Quality Digest Webinar Recordings

Quality Digest Webinar Recordings

Below is a list of recordings of Quality Digest webinars. Some recordings may require registration before playing.



Topic/Recording: CPK: Indispensable index or misleading measure?-20161215 1857-11
Slides: PQ-Cpk-Indispensable_Index_or_Misleading_Measure-Final.pdf
Duration: 1 hour 8 minutes

Are your Cpk values misleading you?

Cpk is a critical index often used to assess quality and maintain customer-supplier relationships. However, if employed incorrectly, CPK can cause more harm than good.

Don’t be deceived. If you provide capability indices to your customers or you require them from your suppliers, join us for this important, 60 minute webinar where you will learn the five steps necessary for legitimate capability analysis.

Steve Daum, Director of Development for PQ Systems
Steve Daum is Director of Development for PQ Systems. He has more than 30 years of experience with statistical process control, control charts, and control charting software. Steve has published papers in a variety of professional journals and has led multiple seminars and presented on statistical process control and issues related to quality to a variety of audiences in the U.S., England, and South Africa.

Matt Savage, SPC Product Manager for PQ Systems
Matt Savage is SPC Product Manager for PQ Systems. He is an experienced consultant to organizations that want to utilize the power of data analysis to improve processes and enhance profitability. He has worked extensively with technical advisory teams and has provided on-site consulting and training in statistical process control for a variety of organizations representing manufacturing, health care, and service organizations in the U.S. and abroad.

Date: December 15, 2016
Topic/Recording: Prevent Alloy Mix-ups and Take Control of Your Supply Chain: Handheld XRF for Fast and Easy Alloy Identification-20161206 1852-1
Slides: Olympus-Prevent-alloy-mixups-12-5.pdf
Duration: 52 minutes

This webinar will review the advances in handheld XRF technology with Olympus’ introduction of Vanta for manufacturing and maintenance QA/QC. Vanta analyzers provide on-the-spot material chemistry and alloy ID for greater confidence that you’re using the right material for the job. For maximum uptime in the most rugged environments, Vanta analyzers are drop tested (MIL-STD 810 G) and IP65 rated*.

Learn how the new Axon™ technology delivers accurate results in as little as 1–2 seconds and provides test-to-test and instrument-to-instrument repeatability. We’ll review how Vanta’s intuitive software enables efficient fleet management for both multi-user and multi-yard operations.

Join us for this webinar presentation to learn how you can add speed and efficiency to your QA/QC process with Vanta handheld XRF.

This webinar will review:
- Why handheld XRF is critical for manufacturing and maintenance applications
- Vanta’s performance, productivity and cost of ownership
- Demonstration of speed on some typical alloys used in manufacturing and maintenance
- Review the performance and precision of alloys (304,316, 321, monel500, 6061, 2014, and more)
- Demonstration of Vanta's new user interface and why the simplicity is important
- Traceability, Exporting and transferring for manufacturing QC and plant/facility maintenance

Date: December 6, 2016
Topic/Recording: ISO 9001:2015 Revision Refresher-20161117 1856-1
Slides: Intertek_Nov_2016_ISO 9001_2015_Changes.pdf
Duration: 1 hour 9 minutes

The ISO 9001 revision was released on September 23, 2015, the first major revision in 15 years. ISO 9001:2015 better addresses the modern organization, with changes such as new clauses, amended terms, and a focus on risk-based thinking and the process approach.

Quality Digest presents, Paula Oddy of Intertek who will cover the history of the ISO 9001 standard and the primary differences between ISO 9001:2008 and ISO 9001:2015. Attendees can expect to learn more about the key changes in concepts and philosophies, and ascertain what changes you do not need to make. All users of ISO 9001:2008 must transition to ISO 9001:2015 by September 23, 2018, and Paula Oddy will help you prepare.

Date: November 17, 2016
Topic/Recording: IATF 16949 - Preparing for the Transition-20161024 1755-1
Slides: TUV_SUD_IATF16949_QDwebinar.pdf
Duration: 39 minutes

The IATF (International Automotive Task Force) has published the new automotive standard IATF 16949. If you have an existing ISO/TS 16949 certificate, the new standard is likely to pose challenges. TÜV SÜD can support you in your transition to IATF 16949.

Presented by: Karleen Bacoccini
Karleen Bacoccini is a TÜV SÜD America Auditor with over 38 years’ experience in Quality Management. She has an extensive background in Program Management, Supplier Quality Development, and ISO/TS 16949:2009. Karleen has additional background in quality and manufacturing consulting, excellent leadership, organization and problem solving skills with expertise in quality, modern manufacturing techniques, and manpower planning.

Date: October 24, 2016
Topic/Recording: Who left the door open? A story of connectivity & the future of metrology-20161013 1803-1
Slides: Hexagon-who-left-door-open.pdf
Duration: 51 minutes

Join Hexagon Manufacturing Intelligence's Milan Kocic, UX Business Development Manager, to learn how Hexagon Manufacturing Intelligence transformed their research into actionable insight, providing their customers with solutions that challenge manufacturers every day.

Today, we are facing a push to improve the way we manufacture. Across the world, manufacturers are facing the same problem: a situation occurs, you have to evaluate and react to the situation, and productivity suffers. This is because most manufacturers have a reactive enterprise, which causes losses in time, money, and productivity.

Industry 4.0 and the IoT promises to revolutionize how products are built, but what does this actually mean to your industry? Additionally, how does this impact your business today? In this webinar, we begin to explore the answers to the following questions:
1. What is smart manufacturing, anyway?
2. How do you obtain real time feedback about your machine’s operation?
3. How can you know everything about your measurement process at any time, any place or on any device?
4. Do you wish there was an “easy” button for CMMs?

Join us for the ‘Who left the door open? A story of connectivity & the future of metrology’ webcast.

Date: October 13, 2016
Topic/Recording: Improving Quality & Efficiency Through Supplier Collaboration
Slides: QD-Improving Quality and Efficiency through Supplier Collaboration.pdf
Duration: 48 minutes

More and more, manufacturers are expanding and globalizing their supply chain to support innovation, reach new markets, and reduce operational costs. However, this can restrict product lifecycle visibility, leaving manufacturers exposed to a higher risk of product issues, consumer safety incidents, and operational inefficiencies.


As a result, organizations are looking for ways to improve transparency and collaboration with their suppliers' operations and quality processes to ensure that products meet quality and safety requirements.


Register now for this one-hour webinar and learn how supplier collaboration and management can help manufacturers:
• Catch quality issues early
• Support quality throughout the supply chain
• Be proactive and reduce risk

Date: September 27, 2016
Topic/Recording: The Market View on Quality Management: What your peers are doing (or not doing) -20160920 1757-1
Duration: 1 Hour 5 minutes

Like many companies out there, the Quality role is considered important, but can vary in size, scope and influence from one place to the next. Everyone may follow a common framework, but there are many ways in which we diverge in our interpretations, or priorities, and our focus areas. We wanted to find out more, so we conducted a survey with a broad range of companies from various industries, sizes and roles that touch Quality and asked them what they value most, what is their biggest challenges and how they are tackling the common problems with respect to Quality Management.

We want to share that with you.

In this webinar, we will review some of the key areas that companies are doing well with Quality, places they need to improve and interesting trends we uncovered during the process. Often times we operate in a vacuum and have limited visibility into how our peers are viewing Quality. This webinar will lift the veil on that and look into what like-minded Quality professionals are doing for you to benchmark yourself.

Presenter: Tim Lozier
Tim Lozier, Director of Product Strategy at Verse Solutions
Tim is the director of product strategy for VERSE Solutions, a quality and compliance management software provider that incorporates key quality processes, such as document control, corrective action, audits and training in a dedicated cloud environment. He has been involved in the quality and compliance industry for over a decade and has an extensive background in quality and compliance management systems. At VERSE Solutions Tim is responsible for driving the innovation and strategy of leading cloud-based quality and compliance management software solutions

Date: September 20, 2016
Topic/Recording: Time to roll up the sleeves – Why you need to transition to the 2015 version of ISO 9001 or 14001 right now! -20160909 1654-1
Slides: New_ISO_9001_2015_SGS.pdf
Duration: 1 hour 15 minutes

In this Webinar, Peter Merrill, a renowned speaker and quality expert, will discuss how significant the changes to the ISO 9001 and 14001 standards are in its 2015 version, and why it's important that organizations consider transitioning their systems immediately – instead of leaving to the end of the transition period.

The incorporation of Risk Management principles in the ISO standards, along with increased role of the management team and other changes will make this change of the standard particularly disrupting to organizations. It's important to understand the impact of these changes and work on gaps towards conformity to the new version as soon as possible.

Webinar topics include:
• A high-level overview of the main changes in the standard
• The impact these changes will have in most organizations
• Implementation steps – how can you bridge your gaps?
• Transitioning your certification audit
• SGS' options for transitioning from ISO 9001:2008 and ISO 14001:2004 to the 2015 version


Peter Merrill, President, QUEST Management Inc.
Peter Merrill is one of North America's foremost authorities on implementation of ISO 9001. He has over twenty years of experience in developing systems with companies such as Ontario Power Generation, Research in Motion, Cameco, A.I.G. and IBM. He was one of the first consultants to take a company to ISO 9001:2015. He has a wide range of practical experience with the ISO 9001:2015 standard.

