Table of Contents

Chapter 1
Introduction
1.0 Overview
1.1 Understanding the Quick Change Process (QCP)
1.2 Quick Change Process Mapping
1.3 A Simple Change Out Test
1.4 What is a World Class Company in Relationship to Change Out?
1.4.1 Definition of World Class
1.4.2 The Ten Steps to World Class Status
1.5 Philosophy of Good Business Practice
1.5.1 Introduction
1.5.2 Definition of Good Business
1.5.3 Definition of Work
1.6 The Concept of Safe Work
1.7 Conclusions

Chapter 2
Change Part Protocols
2.0 Introduction
2.0.1 Understanding Quick Change Tooling (QCT)
2.1 Change Out Vs. Hierarchy of Machine Requirements
2.2 Change Part Protocols
2.3 Change Part Protocols – Clean Up
2.3.1 Clean Up Defined
2.3.2 Part Cleaning Protocols
2.3.3 Safety and Guarding
2.3.4 Edges – Fit and Finish
2.3.5 Entrapment of Liquid or Product
2.3.6 Areas of Dust Accumulation
2.3.7 Validation and Tests
2.3.8 cGMP Compliance
2.3.9 HACCP (Hazard Analysis & Critical Control Point) Compliance
2.3.10 Documentation – Audits and Changes
2.3.11 Material Compatibility
2.3.12 Cleaning Chemistry
2.3.13 Procedures and CBAs
2.3.14 Error Proofing and FMECA
2.4 Change Parts Protocols – Decontamination
2.4.1 Decontamination Defined
2.4.2 Types of Contamination
2.4.3 Temperature Calibration
2.4.4 Temperature Exposure Limits
2.4.5 Time Calibration
2.4.6 Time Exposure Limits
2.4.7 Food Calibration
2.4.8 Food Exposure Limits
2.4.9 Oxygen Calibration
2.4.10 Oxygen Exposure Limits
2.4.11 Dust Calibration
2.4.12 Dust Exposure Limits
2.4.13 Clean Design – Components
2.4.14 Clean Design – Wash Down
2.4.15 Clean Design – Sanitization
2.4.16 Clean Design – Sterilization
2.4.17 Validation and Tests
2.4.18 Documentation
2.4.19 Material Compatibility
2.4.20 Clean Design – Valves
2.4.21 Cleaning Chemistry
2.4.22 cGMP Compliance
2.4.23 HACCP Compliance
2.4.24 Other Regulatory Compliance
2.4.25 Error Proofing and FMECA
2.5 Change Part Ergonomics
2.5.1 User Risks Defined
2.5.2 Health Risks – Chemical etc.
2.5.3 Contortions
2.5.4 Muscle Required
2.5.5 Tools Required
2.5.6 Travel – Distance / Pace / Weight
2.5.7 Reach – Distance / Weight
2.5.8 Twist – Wrist Rotation / Weight / cpm
2.5.9 Turn – Waist Rotation / Weight / cpm
2.5.10 Lift – Distance / Weight / cpm
2.5.11 Time – To Complete Each Cycle
2.5.12 Talent – Skill – Mech. – Elect.
2.5.12.1 No Talent Required for Installation or Removal
2.5.13 Thinking and Alertness Required
2.5.14 Easy Access
2.5.15 Safety – Safety – Safety
2.5.16 No Thinking – One Way Fit
2.5.17 No Tinkering
2.5.18 Event Sequencing – Order
2.5.19 E-Stop and Lockouts
2.5.20 Procedures – CBAs
2.5.21 Error Proofing – FMECA
2.6 Change Part Protocols – Identify and Document
2.6.1 Part Coding & ID
2.6.2 Part Installation CBA
2.6.3 Part Calibrations
2.6.4 Part Center Lining
2.6.5 Part Validation
2.6.6 Part Tests On & Off Machine
2.6.7 Part History
2.6.8 Part Position Set Marking
2.6.9 Loading Marking
2.6.10 Queuing Requests
2.6.11 CCS and Troubleshooting Tools
2.6.12 Part Aids & Gauging
2.7 Change Part Protocols – Design and Specifications
2.7.1 Change Parts / Tools Hierarchy
2.7.2 Change Over Effort
2.7.3 Safety and Guarding
2.7.4 Fault Tolerance
2.7.5 Manuals & As-Built Drawings
2.7.6 Break Out Prints
2.7.7 Inspection Check List
2.7.8 Repair Order CBA
2.7.9 Replacement CBA
2.7.10 Calibration CBA
2.7.11 Reliability Centered Maintenance
2.7.12 Materials in Design
2.7.13 Failure Modes – Fault Analysis
2.7.14 Vibration and Stability
2.7.15 Reliability
2.7.16 Accessibility
2.7.17 Guide Rails
2.7.18 Specifications & Criteria
2.7.19 Error Proofing & FMECA
2.8 Change Part Protocols – Wear & Maintenance
2.8.1 Function Report & History
2.8.2 Storage Media
2.8.3 Spare Parts on Hand
2.8.4 Inventory Control
2.8.5 Change Parts Manual
2.8.6 Break out Prints
2.8.7 Inspection Check List
2.8.9 Repair Order CBA
2.8.10 Replacement CBA
2.8.11 Calibration
2.8.12 Material Use
2.8.13 Failure Mode, Cause and Effects (Part of FMECA)
2.8.14 Reliability Centered Maintenance (RCM)
2.9 Change Parts Protocols – Transfer and Storage
2.9.1 Tooling Availability Defined
2.9.2 Part Storage Media
2.9.3 Storage Temperature
2.9.4 Storage Humidity
2.9.5 Storage Dust Level
2.9.6 Storage Cleanliness
2.9.7 Storage Protection
2.9.8 How to Locate Tooling
2.9.9 Readiness of Tooling
2.9.10 Protection of Tooling
2.9.11 Validation and Tests
2.9.12 Transfer of Tooling From Storage to Point of Use and Back

