Reducing Variation During Design

Design offers the first and best opportunity for reducing variation.  To illustrate the strategies and tools required, consider the task of designing a new pump.  Suppose we are faced with the task of designing a pump capable of delivering solution at a constant rate of 10 ml/min.  Customer usage requires that the flow rate remains […]

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Acceptance Sampling Update

INTRODUCTION An understanding of statistical principles and how to apply them is critical to ensuring compliance with FDA requirements, such as those in the current and July working draft of the good manufacturing practices (GMP) regulation.   Indeed numerous Form 483’s issued by FDA following GMP inspections have cited sampling plans for final, in-process, and receiving

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The Importance of Trending Attribute Data

Dr. Wayne A. Taylor The use of SPC is preferable to relying on acceptance sampling.  It is better to make defect-free product than to sort out the defects later.  However, with attribute data, care must be taken in implementing SPC to avoid only an illusion of change. Suppose a packing operation inspects for missing parts

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Statistically Valid Sampling Plans

Dr. Wayne A. Taylor Numerous 483’s issued by the FDA have cited sampling plans as not being “statistically valid”.  So what is required of a sampling plan to be statistically valid?  Selecting statistically valid sampling plans is a two-part process.  First, one must determine an appropriate objective for the inspection.  Second, one must select a

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