Food Industry Use of Risk-Based Inspections for Corporate ...mddb.apec.org/Documents/2014/SCSC/WKSP/14_scsc_wksp_010.pdf · Corporate Oversight and Governance Submitted by: General

___________________________________________________________________________

2014/SCSC/WKSP1/010

Food Industry Use of Risk-Based Inspections for Corporate Oversight and Governance

Submitted by: General Mills

Workshop on Improved Food Inspection Capacity Building Based on Risk Analysis

Seoul, Korea21-23 May 2014

11

22

Food must be trustworthy

Goals for TodayGoals for Today

• Brief Overview of General Mills Global Business• Elements of Strong Governance & Oversight• Policy and Standards • Levels of audit & inspection used in risk-based prioritization

33

• Brief Overview of General Mills Global Business• Elements of Strong Governance & Oversight• Policy and Standards • Levels of audit & inspection used in risk-based prioritization

General Mills OverviewGeneral Mills Overview

44


55


66


77


88

HACCP HACCP

• Pioneered in the 1960's by Pillsbury– First used when foods were developed for the NASA space program

• U.S. National Advisory Committee published seven HACCP principles in 1989• Codex Alimentarius published HACCP principles in 1993• Adopted by many food processors and governments

99

9

• Pioneered in the 1960's by Pillsbury– First used when foods were developed for the NASA space program

• U.S. National Advisory Committee published seven HACCP principles in 1989• Codex Alimentarius published HACCP principles in 1993• Adopted by many food processors and governments

1010

What Does World Class Food Safety What Does World Class Food Safety Governance Look LikeGovernance Look Like

IntegratedIntegratedSafety Management Safety Management

SystemSystem

IntegratedIntegratedSafety Management Safety Management

SystemSystem

Strong Culture & Strong Culture & LeadershipLeadership


11Appropriate Appropriate

StructureStructureAppropriate Appropriate

StructureStructure

22

Processes & ActionsProcesses & Actions

33Learning & Learning &

DevelopmentDevelopmentLearning & Learning &

DevelopmentDevelopment

44

1111

l Management commitment

l Policies and principles

l Goals, objectives and plans

Culture of reporting Safety incidents

l Line management accountability and responsibility

l Safety personnel

l Integrated organization structure

l Motivation and awareness

l Effective communication

l Incident investigation

l Procedures and performance standards

l Inspections and audits

l Organizational Capability and Capacity Needs Assessment

l Education, Training and Development



1Appropriate Appropriate

StructureStructureAppropriate Appropriate

StructureStructure

2

Processes & ActionsProcesses & ActionsProcesses & ActionsProcesses & Actions

3Learning & Learning &

DevelopmentDevelopmentLearning & Learning &

DevelopmentDevelopment

4

1212

Food Safety OverviewFood Safety Overview

1313


1414


1515


1616


1717

1818

1919

Effective Inspections, Audits and/or Effective Inspections, Audits and/or Investigations require Multifaceted ApproachInvestigations require Multifaceted Approach

Establish Policy, Establish Policy, Standards & Standards &

GuidanceGuidance

Establish Policy, Establish Policy, Standards & Standards &

GuidanceGuidanceCapacity Building,

Training & Educations

Capacity Building, Training & Educations

Risk Ranking & Risk Ranking & Assessment 1st Assessment 1st Level Level –– Facility Facility

based based InspectionsInspections

Risk Ranking & Risk Ranking & Assessment 1st Assessment 1st Level Level –– Facility Facility

based based InspectionsInspections

11stst & 2& 2ndnd Level Level ––Company based Company based

Inspections & Inspections & AuditsAudits

11stst & 2& 2ndnd Level Level ––Company based Company based

Inspections & Inspections & AuditsAudits

3rd Level 3rd Level –– 3rd 3rd Party Accredited Party Accredited

AuditsAudits

3rd Level 3rd Level –– 3rd 3rd Party Accredited Party Accredited

AuditsAudits

2020

Robust Global Policy, Standards and Guidance• Informed by Laws and Regulations • Developed with broad Stakeholder Input• Signed by Senior Leadership

Capacity Building to Assure Understanding & Building Effective Control Programs• Policy changes – typically 12 months to fully implement• Outreach requires multiple touches and approaches – on-line materials, webinars

Risk-based Verification Activities• All “auditable entities” conduct self-assessments• Corporate teams undertake risk-based inspections• 3rd Party Inspections & Audits provide Independence • Regulatory inspections verify control programs in place & effective

Food Safety System Core ElementsFood Safety System Core ElementsFood Safety System Core ElementsFood Safety System Core Elements

11

22

33

Risk Ranking PhilosophyRisk Ranking Philosophy

• Tool to Quantify Food Safety Risk– Inherent – Plant Controllable

• Prioritize Resources– People– Capital

• Measure Progress

2121

• Tool to Quantify Food Safety Risk– Inherent – Plant Controllable

• Prioritize Resources– People– Capital

• Measure Progress

Internal Audit

External Audit

Data Inputs

• Allocation• Prioritization• Food Safety Risk Assessment (FSRA) plans

Resources

Risk Ranking ProcessRisk Ranking Process

2222

Risk Grid Generated

External Audit

Microbiology

Regulatory

• Allocation• Prioritization• Food Safety Risk Assessment (FSRA) plans

GMI Facility Risk Ranking ToolGMI Facility Risk Ranking Tool• Opportunity = Actual risk – Plant lowest possible• Opportunity is plant controllable risk• Used to build improvement targets

2323

GMI Owned Audit PlanGMI Owned Audit Plan

Critical Food safety or regulatory condition leading to likely/actual contamination or major deviation for GHP’s or GMI policy. Follow-up documentation required.Finding Gap(s) noted during physical inspection or program/record review. Does not reach critical finding status. Follow-up documentation required.

