Medical Device Agile Quality Demo


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Presentation demonstrating Agile's support for Medical Device Companies in closed loop quality processes

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  • Understanding that FDA audit practices are based on the systemic review of each of the subsystems of this graph*. Addressing and auditors enquiry into the historical activity in any of these subsystems requires an organization to manage these functions across each subsystem. Product Document and Change Mgmt. – (The 6:00 position on the graph) Is the foundation of the compliant dataset as this is the auditable repository to demonstrate appropriate management of all “historical claims and evidence” for each system. Quality Event Mgmt. – (the 12:00 position) is ALWAYS one system that is audited to confirm you have an intake system to triage all quality events and resolve them by assessing the quality event impact across each of the subsystems. Project & Portfolio Mgmt. FDA expects cross functional management for design control, mfg transfers, and even regulatory submissions. To demonstrate control of all these activities a project & portfolio management practices have to be enforced. Employee Training- This has emerged over the last 18-24 months as an audit target and requires a trigger from a change management system to be effective as all training is linked to the a companies FDA Regulations Quality Management System, plus the documents, processes, and procedures associated with product Management Reviews – With Management at the center of the subsystems FDA expects senior staff to consistent comprehensive review of each of these subsystems * All FDA auditors are trained on the QSIT – Quality System Inspection Techniques which this graph came from) requires that companies defined processes to support each of these sub-systems and audit to make sure management know what is going on
  • Agile is the Aggregator and CAPA Management piece (Web Svc??) Process and Data Flow CRM: Customer Complaints get created in Clarify. Web Services integration replicated product relevant Complaints in Agile. CAPA/BI: Complaints are analyzed in BI. Customer Complaint threshold triggers a notification to QA and Auto creates a CAPA in Agile and links the CC’s to the CAPA. CAPA/ERP: CAPA 8D process: View Affected items and Inventory levels (SAP integration) and initiate a Stop Ship to contain to quality issues. (SAP Integration). CAPA/ERP: Analyze root cause and initiate an ECO or DCO to resolve the issue. Publish ECO changes to SAP. CAPA/CRM: Close & Notify on CAPA resolution and notify update Clarity.
  • The Oracle BI Suite is a comprehensive, integrated solution that enables organizations to have a single business intelligence architecture that can simultaneously access and derive insight from a heterogeneous data sources – like: Historical data sources in data warehouses Real-time data stored in operational data sources and OLTP systems Data stored by various applications Data stored in Files, Excel, XML Data sources that are used by Business Processes The ability to access the data from the heterogeneous data sources is very important – as this is what enables the delivery of real-time, pervasive insight. The BI Server is a scalable, sophisticated data access, aggregation, and calculation engine for real-time intelligence across all these heterogeneous data sources. By nature the data sources will be different and it is critically important that these sources be brought together in a coherent way. Oracle BI provides a unified metadata that enables these sources to be modeled appropriately to provide insight that is personalized and relevant and not just display data. The unified metadata layer creates a common semantic for the data stored in the various data sources. This is critically important as this ensures that any insight derived and delivered from this is consistent – i.e. provides a “single source of truth”. Finally the insight is delivered in a personalized manner through various channels, like interactive dashboards, proactive detection and alerts, ad-hoc analytics, mobile analytics, real-time predictive analytics, advanced reporting, and integrated into other applications using Web Services
