September, 2004

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September Articles

Training in Atlanta

ISO 9001:2000 Lead Auditor - December 6-10, 2004 Orlando, Florida - SpringHill Suites Marriott Village Instructor: Larry Whittington. To enroll, click here. Click on a title to jump to the article: 1. Southeastern Quality Conference: October 18-19, 2004 2. Organization:`The Grouping of Process Information 3. Conditions: The Decision Criteria 4. OfficeSolutions Accelerator for Business Scorecards 5. New ISO 9001:2000 Interpretations 6. Free Listing of ISO 9001 and ISO 14001 Registrations 7. Class Schedule: September, 2004 - November, 2004 AS9100B: Requirements Beyond ISO 9001:2000 Call us at 1-800-404-7585 for this 1-day onsite class. To see previous articles, go to Newsletter Archives. To avoid this newsletter being rejected, or placed in a junk folder, please add <Larry@WhittingtonAssociates.com> to your address book.

Note: Students that have attended a class in Atlanta receive a 20% discount on future Atlanta classes. ISO 9001:2000 Auditor Update September 20, 2004; November 15, 2004 ISO 9001:2000 Lead Auditor October 25-29, 2004; December 13-17, 2004 ISO 9001:2000 Internal Auditor September 21-23, 2004; November 16-18, 2004 Understanding ISO 9001:2000 Requirements September 13, 2004; November 29, 2004 Quality System Documentation September 14-15, 2004; Nov 30- Dec 1, 2004 Implementing ISO 9001:2000 September 16-17, 2004; December 2-3, 3004 Green Belt Certification October 13-15, 2004; November 1-3, 2004 Black Belt Certification  Group 12 (3 weeks): September 20-24 + October 11-15 + November 15-19 Training Classes in Other Cities

The Southeastern Quality Conference will be held at the Cobb Galleria Centre in Atlanta, Georgia on October 18-19, 2004. The conference is sponsored by the Atlanta Section of the American Society for Quality, Institute of Industrial Engineers, and Georgia Tech Economic Development Institute.

Thirty speakers in multiple conference tracks will present quality subjects across a variety of industry sectors. The price is only $275 with early registration (before September 6, 2004) and includes lunch both days. See the conference brochure in PDF format at <http://www.asqatlanta.org>.

A partial list of the thirty speakers includes:

• Larry Whittington - ISO 9001:2000 Document and Record Control: Basic Requirements and Industry Views
  

• Ed Fangman - ISO 9001:2000 Achieves High Marks: Success Story at a Registered High School
  

• Paula Hughey - ISO 9001:2000 Auditing: The Process Approach
  

• Richard Barish, Kathy Greer, Beth Wilbanks, and Kathleen Thomas - The Real Benefits of ISO 9001:2000 - Management Reps Speak Out!

• Craig Cochran - Customer Satisfaction: Tools and Techniques

• Michelle Samuels - A SOXy (Sarbanes-Oxley) Approach to Continuous Improvement

• Elliot Price - Lean Tools and Techniques for Process Improvement

You can see the abstracts for these and other conference sessions at: <http://www.asqatlanta.org>.
Please contact Larry Aft at 404-786-1541 or laft@bellsouth.net to register for the conference.

In past newsletters, we have covered Syntax, Vocabulary, Complexity, Numbers, Format, and Style from our list of writing concepts. This month we pick up with Organization and Conditions.

• Syntax: the arrangement of words

• Vocabulary: the choice of words

• Complexity: the level of detail

• Numbers: the presentation of numerical information

• Format: the way a document looks

• Style: conversational and emphasis methods

• Organization: the grouping of process information

• Conditions: the decision criteria

• Lists: related items, possibly in sequence 

• Alerts: For warnings, cautions, and notes
  

The way information is organized can be as important as the information itself.

Logical Hierarchy
Organize documents for a logical hierarchy of information.

Task Orientation
Focus on the tasks to be performed and group related steps in the same section to avoid the reader having to jump around the document.

Heading Usage
Name the document sections with headings that help the reader comprehend the structure and access information.

Table of Contents
If the document is more than a few pages (as with a quality manual), use a table of contents to help the reader locate subjects quickly by page number.

Step Numbering
Number steps in a process to 1) indicate they are steps, 2) help locate specific steps, and 3) show how steps and sub-steps are related in a hierarchy.

Appendix Usage
Use appendices and attachments to present information that cannot be easily included in the main body of the document. Attachments can incorporate lengthy contingency actions, data sheets, process flowcharts, and sample forms.

Document Identification
Design the document so its first page includes the process name, number, and revision level. When readers look at a document, they should know what process it covers and if it is the current version.
 

In some documents, you must direct the reader to perform an action if a certain condition exists. To avoid confusion, clearly specify the condition to be met and the action to be taken.

Logic Rules
Use IF or WHEN to present the condition and THEN to present the action. For example, “IF the alarm sounds, THEN immediately evacuate”. Always present the condition first, then the action.

