Program (subject to change)

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Thursday, 12 October 2017
8:00a – 9:30a Opening Remarks and Keynote Dave Fleming
9:45a – 10:30a Concurrent Sessions

A1:  Lessons Learned from a ISO 9001:2015 Transition
Presenter: Tamera Hueston

B1: From Audit Requirements to Checklist Items to Evidence Gathering Plans
Presenter: Linda Westfall

C1: Improving an Audit Program
Presenter: Karen Rust

D1: Practical Audit Tools (1 of 2)
Presenter: Jim Lamar

10:45a – 11:30a Concurrent Sessions

A2: Supply Improvement Program (SIP)
Presenter: Carl Douglas

B2: Assessing the Maturity of Your Supplier Quality Management Program through Key Supplier Quality Activities and How to Get to the Next Level
Presenter: Tim Parrent

C2: Comparing Software Quality Auditing and Software Quality Engineering
Presenter: Mark Neal

D2: Practical Audit Tools (2 of 2)
Presenter: Jim Lamar

12:00p – 1:30p Lunch, Announcements and Entertainment
1:45p – 2:30p Concurrent Sessions

A3: Data Integrity and Good Documentation Practices: Not just for the Pharmaceutical Industry
Presenter: Kim V. Strok

B3: The process, legwork and potholes in the transition to ISO 9001:2015
Presenter: Larry Litke

C3: Risk-based Continuous Systems of Systems Data Integrity Auditing of IoT
Presenter: Dr. Byron Mattingly

D3: Writing Effective Opportunities for Improvement Statements – Workshop
Presenter: Denis Devos

2:45p – 3:30p Concurrent Sessions

A4: Understanding Data
Presenter: Joel Smith

B4: “Automotive Security: Challenges, Standards and Solutions”
Presenter: Alexandar Much

C4: Audit Validation Programs Like a Champ (when your time is limited)
Presenter: Cathelene Compton

D4: Enhancing Audit Program Using Dr. Deming 14 points
Presenter: Narendra S. Patel

3:45p – 4:30p Concurrent Sessions

A5: Reaching Waaay Across the Table
Presenter: Monica Peters

B5: Basic Statistics Made Easy
Presenters: Victor R. Prybutok, PhD

C5: STEM Apprenticeships
Presenter: Rose Marie Christopher

D5: Conducting Software Configuration Management Audits
Presenter: Linda Westfall

5:00p – 6:00p Business Meeting
6:30p – 10:00p Gala Reception

 

Friday, 13 October 2017
8:00a – 9:30a Opening Remarks and Keynote Jack West
9:45a – 10:30a Concurrent Sessions

E1: Using External Requirements in the Development of an Effective Audit Program
Presenter: Elena Mack

F1: Sampling for Software Process Assessments, Evaluations, and Appraisals
Presenter: Mark Paulk

G1: What do they do when you’re not there?
Presenter: Stephanie Gaulding

H1: Preparing for Successful Data Integrity Audits (Session 1 of 2)
Presenters: Mary Chris Easterly and Richard D. Schlabach

10:45a – 11:30a Concurrent Sessions

E2: Human Performance and Accountability in Auditing Discussion
Presenter: Grace L. Duffy

F2: Understanding the Context of your Organization in Developing of an Effective Audit Program
Presenter: Joe Raciti

G2: Using Triz for Effective Audit Corrective Action Results
Presenter: Maria Stoletova

H2: Preparing for Successful Data Integrity Audits (Session 2 of 2)
Presenter: Mary Chris Easterly and Richard D. Schlabach

12:00p – 1:30p Lunch, Announcements and Entertainment
1:45p – 2:30p Concurrent Sessions

E3: EED Nuclear QA AUDITOR Training Handbook The Vital Qualification Tool
Presenter: Karen Douglas

F3: A Checklist to Identify and Foster Alignment of Customer-Focused Priorities
Presenter: Jeff Israel

G3: Process Assurance: Addressing your Quality Blind Spot
Presenter: Mark Whitworth

