Archive for December, 2007

Instruction or Quick Reference?

Saturday, December 1st, 2007
Performance Improvement Solutions for Your Business Needs December 2007
In this issue

  • Instruction or Quick Reference?
  • Audit Checklist Methods
  • Healthcare Supply Chain Efficiency
  • International Standard on Project Management
  • 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.

    Newsletter Sign-up

    HAPPY HOLIDAYS!

    Instruction or Quick Reference?
    Audit

    A “cheat sheet” is a concise set of notes used for quick reference. In the academic world, cheat sheets are so named because they may be used by students without the instructor’s knowledge to cheat on a test.

    In the business world, so called “cheat sheets or reference document” are popular in any setting where a quick reference is useful. New employees often make notes on how to perform their job, especially if written instructions aren’t available, supplied instructions are incomplete or complex, or the job training was inadequate. These personal job notes may be also referred to as cheat sheets.

    On the surface, use of cheat sheets would seem to be helpful and may even be encouraged. However, these job notes may not accurately describe the tasks, may be in conflict with written instructions, or be unapproved by management. ISO 9001:2000, clause 4.2.3 states that “Documents required by the quality management system shall be controlled.” So, if cheat sheets are needed by employees to carry out their activities, these cheat sheets would be viewed as documents that must be controlled.

    To control a document means it must be approved prior to use, updated as necessary and re-approved, and identified with the current revision status. Cheat sheets become authorized documents if they are controlled. If not, auditors will write them up as nonconformities.

    Employees do not like their cheat sheets being called nonconformities, especially if the corrective action is to just discard the cheat sheets. The existence of cheat sheets may indicate they are needed, so simply removing them might be a mistake.

    Instead, find out why some employees need the cheat sheets/reference document and take the appropriate action, e.g., improve training, provide mentoring, add the cheat sheets as controlled documents, or include the reference information in existing documents.

    Audits correctly spot the use of these reference items. Make sure your response supports the employees by providing alternative support.

    Audit Checklist Methods

    A checklist is used to compensate for the weakness of our human memory when we want to ensure consistency and completeness in carrying out a task. For example, we use checklists to remind us of important actions or to even plan a trip to the grocery store.

    As auditors, we use checklists to remind us of the audit criteria against which we are to compare the audit evidence. In other words, we compare evidence (statements, observations, documents, and records) to the applicable requirements (customer, organization, standard, and legal).

    To guide novice auditors, a typical checklist contains a suggested set of questions to determine if an area is conforming to the requirements. Unfortunately, the auditors often rigidly adhere to the list of questions and are unlikely to develop their own questions based upon the evidence. And, when they hear reasonable answers to the canned questions, they may accept the responses and not recognize nonconforming situations. The typical checklist gives them the questions to ask, but does not provide the expected answers.

    If you are an instructor giving an exam, you need the answer key to grade the responses. Likewise, an audit checklist should provide the expected answers to judge conformity. So, rather than listing only questions, we should use audit checklists with no questions, only the requirements and the expected evidence.

    Auditors, even new auditors, can develop the basic questions on the fly to ask regarding the applicable requirements. By not providing the questions, each audit is unique and does a better job of sampling the area under audit. Identifying the expected evidence on the checklist helps the auditor decide if the statements made, operations observed, documents reviewed, and records examined are conforming.

    As an example of a traditional checklist for the document control process, it would contain a question like, “Are the documents approved before they are issued?” The response might be, “Yes, I receive an email note from the document owner approving the document before I make it available.” That might sound like a reasonable response, especially if the auditee shows you records matching that practice.

    However, with the proposed checklist, there would be no questions. Instead, under the Requirement column would be: “Approve documents before they are issued.” Under the Evidence column might be something like: “Document owner and quality manager must sign approval form, DC-01.1.”

    Based upon the requirement listed, the auditor might ask, “How are documents approved?” If the same response was received, the auditor would see from the expected evidence that approval from the quality manager was missing and that the required form was not being used.

    An audit checklist is a memory aid and confidence builder for an auditor. It helps the auditor stay focused on the audit objectives and scope. It helps ensure the audit criteria have been addressed. And, it is a repository for the auditor notes and becomes a record of the investigated areas.

    Healthcare Supply Chain Efficiency
    Medical Devices

    More than 175 leaders and experts from healthcare and automotive industries met November 15-16 in Troy, Mich., at AIAG’s AutoMed 2007 to discuss critical work being done by AIAG’s Health Focus Group and its collaborative partners. The group’s driving mission is to improve quality, value and efficiency by eradicating root causes and employing proven automotive processes within the healthcare industry. AutoMed serves as the partnership’s in-gathering venue and communication tool to industry leaders.

    Keynote speaker, Dr. Vinod Sahney, Sr., vice president and chief strategy officer, Blue Cross Blue Shield of Massachusetts, detailed several root causes for the growing healthcare cost crisis, including an aging demographic and chronic disease prevalence. “By global comparison, the U.S. aging demographic is most expensive, due to poor health and the consequential expense paid through retiree benefits,” noted Sahney. Confirming that reality, Ford Motor Company’s medical director, Dr. Walt Talamonti, showed that a shocking 58 percent of the $3.1 billion spent in 2006 by Ford on healthcare was post-retirement cost.

    In response to hospital and provider process inadequacies, solutions are sought in proven quality practices. Mickey Christensen, president of TQM Systems and Dan Reid, purchasing manager for GM Powertrain, presented the Business Operating System (BOS) for Health Care organizations. BOS combines the Malcolm Baldrige Health Care Criteria for Performance Excellence (MBNQA) modifications and ISO, as well as AIAG-owned content. Christensen says BOS is ideal for “application to healthcare because it is process focused and system dependent.” He also highlighted DNV Healthcare’s early initiative in U.S. hospital accreditation as a potential solution to standard practice issues.

    Empowering AutoMed attendees to be the driving force behind long-term solutions, Reid stated, “The people in this room can make a difference in healthcare delivery – within this state, this region, even this nation.” The January 2008 unveiling of AIAG’s Health Care Steering Committee is an answer to that call and shows an increased dedication to building solutions for massive cost-inefficiencies throughout the healthcare industry.

    International Standard on Project Management

    ISO has begun the development of ISO 21500, an international standard on project management.

    BSI British Standards recently hosted the inaugural meeting in London of the new project committee, ISO/PC 236, Project management, established to develop ISO 21500. Over 50 delegates from around the world attended to begin work on the international standard, which is intended to provide generic guidance, explaining the core principles and what constitutes good practice in project management.

    ISO 21500 will build on existing standards and work at the national level. It is intended to be applicable to organizations of all sizes and sectors and will be designed for relative newcomers to project management, or as an aide-mémoire for more experienced practitioners.

    So far, delegations of experts selected by the national standards institutes of 20 countries are participating in the work, with another three countries having observer status. ISO/PC 236 includes three working groups, respectively addressing terminology, processes and informative guidance.

    The secretariat of ISO/PC 236 is held by the American National Standards Institute (ANSI), and it is chaired by Dr. Jim Gordon, of the United Kingdom, who commented: “The development of an international standard will be welcomed by many countries and will have broad relevance to projects in many industries and the public sector.”

    Training Courses
    training

    Our 2008 1st Quarter course schedule is now posted on our website.

    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?

    Contact Us

    Quick Links