Process Mapping, a key milestone in Engineering for Health

Abstract

Engineering for Health does not only imply Research and Development of innovative technologies, techniques and equipment for improving our lives and our health, but also the design and validation of the spaces and departments where these are used and implemented.Designing safe, compliant and contamination-free spaces should track the following steps: define the User Requirements Specifications (URS) know the GMPs and all applicable regulations analyze the process phases and steps (process mapping) prepare process flow diagrams (PDF, process mapping) study personnel, materials & waste flows (process mapping) study the activities carried out in each room (process mapping) classify each room and define systems’ requirements define process & space requirements prepare room association diagrams. One of the most important phases is the in depth knowledge of the process (process mapping): once you know the process you can design the process flow diagram, define the block layout and then the first layout which will be the basis of all further studies and discussions. Process mapping allows you to design departments which follow all the stages of health care, protect patients and operators from contamination, optimize space usage and management and take all issues into account.A correct procedure could be:a block layout definition which respects user, process and regulatory requirementsanalyze and discuss block layout with client until the first layout is definedthe layout goes to system designers with specific requirements for each room (room and equipment log-sheets which relate collected data for each room and equipment)layout correction on the basis of the systems’ design.This procedure can be repeated more times until the final layout meets all requirements: process, GMP, systems, national laws, etc.Only once the final layout has been defined and accepted by all parties can the detailed engineering design be performed. Not only, a correct preliminary design phase is the foundation of all validation steps, from Design Qualification to Performance Qualification.KeywordsProcess MappingRisk AnalysisLayoutEngineeringHealth