H3: Back Room 2.0, Preparation for Unannounced Audits
Presenter: Karen Jozefiak

2:45p – 3:30p Concurrent Sessions

E4: TBD
Presenter: Rick Perlman

F4: Maintaining A Validated GMP Automation System
Presenter: Richard D. Schlabach

G4: An Integrated Approach to Auditing Internal Business Services
Presenter: John Hilbert, CQA

H4: 84 Ways to Go Beyond ISO 9001
Presenter: Richard Hill

3:45p – 4:30p Concurrent Sessions

E5: Gain a Quick Insight to Audit Reports
Presenter: Johanna Rusly

F5: Myth or Consequences
Presenter: George Hummel

G5: A Century of Auditing Quality Assessing Emerging Risks
Presenter: Richard Gibney

H5: Internship Opportunities in the Auditing Field
Presenter: Nitish A. Subandh

14 October 2017
8:00a: On-site ASQ Certification Exams

A1: Beginner
Lessons Learned from a ISO 9001:2015 Transition
Thursday: 9:45a-10:30a
Presenter: Tamera Hueston / bio
As the deadline for organizations to transition from the ISO 9001:2008 standard to the ISO 9001:2015 standard rapidly approaches, many organizations continue to feel the pressure to ensure a successful transition. Their main question is how to best prepare for this activity. This session will look at how one organization thoughtfully and meticulously planned for, and executed a successful transition this past March. We will discuss what steps were taken, what quality tools were utilized, and what actions were most beneficial.
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B1: Beginner
From Audit Requirements to Checklist Items to Evidence Gathering Plans
Thursday: 1:45p-2:30p
Presenter: Linda Westfall / bio
This presentation presents a “how-to” method for translating the audit criteria requirements into useful checklists that auditors can use to organize their audit effort. Attendees will then learn how to those translate checklist items into objective evidence gathering plans to ensure that they gather relevant facts that allow them to effectively evaluate adherence to the audit criteria requirements. Examples of requirements from standards governing the safety critical software industry are used to illustrate the techniques presented.
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C1: Intermediate
Improving an Audit Program
Thursday: 9:45a-10:30a
Presenter: Karen Rust / bio
Identify opportunities for improvement within your audit program. How do you currently identify opportunities for improvement within your audit program? Having a process to identify opportunities for improvement within your audit program gives you a logical and repeatable method to continually improve your process. It all starts with asking the right questions. We will discuss how using a process approach; PDCA and viewing your audit program through the three-layer lens can that can help you to identify impactful opportunities for improvement and lead to an efficient audit system. How could your company benefit from having a more efficient audit program? The better question is: How couldn’t it?
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D1: Intermediate
Practical Audit Tools (Workshop Session 1 of 2)
Thursday: 9:45a-10:30a
Presenter: Jim Lamar / bio
Session 1 of 2: We will present three customizable tools for your internal audit tool kit, including: 1) a process flow diagram in Powerpoint 2) an ISO 9001:2015 process audit checklist in Word  3) an Excel workbook that provides a. a tracking system for auditor competency  b. an audit planning tool  c. an audit reporting tool   Our time will focus how to use these tools and how to customize them to make them fit the culture of your system.  You can use all or any part of what you see.  These tools are generalized versions of the tools used by the North American Saint-Gobain NorPro manufacturing sites. 
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A2: Beginner
Supply Improvement Program (SIP)
Thursday: 10:45a-11:30a
Presenter: Carl Douglas / bio
Every manufacturing company, their suppliers and customers have encountered and deal with supply chain material issues. Either the part(s) do not meet the expectations, did not arrive on time, or both. Material issues cost companies both in terms of financial losses and degraded customer satisfaction. The Supply Improvement Program (SIP) is a proven result driven process that will transform how you manage your suppliers and greatly reduce the occurrences of materials that are not at the right place, at the right time, in the expected condition.
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B2: Intermediate
Assessing the Maturity of Your Supplier Quality Management Program through Key Supplier Quality Activities and How to Get to the Next Level
Thursday: 10:45a-11:30a
Presenter: Tim Parrent / bio
Tim will discuss with the participants three key supplier quality activities. The extent to which these supplier quality activities are performed will allow participants to assess current maturity level of their supplier quality management program. After acknowledging the past and embracing the present maturity level, participants can prepare for the future by prioritizing supplier activities in order to progress to the next maturity level.