Peter is a previous member of the Chairman's Strategic Advisory Group of ISO/TC176 at the heart of strategy development for ISO 9001. He also led the International Working Group which developed the ISO guideline on 'People Involvement' in Management Systems and is currently a member of the ISO communications team responsible for explaining ISO 9001:2015 to new users.

He is also the author of the books "Do It Right the Second Time," "Innovation Generation" and "Innovation Never Stops."

An experienced business planner, Peter is president of Quest Management Inc., past chair of the Toronto section of the American Society of Quality, currently chairs the ASQ Innovation Tank and was previously chief executive of a company within an international corporation which experienced rapid growth.

Karen Bakker, VP, Operations, SGS North America Inc.
Karen Bakker is SGS' VP of Operations for the Certification and Business Enhancement division. She is a Lead Auditor for multiple standards, including ISO 9001 and ISO 14001.  In addition, Karen provides product management support for these products.  Karen has been working with SGS's current clientele to develop transition plans for moving forward to the 2015 version of both of these standards.

Karen has worked in the certification industry for the past 15 years.   Prior to that, she worked with a consulting engineering firm providing development and implementation services to multiple clients for ISO management systems.  Karen has a BS in Engineering from Duke University, a MS in Engineering from Georgia Institute of Technology, and a MBA from Georgia State University

Date: September 9, 2016
Topic/Recording: Become a "Why Not?" Engineering Culture-20160816 1757-1
Slides: Become_A_Why_Not_Engineering_Culture_AUG_16_2016.pdf
Duration: 49 minutes

For over 30 years, Hendrick Motorsports has consistently been one of NASCAR's most successful auto racing teams. In the course of winning 11 Sprint Cup Championships, Hendrick has learned that they must innovate constantly. Learn how Hendrick Motorsports is using intelligent measurement technology to go fast on the track, transforming their organization to a "why not?" (instead of a "we can't") engineering culture. By attending this webcast, you will learn about the transformative power of portable metrology, including:
• How Hendrick Motorsports uses advanced metrology to accelerate their engineering cycle
• Techniques the team uses to leverage data and root cause analysis to consistently improve their process
• How confidence in your quality process drives productivity, and how it has created a "why not?" culture at Hendrick Motorsports
• How organizations like yours can benefit from these insights

Join Hendrick Motorsports Engineer Brandon Evans and Hexagon Manufacturing Intelligence's Portable Regional Sales Manager Scott Grumbles to get on the fast track to creating an engineering culture focused on speed and innovation.

Date: August 16, 2016
Topic/Recording: What Are Companies Doing to Promote a Culture of Quality Management?-20160726 1755-1
Slides: Traqpath_CultureofQualityManagement.pdf
Duration: 1 hour 5 minutes

The new ISO 9001:2015 represents a shift in the mindset of quality management. Gone are the days of the single point or representative for the quality system; the shift is now one that promotes a companywide commitment around quality and the leaders within the organization that will drive in line with quality. So the question becomes, "If we're all enrolled in the quality management effort, and we need to collaborate on our own part in the quality story, then how can we do that in a centralized and common system?"

It's the common, centralized culture of quality that many people struggle with. Quality management has a very important role, but needs to be "consumable" by multiple operational areas within the organization. So how can organizations create a simple, consumable way to gain broad visibility into Quality management, while making it easy and centralized?

We are all busy, and we are also inundated with information every day. We have emails, spreadsheets, conversations, meetings, incidents, and many other factors that are being put in front of our desks each day. How can we eliminate the static and get a clearer picture of Quality and keep that promise to our customers? In this webinar, we will explore these concepts, and 3 ways to help keep quality at the top of the minds of the business, while filtering out the clutter.

You will learn:
• What the ISO 9001:2015 mindset shift means for business, and how you can adapt to it
• What it means to build a "culture of quality" that enrolls the organization
• How you can effectively collaborate on quality management, while keeping it simple
• Three key areas to consider to bring quality to the forefront, and keep it on the top of all minds

Presenter: Tim Lozier, Product Strategy at Traqpath

Date: July 26, 2016
Topic/Recording: Responsible Recycling (R2) Market Drivers and the Benefits of Certification-20160713 1656-1
Slides: R2-2013.pdf
Duration: 1 hour 6 minutes

R2 has been a very fast moving and dynamic standard over the past few years, also thanks to a younger industry segment, e-Waste and re-use electronics. Since the R2 standard was first released in late 2008 with the assistance of the EPA and other stakeholders within the industry, it has gone through one major update in 2013. The updates included details on closure plans, re-used electronics with labeling and testing, downstream due diligence, security with handling data containing components through destruction and/or sanitization, as well as the inclusion of further environmental, quality and safety oversight by requiring the R2 standard to be complimented with RIOS, or with OHSAS 18001 and ISO 14001certifications.

Topics will include:

  • Current market drivers – who is requesting companies to become R2 certified.
  • Economic conditions - why more and more equipment is being recycled
  • Other factors - customer / client pressure on downstream recycling chains, traceability issues, etc...
  • Why certification
  • What it takes to become certified - steps to certification
Jason Teliszczak, JTEnviornmental Consulting, Inc, CEO/Founder
Jason is an entrepreneur with a passion for saving the environment and strengthening personal safety to make the world a more secure place. After earning a B.S. in Environmental academia and to ensure his vision would not be put to waste, he built his own successful consulting firm, JT Environmental Consulting, and has quickly become an expert within the e-Waste & Data Destruction industries. With over 15 years of consulting experience, Jason assists his clients in setting targets and achieving goals.

Organizations throughout the world, from fortune 500 corporations to non-for-profits with under 25 employees, utilize Jason's expertise & knowledge to perform compliance audits, internal audits, maintain and/or become certified to many different standards.

He continues to streamline growth within the industry through working closely with Registrars, and by updating, incorporating and strengthening new standards. Jason currently sits on numerous committees within organizations such as ASIS, NSF, NFPA to develop standards for auditing, supply chain risk management, security officers, security selection and training, security awareness, continuity management, etc. He recently also assisted SERI with introducing the Implementation Guide for R2:2013.

Karen Bakker, VP, Operations, SGS North America Inc.
Karen is a full-time employee of SGS – Certification and Business Enhancement, serving as a Lead Auditor for R2/RIOS, ISO 14001, OHSAS 18001, ISO 9001, and ISO 50001. In addition, Karen serves as the Product Manager for R2/RIOS for North America. Within this role, Karen has conducted over 50 audits to the electronics recycling management systems since 2008 and has supported the other auditors in North America in a technical capacity. Karen also supports the operations management for the US in her capacity with SGS.
Date: July 13, 2016
Topic/Recording: Understanding the FDA's Inspection of Parts 820, 803, and 806 as They Relate to Handling Complaints-20160524 1758-1
Slides: FDA Quality System Regulation Webinar.pdf
Duration: 1 hour 2 minutes

This webinar will introduce the FDA Quality System and some of its history, and provide an overview of Part 820 (particularly the language most similar to ISO 9001), the complaint-handling section, medical device reporting, and Part 806 concerning removals and corrections that take place should your product be involved in a serious incident.

The presentation will demonstrate to industry that a quality system may be doing well with an ISO 13485 certification, but that it alone is not enough. ISO 13485 may meet 90 percent of what the FDA is looking for but it's that other 10 percent that can get you in trouble.

About the presenter
Grant Ramaley is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, convener for the ISO 13485 Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Asian Harmonization Working Party. He is also the director of regulatory affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975.

Date: May 24, 2016
Topic/Recording: Four Steps to an Audit Proof Measurement System-20160512 1756-1
Slides: PQSystems_Webinar_Audits.pdf
Duration: 1 hour 12 minutes

An upcoming audit can be one of the more stressful times of the year for a quality team. Whether you are pursuing a new certification or retaining your current one, audit preparation can be a daunting challenge to even the most diligent organization. While standards such as ISO 17025, TS 16949, AS9100 and FDA differ in many ways, as it relates to the measurement system, there are more similarities than differences. We've packed this 60-minute, engaging webinar with a few key steps you can take to ensure the audit process goes smoothly.

Don't get dinged on your next audit, join our experts as they share practical methods to avoid costly mistakes.

Eric Gasper, GAGEpack Product Manager for PQ Systems
Eric Gasper is GAGEpack Product Manager for PQ Systems. He brings a rich background of technical and business analysis, consulting and team leadership to his role of product manager for PQ's gage management software. Eric has published papers in a variety of professional journals, has led seminars and workshops, and has presented on gage R&R, MSA studies and gage management best practices to a variety of audiences in the U.S.

Matt Savage, SPC Product Manager for PQ Systems
Matt Savage is SPC Product Manager for PQ Systems. He is an experienced consultant to organizations that want to utilize the power of data analysis to improve processes and enhance profitability. He has worked extensively with technical advisory teams and has provided on-site consulting and training in statistical process control for a variety of organizations representing manufacturing, health care, and service organizations in the U.S. and abroad.

