Common Nonconformities

Performance Improvement Solutions for Your Business Needs April 2010

In this issue

  • Common Nonconformities
  • ISO 14001 Outcomes
  • In The News
  • Expectations from ISO 9001 in supply chains
  • Training Courses
  • Greetings!

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    operational and quality systems ISO 9001, AS9100,
    ISO/TS 16949, ISO 27001, ISO 13485, ISO 14001, and
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    Sigma, Lean Enterprise, and other topics of interest
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    Common Nonconformities

    Audit

    The process for any organization to be registered to a
    global standard such as ISO 9001:2008, requires a
    formal conformity assessment. A certification body,
    also known as a registrar, or third party, will conduct
    an initial certification audit, a surveillance audit (once
    or twice a year) or a recertification audit (every three
    years) based on the maturity of your
    system.

    A third
    party auditor’s role is to examine your system and if
    necessary identify any nonconformances.

    In
    ISO 17021, a nonconformity is defined as:

    1. failure to fulfill one or more requirements of the
      management system standard, or
    2. a situation that raises significant doubt about the
      ability of the client’s management system to achieve
      its intended outputs.

    A nonconformity can be identified as a “minor”
    meaning failure to comply with a requirement which is
    not likely to result in management system failure, in
    many cases a single observed lapse or isolated
    incident. A nonconformity identified as a “major”
    meaning an absence or total breakdown of a system
    to meet a requirement, in some cases a number of
    minors related to the same clause or requirement.

    Have you ever wondered what are the
    most
    common nonconformities found by third party
    auditors?

    A training session we recently attended by a major
    global registrar identified sample data from the year
    2009 from over 18,000 minor nonconformities found.

    The top 5 ISO 9001 minor nonconformities
    found were:

    1. 7.6 Control of Monitoring and Measurement
      Equipment- 32%
    2. 4.2.4 Control of Records – 20%
    3. 5.6 Management Review – 20%
    4. 4.2.3 Control of Documents – 16%
    5. 6.3 Infrastructure – 12%

    The top 5 AS9100 Aerospace, 9110
    Maintenance , and 9120 Distributors
    minor nonconformities found were:

    1. 7.5.1 Control of Production and Service Provision –
      36%
    2. 4.2.3 Control of Documents – 26%
    3. 8.5.2 Corrective Action – 14%
    4. 8.2.2 Internal Audit – 13%
    5. 4.2.4 Control of Records – 11%

    The top 5 27001 Information Security
    Management System (ISMS)
    minor nonconformities found were:

    1. Clause 6 – ISMS Internal Audit – 32%
    2. 8.2 Corrective Action – 26%
    3. 4.2.1 Establish the ISMS – 22%
    4. 4.3.2 Control of Documents – 11%
    5. 4.3.3 Control of Records – 9%

    The top 5 14001 Environmental Management System
    (EMS) minor nonconformities found were:

    1. 4.3.2 Legal and Other Requirements – 30%
    2. 4.4.6 Operational Control – 24%
    3. 4.5.2 Evaluation of Compliance – 23%
    4. 4.5.3 Corrective and Preventive Action -12%
    5. 4.5.5 Internal Audit – 10%

    The results show that control of documents and
    control of records are, and have been for a long time
    an issue. Another common thread is corrective action
    and internal audit results.

    Looking to
    improve
    your audit results? Contact us – we deliver process
    based internal auditor training for all these
    management systems.

    ISO 14001 Outcomes

    The International Accreditation Forum (IAF) and the
    International Organization for Standardization (ISO)
    have issued a joint statement on the outcomes to be
    expected as a result of accredited certification to the
    ISO 14001 Environmental Management System (EMS)
    Standard.

    Expected Outcomes for Accredited
    Certification to ISO 14001

    “For the defined
    certification scope, an organization with a certified
    environmental management system is managing its
    interactions with the environment and is
    demonstrating its commitment to:

    • Preventing pollution
    • Meeting applicable legal and other
      requirements.
    • Continually enhancing its environmental
      management system in order to

    What accredited certification to ISO 14001
    means

    The accredited certification
    process is expected to ensure that the organization
    has an environmental
    management system, suitable for the nature of its
    activities, products and services, that conforms to the
    requirements of ISO 14001, and in particular can
    demonstrate for the defined scope that the
    organization:

    A. has defined an environmental
    policy appropriate to the nature, scale and
    environmental impacts of its
    activities, products and services.
    B. has identified
    the environmental aspects of its activities, products
    and services that it can control and /or
    influence and determined those that can have a
    significant environmental impact (including those
    related to suppliers / contractors).
    C. has
    procedures in place to identify applicable
    environmental legislation and other relevant
    requirements, to determine how these apply to its
    environmental aspects and to keep this information
    up to date.
    D. has implemented effective controls
    in order to meet its commitment to comply with
    applicable legal and other requirements.
    E. has
    defined environmental objectives and targets that are
    measurable, where practicable, taking into
    account legal requirements and significant
    environmental aspects, and has programmes in
    place to achieve these objectives and targets.

    F. ensures that people working for or on behalf of the
    organization are aware of the requirements of its
    environmental management system and are
    competent to perform tasks that have the potential to
    cause significant environmental impacts.
    G. has
    implemented procedures for communicating
    internally, as well as responding to and
    communicating (as necessary) with interested
    external parties.
    H ensures that those operations
    associated with significant environmental aspects are
    carried out under specified conditions and monitors
    and controls the key characteristics of its operations
    that can have a significant environmental impact.

