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

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