Date: May 12, 2016
Topic/Recording: Risk Management outside Your Four Walls: Implementing Risk Strategies for the Supply Chain -20160428 1756-1
Slides: EtQ_SupplyChainRiskManagement.pdf
Duration: 1 hour 7 minutes

The dynamic of business today is more complex than ever before. Globalization, product competition and the increasing of the supplier network has driven companies into far more directions. In addition, product competition is at an all-time high, forcing companies to move faster to push product differentiation to the market. All this, and the visibility into compliance is greater than ever. How can companies navigate the complexities within their organization, while keeping a strong level of compliance?

The key becomes one of risk-based thinking in supply chain quality. In this webinar, we will look at the various elements that focus on the ability to connect with the supply chain, while maintaining an acceptable level of compliance. We will look at the risk management activities that organizations are employing to create greater visibility and control in supplier management, building better relationships, and encouraging the supply chain to participate in the quality management process, while limiting risks along the way.

You will learn:
• About the current dynamic of business, and how the supply chain is factoring into the equation
• The current risks associated with the supply chain
• Current mitigation strategies to connect the supply chain to quality
• Review the concept of leveraging risk-based thinking and risk management to supplier management
• Look at the ways in which you can streamline and create efficiencies in supplier involvement in your process

Presenter: Tim Lozier
Director of Product Strategy, EtQ
Tim Lozier is the Director of Marketing and Product Strategy at EtQ Inc., in Farmingdale, New York. Tim has an extensive background in software technology and has been involved in the creation of leading-edge technologies in user interface design and development. Tim is responsible for fostering the development of leading quality management software solutions, and has helped shape EtQ's strategic vision. He provides strategic leadership for EtQ, the leading Enterprise Quality, Environmental Health and Safety, and Compliance Management Software for identifying, mitigating and preventing high risk events through integration, automation and collaboration.

Date: April 28, 2016
Topic/Recording: Building The Quality Network Through Improved Supplier Management
Duration: 42 minutes

A 360 View into Issues Around Product Quality in the Partner Ecosystem
In today's complex, global marketplace, organizations face increasing pressure to maintain profitable growth, while the capability for internal research and development is reduced. Companies continue to search for innovation and growth through mergers & acquisitions (M&A) and outsourcing. Partnerships become increasingly strategic as certain services are outsourced, allowing organization to focus on its core competencies. These partnerships become a complex web of dynamic supply and demand networks, or supply chains.

Despite advances in technology and intra-company communication, each partner, in these deep supply chain webs, has its own method of managing quality events, from (literal) paper processes to automated enterprise quality management systems. There is no single system of record, communication is point-to-point instead of a hub and spoke communication model, and electronic communication is relegated to fax and scanned PDFs. Companies are aware of the problem, but they are unsure where to start. Automated communication around quality issues within the supply chain remains an untapped opportunity.

Register now for this 1-hour webinar and learn best practices for extending quality management through improved supplier management. Industry experts will discuss real-world use cases, and how manufacturers can then take proactive actions to remediate upstream and downstream impact. Ultimately, the goal is to provide safe, quality products to consumers and rectify quality issues sooner.

Date: April 19, 2016
Topic/Recording: Risk Management: Tools and Techniques-20160405 1657-1
Slides: Risk-Based-Approach-to-Product-Quality.pdf
Duration: 1 hour 38 minutes

This is a rare opportunity to learn from and interact with one of today's foremost trainers on lean, risk, and quality. Mike Micklewright has more than 30 years of experience working with everyone, from top managers in the executive suite to those on the shop floor, and his enthusiasm for process and performance excellence is infectious. In this presentation, Mike will help you understand risk as part of a broader business management system that encompasses both quality and lean—ISO 9001:2015 as well as continuous improvement. This is very much a hands-on, tools-based webinar, giving the participant a good understanding of SWOT analyses, hoshin kanri, FMEA, mistake-proofing, jidoka, and much more.

Date: April 5, 2016
Topic/Recording: ISO 50001 - Roadmap to Implementation -20160321 1657-1
Slides: ISO-50001-SGS-3-21-16.pdf
Duration: 1 hour 8 minutes

This Webinar is designed for organizations considering implementing and certifying their Energy Management Systems to ISO 50001. In this informational Webinar, attendees will receive details on the benefits to adopting the standard, useful tips and advice for the implementation, and the steps towards third-party certification.

Webinar topics include:

• Overview of ISO 50001
• Benefits to an organization
• Steps to implementation
• Tips for success
• The certification process – what to expect
 - Steps for an initial audit
 - What does a Certification Auditor look for in an ISO 50001 audit?
 - Dealing with non-conformances


Wil Wang, Managing Director, TransReg LLC

Having over 30 years of experience in petrochemical and chemical industries involving high-risk environmental and occupational health and safety compliance, quality system implementation, assessment, and consultation, Mr. Wilhelm ("WIL") Wang now leads a group of experts at TransReg LLC, a New Jersey USA based management consulting firm and TransReg MEGA DMCC, a Dubai UAE based entity, assisting organizations to better identify, prioritize, and manage issues that are key to business sustainability, from quality, environment, occupational health and safety management, to energy use optimization, asset management, and integrated business system improvement.

Karen Bakker, VP, Operations, SGS North America Inc.
Karen Bakker is SGS' VP of Operations for the Certification and Business Enhancement division. She is a Lead Auditor for ISO 50001, ISO 9001, ISO 14001, OHSAS 18001, and R2/RIOS. In addition, Karen serves as the Product Manager for ISO 50001 for North America. Within this role, Karen has conducted over 50 audits to ISO 50001 for various industries, ranging from automotive/machinery manufacturing to pharmaceutical to metal processing, within the US, Canada, and Mexico and has supported the other auditors in these countries in a technical capacity.

Prior to working with SGS and another certification body, Karen worked for twelve years with an engineering consulting firm, where she supported environmental and energy initiatives amongst numerous clients in various industries.

Karen has a BS in Engineering from Duke University, a MS in Engineering from Georgia Institute of Technology, and a MBA from Georgia State University. With respect to energy initiatives, she has completed courses from the Association of Energy Engineers, including the Certified Energy Manager course.
Date: March 21, 2016
Topic/Recording: Risk-Based Thinking in Quality Management Systems: How to Incorporate Risk into Your Processes-20160308 1856-1
Slides: Based_Thinking_Quality_Management_Systems.pdf
Duration: 1 hour 13 minutes

Presented by Tim Lozier, Director of Product Strategy, VERSE Solutions www.versesolutions.com There is a new term that is being introduced into the dynamic of Quality Management Systems, and that is the concept of "Risk-Based Thinking." With the new ISO 9001:2015 standard and other industry initiatives, there is distinct chatter about how to build more risk-based thinking into processes.

In this webinar, we will look into the concept of risk-based thinking, what it means and how you can apply risk to your Quality Management System. We will specifically look at some of the core tenets of Risk Management, discuss how the standard looks at risk, and look into some of the details around automating risk.

We will address this in our webinar by covering:
• A high level review of some basic Risk Management concepts
• The importance of identifying risk in all operational areas of business
• How you can apply risk-based thinking in your processes
• Where Risk Management applies in the ISO 9001:2015 standard
• A sample of tools for assessing risk

Speaker: Tim Lozier tlozier@versesolutions.com

Date: March 8, 2016
Topic/Recording: Delta Audits – Transition Successfully to ISO 9001:2015 and ISO 14001:2015
Duration: 1 hour

If you have an existing ISO 9001:2008 or ISO 14001:2004 certificate, TÜV SÜD can support you in your transition from ISO 9001:2008 or ISO 14001:2004 to the new ISO 9001:2015 or ISO 14001:2015 by offering DELTΔ audits. DELTΔ audits identify and address the differences or "gaps" between your existing quality management and environmental management system and the new requirements. Join us for "Delta Audits – Transition Successfully to ISO 9001:2015 and ISO 14001:2015," live on Tuesday, February 23rd at 2:00 PM EDT.

Date: February 23, 2016
Topic/Recording: A Methodology for Building a Comprehensive Quality Capabilities Strategy
Duration: 1 hour

To ensure compliance, reduce risk, lower costs and maintain a competitive edge in a today's complex regulatory environment, the introduction of a comprehensive quality management system is essential. The integration of such a system provides dramatic benefits across broad functional areas for many organizations, enabling them to implement automated, highly interactive quality control processes tailored to align with each organization's specific products and business practices. Many of these processes are now widely mandated by organizations such as the FDA, USDA, EPA, and FTCs as more and more quality-related demands are being made on organizations daily practices.

It is vital that a comprehensive quality capabilities strategy is fully-configurable to define, track, manage and report on all critical quality and compliance processes. With the ability to centralize processes in a single integrated system that can adapt to company-specific business processes, organizations gain efficiency, reduce risk and achieve compliance with regulatory standards.

Join Joe Humm, Vice President, Global Sales Operations, Sales & Business Development and Dirk Dusharme, Editor-in-Chief for Quality Digest as they discuss the key considerations for building a comprehensive quality strategy including: determining the objectives and the overall scope of an organization's quality management needs, establishing the short and long-term goals of the strategy, and the importance of integrating both old and new processes into the same system. In addition, the webinar will answer the questions:

"Where do I start?"
"Why should my organization look to implement a comprehensive quality solution"
"What does a world-class quality management system offer that others do not?"