  • The attached slide (it's a build slide so please run it in presentation mode) shows the Agile MD/ ERP workflow and how that impacts DHF/ DMR.  Typically, the "As-Built" for each individual product that is built is done in ERP (serial numbers, lot numbers, actual affectivity dates are added here) while the "As-Designed" or "As-Planned" for each product is done in Agile MD.     Agile MD would be the master Change Management system that handles Revision control of parts and documents being replaced/added/deleted to the "As-Built" products that reside in EBS as a result of quality issues (or similar) that crop up.   Agile MD would also be the master Closed-Loop Quality system that handles the containment, root-cause analysis, and move-forward plan to address quality issues affecting each product (CAPAs and related ECOs).  The CAPA and ECO workflows and all resulting part and documentation changes would be managed in Agile PLM and the resulting new Revision of the updated "As-Planned" product would be passed to ERP through the out-of-box integration (PIP) where the actual product is finalized and built (updated serial numbers, lot numbers, affectivity dates are added)
  • Compliance eng (CE) analyzes BOM for RoHS, finds parts that are exempt, and missing data (BOM view and report) Runs query to find parts that do not have a declaration as a second check Review existing declarations, including IPC1752 and JGPSSI on parts Create declaration to gather missing information (Part Substance) RoHS for real time analysis pass/fail during entry Supplier enters data interactively, show undisclosed, partial, fully disclosed analysis for supplier Supplier adds a substance to get full disclosure, validates, maps to substance library CE evaluates results, publishes data CE runs a BOM rollup in Excel to get total substance data. CE shows top assembly with page three fields for demand, shipments to date for calendar year CE shows final report with Substance totals by application shipments to date and anticipated demand
  • Medical Device Agile Quality Demo

    1. 1. Quality Demo – screenshots – medical equipment Todd Hein – Sr. Director, Medical Devices - Life Sciences IBU
    2. 2. FDA Requirements in one common datatbase : AgileMD Enterprise Quality Management (EQM) Differentiation – Leveraging PLM functionality across the enterprise FDA Quality System Audit “ Support Claims with Evidence” Integrated Quality Event Management The only true close loop system linking quality events to all enterprise records Global Product, Document, & Change Management All QMS/DHF/DMR/Submission records in one enterprise solution 1 2 Synchronized Project & Portfolio Management All regulated projects linked with global document & quality system 3 Open Standards based IT architecture Support integration across the enterprise IT platform 5 Enterprise Quality Analytics & dashboards Comprehensive DW schema to support Enterprise Quality Management Reviews 4
    3. 3. Cross System CAPA process / data flow ERP Agile CAPA Management Customer Complaints Create CAPA Analyze Root Cause Inventory Levels Customers Quality Analyst Support Close & Notify Create CCs Analyze SR Trends Analyze Cycle Time Prompt Actions/Alerts Quality Analytics Publish Product SRs Engineering Change Analyst Manufacturing Staff Containment Action Change Management Implement Change Notify Customer Stop Ship Ship to Locations Replicate CCs NCR’s Supplier Issues Audits CAPA 8D SOP’s DCO’s Documents Product ECO’s
    4. 4. Agile Quality Demo Scenario Demo scenarios numbered
    5. 5. Agile Quality Demo Scenario Demo scenarios numbered Agile “Compliant Dataset”
    6. 6. Agile Quality Demo Scenario Demo scenarios numbered 7.0 Comprehensive Reports 8.0 Enterprise Audit Mgmt
