Ensuring Food Safety withQuality Management SoftwareNicole M. Radziwill, PhD, MBAVP Quality & SCM PracticeASQ Fellow & Editor, Software Quality ProfessionalSonduren FanarredhaSenior Product Marketing ManagerAngelica LaurianoSenior Account Executive – Food & Beverage QWijlTDHLMQ (2:17)

FSMA is a First Step Towards Risk-Based, Science-BasedIntegrated Food Safety & Quality Management“In a food safety system, decisions about resource allocation need to be made consistently inorder to maximize benefits and reduce risks while also considering costs.Food safety risk managers must consider a wide variety of concerns in their decision making,including the needs and values of diverse stakeholders, the controllability of various risks, thesize and vulnerabilities of the populations affected, and economic factors. Although thebalancing of diverse risks, benefits and costs is challenging, the lack of a systematic, risk-basedapproach to facilitate decision making can cause problems ranging from a decrease in publictrust to the occurrence of unintended consequences to society, the environment and themarketplace.”National Academy of Sciences. (2010). Enhancing Food Safety: the Role of the Food and Drug Administration.Committee on the Review of the Food and Drug Administration’s Role in Ensuring Safe Food. Institute of Medicineand National Research Council. Washington, D.C., National Academy Press.

You will learn about:1. Relationships between standards and guidelinesISO 22000:2015, FSSC 22000, ISO/TS 22002,PRPs, GMPs, and HACCP/HARPCObjectives2. How to QMS can ensure consistent and effectiveprocesses across sites and processes, and helpyou make the most of your CAPA process3. Why internal and supplier communication iscritical for the effectiveness of the quality program4. What blockchain is, and how IBM Food Trust isdemonstrating its value and utility right now5. How to get started/increase maturity with QMS& FSMS software

1: Food Safety & Qualitycore components, value propositions

“Food quality is the extent to which all theestablished requirements relating to thecharacteristics of a food are met Food safety is the extent to which thoserequirements relating specifically tocharacteristics or properties that have thepotential to be harmful to health or tocause illness or injury are met.”Alli, I. (2003). Food quality assurance: principles and practices. CRC Press.“Classical quality control methods onlyemphasiz[ing] hygienic quality of finalproducts are inadequate to control hazardsoccurring at early stages of the process.Allata, S., Valero, A., & Benhadja, L. (2017). Implementation of traceability and food safety systems (HACCP) underthe ISO 22000: 2005 standard in North Africa: The case study of an ice cream company in Algeria. Food control,79, 239-253.

Food Protection Risk MatrixFoodQualityFoodFraudMOTIVATED BYECONOMIC GAIN(economically motivatedadulteration/ NTENTIONALMOTIVATED BYHARM/DESIRETO DO HARMSpink, J., & Moyer, D. C. (2011). Defining the public health threat of food fraud. Journal of Food Science, 76(9), R157-R163.

The Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)Rule Adds Rigor to GFSI Recognized SchemesThings an FSMS can do: Establish and maintain ahygienic environmentManage preventive controlsto reduce nonconformancesKeep records that detailwhen activities dictated bythose controls were enactedThings a QMS can do: Howlett, G. (2016, May). The difference between HACCP and HARPC. A case of the Emperor’s New Clothes? Safefood360. Available from ween-haccp-and-harpc/Prevent or reduce recallsReduce defects and variationReduce product lossIncrease customersatisfactionDesign and develop newproducts

lsu fsma compliance datesFrom 0act

“Quality assurance has become acornerstone of food safety policy in thefood industry [which has] started toimplement integrated quality and foodsafety management systems.”Aung, M. M., & Chang, Y. S. (2014). Traceability in a food supply chain: Safety and quality perspectives. Food Control, 39, 172-184.

2: Quality Management for Food Safetyhow HACCP/HARPC, ISO 22000, ISO/TS 22002, FSSC 22000,PRPs, GMP & GFSI recognized schemes work together

GFSI Recognized Schemes printable-version 2.pdf FSSC 22000SQF Code Ed. 8BRC GlobalStandard for FoodSafetyBRC-IOP GlobalStandard forPackaging andPackagingMaterialsIFS Version 6CanadaGAPGlobal Red MeatStandard (GRMS)PrimusGFSStandardIFS PACsecureVersion 1IFS LogisticsVersion 2.1JFSMAsiaGAP