Date: Feburary 2, 2016
Topic/Recording: Five Common Mistakes to Avoid When Applying SPC-20151217 1858-1
Slides: Five-Costly-Mistakes-Applying-SPC.pdf
Duration: 1 hour 4 minutes

Are you incurring costly mistakes by incorrectly applying statistical process control (SPC) techniques? Do you even know? We've packed this 60-minute, engaging webinar with the five most common and costly mistakes when applying SPC.

You will learn:
• The one mistake with limits you should NEVER make
• The one thing you should always do before analyzing process capability
• How a poor measurement system can jeopardize your entire SPC program
• And much more

Don't let these common errors cost you wasteful scrap, valuable time, or even an important customer. Join our experts as they share practical methods to avoid these costly mistakes.


Steve Daum, Director of Development for PQ Systems

Steve Daum is Director of Development for PQ Systems. He has more than 30 years of experience with statistical process control, control charts, and control charting software. Steve has published papers in a variety of professional journals and has led multiple seminars and presented on statistical process control and issues related to quality to a variety of audiences in the U.S., England, and South Africa.

Matt Savage, SPC Product Manager for PQ Systems

Matt Savage is SPC Product Manager for PQ Systems. He is an experienced consultant to organizations that want to utilize the power of data analysis to improve processes and enhance profitability. He has worked extensively with technical advisory teams and has provided on-site consulting and training in statistical process control for a variety of organizations representing manufacturing, health care, and service organizations in the U.S. and abroad.

Date: December 17, 2015
Topic/Recording: Medical Device Single Audit Program - MDSAP-20151208 1858-1
Slides: MDSAP_Quality_Digest_December_2015_FINAL.pdf
Duration: 1 hour 7 minutes

The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers' quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits. TÜV SÜD is authorized to work with clients who would like to participate in MDSAP pilot program. Join our expert for our webinar on the Medical Device Single Audit Program.

Date: December 8, 2015
Topic/Recording: Benchmarking Risk and Compliance with your Peers: How Do You Measure Up? -20151119 1858-1
Slides: VERSESolutions_Compliance_and_Risk_Grader.pdf
Duration: 1 hour 8 minutes

With new standards and regulations putting risk and compliance in the forefront of operations, companies are looking for ways to benchmark and measure their performance. Perhaps the biggest challenge lies in determining how much or how little risk management and compliance activities they need to cover in order to be successful, compliant, and meet standards and initiatives.

In this webinar, we will provide some guidance on how companies are measuring up on their risk and compliance activities. We will look at recent, real-time data on organizations' compliance activities, and review how they are managing these activities. In addition, we will look at a series of common risk assessments that are being recorded in the industry.

This is a great opportunity for you to see how other companies are measuring risk and tackling compliance initiatives. You'll also learn how you can measure against this data, and participate in a discussion on managing risk and achieving compliance in your company today.

This webinar is suited for:

1. Companies that are looking to implement risk-based strategies

2. People who want to see what the most common risk types and hazards are in businesses today

3. Seeing real-world data on organizations' compliance, and their overall "grade" on operational compliance

4. Companies looking to benchmark their compliance against peers

Tim Lozier, Director of Product Strategy at Verse Solutions

Date: November 19, 2015
Topic/Recording: Shift from "Approved Vendor" to Strong Supply Chain Partner-20151110 1859-1
Slides: Building-Partnership-w-Supplier.pdf
Duration: 1 hour 15 minutes

The ISO QMS standards integrate and encourage supplier control and partnering. Learn the benefits of partnering with a supplier, how to make it a true partnership, and recommendations on how to develop a partnership with suppliers. We will also discuss how ISO 9001:2015 now requires organizations to establish criteria for the acceptance of suppliers. Join our expert for our webinar "Shift from 'Approved Vendor' to Strong Supply Chain Partner."

Date: November 10, 2015
Topic/Recording: The Risk Management Primer: Getting Started with Risk in ISO 9001:2015 -20150929 1758-1
Slides: ETQ-QD_RiskPrimer.pdf
Duration: 1 hour 17 minutes

There is a shift in the mindset on quality and compliance, one that is driving businesses to look for a more comprehensive method for measuring operational efficiency. Risk Management planning and processes are becoming a proven method for this shift, as shown in the recent iteration of ISO 9001:2015. Many are interested in building a more risk-based quality and compliance management program, but are often challenged with how to begin their risk journey.

In this webinar, we will explore a practical approach to Risk Management planning, the tools available for identifying and managing risks, and how standards such as ISO 9001:2015 are incorporating risk into its requirements.

Some topics we will consider:
* A high level review of the Risk Management process
* The importance of identifying risk in all operational areas of business
* Where Risk Management applies in the ISO 9001:2015 standard

Common tools for assessing risk


Tim Lozier
Director of Marketing
EtQ, Inc.

Date: September 29, 2015
Topic/Recording: Data, Dashboards and Decisions: Turning Quality Data into Actionable Insights
Duration: 48 minutes

In regulated industries, a large amount of quality event data is captured and stored in tables, databases, or Enterprise Quality Management Systems (EQMS), with hidden value beyond just querying information about a given event. Critical quality data such as customer complaints, audits and audit findings or process deviation becomes highly valuable – even in non-regulated industries – when transformed, aggregated, correlated and visualized to help answer important questions such as:

• Why do certain quality processes take longer to complete than others? 
• Which of my suppliers/contract manufacturers have the most audit findings or complaints?
• What are the bottlenecks in my change control process?

Ultimately, the quality data collected can and should be used to measure not only your product quality, but also the effectiveness of your supply chain and your manufacturing quality system. The resulting analysis can provide actionable insights for your organization, such as when to audit or switch poor-performing suppliers, or what quality workflow process could be streamlined.

Join Jamie Chumas, Product Manager for Sparta Systems, and Dirk Dusharme, Editor-in-Chief for Quality Digest, as they discuss the data and dashboards organizations should capture in order to make strategic decisions. In addition, learn how today's leading manufacturers effectively analyze their quality data to derive meaningful and actionable information to improve the business.

Date: September 15, 2015
Topic/Recording: Increase Your Inspection Productivity with the All NEW InSight L100 Laser Scanner-20150901 1801-1
Slides: Nikon-L100.pdf
Duration: 1 hour

If you believe in the saying "Time is Money" and feel that the painstaking task of inspecting parts is a necessary evil, then Nikon Metrology's NEW InSight L100 laser scanner may be the solution you have been searching for.

In this exclusive webinar featuring the InSight L100, Nikon Metrology's Sales Development Manager, Alex Lucas, will display the versatile L100 in action. This special event will highlight the laser scanner's capability to inspect parts quickly yet thoroughly in multiple applications, showing how this new product can help broaden your company's inspection capabilities.

The L100's new advanced features include a larger field-of-view, improved spatial point resolution, and built-in rotation adapter, making this one of the most ground breaking innovations in laser scanning technology.

Presenter Biography
Alex Lucas is the Sales Development Manager for Scanning Products at Nikon Metrology. Alex's responsibilities include meeting with potential customers to better understand their inspection processes and advising how incorporating laser scanning technology can increase inspection throughput and improve their bottom line. With a degree in Mechanical Engineering from the University of Michigan's Ann Arbor campus, Alex possesses the knowledge to offer a practical and implementable set of hardware and software tools to meet any inspection challenge.

Alex has been married to his lovely and talented wife for nearly nine years and is the proud parent of a warm, tender-hearted six-year old daughter and a loveably rambunctious four-year old son. In his spare time Alex enjoys playing soccer, biking, and tending to his award-winning herb garden.


Date: September 1, 2015
Topic/Recording: ISO 9001:2015: Avoiding Nonconformities During Transition-20150811 1759-1
Slides: Avoiding-Potential-NCs-in-2015_LV.pdf
Duration: 1 hour 14 minutes

Finding a nonconformity or gap in your Quality Management System can impact your business and your customers. TÜVSÜD America can help you avoid nonconformities before they happen.

Date: August 11, 2015
Topic/Recording: EQMS Solution Selection Best Practices for Global Enterprises
Slides: EQMS_Solution_Selection_Best_Practices.pdf
Duration: 1 hour

The results are in: Research has shown that Enterprise Quality Management Software (EQMS) has proven to dramatically transform operations for the better. And organizations are taking notice—recent research based on inputs from more than 1,200 global organizations reveals that 40% of companies were in the planning stages of EQMS in 2014, a number that has risen swiftly over the past decade.

But as any seasoned executive knows, if the wrong EQMS solution is selected, the implementation is doomed before it begins, underscoring the criticality of understanding and selecting the right solution for your company with confidence and conviction.

In this webinar, LNS Research analyst Rob Harrison will present a roadmap for steering the process to successful selection and deployment by examining:

  • Strategies for gaining executive support over the project lifecycle
  • How to develop a core set of EQMS requirements and a long-term solution vision for success
  • Must-have EQMS functionalities for every manufacturing organization
  • Interviews with EQMS deployment veterans

This FREE webinar will show you how to ensure your EQMS selection and implementation process starts and ends with success, from square one to completed roll-out.

