)

Change leaders have high expectations, a vision of the possible and urgency to engage others for fast results. This entertaining, paradigm-shifting and pragmatic session is for leaders, management and work groups wanting to go beyond tactical process improvement. Experience a thought-leading, elegantly simple framework to integrate, simplify and transcend core elements of improvement methodologies such as LSS, change management, ISO9000, VOC, Baldrige, HCAHPS, more.

This fast-paced, interactive session shows you how to:

  • Align strategic objectives with customer values.

  • Connect strategy, daily work and customer insight.

  • Determine who “the customer” really is (beyond labels like buyers, taxpayers, patients).

  • Move from an internal, process focus toward a culture where customer-desired outcomes drive innovation and excellence.

  • Apply key elements of a simple but advanced Voice of the Customer method.

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B4: Align Strategy and VOC (Session 2 of 2) – Robin Lawton – (All)

Change leaders have high expectations, a vision of the possible and urgency to engage others for fast results. This entertaining, paradigm-shifting and pragmatic session is for leaders, management and work groups wanting to go beyond tactical process improvement. Experience a thought-leading, elegantly simple framework to integrate, simplify and transcend core elements of improvement methodologies such as LSS, change management, ISO9000, VOC, Baldrige, HCAHPS, more.

This fast-paced, interactive session shows you how to:

  • Align strategic objectives with customer values.

  • Connect strategy, daily work and customer insight.

  • Determine who “the customer” really is (beyond labels like buyers, taxpayers, patients).

  • Move from an internal, process focus toward a culture where customer-desired outcomes drive innovation and excellence.

  • Apply key elements of a simple but advanced Voice of the Customer method.

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C1: The New FTA Quality Management System Guidelines and the Maryland Transit Administration’s updated Quality Management System Plan - Rick Simon and Ramesh Ganachari - (Beginner)

This presentation will describe and help attendees understand, the highlights of the Federal Transit Administration’s Quality Management System Guidelines that were issued in December 2012 and the details of the Maryland Transit Administration’s (MTA’s) Quality Management System Plan that was updated in March 2013 to comply with the new FTA Guidelines.

The FTA’s 2012 Quality Management System Guidelines retained the same 15 chapters and titles as the 2002 Quality Assurance and Quality Control Guidelines since many grantees and contractors had their Quality Plans organized in this same format. The title was changed to demonstrate that the Guidelines encompass a total Quality Management System.

The MTA’s Quality Assurance Program Plan issued in August 2007 had the same 15 chapters as the 2002 FTA Guidelines and incorporated the requirements of those Guidelines. The title of the updated MTA Quality Management System Plan was also changed while retaining the same 15 chapter format.

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C2: Eight steps that any field-based audit program (factory, construction site, etc.) should be able to do in the field, and if you do just those eight, you have it "nailed." - Tom Barlow - (All)

"Any and every field-based audit can now be entirely done in the field. Whether for a factory, a construction site or any other field condition, the advent of tablet computers and supporting software eliminates the need to go back to the office before publishing audit findings and observations. This is a relatively new circumstance that will revolutionize the way auditors do their work.

There are just eight steps to a successful field-based audit program – if you can accomplish those eight, you have it "nailed."

As the Director of Quality for a multi-branch international construction company, the presenter has been focusing his efforts on developing and implementing the simplest possible robust audit program in order to promote widespread adoption. In the course of evaluating the essentials of field-based auditing, he has identified 8 steps that are common to both the audit process and the general field design and construction processes – in other words, anybody performing these eight steps is auditing quality, regardless if they are a quality manager, a superintendent, a consultant or a foreman. Several of the steps are obvious and have been available for some time. A few flow from recent developments in web-based applications, are not as commonplace and have very powerful capabilities.

The presentation will naturally explain these eight steps. It will also include recommendations about hardware and software and lessons learned to date."

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C3: Re-defining Institutional Quality Control processes - Nestor Infanzon, FAIA (All)

In 2014 the University of Texas El Paso celebrates its 100 year Centennial and over the past decade the institution has been engaged in the pursuit of Tier One status. As a result of this; two unique and important recognitions the institution has been engaged in is an unprecedented re-branding of their operational processes as it adds and expands their building inventory.

This process to enhance their existing quality control and operational efficiency, the institution has expanded their definition on how quality is pursed and how it is implemented on projects, operations, as well as recruitment of their staff. Recognizing the need to have not just excellent staff, the institution also recognized that as we continue to expand our research based building stock, the quality of the design and construction is just part of the program. After the project is completed then the operation of the facility is equally as important and critical to the success of the institution.

