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2024 Audit Division Conference

October 9 - 10, 2024

Find inspiration with exclusive tips, insights, and quality expertise

Keynote Speaker Information

Mike Mascaro
Michael Mascaro

Oct. 9, Opening Keynote


Michael "Mike" Mascaro has spent his career working in sports broadcasting and producing. He has worked for ESPN for 30 years! He covers at least one game per week, keeping him traveling anywhere from 35 - 40 weeks per year. Mike will be sharing with the audience the common threads between our two professional worlds. In addition, he will be presenting the very first John F. Mascaro Scholarship Award which is named after his father. John, who sadly passed away last year, was a longtime member leader for the ASQ Audit Division, an ASQ Fellow, a leader, mentor and friend to many who led and worked on countless efforts related to quality and auditing for multiple Divisions and ASQ. John always told us how he thought that his son Mike would be an interesting Keynote for the Audit Division conference - to share how his experiences relate to quality and even auditing. We are honored to have Mike as our opening Keynote Speaker.


 Rai Chowdhary 

Rai Chowdhary

Oct. 9 Lunch Keynote


Title: The Future is Now – and – It Will Evolve!

Rai brings over 40 years of diverse experience across automotive, aerospace, life sciences, food products, and service industries. His undergraduate studies included Mechanical and Production Engineering. Graduate study was in Materials Science. He holds several ASQ Certifications: CSQP, Six Sigma Black Belt, CQE, and CMQ/OE.  Rai is also a Lead Auditor for ISO 9001, 13485, and 27001.

He has led / participated / witnessed hundreds of audits starting 1995 covering a broad range of industries and regulations; he serves on standards development committees (ISO TC 176, among others). Rai was recognized as “Expert on WG 28 for the development of ISO/TS 10020:2022” (Organizational Change Management).

Rai will share on a number of aspects of being an auditor such as helping auditees change for the better, winning the trust of business leaders so they will listen to you, what every auditor should know about data analytics and information security and harnessing the power of quality tools and auditing methods for financial Independence. We expect this to be an interesting keynote for all attendees!

Shauna Wilson

Shauna Wilson

Oct. 10, Morning Keynote


Title: The Auditor's New Role: Continual Learner!

Shauna Wilson is president of Amazon Consulting, Inc. working in Quality over forty years, Shauna holds the Certus Master Auditor Certifications.  Shauna’s research in virtual team communication and development of virtual auditing methods and auditing experience has made her the leading expert in Remote Auditing. She earned an MS in Engineering focused on Organizational Performance Technologies and Instructional Design.  Shauna wrote InterneTeaming.com: Tools to Create High Performance Remote Teams and co-authored eAuditing Fundamentals: Virtual Communication and Remote Auditing.  Shauna has been featured in Quality Progress, The Auditor, and ASTD’s InfoLine.  Shauna served as the US Expert for PC/TAG302 ISO19011:2018 Auditing Management Systems Guideline. Shauna Wilson was the 2022 recipient of the ASQ Audit Division Paul Gauthier Award.

Summary: A person that audits can find themselves stuck between a rock and hard place with continued changes in audit methods and the growing number of management standards. Choosing the right audit method can help a company meet performance and standard conformance goals.  But how does an auditor stay current on possible audit methods that ensure review of objective evidence and the growing number of different management standards? We will explore how best to consolidate multiple standard requirements like Quality and Cyber Security. We will also focus on how to diversify the audit program by incorporating remote auditing and defining the auditor's new responsibility.


2024 Preconference Tutorials


Denise R
Denise Robitaille


2-Day Course: Monday Oct. 7 –Tuesday Oct. 8

ASQ Member Pricing: $800

Non-ASQ Member Pricing: $950

Course Description: 
The past decade has brought us a global pandemic that forever altered how we work. Additionally, there have been changes in technology, increased focus on climate change and social governance. The ever-present element of risk and the need to understand its consequences continues to inform our decisions. In the past, the role of AI, remote working and digitized processes were rarely part of root cause analysis or corrective action planning.

Corrective action continues to be a vital component of any quality management system. Things happen. The ability to respond to a problem in a manner that mitigates recurrence and incorporates improvement is a hallmark of effective organizations.

This two-day workshop will provide training on the corrective action process. It will incorporate consideration of factors that weren’t yet conceived when many organizations first established their CA programs. The workshop is applicable to individuals who are new to the process as well as those who will benefit from a refresher that focuses the lens on issues like risk, new technologies, remote processes, and global considerations.