2.10 Change Part Protocols – Vendors Support
2.10.1 cGMP Compliance
2.10.2 HACCP Compliance
2.10.3 Engineering Depth
2.10.4 Project Management
2.10.5 Company Structure
2.10.6 Procurement
2.10.7 Expediting
2.10.8 Shipping & Receiving
2.10.9 Flexibility & Adaptability
2.10.10 Documentation & Records
2.10.11 Inspection and QC
2.10.12 Acceptance Testing
2.10.13 Manuals and Training Aids
2.10.14 Scheduling
2.10.15 On Time Delivery
2.10.16 Parts Inventory
2.10.17 History and Experience
2.10.18 Vendor Quality Program
2.10.19 Hot Line
2.11 Change Part Protocols – Continuous Improvement
2.11.1 Proven Technology
2.11.2 Event Sequencing
2.11.3 Tinkering
2.11.4 Adjustments
2.11.5 Resists Jams
2.11.6 Twisting Members
2.11.7 Bending Members
2.11.8 Tooling Specific
2.11.9 Easy to Clean
2.11.10 Minimum Parts
2.11.11 cGMP & HACCP Compliance
2.11.12 Durability
2.11.13 Function, Fit & Finish
2.11.14 Corrosion, Resistance
2.11.15 Heat Resistance
2.11.16 Maintenance and Lubrication
2.11.17 Calibration
2.11.18 Reliability, MTBF & MTOF
2.11.19 Troubleshooting CCS
2.11.20 Loading Stresses
2.11.21 Other Vendors or Substitutes
2.11.22 Error Proofing, RAM & FMECA
2.12 Conclusions

Appendix 1
Regulatory and Information Internet Sites
Regulatory Bodies
International Standards Associations
American Packaging University Links
Links to Packaging Industry Associations and Engineering Groups
Canadian Professional and Industry Societies
Canadian Standards Associations
Canadian Pharmaceutical Industry Organizations
Vendor Organizations

Appendix 2
Current Good Business Practice (cGMP)

Appendix 3
Validation Process & Procedures
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Standard Operating Procedures (SOPs)
Standard Test Procedures (STPs)

Appendix 4
Acronyms, Process Glossary & Common Usage Glossary
FDA-Related Acronyms and Abbreviations
Industry Used Acronyms
Process Glossary
Common Usage Glossary

Appendix 5
HACCP
Hazard Analysis & Critical Control Point Principles & Application Guidelines
U.S. Food and Drug Administration U.S. Department of Agriculture National Advisory Committee on Microbiological Criteria for Foods Adopted August 14, 1997
Executive Summary
Definitions
HACCP Principles

Appendix 6
SQF – Safe Quality Foods Australian Government Initiative
What is Quality Assurance?
Having a Standard
HACCP
SQF

Biography
Paul J. Zepf, P.Eng., CPP

Bibliography