ISO 9001 review

ISO 9001 review is currently being undertaken by ISO/TC176, the umbrella ISO committee for quality management and assurance. The committee draft will be issued in anytime now with drafts for comment published in the second half of 2007 with publication of the revised standard planned for late 2008. The key messages coming out of the process to date are that:

• the current scope and purpose of the standard, the title and the field of application shall remain unchanged from ISO 9001:2000
• given that the current standard was a step change from its predecessor and caused considerable changes to businesses, changes will be limited in this review
• it will remain generic so that it can be applied to all types and sizes of organisation. This one-size-fits-all approach will see the continued growth of sector-specific requirements and schemes
• any changes introduced must provide clear benefits to users
• the quality management principles (as contained in ISO 9000) shall be applied unchanged
• the process model, as shown in ISO 9001:2000 figure 1 below, shall remain unchanged

I’m led to believe that some of the changes are:

• clause 1.2 – clarify the intent of this clause in relation to when exclusions can be made in clause 7 specifically for service organisations
• clause 5 – consider clarification of application of the process approach to top management
• clause 5.4.2 – consider the clarification of quality management system planning in order to meet the quality objectives
• clause 8.2.1 – clarify the requirement for client perception (monitoring versus measurement)
• clause 8.3 – clarify this clause in relation to service organisations
• clause 8.5 – clarify the differences in concepts between corrective action and preventive action

There has been global growth in certification of 18 per cent across 161 countries.

The top five countries for ISO 9001 certification are:

1. China (143,823)
2. Italy (98,028)
3. Japan (53,771)
4. Spain (47,445)
5. UK (45,612)

with India seeing the largest growth of over 12,000 a year.

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Six Sigma: Can DMAIC be improved?

According to Manufacturing Talk:

Root cause analysis is now becoming well established as a structured method for investigating equipment failure and coming up with a sustainable solution.

One of the main tools I’ve used to establish the root cause of issues is the 8 Disciplines (8D) approach,sometimes also referred to as “Team-Oriented Problem Solving” (TOPS). This approach was developed within Ford Motor Company in the 1980s. As the names imply, the approach involves a cross-functional team following eight guidelines (or steps) that have been designed to enable the team to understand a problem, resolve it and take steps to prevent the same or similar problems from recurring in the future. The approach consists of the following 8 Disciplines (8Ds):

1. Use Team Approach: Establish a small group of people with the knowledge, time, authority and skill to solve the problem and implement corrective actions. The group must select a team leader.
2. Describe the Problem: Describe the problem in measurable terms. Specify the internal or external customer problem by describing it in specific terms.
3. Implement and Verify Short-Term Corrective Actions:
   Define and implement those intermediate actions that will protect the customer from the problem until permanent corrective action is implemented. Verify with data the effectiveness of these actions.
4. Define and Verify Root Causes: Identify all potential causes which could explain why the problem occurred. Test each potential cause against the problem description and data. Identify alternative corrective actions to eliminate root cause.
5. Verify Corrective Actions:
   Confirm that the selected corrective actions will resolve the problem for the customer and will not cause undesirable side effects. Define other actions, if necessary, based on potential severity of problem.
6. Implement Permanent Corrective Actions:
   Define and implement the permanent corrective actions needed. Choose on-going controls to insure the root cause is eliminated. Once in production, monitor the long-term effects and implement additional controls as necessary.
7. Prevent Recurrence: Modify specifications, update training, review work flow, improve practices and procedures to prevent recurrence of this and all similar problems.
8. Congratulate Your Team: Recognize the collective efforts of your team. Publicize your achievement. Share your knowledge and learning.

You can view a flowchart of this process here and can grab a copy of a Global 8D form here.

DMAIC-8D Integration

Opinions vary regarding the feasibility of integrating the DMAIC approach with the 8D methodology. In the book Implementing Six Sigma: Smarter Solutions Using Statistical Methods the authors state that:

Tools normally associated with the Six Sigma DMAIC method, for example, Design of Experiments (DOE), could be referenced within the 8D process to help identify and then verify fixes to problems as part of the validation process.

David Hoyle in his book ISO 9000 Quality Systems Handbook suggests that the 8D approach helps to address the measurement, analysis and improvement section of ISO 9001. Whereas Revelle, in the book Manufacturing Handbook of Best Practices: an Innovation, Productivity, and Quality Focus: An Innovation, Productivity, and Quality Focus states that:

8D has not been a major part of management strategy; instead it is controlled closer to the teams.