New Mechanisms for Trust &Competitive AdvantageIncorporation of QualityManagement & ContinuousImprovementGuidelines for Food SafetyManagement SystemsLegally MandatedRequirements for SafetyAntecedents ofSafety and Quality New Science Traceability/Blockchain IFS (QMS ENV SR) BRC (FSMS QMS) SQF Level 3(HACCP FSMS QMS) FSSC 22000 (FSMS) SQF Level 2(HACCP FSMS) FDCA (1938) FSMA (2011) PRPs (e.g. ISO 22002) GMPs (e.g. 21 CFR 110) HARPC (21 CFR 117) SQF Level 1

RelationshipBetween EHS,Quality, & FoodSafetyEHS role works to keep WORKERS & THEENVIRONMENT safe, without negatively impactingproduction speed or product quality.Quality role works to keep THE PRODUCT safe,while managing systematic, repeatable processesthat satisfy operations goals (e.g. yield) and productquality requirements (e.g. taste, value).

QFSQualityFood SafetyDalgiç, A. C., Vardin, H., & Belibagli, K. B. (2011). Improvement of Food Safety and Quality by Statistical Process Control (SPC) in Food ProcessingSystems: A Case Study of Traditional Sucuk (Sausage) Processing. In Quality Control of Herbal Medicines and Related Areas. IntechOpen.

FSMA &ISO 9001:2015Incorporate RiskBased ThinkingRisk-based thinking is introduced to makebetter decisions in uncertain environments: Reduce frequency of losses Reduce likelihood of losses Reduce costs of losses Improve response time Reduce stress Increase communication Enhance learning Capture opportunities for improvementFrom Willumsen, P., Oehmen, J., Rossi, M., & Welo, T. (2017). Applying leanthinking to risk management in product development. In Proc. 21st Intl. Conf.on Engr. Design (ICED 17), Vancouver, 269-278.

FSMA Cornerstone is Food Safety Plan (FSP)Walsh, C., & Leva, M. C. (2018). A review of human factors and food safety in Ireland. Safety Science.

HARPCHACCP is an internationallyrecognized standard for hazardanalysis to: Ensure sanitary conditions formanufacturing, processing, packagingand storagePrevent post-process contaminationDeliver safe, wholesome food with novisible deterioration in qualityHACCPHARPC is a FSMA-driven updateto HACCP that: Adds risk-based thinking and riskmanagementEmphasizes the need to continuouslymonitor and improve GMPs and PRPsGanjyal, G. M., & Coles, C. G. (2017). Preventive controls for human food: an overview.

international standardprescribed by FSMA (21 CFR Part 117)HACCPHARPCAssumes no PRPs in placeAssumes PRPs in place Process Controls Cooking, refrigerationControls during storage ortransportBiological, Chemical, &Physical Hazards Supply Chain ControlsAllergen Controls Cross-contact & labeling Sanitation Controls Radiological (e.g. contaminated soil)Economically Motivated (e.g. fillers)GMPs are regulated and PRPs are not; 21 CFR Part 117 specifies required GMPsFood fraud, under FDA, only addresses hazards that would impact food safety; intentionalsabotage by an insider must also be consideredYou can refer to all Preventive Controls in your FSP as Critical Control PointsFood Safety Plan Parameters/Values can be categorical (Pass/Fail) – unlike CCPs

Allata, S., Valero, A., & Benhadja, L. (2017). Implementation of traceability and food safety systems (HACCP) under theISO 22000: 2005 standard in North Africa: The case study of an ice cream company in Algeria. Food control, 79, 239-253.

Is it a CCP, PRP, or oPRP?A Decision TreeFrom 15Allata, S., Valero, A., & Benhadja, L. (2017). Implementation of traceability and food safety systems (HACCP) under theISO 22000: 2005 standard in North Africa: The case study of an ice cream company in Algeria. Food control, 79, 239-253.

The Process isthe CenterpiecePreventive Controls form thebasis of the control plan, fromwhich individual recordsregarding monitoringrequirements are identifiedTraceability can be assured byexamining all steps of theprocess and devising arecordkeeping process thatincorporates all factors from PCs(Traceability does not span full supply chain)

FMEA Can Be Used to Identify PCsScipioni, A., Saccarola, G., Centazzo, A., & Arena, F. (2002). FMEA methodology design, implementation and integration with HACCP system in a foodcompany. Food Control, 13(8), 495-501.