The planning and Construction Department in conjunction with the Facilities service team has been involved in a series of programs, processes and re-training of the staff to elevate the quality of the processes and staff that they currently employ as well as the future hires. Some of these changes include and not limited to:

  1. Operational Master Planning for Research Based facilities

  2. Re-organization of the P&C Department and Creation of a Research Operational Group

  3. Re-training the P&C Staff alongside of the FS in an in-depth Project Management Certification

  4. New document control programs

  5. Creation of an in-house building inspection group that reports to P&C

  6. New operational processes and program structure

As the University continuous to work towards their Tier One recognition both quality and the management of quality have become synonymous with the goals and expectation of our department and other groups involved in the design, construction and operational management of these assets.

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C4: Using Risk Management Tools For Quality Oversight Planning - Kevin D. Diviness, CMQ/OE, CQA – (All)

In large CM/GC and design-build infrastructure projects, the Contractor (typically a joint venture) assumes a large component of the risk for project delivery. With this level of risk comes greater responsibility and accountability for management of essential functions such as Quality Control/Quality Assurance, Safety, Environmental, Public Information, etc. But this does not relieve the Owner of the responsibility for oversight. A challenge for Owners might be how best to deploy their limited oversight resources on large projects whereby the Contractor has most of the management responsibility.

This session explores how traditional risk management approaches can be employed to determine which aspects of the Contractor’s work warrant the most focus by the Owner. Two tools currently being used on the Regional Transportation District of Denver’s multi-billion dollar FasTracks Program will be presented. Priority Planning is a process that the Owner can used to prioritize Contractor work activities by evaluating the likelihood of failure, the severity of a failure, and the Contractor’s work schedule to assign verification inspection resources. Performance Matrices can be used to report areas of Steady Performance, Good Trends, Current Challenges, and Ongoing Challenges so that all project stakeholders are aware of what’s going well, and what requires corrective action. When used collaboratively, the Performance Matrix can help in updating the Priority Plan so that the Owner’s verification inspectors are always focused on areas of highest risk to the project.

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D1: Global Auditing and Possible Ways to Connect the Dots – Ray Crawford – (All)

If your company has a global reach and needs to identify possible weaknesses across different global units perhaps an Audit Protocol covering the ISO standards of 9001, 14001 and 18001 might help to identify global strengths and weaknesses. A standardized set of key business processes that are evaluated using the ISO standard clauses by a single registrar should help to identify and coordinate these standards and what the focus areas should be from year to year.

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D2:Quality and Effectiveness Assessment in Higher Education - Milton Krivokuca – (All)

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D3: The Risk and Compliance Paradigm: Risk Management’s Impact on QMS - Tom Barlow – (All)

In recent years, the market has been driven to establish a new benchmark on quality and compliance. Risk management is fast becoming the new standard for measuring and monitoring compliance activities.

This session will explore the strategy behind risk in compliance; define the various ways and terms associated with risk; and discuss how business processes are incorporating risk throughout the enterprise, driving a proactive approach to continuous improvement. We will specifically address how risk is shaping compliance within industries today, and illustrate where risk can be applied to ensure the highest level of quality and compliance, including:

   • Risk in Design: We will explore the concept of incorporating risk-based methods into the design phase of the product lifecycle. Through the use of risk-based tools (FMEA, Hazard Analysis, etc.) organizations can identify potential risks early in design, reduce the number of in-field failures, and take a proactive approach to risk mitigation.

   • Risk in Process: We will examine the benefits of incorporating risk into the many post-market processes that affect quality and compliance. Most significantly, we will look at how risk assessment uses tools such as a risk matrix to determine which events are most critical to an organization. Risk assessment can then effectively filter critical events in a quality system, shifting the focus to those events that pose the greatest risk to the organization.

   • Enterprise Risk Management: Finally, we will discuss how risk methodologies and risk-based tools apply to the enterprise as a whole. Enterprise Risk Management utilizes risk at all levels of the organization (financial, HR, GRC, operations, etc.), but the tools and the process of identifying and mitigating risk remain similar. We will look into the common practices of enterprise risk management and how to effectively mitigate risk on an enterprise level.

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D4: Addressing common Lean Six Sigma deployment challenges - Pete Roy – (All)

Lean Six Sigma deployments often face the same obstacles. Difficulties frequently include rolling up data, sharing best practices, process discipline, rework, managing phase approvals, among other things. See how Minitab can help your deployment overcome these challenges with our newest product offering, Qeystone.

