Managing the Supply Chain with TrackWise
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There are many concerns when facing quality management within organizations and big companies. There are always high risks in the supply chain. Furthermore, there are risks with internal infrastructure and the value chains (from distribution to retail to the consumer).
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Managing the Supply Chain with TrackWise
- 1. By Completing the Quality Picture Managing the Supply Chain
- 2. Quality Challenges within an Organization INTERNAL INFRASTRUCTURE Brand Owner MESERP Manufacturing & Packaging Finance & Sales Quality Management EQMS Regulatory Bodies Master CAPA Master Change Control Master Deviations Master Investigation SUPPLY CHAIN Tier 1 Suppliers Contract Manufacturers & Packagers No Quality Visibility Tier 2, 3 Suppliers & Supplier’s Suppliers Distribution Retail Consumers VALUE CHAIN
- 3. Example: Contract Spending Grouping and Rations 3 32% DIRECT 25% ENTERPRISE 22% SALES & MKTG 21% R&D MGT Raw Materials Packaging Contract Mfg. Transportation Capital 9% 6% 8% 5% 4% Services Corp Svs IT Energy Telecom 16% 4% 3% 1% 1% Creative Marketing Promotion Meetings Travel 3K 2K 4K 5K 2K 18K 2K 3K 1K 1K 6% 6% 8% 5% 3% 5K 5K 15K 36K 20K Services Corp Svs 12% 9% 24K 11K % of Costs# Suppliers % of Costs# Suppliers % of Costs# Suppliers % of Costs# Suppliers 3 categories are under scrutiny by Regulatory Agencies – Must be fully audited Quality Transaction s 20K 10K 100K Total 9K 23% 130K
- 4. The Challenge 4 Business Impact Overhead Costs Out of Stock Costs Organizational Impact Compliance & Litigation Market Impact Time = Money Poor Quality = Danger Poor Quality Affects Brand Reputation Raw Material Supplier Product shipped late Product damaged Manufacturing delays Scrap, delays in Mfg & shipping Issues Manufacturing Facility Distribution delays Impact Packaging Product out of spec Product mislabeled Shipped wrong product Manufacturing Facility Issues Issue not captured Dangerous product distributed Impact Contract Manufacturers & Packagers Issues Not Captured: Poor quality product delivered Issue Distributor Issue not captured Poor quality product delivered Impact Poor information+ No visibility Inconsistent processes + Reactive Environment= Pharmacy (Out of Stock) Consumers Distributor
- 5. Supplier Quality Management Addressing the Challenge 5 Raw Material Supplier Packager Contract Manufacturers & Packagers Consistent Quality Manufacturing Quality Few Manufacturing Delays Fewer Shipping Delays Less Product Quarantined Less Waste/Rework Protected Supply Chain Quality Processes Interactive Supplier Scorecard Real-Time Consistent Accurate TrackWise Analytics On-Time Shipping Fewer Damaged Products Product In Spec Accurate Labeling Right Product Shipped Product In Spec Accurate Labeling Correct Product Shipped Fewer Damaged Products Better Visibility Efficiency
- 6. Meeting the Needs of the Organization 6 IT Accuracy Speed QA Processes Supplier Nonconformance Supplier Audits Supplier Onboarding Risk/ Compliance Warning Letters/Decrees (483s) Recalls Internal Teams Need to Increase Visibility QA MANUFACTURINGPROCUREMENT
- 7. The Challenge Technology Driving Efficiency & Accuracy 7 TrackWise Analytics Lost or incomplete data at time of business decision Days or months to receive data Paper-based Audits Resulting in negative monetary impact Manufacturing Process ISSUE VOLUME Quality Processes On Premise SQM TIME ACCURACY
- 8. Addressing the Challenge Technology Driving Efficiency & Accuracy 8 Complete data at time of business decision Electronic Audits One Click Electronic Upload Resulting in positive monetary impact Manufacturing Process ISSUE VOLUME Quality Processes On Premise SQM TIME ACCURACY Via TrackWise Analytics
- 9. The Challenge Supplier Audits 9 Suppliers and CMOs to Be Audited Critical Suppliers Important Suppliers General Suppliers No Quality Visibility Supplier qualification Risk Assessment Interim Check Supplier qualification Risk Assessment Interim Check Supplier qualification Risk Assessment Interim Check No Quality Visibility 1. Online Assessment 2. Audit Execution 3. Observations & CAPAs Supplier Audit Checklist Prioritize Schedule Manage Cumbersome Resource Intensive Difficult to coordinate Execute Inconsistent Remediate Detached Measure Inaccurate Decisions No Quality Visibility
- 10. Addressing the Challenge Supplier Audits 10 Critical Suppliers Important Suppliers General Suppliers Prioritize Schedule Manage Informed Systematic Efficient Execute Consistent Remediate Integrated Measure Accurate Decisions Complete Measure and Inform Audit Management Audit Execution Audit Planning Supplier Audit Checklist 1. Online Assessment 2. Audit Execution 3. Observations & CAPAs Suppliers and CMOs to Be Audited Supplier qualification Risk Assessment Interim Check Supplier qualification Risk Assessment Interim Check Supplier qualification Risk Assessment Interim Check
- 11. The Challenge Product Non-Conformance Paper based Management Slow Response Detached Issue Identified Notification SCAR Reviewed Action Item Extension Approved Product Damaged Notification Received Supplier Response Due Date Extension Product Damaged (Repeat Issue) Quarantine Days or months to receive data No Visibility Quality Processes Product Manufactured Product Shipped Issue Missed Poor Quality = Danger Poor Quality = Brand Reputation
- 12. The Solution Product Non-Conformance Quarantine SafeQuality Visibility Quality Processes Issue Identified Notification SCAR Reviewed CAPA Approved Action Item Reminders Product Damaged Notification Received Supplier Identification Root Cause CAPA Plan Effectiveness Check Electronic Record Management Efficient Response Connected e On time TrackWise Analytics Efficient Response Product Manufactured Product Shipped Electronic Record Management
