Presented by Presented by

INTRODUCTION TO PRINCIPLES INTRODUCTION TO PRINCIPLES OF INSPECTING / AUDITING FOOD OF INSPECTING / AUDITING FOOD

PLANTSPLANTS

Qua

lity

Pro

gram

s

Qua

lity

Pro

gram

sIQSIQS

Food Safety P

rogram

Food Safety P

rogramPrerequisitPrerequisitee

ProgramsPrograms

How well we are How well we are doingdoingInspections/AuditsInspections/AuditsPerformance Performance IndicatorsIndicators

Values/Skills/Values/Skills/Knowledge Knowledge CreationCreation

Education/TrainingEducation/Training

Plant CulturePlant Culture

Quality PoliciesQuality Policies

INSPECTING/AUDITINGINSPECTING/AUDITINGAND IQSAND IQS

INSPECTION & AUDIT INSPECTION & AUDIT DEFINEDDEFINED

• InspectionInspection: Evaluating a brief/given : Evaluating a brief/given moment in timemoment in time

• AuditAudit: Historical perspective of : Historical perspective of program conformanceprogram conformance

JUSTIFICATIONJUSTIFICATION

• Why Inspect & Audit a Food Plant?Why Inspect & Audit a Food Plant?– LegalLegal– MoralMoral– MarketMarket– Economic & FinancialEconomic & Financial

JUSTIFICATIONJUSTIFICATION

• LegalLegal– U.S. Food, Drug and Cosmetic Act 1938 U.S. Food, Drug and Cosmetic Act 1938

• Section 402(a)(3) Section 402(a)(3)

– A food A food shallshall be deemed to be adulterated if it be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, consists in whole or in part of any filthy, putrid, or decomposed substances, or if it is otherwise or decomposed substances, or if it is otherwise unfit for food.unfit for food.

• Section 402(a)(4)Section 402(a)(4)

– A food A food shallshall be deemed adulterated if it has be deemed adulterated if it has been prepared, packed, or held under been prepared, packed, or held under unsanitary conditions whereby it unsanitary conditions whereby it maymay have have become contaminated, or whereby it become contaminated, or whereby it maymay have have been rendered injurious to health.been rendered injurious to health.

JUSTIFICATIONJUSTIFICATION

• Legal (cont)Legal (cont)– Preamble to GMPsPreamble to GMPs

• Management shall take all reasonable Management shall take all reasonable measures and precautionsmeasures and precautions

– Regulated HACCP (U.S., Europe, other)Regulated HACCP (U.S., Europe, other)– Plant Security Plant Security – ISO/IQSISO/IQS

JUSTIFICATIONJUSTIFICATION

• Moral ObligationMoral Obligation– Protect health of customersProtect health of customers

• Market ExpectationMarket Expectation– Satisfy customers’ expectationsSatisfy customers’ expectations

• Value perceived for price paidValue perceived for price paid

JUSTIFICATIONJUSTIFICATION

• Economic/FinancialEconomic/Financial– ExternalExternal

• Customer RetentionCustomer Retention

• Brand ProtectionBrand Protection

• RecallsRecalls

– InternalInternal• Process Improvements/EfficienciesProcess Improvements/Efficiencies

– Raw materials Raw materials

– WasteWaste

– Non-conforming productsNon-conforming products

– Finished product Finished product

• Break Even PointBreak Even Point

• Return on investmentReturn on investment

Assess areas of known Assess areas of known risk to the organizationrisk to the organization

Assess resource Assess resource requirementsrequirements

Evaluate compatibility of Evaluate compatibility of departmental goals, departmental goals, objectives, and quality objectives, and quality policy statementspolicy statements

Confirm conformance to Confirm conformance to procedures and work procedures and work instructionsinstructions

Stay in touch with the Stay in touch with the organizational changesorganizational changes

PURPOSE OF INSPECTING & PURPOSE OF INSPECTING & AUDITINGAUDITING

Factual information for Factual information for management decisionsmanagement decisions

Determine effectiveness of Determine effectiveness of the organizational goalsthe organizational goals

Provide positive and Provide positive and negative feedbacknegative feedback

Satisfy regulatory, Satisfy regulatory, customer, and pre-contract customer, and pre-contract requirementsrequirements

Identify opportunities for Identify opportunities for improvement and corrective improvement and corrective action projectsaction projects