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Keynote Denise Robitaille, Quality Management Systems Specialist Robitaille Associates

Denise Robitaille brings years of experience in business and industry to her work in the quality profession. As the principal of Robitaille Associates she has helped numerous companies in diverse fields including electronic assembly, biotechnology, machine shops, navigational instrumentation, packaging manufacturers and distributors to achieve ISO 9001 registration and to improve their quality management systems.

Denise is a RAB certified lead assessor, an ASQ Certified Quality Auditor and a senior member of the American Society for Quality. She is also a member of US TAG to ISO/TC176, the committee responsible for updating the ISO 9001 family of standards. She is an internationally acclaimed speaker on a variety of topics.

Denise is the author of numerous articles, a columnist for Inside Standards and the author of several books including: The Corrective Action Handbook, The Preventive Action Handbook and The Management Review Handbook.

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Timothy H. McKay, P.E. Executive Vice President, Growth and Regional Development

Timothy H. McKay, a professional engineer who graduated with a BSCE from Michigan Technological University began serving DART as a consultant in 1987. 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 Light Rail Train Vehicle Design and Assembly.

Notable projects include the 28-mile, 20-station Green Line light rail project (the longest light rail expansion in North America), the Platinum LEED-rated DART Police Headquarters at Illinois Station (conversion of Monroe Shops, listed on the National Register of Historic Places), and the 3.5-mile long Trinity Railway Express Belt Line Grade Separation Project which utilized composite railroad crossties.

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A6: Impact of ISO 9001:2015 for Companies Upgrading to the New Standard –Denis Devos – (All)

The next revision of the ISO 9001 Standard is the most complete rewrite since 2000. Significant changes include new clause numbers and new sections, the introduction of risk assessment during planning, and language that is more appropriate to service industries. This must-see session will take participants through the draft standard and discuss many of the changes and their implications.

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A7: How Disney Behavior Audits Will Make Your Employees and Business Successful-Advanced Application – Bret Pfost – (All)

This session will provide professionals with tools to operate a successful business. This simple behavior tool can change the way your employees perform and give you the full outcome desired to increase revenue and productivity in your business. Observe how to implement a simple auditing structure process to change the behavior of your employees. Learn through role-play scenarios how to take this auditing tool back to your own business and successfully utilize it in your operation/business. Learn how your business can increase revenue, decrease complaints, and make a safer environment through implementing auditing practices.

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Keynote Paul Palmes President, Business Standards Architects, Inc. of Fargo, ND and Prescott, WI

Paul Palmes is a principal consultant/owner of Business Systems Architects, Inc., Fargo, North Dakota.

Mr. Palmes is a senior member of the American Society for Quality, a Certified Quality Manager and BSI Certified Lead Auditor. Vice Chair and Membership Chair of the US TAG to ISO TC 176. He represented the United States as lead delegate and working group secretary in the development of international guidance standard, ISO 10014 – “Quality Management Systems: Realizing Financial and Economic Value” and serves as US SC3 Head of Delegation for international TC 176 meetings. He is an active Podcaster with world-wide listeners through his “Quality 101” program series at http://www.pdcauditing.com.

His publications include two books, “Process Driven Comprehensive Auditing,” and “The Magic of Self Directed Work Teams,” published by ASQ Quality Press, an October 2003 article in Quality Progress Magazine concerning Sarbanes Oxley compliance and the importance of Quality and Environmental audits, and May/July 2005 articles in ISO Management Systems Magazine regarding revision of ISO 10014. “Sarbanes Oxley: Potential Synergies and Possible Threats” released in September 2006 in ISO Management Systems Magazine, Geneva, Switzerland, joins his most recent articles written in 2007 and 2008 for ASQ’s Quality Progress magazine and The Auditor Newsletter, published by Paton Press.

He is a member of the Steering Committee of the Open Compliance and Ethics Group (OCEG), developing fully integrated ethics and compliance guidelines for US public corporations. He serves as US TAG representative and International TC 176 Liaison to the IAF’s ISO 9000 Advisory Group (IAG), is a member of the Auditing Practices Group (APG), and the Quality Council of the ANSI/ASQ National Accreditation Board (ANAB).

