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
Input Protocols (IP)
2.0 Introduction to Input Protocols
2.1 Input Protocols – Supplier Support
2.1.1 cGMP Compliance
2.1.2 HACCP Compliance
2.1.3 Other Regulatory Compliance
2.1.4 Procurement
2.1.5 Expediting
2.1.6 Shipping and Receiving
2.1.7 Holding Environment
2.1.8 Procedures – CBAs
2.1.9 Documentation and SOPs
2.1.10 Inspection Check List
2.1.11 Quality Attributes
2.1.12 Specifications
2.1.13 Sampling
2.1.14 Scheduling
2.1.15 Inventory and Queuing
2.1.16 Design for Use
2.1.17 Supplier Quality Program
2.1.18 Hot line
2.1.19 Multiple Suppliers
2.2 Input Protocols – Cleanliness and Order
2.2.1 Supervision – Control
2.2.2 Training – Care and Use
2.2.3 Warning Media
2.2.4 Clothing and How to Dress
2.2.5 Personal Hygiene
2.2.6 Responsibility
2.2.7 Accountability / Authority
2.2.8 Procedures – SOPs and CBAs
2.2.9 Documentation – All Supplies and Components
2.2.10 Enforcement – Patience, Prudence, Persistence
2.2.11 Needed Supplies on Hand
2.2.12 cGMP Compliance
2.2.13 HACCP Compliance
2.2.14 Other Regulatory Compliance
2.3 Input Protocols – Decontamination
2.3.1 Contamination Defined
2.3.2 Types of Contamination
2.3.3 Temperature Exposure Limits
2.3.4 Temperature Monitoring Calibration
2.3.5 Time Exposure Limits
2.3.6 Time Monitoring Calibration
2.3.7 Foreign Food Exposure Limits
2.3.8 Food Monitoring Calibration
2.3.9 Oxygen Exposure Limits
2.3.10 Oxygen Monitoring Calibration
2.3.11 Dust Exposure Limits
2.3.12 Dust Monitoring Calibration
2.3.13 Clean – Air Lock
2.3.14 Clean Design – Clothing
2.3.15 Clean Design – Dressing
2.3.16 Clean Design – Dressing Room
2.3.17 Clean Design – Work Area
2.3.18 Validation & Tests
2.3.19 Documentation, SOPs and CBAs
2.3.20 Material Compatibility
2.3.21 Cleaning Chemistry
2.3.22 cGMP Compliance
2.3.23 HACCP Compliance
2.3.24 Other Regulatory Compliance
2.3.25 Error Proofing and FMECA
2.4 Input Protocols – Design, Specification, and Tolerances
2.4.1 History of all Inputs
2.4.2 Design Criteria
2.4.3 Fit and Function of all Inputs
2.4.4 Safety Aspects of Inputs and Materials
2.4.5 Material Selection
2.4.6 Producing, Transportation and USE Environment
2.4.7 Detail Design Drawings
2.4.8 Documentation of all Input Tests and Results
2.4.9 Approved Production Drawings
2.4.10 Proper Geometrical Dimensioning & Tolerancing GD&T ASME Y14,5
2.4.11 Input Stability – Chemically, Physically, Electrically
2.4.12 Design for Manual Application
2.4.13 Design for Automatic Application
2.4.14 Error Proofing and FMECA Input Protocols – Transfer and Storage
2.5 Input Protocols – Transfer and Storage
2.5.1 Supplier Storage Capacity
2.5.2 Supplier Storage Dust Levels
2.5.3 Supplier Storage Cleanliness
2.5.4 Supplier Storage Access
2.5.5 Supplier Storage Security
2.5.6 Protection During Storage
2.5.7 Supplier Storage Temperatures
2.5.8 Supplier Storage Humidity
2.5.9 cGMP Compliance
2.5.10 HACCP Compliance
2.5.11 Inventory Control
2.5.12 Wastage and Rework
2.5.13 Method of Transportation
2.5.14 Protection During Transportation
2.5.15 Transportation Environment
2.5.16 Transportation Vibrations
2.5.17 Transportation Security
2.6 Input Protocols – Continuous Improvement
2.6.1 Customer Concerns and Issues
2.6.1 Keep a Pro-Active Status
2.6.3 In - House Feedback System
2.6.4 Customer Feedback System
2.6.5 Design Improvements
2.6.6 Tolerance Improvements
2.6.7 Materials Improvements
2.6.8 Process Improvements
2.6.9 Reliability and MTBF
2.6.10 Troubleshooting CCS
2.6.11 Production Efficiencies
2.6.12 Error Proofing, FMECA and Action Plan
2.6.13 CBAs and Training
2.6.14 Output Capacity Improvements
2.7 Conclusions

