Quality Digest LIVE, December 8, 2017

This episode of Quality Digest Live, from December 8, 2017, provides an in-depth exploration of several critical topics relevant to quality management, manufacturing trends, and organizational efficiency. The hosts, Mike Richman and Dr. Sean, discuss the evolving landscape of smart manufacturing technologies, the importance of quality management systems (QMS), and the broader societal implications of automation. The broadcast serves as a snapshot of industry concerns and technological advancements from that period, emphasizing the need for adaptable systems and proactive management in an increasingly automated world.

The discussion begins by highlighting key smart manufacturing trends, including the growing adoption of cobots, advancements in production 3D printing, and the pervasive influence of the Industrial Internet of Things (IIoT). Smart manufacturing is defined as making all manufacturing process information available precisely when, where, and in the form it is needed across the entire supply chain, largely driven by digital technologies. The hosts elaborate on the rapid growth of augmented reality (AR) in manufacturing and field operations, enabling workers to access critical information and live assistance directly in their line of sight. This segment underscores the transformative potential of these technologies in enhancing productivity and operational intelligence.

A significant portion of the video is dedicated to the essential elements of a robust Quality Management System, drawing insights from an article by Tim Lozier of ETQ. The discussion centers on a "tools-based approach" to QMS, identifying five crucial needs: flexibility, traceability, risk-based thinking, integration, and reporting. Each element is explored in detail, emphasizing how modern QMS software should be configurable to an organization's specific needs, ensure seamless data flow across departments, incorporate human-analyzed risk assessments, break down operational silos, and provide actionable insights from vast amounts of data. The hosts also touch upon the evolution of QMS software in parallel with ISO 9001 standards, moving from simple checklists to sophisticated process and risk-based approaches. The broadcast concludes with a thought-provoking debate on the net impact of automation on jobs, considering historical precedents and the need for workforce retraining.

Key Takeaways:

• Defining Smart Manufacturing: Smart manufacturing leverages digital technologies to ensure all process information is available precisely when, where, and in the required format across the entire manufacturing supply chain, optimizing decision-making and operations.
• Emerging Manufacturing Technologies: Key drivers of smart manufacturing in 2017 included collaborative robots (cobots), advanced 3D printing, and the Industrial Internet of Things (IIoT), all contributing to increased automation and efficiency.
• Impact of Augmented Reality (AR): AR was identified as a rapidly growing technology, proving highly useful in manufacturing and field work by providing immediate, in-context access to documents, work instructions, or live expert assistance directly to the user's view.
• QMS Flexibility and Configurability: A superior Quality Management System (QMS) should be flexible and configurable, allowing organizations to adapt the software tools to their specific processes, forms, and reporting needs, rather than forcing the organization to conform to the software.
• Importance of QMS Traceability: Effective QMS requires robust traceability, ensuring seamless data flow and connection across disparate sections of the enterprise. This prevents redundant data entry (e.g., customer complaints) and maintains data integrity throughout the operational lifecycle.
• Risk-Based Thinking in QMS: Incorporating risk-based thinking, aligned with standards like ISO 9001:2015, is crucial. While tools can automate risk evaluation (e.g., FMEA, RPN), human interaction is essential to analyze the meaning of those risks and determine appropriate mitigation strategies (accept, reduce, compensate, transfer, or avoid).
• QMS Integration for Quality: Silos are detrimental to quality. Integrating various functional areas of the enterprise through the QMS enhances overall visibility, accelerates issue identification, and fosters increased collaboration across teams.
• Actionable QMS Reporting: A robust QMS generates significant data. The ability to effectively analyze this data and extract critical, actionable insights is vital for continuous improvement and for moving the needle on organizational performance, distinguishing effective QMS from merely compliant ones.
• Evolution of QMS Software: The development of QMS software has mirrored the evolution of quality standards like ISO 9001, transitioning from simple checklist-based systems to more sophisticated platforms that support process-oriented and risk-based approaches, offering greater flexibility for diverse industries.
• Stakeholder Engagement in Standards Development: The discussion on the ANSI standard for remanufacturing highlights the critical role of stakeholder feedback in shaping international standards. Organizations are encouraged to participate in comment periods to ensure standards reflect their operational realities and interests.
• Automation's Impact on Employment: The video delves into the debate surrounding job displacement versus job creation due to automation. While some predict net job losses, the hosts suggest a shift towards higher-value jobs requiring advanced skills, emphasizing the need for continuous education and STEM training to prepare the workforce for future roles.

Tools/Resources Mentioned:

• ETQ: A company specializing in quality management software, whose insights are featured regarding QMS needs.
• Mitutoyo Corporation: A sponsor mentioned as a provider of measurement and inspection solutions, including CMMs, sensors, and metrology data management software.
• Quality Digest: The host publication and channel, providing resources and commentary on quality management.
• ANSI (American National Standards Institute): An organization involved in the development and oversight of standards, mentioned in the context of a new remanufacturing standard proposal.
• ISO 9001:2015: An international standard for quality management systems, specifically referenced for its emphasis on risk-based thinking.

Key Concepts:

• Smart Manufacturing: An umbrella term for manufacturing that is highly digitalized and connected, leveraging information across the supply chain for optimal decision-making.
• Augmented Reality (AR): A technology that overlays digital information onto the real world, enhancing human perception and interaction, particularly useful for instructions and remote assistance in industrial settings.
• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, often supported by software tools.
• Risk-Based Thinking: A core principle in modern quality management, requiring organizations to identify, assess, and address risks and opportunities to ensure the QMS achieves its intended results.
• Traceability: The ability to track and verify the history, location, or application of an item or activity by means of recorded identification, crucial for quality control and regulatory compliance.
• Integration: The process of combining different systems, processes, or data sources to work together seamlessly, eliminating silos and improving overall operational visibility and efficiency.
• Configurability: The ability of a software system to be customized or adapted to specific user requirements without requiring changes to its core code, offering flexibility to diverse organizational needs.