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A8: Risk-based 3rd Party Vendor Audits of Agile Developed Software - Byron Mattingly, PhD, MPH, MBA

Software supplier audits are often a weak spot in a validation and a HUGE hole in purchasing controls and supplier management. According to John W. Helgeson, “[t]he purpose of software quality audits is to monitor software development, the development process, and to help management obtain an independent view of the software development status” (The Software Audit Guide, ASQ Press 2010, p. xv). An audit program of vendor software developed using agile methodologies thus raises particular challenges because of the reliance of such methodologies on “hidden” software tools that sustain the validation environment. This session focuses on auditing software vendors that utilize Agile methodologies (e.g., “test-first,” “loose coupling,” etc.) and some of the newer quality tools and technologies in their software development processes: test-driven development, continuous integration, and continuous verification using automated testing:

   1. How do you audit such software, including the “hidden” software tools behind it?

   2. Which areas should be investigated?

   3. What are some of the most important questions to ask?

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A9: Going beyond the Audit in a Medical Device Regulated Industry - John A. Freije – (All)

Maintaining compliance in a FDA Regulated Industry is challenging enough within your own organization. How does one go about maintaining compliance when the operations are outside of your control? Comment 105 of the Preamble to the 1996 Quality System Regulation states:

“The capability of the product or service suppliers should be reviewed at intervals consistent with the significance of the product or service provided and the review should demonstrate conformance to specified requirements.”

It's not feasible to be at your supplier’s facility every day to observe production nor does this foster a strategic alliance built on trust with your supplier. Incoming inspection is only a portion of ongoing monitoring activities that must be conducted and is after-the-fact. Audits give us an initial and intermittent assessment of the supplier's quality system, but are not conducted at a frequency that gives us assurance our supplier is continuously meeting our specified requirements, including quality requirements. Similar to Management Review of your internal processes, your key or critical suppliers should partake in frequency-based quality evaluations commensurate with product risk. Including your suppliers in your Management Review gives more assurance you are compliant with 21 CFR 820.70 (a)(2). This presentation will prepare quality professionals to go beyond the bare minimum of 21 CFR 820 by implementing and maintaining a Periodic Supplier Quality Evaluation (PSQE).

Presentation Objectives:

   • Taking a proactive stance on monitoring component and device characteristics during

   production that is outside of your control

   • Implementing a tool to help meet requirements with regards to monitoring and

   controlling of process parameters for component and device characteristics for

   outsourced product

   • Benefits of implementing a Periodic Supplier Quality Evaluation

   Increased communication and strategic alliance with critical/key suppliers

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A10: Internal Auditing 2.0 What QMS Training Organizations Won’t Teach You - Bill Hackett – (Beginner to Intermediate)

Organizations providing internal auditing training often miss several important aspects of actually conducting internal audits. Most programs tend to be weak on the psychology of auditing and in the development of effective auditing techniques. This session will focus of both of these issues which tend to add stress to the internal auditing function with organizations.

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B6: Bridging the Gap between PLM and Change Management - Tom Barlow - (Intermediate)

This presentation will describe the core methodology of an effective Change Management solution and provide insight into how the robust functionality of a QMS can be leveraged in the Change Management process. It will discuss how although PLM is effective in managing processes and product data, Change Management requires much more flexibility, security and workflow process to automate processes, manage change, and provide proper visibility into the effects of the change.

Attendees will gain a basic understanding of how QMS functionality is ideal for managing change and how, through the use of Change Management, quality is linked throughout the product lifecycle as opposed to just the end product and is tracked at design, production, suppliers, and post-production—providing a real-time quality benchmark at every step of the process.

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B7: Evolution and Revolution in Decision Making - Grace L. Duffy, LSSMBB, CMQ/OE, CQA, CQIA – (All)

Decision making is one of the most exciting activities managers do amid the changes of business today. Much is written about Continuous Improvement and how to make it happen. Not all the literature addresses the decision making process that goes along with that improvement. Some of those decisions are not easy. This presentation considers some of the ways that managers can maximize their skills in both strategic and operational decision making to better support the long term success of their organization.

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B8: Moving Quality Towards the Aesthetic - Kurt Stuke, DA, CMQ/OE, CQA, CQIA, CSSGB – (Beginner)

Within quality, our attention is typically consumed by the business at hand. We seldom stop to examine the philosophy of our craft. But how we frame quality through our philosophical presuppositions shapes the very conversations we hold and the on-going practices we employ. Given such influence, the cost to quality of not taking the time to examine our philosophical vision is potentially staggering. What is the cost to quality of adhering to a vision that is not only unquestioned but is also pre-modern (several centuries old)?

