Predictive Riskbased Evaluation for Dynamic Import Compliance Targetin - PDF document

Predictive Riskbased Evaluation for Dynamic Import Compliance Targeting(PREDICT)Updated February 2014 Number of Import Entry LinesElectronically Screened per Fiscal Year Since 2002* Projected 5,000,00010,000,00015,000,00020,000,00025,000,00030,000,00035,000,000 foods Firms,productcodeEntry Filer OASISElectronic TransactionsImport Entry Lines Review? FDA District Entry ReviewerYes Division of Food Defense Targeting OK? Yes “May proceed”message “FDA review”message PN screening food801(a) screeningPREDICT othersfoods FDA District Entry Reviewer Initial Action? Field ExamSample, AnalyzeCompliance Officer “May Proceed”message Results? Complianceaction Detain w/oPhysical Exam Detain Release withcomment Release Good Documentsrequestedby FDA Bad IB release FDA Field and Compliance Workflow 4 PREDICT PurposeImprove import screening and targeting to Prevent the entry of adulterated, misbranded, or otherwise violative goodsExpedite the entry of nonviolative goods MethodReplace the admissibility screening portion of FDA’s legacy electronic system for processing import entries. 5 PREDICT MethodUse automated data mining and pattern discoveryUtilize opensource intelligenceProvide automated queries of Center databases where relevant (i.e., registration and listing, marketing approval status, lowacid canned food scheduled processes, etc.) PREDICT MethodImprove the targeting of entry linesby Scoring each entry line on the basis of risk factors and surveillance requirementsIncrease the number of automated, realtime, riskbased “May Proceed” decisions, thereby giving entry reviewers more time to evaluate higherrisk linesFor those lines not given an automated “May Proceed,” providing reviewers with the line scores and the reasons for those scores Examples of source data for PREDICT screening rulesResults of field exams and sample analyses of previous entriesResults of facility inspections (foreign and domestic)Ratings of inherent product risks Accuracyof product and facility coding by entry filers and importers 8 Risk types to be included in targeting scoresCompliance risk of firms associated with the imported lineProductrelated Inherent health riskIncremental health risk in view of previous FDA physical examination results for products of the same manufacturerRisk factors identified by the FDA or other sources that create the need to implement expert rules indicating further action by field staff Note:Productrelated risk factors are continually under development. Accurate, Consistent, & Complete DataTo expedite entry screening by PREDICT, importers and entry filers must provide:Consistent, accurate identifiers for firmsAccurate product codesAll relevant affirmations of complianceWith those data elements, PREDICT will be able to issue a system ‘May Proceed' quickly for lowrisk shipments not held due to any other screening criteriaData anomalies and poor data quality are used to adjust the risk scores��10 Affirmations of ComplianceAffirmations of compliance are data elements submitted voluntarily to the FDA to expedite the entry review process. For example:Establishment registration numberProduct listing numberProduct approval numberRadiological health product report accession numberLow Acid Canned Food/Acidified Foods establishment and process identifiers With PREDICT:Affirmations of compliance With accurate and completeaffirmations of compliance, PREDICT will validate information against internal databases. If an automated lookup fails, the entry line will be forwarded to an entry reviewer for manual processing.��12 Importers and FilersThequality of the data submitted to the FDA will count more than ever.Importers need to work closely with filers to ensure data quality. Poor data quality or missing data will increase the targeting scoresfor your subsequent entry lines (importers and filers). Higher risk scores increase the likelihood of physical examination by the FDA.��13 Thank you for your time!��14