    7. 7. Demo Script – General Navigation <ul><li>Script Overview </li></ul><ul><ul><li>CFR Part 11 Compliance </li></ul></ul><ul><ul><li>Global process with local needs </li></ul></ul><ul><ul><li>Search capabilities </li></ul></ul><ul><li>Business Issue </li></ul><ul><ul><li>Ability to meet regulatory requirements for electronic signature and audit traceability </li></ul></ul><ul><ul><li>Ability to standardize processes while supporting local requirements </li></ul></ul><ul><ul><li>Ability to provide quick and easy access to data </li></ul></ul><ul><li>Benefits to Philips </li></ul><ul><ul><li>Meets external audit requirements and reduces compliance activities </li></ul></ul><ul><ul><li>Provides a platform for a common process with flexibility to meet local requirements </li></ul></ul><ul><ul><li>Simplifies access to data for better decision making </li></ul></ul>
    8. 8. Agile Quality Demo Scenario – 1.0 Customer Complaints Scenario – “screen flicker” CC – auto link to Final P/N & revision Q/A Define disposition & monitor status Auto create feature
    9. 9. Customer Customer Complaint Cover Page Captures details, severity, disposition and action taken
    10. 10. Customer complaint linked to specific product AND revision
    11. 11. Customer Complaint – workflow and sign-off history
    12. 12. Customer Complaint related to CAPA with “smart rule”
    13. 13. Demo Script 1 – Log a Customer Complaint <ul><li>Script Overview </li></ul><ul><ul><li>Initiate a Customer Complaint (CC) and identify product (and revision) affected </li></ul></ul><ul><ul><li>Select failure code and document immediate action taken </li></ul></ul><ul><ul><li>Route to Quality team for disposition </li></ul></ul><ul><ul><li>Provide disposition, approve and monitor CC until disposition has been completed </li></ul></ul><ul><li>Business Problem </li></ul><ul><ul><li>Document a customer issue so that corrective action may be taken </li></ul></ul><ul><ul><li>Monitor corrective action to ensure it is completed </li></ul></ul><ul><li>Benefits to Philips </li></ul><ul><ul><li>Reduced cycle time to act on CCs </li></ul></ul><ul><ul><li>360 degree view of quality history </li></ul></ul><ul><ul><li>Ability to monitor trends and recurring issues over time </li></ul></ul>
    14. 14. Agile Quality Demo Scenario – 2.0 Internal NCMR Scenario – “screen flicker” at functional test Q/A – auto link to sub assy P/N & revision Supplier notification Auto Product Risk assessment
    15. 15. Non Conformance Material Report Cover page
    16. 16. NCMR linked to specific sub assembly AND revision
    17. 17. NCMRE workflow with supplier notification
    18. 18. NCMR linked to CAPA with “smart rule” and test results attached for evidence
    19. 19. Demo Script 2 – Log a Non-Conformance Report <ul><li>Script Overview </li></ul><ul><ul><li>Initiate a Non-Conformance Report (NCR) </li></ul></ul><ul><ul><li>Identify immediate containment action and route for approval </li></ul></ul><ul><ul><li>Provide disposition, approve and monitor NCR until disposition has been completed </li></ul></ul><ul><li>Business Problem </li></ul><ul><ul><li>Document an internal quality issue </li></ul></ul><ul><ul><li>Ensure exposure to additional material defects are addressed </li></ul></ul><ul><ul><li>Determine disposition with proper approvals </li></ul></ul><ul><ul><li>Monitor corrective action to ensure it is completed </li></ul></ul><ul><li>Benefits to Philips </li></ul><ul><ul><li>Reduced cycle time to act on NCRs </li></ul></ul><ul><ul><li>360 degree view of quality history </li></ul></ul><ul><ul><li>Ability to monitor trends and recurring issues over time </li></ul></ul>
    20. 20. Agile Quality Demo Scenario – 3.0 Supplier Issue Scenario - “screen flicker” NCMR – copy & save Auto supplier request & input
    21. 21. Supplier NCMR cover page – with action details
    22. 22. SNCMR linked to specific sub-assembly and revision
    23. 23. Supplier NCMR workflow with supplier activity
    24. 24. NCMR linked to CAPA with “smart rule” and test results attached for evidence, plus a link to a associated website
