--- title: "QMS Optimization Workshop Template" type: white-paper publisher: Ketryx source: "https://www.ketryx.com/assets/qms-optimization-workshop-template" content: text extracted from PDF (layout/tables/figures not preserved) --- # QMS Optimization Workshop Template *Source: [https://www.ketryx.com/assets/qms-optimization-workshop-template](https://www.ketryx.com/assets/qms-optimization-workshop-template)* --- QMS Optimization Workshop Template A practical, risk-based working session for regulated teams Confidential - Ketryx Corporation Workshop Purpose To streamline QMS workflows and artifacts by removing process redundancy, clarifying purpose, and introducing automation/AI support, while strengthening quality and compliance. How to Use This Template This template is designed to help your team run a focused, high-impact workshop to streamline your QMS and accelerate development. Follow these steps to get the most out of it: 1. Share the template before the workshop: Give participants context and invite them to bring real examples (good and painful ones). 2. Print or share the artifact templates: Have screenshots or exports of your current change requests, anomalies, requirements, tests, and release workflows on hand. 3. Capture every idea, then prioritize: Donʼt debate each change in the moment. Collect ideas, then agree together on the most impactful improvements. 4. Separate practice tweaks from SOP changes: Many improvements don't require rewriting procedures. Start with the most lightweight changes first. 5. Translate decisions into action: Assign owners, timelines, and sprint slots for the highest-impact updates. 6. Update templates and enable automation: Apply the agreed adjustments to your QMS artifacts and activate AI checks/agents where possible. 7. Communicate the changes to your team: Share whatʼs changing and why. 8. Re-run this workshop every 612 months (or more): Reevaluate your QMS on a regular basis. Repeating this session prevents process creep and keeps documentation meaningful. Pro tip: The most valuable conversation usually happens when someone asks, “Why do we have this field/process in the first place?ˮ If the answer is “because we always have,ˮ it's a candidate for simplification or automation. Confidential - Ketryx Corporation 2 Who Should Attend Role Contribution Product User intent, scope clarity, requirement hygiene Engineering Technical practicality, dev workflow efficiency Quality Regulatory rigor, SOP alignment, risk controls Ideal group size: 612 Format: 90 minutes, in person or via shared whiteboard Workshop Goals Customize these goals to fit your team. Here is a sample list: ● Reduce effort while maintaining (and strengthening) compliance ● Apply a risk-based lens to QMS artifacts ● Define what is required , what is nice to have , and what is waste ● Identify where automation & AI can help ● Produce a prioritized action plan with owners and timelines Artifacts to Review 1. Change Requests 2. Requirements & Specifications 3. Tests & Executions 4. Anomalies / Deviations 5. Releases & Approvals If you use additional artifacts (e.g., CAPA, audit logs, risk items), add as needed. Prep Work Before the session: ● Export/report current templates for each item type, including all relevant fields ● Gather sample records for each (good & frustrating examples) ● Print / share your traceability matrix (or equivalent view) ● Pull SOP/QMS references for regulated fields (so you know whatʼs fixed vs flexible) Confidential - Ketryx Corporation 3 Optional but powerful: ● Export cycle time data (i.e. how long it takes to go from change request to release) ● Pull defect escape rate or RTM coverage report Board Setup Create four columns on a Miro page or other whiteboard. Hereʼs our Miro template if youʼd like to see what we used! We recommend this board structure because it creates enough constraint to surface real issues and turn them into action. Pain Points Quick Wins Open Questions AI / Automation Opportunities This slows us down We can fix this in the current sprint Needs more exploration Where AI can draft, link, flag, or check Before starting, agree on the specific outcome you want from this workshop. Be explicit about what should be different when you leave, for example clearer decision criteria, fewer required fields, faster review cycles, or defined automation opportunities. A shared objective keeps the discussion focused on measurable improvement. Confidential - Ketryx Corporation 4 Start by applying the four-column board to your change request workflow. As you review real change requests, capture what slows teams down, what can be fixed immediately, what needs deeper discussion, and where automation or AI could reduce manual effort. This creates a shared baseline before moving downstream. Once the team aligns on change requests, repeat the same process for other parts of the QMS, including requirements and specifications, test cases and executions, anomalies, and deployment and release workflows. Using the same structure across each area makes patterns visible, reduces duplication between artifacts, and helps teams apply improvements consistently across the lifecycle. Confidential - Ketryx Corporation 5 90Minute Agenda The agenda below is designed to keep the session focused, fast-moving, and outcome-oriented. Each segment builds on the last, guiding the team from surfacing friction to agreeing on concrete changes and next steps within a single 90-minute working session. Phase Time Activity Opening Context 5 min State goals, principles, and success measures Round 1 CRs 15 min 5 min of individual notes on whiteboard followed by discussion & decisions Round 2 Requirements & Specs 15 min Same structure Round 3 Tests 15 min Same structure Round 4 Anomalies 15 min Same structure Round 5 Releases 10 min Same structure Prioritization 10 min Agree on most impactful changes, action items Next Steps 5 min Assign owners and timelines Facilitator Prompts ● “Whatʼs slowing you down?ˮ ● “Where are we duplicating information?ˮ ● “Where can AI speed up manual processes?ˮ ● “If an auditor asked ‘why does this field exist?ʼ — what would we say?ˮ Confidential - Ketryx Corporation 6 Decision Criteria When evaluating fields, workflows, or templates, ask: ✅ Does this reduce risk? ✅ Does this improve traceability? ✅ Does this clarify intent? ❌ Does this duplicate information? ❌ Does this only exist because “it always hasˮ? If it doesn't reduce risk or add clarity, consolidate or eliminate. Outputs Your workshop should produce: Output Description Field removals / renames Places where you can remove or deduplicate fields while keeping integrity Template improvements Place where you can modify existing processes Practice changes Adjustments to best practices AI guardrails Where to apply automatic trace links, drift checks, completeness scans Staffing / workflow tweaks E.g., time-zone based review coverage Prioritized roadmap What to implement first Confidential - Ketryx Corporation 7 Example “Quick Winˮ Ideas ● Make acceptance criteria explicit fields (or clearly structured sections) ● Remove any fields that duplicate test evidence ● Require “Observed vs. Expectedˮ for anomalies ● Standardize steps-to-reproduce templates ● Reduce screenshots and text walls; replace with links ● Implement AI agents for: ○ Missing traceability links ○ Duplication across items ○ Risk field completeness Follow-Up Plan After the workshop: ● Document decisions ● Update templates + SOPs (if needed) ● Enable AI/automations ● Re-train team on the updated workflow ● Re-run workshop every 612 months (or more) This workshop helps regulated teams move faster and stay compliant by aligning on risk-based documentation, removing waste, and using automation to enforce quality. Confidential - Ketryx Corporation 8