If we really want to discuss the evolution of quality, we must examine our intellectual vision.

In this presentation, we will explore the theoretical and practical advantages gained by turning from a vision founded in Enlightenment sensibilities and turning towards more current views. Through the joining of quality, art, and philosophy, we will advance a description of quality that, like art, has the power to move us.

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B9: Global Harmonization: Standardizing Quality Management Processes to Promote Consistency throughout a Global Enterprise – Tom Barlow – (Intermediate)

As businesses become increasingly global in nature, it is more important than ever to have standard practices throughout these enterprises. A product from one area should be identical to another produced in another area—it should be of the same quality and held to the same standards. This not only applies to products but processes as well. A global empire needs consistency and conformity to be successful.

In this session, we will look at the elements of a successful Global Harmonization initiative, including:

People: An organization needs someone to manage elements that are being tracked and make small changes—they need compromise. They must identify teams that will verify the process, oversee the process and ensure it is running smoothly, find common areas for standardization, and have teams travel to other sites to ensure the process is going as expected.

Processes: The software needs to adapt to having multiple processes that are operating in a corporate standard. The characteristics of an effective process include being repeatable, adaptable to any system throughout the enterprise, having only one SOP and work instruction, and being auditable and scalable.

Governance: Finally, without governance an organization may fall into a pattern of separation. Proper governance ensures that all standardized processes are followed exactly, by tracking progress, ensuring issues are resolved, and ensuring effective communication. Governance helps determine plans for future and change management prepares all users for adapting to the new process.

This session will further explain the benefits of Global Harmonization such as consistency, lowered cost of system administration, and increased visibility across the enterprise. It will demonstrate how Global Harmonization allows facilities to be synced up in how their corporate culture approaches quality. It ultimately allows different sites to speak the same language because they will be following a common framework—while remaining unique.

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B10: Increasing Risk Management Prowess – As much an art as a skill - Paul Armstrong – (Beginner)

This session will show ways to help a team appreciate their risk posture by scrimmaging their situations and seeing how risk is considered and managed.

Risk management is increasingly the responsibility of quality managers. The typical approaches to implementing and managing risk is based on objectively categorization of events based on rigorous predictions of severity, probability and, in FMEA, detection. This rational categorical approach provides consistency and a basis for organizational decision-making. However, this purely objective consideration of events as high or low risk does not include a key element that underscores all risk management. That key element is that risk only exists as it is assumed and understood by people. It is not a purely objective set of threat vectors.

As stated by Deming, management is prediction, and that is particularly true for risk management. Deming also showed how profound knowledge is equally parts objective and subjective. Applying that to risk management reveals a need to combine the objective calculation of consequence and probability with the psychological factors such as fear of losing and desire of winning. In other words, risk management is as much about the organization’s attitude of risk as it is about a red, yellow or green location on a risk breakdown structure. Risk and quality managers need to ensure that not only is there alignment of the operational definitions but also a broad appreciation of subjective factors such as risk tolerance.

Psychology and sociology play a major role as group dynamics accentuate both fear of risk and risk seeking behaviors. To help teams learn not only the objective side of risk management, there is a novel approach that allows teams to simulate risk situations and to see how they profoundly manage risks. Using the science of play, scrimmage type events can not only refine the operational definitions of high risk, but also unveil the equally critical attitudes towards risk. This dynamic approach improves the art of risk management and provides quality managers with a sneak preview of their organization’s knack for risk management.

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C6: Effective Communication of Audit Scope and Results - Benjamin Trujillo, CQA – (Beginner)

On the surface, quality auditing seems a straightforward affair. The auditor develops a checklist based on the quality standard in force on the project or program to be audited, visits the body to be audited, and collects evidence to confirm whether the organization has adequately met the requirements of the standard. There are occasions, however, where the organization being audited has a limited understanding of the nature of the requirements they are being audited against. In such instances, the auditor may find themselves simultaneously educating and auditing the organization. This can be especially true when performing internal audits, where the option to terminate the audit may not exist.

Drawing on experiences over the past year of auditing various design and construction processes, I have pulled together some lessons I have learned in how to effectively work with such organizations. The development of the audit plan, the information gathering portion of the audit, development of the audit report, and the verification of implementation of corrective actions all present the auditor with unique opportunities to help the audited organization improve. This presentation will discuss some of the challenges I have faced in effectively performing and communicating audit results and the solutions I have developed in the face of these challenges.

