Quality and Risk Software for Microsoft Office 365

This video provides an in-depth exploration of BPA Quality 365, an all-in-one, interrelated quality and risk management software solution built on the Microsoft Office 365 platform. The presenter, Boris Lutz, CEO and founder at BPA Solutions, introduces the tool as designed to address common compliance standards, specifically highlighting ISO 9001:2015 and 21 CFR Part 11, making it suitable for regulated industries regardless of company size. The core purpose of BPA Quality is to foster a participative Quality Management System (QMS) by engaging all collaborators and facilitating continuous improvement through a user-friendly, integrated approach.

The solution leverages the full suite of native Office 365 tools, including instant discussions, collaborative features, Microsoft Office applications, mobile solutions, workflow automation, and powerful reporting capabilities. It is designed with modular functions, allowing power users to customize and extend the solution without requiring any code. The system features role-based navigation, where displayed links are tailored to user permissions, covering areas like stakeholder management, process maps, strategic quality improvement, preventive risk management, compliance documents, best practices, and equipment management. A "What's New" cockpit keeps users informed of recent QMS changes, while manual and workflow tasks are prominently displayed on the home page.

The video details several key modules and functionalities. The process map serves as the primary entry point for end-users, offering a 360-degree view of each process, including related compliance documents, risks with severity based on a risk matrix, improvement opportunities, KPIs, and best practices. An organizational chart allows drilling down into QMS processes grouped by responsibility, tracking associated collaborators, competencies, and training, thereby eliminating the need for manual spreadsheets. The non-conformance module enables internal or external users to declare issues, even via email, triggering a workflow to investigate, plan, and verify corrective actions (CAPA) before closure. A customizable non-conformance CAPA dashboard provides instant metrics without manual input. Mobile apps, built with PowerApps, allow remote declaration of non-conformances, photo capture, and geo-location, with automatic alerts and mobile decision-making. Microsoft Flow (now Power Automate) is used for building customizable workflows for resolution steps. The audit module facilitates planning audits in a shared calendar, inviting participants, selecting checklist questions, automatically generating reports, and declaring audit-related findings, actions, and risks. Finally, a dedicated risk module promotes a preventive attitude, showing the evolution of risk severity over time based on impact and probability, while document approval workflows drastically reduce the effort for document management and ensure collaborators are aware of changes. The system integrates with Microsoft Power BI for dynamic reporting, ultimately aiming for higher product and service quality with fewer errors.

Key Takeaways:

• Integrated QMS and Risk Management: BPA Quality 365 provides a comprehensive, all-in-one solution for managing quality and risk, ensuring that these critical aspects are interrelated and continuously improved.
• Regulatory Compliance Focus: The software is specifically designed to meet stringent compliance standards, explicitly mentioning 21 CFR Part 11 and ISO 9001:2015, making it highly relevant for regulated industries like pharmaceuticals and life sciences.
• Leverages Microsoft Office 365 Ecosystem: The solution is built natively on Office 365, enabling seamless integration with familiar tools for collaboration, mobile access, workflow automation, and reporting, enhancing user adoption and efficiency.
• Participative QMS Approach: It promotes engagement from all collaborators, making the QMS participative rather than a top-down mandate, which can lead to better adherence and continuous improvement.
• No-Code Customization: Power users can customize and extend the solution's modular functions without programming knowledge, allowing organizations to tailor it to their specific needs and evolving requirements.
• 360-Degree Process View: The process map offers a holistic view, linking processes to compliance documents, associated risks (with severity based on a risk matrix), improvement opportunities, KPIs, and best practices.
• Streamlined Non-Conformance and CAPA Management: The system automates the entire non-conformance lifecycle, from declaration (including mobile and email inputs) through investigation, root cause analysis, CAPA planning, verification, and closure, providing instant metrics via a customizable dashboard.
• Mobile Capabilities for Field Operations: PowerApps enable the creation of mobile applications for remote declaration of non-conformances, photo capture, geo-location, and mobile decision-making, improving real-time data collection and response.
• Proactive Risk Management: A dedicated risk module supports a preventive attitude by allowing risk assessment, tracking the evolution of risk severity over time based on impact and probability, and helping avoid unfortunate events.
• Automated Document Control: Document approval workflows significantly reduce the time and effort involved in managing document changes and approvals, ensuring that all collaborators are informed about new or updated documents.
• Efficient Audit Management: The audit module facilitates planning, scheduling, checklist management, automatic report generation, and the declaration of findings, actions, and risks directly from the audit page, streamlining compliance verification.
• Powerful Business Intelligence and Reporting: The solution integrates with Microsoft Power BI, allowing power users to build and share dynamic reports in minutes for any process, providing actionable insights for auditors and management.
• Elimination of Manual Processes: The system replaces manual tracking methods, such as spreadsheets for responsibilities, competencies, and training, and automates dashboard updates, reducing human error and increasing efficiency.

Tools/Resources Mentioned:

• Microsoft Office 365
• Microsoft PowerApps
• Microsoft Flow (now Power Automate)
• Microsoft Power BI
• ISO 9001:2015
• 21 CFR Part 11

Key Concepts:

• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Risk Management: The process of identifying, assessing, and controlling threats to an organization's capital and earnings.
• 21 CFR Part 11: Regulations issued by the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• ISO 9001:2015: An international standard for quality management systems, providing a framework for organizations to ensure consistent quality of products and services.
• CAPA (Corrective and Preventive Actions): Actions taken to eliminate the causes of non-conformities or other undesirable situations to prevent recurrence (corrective) or occurrence (preventive).
• Non-conformance: A deviation from a specification, standard, or expectation.
• Audit Management: The systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
• Document Control: The process of ensuring that all documents related to a QMS are properly managed, including creation, review, approval, distribution, and archiving.
• Process Map: A visual representation of the steps involved in a process, showing the sequence of activities and decision points.
• Risk Matrix: A tool used in risk assessment to define the level of risk by combining the likelihood of an event with the severity of its consequence.