How to Conduct Effective Process Based Audits

Performance Improvement Solutions for Your Business Needs February 2007
In this issue

  • How to Conduct Effective Process Based Audits
  • Changes Ahead for AS9100 Aerospace Standard
  • TL9000 Handbook R4.0
  • New Baldrige Criteria Published
  • Training Courses and Schedule
  • Greetings!

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    Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, lean enterprise, and other topics of interest to our readers.

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    How to Conduct Effective Process Based Audits

    What is a process based audit? Lets begin by reviewing the definition of an audit from ISO 9000:2005, Fundamentals and Vocabulary, clause 3.9.1. An audit is:

    “a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.”

    In other words, an audit is a planned, organized, and documented set of activities performed by impartial and objective auditors. The audit process collects evidence from an area to evaluate conformity to the applicable requirements. Audit evidence is factual, not based on opinion or hearsay.

    The sources of audit evidence are:

    • Statements (noted during audit interviews)
    • Observations (made watching the activities)
    • Documents (reviewed before and during the audit)
    • Records (examined to evaluate past conformity)

    The primary audit criteria are:

    • Standard (e.g., ISO 9001:2000)
    • Company (organization’s requirements)
    • Customer (as expressed in contracts and orders)
    • Legal (from statutes and regulations)

    The definition of a Process is a set of interrelated or interacting activities which transforms inputs into outputs. The inputs of a process are the outputs from other processes.

    The standard promotes the adoption of the process approach to develop, implement, and improve. An effective process based auditor should “Identify the Relationship to the Standard.” How does the process intersect with the standard requirements? Next, you need to “Learn the Process.” Before you can audit a process you must become familiar with it. You need to learn how it is supposed to work, what it supposed to do, what are the inputs, outputs, activities, resources, measures, and controls.

    A “Document Review” requires reading and understanding the associated documentation for the process you are auditing. Another important step is to develop auditing questions based on the standard’s requirements and the “Process Interfaces.” The interfaces are the process handoffs. In essence we are not looking at does the requirements exist, but are they clearly defined and understood by the process using them.

    The ultimate goal of auditing a process based management system is to ensure the system is effective, improves the business, and satisfies the standard requirements.

    A structured methodology for moving your audit results from boring to brilliant can be learned.

    Changes Ahead for AS9100 Aerospace Standard

    During the seven years since the release of the 9100 aerospace quality management system (QMS) standard, it has been adopted by nearly every major aerospace prime manufacturer in the world, both for use internally and for flow-down throughout the aerospace supplier chain. As of January 2007, there were more than 6,300 third-party registrations to the 9100 standard worldwide, including more than 3,200 in the United States, and these numbers are expected to grow.

    The data mining period, which extended from January 2006 until August 2006, garnered about 340 comments and change recommendations to 9100.

    Some of the items that were challenged were the aerospace requirements in subclauses 4.2.2 and 8.2.2. In subclause 4.2.2, “Quality manual,” users were having a difficult time understanding the intent behind the requirement to show the relationship between the standard’s requirements and documented procedures; in some cases this caused unnecessary, nonvalue-added work. In subclause 8.2.2, “Internal audit,” the aerospace requirement to measure the effectiveness of selected audit tools generally wasn’t understood, and even when it was, the cost often exceeded the benefit. In either case, auditability of this requirement is an issue. Both of these topics, as well as the other valid challenges to existing requirements, will be reviewed to determine if the requirements can be clarified, revised in scope or deleted.

    Other items to be clarified include statistical sampling in subclause 8.2.4 (What’s statistically valid? What’s the statistical validity of this requirement as written?), and first-article inspection (FAI) in subclause (Is it necessary to perform FAI or only have a process for it? What’s a “part,” and does it include assemblies?) Clarifications were also requested in other sections of the standard–in particular, subclauses 7.3, “Design and development”; 7.4, “Purchasing”; and 7.5, “Production and service provision.” These requests are understandable, given the high number of aerospace requirements in these subclauses.

    As announced at the November 2006 meeting of ISO/TC 176 in Busan, Korea, the amended ISO 9001:2000 standard is scheduled to be released in May 2009. The IAQG 9100 Team is working to release the 9100 revision as soon as possible after the release of the ISO 9001 standard.

    TL9000 Handbook R4.0

    The new TL 9000 Quality Management System (QMS) Requirements Handbook, Release 4.0, must be used for all audits after June 30, 2007. Auditors must have delta training before conducting a third party audit to R4.0.

    Summary of Changes:

    • ISO 9001:2000 Base Remains Unchanged
    • 30% of Adders Remain Unchanged
    • 30% of Adders have Minor Changes
    • 40% of Adders have Major Changes or are New

    These requirements designed to:

    • Ensure intended results instead of specifying methods of doing
    • Emphasize design process quality measurements
    • Add required testing (regression, document verification, stress, abnormal condition, and system), and
    • Broaden the scope of certain requirements, e.g., from software only to common or, hardware and software

    A companion document is the TL 9000 Measurements Handbook (Release 3.5). It is a comprehensive guide to measurements processing, usage, responsibilities, and requirements. This book defines the minimum set of performance measurements to assess progress and evaluate results of quality management system implementation. It identifies performance measurements that are key in the telecom industry:

    • Common Measurements
    • Outage Measurements
    • Hardware Measurements
    • Software Measurements
    • Service Quality Measurements

    There is a net gain of 9 adders for a total of 90 adders.

    New Baldrige Criteria Published

    The 2007 Baldrige criteria for performance excellence in education and health care, and in business and nonprofit organizations, were recently published on the Baldrige National Quality Program.

    The Baldrige criteria help companies understand performance management from a systems perspective. They use validated, leading-edge management practices against which an organization can measure itself.

    The Baldrige criteria speak a common language for communication among organizations for sharing best practices and are accepted internationally as the model for performance excellence. In addition, the Baldrige National Quality Program offers a worksheet for self-analysis that can be used to identify an organization’s strengths and opportunities for improvement, as well as to establish action plans and goals.

    There are three versions of the criteria available:

    1. Criteria for Performance Excellence
    2. Education Criteria for Performance Excellence
    3. Health Care Criteria for Performance Excellence

    Training Courses and Schedule

    We are pleased to inform you that our 2007 courses are now posted on our website.

    To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded CEUs

    All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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