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Whittington Newsletter )
QMS, EMS, Information Security, Services Management, and Six Sigma June 2008
In this Issue
  1. Safer at Work or Home?
  2. Document Control Software Features
  3. Code of Conduct for Internal Auditors
  4. Lean Software Development
  5. Incident and Problem Management
  6. Class Schedule

Greetings!

Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site.

Our newsletters provide guidance on ISO 9001, AS9100, ISO 13485, ISO/TS 16949, TL 9000, ISO 14001, ISO 27001, ISO 20000, ISO 22000, and related ISO standards, as well as, Six Sigma.

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.


Safer at Work or Home?

The idea of on-the-job safety has been incorporated into business policies and culture for decades. And, injuries at work have been lowered substantially. However, companies are now recognizing that a more serious threat exists: off-the-job injuries.

According to the National Safety Council, for every person killed at work, 11 are killed away from work. And, for every person suffering a disabling injury on the job, two people are similarly injured off the job.

Off-the-job injuries cause people to miss more than 3 times as many days from work as those suffered on-the-job. The cost of these off-the-job injuries exceeds those at work by $80 billion each year.

As a result of these statistics, organizations are now talking "Safety 24/7". They recognize that safety awareness shouldn't be turned off when an employee leaves for home.

To read more about off-the-job safety programs, see "Staying Clocked In", an article written by Kyle Morrison, an associate editor with Safety + Health. For more information on the National Safety Council, which publishes Safety + Health, go to their web site: http://www.nsc.org.

To get a free subscription to Safety + Health, go to this magazine web site. Note: If you order the magazine from the NSC web site, you will pay for the subscription.

Document Control Software Features

Are people in your organization spending too much time filing and retrieving documents and forms? Are document control issues causing process problems and audit findings? Maybe it is time to implement a document management system.

The most important consideration when evaluating document management software is how easy is it to create, approve, release, secure, access, revise, and archive documents.

Basic and advanced features of a document management system are listed below:

Document Creation

  • Support different document types
  • Store in original document formats
  • Provide customizable layout options
  • Offer manual or automated numbering
  • Provide use of prefix and suffix
  • Import existing documents and forms
  • Offer scanning of hard copy records
  • Allow linking of related documents
Approval Routing
  • Include automated routing and approval
  • Provide unique approvals per document
  • Monitor document approval status
  • Route documents serially or in parallel
  • Support routing for team collaboration
  • Send reminder notes for document reviews
  • Issue management escalation notices
Document Release
  • Distribute document files electronically
  • Record and display electronic signatures
  • Convert documents to PDF format
  • Track hardcopy document distribution
Document Retrieval
  • Define user access per document
  • Provide search and view queries
  • Filter and sort to locate and print
  • Link related documents together
  • Offer full text database searches
  • Allow controlled remote access
Revision Control
  • Provide automated periodic reviews
  • Keep records of completed reviews
  • Include a change request process
  • Offer customized approval process
  • Produce master list reports
  • Archive old document revisions
  • Restore an archived document
  • Link to process training requirements
  • Send notices of review requests
  • Maintain document history
  • Track revision times and trends
Document Security
  • Provide password protection
  • Include multi-layered user access
  • Allow use of electronic signatures
  • Permit document encryption
  • Prevent unauthorized viewing
  • Keep audit trails of user access
  • Offer proof files are unaltered
Software Selection
  • Look at software buyer guides
  • Try a trial CD or online demo
  • Focus on software ease-of-use
  • Count the clicks and screens
  • Evaluate multi-user license
  • Identify available support
  • Consider product upgrades
  • Determine price and fees
  • Consider modular feature design
  • Examine scalability for growth
  • Look at user references
  • Evaluate industry sector solutions
  • See if built-in ISO, TS, AS, TL support
  • Evaluate training and installation help
  • Decide if client-server or application service provider (ASP)
  • Consider monthly usage fee, if ASP
  • Determine fee to export if quit ASP
  • Check integration with other applications
  • Consider SOX compliance (Finance)
  • Consider HIPAA privacy (Health)
  • Consider 21 CFR requirements (Medical)
Installation Steps
  • Install software product
  • Learn software operation
  • Customize for your system
  • Establish naming convention
  • Define access and security
  • Create new documents
  • Run some simple tests
  • Pilot a single application
  • Train users on its operation
  • Scan hardcopy files (as needed)
  • Import electronic documents
  • Respond to usage issues
Benefits
  • Quicker to create documents
  • Faster to approve documents
  • Awareness of document changes
  • Secure documents and records
  • Quicker access to documents
  • Only most recent version available
  • Access while employees travel
  • Access by suppliers and customers
  • Fewer obsolete documents
  • Opportunity for more collaboration
  • Automation of tedious tasks
  • Less costly document control
  • Reduced business process times
  • Frees up time for core business
  • Reduced number of audit findings
You may want to know which software product I recommend. I don't. Although I've seen a lot of software solutions, the best choice will depend on your document management needs, your industry requirements, if you or an ASP will provide the host, the need to integrate with other applications, and what you are willing to pay.