    25. 25. Demo Script 3– Log a Supplier Issue <ul><li>Script Overview </li></ul><ul><ul><li>Initiate a Supplier Issue </li></ul></ul><ul><ul><li>Identify follow-up action requested and notify supplier </li></ul></ul><ul><ul><li>Receive feedback from supplier and monitor NCR until follow-up has been completed </li></ul></ul><ul><li>Business Problem </li></ul><ul><ul><li>Document a supplier quality event </li></ul></ul><ul><ul><li>Determine follow-up actions with proper approvals </li></ul></ul><ul><ul><li>Monitor corrective action to ensure it is completed </li></ul></ul><ul><li>Benefits to Philips </li></ul><ul><ul><li>Reduced cycle time to act on NCRs </li></ul></ul><ul><ul><li>360 degree view of quality history </li></ul></ul><ul><ul><li>Ability to monitor trends and recurring issues over time </li></ul></ul>
    26. 26. Agile Quality Demo Scenario – 4.0 CAPA (8D process) <ul><li>Scenario – aggregate Q/A events (CC/NCMR/Supplier Issue) </li></ul><ul><li>Auto CAPA triggers w/rules for risk assessment </li></ul><ul><li>Auto Linked to DHF/DMR archive </li></ul><ul><li>Synchronized Root cause change mgmt -evidence </li></ul><ul><li>Stop ship for ERP-SAP </li></ul>
    27. 27. CAPA cover page
    28. 28. AgileMD Enterprise Quality Management (EQM) Quality Event Scenarios Need this view updated for cover page on previous slide
    29. 29. CAPA with aggregated quality events and affected documents requiring action defined by CAPA
    30. 30. CAPA workflow and status
    31. 31. <ul><li>All CAPA activity managed in one systems including: </li></ul><ul><li>Associated CC/NMCR/SNCMR with smart rules </li></ul><ul><li>Associated DHF, DMR, work instructions, Product risk assesment documents and change activity </li></ul><ul><li>Stop ship notification for ERP system </li></ul>
    32. 32. CAPA with attached documents and websites to support CAPA investigation
    33. 33. Complete history of CAPA activity provides realtime status and auditable archive
    34. 34. AgileMD Enterprise Quality Management (EQM) Quality Event Scenarios
    35. 35. Demo Script 4 – Initiate a CAPA Referencing Previous Events <ul><li>Script Overview </li></ul><ul><ul><li>Initiate a Corrective Action / Preventative Action (CAPA) </li></ul></ul><ul><ul><li>Identify all Affected Items </li></ul></ul><ul><ul><li>Follow the 8D corrective action process </li></ul></ul><ul><ul><li>Monitor CAPA to ensure all actions have been completed </li></ul></ul><ul><li>Business Problem </li></ul><ul><ul><li>Need for root cause analysis and long term corrective/preventative action </li></ul></ul><ul><li>Benefits to Philips </li></ul><ul><ul><li>Reduced cycle time to act on CAPAs </li></ul></ul><ul><ul><li>360 degree view of quality history </li></ul></ul><ul><ul><li>Ability to consolidate multiple quality events into a single corrective action process </li></ul></ul><ul><ul><li>Ability to monitor trends and recurring issues over time </li></ul></ul>
    36. 36. Agile Quality Demo Scenario – 5.0 Internal Audit Scenario –internal audit Site specific controls Link to DMS system w/chg mgmt
    37. 37. Site Audit Cover page
    38. 38. QMS Procedures selected to be audited – site specific
    39. 39. Audit workflow with and reviewers/approvers identified below
    40. 40. Demo Script 5 – Initiate Internal Audit of a Document <ul><li>Script Overview </li></ul><ul><ul><li>Initiate an Internal Audit </li></ul></ul><ul><ul><li>Identify audit findings </li></ul></ul><ul><ul><li>Monitor until follow-up has been completed </li></ul></ul><ul><li>Business Problem </li></ul><ul><ul><li>Ensure internal processes are being followed </li></ul></ul><ul><ul><li>Document an internal audit and findings </li></ul></ul><ul><ul><li>Monitor follow-up to ensure it is completed </li></ul></ul><ul><li>Benefits to Philips </li></ul><ul><ul><li>Reduced cycle time to prepare and conduct audits </li></ul></ul><ul><ul><li>360 degree view of quality history </li></ul></ul><ul><ul><li>Ability to monitor trends and recurring issues over time </li></ul></ul>
    41. 41. Agile Quality Demo Scenario – 6.0 ERP/BI Interface <ul><li>Complete </li></ul><ul><li>Open </li></ul><ul><li>Integrated </li></ul>
