P1252109402nINsx

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Wenger System Overview (Q/A, HACCP, ISO) FDA
Animal Feed Safety System Meeting September 23,
2003
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Introduction
Wengers Feed Mill, Inc. -Manufacturer of bulk
poultry and swine diets -Family owned and
operated since 1944 -Headquarters in
Rheems, PA -Operating 6 mills (5-PA,1-MD) -Provi
de Nutritional, Analytical Research
Services -Pullet Growing Egg Marketing
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Overview

• Description of the WFM Quality Assurance Program
• HACCP what its good for
• why we did it..
• 3. The next step
• The Wenger System

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Q/A
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WFM Quality Assurance Program

• Product Design and Labeling
• Ingredient Selection
• Approved Suppliers List
• Production Scheduling
• Flushing Sequencing

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WFM Quality Assurance Program

• Manufacturing
• Work Instructions
• Preventative Maintenance
• Delivery

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HACCP
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HACCP

• Comprehensive risk analysis, focus on potential
  human food-related illness risk factors
• Over 150 man hours spent identifying potential
  risks

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HACCP

• Formal system for identifying risks and tracking
  non-conformances
• Identifying weak-spots in our system and
  providing the tools to fix them
• Transportation

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The WENGER SYSTEM
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What is Management System?

• A frame work for managing an organizations
  significant environmental, safety and quality
  aspects, which places reliance on a systems
  approach, not on individuals
• Holistic management and total employee
  involvement
• Proactive vs. reactive thinking.

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WS Components
Regulatory (GMPs) Quality (ISO
9001) Environmental (ISO 14001) Safety (OHSAS
18001) Human Food Safety (HACCP)
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Compliance Based Systems vs. ISO 9001 QMS
Compliance Based ISO 9001 QMS
Regulatory driven programs and processes aimed at maintaining compliance Beyond compliance programs and procedures aimed at continual improvement
Reactive - quality issues not considered in business planning function Proactive - Plan for and anticipate quality issues with new processes, products and services
Cost center- quality management is a necessary evil Strategic business unit - QMS will can add to bottom line

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Why Organizations Implement a Management System

• Improved compliance
• Reduction in liability and risk
• System for prioritizing resources
• Decrease costs
• Market advantage
• Pressure from interested parties
• CONTINUAL IMPROVEMENT

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Continual Improvement Model
4.3 Planning
4.6 Management review
4.4 Implementation and operation
4.5 Checking and corrective action
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Implementation Tasks Completed
? Gap analysis ? Top management overview ?
WS Policy development ? Aspects and hazards
analysis ? Policy training ? WS Manual
development ? Registrar request for proposal ?
Steering Committee overview ? Interviewing
Registrars
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Implementation Tasks Pending
? Complete documentation ? Training and
education ? Pre-Audit Internal and
External ? Certification Audit Goal to be
completed and receive certification by end of 1st
quarter 2004.