Manufacturing Execution and Factory Automation Drive Product Quality. Silvio Saouaf Product Manager, Camstar Systems, Inc.

Transcription

1 anufacturing Execution and Factory Automation Drive Product Quality Silvio Saouaf Product anager, amstar Systems, Inc.

2 amstar Has Been a Leader for Over 25+ Years ompany At A Glance Privately Held Founded 1984 Offices USA harlotte, ; San Jose, A APA Singapore; Shanghai; alaysia EEA Germany; etherlands; Ireland Industries Solar Semiconductor edical Devices BioTech/BioPharma olled Goods Electronics Headquartered in harlotte, orth arolina

3 edical Equipment edical Device edical Supplies Hybrid Pharmaceutical Finishing Pharmaceutical Active Ingredient Biotech & Personalized edicine amstar ustomers Across Life Sciences Discrete Assembly Discrete epetitive Batch Top 5 ed Dev 2 Subsidiaries Top 5 ed Dev Top 5 ed Dev Top 5 ed Dev 3 Subsidiaries Top 5 ed Dev

4 Product Quality ealized across Innovation Lifecycle & Value hain hange & Doc gt Development & Design Document anagement Innovation Lifecycle Value hain ew Product Introduction Sales & arketing Production Planning Sourcing / Supply hain anufacturing Delivery Logistics After Sales Service Submissions & Tech Pubs equirement & Portfolio gt

5 Advancing Product Quality: A Holistic losed-loop Approach Advancing Product Quality Define the product/process USE DESIG Enforce manufacturing per product/process IPOVE F. PLA anage service & repair, and bring together internal and customer feedback Improve current and future product designs through learning from all prior stages And continuously enhance process and product quality. Then regulatory compliance becomes a natural outcome, rather than a singular objective.

6 ost of esolution Product Quality ealized across Innovation Lifecycle & Value hain High Investing in Prevention will Drive Down Overall ost ecall ost of Good Quality ost of Poor Quality omplaint Low fg Enforcement Supplier Quality on-onformance Discovery Time Value hain Supplier Assessment Design Engineering anufacturing Distribution ustomer Field

7 ecalls, ecalls Everywhere

8 Product Quality ealized across Innovation Lifecycle & Value hain EP EP/PL Suppliers Demand Variability Orders Design Variability Product Providers eceiving Inspection Patients Process/Product Variability ustomer ework As Built History oute Assurance Identification and Traceability

9 eal-time Enforcement - aterial Suppliers eceiving Inspection Enforcing materials per BO or recipe orrect component and revision orrect quantity or volume ot expired Supports discrete and batch processes Kitting, campaign dispensing Serialized components or lot-based materials Providers Patients Process/Product Variability ustomer As Built History oute Assurance Identification and Traceability

10 eal-time Enforcement - an Suppliers eceiving Inspection Enforcing Operator Training and ertification Presents correct process revision (existing or new) Allows operator to proceed only if trained and certified on product, process, spec, equipment, etc. Ensures regulatory compliance Providers Patients Process/Product Variability ustomer As Built History oute Assurance Identification and Traceability

11 eal-time Enforcement - achine Suppliers eceiving Inspection Enforces esource Usage and eadiness Ensures equipment or instrument is appropriate per specification Allows use only if maintained per schedule Ensures regulatory compliance Providers Patients Process/Product Variability ustomer As Built History oute Assurance Identification and Traceability

12 eal-time Enforcement - easure Suppliers eceiving Inspection Ensure all data is complete an stop product or process if result is out-of-spec Automated data collection and machine automation for speed and accuracy Prevents scrap with SP and early warnings eal-time notification and action for OOS/OOT conditions Prevents quality escapes Providers Patients Process/Product Variability ustomer As Built History oute Assurance Identification and Traceability

13 eal-time Enforcement - ethod Suppliers eceiving Inspection Enforce outes, Processes, Tasks, Exceptions Support complex processes Alternate accepted routes and rework procedures B hold, review, disposition Planned deviations Split, merge, bin Eng hange (Product, Process) Providers Patients Process/Product Variability ustomer ework As Built History oute Assurance Identification and Traceability

14 eal-time Enforcement - Supplier Suppliers eceiving Inspection Ensure Supplier Quality Enforcing that Supplier delivers high-quality raw materials eal-time visibility into Supplier process to ensure they are building to your defined specs Eliminates Source of Poor Supplier Quality Provides Supply hain aterial Traceability & Genealogy Providers Patients Process/Product Variability ustomer As Built History oute Assurance Identification and Traceability

15 How an Automation Advance Product Quality? Automates Data ollection Direct equipment integration, such as a weigh scale or machine Eliminates human error of capturing and recording data collected from the equipment Ensure achine Parameters Automate downloading of machine settings, without the need for human decision Error Proof Execution Transform islands of automation As-manufactured history is complete for correlation and root cause analysis educes Variability

16 How an Automation Advance Product Quality? High Speed Data ollection for Data Analysis Automatically collect hundreds of WIP and Process data points per second Data can be analyzed and correlated with logistics information to improve and refine the product or process definition Enable ontinuous Improvement

17 How Do You easure the Impact of a Quality Solution Over Time? Dynamic Adaptation Performance anagement Production & Quality ontrols Process Leaning Process Automation

18 How Do You easure the Impact of a Quality Solution Over Time? A reduction in the number of quality issues A reduction in the severity of issues ore preventive actions over time Better designed products/processes Fewer issues from the field Improved customer satisfaction Positive impact on top, middle and bottom line Learning Organizations Improved Product Performance (ADAPT) Shift from ompliance Focus to Quality Performance Focus

19 Questions? Silvio Saouaf, Product anager, amstar Systems, Inc.

20 Thank You