Date: July 14, 2015
Topic/Recording: The Positive Impact Managing Supplier Quality has on Meeting Your Regulatory and Operational Goals
Slides: Positive-Impact-Supplier-Quality-Management.pdf
Duration: 1 hour

The growing complexity of your Supply Chain and the need to continue globalization, along with the coming roll-out of the new FSMA regulations put a huge burden on Consumer Goods manufactures ability to sustainably manage cost and drive revenue.

Join Dirk Dusharme, Editor in Chief of Quality Digest and Brandon Henning, Director, CPG Industry Solutions at Sparta Systems, as they discuss best practice methodology to manage supplier quality. In addition, they'll examine Sparta Systems connected supplier quality solutions and how they enable manufactures to reduce cost, enable regulatory compliance, and drive efficiency by simplifying the complexity of managing your growing material/ingredient supplier network.

Date: June 30, 2015
Slides: 2015-06-04_Quality Digest_IMS_plus_Software.pdf
Duration: 1 hour 3 minutes

The advent of the High Level Structure (HLS) with the new ISO 9001:2015, ISO 14001:2015 and ISO 45001:2016 standards will encourage companies to adopt Integrated Management Systems. Not only will it aid in the ease of implementation, but it will result in significant savings.

Chad Kymal, the presenter of this webinar and CTO of Omnex, just published a book on Integrated Management Systems for ASQ with Greg Gruska, Omnex Senior Consultant and Dan Reid, Omnex Director of Consulting. In the book they say "…without software , it would be quite difficult to implement integrated management systems in large organizations." Integrated Management Systems provide savings to organizations by both integration and standardization of an Enterprise Wide Management System. In fact there is savings of $730,000 in a medium sized organization for integration and a savings of $4.285 Million for a company with three sites for integration and standardization. Download the Executive Primer for Free.

Join Chad Kymal to understand the definition of integration and standardization and the requirements of an Enterprise Integrated Quality Management System Software.

Date: June 4, 2015
Slides: Effective-Strategies-for-Complaint-Handling-Unabridged.pdf
Duration: 1 hour 7 minutes

Take the complaint handling process from just a regulatory requirement to a strategic process for reducing risk, increasing customer confidence, and improving business performance.

Date: May 19, 2015
Slides: Mitigating-Supplier-Risk-through-Cloud-Based-Quality-Management-Portals.pdf
Duration: 1 hour 1 minute

Regardless of the number of suppliers an organization is managing, having an effective technological infrastructure for supplier management can streamline quality assurance practices, create efficiencies in supplier oversight and ultimately mitigate risk in Quality Management compliance in the supply chain.

This webinar will discuss how Enterprise Quality Management solutions can expedite communication and transparency between an organization and its suppliers, while mitigating risk of data security. As organizations centralize the management of component manufacturers and harmonize supplier quality procedures across multiple divisions, implementing an automated process for supplier management is the next step in creating cost-effective and efficient supplier quality management.

Some topics we will consider:

• How the supply chain can interact with your Quality System--opportunities and challenges
• How to leverage cloud-based technology to better collaborate with the supply chain
• The benefits of including suppliers in your quality processes
• Why a supplier portal will increase visibility while keeping you in control of your compliance processes

Date: May 5, 2015
Topic/Recording: FDA Initiatives and Regulatory Trends for Life Sciences
Slides: FDATrends_and_Initiatives.pdf
Duration: 1 hour

Join Larry Spears, former Deputy Director for Regulatory Affairs at the FDA Center for Devices and Radiological Health, Office of Compliance, and Dirk Dusharme from Quality Digest, as they discuss FDA trends for regulatory affairs over the next several years along with upcoming FDA initiatives and what impact that will have on Life Science establishments.


During this webinar, you will learn about:
• Increase in focus on Agency transparency
• Impact on FDA of global market growth
• Different strategies for inspections
• Potential changes in compliance tools

Date: April 21, 2015
Slides: MiCAT-Planner-Quality-Digest-Webinar.pdf
Duration: 56 minutes

In this webinar we will be introducing the MiCAT Planner automatic measurement program generation software that uses 3D CAD models and Product and Manufacturing Information (PMI) to enable one-click automated generation of measurement programs. With this new program, a complex program that previously would have taken five hours to complete manually can now be completed in 15 minutes.


Aerospace, defense and medical device manufacturers will realize significant savings in time and money by making the automatic measurement program generation software MiCAT Planner a part of their digital product definition strategy.


Benefits that will be presented in the MiCAT Planner webinar.


• Streamlined processes
• Improved productivity
• Reduced manufacturing costs
• Enhanced traceability
• Part measurement consistency
• CMM configurations can be changed at any point
• Workflow automation


About the presenter
Larry Maggiano is a senior systems analyst at Mitutoyo America Corporation's HQ in Aurora, Illinois. He has an extensive background in dimensional metrology and is focused on advanced digital (CAD to CMM) metrology processes. Maggiano is a member of ASME Y14.41 (Digital Product Data Definition Practices) and chairs the Dimensional Metrology Standards Consortium (DMSC) Quality Measurement Directives working group. He is an active participant in the PDES, Inc. Testing the Digital Thread project as well in the National Institute for Standards and Technology (NIST) project for Investigating the Impact of Standards-based Interoperability for Design to Manufacturing and Quality in the Supply Chain Project (Grant Award Number - 70NANB14H314). He joined Mitutoyo in 1991 and has held positions at Mitutoyo in service, applications, and management.
Date: April 9, 2015
Slides: ISO9000Automation.pdf
Duration: 1 hour 6 minutes

When we look at the upcoming ISO 9000:2015 standard, we don't necessarily see a change in the actual requirements, but in the approach. We're not necessarily seeing a major shift in the requirements, but more so in the mindset.

In this webinar, we will look into this shifting mindset and how the revised standard means that there is no one quality representative and therefore no one person is dedicated to quality. ISO 9001:2015 is a broad look at everyone's commitment to quality, to customers and beyond. So if there isn't one core person that "owns" quality, where does quality live, and how does the entire company become enrolled?

We will address this in our webinar by covering:
• The importance of a centralized, common, and collaborative environment that not only gives us the visibility into where we are in our QMS, but also makes us active participants and champions of quality.
• How the broader approach provides a much more flexible interpretation of the ISO standard to enable companies to focus on consistency, customer focus, leadership, people-focus and improvement.
• How this new interpretation brings ISO to a new level of focus, and also recognizes the changes in technology and practices to quality, helping people to implement technology to automate and build flexibility into their QMS solutions.
• Technology considerations to keep in mind to ensure compliance

Date: March 24, 2015
Slides: FARO-Next-Generation-Scanning.pdf
Duration: 48 minutes

Engineers and manufacturers are constantly striving to improve product quality, reduce required inspection times, and maximize productivity – the newly released Laser Line Probe HD is a breakthrough in 3D Laser Scanning Technology and is a critical tool for that effort.

The FARO Edge ScanArm HD combines the convenience of an Edge FaroArm with the power of the Laser Line Probe HD to provide a fast, accurate, and portable contact/non-contact 3D measurement solution.

Whether you're doing inspection to CAD or reverse engineering, join us to learn how the ScanArm HD can revolutionize the way you measure your parts.

Join us to learn:

  • What is Laser Scanning and how does it work
  • Key performance improvement of the ScanArm HD
    • Capture rate of 560,000 points/sec
    • New blue laser for noise reduction
    • Ability to seamlessly scan across diverse surface materials
    • Reliable, repeatable and highly accurate measurement data
  • The ROI – how the ScanArm HD can improve your bottom line

Presenter: Chad Crisostomo
Chad Crisostomo started at FARO in 2005 as an Applications Engineer, working directly with customers to solve complex measurement challenges. Currently, Chad is the Technical Product Manager for the FaroArm product line where he focuses on advancing the future of contact and non-contact metrology. In his spare time, he enjoys running, reading technology blogs, being a newborn dad, and chasing microns.
Date: March 10, 2015
Slides: RB_Manage-Product-Quality-in-Supply-Chain.pdf
Duration: 54 minutes

Global product quality is impacted by financial pressures, regulatory requirements and a complex, global supply chain.

Join Dirk Dusharme, editor in chief of Quality Digest and Ron Brown, recently retired CIO, Global R&D & Global Nutrition Group, PepsiCo Inc., as they examine some of the biggest challenges in ensuring global quality across a complex supply chain and what best practices were incorporated at PepsiCo to achieve business value.  

During this webinar, we will discuss:

  • Addressing the food safety challenge  - what was learned at PepsiCo
  • Understand the failure points across your supply chain
  • Aligning your functional and business needs, to business and corporate objectives
  • Ensuring effective prioritization in a complex and multifunctional environment
  • Planning for change and how to focus on sustainable added value to the business
Date: Feb. 24, 2015
Slides: Visibility-into-processes-across-business-ecosystem.pdf
Duration: 1 hour
Description: The world of manufacturing is becoming more complex by the day as a result of an increased reliance on Contract Manufacturing Organizations (CMOs) to generate finished goods, and the fact that manufacturers are continuing to expand their tiered supplier networks across the globe. Doing this has helped manufacturers find the goods and services they need, when they need it, and typically helps them find a price point that meets their budget. But in return it has created an environment and set of processes that can be difficult to effectively administer at scale. When you couple this with the fact that regulatory agencies are more aggressively enforcing regulations that hold manufacturers responsible and accountable for quality across all points in the value delivery chain, including that of suppliers and CMOs, the risks associated with global outsourcing are high and the margins have the potential to be eroded quickly as a result of poor operations and supply chain management.

