Archive for the ‘System Development’ Category


    Supplier Performance

    By on Monday, June 20th, 2011 | Comments Off

    In my auditing travels, one practice that I see on a regular basis that makes no sense is the practice of measuring supplier performance. Specifically combining objective measures and subjective measures and trying to calculate a formula for acceptance.  Let’s get one thing straight.  It cannot work!  Let me explain the typical story.

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    Internal Laboratory Scope

    By on Friday, April 24th, 2009 | Comments Off

    Internal Laboratory Scope vs Internal Laboratory Manual TS 16949 requires internal laboratories to have a Laboratory Scope. There are specific requirements for this.

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    ISO 9001 2008 Revisions

    By on Monday, April 6th, 2009 | Comments Off

    The new ISO 9001 2008 standard is now available.  While no requirements have changed and no new requirements have been added, there are some valuable clarifications that may change the approach that an organization would take in order to gain the maximum value from their system. There are several changes which emphasis analysis and measurement. [...]

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    Critical Analysis and Root Cause

    By on Friday, March 27th, 2009 | Comments Off

    8D, 7Step, Drill Wide and Deep, etc. etc. etc.  These are all excellent processes, if they are used effectively.  Critical analysis of hundreds of corrective action records has drawn me to conclude that any of these processes can work, but most don’t. 

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    Corrective Action

    By on Tuesday, March 24th, 2009 | Comments Off

    Many organizations appear to have a real problem with improvement, particularly the difference between corrective action, preventive action and continual improvement as required by ISO quality management systems. 

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    Critical Thinking in the Workplace

    By on Sunday, March 15th, 2009 | Comments Off

    Critical Thinking is thinking that is purposeful and directed. During the early industrial revolution, employees were considered machines.  Employers neither wanted nor expected them to think.  Today in our constantly changing and evolving work places and with the constant requirement to improve our products our services and our prices, no organization can exist, let alone [...]

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    The Process Based Organization

    By on Friday, March 13th, 2009 | Comments Off

    Many businesses today are still trying to manage departments or people rather than processes.   This may be because many organizations have trouble understanding the difference.

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    Why ISO 9001 Systems Fail: Part 2

    By on Sunday, March 1st, 2009 | Comments Off

    We often wonder why so many managers treat quality management systems with disdain. My observations are that there is a lot of “dog doodo” in our ice cream. The HÄAGEN-DAZS® Ice Cream problem (see “Why ISO 9001 Systems Fail-Part 1”) occurs widely through the design, development, and implementation of quality management systems, but one particularly [...]

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    Why ISO 9001 Sytems Fail

    By on Sunday, March 1st, 2009 | Comments Off

    Why don’t managers and senior managers embrace ISO 9001 systems?  Why do so many organizations provide only lip service to the requirements of their quality management systems? The answer: “The HÄAGEN-DAZS® Ice Cream Problem.”

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    • TS 16949 PROCESS AUDITING GUIDEBOOK/ KINDLE VERSION

      A GUIDE FOR AUDITORS WHO WANT TO PROVIDE THOROUGH, EFFECTIVE AND VALUE ADDING AUDITS

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