Included in the workshop will be:

    ·     Obstacles to the corrective action process
    ·     Deciding how and when to initiate corrective action
    ·     Role of risk throughout the process
    ·     Ensuring the right people are participating in the process
    ·     Root cause analysis
    ·     Corrective action planning
    ·     Implementation
    ·     Verifying both implementation and effectiveness
    ·     Supplier SCARs
    ·     Responding to customers

Instructor Bio: Denise Robitaille has authored over a dozen books on a variety of quality topics including The Corrective Action Handbook. She has participated internationally in standards development for over 20 years and has served in several leadership roles, including her current position as chair of TC176/SC1 the committee responsible for ISO 9000, the guidance on quality fundamentals and terminology which is the foundation for ISO 9001.

She also chairs PC302 the committee responsible for revising the ISO 19011 guidance standard on auditing quality management systems. She has facilitated the implementation of ISO 9001 for multiple organizations for over 25 years. She is a Fellow of the American Society for Quality and a certified lead assessor.

Denis Devos
Denis Devos


2-Day Course: Monday Oct. 7 –Tuesday Oct. 8 

ASQ Member Pricing: $800

Non-ASQ Member Pricing: $950

Course Description: This two-day course is for novice and experienced auditors who are looking to increase the effectiveness of their audit reports. Many organizations feel like their internal audits do not get the management visibility and attention that they deserve.  A more professional approach to internal audit reporting can help to improve this condition. A common shortcoming of many audit reports is that they are only a list of nonconformances and do not accurately reflect everything that was examined during the audit, leading the reader to wonder if all processes and requirements were examined. Participants will learn how to write effective non-conformance reports and Opportunities for Improvement and how to compile it together into a comprehensive audit report that is easy to read and understand. This course is ideal for both new and experienced internal auditors. Every organization has compliance obligations that it must manage effectively.

Instructor Bio: Denis Devos is a professional engineer with a long career providing QMS training and advisory services.  He is a Fellow of the ASQ, the current Chair of the ASQ Quality Management Division and is a recognized expert in the application of the ISO 9001, IATF 16949 and ISO 14001 Standards.  Denis was the developer of the Risk is the Compass risk-based audit model in 2001.  He works with clients in a variety of industries, providing internal audit services and training for QA practitioners and internal auditors   Denis is a regular contributor to the Audit Division conference, having shared his insights and expertise with us for over 15 years in a row.  He also contributed to the published ASQ Certified Quality Auditor Handbook, Fifth Edition.

Angelo Scangas
Angelo Scangas


1-Day Course: Tuesday Oct. 8 

ASQ Member Pricing: $400

Non-ASQ Member Pricing: $550

Course Description: This course is designed for engineers, technicians, and professionals focusing on product and process risk, this course teaches you the common risk-management methods used in product design and manufacturing processes. Using case studies and interaction, you will practice identifying and analyzing potential product and process hazards using the FMEA risk analysis template.

Application of risk management to medical devices and other industries defines a standard process for identifying risks at all stages in a product’s life cycle, from product design to production and post-production use. The goal of this workshop is to develop a risk management plan that can assess, evaluate, identify controls, and monitor the risks associated with each life-cycle stage.

Learning Objectives
Through training, participants will be able to:
·     Describe the Risk Management Process as defined in ISO 14971:2019
·     Identify how ISO 14971:2019 relates to ISO 13485:2016 Risk Management Requirements
·     Leverage the relationship of ISO TIR 24971:2020 to ISO 14971:2019
·     Identify and Quantify Risks for their Organization
·     Apply Risk Management Tools and how they align with the Product Life Cycle and requirements in ISO 13485:2016

Workshop Outline
·     Applicable standards and normative references
·     Terms and definitions
·     General requirements for risk management system: process, responsibilities, competence of personnel, risk management plan and file
·     Risk analysis
·     Risk evaluation
·     Risk control
·     Evaluation of overall residual risk
·     Risk management review and risk management file
·     Production and post-production activities
·     Impact of the risk analysis on the QM-system

Instructor Bio: Angelo Scangas is President of Quality Support Group, Inc., an International Consulting and Training organization. Angelo has a B.S. in Chemical Engineering, M.S. in Manufacturing Engineering and a MBA.  Angelo is a senior member of the American Society for Quality and a long-time member leader of the ASQ Audit Division (Webinar Chair). Angelo has more than 30 years of experience in the Medical Device, Consumer, Electronic, Healthcare and Chemical Industries working in product development, manufacturing, quality assurance and process improvement.