Code of Conduct for Internal Auditors

Ethics are the principles of conduct governing an individual or a group. Ethical behavior is the foundation of professionalism.

Auditors certified by the RABQSA are required to sign a Code of Conduct. Most internal auditors are not certified auditors, yet it would be appropriate for them to also sign a code of conduct.

Years ago, I created a Code of Conduct for internal auditors based on the IIA Code of Ethics, the RABQSA Code of Conduct, and the IRCA Code of Conduct. I recently examined the current codes from these organizations, as well as, considered the ISO 19011 Audit Principles and the Auditor Ethics paper from the ISO 9001 Auditing Practices Group, to update my Internal Auditor Code of Conduct.

Audit program managers could ask their internal auditors to sign this code of conduct each year to emphasize the importance of adhering to the principles and ethics of the organization.

Purpose
To communicate the integrity, objectivity, confidentiality, and competence expected of internal auditors, as well as, to provide a means for them to pledge their commitment to these principles.

Integrity
The integrity of internal auditors establishes trust and provides the basis for relying on their judgment. As an internal auditor, I pledge to:

1. Perform my audit assignments with honesty, accuracy, fairness, and discretion.
2. Not engage in activities that might discredit the audit program or our organization.
3. Report audit results truthfully and disclose any unresolved diverging opinions.
4. Act in a professional and courteous manner, even under adverse audit conditions.

Objectivity
Internal auditors must be objective in gathering, evaluating, and communicating information about the activities being examined. They must make a balanced and impartial assessment of all the relevant facts and not be unduly influenced by their interests, or those of others, in making judgments. As an internal auditor, I pledge to:

5. Disclose any activity or relationship that may affect my unbiased assessment.
6. Not accept anything that may impair, or appear to impair, my judgment.
7. Include all the material facts to avoid any distortion of my audit report.

Confidentiality
Internal auditors must respect the value and ownership of the information they receive and not disclose it without the appropriate authority, unless obligated for legal or professional reasons. As an internal auditor, I pledge to:

8. Be prudent in the use and protection of the information acquired during my audit duties.
9. Not use the information for personal gain or in any way detrimental to the organization.

Competence
Internal auditors must apply their knowledge, skills, and experience in the performance of their assessment duties. As an internal auditor, I pledge to:

10. Accept assignments only if I possess the necessary knowledge, skills, and experience.
11. Perform audits in accordance with the procedures and practices of the organization.
12. Continually improve my proficiency and the quality and value of my audit services.
13. Assist other auditors under my supervision to develop their audit management skills.
14. Use my auditing knowledge to help improve the quality of our products and services.
15. Prepare well for my audit assignments and report findings using verifiable evidence.

I agree to act in accordance with this code of conduct to uphold the integrity of our audit program and the ethical standards of our organization.

Signed by: __________________________
Printed Name: _______________________
Date: ______________________________


If you have any comments or suggestions for the proposed Internal Auditor Code of Conduct, please send them to Larry@WhittingtonAssociates.com.

Lean Software Development

Software development can greatly improve its business performance by discovering and embracing its kinship to classic (non-software) industries. Perhaps the most important thing software has to gain is guidance on how to implement Lean production.

Lean production has, on average, doubled productivity and tripled quality for the classic industries. According to James M. Sutton with Lockheed Martin Aeronautics, early applications of Lean to software have exceeded those results.

Software development is an ideal subject for Lean because its product is pure information that lacks the physical limitations of durable goods, as well as, most of the soft issues of service activities. In software development, Lean can remain focused on the primary issues of value and waste. This allows the Lean tools to work with unusual effectiveness.

One of the biggest challenges for software development approaches has been to keep up with the growth in size and rigor of customer systems. Lean scales up easily for large systems. It works well in plan-ahead life cycles such as the Department of Defense acquisition system. Lean also provides the evidence and assurance needed for safety-critical and high-security applications. These capabilities make it well-suited for the defense and aerospace domains, and for most other domains as well.

Mr. Sutton says it is time for software to take its place as a classic industry and leverage the strengths of Lean production. Lean enables faster code production, smoother integration with other products, fewer surprises to budget and schedule, better quality, and happier customers. Lean converts software from management's biggest worry into one of its best means for assuring business success. Embracing Lean ushers software into the fold of classic industry as a welcome and synergistic partner.

For more information, see Mr. Sutton's article, "Welcoming Software Into the Industrial Fold", in the May 2008 issue of CrossTalk, the Journal of Defense Software Engineering.

Incident and Problem Management

The ISO 20000 standard for IT Service Management includes requirements for incident and problem management.

Incident and problem management are separate resolution processes, but they are closely linked. Incident management deals with restoring services to users. Problem management is concerned with identifying and removing the causes of incidents.

