Validation And Verification: A Practical, Industry-driven .
General interest paperValidation and Verification: A Practical,Industry-driven Framework Developed toSupport the Requirements of the FoodSafety Modernization Act (FSMA) of 2011Robert E. Brackett,1* Wilfredo Ocasio,2 Kevin Waters,2 Jeffrey Barach3 and Jason Wan1123Institute for Food Safety and Health, Illinois Institute of Technology, 6502 South Archer Road, Bedford Park, IL 60501, USAThe National Food Laboratory LLC, 2441 Constitution Drive, Livermore, CA 94551, USABarach Enterprises LLC, 2904 Melanie Lane, Oakton, VA 22124, USAABSTRACTA joint workshop of industry and academia, The Preventive Controls Summit 2013 — Validation and VerificationPrinciples, was held in October 2013 to gather input and current thinking on the validation and verification practicesindustry needs in order to comply with new Food Safety Modernization Act (FSMA) regulations. The workshopdiscussions resulted in development of a framework approach that proposes several activities that are important toachieve FSMA food safety goals and regulatory requirements. These include: (1) using science-based tools to constructand validate effective preventive controls for hazards, (2) considering validation and verification as separate programs,and (3) managing the food safety system with appropriate verification activities and conscientious staff that canrecognize and adapt when change is needed. The framework strategy was built around the background teachings ofthe Hazard Analysis and Critical Control Points (HACCP) validation and verification principles, industry experiencesand the information provided in the proposed FSMA rules. This white paper describes such a framework and suggestshow food industry companies can meet Food and Drug Administration (FDA) expectations regarding FSMA validationand verification activities. With over 150 industry and academia participants sharing their ideas and input at breakoutsessions, this framework represents a broad spectrum of current thinking regarding this important subject.PREFACEWhy the Summit and Framework?PurposeThe purpose of this white paper and framework is to assistfood companies in meeting the validation and verificationrequirements that are expected to be promulgated inresponse to the Food Safety Modernization Act. Experiencewith Hazard Analysis Critical Control Point (HACCP)systems has shown that to build an effective Food SafetyManagement System that is scientifically and technicallysound, it is essential to have scientific evidence of preventivecontrol effectiveness (validation) and to assess compliancewith the Food Safety Plan and the supporting programs(verification). Regardless of size, all establishments needto validate and verify the activities described in their FoodSafety Plan and the risk-based preventive controls that havebeen or will be implemented to control food safety hazards.A framework approach is offered to provide the user with aset of tools and guidance will make it easier to accomplishCorresponding author: Phone: 1 708.563.1577; E-mail: rbrackett@iit.edu410Food Protection TrendsNovember/Decemberthe tasks of validation and verification. The frameworkbuilds on existing industrial practices and guidance on howto conduct and document validation and verification tasks.ApplicabilityThe production of safe food is the responsibility of foodestablishments. This means that not only must companiesmeet minimum regulatory requirements but they shouldendorse and establish programs and practices that exceedthe basic requirements. Companies recognize that thisenhanced level of responsibility is not only good business,but is “the right and responsible thing to do.” This whitepaper is intended to offer practical guidance to assist allsize food facilities to meet their validation and verificationrequirements under the Food Safety ModernizationAct (FSMA) regulations and to give insight into howcompanies can build world class food safety systems thatmeet regulatory requirements, minimize or eliminatefood safety risks, and demonstrate enhanced stewardship.