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C2: Intermediate
Comparing Software Quality Auditing and Software Quality Engineering
Thursday: 10:45a-11:30a
Presenter: Mark Neal / bio
As software development organizations evolve, Quality is considered during each activity throughout the software life cycle. While there is always a place for independent auditing at key stages of development, we have found that software quality engineering embedded within the development team provides numerous benefits and results in fewer compliance or technical issues that may be volatile with team members or leadership at the time of system release. This presentation will explain the differences between quality auditing and quality engineering, how to evolve toward quality engineering and when auditing is useful after quality engineering is established.
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D2: Intermediate
Practical Audit Tools (Workshop Session 2 of 2)
Thursday: 10:45a-11:30a
Presenter: Jim Lamar / bio
Session 2 of 2: We will present three customizable tools for your internal audit tool kit, including: 1) a process flow diagram in Powerpoint 2) an ISO 9001:2015 process audit checklist in Word  3) an Excel workbook that provides a. a tracking system for auditor competency  b. an audit planning tool  c. an audit reporting tool   Our time will focus how to use these tools and how to customize them to make them fit the culture of your system.  You can use all or any part of what you see.  These tools are generalized versions of the tools used by the North American Saint-Gobain NorPro manufacturing sites. 
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A3: Beginner
Data Integrity and Good Documentation Practices: Not just for the Pharmaceutical Industry
Thursday: 1:45p-2:30p
Presenter: Kim V. Strok / bio
A fundamental principle of a quality management system is “Evidence-based decision making.” The principle is followed by the statement “Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.” This principle is dependent on the integrity of data. In addition to helping make good business and quality decisions, data integrity has implications to product quality, customer satisfaction, and end-user health and safety. Data Integrity and Good Documentation Practices (GDP) are well known in the life science industry, but not as well defined in other industries. This presentation will provide an introduction to Data Integrity, Good Documentation Practices, and “ALCOA” principles used in the life science industry; and illustrate why Data Integrity is important for all industries’ quality management systems.
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B3: Intermediate
The process, legwork and potholes in the transition to ISO 9001:2015
Thursday: 9:45a-10:30a
Presenter: Larry Litke / bio
This session will detail the road traveled to upgrade the ISO 9001 registration to ISO 9001:2015. The what, how, when, why, and wow of laying out the road map and taking the trip to achieving registration to ISO 9001:2015. This trip will start with acquiring the map, ISO 9001:2015, and laying out the trip desired, including coffee breaks, and reaching the finish line still standing. Detours, slow traffic, open stretches, and road hazards are all important when planning the trip. So climb in and let’s look at our map and see the one route needed to get to the finish line.
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C3: Advanced
Risk-based Continuous Systems of Systems Data Integrity Auditing of IoT
Thursday: 1:45p-2:30p
Presenter: Dr. Byron Mattingly / bio
This session examines how refactoring (complex adaptive) systems of (complex adaptive) systems of the Internet of Things (IoT) partitioned by risk can be used to continuously audit data integrity flows similar to block-chaining techniques used to establish non-reputable financial audit trails.
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D3: Beginner
Writing Effective Opportunities for Improvement Statements – Workshop
Thursday: 3:45p-4:30p
Presenter: Denis Devos / bio
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: Beginner
Understanding Data
Thursday: 2:45p – 3:30p
Presenter: Joel Smith / bio
Whether you like it or not, functioning in business today requires you to constantly interpret graphs and statistics and decide what action or inaction should be taken based on them. While these can be incredibly powerful and informative, there are also some very common misunderstandings that can result in data being a liability rather than an asset. Once you understand the fundamental concepts of data analysis, however, you are armed to ask the important questions and fully grasp what you can – and cannot – determine based on a number. In this talk, very simple and fun examples will be used to illustrate ideas such as population versus sample and correlation versus causation. There won’t be any math, and participants won’t need to be familiar with an industry to understand the material. They will however walk out much more confident in their statistical IQ!

