Posts Tagged ‘manufacturing department’

Systems Engineering In Medical Device Design – Instructions, Part 2

Monday, January 14th, 2013
     Last time we discovered that clearly written instructions are one of the desired end results of the Development stage of the systems engineering approach to medical device design.  We learned that one of the objectives of these instructions is to make sure the devices are manufactured in a cost effective manner and with minimal defects during the Production stage. 

    Other instructions created during the Development stage are those addressing quality control inspections and testing instructions.  The objective of the quality control department is to ensure that, during the Production stage, the end product has been assembled correctly, making use of the prescribed parts, and absent manufacturing defects.  This end is achieved by virtue of the fact that the quality control department staff is usually not under the management of the engineering or manufacturing departments, therefore they are positioned to offer an impartial assessment of the production process. 

     An undesirable side effect of quality control’s impartiality is that because they are not intimately involved in the design process, a great deal of collaboration must take place between them and design engineers to produce quality control instructions which meet objectives.  To this end, many discussions must take place concerning subject matters as diverse as requirements for component dimensions, component material properties, and the proper assembly of parts.

     Next time we’ll continue our discussion on the Development stage by further examining how instructions are developed to ensure that the quality control department meets its objectives while performing inspections and tests during the Production stage.

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Medical device quality control.