Facilities initiating a new Food Safety ManagementSystem to meet FSMA requirements, as well as thosecurrently implementing voluntary HACCP, should benefitfrom the approaches and practices described here to helpthem develop a new Food Safety Management Systemor to upgrade their current system so as to be betterpositioned to address FSMA regulations and enhancethe safety of their products. It is important to note thatthis document is not a one-size-fits-all guide. Eachcompany must decide on its own what is the best way todevelop and implement the operational and regulatoryprograms needed to address validation and verificationrequirements. For small- to medium-size companies,this may be especially challenging and could mean theywill need to seek outside expertise when establishing theprograms for their Food Safety Management System.INTRODUCTIONThe Food Safety Modernization Act (FSMA) of 2011and the proposed regulations (9) gives the Food and DrugAdministration (FDA) a mandate for regulatory oversightof food safety systems that scientifically addresses hazardsand that puts greater emphasis on preventing foodborneillness rather than just managing food safety failures. Theintended outcome of these new regulations is to furtherensure the United States’ food supply is safe by shifting thefocus away from responding to contamination and towardpreventing it. FSMA advances the principles and practicesof the globally accepted HACCP systems approach to a newlevel of managing food safety issues. Like HACCP, FSMA isa risk-based safety management approach focused on hazardanalysis and prevention of problems in order to ensurethe production of food products that are safe to consume.They are both based on a common-sense application oftechnical and scientific principles to the food productionprocess from harvest to production and to consumption.The seven principles of HACCP are incorporated into theFSMA framework and are applicable to all aspects of foodproduction that FDA regulates. FSMAcarries forward the most basic conceptunderlying HACCP, that prevention isfar more effective than inspection.By themselves or with the assistanceof others, food establishmentsshould have sufficient informationconcerning the food and the relatedproduction procedures they are usingto be able to identify where and howfood safety problems may occur. Ifthe “where” and “how” are known,risk-based prevention becomesmanageable. As noted early on withthose adopting HACCP, finishedproduct inspection and testing is notthe most effective way to ensure food safety. A modernFood Safety Management System deals with hazard analysisand control measures (resulting in specific process controls,operational controls, and prerequisite programs) affectingthe safety of ingredients, the processes, and the product.The objective is to use risk-based decisions, based on soundscience, with a systems approach to make the product safeand to enable management to prove its safety.Many in the food industry are already familiar withHACCP and its principles; however, some are seekingadditional resources to help them upgrade their FoodSafety Management System to conform with FSMAregulations. Experience with HACCP has shown that twoof the system’s operational activities are typically difficultto understand and can be complicated to put into practice.The hazard analysis and the assignment of preventivecontrols require a level of food safety experience andsignificant knowledge of hazards and controls. Theactivities of validation and verification are likewisedifficult concepts to grasp and present a challenge tothe food safety team. The hazard analysis activity andhow it is achieved is sufficiently described in availableliterature and technical publications; however, industryhas recognized the need for additional assistance andguidance with FSMA validation and verification. Industryleaders at the Institute for Food Safety and Health(IFSH) and The National Food Laboratory, LLC (TheNFL) assembled a workshop, The Preventive ControlsSummit 2013 — Validation and Verification Principles,on October 9, 2013, to provide helpful guidance toassist industry with the understanding, establishment,and implementation of the principles of validation andverification in development of FSMA food safety plans.VALUE OF A FRAMEWORK APPROACH WITHMANAGEMENT INVOLVEMENTHACCP principles were first adopted by the industryand subsequently incorporated into U.S. and internationalregulatory schemes. This shifted theprimary food safety focus awayfrom the activities of regulatoryinspection to a more comprehensive“systems approach” that utilizes thepower of prevention to mitigatefood safety hazards. Although thesystems approach is more complex,it is more effective than a mode ofaction that reactively finds and fixesproblems. Experience with manyyears of HACCP implementation hasshown that validation and verificationactivities remain somewhat difficultto understand and manage becausetheir functions are often interpretedfoodprotection.orgFood Protection Trends411
