Managing SMEs: Extracting Technical Knowledge for Better SOPs & Reports

In regulated life sciences environments, procedures, reports, and technical documents form the foundation of compliance. Standard operating procedures, validation protocols, investigation reports, and work instructions must accurately describe how work is performed and provide clear, repeatable guidance to those executing tasks.

Yet many organizations struggle to produce documentation that truly reflects reality. Critical knowledge often resides in the heads of subject matter experts (SMEs) - engineers, scientists, operators, and technicians who understand processes deeply but may not communicate them clearly or completely in writing. The result is a gap between what is written and what actually happens on the floor, creating risk for errors, deviations, and inspection findings.

This webinar focuses on closing that gap by teaching practical techniques for extracting and translating SME knowledge into usable, compliant documentation. Participants will learn how to engage experts effectively, ask the right questions, and uncover the tacit or "tribal" knowledge that is rarely captured in formal procedures. Many SMEs explain processes verbally or assume certain steps are obvious, leaving critical details undocumented. Others provide highly technical explanations that overwhelm readers or obscure key actions. Without structured methods for gathering and organizing information, writers often end up with procedures that are either incomplete or unnecessarily complex.

The session introduces proven interviewing and observation strategies that help writers move beyond surface explanations. Techniques such as process walk-throughs, shadowing, and scenario-based questioning reveal how tasks are truly performed, including decision points, exceptions, and informal workarounds. Participants will learn how to convert these insights into clear, actionable steps that support consistent performance and regulatory compliance. Emphasis is placed on distinguishing between essential instructions and background theory, ensuring that procedures remain focused and usable.

Another key challenge addressed is managing conflicting inputs. Different SMEs may describe the same process in different ways based on personal habits or historical practices. Without careful facilitation, documentation can become inconsistent or overly complicated. Participants will explore methods to reconcile disagreements, standardize approaches, and document decisions using objective evidence rather than preference.

Finally, the webinar covers techniques for simplifying complex science and avoiding over-technical language. Clear, concise writing reduces cognitive load, improves comprehension, and decreases the likelihood of errors. By applying plain-language principles, logical structure, and visual aids, organizations can create documents that support performance rather than hinder it.

By combining effective SME engagement with practical writing strategies, participants will gain a repeatable process for producing documentation that is accurate, clear, and inspection-ready - ultimately improving both operational reliability and compliance outcomes.

Why should you Attend:
If you’ve ever struggled to turn expert knowledge into clear, usable procedures — or found that your SOPs don’t match what actually happens on the floor — this webinar will give you the tools to fix the problem. You’ll learn how to interview and observe SMEs effectively, capture hidden or “tribal” knowledge, resolve conflicting inputs, and translate complex technical details into simple, actionable instructions that people can follow consistently. By improving how you gather and communicate information, you’ll create stronger documentation, reduce deviations and rework, and produce audit-ready procedures and reports that truly reflect real-world operations

Areas Covered in the Session:

• Welcome & Objectives (5 min)
• Why technical knowledge is often trapped in people, not documents
• Risks of undocumented or poorly documented processes
• The gap between SMEs and writers
• Session goals and expected outcomes
• Learning objectives
• The SME Challenge in Regulated Environments (6 min)
• Dependence on “tribal knowledge”
• Experts who explain verbally but not clearly in writing
• Assumptions that “everyone already knows this”
• Overly technical or incomplete procedures
• Compliance and training risks
• Impact during audits and inspections
• Preparing for Effective SME Engagement (7 min)
• Defining scope and objectives
• Understanding the process beforehand
• Reviewing existing documentation
• Identifying the right SMEs
• Planning structured sessions
• Creating focused question lists
• Setting expectations for time and outcomes
• Building trust and rapport
• Interviewing Techniques That Work (10 min)
• Structured vs unstructured interviews
• Open-ended vs closed questions
• “Walk me through the process” method
• Shadowing and observation
• Asking “why” and “what happens if”
• Clarifying assumptions
• Capturing tacit knowledge
• Avoiding jargon overload
• Recording and validating information
• Extracting decision points and risks
• Turning Tribal Knowledge into Procedures (10 min)
• Identifying steps vs explanations
• Converting verbal descriptions into actions
• Writing observable, measurable tasks
• Sequencing steps logically
• Defining responsibilities
• Capturing exceptions and contingencies
• Including controls and checkpoints
• Using visuals, flowcharts, and job aids
• Ensuring completeness and usability
• Verifying accuracy with SMEs
• Handling Conflicting SME Inputs (7 min)
• Common sources of disagreement
• Variability between shifts or departments
• Distinguishing preference vs requirement
• Using evidence and data to resolve conflicts
• Standardization strategies
• Facilitated consensus techniques
• Escalation paths when needed
• Documenting decisions and rationale
• Simplifying Complex Science & Avoiding Over-Technical Language (8 min)
• Writing for the user, not the expert
• Plain-language principles
• Reducing sentence length and complexity
• Eliminating unnecessary jargon
• Defining essential terminology
• Using visuals instead of dense text
• Layered documentation approaches
• Testing readability
• Examples of before/after simplification
• Practical Workflow for SME-Based Writing Projects (5 min)
• Plan ? Interview ? Observe ? Draft ? Validate ? Revise ? Approve
• Iterative review cycles
• Version control and change management
• Time-saving templates
• Continuous improvement
• Key Takeaways & Wrap-Up (2 min)
• Knowledge must be captured, not assumed
• Structure improves SME collaboration
• Observation reveals hidden steps
• Clarity improves compliance
• Simpler documents perform better
• Good writing reduces deviations and findings

• Quality Assurance (QA)
• Quality Control (QC)
• Regulatory Affairs
• Compliance and Governance
• Internal Audit
• Manufacturing Operations
• Production Management
• Validation and Engineering
• Training and Learning & Development
• Document Control and Technical Writing
• CAPA and Investigation Teams
• Risk Management
• Supplier Quality Management
• Laboratory Operations
• Site and Plant Leadership
• Continuous Improvement / Operational Excellence
• Data Integrity and CSV/CSA Teams
• Clinical Operations (GCP environments)
• Contract Manufacturing Oversight
• Executive Quality and Compliance Leadership