The SPC Troubleshooting Guide
by Ronald Blank

The SPC Troubleshooting Guide (Qual-ity Resources, 1998) identifies common problems associated with statistical process control and recommends corrective actions to remedy ineffective systems. Written in a concise, user-friendly format that requires minimal mathematics background, the guide assists readers in understanding what can and cannot be expected of an SPC system. The author describes five universal SPC principles and explains why violating them will result in out-of-control SPC charts. The book also provides definitive corrective actions as well as a four-step method for ensuring their effectiveness.

The Root Cause
Analysis Handbook
by Max Ammerman

In The Root Cause Analysis Handbook: A Simplified Approach  to Identifying, Correcting and Reporting Workplace Errors (Quality Resources, 1998), Max Ammer- man explains the methodology behind root cause analysis and how it can be implemented in the workplace. The book includes a walk-though example and discusses in detail the nine steps that make up the process. The steps are accompanied by hints and shortcuts to make an evaluation easier and faster, and include pitfalls that analysts should avoid. This handbook shows readers how to evaluate an event, define and investigate the problem, identify the cause, implement corrective actions, and report findings and recommendations.

The CE Mark: Understanding the Medical Device Directive
by Les Schnoll

The European Union’s Medical Device Directive, formally known as 93/42/EEC, is one of the EU’s most frustrating and difficult-to-decipher mandates. Les Schnoll, director of quality at the Southern Research Institute, clearly and thoroughly explains the directive for medical device manufacturers. The book includes an overview of the directive, an in-depth analysis of the articles, a description of the annexes, conformity assessment routes and how to use the CE Mark. The CE Mark: Understanding the Medical Device Directive (Paton Press, 1997) is a must read for anyone exporting medical devices to the European Union.

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