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C7: Integrating Quality into Project Management - Hamid A. Qaasim – (All)

Over the years there have been many quality initiatives aimed at improving the quality of products or service. Thousands of quality manuals have been produced for companies, departments, and projects to describe how quality will be checked, verified, or audited. In the industry we have developed numerous processes such as TQM, six sigma, green belt, black belt, and quality improvement circles. While, many of us consider ourselves expert in some area of quality assurance or quality control, who has developed the text, manual, or plan for the project manager to get it right the first time? When examined closely few quality plans provide direct instruction and assistance to the project manager on how he or she achieves quality. Most tell the project manager what the quality procedures are, who will judge quality, what metrics they will use, and what happens when quality is nonconforming. In this session, we will describe how to go from quality programs, plans, and manuals to working directly with the project manager as a coach, and advisor so that they understand how to utilize common project management tools to achieve a quality product or service. Although there are many quality professionals who are good at verification, auditing, and process improvement; it is far better for an organization to have project managers and department managers who are good at integrating quality into their planning, meetings, and execution of the work.

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C8: Valley Metro Northwest Extension Light Rail Project – CM@Risk Quality Assurance Roles - Rick Brown and Toni Cotrill – (All)

The presentation will describe the unique Quality Assurance\Quality Control roles and interfaces in the Valley Metro Northwest Light Rail Extension CM@ Risk Project. It will discuss and identify the various organizations and their QA/QC roles and responsibilities and how they interface and work successfully together. This project has a unique and hybrid project flow that has not been performed on a prior Valley Metro project..

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C9: Auditor Behaviors – The Human Element of Auditor Training – Tim McClure – (Beginner to Intermediate)

This session will provide the attendees with an insight on how auditor human behavior affects an audit and why providing training can be of benefit to the audit and to your company. The focus of the session covers:

   1. Preparing for the Audit - Knowing the Product, Supplier, Local Customs and Protocols

   2. Communications – Listening, Speaking, Judgment, Evaluation, Inferences and Attitude

   3. Interview Situations – Criticism, Empathy vs. Sympathy, and Nit Picking

   4. Problem Situations – Personalities and Deception

   5. Ethics – Credibility, Fairness, Objectivity, Diplomacy and Appearance

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C10: Executive Panel Discussion - Tim McKay, Wm Thomsen, Celia Gray, Darren James, & other industry executive leaders

Riveting discussions on the benefits / value of new technologies in quality used with today’s current delivery methods.

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D6: The Many Faces of Auditing - Sandor G. Juhasz, CMQ/OE, CQA – (All)

The focus of this presentation will be to present the many types of audits that can be conducted on a project and how each has purpose, type and result. For example,

   • Contract, System, Discipline, Surveillance and Sub-contractor” Audits.

The speaker will use audit results & lessons learned from the ESA Project and tie it together with BOK information from both (CQA & CMQ/OE) study material.

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D7: Risk-based Agile Development of Mobile Medical Apps in Healthcare IT- Byron Mattingly, PhD, MPH, MBA – (All)

This session focuses on risk management / control throughout the software lifecycle and how to use the FDA’s Mobile Medical Applications (draft) guidance and the FDA’s so-called “Agile Manifesto” (AAMI TIR 45: 2012 Guidance on the use of AGILE practices in the development of medical device software) to optimally deploy smartphone and tablet apps in a rapidly changing healthcare technology landscape. Specific examples illustrate the importance of supporting Agile systems engineering and software development best practices (e.g., “test-first,” “loose coupling,” etc.) with some of the newer quality technologies: test-driven development, continuous integration, and continuous verification using automated testing. First, the scope of the definitions for mobile platforms, mobile applications, and mobile medical applications (as per the FDA’s guidance) is examined in the context of validations of iPad and Android-based tablet apps. Next, the AAMI TIR 45: 2012 is investigated with respect to Scrum software development. Finally, mobile medical apps will be considered as complex systems in the validation context of IEC 62304. Emphasis is placed on User Needs and Intended Use, and partitioning System Requirements by risk into coherent and cohesive software sub-systems and into their corresponding functional validations.

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D8-10: A GPS for Statistics Workshop (3 Part Sessions) - Jose Padilla - (All)

Learn how you can get everything you need to manage Lean Six Sigma projects in Quality Companion by Minitab®, starting with built-in Roadmaps to organize your project and help your whole team stay on track. Companion’s extensive set of integrated soft tools, including a powerful value stream map creator, makes each step of your project easier and faster. And when you have questions, Companion’s built-in coaches provide expert guidance throughout your entire project.

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