Engineering Expert Witness Blog

      If you’re like some people you try to avoid reading these instructions, preferring to forge ahead to the assembly/usage stage as quickly as possible, and you’ve probably had your fair share of times that this approach didn’t pan out.  You were forced to re-do things and crack open the instruction manual anyway.  If the instructions were written clearly, you may have eventually come to regard them as indispensable.

     Clearly written instructions are one of the desired end results of the Development stage of the systems engineering approach to medical device design that we’ve been discussing.  These instructions flow naturally from the finalized detailed design which has been produced earlier in this stage.  Instructions aid consumers in the assembly, usage, and maintenance of the device, making for a satisfied customer. 

     Instructions also aid in the efficient and proper manufacture of devices.  Without them assembly personnel wouldn’t work as efficiently, and the end result might not be a desirable one.  It’s easy for parts to end up where they don’t belong, adjustments to be off, etc.  Just think about the last “assemble it yourself at home” project you were involved in.

     The desired result is for instructions produced to be well defined and capable of instructing line assembly personnel in the actual construction of the medical device that takes place during the Production stage.  Subjects such as parts identification, assembly procedures, and layout of assembly lines are discussed, all of which are needed to plan out the manufacturing process effectively.  The objective is to manufacture the devices in a cost effective manner and with minimum probability of defects.

     Next week we’ll continue our discussion on instructions, focusing on those that are produced during the Development stage that serve the purpose of guiding quality control technicians during the Production stage.

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