Incident Management
An incident is defined as any event which is not part of the standard operation of a service and which causes or may cause an interruption to, or a reduction in, the quality of that service.

The ISO 20000-1 Specification standard requires the following steps be taken for incident management:

  • Record all incidents
  • Adopt procedures to manage the impact of incidents
  • Define in procedures the recording, prioritization, business impact, classification, updating, escalation, resolution, and formal closure of all incidents
  • Keep the customer informed of the progress of their reported incident or service request and alerted in advance if their service levels cannot be met and an action agreed
  • Give access to all staff involved in incident management to relevant information such as known errors, problem resolutions, and the configuration management database
  • Classify and manage major incidents according to a process
The ISO 20000-2 Code of Practice reminds us that incidents may be reported by telephone calls, voice mails, visits, faxes, letters, or emails. They can also be recorded directly by users that have access to your incident recording system, or by automatic monitoring software.

The incident management process should include priority assignment and first line resolution or referral. In addition, the process should address security issues, incident tracking, incident verification and closure, and escalation paths.

The incident management staff should have access to an up-to-date database containing information on technical specialists, previous incidents, known errors, workarounds, and checklists that will help them restore service to the business.

Final closure of an incident should only take place when the initiating user has been given the opportunity to confirm the incident has been resolved and service restored.

Problem Management
A problem is defined as an unknown underlying cause of one or more incidents.

The objective of problem management is to minimize disruption to the business by proactive identification and analysis of the cause of incidents and by managing problems to closure.

The ISO 20000-1 Specification standard requires the following steps be taken for problem management:
  • Record all identified problems
  • Adopt procedures to identify, minimize, or avoid the impact of incidents and problems
  • Define in procedures the recording, classification, updating, escalation, resolution, and closure of all problems
  • Take preventive actions to reduce potential problems, e.g., following trend analysis of incident volumes and types
  • Pass to the change management process any changes required to correct the underlying cause of problems
  • Monitor, review, and report on effectiveness of problem resolution
  • Ensure problem management is responsible for making up-to-date information on known errors and corrected problems available to incident management
  • Record actions for improvement identified during this process and input into a plan for improving the service
The ISO 20000-2 Code of Practice says that incidents should be classified to help determine the causes of problems. And, when the root cause has been identified, along with a method of resolving the incident, the problem should be classified as a known error.

Known errors should be recorded in the knowledge database together with any workarounds. Information on workarounds, permanent fixes, and problem status should be communicated to those affected and those that support the affected services.

The problem management process should cover identifying any incidents that breach service level targets, as well as, defining escalation points and recording resources used and any actions taken.

Problem reviews should be held to investigate unresolved, unusual, or high impact problems. These reviews look for process improvements to prevent recurrence of the incidents, and to examine incident levels against service targets.

We offer ISO 20000 courses that explain the following topics:

Service Delivery
capacity management
service continuity
availability management
service level management
service reporting
information security management
budgeting and accounting for IT services

Control Processes
configuration management
change management

Release Processes
release management

Resolution Processes
incident management
problem management

Relationship Processes
business relationship management
supplier management

ISO 20000 Class Schedule
Understanding ISO 20000
Implementing ISO 20000
ISO 20000 Internal Auditor

Class Schedule

ISO 9001:2000
Understanding ISO 9001:2000
Implementing ISO 9001:2000
Quality System Documentation
ISO 9001:2000 Internal Auditor
ISO 9001:2000 Lead Auditor

ISO 14001:2004
Implementing an EMS
ISO 14001:2004 Internal Auditor
ISO 14001:2004 Lead Auditor

ISO/TS 16949:2002
ISO/TS 16949:2002 Internal Auditor
ISO/TS 16949:2002 Lead Auditor
Understanding and Implementing ISO/TS 16949:2002

AS9100B:2004
AS9100 Internal Auditor
Implementing AS9100
AS9100 Lead Auditor

ISO 27001 / ISO 17799
ISO 27001 - Understanding an ISMS
ISO 27001 - ISMS Implementation
ISO 27001 - ISMS Internal Auditor
ISO 27001 - ISMS Lead Auditor

ISO 20000
Understanding ISO 20000
Implementing ISO 20000
ISO 20000 Internal Auditor

ISO 22000
Understanding ISO 22000
ISO 22000 Internal Auditor
Understanding HACCP
Implementing SQF Systems
Advanced HACCP

ISO 13485:2003
Understanding ISO 13485:2003
ISO 13485:2003 Internal Auditor
Implementing ISO 13485:2003
ISO 9001 Lead Auditor - ISO 13485 Emphasis

Capability Maturity Model Integration
Introduction to CMMI v1.2

Six Sigma
Introduction to Statistics
Green Belt Certification
Black Belt Certification

Books
See our list of ISO 9001, Auditing, and Six Sigma books. Includes book descriptions and links to Amazon.

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