Best Practices for Successful Document Control

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Performance Improvement Solutions for Your Business Needs January 2009
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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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Best Practices for Successful Document Control
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Software or a home grown system? Your choice will depend on your document management needs, your industry and company requirements, the need to integrate with current applications, and what you are willing to pay.

Determine the scope of this initiative and define your business objectives. Is your company looking for a document management solution that spans the enterprise or can you focus on the needs of a single department or division? What business drivers are compelling you to get started-Loss of documents? Pressure from competitors? Requests from customers? To ensure buy-in and avoid surprises, be sure to involve key stakeholders up front, not just the document control department but all departments that will be affected by the solution. Prioritize your desired system capabilities. Make a list of must-haves, nice-to-haves, and bells and whistles.

Characterize the types of documents you want to control, as well as their owners. This doesn’t mean you need to conduct a physical inventory of every document. Rather, create a list of the different types of documents that require management control -for example, Web pages for a public website, product brochures, customer documentation, online forms, and the process each department uses to create, maintain, version, and archive documents.

Identify categories of new documents. Documents that may need to be written or revised based on an interpretation of regulations, and fixed content-content that doesn’t change once it has been created, like signed contracts or financial statements- that need to be stored. When possible, create a working title and/or a short description of a new document and assign an owner to it-a department name or person.

Review, update, and reapprove as necessary. Conduct this chain of events on documents based on business triggers or real-world events that have the power to affect a document. Some examples include the introduction of new products, equipment and processes; change in business focus; technological breakthroughs; and improved methods or practices. Because this approach is driven by actual events that make document review immediately relevant, it introduces a sense of urgency that’s not present in the periodic approach.

If an organization decides to use this method, it needs to define the business triggers and responsibilities clearly in the document control procedure. The document administrator will typically monitor operations for these business triggers and ensure that the relevant documents are reviewed, updated as necessary and reapproved.

Create a department or company-wide standard document review. Establish a cycle that identifies the personnel who are responsible for providing input or feedback-Research, Planning, Draft1, Final-and standards for critical schedule milestones involved in completing documents on time. Develop a culture so subject matter experts understand that their role is critical for producing the best documentation.

Use the internal audit process to review documents. Keep in mind, however, that internal audits are sampling processes. If an organization intends to use its internal auditing process to satisfy this requirement, then extra care must be taken when planning and scheduling audits to ensure that all documents are sampled during an extended period.

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Financial and Economic Benefits with ISO 9001
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Important information to share with our readers again in these current economic times:

ISO 10014:2006, Quality Management – Guidelines for Realizing Financial and Economic Benefits. This document explains how to achieve financial and economic benefits with ISO 9001:2000, and ISO 9001:2008 thus effectively uniting top management and the quality manager. It helps management and quality professionals appreciate each other’s perspectives and serves as a common “language” between top management and quality professionals.

It is actually noteworthy that top management’s view of operations is usually expressed in financial terms while quality expresses itself using data and details that support reduction of variation or improvement, but often only implies the resulting financial gains. The Guidelines could well become bedside reading both for top managers and for those quality professionals who may need to convince them.

The user starts with a self-assessment, using a basic maturity model to define how well the organization has implemented each of the Eight Quality Management Principles. A straightforward five-point maturity scale is used to score the organization’s response to each question. The results are summarized by principle and any score less than three indicates that the organization may benefit from improvements to its activities related to that principle.

Users should focus on the principles they scored the lowest on, as well as those that are most important to the organization. For example, a service organization for which customer satisfaction is critical might have a low score in the “customer focus” principle and will recognize that better implementation of the “people” and “leadership” principles will also be critical. The organization’s improvement plan might include activities to improve how all three of these principles are implemented.

Paul C. Palmes, the ISO 10014 project secretary, explained: “This project included experts in finance and quality from around the world. Throughout the entire process, it was clear that we were creating a new and important tool to bridge the often confusing gaps in language and measurement between top managers and quality professionals. If our efforts were successful, they will be better able to work together, speak in terms both understand, and, using common tools, measure results from a financial perspective.”

