Investing in product assurance to ensure that: better is not the enemy of good

A comprehensive program for assessing and validating new processes before they are implemented in production is outlined. An example describing how the program was applied to a process in the manufacture of the lithium/iodine batteries used as power sources for implantable pacemakers is given. This program involves prototype builds, process validation builds, reliability and quality assessment, sensitivity analysis, rational tolerancing, capability analyses, search for sources of variation, and follow-up analyses. This comprehensive approach was successfully applied to the process validation of the substrate anode coating method. The result is the manufacture of a battery which continues the tradition of high reliability, exhibits reduced cell-to-cell performance variability, and is more efficient to manufacture