Please join Joe Humm, Vice President, Global Sales Operations for Sparta Systems, and Dirk Dusharme, Editor in Chief of Quality Digest, for a webinar where they'll discuss how organizations are addressing these challenges to:

1. Effectively enable CMOs and Suppliers to more easily collect and share quality related information
2. Efficiently provide Supplier and CMO quality information across departments within a manufacturer
3. Build a culture of quality and collaboration both internally and externally through the use of information
Date: Jan. 27, 2015
Topic/Recording: The Impact ISO 9001 Revisions Will Have on Your Business and to Your Quality Management System
Duration: 1 hour

The constant changing regulatory environment, combined with social, economic and industry challenges can make it difficult to consistently produce high quality products.  Having an integrated quality management system allows for visibility into manufacturing and supply chain problems before they become a financial burden.

During this webcast, Rick Calabrese, Global Quality Director of Quality Systems of Sartorius and Dirk Dusharme, Editor in Chief of Quality Digest, discuss the values of ISO 9001's core competencies and how the new changes will affect manufacturers quality processes.

Date: Dec. 9, 2014
Topic/Recording: ISO 27001: Introduction and the Road to Certification-20141118 1903-1
Duration: 1 hour 3 minutes

The need for Information Security awareness, infrastructure, and policies is more evident today than it has ever been of past. From households to small-, medium-, and large-sized businesses, we are all susceptible to cyber-attackers and data breaches. Whether you are an Information Security or Information Technology professional, consultant, (e.g., Analyst, IT staff, CISO, etc.) or student, you will benefit from this webinar.

The webinar will cover topics from "What is ISO 27001" to "The Certification Step-by-Step process."

Date: Nov. 18, 2014
Topic/Recording: Digital Microscopy in Quality Assurance and Control -20141104 1849-1
Duration: 1 hour 8 minutes

The age of advanced digital microscopy is here—highly sophisticated image processing and analysis can now be performed with the same ease of use one would expect from a smartphone or tablet. Specifically designed for the needs of QA/QC control labs, the OLYMPUS DSX Series opto-digital microscope can help you enhance your quality control processes while allowing more team members to easily perform advanced imaging and analysis tasks.

Within this webinar, Product Applications Manager Robert Bellinger will walk you through the latest advancements in digital microscopy, showing you how easy it can be to achieve absolute performance reliability:

• Create and find the right high-resolution images without years of training or hours of skillful adjustment
• Achieve precise 3D measurement made possible by superior optics and today's most sophisticated image processing
• Rest assured that you are creating accurate, repeatable measurements backed by full traceability
• Enjoy automatic calibration that removes manual calibration bias and provides correlation of system measurements
• Seamlessly acquire, process, and measure images while creating valuable data and automatically generating custom reports
• Capture images beyond the field of view with panoramic imaging in manual (live) or automated stitching
• Increase contrast beyond the human eye by observing light and dark features in the same field of view
• Enhance user comfort while ensuring consistent operator-to-operator performance

This informative webinar will also include realistic sample analysis demonstrations. The DSX digital microscope is ideal for the observation, measurement, and analysis of virtually any material including electronic components, ink on paper, metal components, cloth, metallographic structures, semiconductors, and medical device materials.

Discover the power of today's most advanced digital microscope and discover a new level of flexibility and functionality backed by reliable, repeatable, reproducible data.

Date: Nov. 4, 2014
Topic/Recording: Root Cause Analysis Tools and Techniques-20141021 1757-1
Duration: 1 hour 8 minutes

When identifying a problem, many organizations have the tendency to jump to a solution. A systematic analysis of the problem to determine a root cause before considering potential solutions is often missed.

On the other hand, Root Cause Analysis can assist with the identification and definition of problems. After understanding the problem it can be further analyzed using the right root cause analysis tools.

This webinar will cover:
• Root Cause Analysis - How to start and process
• Problem Description and Tools
• RCA Tools: 5 Whys, Cause-and-Effect Analysis, Brainstorming
• Common Pitfalls
• Q & A

About the Presenter
Edna Falkenberg is the Manager of Quality and R&D, for TÜV SÜD America's Medical Health Services Division. She joined TÜV SÜD in 2011 as Lead Auditor, Active medical products. Prior to that Ms. Falkenberg spent ten years at Karl Storz GmbH & Co. KG in various function, including Manager Regulatory and Standards Compliance, Special Projects and Environmental Compliance Engineer and finally Director, Quality Systems and Regulatory Affairs. Ms. Falkenberg graduated from University of Applied Sciences, Lübeck (Germany) with a B.S. in Biomedical Engineering.

Date: Oct. 21, 2014
Topic/Recording: Hacking Risk Management: 3 Ways to Easily Build Risk into Your Processes -20141007 1757-1
Duration: 1 hour 3 minutes

We hear it all the time in our professional lives – "Risk Management". We know we need to do it, but often the challenge becomes where to start, and what it all entails. Risk Management and Risk Assessment can be complex for many industries, but it doesn't have to be. The concepts behind Risk are actually very basic and common to businesses today. Chances are, many compliance professionals are already conducting some level of Risk Assessment and may not even know it.

In this webinar, we are going to dissect the whole concept behind Risk Management and break it down into the most basic terms – "What is the Risk Management process, and how does it factor into existing processes?" Next we will look at three levels in which you can take your processes and enhance them with Risk elements:

Level 1: Decision Trees – We will review the most basic type of Risk Assessment that can easily be managed, tracked and consumed by all personnel.

Level 2: Risk Matrix and Risk Assessments – Taking it a step further, we will look at how you can incorporate more calculated levels of risk that measure multiple factors to give you a systematic and objective decision.

Level 3: Risk Reporting and Trending – Finally, we will look at how Risk can be used not only to help make in-process decisions, but also report and discover trends that can lead more proactive risk-based planning.

About the Speaker:
Glen Fraser is the Senior Product Manager for VERSE Solutions, a cloud-based Quality and Compliance management solution. Glen Fraser has been involved in the IT industry for more than 30 years and Compliance for more than 15 years. Glen has owned his own consulting firm, built and managed product solutions for Risk and Compliance, as well as managed overall strategy for taking operational processes and automating them. Glen currently provides industry and technical guidance on building best practices into VERSE Solutions cloud-based Quality and Compliance products.

Date: Oct. 7, 2014
Topic/Recording: Implementing a CAPA System-20140923 1756-1
Duration: 1 hour 16 minutes

Corrective and Preventive Action (CAPA) is one of the most challenging quality system elements that companies face during inspections and audits. CAPA is a fundamental management tool that should be used as such in every quality system by implementing better metrologies and applying effective risk-based filters. A robust and effective CAPA program is especially important for medical device manufacturers. An effective CAPA system that identifies and eliminates (potential) non-conformities enables both regulatory compliance and at the end cost savings. Join TÜV SÜD America for their webinar CAPA E-ssentials to learn more about the importance, requirements, and essential elements of a CAPA program. The webinar will also discuss common pitfalls and guidance on how to implement a CAPA system.

Date: Sept. 23, 2014
Topic/Recording: Stop Half-S'ing It: 5S Starts with a Standardize and Sustain Mindset-20140826 1757-1
Duration: 1 hour 5 minutes

Most companies have a very difficult time sustaining their 5S efforts, making the entire 5S process a waste in itself. And yet, if an organization cannot sustain the improvements they made during the 5S process and are consequently not driving further improvements in the area /process of interest, this organization has little chance of having any success in any of its lean endeavors. 5S improvements will only be sustained by a change in culture, priorities, systems, and responsibilities and it all begins with sound Standardization and Sustain systems – the 2S's that are oftentimes overlooked or under-focused. This webinar will demonstrate to the viewer the importance of any organization properly Preparing for Standardize and Sustain, as a step 0, before the 5S process if rolled out. The webinar will provide sound and practical advice that you can use immediately within your organization.

Presented by Mike Micklewright
A dynamic international speaker, Micklewright has addressed thousands of people and specializes in creating lean and continuous improvement cultures, effective quality management systems, lean leadership, the principles of W. Edwards Deming, auditing, competency-based training through TWI, participative problem solving, global standardization, and root cause analysis.

Date: Aug. 26, 2014
Topic/Recording: Creating an Integrated Compliance System: Kimberly-Clark's Quality Management Solution Tied to SalesForce.com-20140729 1756-1
Duration: 1 hour 1 minute

As businesses grow and expand, they often see an increase in complexity. This comes from a global market, rapid pace of business and consumer demand, and more and more business systems to keep up with the pace of business. Amidst this complexity, compliance and quality are at a premium—companies need to keep up with their demand, and maintain a high level of compliance. Many leading organizations are seeking ways to improve operations, while keeping compliance as the central "hub" for their business.

Join us in this free webinar to learn more about how companies are building solutions to create a central hub for quality and compliance and the common processes and business systems that tie into this hub. Kimberly-Clark will present how they were able to achieve an integrated system by linking their Quality Complaint Handling system to their Salesforce.com (SFDC) platform. See how this enabled them to increase visibility, response times, and connection from post-market events to quality and compliance processes.