For more information on the Quality Management Principles, purchase ISO 10014:2006 at the ANSI Book Store.

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Common framework for RFID frequencies
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In the context of growing adoption of radio frequency identification (RFID), particularly in open supply chain applications and the concurrent development of innovative products and services, the International Standard ISO/IEC 18000-1 has been revised.

ISO/IEC 18000-1:2008, Information technology – Radio frequency identification for item management – Reference architecture and definition of parameters to be standardized, defines the generic architecture concepts in which item identification may be commonly required within the logistics and supply chain and defines the parameters that need to be determined in any standardized air interface definition in the subsequent parts of ISO/IEC 18000.

All parts of ISO/IEC 18000 provide the specific values for definition of the air interface parameters for a particular frequency/type of air interface from which compliance (or non-compliance) with Part 1 of ISO/IEC 18000 can be established.

ISO/IEC 18000- 1:2008 also gives examples of conceptual architectures in which these air interfaces are often to be utilized. It provides parameter definitions for communications protocols within a common framework for internationally useable frequencies for RFID.

It also provides reference information in respect of patents that have been declared to the developers of ISO/IEC 18000 as pertinent and provides reference addresses in respect of regulations under which ISO/IEC 18000 must operate.

Charles Biss, Chair of Joint Technical Committee JTC1observes: “Logistics, supply and distribution systems are an indispensable part of modern society. The market interest in unique permanent identification of supply chain items has dramatically increased and additional standards are under development by SC 31 to accommodate market sectors and supply chain items.”

Purchase the ISO/IEC 18000- 1:2008 Standard at the ISO Store.

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Be Heard on ISO 26000,The Social Responsibility Standard
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The Jan. 30, 2009 deadline is fast approaching for submitting comments to ISO on ISO 26000, the standard on social responsibility that’s now being developed.

ISO, the International Organization for Standardization, has decided to launch the development of an International Standard providing guidelines for social responsibility (SR). The guidance standard will be published in 2010 as ISO 26000 and be voluntary to use. It will not include requirements and will thus not be a certification standard.

There is a range of many different opinions as to the right approach ranging from strict legislation at one end to complete freedom at the other. We are looking for a golden middle way that promotes respect and responsibility based on known reference documents without stifling creativity and development.

The need for organizations in both public and private sectors to behave in a socially responsible way is becoming a generalized requirement of society. It is shared by the stakeholder groups that are participating in the WG SR to develop ISO 26000: industry, government, labor, consumers, nongovernmental organizations and others, in addition to geographical and gender-based balance.

To download a copy of the latest draft and to e-mail your filled-out comment form to the ASQ Standards Group by January 30, 2009, Visit ASQ Standards Central.

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AS9100 IAQG OASIS
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The International Aerospace Quality Group (IAQG) wants to ensure continual improvement in the aerospace supply chain by focusing on:

  • Details and appropriateness of nonconformities identified during an audit.
  • Depth and adequacy of the root cause analysis and related corrective action plan.

This IAQG activity was initiated because of the perception of poor root-cause analysis by AS9100 certified organizations, and the soft grading of findings by third party auditors. As a result, IAQG now requires certification bodies to enter additional information into the Online Aerospace Supplier Information System (OASIS), including:

  • The audit report.
  • One corrective action report for each finding written during an audit, and
  • Corrective action plan with root cause analysis for each finding.

If you were not aware that your company AS9100 certification body didn’t in the past, it will now require a root-cause analysis and corrective action plan to be submitted for each nonconformity reported in an audit. The certification body will review your responses before the next audit and provide feedback on any inadequate root cause analysis or corrective action plan.

The certification body will upload the audit nonconformities and corrective action plans into the OASIS database. Since organizations control their own data in OASIS, they can determine who will have reviewing rights to this data.

OASIS Resource – To view the Supplier Chain Management Handbook, go to this IAQG Website Portal.

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

Understanding & Implementing ISO9001:2008
ISO 9001:2008 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

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