Rai Chowdhary
Rai Chowdhary

(includes selected questions based on ISO 27001)”

1-Day Course: Tuesday Oct. 8 

ASQ Member Pricing: $400

Non-ASQ Member Pricing: $550

Course Description: Just about all QMS standards - ISO 9001, 13485, IATF 16949, AS 9100D, TL 9000 and many regulations such as FDA 21 CFR 820, EUMDR, and USDA, include or contain references to the use of data for one or more reasons. Furthermore, it is a data driven world we live in; not only there is increasing reliance on the use of data and analytics, but the pace of data generation is astounding. According to one source*, the amount of data created, captured, copied, and consumed worldwide from 2010 to 2025 is estimated to increase by 90X. This naturally comes with enormous information security risks as well.

* https://www.statista.com/statistics/871513/worldwide-data-created/

However, the sad part is that a vast majority of the auditors (various disciplines) lack the knowhow and skills to understand enough about data, analytics, and formulating the right questions to ask during an audit – even though the standards and regulations (indicated above) specifically require use of appropriate data analysis.

Join us for a unique, timely, and engaging event as Rai shares his know-how on what every auditor should look for when examining data, its analysis, and information security.  Here are the key takeaways:

1.       The chain from events and situations to data, its analysis, reporting, presentation interpretation – and errors in the same. Understand how error propagation can severely compromise analyses and information.  

2.       Hands on practice with numerous audit case studies and develop / create the right questions to ask in each case. You can subsequently use these while conducting audits.

3.       In class practice on (using Excel on your laptop) data set provided by Rai and develop the ability to spot the right areas / process steps where audits will be most effective.

4.       Understand key points from ISO 27001 that are applicable to data, analytics information security, and - .

5.       Learn over 20 things you can do to boost immunity against data errors at your organization.

Instructor Bio: Rai Chowdhary brings over 40 years of diverse experience across automotive, aerospace, life sciences, food products, and service industries. His undergraduate studies included Mechanical, Production Engineering. Graduate study was in Materials Science. He holds several ASQ Certifications: CSQP, Six Sigma Black Belt, CQE, and CMQ/OE.  Rai is also a Lead Auditor for ISO 9001, 13485, and 27001.

He has led / participated / witnessed hundreds of audits starting 1995 covering a broad range of industries and regulations; he serves on standards development committees (ISO TC 176, among others).

Rai was recognized as “Expert on WG 28 for the development of ISO/TS 10020:2022” (Organizational Change Management).

Lance Coleman
Lance Coleman

1/2-Day Course: Tuesday Oct. 8, 1:00 pm – 5:00 pm 

ASQ Member Pricing: $200

Non-ASQ Member Pricing: $350

Course Description: The 7 Habits of Highly Effective People by Steven R. Covey has sold over 40 million copies worldwide and presents a principle centered approach for solving both personal and professional problems, by drawing wisdom from actual case studies and shared anecdotes around the 7 principles.

Attendees will learn during this session, Quality, auditing and Lean tools that will provide a practical means of successfully implementing each of the 7 principles on a consistent basis. Tools to be taught in support of each of the 7 principles are:

1.      Be proactive

a.       Risk management

b.       Preventive action

2.       Start with the end in mind

a.       Hoshin Kanri

b.       Improvement kata

3.       First things first

a.       LSW

b.       Quad analysis

4.       Seek win-win scenario

a.       NGT and Multi-voting

b.       Negotiation skills

5.       Seek first to understand and then to be understood

a.       Active listening

b.       Direct Observation

c.       Data analysis

6.       Synergize by combining different strengths and perspectives

a.       Successfully working in teams

7.       Sharpen the saw by continuously improving

a.       Maslow’s Hierarchy

b.       Inverse Ishikawa    

c.       S.W.O.T. Analysis

Instructor Bio: Lance B. Coleman Sr. is an American Society for Quality Fellow as well as, Certified Quality Engineer, Quality Auditor, Supplier Quality Professional, and Six Sigma Green Belt. He is also an Exemplar Global certified ISO 9001:2015 & ISO 13485:2016 Lead QMS Auditor. Lance is the author of three books – “Managing Organizational Risk Using the Supplier Audit Program (Quality Press 2018), “Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement and Data Analysis (Quality Press 2015)” and “The Customer Driven Organization: Employing the Kano Model (Productivity Press 2014)” and as well as, many articles on quality, Lean implementation and risk management. He is also the Editor for the 5th Edition of the ASQ Certified Quality Auditor Handbook (Quality Press 2020).  Lance was 2018 ASQ Lean Enterprise Division Chair and 2016-2018 Chair of ISO TAG 302 –Auditing Management Systems. He also is presently an instructor for the ASQ Certified Supplier Quality Professional and Certified Quality Auditor exam preparatory courses as well as, the ASQ Lean Foundations and Auditing for Improvement courses.  He has presented, trained and consulted throughout the United States and abroad. Lance is currently a Director of Quality Assurance and Regulatory Affairs for IDEX Health and Science, LLC in Oak Harbor, Washington.