Some capabilities we will consider:
• How leveraging capabilities of the SFDC customer relationship system with their quality workflow system has resulted in a more efficient and effective complaint handling process.

• The method of entering complaint data and attachments into the SFDC system and submitting them to the quality system electronically, which creates a complaint within the system that is assigned to the appropriate team for further processing.

• How the quality system streamlines the complaint resolution process, by sending the complaint information back to the SFDC system to ensure the necessary parties are aware of the complaint status.

• Why integration of SFDC with the quality system has resulted in significant lead time reductions, elimination of manual processes, enhanced visibility and improved reporting capability


Date: July 29, 2014
Topic/Recording: Risk Assessment and the Quality Management System-20140708 1800-1
Duration: 1 hour 2 minutes

In the world of quality management systems (QMS), the nature of the relationship between risk management and preventive actions is often confused and misunderstood. Indeed, some believe that a thorough risk assessment process replaces the need for preventive action.

In fact, risk management and preventive action are sequential, complementary elements that are essential to the QMS. In this webinar, stakeholders throughout the organization can learn how to effectively manage risk through the QMS.

Hosted by Dirk Dusharme, editor in chief of Quality Digest

Presented by Hermann Ries, lead auditor for TUV SUD America Inc


Date: July 8, 2014
Topic/Recording: Turning Today's Quality Challenges Into a Source of Competitive Advantage with Closed-Loop Quality Management -20140617 1801-1
Duration: 1 hour 6 minutes

For quality and operational professionals, it's not enough anymore just to produce high-quality products. Driven by factors such as rising customer standards and activity, increasingly stringent regulatory environments, and complex global supply chains, market leading companies today are connecting data around these and other challenges, or "closing the loop," to continuously improve upstream operations.

Developing these Closed-Loop Quality Management capabilities requires architecting business processes like corrective and preventive actions and document management throughout engineering, manufacturing, the supply chain and customer experience.

Today's market leaders understand that quality is a shared responsibility, not a department, and are supporting these business processes through the use of enterprise applications like Manufacturing Operations Management (MOM), Enterprise Resource Planning (ERP), Statistical Process Control (SPC), Enterprise Quality Management Software (EQMS), Product Lifecycle Management (PLM), and others to foster collaboration, improve analytics, and present a single version of the truth.

In this free webinar, the presenters will draw upon research data collected from more than 1,000 quality executives to detail the critical steps and components needed for creating the type of robust closed-loop quality management environments that push companies to the top of the market.

Specifically, LNS will cover:

* The business process and enterprise applications that must be harmonized and managed centrally vs. those that should remain locally managed
* The most important metrics for effectively benchmarking closed-loop quality management initiatives
* The current state of closed-loop quality management capabilities by industry
* Strategies for enhancing closed-loop quality management and quality analytics to enable increasingly predictive decision making


Date: June 17, 2014
Topic/Recording: Sustaining Lean Improvements While Adding Spark to Your QMS-20140306 1900-1
Duration: 1 hour 9 minutes

Most lean experts agree that one of the most difficult parts of lean is sustaining the improvements that have been made. Yet, an ISO-based quality management system is all about an organization ensuring the "effective planning, operation, and control of its processes."


In this webinar, you will learn how fully integrating lean into the QMS can help an organization develop and deploy a much more effective business management system while reducing the waste that has been created through redundant systems. This can also add life to a stale QMS that is perhaps failing to drive continuous improvement, all the while adding sustainability to lean improvement efforts.


Presented by Mike Micklewright
A dynamic international speaker, Micklewright has addressed thousands of people and specializes in creating lean and continuous improvement cultures, effective quality management systems, lean leadership, the principles of W. Edwards Deming, auditing, competency-based training through TWI, participative problem solving, global standardization, and root cause analysis.


Date: March 6, 2014
Topic/Recording: Understanding Your Quality Management Maturity -20140218 1456-1
Duration: 1 hour 16 minutes

With the myriad of cost, supplier, and regulatory challenges facing today's global organizations, it comes with little surprise that most executives are increasing their focus on quality management. Market leaders have come to understand that managing quality across the value chain is critical to business performance, and are relying on a variety of resources—across people, processes, and technology—to effectively do just that. However, taking quality management to the next level requires a thorough understanding of your quality management maturity.


In this webcast, LNS Research and Sword Achiever will discuss the Enterprise Quality Management Software (EQMS) space and the four progressive stages of quality management maturity. Senior leaders in attendance will gain a thorough understanding of what separates market leading performers from average performers, and the right steps to transform quality into a competitive advantage. Specifically, it will cover the following:


• EQMS Drivers and Challenges LNS Research's 2013 Quality Management Survey
• An Overview of LNS Research's EQMS Framework
• Benchmark Data on the Performance Benefits of EQMS
• Overview of Technology Adoption Roadmap to support Maturity Model (presented by Sword Achiever)
• Actionable Recommendations for Advancing Your Quality Maturity

Date: February 18, 2014
Topic/Recording: Building the Foundation of Enterprise Quality Management Throughout the Product Value Chain-20131219 1900-1
Duration: 1 hour 1 minute

As product and process complexity continues to increase in manufacturing, holistically managing quality at the enterprise level is a critical capability for companies looking to deliver world-class products to market on-time, on-budget, and on-quality. Unfortunately, many companies today are still challenged by managing quality as a silo'ed corporate function with manual process and limited connection to procurement, engineering, manufacturing, supply chain, or service.


In this webcast, attendees will learn how to overcome these challenges from two speakers, LNS Research President and Principal Analyst Matthew Littlefield and Supplier Quality Process & Audit Manager at GE Healthcare, Mark Bienkowski.


Littlefield will start by sharing LNS Research's framework for successfully implementing Enterprise Quality Management Software (EQMS) as well as recent benchmark data on the benefits companies enjoy from taking this approach. He will pay particular attention to best practices for establishing the right culture, business process framework, and metrics scorecard for the successful use of software to improve quality management. Bienkowski, will continue the discussion by sharing how GE Healthcare has successfully managed quality at the enterprise level, with a detailed analysis of how software, metrics, and business process has come together to deliver tangible business results. The event will then conclude with a live question and answer session for all attendees.

Date: December 19, 2013
Topic/Recording: Closed-Loop Quality and the Customer-Centric Organization-20131119 1900-1
Duration: 1 hour 1 minutes

Many of today's manufacturing companies are striving to do more than simply sell traditional products. Market-leaders are transforming relationships with customers to deliver a complete solution that leverages cutting-edge technology and offers innovative value-added services. Industries like automotive, aerospace, consumer products, and industrial equipment are accelerating this trend towards customer-centricity with a combination of cloud, machine-to-machine, the Internet of Everything, mobility, social, and big data analytics.


Unfortunately, many quality organizations are struggling to keep pace with these changes. Disconnected and disparate quality systems limit many companies' abilities to capture value from the new wealth of information and use it to drive continuous improvement across the value chain.


Join Quality Digest's Editor-in-Chief, Dirk Dusharme, and LNS Research's President & Principal Analyst, Matthew Littlefield, for a discussion on how EQMS, closed-loop quality strategies, and harmonized quality processes for NC/CAPA, Audit Management, Complaint Management, and more can help companies respond to the demands of becoming a customer-centric organization.


Specifically, the webinar will cover:
• The internet of everything and the changing nature of manufacturing
• Quality insights found in machine-to-machine connections
• Quality insights found in social data
• The benefits of harmonized quality processes like NC/CAPA, Audit Management, and Complaint Management
• Real world examples of EQMS supporting the customer-centric organization

Date: November 19, 2013
Topic/Recording: Why Risk Management is Important in Quality and Compliance Management Systems-20131022 1801-1
Duration: 1 hour 3 minutes

This webinar explores the strategy behind risk in compliance, the methods most often used in risk management today, and how to apply risk management to ensure a greater level of quality and compliance. We demonstrate the transformation of Risk Management as a benchmark for compliance, and review some of the key risk tools and the processes in which they are best suited.


Topics include:
How to measure compliance in the complexity of business today
How Risk Management processes drive new ways of looking at compliance
Key Risk tools being used in common compliance processes
The importance of Risk reporting
Case Studies on Risk from leading industries


Presented by Tim Lozier

Date: October 22, 2013
Topic/Recording: Exploring the Revolution in Multipoint Gauging in Metrology Applications-20131008 1757-1
Duration: 45 minutes

A new breed of multiplexors utilizing revolutionary multi-channel electronics is enabling a paradigm shift in metrology applications – especially in production line measurement systems. This webinar explains the fundamentals of multipoint gauging and explore the possibilities created when up to 250 devices and sensors can be connected to a single, modular platform, such as HEIDENHAIN's new MSE 1000.

Presenter: Stuart Graham, Product Specialist for Metrology at Heidenhain Host: Dirk Dusharme, Editor in Chief, Quality Digest

Date: October 8, 2013
Topic/Recording: Dynamic Duo: Quality Inspection with FARO and PolyWorks|Inspector-20130716 1756-1
Duration: 1 hour 3 minutes

FARO Technical Product Manager, Chad Crisostomo, and PolyWorks USA Application Specialist, Tim Benjamin, showcase how the FARO Edge ScanArm and Polyworks software work together to save manufacturing businesses time and money while improving efficiency and reliability on the workfloor. Questions answered will include:

· What is a FARO Edge ScanArm?
· What is laser scanning?
· What are typical applications for the FARO Edge ScanArm?
· What is PolyWorks|Inspector?
· How does PolyWorks|Inspector handle contact and non-contact 3D measurement systems?
· What is a typical part inspection process in PolyWorks|Inspector?