differently than intended. The food safety team mayfind these concepts hard to grasp and conclude thatit is difficult to derive a comprehensive Food SafetyManagement System that operates effectively. In simpleterms, difficulty is generally related to: (1) the distinctionbetween monitoring procedures and verificationactivities and; (2) the differences between validationand verification activities and actions. Since validation isgenerally described as one of the activities of verification,the two become intertwined and the distinction betweenthe two can become vague. This ambiguity can result inconfusion and an inappropriate food safety plan.The framework approach presented here is a way todeconstruct the two activities (validation and verification)into simple language that allows even inexperiencedpersons to understand what needs to be done andto assemble resources, both internal and external, toaddress the tasks. A framework can convey a systemspathway describing what tasks to do, how to go aboutdoing them and how these actions make the Food SafetyManagement System more effective. A framework can alsoremove barriers to understanding and implementation,as well as assist management with proper training andtask inspection. There is value in considering these twoactivities within the context of a systems structure. Otherindustries have considered applying system engineeringapproaches to enhance safety. Nancy Leveson (19)has proposed the application of system engineeringto pharmaceutical safety, with potential outcomes ofenhancing the safety of current drugs while at the sametime encouraging the development of new drugs.Adapted from graphic by John Helferich, Engineering Systems Division, Massachusetts Institute of Technology (MIT)FIGURE 1. The food safety management system: Systems–Theoretic based design showing a hierarchical safety control structure412Food Protection TrendsNovember/December
The FSMA shifts the food safety focus away fromreaction and response and toward prevention, so thatprudent preventive measures can be built into all partsof the Food Safety Management System. Following aframework can guide development of system componentsand provide ongoing improvements in safety by adoptingproven safety strategies and addressing structuralconstraints. In order for the system to be effective and tofunction properly, all managers must be deeply committedand engaged with all aspects of the program. One may ask,“Who is responsible for the safety of products produced?”As was confirmed by the Summit participants, severallevels of employees (corporate management, supervisorsand lineworkers) set the tone and carry out the foodsafety functions that lead to a first class food productionoperation. For validation and verification activities, thesame is true. It takes: (1) corporate managers to set thepolicies and standards, define accountability, and identifythe roles of all, and (2) supervisors and line workers toimplement the programs and ensure that the functionsare effective and are carried out properly. Generally oneperson has ownership of the food safety program andpolicy for the company. This individual’s role is oversightof establishment and effectivenessof the system, implementation,management of operations, changemanagement, and setting a goal ofcontinuous improvement. Manycompanies have assigned this role toa manager with a title such as VicePresident (VP) of Food Safety orFood Safety Coordinator.One often overlooked means ofachieving a truly dynamic and resilientsystem is that of providing managersand workers with information aboutchanges occurring with food safetyhazards and emerging risks, thusallowing them the ability to developnew means of addressing these newvulnerabilities. Information sharedacross all levels of the Food SafetyManagement System about new risks,changes in the production process,management changes, consumercomplaints, production failures, andnear-misses enhances the continuousimprovement of the processby triggering revalidations andverification tasks. The applicationof system engineering practicesthrough the required verificationactivities will also improve foodsafety system outcomes.Figure 1 shows the integration of management into aFood Safety Management System, a Systems-Theoreticbased design. Safety is enhanced through managerialinvolvement and decisions regarding process changes.Managers are an integral part of the Food SafetyManagement System. Thus, validation and verificationof the system must include the manager’s role andresponsibilities in the Food Safety Management System.An important aspect is the need for management to beincluded in the Food Safety Management System andfor processes to be routinely validated and verified withthe collection of data and documentation regarding theperformance of the system. Part of food safety verificationis the opportunity for continuous improvement to avoidfuture failures. With the tools of corrective actions fornon-conformance occurrences and record keeping withreview, management can continually revise and improvethe food safety system making it more effective. Progresson improving safety therefore ultimately depends onproviding workers and managers with the information anddata about changing vulnerabilities and then giving themthe ability and means for meeting these challenges (14).VALIDATION ANDVERIFICATIONThe National Advisory Committeeon Microbiological Criteria for Foods(NACMCF) defines verificationas those activities, other thanmonitoring, that determine thevalidity of the HACCP plan andverify that the system is operatingaccording to the plan (21). There aretwo objectives to the 6th HACCPprinciple: (1) to determine if theplan is valid, i.e., that it is adequate tocontrol hazards associated with theproduct when the plan is properlyimplemented, and (2) to verify thatthe HACCP system is operatingaccording to the plan, i.e., that theplan is being followed.It is important to realize thatapplication of this principle includesa wide array of activities in twomajor areas, validation of efficacyand verification of compliance. Thefact that the NACMCF definition ofverification includes the activitiesof validation has resulted in muchconfusion about which activitiesare verification and which arevalidation. Perhaps changing thenames would lessen the confusion.foodprotection.orgFood Protection Trends413
