Confined Production Processes for Non-Food Corn - Seed Science ...

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DefinitionsSystem: A set of interrelated or interacting elements.Process: A list of activities that use resources to transforminputs into outputs.Subprocess: A part of a process.Activities: Component tasks that make up a process.Procedure: A specified way to perform an activityProcess Management• Identification of critical systems that must be defined,controlled, and maintained.• Critical actions must be repeatable and measurable.• System design must allow for changing needs.• Regulatory and customer requirements must beidentified and incorporated into the system.Process Management Implementation• Identify critical processes.• Analyze all processes, including inputs, outputs,and lost living material.• Document critical processes.• Train employees and communicate expectations.• Define measurement criteria.• Audit the process.Our objective is to create and study examples of the firstthree steps of process management implementation so thatindustry and regulators can use the examples when theyevaluate and implement real cases. Industry includes allsteps in process management implementation.Flowcharting is useful as a process tool because it• provides a visual representation of each step inthe process;• graphically displays functional activity and providesa visual understanding of interrelated occurrences;• provides an understanding of the entire process;• allows modifications and disconnects to be identified;and• displays a clear relationship between inputsand outputs.The flowcharts follow process control. Frequently,the process control corresponds to material flows.The symbols that we have used are standard symbolsused for process management with the addition of theinput/output oval. See Figure 2.Process TitleStart/EndFIGURE 2. SYMBOLSActivityHopefully, our examples point out the critical processfactors and control points, so that the industrialimplementation can balance biosafety, process control,and work efficiency. Those who implement processesshould not take the procedures presented here directly.When these procedures are put into action, users shouldadapt processes; add more detail; and monitor, measure,and revise activities and procedures to better achieve safeand efficient production.ConnectorInput orOutputDecisionReport orData
Processes can be described with varying levels ofaggregation and detail. Figure 3 describes a system forthe creation and production of PMPs and PMIs at avery high level of aggregation.In our situation, we have made the flowcharts for thesesystems that are not as detailed as would be required bya process management exercise, but they provide moreexplicit material flow descriptions than would be presentin typical process management designs.FIGURE 3. PMP/I PRODUCTION SYSTEM PROCESSESStartTransformationand Selection inthe LaboratoryPreliminaryEvaluation in theGreenhouseBreed ProductionCultivars in theResearch NurseryStore andInventoryResearch SeedFoundation andField ProductionGrain Transport,Processing,Storage, andShipmentTo Pharm orIndustrialProcessorIntroduction 13
Page 5: A necessary first step in the proje
Page 8 and 9: There are no other restrictions on
Page 10 and 11: IntroductionIt is our expectation t
Page 12 and 13: take place, we suggest that in prac
Page 16 and 17: Laboratory andGreenhouse ProcessesR
Page 18 and 19: NIH GUIDELINES AND PMPS OR PMISWe h
Page 20 and 21: The event-specific probe becomes a
Page 23 and 24: PCR,Expression &Copy NumberTestsA t
Page 25 and 26: Lab Checks onPMP IdentityEvent Info
Page 27 and 28: Event InfoDatabasePlan Action forNe
Page 29 and 30: NURSERIES AND THEIR MANAGEMENTNurse
Page 31 and 32: target field in inverse proportion.
Page 33 and 34: FIGURE 6. NURSERYNurseryManagement
Page 35 and 36: Nursery PlanMark and LabelRanges an
Page 37 and 38: Label, Sign andRecord PlotHistoryNo
Page 39 and 40: PollinationInspection.Remove Off-ty
Page 41 and 42: Pollination ofSurrounding inToleran
Page 43 and 44: Contain PMP PlantMaterialYesAll PMP
Page 45 and 46: Receive Corn,Verify, Label,RecordRe
Page 47 and 48: Nursery PlanRegulatoryTestsEvent In
Page 49 and 50: 5. POLLEN DRIFT CONSEQUENCES,EFFECT
Page 51 and 52: 11. DETASSELING MACHINE16. EMPTYING
Page 53 and 54: Assuming production of PMPs or PMIs
Page 55 and 56: • Specialized equipment is used f
Page 57 and 58: TABLE 2. CHARACTERISTICS OF PRODUCT
Page 59 and 60: APHIS standards do not currently di
Page 61 and 62: Clean PlanterField HistoriesPlanter
Page 63 and 64: AreRoguePlantsNormal?NoIsContaminat
Page 65 and 66:
Remove Off-typesAfter FloweringYesW
Page 67 and 68:
Processing& StorageFIGURE 10. PROCE
Page 69 and 70:
Record Ear andTrack Weight &Moistur
Page 71 and 72:
Check All Grainand Trash Weightsand
Page 73 and 74:
Clean BinCheck IncomingWeight Again
Page 75 and 76:
Destroy VolunteerPlant MaterialChec
Page 77 and 78:
• Properly document test results
Page 79 and 80:
D. Second Year Field Management•
Page 81 and 82:
E. Product storage and disposition
Page 83 and 84:
No system is risk free, but some sy
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