Audits Are a Critical Part of Continuous Improvement

This webinar, titled "Audits Are a Critical Part of Continuous Improvement," provides an in-depth exploration of how an integrated Quality Management System (QMS) can streamline audit processes and elevate quality from a mere compliance issue to a strategic business differentiator. Presented by David Isaacson and Tom Barlow from ETQ Reliance, the session highlights the challenges organizations face with traditional audit management and demonstrates how their QMS platform offers solutions for more effective, efficient, and compliant auditing.

The presentation begins by outlining common challenges in audit management, such as wasted time on preparation, inconsistent data across multiple systems, lack of visibility into supplier information, and the limitations of paper-based or disparate electronic systems (e.g., SharePoint, Excel). It then introduces ETQ Reliance as a web-based, workflow-driven business process automation platform, featuring 42 pre-configured applications, including a core audit management module. The system is built on a highly configurable, no-code platform (ETQ Designer) hosted on Amazon Web Services (AWS), emphasizing ease of use, scalability, and future-proofing for evolving organizational needs.

A significant portion of the webinar details the "genetics" or core capabilities infused across the ETQ Reliance platform: adaptability through configuration, connectivity for linking related processes and integrating with external systems (ERP, HR), contextual awareness for managing organizational hierarchies and user-specific data views, external collaboration for engaging suppliers and contractors, and anywhere access via cloud and mobile apps (including offline capabilities, voice-to-text, and camera integration for objective evidence). The audit process within ETQ Reliance is comprehensively covered, from importing existing audit types and checklists to robust audit planning, scheduling (including ad-hoc and external audits with Outlook integration), and execution using various styles (paper, web, mobile, Excel). Crucially, the system enables direct launching of follow-up actions—such as recommendations, quality events for investigations, or corrective actions (CAPAs), including supplier corrective actions—from audit findings, ensuring full traceability and accountability.

The discussion extends to audit reporting capabilities, allowing for export into PDF and Excel formats, and the system's ability to facilitate continuous improvement by linking subsequent audits to previous ones, providing auditors with historical context and open issue tracking. The broader value proposition of a comprehensive QMS across the entire product lifecycle (design, suppliers, manufacturing, sales, customer feedback) is also emphasized. A case study featuring Avenos, a medical device provider, illustrates tangible benefits: $500,000 in savings and a 92% reduction in audit preparation lead time by transitioning from manual to automated audit processes, significantly reducing the risk of non-compliance and enhancing confidence with regulatory bodies like the FDA. The webinar concludes with a Q&A session, addressing practical aspects like internal auditor tips, implementation timelines, supplier audit approaches, and leveraging audit findings for trending, lessons learned, and even future AI recommendations.

Key Takeaways:

