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Process Traceability - A Critical
Component of Medical Molding
Curt Norby,Product Manager - Software Solutions
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Process Traceability
What is it?
Why do it?
Possible solutions
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What is Process Traceability?
The Collection and Secure Storage ofProcess Information relating
to the
complete process. From Pellet to Part.
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What is Process Traceability?
Automatic Collection of Process Variablesfrom each Machine
Cycle.
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What is Process Traceability?
Electronic Signature Automatic andPermanent Storage of Process
Variables
for each Machine cycle.
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What is Process Traceability?
Material Lot Tracking
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What is Process Traceability?
Simple and Fast Retrieval of the ProcessRecords.
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Why is Process Traceability Important?
Assist With:
cGMP Compliance
ISO Compliance
FDA 21 CFR Part 11 Compliance
Improve Quality
Track Material Lots
Improve Overall Efficiency
Improve Profitability
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More Accurate Measurements & Results
Manual Method vs. Automated Method
Automated Monitoring
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Automated Monitoring
Information is more Timely
Real-Time vs. Waiting for Data Entry
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What is Required for Complete Traceability?
Alert, Alarm and Notify WhenProcess Changes Occur.
Whether it is a Manual, Automatic orEquipment Failure alert
keyindividuals of the change.
Local Machine AlarmsSystem Alerts via Networked Messages
Email/SMS Alerts
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What is Required for Complete Traceability?
Event Logging
When data is entered into the system such as
downtime and scrap a data record is created to identifythe event
and when it occurred.
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What is Required for Complete Traceability?
Material Lot TrackingAutomatically attaches any Lot History
Information to the
Process History.
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What is Required for Complete Traceability?
PM Activity and HistoryAutomatically Notify Key Individuals of
pendingMaintenance Tasks.
Keep History of Maintenance Tasks as they arecompleted on
Machines and Tooling Components.
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What is Required for Complete Traceability?
Tracking and Labelingof Completed Product
Print Labels with Job, Partand Traceabilityinformation
On demand at the machine.
Pre-Print Labels
C St d #1
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Case Study #1
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C St d #3
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Case Study #3
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Benefits of Traceability
Elimination of scrap and rework
Reduction of inspection and test
Greater customer satisfaction Move from problem solving to
problem
prevention
Increased machine up time and yields
Reduction in cycle times
Reduction in manufacturing cost
Improved profitability & ROI
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Plant wide solution (Web enabled)
Automatically capture all process andproduction data for
permanent record
Integrate with existing Security Models
Data that is viewable in real time, fromanywhere
Improve output from existing capital equipment
Allocate jobs where they will run most efficiently
Track process data to improve quality
Automatically track maintenance of all plantequipment
Transfer data to and from other IT systems
What Should a Process & ProductionMonitoring System Do For
You?
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Introducing Shotscope NX
Real-time Production Monitoring Real-time Process Monitoring
Simple, Independent MachineConnection. Husky and Non-Husky
Machines Any Process, not limited to Injection
Molding
ERP Links
Job Scheduling Preventive Maintenance for both
Machines & Molds
SPC & Shot Profile Waveform
Analysis Energy Management
Complete System Architecture Options
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Complete System Architecture Options
HuskyMachine
with
PolarisController
Non-HuskyMachines.
One DataCollector, One
Touchscreenand Multiple
DAQs
Non-Husky
Machines.One DataCollector, OneExternal PCper Machineand
MultipleDAQs
Non-HuskyMachines.One Data
Collector, OneTouchscreenand OneDAQ.
HuskyMachine,G or X LinewithExternalPC.
Truly Plant Wide Solution
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What cannot be measured,
cannot be managed
S l ti
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Solutions
Total Single Source SolutionHMED
Altanium
Ultra-Sync
Shotscope NX
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Questions?
Curt Norby ([email protected])
