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
Machine Protocols
2.0 Introduction
2.1 Machine Protocols (MP)
2.2.1 Clean Up Defined
2.2.2 Ability to be Easily Cleaned
2.2.3 Safety and Guarding
2.2.4 Edges – Fit and Finish
2.2.5 Entrapment of Liquid or Product
2.2.6 Dust and Liquid Build Up
2.2.7 Validation and Tests
2.2.8 cGMP Compliance
2.2.9 HACCP Compliance
2.2.10 Documentation – Audits and Changes
2.2.11 Material Compatibility
2.2.12 Cleaning Chemistry
2.2.13 Procedures and CBAs
2.2.14 Error Proofing & FMECA

2.3 Machine Protocols – Decontamination
2.3.1 Decontamination Defined
2.3.2 Types of Contamination
2.3.3 Temperature Calibration
2.3.4 Temperature Exposure Limits
2.3.5 Time Calibration
2.3.6 Time Exposure Limits
2.3.7 Food Calibration
2.3.8 Food Exposure Limits
2.3.9 Oxygen Calibration
2.3.10 Oxygen Exposure Limits
2.3.11 Dust Calibration
2.3.12 Dust Exposure Limits
2.3.13 Clean Design – Structure
2.3.14 Clean Design – Wash Down
2.3.15 Clean Design – Sanitization
2.3.16 Clean Design – Sterilization
2.3.17 Validation and Tests
2.3.18 Documentation
2.3.19 Material Compatibility
2.3.20 Clean Design – CIP
2.3.21 Clean Design – Pigging
2.3.22 Clean Design – Valves
2.3.23 Cleaning Chemistry
2.3.24 cGMP Compliance
2.3.25 HACCP Compliance
2.3.26 Other Regulatory Compliance
2.3.27 Error Proofing and FMECA
2.4 Machine Protocols – Safety and Ergonomics
2.4.1 User Risks Defined
2.4.2 Contortions
2.4.3 Muscles Required
2.4.4 Tools Required
2.4.5 Travel – Distance / Pace / Weight
2.4.6 Reach – Distance / Weight
2.4.7 Twist – Wrist Rotation / Weight / cpm
2.4.8 Turn – Waist Rotation / Weight / cpm
2.4.9 Lift – Distance / Weight / cpm
2.4.10 Time – To Complete Each Cycle
2.4.11 Talent – Skill – Mech. – Elect.
2.4.12 Thinking – Alertness Required
2.4.13 Easy Access
2.4.14 Safety – Safety – Safety
2.4.15 E-Stops and Lockouts
2.4.16 Procedures – CBAs
2.4.17 Error Proofing – and FMECA
2.4.18 No Thinking – One Way Fit
2.4.19 Event Sequencing – Order
2.5 Machine Protocols – Concepts, Design, and Specifications
2.5.1 Change Parts / Tools Hierarchy
2.5.2 Change Over Effort
2.5.3 Safety and Guarding
2.5.4 Operator’s Panel
2.5.5 The Concept
2.5.6 Manuals & As Built Drawings
2.5.7 Break Out Prints
2.5.8 Inspection Check List
2.5.9 Repair Order CBA
2.5.10 Replacement CBA
2.5.11 Calibration CBA
2.5.12 Materials in Design
2.5.13 Vibration and Stability
2.5.14 Reliability and RCM
2.5.15 Accessibility
2.5.16 Specifications & Criteria
2.5.17 Sequence of Operation
2.5.18 Troubleshooting & CCS
2.5.19 Error Proofing and FMECA
2.6 Machine Protocols – Wear and Maintenance
2.6.1 Function Report & History
2.6.2 Parts Storage Media
2.6.3 Spare Parts on Hand
2.6.4 Inventory Control
2.6.5 Parts Manual
2.6.6 Break out Points
2.6.7 Inspection Check List
2.6.8 Repair Order CBA
2.6.9 Replacement CBA
2.6.10 Calibration
2.6.11 Machine Upgrades
2.6.12 Material Application Review
2.6.13 FMECA Program
2.6.14 Training and Troubleshooting
2.6.15 Reliability Centered Maintenance
2.7 Machine Protocols – Vendor Support
2.7.1 cGMP Compliance
2.7.2 HACCP Compliance
2.7.3 Engineering Depth
2.7.4 Project Management
2.7.5 Company Structure
2.7.6 Procurement
2.7.7 Expediting
2.7.8 Shipping & Receiving
2.7.9 Flexibility & Adaptability
2.7.10 Documentation & Records
2.7.11 Inspection and QC
2.7.12 Acceptance Testing
2.7.13 Manuals and Training Aids
2.7.14 Scheduling
2.7.15 On Time Delivery
2.7.16 Parts Inventory
2.7.17 History and Experience
2.7.18 Supplier Quality Program
2.7.19 Hot Line
2.8 Machine Protocols – Continuous Improvement
2.8.1 Proven Technology
2.8.2 Event Sequencing
2.8.3 Tinkering
2.8.4 Adjustments
2.8.5 Description of Design Criteria or Requirements for Quick Change Guide Rails
2.8.6 Resists Jams
2.8.7 Twisting Members
2.8.8 Bending Members
2.8.9 Tooling Specific
2.8.10 Easy to Clean
2.8.11 Minimum Parts
2.8.12 CGMP Compliance
2.8.13 Durability
2.8.14 Simple Function
2.8.15 Good Fit & Finish
2.8.16 Corrosion Resistance
2.8.17 Heat Resistance
2.8.18 Maintenance and Lubrication
2.8.19 Calibration
2.8.20 Reliability, MTBF and MTOF
2.8.21 Troubleshooting CCS
2.8.22 Loading, Stresses
2.8.23 Error Proofing, RAM, & FMECA
2.9 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 Manufacturing 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
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