Chapter 3
Training – The Critical Ingredient
3.0 Introduction
3.1 Make Up of the Trainees
3.2 The Critical Nature of Training
3.3 Timing of Training
3.4 Training Focus
3.5 The Training Plan
3.6 Training Locations
3.7 The Depth and Frequency of Training
3.8 Training of Seasonal Employees
3.9 Manuals and Other Self-Help Tools
3.9.1 Tips on Writing and Small Manuals
3.9.2 Tips on Good Manual Writing Practices
3.9.3 Text Organization
3.9.4 Some Notes on Style and Format
3.9.5 Tips on Printing and Binding
3.10 Training Related to Current Good Manufacturing Practice (cGMP) Using CBAs or SOPs
3.10.1 The Main Principles of Good Manufacturing Practice (GMP)
3.10.2 Current Best Approach (CBA) and Standard Operating Procedures (SOP)
3.11 Performance Reviews and Continuing Improvements
3.11.1 People
3.11.2 Machinery
3.11.3 Production Supplies/Materials
3.11.4 Sanitation or Cleanliness
3.12 Company Wide Specifications
3.13 Equipment Effectiveness Analysis
3.14 Retrofits, Adjustments and Additions to New, Modified or Existing Production Lines – Continuous Improvement
3.15 The Team Approach
3.15.1 The Make Up of the Team
3.15.2 The Timing of Team Meetings and Scope
3.15.3 Management of Risk
3.15.4 Technical Risk
3.15.5 Financial Risk
3.15.6 Marketing Risk
3.15.7 Political Risk
3.15.8 Risk in a Nutshell
3.16 Outline for a Comprehensive Packaging Line Technician / Operator Basic Training Program
3.16.1 Training Program Objectives
3.16.2 Requirements of Personnel
3.16.3 Program of Studies for Production Line Personnel
3.17 Conclusions

Chapter 4
Ergonomics
4.0 Introduction
4.1 Common Injuries
4.2 To Lift or Not to Lift
4.3 Ergonomic Answers
4.4 OSHA’s Influence (United States)
4.5 Ergonomic Alert
4.6 The Role of Ergonomics in Today’s Production Process
4.7 Why Ergonomics Matters
4.8 Task Interleaving: Systematic Planning
4.9 Dock Safety Results in Improved Productivity
4.10 Extendible Conveyors Reduce Lifting
4.11 The Ergonomics of Lift Trucks
4.12 The Role of Ergonomics in Picking
4.13 Specialization and Customization
4.14 Reducing the Human Element in Packing
4.15 Ergonomics in Package Design
4.16 Ergonomics in Packaging Machine Design
4.17 Machine Design Checklist
4.18 Ergonomics in Workstation Design
4.19 Conclusions
4.19.1 General References
4.19.2 Anthropometric References
4.19.3 Ergonomics Websites

Chapter 5
Production Line Maintenance
5.0 Introduction
5.1 What is Maintenance (As it Pertains to Production)?
5.2 Maintenance by a Key Experienced or Skilled Tradesperson
5.3 Breakdown Maintenance
5.4 Planned Maintenance
5.4.1 Replacement Parts
5.4.2 Records
5.4.3 Future Demands
5.5 Preventative Maintenance
5.5.1 Records
5.5.2 Work Order Systems
5.6 Computerized Maintenance Programs
5.7 Predictive Maintenance
5.8 Use of DFA and CSS Techniques for Continuous Improvements and Repairs
5.9 Reliability Centered Maintenance (RCM) or Reliability Improvements Program (RIP)
5.10 Root Cause Failure Analysis (RCFA) and Failure Mode, Effects and Critical Analysis (FMECA)
5.11 Maintenance Materials Management
5.12 Contract Maintenance Management
5.13 Skills and Training Development
5.14 Research and Technology for Maintenance
5.15 Conclusions

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

Appendix 2
Current Good Manufacturing Practices (cGMP)

Appendix 3
Validation Process & Procedures
Design Qualifications (DQ)
Installation Qualifications (IQ)
Operational Qualifications (OQ)
Performance Qualifications (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
US 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

References