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
People Protocols (PP)
2.0 Introduction to People Protocols
2.1 Safety, CBAs and SOPs
2.1.1 Lockouts & E-Stop – (number, location, type)
2.1.2 Guarding, Doors, Swithces
2.1.3 Warning Media – Lights, Horns, Displays, Alert Aids, etc.
2.1.4 Error Proofing Passive/Active
2.1.5 Accessibility – Equipment and Management
2.1.6 Supervision – Hands On
2.1.7 Training – Comes from CBAs and the Right Mix
2.1.8 Responsibility
2.1.9 Accountability / Authority
2.1.10 QC – What is a Quality Product or Package
2.1.11 Procedures – SOPs & CBAs
2.1.12 Documentation – Parts, Control Logic, Machine History, Changes
2.1.13 Health & Welfare – Morale, Environment
2.1.14 OSHA Compliance
2.1.15 Other Regulatory Compliances
2.1.16 Labor Compliances
2.2 Cleanliness and Order
2.2.1 Supervision
2.2.2 Training – CBAs
2.2.3 Warning Media – Particulate, Humidity, Pressure Sensors etc.
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
2.2.10 Enforcement – Patience, Prudence and Persistence
2.2.11 Needed Supplies on Hand
2.2.12 cGMP Compliance
2.2.13 HACCP Compliance
2.2.14 Other Regulatory Compliance
2.2.15 Everything Always in its Proper Place. Order and Safety Go Together
2.3 People Protocols – Decontamination
2.3.1 Decontamination Defined
2.3.2 Types of Contamination
2.3.3 Clean Design – Air Lock and Filtering
2.3.4 Clean Design – Clothing
2.3.5 Clean Design – Dressing
2.3.6 Clean Design – Dress Room
2.3.7 Clean Design – Work Area
2.3.8 Validation and Tests
2.3.9 Documentation – SOPs
2.3.10 Material Compatibility
2.3.11 Cleaning Chemistry
2.3.12 cGMP Compliance
2.3.13 HACCP Compliance
2.3.14 Other Regulatory Compliance
2.3.15 Error Proofing and FMECA
2.4 People Protocols – Storage, Transfer and Staging
2.4.1 cGMP Compliance
2.4.2 HACCP Compliance
2.4.3 Receiving Checks and Verifications
2.4.4 Quarantine and Isolation
2.4.5 Holding Environment
2.4.6 Security
2.4.7 Protection During Storage
2.4.8 Types of Transfers and Lengths Within the Plant
2.4.9 Protection During Transfers
2.4.10 SOPs – What to Do
2.4.11 CBAs – How to Do It
2.4.12 Scheduling (ERP)
2.4.13 JIT or On Demand Approach
2.4.14 Labor Positioning or Duties
2.4.15 Labor Utilization
2.4.16 Staging Checks and Verification
2.4.17 Staging Inputs
2.4.18 Equipment or Aids Required
2.4.19 Ergonomics
2.5 People Protocols – Loading and Housekeeping
2.5.1 Quality Control (QC) Checks
2.5.2 CBA Loading Material Inputs and Supplies
2.5.3 CBA Operating Policy
2.5.4 CBA Run Up or Start Up
2.5.5 How do you Handle Wastage?
2.5.6 How Do you Handle Rework
2.5.7 Reporting Failures
2.5.8 Reporting Input Jams
2.5.9 Troubleshooting and CCS
2.5.10 Line Order and Cleanliness
2.5.11 Operator Standby Position
2.5.12 Pro-Active Checks
2.5.13 Observation Reports
2.5.14 Interacting with Other Operators
2.5.15 Knowledge of the Production Line
2.5.16 Cross- Training
2.5.17 Operator Relief
2.5.18 Operator Rotation

2.6 People Protocols – Skill Level and Training
2.6.1 Safety, Safety, Safety
2.6.2 Create a Positive Change in Behavior That is Measurable
2.6.3 Do They Have the Talent or Skill for the Job? Test Them
2.6.4 Provide the Knowledge and Experience Necessary to Control the Process
2.6.5 Provide the Knowledge and Experience Necessary to Change out the Line
2.6.6 Provide the Knowledge and Experience Necessary to Maintain the System
2.6.7 Provide Quality Documentation and Training Aids
2.6.8 Ongoing Process (SOPs with CBAs Supporting)
2.6.9 Updating and Retesting – Auditing
2.6.10 How to Troubleshoot a Problem
2.6.11 More is Better. Can Never Over-Train if the Training Program has Value
2.6.12 Technology, Transfer and Training – The Training Program
2.7 People Protocols – Company Policy & Management
2.7.1 cGMP Compliance (For Food and Pharmaceutical Companies)
2.7.2 HACCP Compliance (for Food Companies)
2.7.3 Training Plan
2.7.4 Test Methods
2.7.5 Remedial Program
2.7.6 Procedures – CBAs
2.7.7 Documentation – SOPs
2.7.8 Responsibility, Authority and Accountability
2.7.9 Behavior and Attitude
2.7.10 Operating Aids and Support
2.7.11 Operational Requirements
2.7.12 Production Planning and Flow
2.7.13 Lunches, Breaks, Meetings etc.
2.7.14 Base Educational Requirements
2.7.15 Degrees of Decision Freedom
2.7.16 Building up an Experience Base
2.7.17 Search for Talent – Inside and Out
2.7.18 Acquisition of Data to Make Good Business Decisions
2.7.19 Never Manage – Lead by Example
2.8 Conclusions

Appendix 1
Regulatory and Information Internet Sites
Regulatory Bodies
International Standards Association
American Packaging University Links
Links to Packaging Industry Association 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 Qualifications (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