Using Lean Methods to Improve RIM Practices

This presentation provides an in-depth exploration of applying Lean and Kaizen continuous improvement methodologies to Records and Information Management (RIM) practices within the highly regulated pharmaceutical industry, using Sanofi as a case study. The speaker, an associate director in Information and Records Management and a Lean leader at Sanofi, details how these methods—originally formalized in manufacturing—are essential for streamlining work, reducing waste, and ensuring compliance in complex, cross-functional environments. The primary motivation for adopting Lean at Sanofi stemmed from the need to harmonize disparate systems and processes following numerous mergers, acquisitions, and divestitures, which had resulted in varying finance, procurement, IT, and RIM systems across the organization.

The core of the methodology revolves around the Lean mindset: achieving more with less while delivering value to delighted customers (internal and external). A critical step is distinguishing between value-added activities (processes customers will pay for), business-required non-value-added activities (mandated by regulation like FDA or Sarbanes-Oxley compliance), and pure waste (non-value-added activities requiring time, money, and effort). The presentation emphasizes that while business-required activities cannot be eliminated, their impact must be minimized through simplification and combination of steps. Value creation is measured across multiple dimensions, including quality, speed, cost avoidance, revenue growth, employee/customer satisfaction, and regulatory compliance.

The structured framework used for process improvement is DMAIC (Define, Measure, Analyze, Improve, Control). The Define phase establishes the project charter, scope, and goals, incorporating the "voice of the customer." The Measure phase involves creating a detailed current state map (value stream map) to visually identify pain points, bottlenecks, and cycle times. The Analyze phase focuses on identifying the root causes of problems and waste, often utilizing tools like the "Five Whys." Finally, the Improve phase involves brainstorming, prioritizing solutions using a Benefit Effort Matrix (targeting quick wins), and developing a future state map, followed by the Control phase, which implements the solution, documents new methods, and ensures change management is in place to sustain improvements. The speaker highlights the use of Kaizen events—intensive, typically three-to-five-day workshops—to quickly solve medium-sized, cross-functional problems within a 90-day timeframe, fostering collaboration between departments like RIM, IT, and Legal.

Key Takeaways: • Harmonization is Critical Post-M&A: In the life sciences sector, mergers and acquisitions necessitate a standardized approach to records management, policies, and systems (e.g., finance, IT, RIM) to achieve operational efficiencies and ensure consistent compliance across different organizational parts and geographies. • Lean Focuses on Value and Waste: Only about 5% of activities in a typical process are truly value-added; the challenge is identifying and minimizing the remaining non-value-added activities, which include both pure waste and necessary, business-required compliance steps. • Regulatory Compliance is a Business Requirement: Activities required by regulatory bodies (FDA, GxP, Sarbanes-Oxley) are non-value-added from a customer payment perspective but are essential for business survival and must be minimized or simplified, not eliminated. • Waste Identification (TIMPWOOD): The eight types of waste to identify and eliminate are: Transport (unnecessary movement of work/materials), Inventory (excess material or information on hand), Motion (unnecessary movement of people), People (unused human talent/ideas), Waiting (idle time for the next step), Overproduction (making more or earlier than required), Overprocessing (adding more value than the customer wants or pays for), and Defects (errors leading to rework). • DMAIC is the Improvement Framework: The Define-Measure-Analyze-Improve-Control methodology provides a structured, consistent approach to solving problems, ensuring that improvements are measurable and sustainable across different projects. • Visualizing Processes is Essential: Using value stream mapping (current state map) with color coding (Green for value-add, Purple for inspection, Yellow for transport, Blue for storage/waiting) helps teams visually identify waste, bottlenecks, and rework loops (represented by red lines). • Root Cause Analysis is Key: The Analyze phase should utilize tools like the "Five Whys" to drill down past symptoms to the actual root cause of waste or defects, preventing problem recurrence. • Prioritize Quick Wins: Solutions should be prioritized using a Benefit Effort Matrix, focusing on "quick wins" (high benefit, low effort) that provide immediate efficiency gains and boost team morale, deferring high-effort, low-benefit activities. • Cross-Functional Collaboration is Mandatory: Kaizen events are most effective when addressing transversal processes that span multiple functions (e.g., RIM, IT, Legal, HR), requiring representatives from disparate groups to understand each other's challenges and co-create solutions. • Measure Success Beyond Cost: Value creation metrics include traditional business metrics (cost avoidance, revenue growth) alongside customer and employee satisfaction, compliance adherence, and reduction in internal effort/time (cycle time reduction).

Tools/Resources Mentioned:

• DMAIC: Define, Measure, Analyze, Improve, Control methodology.
• Kaizen: A lean workshop format, typically 3-5 days, used for focused continuous improvement on medium-sized problems.
• Value Stream Mapping (Current State Map): A visual tool used to map every step of a process, identifying cycle times, waste, and bottlenecks.
• Five Whys: A root cause analysis technique involving repeatedly asking "why" to uncover the underlying cause of a problem.
• Benefit Effort Matrix: A prioritization tool used to categorize potential solutions based on their anticipated benefit and required implementation effort.
• SIPOC Chart: Suppliers, Input, Process, Output, Customers chart, used for high-level process overview.
• Visio: Software mentioned for digitally mapping processes.

Key Concepts:

• Lean Mindset: The philosophy of achieving more with less, focusing strictly on generating customer value and eliminating waste.
• TIMPWOOD: An acronym representing the eight categories of waste: Transport, Inventory, Motion, People, Waiting, Overproduction, Overprocessing, and Defects.
• Cycle Time: The total time taken for a process to complete, used as a metric for measuring improvement (speed).
• Voice of the Customer (VOC): Understanding customer requirements and how they measure success, used to define project goals.

Examples/Case Studies:

• Program Harmonization: Standardizing records retention schedules, destruction processes, and off-site storage procedures across Sanofi entities following the acquisition of companies like Genzyme.
• Litigation Support: Improving processes related to legal hold and e-discovery, a critical function in the highly litigious pharmaceutical world.
• Centralization of Storage: A Kaizen event focused on centralizing box storage operations between two groups, resulting in better resource utilization and cost reduction.
• Computer Lifecycle Management: An event analyzing the process of provisioning computers for onboarded employees, which generated multiple subsequent improvement projects due to the cross-functional nature of the process.
• Historical Records Preservation: Implementing an overlayer on the normal records destruction process to identify and preserve historical records of interest, balancing compliance with archival needs.