“HACCP areas posing the greatest risk to food safety were verification,recordkeeping and correction action. Nonconformities were found inHACCP systems which worked for several years. This raises the questionwhether food producers who implemented HACCP system really guaranteecomplete food safety incorporation of FMEA within the verificationprocedure of HACCP system may be a convenient tool for better foodsafety assurance.”Trafialek, J., & Kolanowski, W. (2014). Application of Failure Mode and Effect Analysis (FMEA) for audit of HACCP system. Food Control, 44, 35-44.

3: Importance of Communicationmaintaining transparency and visibility across organizationalboundaries in the supply chain can prevent errors & disasters

“An on-site audit [requires gathering up-to-date information,]communication of results and [sharing] observations amongteam members and with the auditee.”“QMS can reduce the appearance of defective products improve internal communication, increase customer’ssatisfaction, and therefore [market share, increasing]opportunities for expansion in new markets.”Kotsanopoulos, K. V., & Arvanitoyannis, I. S. (2017). The role of auditing, food safety, and food quality standards in the foodindustry: A review. Comprehensive Reviews in Food Science and Food Safety, 16(5), 760-775.

Quality Eventsindicate that quality & foodsafety goals are not beingmet and action is needed Nonconforming productIncidents/near missesCustomer complaintsRecalls/warranty callsDeviations (from SOP)Out-of-control Action PlansIndustry-specific events (e.g. recalls)Serious orsystematic?not reallycontainmentyesCAPA

Quality Controlsto prevent or correct unwantedor unexpected change stability and consistency CalibrationsMaintenanceInspectionsAllergen & sanitation controlsSupply chain controlsProcess validationMistake-proofingIn-situ process monitoringEnvironment monitoringProfessional testing/competencyassessmentTraining programs and remindersCorrective actions takenInformation security/network security

Corrective Actionsare the CoreMany different kinds of corrective actionsare required to maintain food safety and quality,while continuously improving: Supplier CAR Customer CAR CAR for nonconforming product CAR for deviation(s) from process CAR for inadequate PRP CAR for allergen or sanitation issue CAR for supply chain controls CAR for inadequate/ineffective CCP/PC Internal Audit CAR Supplier Audit CARIFS. (2017, November). IFS Food: Standard for auditing quality and food safety of food products. Version 6.1.

Soares, N., Martins, C., & Vicente, A. A. (2016). Food safety management system EN ISO 22000: 2005. Available 1822/56460/1/document 29693 1.pdf

Soares, N., Martins, C., & Vicente, A. A. (2016). Food safety management system EN ISO 22000: 2005. Available 1822/56460/1/document 29693 1.pdf

“An accurate and complete transmission of informationbetween the food chain and external stakeholders willensure, in a more efficient way, the identification and controlof all relevant risks to food safety.” Share information about food safety throughout the food chain and inside the organizationInform the Food Safety Team (FST) of any change that may compromise food safetyProvide faster update(s) and distribution of new documentation, [provides automatic] evidence of [changes] Soares, N., Martins, C., & Vicente, A. A. (2016). Food safety management system EN ISO 22000: 2005. Available 1822/56460/1/document 29693 1.pdf

4: Emerging Technologies for Traceabilityhow IBM Food Trust has demonstrated thatHyperledger blockchain can add value in this industry

TraceabilityAung, M. M., & Chang, Y. S. (2014). Traceability in a food supply chain: Safety and quality perspectives. Food Control, 39, 172-184.

Blockchain Depends on Hashing Convert an object to a sequence of letters and numbers from which you can’trecover the original objectLots of hashing algorithms:– MD5, SHA1, CRC32, SHA256, SHA512, XXHASH32, MURMUR32Goal is to “minimize collisions” phrase - "Here is my password" digest(phrase, "crc32")[1] "61835063" digest(phrase, "murmur32")[1] "611907fc" digest(phrase, "md5")[1] "6303034c25d4e1763f2dd30341ddb0d5"

Hash My Cat kitty - readJPEG("kitty.jpg") digest(kitty, 5ae2b282bf81dc0182f7552f60d"

Hash My Cat1234

digest(kitty, 5ae2b282bf81dc0182f7552f60d"Small changes in an object Large change in a hash “Break” a blockchain digest(kitty2, 5ae2b282bf81dc0182f7552f60d" digest(kitty3, a25c76aec5f3aa17e7e8b184362" digest(kitty4, 5ae2b282bf81dc0182f7552f60d"

Blockchain Data StructureFrom 016

Blockchain Value Propositions Immutable record of peer-to-peer transactionsRelief from a central authorityTransparent recordkeepingPrivate channels to protect data privacyImmediately auditable Requires modeling: ParticipantsAssetsTransactionsConditions for Transactions(“Smart Contracts”)

“ in the end it is all about howorganizational insights and knowledgeare turned into strategic insights andadvantage.”-- Harry Hertz, Director Emeritus Baldrige Performance Excellence Program

5: Advancing Your EHSQ Maturitywith Softwaremoving to the next level

Leavoy, P. (2013). The Essential Guide to the Food Safety Modernization Act (FSMA): Everything You Need to Know AboutAmerica’s Coming Food Safety Revolution. Intelex Insight Report.