Expected Takeaways
• An understanding of the difference between a sample and a population, and why you will never know anything about a population
• How to tell whether the analysis you are seeing represents a correlation – which may or may not be useful – or causation, which is almost certainly useful.
• Why you should embrace random variation instead of hiding from it!

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B4: Intermediate
“Automotive Security: Challenges, Standards and Solutions”
Thursday: 2:45p – 3:30p
Presenter: Alexandar Much / bio
In recent years several studies (for example, Koscher et al. 2010; Miller and Valasek 2014b; Christian 2010) have revealed a growing security threat potential for automotive systems originating from different trends such as:
• System and software complexity: for example, functionality per electronic control unit (ECU), lines of code
• Connectivity and interoperability: for example, WiFi, Bluetooth, Ethernet, Internet, Car2Car, Car2X
• Faster time-to-market due to the need to adapt quickly: for example, apps, third-party software

This presentation details the challenges faced by automotive manufacturers and suppliers; discusses related standards, norms, and regulations, and their applicability; gives insight into some solutions for security use-cases; and shows exemplary solutions for the integrity of automotive ECUs. Expected takeaways include insight from a practitioner into Automotive Security Overview of current standards, norms and activities sharing some “provocative” thoughts on the matter.
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C4: Intermediate
Audit Validation Programs Like a Champ (when your time is limited)
Thursday: 2:45p – 3:30p
Presenter: Cathelene Compton / bio
This presentation will guide an auditor on how to audit validation programs when there is limited time. Most auditors are only granted access to a one or two-day audit. How does one tackle Validation when there are other Quality Systems to audit? This presentation will steer the auditor to specific areas to tackle when looking at Validation documentation including how to cite the observations when found to CFR references.
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D4: Intermediate
Enhancing Audit Program Using Dr. Deming 14 points
Thursday: 2:45p – 3:30p
Presenter: Narendra S. Patel / bio
Embracing Deming management principals in Quality Audit Program improve the organizational effectiveness significantly. Deming 14 points used as management tools in getting senior management/ executives engaged in providing leadership throughout the auditing process; improve employee’s morale, remove the barriers between employees and management. You will also learn to use Dr. Shewhart statistical techniques in managing your Audit program which will delight your internal & external stake holder, compliance agencies such as ISO registrar, Government regulatory agencies EU, FDA, EPA etc. It will also reduce the audit costs. Risks assessment tools such as HACCP, FMEAs, and FTA will be explained; these tools improve the quality, reliability & safety of product and services and enhance the customer satisfaction.
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A5: Beginner
Reaching Waaay Across the Table
Thursday: 3:45p-4:30p
Presenter: Monica Peters / bio
We wear many hats: auditors, auditees, change agents and implementers. When it gets down to the implementation or transition of a quality management system, we just can’t do it alone. We go to classes, we join seminars, we hire consultants, and we take advantages of conferences. We can build the best quality management system the world has ever seen – on paper. It’s where the rubber meets the road, or the people doing the work, that the real implementation begins. It is well known that all levels of the organization need to “buy into” the quality management system. The challenge to modern workforce is translating the requirements into what does it mean and how it can positively impact their job. From upper leadership to where the work is performed, hear the lesson on how we translated the standard into something understandable and meaningful for the team.
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B5: Beginner
Basic Statistics Made Easy
Thursday: 3:45p-4:30p
Student Presenters: Victor R. Prybutok, PhD / bio
This presentation introduces basic statistics to the novice. Covered topics include an overview of discrete and continues distributions. Distributions covered include the binomial, Poisson, and the normal distribution. The distribution of the sample mean is also discussed. The role of basic statistics in sampling and auditing is introduced so that attendees gain an understanding of the practical applications of statistics.
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C5: Intermediate
STEM Apprenticeships
Thursday: 3:45p-4:30p
Presenter: Rose Marie Christopher / bio
Rx Research Services, President, Rosemarie Christopher, leverages 29 years of search/staffing STEM trained and experienced professionals, to address the contingent worker issues of employers in today’s ‘gig’ economy, and the need of newer Graduates, displaced mid career Scientists and Veterans to gain entry into the complex life sciences industries world.