    42. 42. AgileMD – Leveraging enterprise quality data Automatically consolidating quality across the IT platform Oracle BI Server Proactive Detection and Alerts Disconnected Analytics Ad-hoc Analysis MS Office Plug-in Reporting & Publishing Interactive Dashboards OLTP & ODS Systems Data Warehouse Data Mart SAP, Oracle Custom Apps Files Excel XML Business Process Multidimensional Calculation and Integration Engine Intelligent Caching Services Simplified Business Model and Abstraction Layer Intelligent Request Generation and Optimized Data Access Services <ul><li>Key capabilities </li></ul><ul><li>Consolidate and standardize BI tools </li></ul><ul><li>Seamless user experience across products </li></ul><ul><li>Conditional navigations </li></ul><ul><li>Unified metadata and shared services </li></ul>Oracle BI Suite Enterprise Edition
    43. 43. Enterprise Value – AgileMD/ERP Integration Synchronizing design/mfg & regulatory content with change/quality history Automating the Prototype – Commercialization process to provide compliance integrity & business efficiency As Designed As Built ERP Agile DMR / Item Master Integration (Proto - Commercial) Design Analysis (Quality & Change Mgmt) MBR/DHR (Lot Info) Sale/Ship Info Procurement ($$ / Lead-time) Router & Inventory Pick NPD/DHF QMS Reg. Sub Design Change
    44. 44. Stop ship notification automatically triggers ERP system from CAPA workflow
    45. 45. Deviation notification automatically triggers ERP system from CAPA workflow
    46. 46. Agile Quality Demo Scenario – 7.0 Reporting <ul><li>Scenario – Quality reporting & analytics </li></ul><ul><li>KPI – threshold filters and triggers </li></ul><ul><li>Drill down capability </li></ul>7.0 Comprehensive Reports 8.0 Enterprise Audit Mgmt
    47. 47. AgileMD Enterprise Quality Management (EQM) Quality Event Scenarios Out-of-the Box dashboard provides comprehensive view of all quality events, status, and performance
    48. 48. QMS Analytics 200+ Out-of-the Box analytic reports enable pro-active management of quality with notification filters, dynamic drill-down analysis, and KPI’s
    49. 49. Comprehensive search capabilities to analyze impact of change,
    50. 50. Demo Script 6– Reporting, Dashboard, Workflows and Web UI <ul><li>Script Overview </li></ul><ul><ul><li>Show standard reports, dashboard and analytics capabilities </li></ul></ul><ul><ul><li>Demonstrate workflow capabilities </li></ul></ul><ul><ul><li>Demonstrate web user interface </li></ul></ul><ul><li>Business Problem </li></ul><ul><ul><li>Ability to find data needed for decision making </li></ul></ul><ul><ul><li>Ability to tailor views of data for specific users </li></ul></ul><ul><ul><li>Ability to present results with little effort </li></ul></ul><ul><ul><li>Ability to configure workflows to meet specific process requirements </li></ul></ul><ul><li>Benefits to Philips </li></ul><ul><ul><li>Reduce access time to data </li></ul></ul><ul><ul><li>Reduce manual collection and formatting of data for reports </li></ul></ul><ul><ul><li>Improve decision making with more timely data </li></ul></ul><ul><ul><li>Ability to monitor trends and recurring issues over time </li></ul></ul>
    51. 51. Agile Quality Demo Scenario – 8.0 External Audit Mgmt Scenario External audit management One system for docs/parts change mgmt & quality Link to DMS & Cobra system 7.0 Comprehensive Reports 8.0 Enterprise Audit Mgmt
    52. 63. PLM Process Dependencies Customer Complaint CAPA Stop Ship Change Order Deviation Non-Conformance
    53. 64. Close-loop quality/change analysis with DMS Quality “ triage” End CC & NCR Identified CAPA initiated On NPI&L Initiate Design Control Audit Review associated DHF/DMR Define changes required Root cause Analysis Monitor changes <ul><li>Proactive Change mgmt driven by quality </li></ul><ul><li>One auditable archive for all regulatory documents (QMS/DHF/DMR/Reg Submittals) </li></ul><ul><li>Comprehensive enterprise analysis </li></ul><ul><li>Close loop quality & change process </li></ul>Close out Corrective Action Quarterly Quality Review
    54. 65. Enterprise Quality Management Effectiveness Visibility is the key! <ul><li>Quality icon makes everyone aware of quality events associated with Part/process/procedures in AgileMD compliant dataset. Blah blah blah….. </li></ul>