1. Presented by INTRODUCTION TO PRINCIPLES OF INSPECTING / AUDITING FOOD PLANTS

2. Quality Programs IQS Food Safety Program PrerequisitePrograms How well we are doing Inspections/Audits Performance Indicators Values/Skills/ Knowledge Creation Education/Training Plant Culture Quality Policies INSPECTING/AUDITING AND IQS

3. INSPECTION & AUDIT DEFINED Inspection: Evaluating a brief/given moment in timeInspection: Evaluating a brief/given moment in time Audit: Historical perspective of program conformanceAudit: Historical perspective of program conformance

4. JUSTIFICATION Why Inspect & Audit a Food Plant?Why Inspect & Audit a Food Plant? –Legal –Moral –Market –Economic & Financial

5. JUSTIFICATION LegalLegal –U.S. Food, Drug and Cosmetic Act 1938 Section 402(a)(3)Section 402(a)(3) –A food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substances, or if it is otherwise unfit for food. Section 402(a)(4)Section 402(a)(4) –A food shall be deemed adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated, or whereby it may have been rendered injurious to health.

6. JUSTIFICATION Legal (cont)Legal (cont) –Preamble to GMPs Management shall take all reasonable measures and precautionsManagement shall take all reasonable measures and precautions –Regulated HACCP (U.S., Europe, other) –Plant Security –ISO/IQS

7. JUSTIFICATION Moral ObligationMoral Obligation –Protect health of customers Market ExpectationMarket Expectation –Satisfy customers’ expectations Value perceived for price paidValue perceived for price paid

8. JUSTIFICATION Economic/FinancialEconomic/Financial –External Customer RetentionCustomer Retention Brand ProtectionBrand Protection RecallsRecalls –Internal Process Improvements/EfficienciesProcess Improvements/Efficiencies –Raw materials –Waste –Non-conforming products –Finished product Break Even PointBreak Even Point Return on investmentReturn on investment

9. Assess areas of known risk to the organization Assess resource requirements Evaluate compatibility of departmental goals, objectives, and quality policy statements Confirm conformance to procedures and work instructions Stay in touch with the organizational changes PURPOSE OF INSPECTING & AUDITING Factual information for management decisions Determine effectiveness of the organizational goals Provide positive and negative feedback Satisfy regulatory, customer, and pre- contract requirements Identify opportunities for improvement and corrective action projects