- 13. The Challenge Supplier Onboarding 13 Supplier A Inconsistent Processes Inefficient Management Poor Recordkeeping Onboarding x Supplier x Material o Raw Material x 1,000’s Poor Onboarding and subsequent management leading to: Less Compliance More Risk Higher Costs Material #1 Cert Material #2 Cert Product Manufactured Non-Compliant Certs. = Danger Poor Recordkeeping = Brand Risk Manufacturing Facility 2 Material Certification Material #1 Received – Improperly Filed PLM – Cert Flagged - Out of Date Material Certification Material #2 No Cert Received PLM – Supplier Flagged w/ Cert
- 14. The Solution Supplier Onboarding 14 Supplier A Consistent Processes Efficient Management Electronic Recordkeeping Onboarding x Supplier x Material Raw Material x 1,000’s Automated onboarding and subsequent management leading to: Material #1 Cert Material #2 Cert Product Manufactured Compliant Certs. = Quality Sound Recordkeeping = Brand Protection Manufacturing Facility 2 Certification Doc Posted Business Rules Safe Material Material #1 Supplier Onboarding Received Systematic Efficient Delivered Material #2 Certification Doc Posted Business Rules Safe Material Received Systematic Efficient Delivered AutomatedProcessing SQM
- 15. VP Procurement VP of QA VP Manufacturing Stratas – Supplier Scorecard Accurate Data When you need it 15 Manufacturing Metrics Greater Transparency Better Accountability More Efficiencies Net Effects PROCESS FLOW METRICS 8 Materials Waiting Time Quotient MWTQ Percent (%) Ratio of waiting time for materials to total manufacturing lead time (TML) 9 Line Efficiency LE Percent (%) Ratio of actual process throughput to the theoretical idea throughput based on the pace and cycle time at the bottleneck station. QUALITY METRICS 10 Scrap Rates SR Percent (%) Percentage of units starting as raw material that are lost as scrap from all steps in the process. 11 Rework Rates RR Percent (%) Percentage of units starting as raw material that have to be reworked at least once in the process. FINANCIAL METRICS 12 Cost per Part CPP $/unit Total cost per unit for raw materials, processing and indirect overhead.
- 16. Stratas Protecting the Supply Chain from Supplier Issues 16 Manufacturer 1 Manufacturer 2 Manufacturer 3 Contract Manufacturers Suppliers Packagers Certified Trending Negative Certified Not Certified Certified Remediate SQM by Manufacturing Facility Corporate Distributors Retail Industrial Internet Consumer Can you get to the data you need to protect your entire supply chain?
- 17. Risk Scorecard Integration Sources 17 Supplier Audits CARs Incoming Inspections Contracts / POs Inventory Management Bill of Materials Supplier Questionnaire TrackWise EQMS MES ERP PLM
Editor's Notes
- “Rules of engagement” for the Value Messaging meeting. (16-17 slide per vertical – after breakout) Meeting Agenda & Approach Each person (KR, Kelly and Mohan) will be given 30-35 minutes to present their deck to the team Each person will receive anonymous feedback from their teammates using the attached form Note: I will be abstaining from providing feedback (verbal or written) and will simply play a time moderator role You may choose to accept the feedback and incorporate it into your final product, or you may decline the feedback Meeting Outcome Coming out of the meeting, the desired outcome is as follows: A polished deck that is ready to present to John McNeill within 1 week of the meeting on the 24th (including peer feedback if you so choose) A polished deck script (i.e., written voice over) that is ready to present to John McNeill within 1 week of the meeting on the 24th (including peer feedback if you so choose) I will look to reserve some time with John in late July or early August to allow each of you to present to John. At that point in time, I would expect the team to be prepared to take the best ideas from the 3 verticalized decks and work toward a standard deck (where it makes sense) with minor mods based on each vert. Notes: We are setting a new standard for Sparta, so please feel free to take liberties with the following if you feel it bolsters your story: Existing Business Drivers The Problem & The Solution Chalk Talk – Off Limits – No liberties permitted Existing Value Pillars Look, feel and graphics – We’ll calibrate with Marketing at the appropriate time
- KEY TAKEAWAYS: Current EQMS solves internal problems, but externally you have no visibility. POINTS: You have harmonized on your internal systems. Protect supply chain and consumer. Show quality processes. A disconnected supply chain presents an issue for quality management, because historically this used to be a very orderly, within the four walls type of business process when manufacturing and supply businesses were highly verticalized. A firm may have strong supplier quality management system that include vendor qualification and management of the lifecycle of issues and changes, regular audits of suppliers and external manufacturers and a series of quality related activities such as deviations and non-conformances, change controls that go back and forth, and supplier corrective actions. But these same firms might still support supplier quality in the same, manual, error prone fashion. And over the course of time, the network of suppliers and contract manufacturers just gets more complicated, and the communication with these becomes a bigger issue. The risk here is the lack of visibility into what suppliers are doing.
- Prioritize – No ASL, no risk measure Schedule – Sourcing Limited Availability Manage – Historical Reseach (TW) Execute – All Manual (AEP) Remediate – Phone, fax, email, No Visibility Measure – No Scorecard or risk measure
- Prioritize – No ASL, no risk measure Schedule – Sourcing Limited Availability Manage – Historical Reseach (TW) Execute – All Manual (AEP) Remediate – Phone, fax, email, No Visibility Measure – No Scorecard or risk measure
- Process flow to Driving process Biz engine – when last step (certify recd) – add expir date for recertify reminder Integr with Doc Mgt Visio – Business Decisions