This presentation features the experiences, and accelerated journey of two STEM Apprentices, one drug; one food industry, through the ‘On the Job Training’ (OJT); ‘On the Job Learning’ (OJL) processes and how early acquisition of industry recognized certifications (ASQ, CQIA; CHA; CQA; CPGP), creates advantages for work in the ‘gig’ economy.
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D5: Intermediate
Conducting Software Configuration Management Audits
Thursday: 1:45p-2:30p
Presenter: Linda Westfall / bio
Software configuration management audits provide assurance by validating that the software products are implemented in accordance with their requirements and that the software configuration management processes were followed and their objectives were achieved. This presentation will discuss discusses the purpose of each of the three types of SCM audits and how to conduct Software Configuration Management (SCM) audits, including:
• Functional Configuration Audit (FCA)
• Physical Configuration Audit (PCA)
• In-Process SCM Audits
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E1: TBD
Using External Requirements in the Development of an Effective Audit Program
Friday: 10:45a-11:30a
Presenter: Elena Mack / bio
In order to develop and maintain an effective audit program, an organization must evaluate the application, or intended use, of the outputs for the program. An organization can no longer rest on belief that simply confirming adherence to existing ‘general’ standards assures the organization’s readiness to meet changing regulated environments and emerging customers’ needs. All external requirements must be considered. Specific requirements (regulatory, customer, etc.), aligned with the organization’s planning outputs, can be incorporated into the audit program to evaluate the preparedness and readiness of the organization to meet its goals. The outputs from the program can also be designed to be utilized as inputs that are used directly by our external interested parties and can also be used to help measure the effectiveness of specific deliverables (products or services), the organization or its overall management system. Expected takeaways include understanding how external factors influence the audit program, considering customer requirements when determining audit criteria, and designing an audit program that goes beyond confirming compliance.
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F1: Intermediate
Sampling for Software Process Assessments, Evaluations, and Appraisals
Friday: 9:45a-10:30a
Presenter: Mark Paulk / bio
Software process assessments can be dated to 1987 as introduced by Watts Humphrey at the Software Engineering Institute. Assessments were originally formed as an internal review, usually with external consultants, to identify the process strengths and weaknesses of an organization with the aim of widening the use of strengths and shoring up weaknesses. Software process assessments were performed against an external standard: initially Humphrey’s software process maturity framework, which was refined to be the Capability Maturity Model for Software, and which is now the CMM Integration (software and systems engineering) for Development. Software capability evaluations were added in 1988 to be used in source selection: including process maturity in selecting a supplier from a set of potential vendors. As time went by, both the models and the methods for using them evolved and inspired related models and methods. Choosing the projects to be investigated was an integral part of the methods. Initially the guidance for choosing projects was simple: pick four or five representative projects for the organization. While this was reasonable for assessments, which were internally focused on self-improvement, for evaluations where the evaluators were external and determining whether the organization would win business, stronger criteria were needed. Eventually, in the context of the eSourcing Capability Models (for IT-enabled services), a statistical basis for selecting a representative sample of engagements (projects in the software development context) was developed.
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G1: Intermediate
What do they do when you’re not there?
Friday: 9:45a-10:30a
Presenter: Stephanie Gaulding / bio
Assessing suppliers is an important part of any quality management system but how do you build confidence that they’re doing “the right thing” when you’re not there. We’ve all encountered organizations where they say one thing in their procedures and do another. This is the result of an organization’s culture which drives not only how they behave but also their decision making process. But since culture is not a tangible thing like a procedure or process that can be reviewed against standards, how can you gain confidence through your audit that you understand the real culture working behind the procedures and processes in an organization. In this session, we will explore typical signs of “good” and “bad” organizational culture and discuss several techniques for gathering “data” on an organization’s culture as part of conducting an on-site audit. We’ll also explore how to build that cultural assessment into a supplier management program.