Consistent Terminology
Use consistent terminology. Remember, IF signals a condition that may occur, whereas WHEN implies a condition that is likely to happen.

Flowchart Decisions
Flowcharts can be used to visually depict the conditional steps. The condition is described in the decision symbol (diamond) and the different actions shown as lines to the applicable process steps.

Logic Tables
Consider using logic tables to simplify complex conditional information. Logic tables put conditions in one column and actions in the corresponding column.

Microsoft recently announced a Business Scorecard addition to their suite of Office Solution Accelerators.

Accelerator for Business Scorecards
Simplify the creation and management of business scorecards to achieve faster, better decisions aimed at improving business performance.
 
Accelerator for Sarbanes-Oxley
Better manage compliance initiatives related to the Sarbanes-Oxley Act by having more visibility over your company's financial processes and controls.
 
Accelerator for Six Sigma
Deliver faster financial and operational benefits from your investments in the Six Sigma methodology.
 
Although the Accelerators are free, they require one or more programs, servers, or services in the Microsoft Office System. The actual requirements depend on each Accelerator. The most common requirements, however, are Office 2003 Editions, Windows® SharePoint Services, and SharePoint Portal Server 2003.

ISO Technical Committee 176 established a web site for ISO 9001:2000 interpretations at <http://www.tc176.org/Interpre.asp>. Their initial set of 14 interpretations were included in our January 2004 newsletter. The ISO 9001:2000 interpretations added since that time are shown below.

ISO 9001:2000 Interpretation RFI – 026
Request: ISO 9001:2000 Clauses: 4.2.2 c) and 4.1 b)
Does Clause 4.2.2 c), require that the manual include a description of the processes, in addition to a “description of the interaction between the processes of the QMS ”?
Background: Attention is also drawn to the connection between Clause 4.2.2 c) and Clause 4.1 b), where the organization is required to “determine the sequence and interaction” of the processes. On this problem of interpretation there is a divergence of opinion between an organization and a Certification Body.
Interpretation: No

ISO 9001:2000 Interpretation RFI – 001
Request: ISO 9001:2000 Clause: 4.2.3 a)
Does documented purchasing information that is part of the quality management system, have to be approved according to 4.2.3 a)?
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 004
Request: ISO 9001:2000 Clause: 4.2.3 a)
Do documented inspection and test procedures that are part of the quality management system, have to be approved according to 4.2.3 a)?
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 021
Request: ISO 9001:2000 Clause: 5.4.2
Is it a requirement of Clause 5.4.2 to have a document that describes the objectives, timeframe, action and responsibilities? (Note: The description of this document is not the same as the definition of “Quality Plan” in ISO 9000:2000, paragraph 3.7.5)
Background: Some users interpret Clause 5.4.2 of the standard to require a document (quality plan) that describes the objectives and the responsibilities etc. This is in addition to the quality manual and procedures document already established to control the relevant processes.
Interpretation: No

ISO 9001:2000 Interpretation RFI – 003
Request: ISO 9001:2000 Clause: 6.3
Does Clause 6.3 require records of the maintenance of infrastructures?
Interpretation: No

ISO 9001:2000 Interpretation RFI – 022
Request: ISO 9001:2000 Clause: 7.1
Does the use of the word “form” in the last sentence of this clause, mean that the output of the planning process must be documented?
Background: There has been some confusion due to the word “form” being interpreted as meaning “document used to record data”.
Interpretation: No
Rationale: The word “form” means usual/suitable format.

ISO 9001:2000 Interpretation RFI – 009
Request: ISO 9001:2000 Clause: 7.2.1 a)
Does the word “specify” or “specified” quoted in various clauses require documentation? Clauses 7.2.1 a) and b), 7.3.3 d), 7.3.6 and others.
Interpretation: No
Rationale: A relevant example to support the answer is in the definition of procedure (ISO 9000:2000, 3.4.5), “specified way to carry out an activity or process (3.4.1)”, with “Note 1 Procedures can be documented or not”.

ISO 9001:2000 Interpretation RFI – 002
Request: ISO 9001:2000 Clause: 7.4.3
Does Clause 7.4.3 require records of the verification of purchased product?
Interpretation: No

ISO 9001:2000 Interpretation RFI – 039
Request: ISO 9001:2000 Clause: 7.6 a)
Clause 7.6 a) states: “Where necessary to ensure valid results, measuring equipment shall a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.” Can the word “OR” in the phrase “be calibrated or verified at specified intervals….” be interpreted as meaning that these two activities are always mutually exclusive?
Background: According to the concept of metrological confirmation established in ISO 10012:2003 (e.g. Figure 2 Metrological confirmation process for measuring equipment) for carrying out verification activities, it is indispensable to define the measuring equipment metrological requirements, and the latter are compared against the results of calibration activities.
Interpretation: No
Rationale: Calibration and verification can both be applicable depending on the situation.