Nevertheless, it will be helpful to many to considervalidation and verification as distinct functions. Therole and position of these operations in a FSMA foodsafety system is shown in Fig. 2. They help complete thesystems approach and, as shown, have a major role in theinitiation, implementation, reanalysis, and audit aspectof system improvement.Initial validation of the food safety system (FSS)determines if the system is doing the right thing andeffectively controlling the hazard. Once the food safetysystem is initiated and operational, verification of thesystem ensures that the system has been implementedcorrectly and followed. Validation activities that resultfrom reanalysis and verification audits supply thecontinuous improvement of the food safety system. Thefoundation of the Food Safety Management System is theCorporate Food Safety Policy and in turn a functioningFood Safety Culture. Management’s job is both toestablish the environment for a strong functioning foodsafety system and to ensure personnel help to completethe cycle depicted within the food safety system so thatthe Food Safety Management System always controls thefood safety hazards.ValidationValidation consists of establishing and documentingthe scientific evidence that food safety hazards are beingeffectively controlled through preventive means. Thatproof can come from a variety of sources (e.g., scientificliterature, in-house studies, mathematical modeling,and regulatory resources). An “initial validation” takesplace as the food safety system is being developed andduring its initial implementation. The goal is to ensurethat the food safety system is valid (i.e., actually works)for controlling food safety hazards associated with theoperations, ingredients, process, and product. Theimportance of selecting and establishing the correctscience-based procedures during the validation processFIGURE 2. Validation and verification of the food safety management system414Food Protection TrendsNovember/December
cannot be overstated. It does no good to monitor andverify ineffective control measures. Often, small- to midsized companies will not have sufficient internal expertiseto determine the scientific basis for their validationprocesses. To complement internal staff, externalexpert guidance and outside resources may be neededfor complex validation activities. In documenting thescientific basis for control, the validation team establishesa validation plan to be used for validating the food safetysystem (Appendix A-1). This information forms part ofthe structure and support documentation that regulatoryagencies will seek as they inspect the company’s foodsafety plan.Validation, then, is considered an ongoing componentof the system that is set in place initially, and one thatmay need revision if certain aspects of the operations,management, food safety objective, ingredients, or theprocess changes. A significant change or a scheduledreview (the proposed FSMA rule says at least once every3 years) could trigger a “reanalysis” of the safety needsto adjust the parameters of control (such as modifyingcritical limits because of discovery of a more resistantpathogen). The reanalysis could lead to a new revalidationthat replaces the initial validationin response to new informationsuggesting the system needs to berevised (see Appendix A-2, and itslist of reasons for reanalysis). Thus,the primary objective of validationis to: (1) set the initial scientificbasis for the preventive controls’ability to effectively control thehazards, and (2) make adjustmentsin the controls, if needed, to ensurethe food produced is safe. Thistype of systems approach, beingconducted before, during, andafter a scheduled time frame, isvery effective in establishing andmaintaining food safety as well as inproviding continuous improvement.Some well-known and establishedrules for achieving food safety, oftenused as the basis for process controls,are referred to as “safe harbors.” Theproper use of safe harbors can givelegitimacy to a control measure, butcaution is advised to ensure that if asafe harbor (see examples in FDA’sJuice or Fish and Fishery ProductsHazards and Control Guides) (10,11, 12, 24, 25) is used, it is seen as astarting point that needs to be carefullyreviewed for applicability to thespecific product and process. The validation team must be sureto connect the safe harbor and the process details together forit to be valid and for it to achieve “doing the right thing” fromthe standpoi
These include: (1) using science-based tools to construct and validate effective preventive controls for hazards, (2) considering validation and verification as separate programs, and (3) managing the food safety system with appropriate verification activities and conscientious staff that can
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