    J. has established and (where practicable) tested
    procedures to address and respond to emergencies
    that can have an effect on the environment.

    K. periodically evaluates its compliance with
    applicable legal and other requirements.
    L. aims
    to prevent nonconformities, and has procedures in
    place to (1) Correct any nonconformities that do occur,
    and (2)Analyze the cause of any such nonconformities
    and take corrective action to avoid their recurrence.

    M. has implemented effective internal audit and
    management review procedures.

    We can
    assist you and your organization with all your EMS
    needs –
    Contact Us.

    In The News

    As we all know business conditions continue to be
    challenging. Organizations who reduce process
    waste can control their costs better, increase
    efficiency, and maintain customer focus will come out
    as winners.

    Our new senior consultant,
    Mathew Nadakal has a passion for process
    improvement.
    He has many years of
    experience in implementing lean enterprise systems
    in firms with great success.
    A Lean Six Sigma Black Belt, Mathew has a track
    record of making significant improvements in cycle
    time, waste, scrap, errors and increased revenue in
    manufacturing, transactional processes, and new
    product development.

    Mathew will be a
    regular contributor to our newsletter-

    Robust Metrics for Process
    Improvement – Many
    organizations are still not measuring their key
    processes effectively. This makes continuous
    improvement almost impossible to achieve. One of
    the most powerful metrics for measuring process
    performance is Lead Time (LT).

    Lead Time is defined at a work level the elapsed time
    work becomes available to an individual or working
    group, until it has been completed and given to the
    downstream customer. Lead time includes process
    and delay time. At a organizational level, lead time is
    the complete elapsed time from the first step to the
    last step of a process. Lead time is often referred to
    as throughput or turnaround time.

    Our
    website now has enhanced detail
    regarding
    Performance and Profit Enhancement Services, ITAR,
    MIL-PRF-31032 QMS, and more. Look for further
    information to follow next month on process
    performance metrics. Contact Mathew to personally
    discuss your needs and how we can help you
    increase your profit.

    ASQ Phoenix, AZ Chapter
    April 8, 2010 – Topic: 8 Disciplines of Problem Solving
    Walter Tighe, SES President Meeting
    Speaker.

    Arizona Technology Council 2010
    Business & IT Expo April 29, 2010

    Phoenix Convention Center – We are an AZ Tech
    Council Member and Exhibitor at this event. Stop by
    and visit us for a chance to win a free IPOD.

    ISO 26000 Progresses on to Final Draft– —
    The future
    International Organization for Standardization (ISO)
    standard, ISO 26000-“Guidance on social
    responsibility,” has just passed another important
    development stage with confirmation that support by
    ISO’s national members and by participating liaison
    organizations is strong enough for it to be progressed
    to a final draft international standard (FDIS). This is
    the final stage in the development of an ISO standard
    before it is published as a fully fledged ISO
    international standard.

    For more information
    on ISO 26000 see the dedicated web
    site
    .

    Expectations from ISO 9001 in supply chains

    Just what can purchasers reasonably expect from
    suppliers who put forward their company’s ISO 9001
    certification as an argument in favor of their products
    or services? ISO provides answers to this and related
    questions in an updated edition of its online brochure

    The document is particularly aimed at purchasing
    managers of business enterprises and public sector
    officials responsible for procurement, but it will also
    be useful for organizations representing consumer
    interests – as well as for consumers
    themselves.

    It provides concise answers to
    common questions such as:

    • How does ISO 9001 help you in selecting a
      supplier?
    • How can purchasers be sure that the products
      they receive will meet their requirements?
    • How can you have confidence that your supplier
      meets ISO 9001?
    • Can suppliers claim that their goods or services
      meet ISO 9001?
    • What can a customer do if things go wrong?

    In addition, the document serves as a “mini-primer” to
    ISO 9001 because it includes brief, but essential,
    explanations of the standard, quality management
    systems and the options for claiming conformity with
    ISO 9001.

    Training Courses

    training

    To see the course description, schedule, and
    on-line
    registration click on the course title below. View all our Courses.

    See our Web-Based courses.


    Understanding and Implementing
    ISO9001:2008

    ISO
    9001:2008 Process Based Internal Auditor


    Documenting Your Quality Management System


    Understanding and Implementing AS9100C:2009
    Aerospace-NEW


    AS9100C:2009 Process Based Internal Auditor-
    NEW



    Documenting Your Quality Management System


    Understanding and Implementing
    ISO/TS16949:2009 Automotive-


    ISO/TS16949:2009 Process Based Internal
    Auditor-


    Documenting Your Quality Management System


    Understanding and Implementing
    ISO14001:2004 Environmental


    ISO14001:2004 Process Based Internal Auditor


    The Five Pillars of a Lean Workplace
    Organization

    Continuous Process
    Improvement

    Lean Six Sigma
    8 Disciplines (8D) of
    Problem Solving-


    Understanding and Implementing ISO 13485:2003
    Medical Devices

    ISO
    13485 Process Based Internal Auditor


    Understanding and Implementing ISO 27001:2005
    Information Security

    ISO
    27001 Process Based Internal Auditor

    All courses can be delivered at your company.
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    see a course, location, or date that fits
    your needs?


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