The Process Approach to Auditing

Performance Improvement Solutions for Your Business Needs October 2006
In this issue

  • The Process Approach to Auditing
  • Documents of External Origin
  • Quantitative Results from ISO 9001:2000
  • Reluctant to use a Quality Tool?
  • News and Events
  • Greetings!

    Welcome to Sustaining Edge Solutions e-Newsletter!

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

    If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.

    Thanks for your support!

    The Process Approach to Auditing

    Are you confused about the process approach to auditing? Let us begin with one definition of a process: a set of interrelated or interacting activities which transform inputs into outputs.
    As a result, a process audit is an objective evaluation of a process to determine the extent to which the process is meeting its requirements. Using the process definition, the process audit includes an examination of process inputs, activities, outputs, and outcomes.
    However, a process is part of a larger set of processes (a system) that define an operational and quality management system. Therefore, a process audit must also consider the linkage and interaction of a process with these other processes.

    A process approach methodology helps illustrate the process elements to be audited.

    1. PROCESS (Identify the Process)
    2. INPUTS: (What Received, When, and from Who)
    3. WHAT – Resources: (Equipment, Tools, and Software)
    4. WHO – Resources: (People, Skills, and Experience)
    5. METHODS: (Procedures, Instructions, and Controls)
    6. MEASURES: (Performance Results and Objectives)

    Want to move your auditing program from boring to brilliant and learn more on how to use this approach to developing effective audit checklists and sustained results?

    Documents of External Origin

    Many organizations have a difficult time or are unclear as to these types of documents.
    Let’s clarify: A document of external origin is explicitly one that originates from outside the organization and contains specific information that the organization needs to fulfill customer requirements, maintain their quality management system (QMS) or comply with statutes, for example.

    These documents have their own category because they’re handled differently from those created by the organization. Because of their origins, they carry restrictions. An organization may use them, but it cannot change them, because the authorization for revisions, approvals, withdrawals, etc., resides with those who authored the document. Examples of documents of external origin include:

    Examples of documents of external origin:

      • National/international standards (e.g., ISO 9001, ISO/TS 16949, ISO 17025, etc.)
      • Customer specifications (e.g., drawings, schematics, bills of material, contractual requirements, etc.)
      • Industry and product standards (e.g., clean room standards, National Electrical Manufacturers Association codes)
      • Statutory and regulatory requirements (e.g., OSHA, Environmental Protection Agency, Child Safety Protection Act, Food and Drug Administration, et al.)
      • Operating and repair manuals (i.e., manuals needed to use or maintain equipment)
    • The typical problem that arises with this category is because they aren’t created by the organization, individuals don’t perceive these documents as part of the QMS documentation. If it defines requirements you need to make your organization run or bring product to market, it’s a document that must be controlled.

      Quantitative Results from ISO 9001:2000

      Did you know that the ISO 9001:2000 operational and quality system standard has spread across industry and service – and that implementing the standard results in bottom-line benefits?

      ISO 10014:2006 provides guidelines for realizing financial and economic benefits from the application of the ISO 9000 quality management principles.

      ISO 10014:2006 is directed to top management of an organization and complements ISO 9004 for performance improvements. It provides examples of achievable benefits and identifies management methods and tools that are available to assist with the achievement of those benefits.

      See how our client realized the financial benefits of ISO 9001:2000 application. “Moved from a tier 4 (customer audit failure) to tier 1 supplier and a signed 10 year contract.”

      Reluctant to use a Quality Tool?

      Quality Digest asked its readers:
      “Is your Company Reluctant to use a Quality Tool?”
      Top 5 responses:

      1. Six Sigma 35.3%
      2. ISO 9001 25.7%
      3. Statistical process control 25.1%
      4. FMEA 22.2%
      5. Kaizen 18.6%

      What Quality Tool(s) is your company reluctant to use? Send us an e-mail with your input and we will publish the results anonymously in our November issue.

      News and Events

      Preview our October events and training opportunities

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