Expected Takeaways include:
1) Learn several techniques for gathering “data” on an organization’s culture
2) Learn typical signs of “good” and “bad” organizational culture
3) Learn how to integrate cultural assessment into a supplier management program.
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H1: Intermediate
Preparing for Successful Data Integrity Audits (Session 1 of 2)
Friday: 9:45a-10:30a
Presenter: Mary Chris Easterly and Richard D. Schlabach / bio
Session 1 of 2: Regulatory authorities around the globe are focusing on data integrity during their inspections of pharmaceutical and medical device companies.  Quality auditors can help their organizations reduce risk by ensuring that data integrity issues are identified and product quality is protected.  This session will address: · data integrity concepts and principles · regulatory requirements related to data integrity · specific areas where regulatory authorities focus their inspections · key areas for auditors to assess for electronic and paper records Attend this presentation to learn the current expectations for data integrity as well as techniques and tools for conducting effective data integrity audits.
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E2: Intermediate
Human Performance and Accountability in Auditing Discussion
Friday: 9:45a-10:30a
Presenter: Grace L. Duffy / bio
Automated data gathering is improving our ability to audit many processes. What happens when there is still a significant human element to the process under study? This session is a facilitated discussion of options to address barriers we face with human performance issues, including lack of accountability and the “hero syndrome” of those working in a fast paced, interrupt driven environment. How can we use existing operational measures to ensure adherence to designs and outcomes? What leadership or process techniques are most effective in preparing for and managing an internal audit to reinforce long-term human performance excellence?
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F2: Beginner
Understanding the Context of your Organization in Developing of an Effective Audit Program
Friday: 10:45a-11:30a
Presenter: Joe Raciti / bio
Understanding the context of one’s organization is key in the development and implementation of a sustainable audit program. Identification of critical to quality inputs for the products and services provided, along with a clear understanding of the organizational history, including internal and external issues, provides the basis for the sound approach in your audit program. The landscape of the organization, incorporating locations, resources, agreed upon organizational approach on risk, and external requirements (regulations, standards, customer requirements, etc.) defines the boundaries for the design and implementation of the program. Outputs from planning activities within the organization provide targeted organizational goals and objectives that can be used to identify appropriate targets to which the overall audit program can be designed, implemented and focused. Proper strategic planning and tactical execution ensure overall program success.

Expected Takeaways include:
• Understand how context of the organization impacts an audit program
• Learn to develop the audit program considering past, present, and future Share perspectives of a successful program.
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G2: Beginner
Using Triz for Effective Audit Corrective Action Results
Friday: 10:45a-11:30a
Presenter: Maria Stoletova / bio
Effective corrective actions after quality audits and quality improvement are critical for an organization’s growth, sustainability, and competitiveness. TRIZ (a Russian acronym for the Theory of Inventive Problem Solving) is a structured method to generate innovative solutions for quality and supply chain issues.
The TRIZ methodology complements other quality tools with a systematic approach to quality problem solving. TRIZ enhances the solution development stage by enabling time efficient and low-cost solutions. Principles, benefits, examples and short case-studies from selected industries demonstrate TRIZ applications.

