Appreciate Your Documentation

Sustaining Edge Solutions, Inc. Newsletter )
Performance Improvement Solutions for Your Business Needs April 2008
In this issue

  • Appreciate Your Documentation
  • ISO 20000 – What is Coming Next?
  • Nonconformity, Defect, or Finding
  • ISO 13485 and GMDCAS
  • Manufacturing Engineering
  • Training Courses
  • 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 13485, ISO 14001, and others. This includes process improvement methods 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.

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    Appreciate Your Documentation
    Audit

    Why do so many organizations spend valuable time and resources generating and maintaining paperwork systems? Asking to see documentation often results in responses about bureaucratic or time-consuming paperwork.

    The following are six key benefits to help understand the importance of documentation in all operational processes:

    1. Accountability: If a process requires documentation, it is much more likely to occur and be utilized. Effective documentation identifies process connections. The completed documentation becomes the key to opening the door to the next step. For example, contract approval would require a documented review of the terms before being accepted.

    2. Completeness: If standard forms or checklists are incorporated into a process, these tools become roadmaps to ensure process consistency. Good documentation should show a clear relationship of required inputs and outputs. For example, a machinist might feel tempted to omit measurement data to speed product delivery. But if the inspector ensures the documentation is complete, the process owner will have to include all data requirements to complete the job.

    3. Consistency: If given the chance, individuals will complete a given task in many ways. A consistent approach creates organizational efficiency. For example, if a form being used is understood and standardized, the processes used to create the documentation also are standardized.

    4. Timeliness: When a deadline is important, documentation is important. The knowledge that a document, form, or record must be signed and dated to a schedule, encourages compliance with the schedule. For example, if your required to submit recurring financial information to corporate each month, you will take the steps necessary to collect and document that information in a timely manner.

    5. Communication: Documentation increases the communication flow between team members. With the increased speed of project activities using e-mail and software, the need for documentation is ever increasing. For example, good meeting minutes and documented action plans allow individuals accessibility to electronic information formats at all times.

    6. Record: A documented record of actions, decisions, product data can provide the necessary information for years later and protect the company and its employees. For example, a customer’s claim of design error can end up in litigation. If good records are kept, the records would be invaluable for any subsequent actions.

    Remember, if documentation is required and not yet completed, the task is not done. The doing and documenting are complementary and very necessary. Thanks to Dan Domalik for his information insights.

    ISO 20000 – What is Coming Next?

    The 1Q08 issue of the TickIT quarterly journal contains an article by Graham Cox on the future of ISO 20000, the IT services management standard. ISO 20000 was published in 2005 in two parts. Part 1 is the Specification and used for certification; Part 2 is the associated Code of Practice.

    Parts 1 and 2 of ISO 20000 are in the review process and a revised Part 1 is expected in 2009 and the updated Part 2 in 2010. Both parts will take into account ITIL v3.

    The new Parts planned for the ISO 20000 family are:

    Part 3: Guidance on Scope and Applicability. This new Part may be issued as a Technical Report to allow faster publication, perhaps by the end of 2008.

    Part 4: Process Reference Model. This new Part will work in conjunction with ISO 15504-8 as the Process Assessment Model for service management. Together, they will define a multiple stage capability and maturity model aligned to ISO 15504, also known as SPICE: “Software Process Improvement and Capability Determination”, a framework for the assessment of software processes.

    In addition, an incremental approach to conformity has been approved for development. The first stage of this approach would give advice to companies on requirements for reactive activities. The next stage would be mainly advice on requirements for proactive activities. The final stage would be advice on requirements for full integration. This incremental approach might lead to the requirements being subdivided to provide stages for conformity.

    You can read the full article, and its discussion of TickIT and CMMI in relation to ISO 20000, at the TickIT Website

    Nonconformity, Defect, or Finding

    Nonconformity

    Are you using the right term? What do you call it when a requirement is not met? ISO 9000:2005, 3.6.2, defines the non-fulfillment of a requirement as a “nonconformity”. As expected, “conformity” is defined in 3.6.1 as the fulfillment of a requirement.

    However, some auditors use “conformance” and “nonconformance”. Does it matter? ISO 9000:2005, 3.6.1, states that although conformance is synonymous with conformity, it is deprecated. What does that mean? Well, “deprecated” refers to a term that is considered obsolete and being phased out. That being the case, it is preferable to use the terms Conformity and Nonconformity.

    Defect

    If a nonconformity relates to the intended or specified use of the product, the correct term becomes “defect”. ISO 9000:2005, 3.6.3, cautions that using the term “defect” has legal connotations related to product liability issues and should be used with extreme caution.

    Finding

    When you hear about audit findings, you probably think that problems or concerns are being reported. Is that always the correct interpretation? ISO 9000:2005, 3.9.5, defines a “finding” as the result of an evaluation of the collected audit evidence against audit criteria. It states that findings can indicate either conformity or nonconformity with audit criteria, or opportunities for improvement. So, findings can also be good. It’s just that audit reports tend to focus on those findings that are nonconformities.

    ISO 13485 and GMDCAS

    GMDCAS stands for “Global Medical Device Conformity Assessment System”, a program initiated by the International Accreditation Forum (IAF).

    As many as 150 countries have no medical device regulations. Several of these countries are considering establishing their own, unique regulatory requirements, with more countries to follow. As a result, there is a strong need to develop a third party accreditation program that can be used by all countries.

    Since these countries rely heavily on imported medical devices, their development of national QMS accreditation requirements could cause a serious adverse impact on that country’s local healthcare system. Why? Because most medical device manufacturers cannot justify making special accommodations for a single, small market. In addition, many certification bodies might find it economically infeasible to apply for a separate accreditation for just a few clients.

    Without a globally accredited QMS certification program for medical devices, the unintended consequence for these developing countries may be to lose their current access to healthcare technologies.

    The IAF has established a Working Group for the ISO 13485 GMDCAS program. This group includes representatives from the United States, Canada, European Union, Australia, Japan, and China. It also includes industry experts in medical device regulations and standards.

    Manufacturing Engineering

    Manufacturing Engineering Magazine’s web streaming video channel, METV, now offers two complete video programs online each month on demand. The magazine and METV are products of the Society of Manufacturing Engineers.

    The April program is “Rapid Prototyping and Casting.”

    The offerings can be viewed at METV.

    Training Courses
    training

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

    Understanding & Implementing ISO9001:2000
    ISO 9001:2000 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding & Implementing AS9100B:2004
    AS9100B: 2004 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding and Implementing ISO/TS16949:2002
    ISO/TS16949:2002 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding and Implementing ISO14001:2004
    ISO14001:2004 Process Based Internal Auditor

    The Five Pillars of a Lean Workplace Organization
    Continuous Process Improvement
    Lean Six Sigma

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

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