Date: July 16, 2013
Topic/Recording: The Global State of EQMS Software-20130625 1805-1
Duration: 1 hour 2 minutes

In the upcoming webcast "The Global State of Enterprise Quality Management Software" President and Principal Analyst of LNS Research, Matthew Littlefield, will present the key research findings from a yearlong benchmark study of over 500 global quality executives. These findings will highlight how market leaders are using EQMS to both ensure compliance and make operational improvements. Specific results and recommendations will include strategies for:

· Aligning quality objectives with operations as well as the CFO
· Ensuring the right leadership and change management capabilities are in place for a global EQMS deployment
· Harmonizing processes such as CAPA or Audit Management globally
· Improving OEE, New Product Introductions, On Time Deliveries, and Cost of Quality with specific EQMS capabilities
· Extending EQMS globally to improve supplier quality management
· Effectively leveraging emerging technologies like analytics, mobility, and the cloud

Date: June 25, 2013
Topic/Recording: Defining and Building a Risk Management Strategy for Quality and Compliance Management Systems-20130430 1800-1
Duration: 1 hour 2 minutes
Description: As industries increase in complexity and worldwide scope, the need to maintain a high level of compliance becomes more critical. Companies are looking for ways to keep up with the pace of business and drive innovation, without sacrificing compliance, quality or safety. Risk is becoming a way for companies to streamline their complex operations, while keeping the same level of compliance that is expected of them. Join us as we review some of the key concepts behind Risk management and how you can effectively implement risk into your existing operations. We will explore the reasons why Risk management is an elusive concept for many organizations, and how to overcome the challenges surrounding risk to build a program that makes sense for your business. Finally, we will look at some of the risk tools being utilized by many businesses today, and demonstrate a few examples of how they are used.

• Review of Risk Management processes
• How to define risk and implement within the Quality and Compliance system
• Key Tools and Technologies behind Risk
• Case Studies on how Risk is being implemented in business

This in-depth webinar will demonstrate the transformation of Risk Management as a benchmark for compliance, and review some of the key risk tools and the processes in which they are best suited.

Presenter: Morgan Palmer, CTO, EtQ Inc.
Host: Dirk Dusharme, Editor in chief, Quality Digest
Date: April 30, 2013
Topic/Recording: Drive Business Success Using an Effective Complaint Management Solution
Duration: 1 hour 5 minutes
Description: The March 2013 issue of Silver Sheet stated that "Complaint Management" is now the #1 most frequently cited FDA 483 observation.  An effective complaint management strategy not only incorporates compliance requirements and insights, but also should define strategies and techniques for using effective complaint management as a means for driving business success and reducing risk in several areas including compliance.

Come join Dirk Dusharme, editor-in-chief of Quality Digest and industry expert, Dick DeRisio, as he explains some challenges he's experienced with complaint handling and the strategies he's learned to manage through the process with successful results.
Date: April 16, 2013
Topic/Recording: ProjectionWorks 3D Optical Projection System for Work Instuctions-20130226 1857-1
Duration: 1 hour 6 minutes

ProjectionWorks is an Augmented Reality tool for improving the quality of the assembly of complex systems. This exciting new technology has already been providing new opportunities for significantly improving first-time quality in the aerospace industry for the past three years. It is a system that allows an assembly technician or inspector to "see" the next assembly step, properly placed, in full scale, 3D, and in color. Three months ago at the annual Defense Manufacturing Conference, ProjectionWorks was awarded the DOD's highest honor for manufacturing technology -- the Manufacturing Technology Achievement Award -- as the most significant technology for improving quality, reducing costs, and shortening delivery times. This technology is applicable to any manufacturing process that involves many steps/components where the size and complexity of the operations do not lend themselves well to robotic automation. If you believe that your current documented processes are good, and if people would only follow them then your quality issues would be vastly mitigated, then you will not want miss this webinar.

Delta Sigma Presenter -- Roger Richardson, CEO of Delta Sigma
Quality Digest Moderator -- Dirk Dusharme, Editor in Chief

Date: February 26, 2013
Topic/Recording: Harmonized QMS for Labeling Integrity
Duration: 1 hour 8 minutes

Does your quality management system ensure the integrity of your labels?

Why label management needs to be part of your QMS.

Whether a company's labeling requirements are limited to meeting narrow internal needs, or must adhere to complex requirements like UDI, effective label management is vital to productivity and profitability. Incorrect or noncompliant labeling is a leading cause of recalls. Poor labeling of hazardous materials leads to injuries and fines. In addition, regardless of the industry, warranty management and traceability requirements absolutely depend upon error-free labels.

In this webinar we will demonstrate how a harmonized QMS prevents common label problems from jeopardizing production, compliance, and safety.

IBS Presenter -- James Hartford, Customer Support Manager for IBS America
Guest Presenter -- David Martin, President of Pragmatyxs
Quality Digest Moderator -- Dirk Dusharme, Editor in Chief

Date: January 29, 2013
Topic/Recording: EQMS: Accelerating Quality Outcomes cosponsored with Quality Digest
Duration: 1 hour 1 minutes
Description: Quality Management Systems should be an integral part of a company's business and information systems strategy. Many quality system owners struggle to communicate the value of their systems in relation to core pillar supply chain, enterprise resource planning, and innovation management systems. Companies who incorporate quality management systems into their enterprise architecture strategy have higher gross margins. They have fewer quality incidents per lot/batch/unit produced. They introduce new products and product changes faster. They have fewer, better suppliers who partner more closely to increase customer value. This webinar will allow quality professionals to better estimate and communicate the value of their quality management systems accelerating quality management outcomes that can be measured by their financial and operational peers.
Date: Nov. 20, 2012
Topic/Recording: Risk Management 2.0: The Expanding Role of Risk Mitigation in Industries
Duration: 1 hour 10 minutes
Quality and compliance systems often use Risk as a reactive measure based on post-market feedback; however, there is a growing trend in the industry to create a holistic approach to Risk Management, utilizing both proactive and reactive risk factors. To this end, Risk Management can be applied to all aspects of the enterprise and risk can influence quality at many different levels.

This webinar will show how risk can be applied to processes as well as products, describe how risk mitigation is more than a post-production event, and how Risk can be applied in design, change, and beyond.
Date: Oct. 10, 2012
Topic/Recording: uniPoint Quality Management Webinar
Duration: 1 hour 6 minutes
Are you investigating best practices in your manufacturing or distribution process? Do you want to control your internal processes effectively and do you have a continuous improvement process in place, or are considering getting certified for a quality standard?

If so, please join us for a uniPoint Quality Management Webinar

Specifically you will learn:

* How to eliminate manual tracking of continuous improvement processes
* How to change your quality department cost center into a measurable cost-savings center
* How to get away from tracking costs on spreadsheets
* The business value of quality management software
* How hundreds of companies are using uniPoint software as a best-practices tool for their organization
Date: Sept. 26, 2012
Topic/Recording: SpatialAnalyzer Webinar - Portable Metrology Software
Duration: 1 hour 1 minute
Attend the free SpatialAnalyzer (SA) webinar and learn how SA can help you improve productivity. SA is a fully traceable, 3D graphical software package that interfaces with over 120 portable metrology instruments. SA helps you save time, increase accuracy, reduce scrap, and lower operational costs.

Whether you're new to SA or an advanced user, attend the free webinar and learn more about SA's measurement, alignment, inspection, analysis, reporting, optimization, and automation capabilities, as well as the newest capabilities in the latest software release.

David O'Neal, VP of US Sales, and Todd Burch, Director of Training, will explain and demonstrate the newest capabilities of SA contained in the SA 2012.07.09 release. They will also show some of SA's advanced metrology capabilities, so register today!
Date: Aug. 21, 2012
Topic/Recording: How an EQMS can protect your customers, keep you compliant, and have a positive effect on your bottom line
Duration: 1 hour 4 minutes
Description: For too long, Quality Assurance has been viewed as a cost center and a necessary evil in the highly regulated industries. The problem has been the control of quality processes in siloed disconnected systems, with little management visibility and oversight of issues. This webinar will explore bringing related processes together on a global basis, and integrating systems to create transparency and effective and timely decision making. We will also examine how improved quality creates not only safer products, but also creates efficiencies and measurable cost savings.
Date: June 26, 2012
Topic/Recording: Reducing the Cost of Quality through Alternative Check Fixtures
Duration: 1 hour 10 minutes
Check fixtures are a staple for manufacturers around the globe; however, the rise of lean manufacturing and six sigma programs have given way to a more efficient way of checking critical features and providing quantitative data to monitor manufacturing trends. The implementation of alternative check fixtures allow users to quickly collect and check measurements, while reducing overall costs and collecting quantifiable data.

You will learn:
- Introduction to Check Fixtures
- Implementation of Alternative Check Fixtures
- Real-World Applications
Date: April 24, 2012