Expected Takeaways include:
• Introduction and overview on what TRIZ is.
• Examples the use the TRIZ concepts
• Explain the value of TRIZ as a corrective action tool for Audit findings
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H2: Intermediate
Preparing for Successful Data Integrity Audits (Session 2 of 2)
Friday: 10:45a-11:30a
Presenter: Mary Chris Easterly and Richard D. Schlabach / bio
Session 2 of 2: Regulatory authorities around the globe are focusing on data integrity during their inspections of pharmaceutical and medical device companies.  Quality auditors can help their organizations reduce risk by ensuring that data integrity issues are identified and product quality is protected.  This session will address: · data integrity concepts and principles · regulatory requirements related to data integrity · specific areas where regulatory authorities focus their inspections · key areas for auditors to assess for electronic and paper records Attend this presentation to learn the current expectations for data integrity as well as techniques and tools for conducting effective data integrity audits.
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E3: Intermediate
EED Nuclear QA AUDITOR Training Handbook The Vital Qualification Tool
Friday: 1:45p-2:30p
Presenter: Karen Douglas / bio
Auditing of Quality Assurance Programs for both the commercial nuclear sector and defense nuclear applications requires knowledge of nuclear safety principles and practices for compliance with regulatory constraints. Training and qualification for auditors assessing programs authorizing nuclear activities or accepting nuclear safety structures, systems, and components incorporates distinct principles tailored to ensuring nuclear operations are performed safely.
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F3: Intermediate
A Checklist to Identify and Foster Alignment of Customer-Focused Priorities
Friday: 1:45p-2:30p
Presenter: Jeff Israel / bio
Organizations face many challenges trying to beat the competition by excelling in customer care and focus. In this session we will examine a number of factors that taken together, collectively reflect the extent of an organization’s customer-centricity. Different stakeholders and customer satisfaction process owners have different points-of-view and attitudes about what can and cannot be done to improve customer satisfaction. As a result, we see evidence of inconsistencies due to differences in management’s stated intentions; employee perceptions and cynicism; and, sub optimization due to competition between departments and functions. These inherent challenges increase the stakes to attain alignment throughout the organization. Getting assessment data from the right stakeholders, and moving toward consensus can highlight both current gaps and opportunities which can be turned into customer-centric advantages.
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G3: Intermediate
Process Assurance: Addressing your Quality Blind Spot
Friday: 1:45p-2:30p
Presenter: Mark Whitworth / bio
Mark will touch on common quality techniques and their production-oriented bias, and why they don’t address the variability that generates most of the failures for quality-focused organizations. He’ll discuss the use of layered process audits as a way to significantly improve quality, highlight some challenges of their own, and he’ll close by demonstrating ways to eliminate those issues and sharing performance metrics from other organizations that have started taking this approach.
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H3: Beginner
Back Room 2.0, Preparation for Unannounced Audits
Friday: 1:45p-2:30p
Presenter: Karen Jozefiak / bio
Back Room 2.0 will cover the vital, behind-the-scenes activities that help an audit flow smoothly. Hear about specific and practical tools and organization tips that will make your company shine. Tools, organization and communication decisions, made before the auditor’s arrival, will make the day of the audit easier. Back Room 2.0 intends to provide suggestions that, when implemented, will help make the day of an audit less stressful for all involved.
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E4: Beginner
TBD
Friday: 2:45p – 3:30p
Presenter: Rick Perlman / bio
This presentation will supply the participants with the practical background on conducting a compliance audit. The audit standard that will be used will be 21CFR211, but the principles of auditing transcend the standard. The scope will include preaudit activities, conducting the audit, and audit follow up. This will be a pragmatic approach from the experiences that come from auditing. Technical knowledge of the standard is helpful for this activity but not a requirement.
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F4: Advanced
Maintaining A Validated GMP Automation System
Friday: 2:45p – 3:30p
Presenter: Richard D. Schlabach / bio
A new automation system has been successfully validated and has been approved for its Operational Phase of the system lifecycle. The primary focus will now become maintaining the system in a manner to ensure it remains in a validated state.
The purpose of this presentation is to highlight several processes that will need to be in place and operating well to keep the system validated. Examples have been provided from previous experience, and auditing techniques have also been added to assist with auditing automation systems currently in their Operational Phase.
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G4: Intermediate
An Integrated Approach to Auditing Internal Business Services
Friday: 2:45p – 3:30p
Presenter: John Hilbert, CQA / bio