• Strategic Importance of Audits: Audits are transitioning from mere operational compliance to critical strategic initiatives and business differentiators, requiring robust management systems.
• Overcoming Audit Challenges: Integrated QMS solutions address common pain points like time-consuming audit preparation, inconsistent data across disparate systems, lack of supplier visibility, and the limitations of paper-based processes.
• Centralized & Electronic Audit Management: A QMS provides a single, centralized electronic system for planning, conducting, and reporting audits, making information readily available and improving overall efficiency.
• Configurability for Adaptability: Platforms like ETQ Reliance offer high configurability without programming, using tools like a drag-and-drop designer, allowing organizations to tailor audit workflows and forms to their specific and evolving needs.
• Seamless Process Connectivity: The QMS facilitates strong connectivity by linking related quality processes (e.g., audit findings to corrective actions or quality events) and integrating with external enterprise systems (ERP, HR) to leverage existing data.
• Contextual Awareness for Global Operations: Large organizations can define hierarchical structures within the QMS, enabling users to view only relevant information while providing managers with comprehensive, real-time oversight across global locations or business units.
• External Collaboration: Features like external collaboration allow organizations to involve suppliers and contractors directly in the audit process, enabling them to provide responses or participate in actions within the system.
• Anywhere Access & Mobile Capabilities: Mobile applications with offline functionality, voice-to-text, and camera integration streamline on-site audits, allowing auditors to capture observations and objective evidence efficiently, even without internet access.
• Comprehensive Audit Lifecycle Management: The system supports the entire audit lifecycle, from importing audit types and planning (including approval workflows) to scheduling ad-hoc and external audits, and generating detailed reports.
• Automated Follow-Up Actions: Audit findings can directly trigger and link to follow-up actions such as recommendations, quality events (for investigations, root cause analysis, risk assessment), or corrective actions (CAPAs), ensuring issues are addressed with full traceability.
• Flexible Audit Execution: Organizations have the flexibility to conduct audits using various methods, including paper, web-based interfaces, mobile apps, or through Microsoft Office integration (e.g., Excel spreadsheets for checklists).
• Continuous Improvement through Historical Data: The QMS enables the linking of subsequent audits to previous ones, allowing auditors to review past responses ("previous comments") and track open issues, fostering a culture of continuous improvement.
• Quantifiable ROI: Case studies, such as Avenos (a medical device provider), demonstrate significant financial and efficiency gains, including $500,000 in savings and a 92% reduction in audit preparation lead time.
• Reduced Risk & Improved Productivity: Broader customer data indicates a 20% reduction in time spent planning/reporting audits, a 50% reduction in supporting external audits, and a 50% reduction in audit findings, leading to improved productivity and reduced non-compliance risk, which is vital for regulated industries.
• Leveraging Audit Learnings: Audit findings can be used for trending analysis (via analytics tools), establishing "Lessons Learned" knowledge bases, and potentially informing future AI-driven recommendations for problem-solving.

Tools/Resources Mentioned:

• ETQ Reliance: The core Quality Management System platform.
• ETQ Designer: A drag-and-drop tool for configuring the ETQ Reliance platform without programming.
• Amazon Web Services (AWS): The cloud environment hosting ETQ Reliance.
• Outlook Calendar: Integration for scheduling audit events and invitations.
• ETQ Insights: An analytics tool for performing trending on past findings and creating dashboards.
• ETQ Academy: An online learning management platform for both end-users and administrators to learn about the system.
• ETQ Community: A platform for ETQ customers to collaborate and share information.

Key Concepts:

• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Harmonization: The process of standardizing quality management approaches across different business units or global locations within an organization.
• Digital Transformation: The integration of digital technology into all areas of a business, fundamentally changing how it operates and delivers value.
• Workflow: A predefined sequence of steps or tasks that a process must follow within the system, ensuring consistency and accountability.
• Contextual Awareness: The system's ability to understand a user's role and organizational context, displaying only relevant information and records.
• External Collaboration: Extending system access and functionality to external parties like suppliers or contractors to facilitate joint processes.
• Anywhere Access: The ability to access the system from any device (desktop, mobile) and location, including offline capabilities for mobile users.
• Corrective Action (CAPA): A process to identify the root cause of a non-conformance or other undesirable situation and implement actions to prevent its recurrence.
• Quality Events: A new application in ETQ Reliance designed to manage and investigate quality-related incidents, potentially leading to root cause analysis and risk assessment.
• Lessons Learned: A process of documenting insights gained from an experience (e.g., an audit finding) to improve future performance.

Examples/Case Studies:

• Avenos: A medical device provider that implemented ETQ Reliance for audit management, achieving $500,000 in savings and a 92% reduction in lead time for audit preparation by automating their processes. This led to increased confidence from auditors, reduced risk of human error, and ultimately better patient outcomes.
• Johnson & Johnson: Mentioned as a company that needed to harmonize its quality management approach to a single, broadly capable, flexible QMS.
• Vertical Farming Venture: A company that implemented ETQ Reliance to promote food safety, higher crop yield, and improved compliance, seeing drastic time savings in audits.