Process Traceability - A Critical Component of Medical Molding

Curt Norby, Product Manager - Software Solutions

Process Traceability
What is it? Why do it? Possible solutions

What is Process Traceability?

The Collection and Secure Storage of Process Information relating to the complete process. From Pellet to Part.

What is Process Traceability?

Automatic Collection of Process Variables from each Machine Cycle.

What is Process Traceability?

Electronic Signature Automatic and Permanent Storage of Process Variables for each Machine cycle.

What is Process Traceability?

Material Lot Tracking

What is Process Traceability?

Simple and Fast Retrieval of the Process Records.

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

Automated Monitoring
More Accurate Measurements & Results

Manual Method

vs.

Automated Method

Automated Monitoring
Information is more Timely

Real-Time

vs.

Waiting for Data Entry

What is Required for Complete Traceability?

Monitoring and Storage of the Process Information
Automatically capture Process Variables from each machine cycle on each machine.

What is Required for Complete Traceability?

Alert, Alarm and Notify When Process Changes Occur.
Whether it is a Manual, Automatic or Equipment Failure alert key individuals of the change.
Local Machine Alarms System Alerts via Networked Messages Email/SMS Alerts

What is Required for Complete Traceability?

Documenting & Charting of the Process
Display Real-Time Results of Each Machine Cycle. Provide Complete SPC charting of the Process.

What is Required for Complete Traceability?

Security
Data Entry must be restricted to those who have been trained and authorized to make data entry and/or changes. Utilize Existing Security Systems.
By using Network Domain Security, one can use an existing Network Security model. Use the same login credentials you use to login to your desktop PC each day.

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 identify the event and when it occurred.

What is Required for Complete Traceability?

Material Lot Tracking
Automatically attaches any Lot History Information to the Process History.

What is Required for Complete Traceability?

PM Activity and History
Automatically Notify Key Individuals of pending Maintenance Tasks. Keep History of Maintenance Tasks as they are completed on Machines and Tooling Components.

What is Required for Complete Traceability?

Tracking and Labeling of Completed Product
Print Labels with Job, Part and Traceability information
On demand at the machine. Pre-Print Labels

Case Study #1

Case Study #2

Case Study #3

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

What Should a Process & Production Monitoring System Do For You?

Plant wide solution (Web enabled) Automatically capture all process and production data for permanent record Integrate with existing Security Models Data that is viewable in real time, from anywhere 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 plant equipment Transfer data to and from other IT systems

Introducing Shotscope NX
Real-time Production Monitoring Real-time Process Monitoring Simple, Independent Machine Connection. 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

Non-Husky Machines. One Data Collector, One Touchscreen and One DAQ.

Husky Machine with Polaris Controller

Husky Machine, G or X Line with External PC.

Non-Husky Machines. One Data Collector, One Touchscreen and Multiple DAQs

Non-Husky Machines. One Data Collector, One External PC per Machine and Multiple DAQs

Truly Plant Wide Solution

What cannot be measured, cannot be managed

Solutions
Total Single Source Solution
HMED Altanium Ultra-Sync Shotscope NX

Questions?

Curt Norby (cnorby@husky.ca)