PDA-FDA Joint Regulatory Conference - Supply Chain Case Study Rev A Publish
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Global Supplier Quality Management Case Study
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PDA-FDA Joint Regulatory Conference - Supply Chain Case Study Rev A Publish
- 1. Supply Chain Case Study: Better Data Faster Gerard Pearce
- 2. THIS SESSION How we defined a suitable Technology Platform How we built a setting for Data Access & Sharing Lessons Learned & Best Practices Agenda: 5 10 15 20 25 intro history overview actions, methods and impact future recap
- 3. HISTORY The Challenge: Visibility and Control organizational boundaries Supplier Supplier Supplier Supplier Supplier Supplier Supplier functional boundaries system boundaries quality results OK marginal OK OK OK incomplete poor OK poor OK OK ?
- 8. Security
- 10. Existing Systems
- 12. OVERVIEW Event-centric Crosses borders Links stakeholders Automates processes ‘Sensitive’ Pushy
- 16. Verisign (128 Bit SSL Encryption)
- 17. Data Encryption (3-DES)Open Standards OVERVIEW
- 18. People Harnessed feedback Pushed responsibility for data to source Challenged boundaries Promoted self-help Tools Used readily-available gadgets, and “stole with pride” Established open, web-based architecture Developed a ‘connectivity toolbox’ Video training Process Process drove system, not the reverse Used system to enforce business rules Eliminated duplicate/redundant activity Captured data once ACTIONS
- 19. METHODS Long-term vision/roadmap Started with the practical, but had end game in mind Adaptable, open philosophy Thought through constraints and consequences Handed over the baby Smart make/buy decisions Proven development approach SDLC Early prototyping Modeling ‘Acting out’ scenarios diy d
- 20. IMPACT System momentum: In its tenth year Over 5,000 active user accounts worldwide 3,000 unique logins a month Over 400,000 email notifications, timesheets, password reminders, escalations, reminders and ‘canned’ reports 1,200 transactions a second Licensed to global players
- 21. IMPACT Typical enhancement rationale: Time savings at each process point for Supplier Audit Program ‘X’ : Event batch creation using the SRF screen: 15 minutes per audit x 30 audits per month = 7.5 hours per month File tags, descriptions and batch loading: 10 minutes per audit x 50 audits per month = 8.3 hours per month CAPA creation: 1 minute per CAPA x 100 CAPAs per month = 1.7 hours per month Auto notifications: 5 minutes per audit x 50 audits per month = 4.2 hours per month CAPA approval by client: 5 minutes per CAPA x 75 CAPAs per month = 6.25 hours per month Help Desk Backend Changes: 10 minutes per backend change x 20 per month = 3.3 hours per month Total Savings: 28 hours per month at current program volume.
- 22. FUTURE external clients internal clients review process system evolution input technology standards
- 23. RECAP & TAKE-AWAY Defining an acceptable Technology Platform Recognized the whole challenge Looked at design forces (Strategic Vision, Drivers, Foundation, Constraints) Understood boundaries - stayed open Building a setting for Data Access & Sharing Broke boundaries, simplified Grew a list of work-arounds (connectivity toolbox) Harnessed the ‘Human Factor’ Lessons Learned & Best Practices Beware silver bullets Standard IT rules apply Don’t reinvent, steal with pride, evolve It’s a tool, dummy!
- 24. Questions and further information:Gerard Pearce310-802-4448gpearce@sqaservices.com