0GMPs(PROCESS)SanitationControls AllergenControlsQMS FSMSSOLID FOUNDATIONAdapted from FDA. (2016). Key Facts about Preventive Controls for Human Food (PCHF). Available ulation/fsma/ucm584807.pdfMonitoringCorrective Action ProceduresVerificationRecords

Software Support for Food Safety & QualityRequirementApplication TypeTasksDocument Control & TrainingManagementDocument Control &Training ManagementAlways know which SOPs and work instructions are current, managereview and approval paths, make sure your PCQI(s) have up-to-datequalifications (21 CFR 117.8), see which staff need to be updatedInternal AuditsAudit & InspectionManagementMaintain checklists for ensuring PRPs/GMPs are met, manage andmonitor inspections, monitor allergens, monitor process controls (, keep track of receiving and loadingMaintain HACCP/HARPCControls & RecordsProcess Hazard Analysis;Control Plan; Monitoring &MeasurementIdentify process steps, hazards, and control plans; record calibration,maintenance, inspection, and preventive controls tasksManage Nonconformances &ComplaintsNonconformanceReporting (NCR);Customer ComplaintsTrack customer, internal, and supplier corrective nonconformances &complaints; automatically escalate according to rules & remind peoplewhen tasks and actions are upcoming or overdueManage Corrective Actions &CorrectionsCorrective and PreventiveAction (CAPA)Track customer, internal, and supplier corrective actions and identifytrends and patterns; keep track of minor (non-event) CorrectionsSupplier Preventive ControlsSupplier RelationshipMgmt, Supplier CAPASee which suppliers have failed audits, expired documents, orcorrective actions that need attention; provide supplier portalsChange ManagementManagement of ChangeKeep track of improvements and adjustments to processes and

Step 1:Computerization & ConnectivityStep 2:Visibility & TransparencyStep 3:Predictive CapabilityStep 4:Adaptability & Self-Learning

Step 1:Computerization & ConnectivityStep 2:Visibility & Transparency?Step 3:Predictive CapabilityStep 4:Adaptability & Self-Learning

Sonduren FanarredhaSr. Product Marketing Manager, Quality & SupplierModerator

Challenges Now & in theFuture1Siloed data is insufficient to identify trendsand make informed decisions using realtime insights within the organization and its32with ever changing standards, industryrequirements and regulations*Source: Intelex Quality Survey December 2016systems and lack of integration betweenprocesses in the organization and throughsupplierssupplier ecosystemEnsuring all operations are in ComplianceReduced Productivity due to disparate4Difficult to build a Culture of Qualitywithout the right tools and partners

Intelex is the leader in EHSQsoftwareMost organizations begin their EHSQ journey with the objective of compliance in mind.Intelex helps you achieve more than compliance and cost avoidance by accelerating yourEHSQ maturity progression, leading to business transformation.

Intelex QMS & PlatformModernize and simplify your QMSAllianceIntegrated QMSRich ReportingMobilePower of CloudLeverage the power ofEngagement andCollaboration to unlock thefull potential of your QMSIntegrated EHSQ solution toconnect applications acrossour platform for a fullyautomated and tailoredexperienceUse preformatted andcustom reports, graphsand scorecards for at-aglance insights on allaspects of your business.Streamlined and simpleuser interface on mobile toput Intelex into the handsof people that matter mostOur cloud based EHSQsolution provides quickimplementation time andcost savingsIntelex is the only EHSQ software with a truly integrated qualitymanagement system to help you manage the breadth of your business

Transform to Survive

Angelica Lauriano - PanelistSenior Account Executive – Food & BeverageIntelex [email protected]: Angelica Lauriano760-500-8066

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Supplier CAR Customer CAR CAR for nonconforming product CAR for deviation(s) from process CAR for inadequate PRP CAR for allergen or sanitation issue CAR for supply chain controls CAR for inadequate/ineffective CCP/PC Internal Audit CAR S