ISO 9001:2000 Interpretation RFI – 034
Request: ISO 9001:2000 Clause: 8.2.1
In the situation described in the background information, does the standard require an organization to consider also the end user as a customer for monitoring satisfaction?
Background: An organization designs and manufactures a product to its own specifications and sells it to end users through a distribution chain. It is not technically modified between the organization and the end user. The end user can identify the organization through the use of a brand name or a trademark. The organization has contracts with distributors, which in turn sell to stores where end users buy the product.
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 016
Request: ISO 9001:2000 Clause: 8.3
When an organization detects, after delivery or after use has started, a product which does not conform to one of the “requirements specified by the customer” (Clause 7.2.1 a)), does the standard require that the organization inform the customer of the nonconforming product?
Interpretation: No
Rationale: The last paragraph of Clause 8.3 specifies that it is the organization’s responsibility to take appropriate action regarding the nonconforming product.

ISO 9001:2000 Interpretation RFI – 017
Request: ISO 9001:2000 Clause: 8.3
When an organization detects, after delivery or after use has started, a product which does not conform to one of the “statutory and regulatory requirements related to the product” (Clause 7.2.1 c)), does the standard require that the organization inform the competent authority of the nonconforming product? Interpretation: No
Rationale: The last paragraph of Clause 8.3 specifies that it is the organization’s responsibility to take appropriate action regarding nonconforming product.

ISO 9001:2000 Interpretation RFI – 024
Request: ISO 9001:2000 Clause: 8.5.1
Does the continual improvement of the QMS required by Clause 8.5.1 also cover the “improvement of the product related to customer requirements” required by Clause 5.6.3 b) to be included as an output of the management review?
Background: Clause 5.6.3 mentions in bullet a), the improvement of the “effectiveness of the quality management system” and adds, in bullet b), the “improvement of the product related to customer requirements”. Clause 8.5.1 requires only the “improvement of the effectiveness of the quality management system”, with no mention to the “improvement of the product related to customer requirements”.
Interpretation: No

Want to locate a registered supplier anywhere in the world? Access <http://www.whosregistered.com>. This free site maintained by QSU Publishing Company is the largest international listing of ISO 9001 and ISO 14001 certificate holders.

As part of this global online service, the site includes the entire worldwide database of some 50,000 certificates issued by British Standards Institution (BSI), the world’s largest issuer of third-party management systems certificates. In addition, the database holds another 80,000 listings from other registrars and is receiving additional entries daily (for an overall total of more than 130,000 listings). There is no charge for registered companies to be included. However, the information must come from a recognized registrar to ensure the integrity of the listings.

Records in the database provide the following information:

• Company Name

• Division

• City

• State or Province

• Country

• Registrar

• Standard - ISO 9001, ISO 14001, and sector-specific (e.g., ISO/TS 16949, AS9100, TL 9000, and ISO 13485)

• Certificate Number

• Product or Service (Scope of Registration)

Note: You can search the database on the fields shown above in bold.

To enroll in these public classes, go to Class Schedule at our web site, or call us at 800-404-7585. Classes taught by Larry Whittington are shown in yellow.

ISO 9001:2000 Lead Auditor (RAB Accredited) - BSI Management Systems
Initial course version developed by Larry Whittington

ISO 9001:2000 Internal Auditor (RAB Accredited) - BSI Management Systems

September	October	November
21-23  Atlanta, GA	13-15  Chicago, IL	16-18  Atlanta, GA
22-24  Charlotte, NC	- -	16-18  San Jose, CA

ISO 9001:2000 Auditor Update - The Process Approach
Course developed by Larry Whittington

Implementing ISO 9001:2000
Course developed by Larry Whittington

September	October	November
16-17  Atlanta, GA	25-26  Chicago, IL	08-09  Reston, VA
23-24  Los Angeles, CA	- -	- -

Understanding ISO 9001:2000

September	November
17  Kansas City, MO	15  San Jose, CA

Understanding ISO 9001:2000 Requirements (Atlanta Only - $295)
Course developed by Larry Whittington

September	November
13  Atlanta, GA	29  Atlanta, GA

Quality System Documentation (ISO 9001:2000)
Course developed by Larry Whittington

September	December
14-15  Atlanta, GA	09-10  San Diego, CA
30-01  Pittsburgh, PA	- -

The above public courses can be offered on-site at your facility. In addition, we offer these on-site courses:

• Understanding ISO/TS 16949:2002 Requirements (1 Day) - Course developed by Larry Whittington

• Internal Quality Auditing (2 Days) - Course developed by Larry Whittington (based on ISO 19011)

• AS9100B: Requirements Beyond ISO 9001:2000  (1 Day) - Course developed by Larry Whittington

To arrange an economical on-site class, please call us at 800-404-7585.

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All Rights Reserved.
242 Highlands Drive, Woodstock, GA 30188
770-517-7944 or fax 770-517-7945

 
Whittington & Associates provides training, consulting and auditing services for quality systems based on
ISO 9001, ISO/TS16949, TL9000, AS9100, ISO 13485, as well as, ISO 27001, ISO 20000, ISO 22000, and ISO 14001.