I personally believe that the 8D approach can be integrated with the DMAIC framework. However as stated above, there has been a lot of discussion on whether this is possible or not. It has been suggested that although quick wins are allowed within the DMAIC methodology, management impatience requires more flexible solutions, depending on the situation. This is where the emergency response actions and interim containment plans detailed in the 8D program would be of benefit.

This graphic explains how the eight stages of the 8D approach and the DMAIC framework could be integrated:

What do you think? Is integration possible? If not, why?

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Battle of the Improvement Systems

In this post I’ll be exploring the differences between ISO 9001, Total Quality Management (TQM) and Six Sigma, along with how both 9001 and TQM could be combined with the power of Six Sigma.

Six Sigma builds upon many of the successful elements of the previous quality improvement strategies and incorporates unique methods of its own. Compared to other quality management and improvement systems, Six Sigma stands out as a methodology for identifying the causes of specific quality problems and solving those problems. Six Sigma can often be used to complement other quality management or improvement systems.

Indeed this paper suggests that Six Sigma should be integrated with established quality concepts whereby quality management systems are the most disseminated approaches. However, it notes that,

“… The challenge is to combine conveniently aspects of both approaches to reach a maximum benefit through a targeted application …”

ISO 9001 objectives

ISO 9001 is a Quality Management System, which includes specialized quality management standards for specific industries. A Quality Management System is a system of clearly defined organizational structures, processes, responsibilities and resources used to assure minimum standards of quality and can be used to evaluate an organizations overall quality management efforts. An ISO 9001 certification assures a company’s customers that minimum acceptable systems and procedures are in place in the company to guarantee that minimum quality standards can be met.

Comparison with Six Sigma

ISO 9001 and Six Sigma serve two different purposes. ISO 9001 is a quality management system while Six Sigma is a strategy and methodology for business performance improvement.

ISO 9001, with guidelines for problem solving and decision making, requires a continuous improvement process in place but does not indicate what the process should look like while Six Sigma can provide the needed improvement process. Meanwhile, Six Sigma does not provide a template for evaluating an organization’s overall quality management efforts whereas ISO9001 does.

Combining Six Sigma with ISO

Six Sigma provides a methodology for delivering certain objectives set by ISO such as:

1. prevention of defects at all stages from design through servicing;
2. statistical techniques required for establishing, controlling and verifying process capability and product characterization;
3. investigation of the cause of defects relating to product, process and quality system;
4. continuous improvement of the quality of products and services.

Six Sigma supports ISO and helps an organization satisfying the ISO requirements. Further, ISO is an excellent vehicle for documenting and maintaining the process management system involving Six Sigma. Besides, extensive training is required by both systems for successful deployment.

TQM objectives

Total Quality Management (TQM) is a structured system for satisfying internal and external customers and suppliers by integrating the business environment, continuous improvement, and breakthroughs with development, improvement, and maintenance cycles while changing organizational culture. TQM aims for quality principles to be applied broadly throughout an organization or set of business processes. In the book, What Is Six Sigma? Pande and Holpp state,

“… In the 1980s, Total Quality Management (TQM) was popular. It too was an improvement-focused program, but it ultimately died a slow and silent death in many companies. …”

Why? Well, in the book The Six Sigma Handbook Pyzdek states,

“… In many TQM programs of the past people were unable to point to specific bottom-line benefits, so interest gradually waned …”

So how does TQM compare with Six Sigma?

Comparison with Six Sigma

TQM and Six Sigma have a number of similarities including the following:

1. A customer orientation and focus
2. A process view of work
3. A continuous improvement mindset
4. A goal of improving all aspects and functions of the organizations
5. Data-based decision making
6. Benefits depend highly on effective implementation

A key difference between TQM and Six Sigma is that Six Sigma focuses on prioritizing and solving specific problems which are selected based on the strategic priorities of the company and the problems which are causing the most defects whereas TQM employs a more broad based application of quality measures to all of the company’s business processes.

Another difference is that TQM tends to apply quality initiatives within specific departments whereas Six Sigma is cross functional meaning that in penetrates every department which is involved in a particular business process that is subject to a Six Sigma project.

TQM also provides less methodology in terms of the deployment process whereas Six Sigma’s DMAIC framework provides a stronger platform for deployment and execution. For example, Six Sigma has a much stronger focus on measurement and statistics which helps the company define and achieve specific objectives.

Combining TQM with Six Sigma

Six Sigma is complementary to TQM because it can help to prioritize issues within a broader TQM program and provides the DMAIC framework which can be used to meet TQM objectives.

Is your quality system integrated with Six Sigma or do you apply the principles of TQM in a Six Sigma environment? What have been your experiences? Leave a comment below.

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