2017, our A/E company turned 100! Managing quality, risks, and supporting our stakeholders has evolved to a greater commitment for our leadership. It doesn’t matter if we are addressing our deficiencies, improving our audit practices or training staff, the audit environment is always in a continuous state of change. Our goal has to be to eliminate our deficiencies so we can improve client satisfaction. If our company is led to execute continuous improvement for our internal corporate services then quality will be integrated in all parts of our business. This presentation focuses on the benefits of auditing internal corporate services, the steps it took to get here and where do we go from here. If we concentrate the audit internally, there can be many benefits for our business and clients including continuous improvement of the quality culture.
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H4: Intermediate
84 Ways to Go Beyond ISO 9001
Friday: 2:45p – 3:30p
Presenter: Richard Hill / bio
The ICT (Information and Communications Technologies) industry’s TL 9000 QMS standard, currently based on ISO 9001:2015, adds 84 specific, detailed requirements onto the generic foundation of ISO 9001 – and practically all of them are quite relevant outside the ICT world. This presentation will explore many of them, and show how any organization’s QMS could be strengthened by adopting them, as well as how an awareness of them could drive more value-added audits. Requirements in the areas of customer focus, external provider management, employee support, business continuity planning, quality planning, and design planning and control, among others, will be reviewed.
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E5: Beginner
Gain a Quick Insight to Audit Reports
Friday: 3:45p-4:30p
Presenter: Johanna Rusly / bio
When audit reports are presented, all eyes are watching, and all ears are listening carefully. Everyone would like to know what has happened, what is happening, and what will be done. Grab the attention! Audit reports should be presented in such way that the reports can be digested easily by all audiences and stakeholders. How many times we have seated or listened to a presentation when numbers are listed in a table that do not explain very much? The fact that many of us can easily learn and digest something from simple to advanced forms or stages has prompted me to think that effective use of data visualization techniques in audit reports and presentations – can enhance the understanding and acceptance of audit findings. Start from the summary level with a brief text that is supported by a summary graph. Examples of summary graphs include but not limited to bar graph, pie charts, bubble charts, line charts, geo chart, and scatter plot diagrams. This will trigger some curiosities from the audiences. When that happens, drill down to the detail information. Conclude the report with the following: conclusion and recommendation. You can also create some data visualization graphs to show the simulated effect for the recommendation. There are tools and software offered by many vendors and companies available out of the box, or customized, as well as those that are available for free download. You have the array of options to enrich your audit reports and get the acceptance of the report that you desire. To complete this presentation, I will use an example data from a café that serves coffee and tea beverages to show the application of data visualization techniques from the gathered data to report finding presentation.
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F5: Intermediate
“Myth or Consequences”
Friday: 3:45p-4:30p
Presenter: George Hummel / bio
Since ISO 9001 was first published in 1987, myths have been perpetuated concerning the Standard.  Furthermore, since the rise of social media, these myths have spread like weeds across the internet.  Many users who have implemented a quality management system have been ‘sold’ these myths by consultants and auditors. Many myths arise from auditors and or consultants who push their own interpretations, and from users themselves by not having read the standard. Buying into a myth or two can lead to non-value added and often expensive consequences.  This leads to frustration with the user blaming “ISO.” This presentation explores myths in the areas of: Documentation, Management review, Training, Quality manuals, “ISO says…,” Risk-based thinking, Scope, Internal audits, Flexibility & creativity. Transition, Certification made “simple.”
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G5: Intermediate
A Century of Auditing Quality Assessing Emerging Risks
Friday: 3:45p-4:30p
Presenter: Richard Gibney / bio
This presentation will discuss the development of a comprehensive quality and audit program for an Architecture/Engineering firm that has occurred over the past several decades. Included will be a review of the hurdles that have been overcome, from both an implementation and acceptance standpoint. Discussion includes the continual growth in the program and the vision for tomorrow and how the audit program supports our “Drive to Zero” initiative, to have no service failures. This presentation will provide the attendee with insight into how to develop a sustainable audit program that builds on the past to improve the future. The question management asks is no longer solely focused on whether we are doing the right things, but rather asks “how can the audit identify tomorrow’s issues so that we can continue to be a sustainable company for the next 100 years?” 
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H5: Beginner
Initiating an Auditing Internship Program for a Win-Win
Friday: 3:45p-4:30p
Presenter: Nitish A. Subandh / bio
Internship programs, when properly administered cost effective and forward thinking solutions to workforce and production issues. High quality candidates abound in universities all over the United States. Interns offer fresh insights and a valuable extra set of hands while earning experience and references for future employment. Information was gleaned from existing auditing internship programs and interviews with auditing professionals to explore how to utilize interns in the auditing field.
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