Supply Chain Complexity (cases produced, type of products, distribution reach, single source plant)Previous Audit & Certification ResultsInternal/External Activity

Audit Finding CategoriesAudit Finding CategoriesAudit Finding CategoriesAudit Finding Categories Audit ConsiderationsAudit ConsiderationsAudit ConsiderationsAudit Considerations

2424

• Most GMI facility receive a independent Corporate/ 2nd party audit annually. Consideration impact length of audit. • All GMI facilities received a Corporate-Managed 3rd party GHP audit or Food Safety System Certification (FSSC) audit.

Finding Gap(s) noted during physical inspection or program/record review. Does not reach critical finding status. Follow-up documentation required.Observation Insignificant deviation form requirements. Isolated or minor food safety gap(s). No follow-up documentation required.

Internal/External ActivityPlant & Leadership Team HistoryAuditor Judgment*Audit plans are approved and signed by senior leadership. Summary reports issued annually.

GMI 3GMI 3rdrd Party CertificationParty CertificationGlobal Global Food Safety Initiative (GFSI)Food Safety Initiative (GFSI)

Reduce food safetyrisks

Manage cost in the supply chain

GFSI Mission & ObjectivesGFSI Mission & ObjectivesGFSI Mission & ObjectivesGFSI Mission & Objectives GFSI Benchmarked SchemesGFSI Benchmarked SchemesGFSI Benchmarked SchemesGFSI Benchmarked Schemes

2525

Developcompetencies and capacity building

Knowledgeexchange and

networking

Collaboration between some of the world's leading food safety experts from retail, manufacturing and food service industry, as well as service providers associated with the food supply chain. Based on globally recognized standards such as HACCP.GFSI is a non-profit foundation.

Raw Materials Example:Raw Materials Example:Risk Assessment ProcessRisk Assessment Process

2626

Audit and Inspection ProcessAudit and Inspection Process

PrePre--WorkWorkPrePre--WorkWork Plant AuditPlant AuditPlant AuditPlant Audit Follow UpFollow UpFollow UpFollow Up

2727

l Previous audits –internal and 3rd partyl Incident historyl Management Changesl Regulatory & Consumer Contacts

PrePre--WorkWork

l Physical Facility Inspectionl Program Reviewsl Documentation Reviewl Training Recordsl Close-out Meeting

Plant AuditPlant Audit

l Issue Audit Report l Track Corrective Action Completionl Update Audit Database

Follow UpFollow Up

Understanding Where a Facility/Company is on the ContinuumUnderstanding Where a Facility/Company is on the ContinuumUnderstanding Where a Facility/Company is on the ContinuumUnderstanding Where a Facility/Company is on the Continuum

Food Safety Management ContinuumFood Safety Management Continuum

44

2828

Level 0:Transactional

No SpecificationsNo Audits

No Approval Procedures

Level 0:Transactional

No SpecificationsNo Audits

No Approval Procedures

00Level 1:

Customer/Buyer Relationship

Technical Data SheetSupplier Survey

Approval Procedures

Level 1:Customer/

Buyer RelationshipTechnical Data Sheet

Supplier SurveyApproval Procedures

11Level 2:

Core SuppliersTechnical Data Sheet

SpecificationsSupplier Surveys

Approval Procedures3rd Party Audits

Level 2:Core Suppliers

Technical Data SheetSpecifications

Supplier SurveysApproval Procedures

3rd Party Audits

22 Level 3:Partnerships



Approval Procedures3rd Party Audits2nd Party Audits

Supplier ScorecardsExternal Technical

Experts

Level 3:Partnerships



Approval Procedures3rd Party Audits2nd Party Audits

Supplier ScorecardsExternal Technical

Experts

33 Level 4:Industry Leaders

PartnershipsCore Suppliers



3rd Party Audits2nd Party Audits

Supplier ScorecardsInternal Technical Experts

Training & EducationFood Safety Investment

Level 4:Industry Leaders

PartnershipsCore Suppliers



3rd Party Audits2nd Party Audits

Supplier ScorecardsInternal Technical Experts

Training & EducationFood Safety Investment

44

Share Many Common ElementsShare Many Common Elements

“Regulated Industry”

“Regulators”

Expectations Policy & Standards Laws & RegulationsEducations &

AwarenessGuidance Documents &Training Outreach & Guidance Documents

2929

Educations & Awareness

Guidance Documents &Training Outreach & Guidance Documents Skills Needed

Process & Systemsto Produce Safe Food Knowledge & Critical Thinkingto Assess Food Safety Control ProgramsRisk-based Assessment

Qualitative &Quantitative Data Qualitative & Quantitative Data Outcome

ComplianceSafe food for Consumers ComplianceVerification of Control Programs that lead to Safe food for Consumers

Mission Accomplished!Mission Accomplished!

The job isn’t finished until our BRAND, our

PRODUCTS is safely consumed by

our consumers

3030

The job isn’t finished until our BRAND, our

PRODUCTS is safely consumed by

our consumers

Your Brand is your REPUTATION

Thank You!Thank You!

3131

Contact InformationContact Information

WeeNee NgHead of Regulatory Affairs – Asia / Middle East / Africa Region

General Mills 168 Robinson Road . #26-01Capital Tower . Singapore 068912Phone: (65) 6305 6680Mobile: (65) 9856 6699Email: [email protected]

WeeNee NgHead of Regulatory Affairs – Asia / Middle East / Africa Region

General Mills 168 Robinson Road . #26-01Capital Tower . Singapore 068912Phone: (65) 6305 6680Mobile: (65) 9856 6699Email: [email protected]