Thursday, March 31, 2011

Six Sigma methodologies :: DMAIC and DMADV

  DMAIC Vs DMADV

DMAIC and DMADV are two Six Sigma methodologies that eliminate defects from a process or product. It’s important to understand DMAIC and DMADV and when it is most appropriate to use each methodology.

Everything in business is a process. Sales people have a list of companies and contacts that they work in a certain fashion to produce a sale, production receives an order and schedules the manufacturing, the product is built, packaged, shipped and invoiced. If the packing department has a problem with their process then should they fix it with a DMAIC or DMADV (also referred to as DFSS) type project?

The Similarities of DMAIC and DMADV

Let's first look at the DMAIC and DMADV methodologies and talk about how they're alike. DMAIC and DMADV are both:
  • Six Sigma methodologies used to drive defects to less than 3.4 per million opportunities.
  • Data intensive solution approaches. Intuition has no place in Six Sigma -- only cold, hard facts.
  • Implemented by Green Belts, Black Belts and Master Black Belts.
  • Ways to help meet the business/financial bottom-line numbers.
  • Implemented with the support of a champion and process owner.

The Differences of DMAIC and DMADV

DMAIC and DMADV sound very similar. The acronyms even share the first three letters. But that's about where the similarities stop.

DMAIC
Define
Define the project goals and customer (internal and external) deliverables

Measure
Measure the process to determine current performance

Analyze
Analyze and determine the root cause(s) of the defects

Improve
Improve the process by eliminating defects

Control
Control future process performance

DMADV
Define
Define the project goals and customer (internal and external) deliverables
Measure
Measure and determine customer needs and specifications
Analyze
Analyze the process options to meet the customer needs
Design
Design (detailed) the process to meet the customer needs
Verify
Verify the design performance and ability to meet customer needs







When to Use DMAIC

The DMAIC methodology, instead of the DMADV methodology, should be used when a product or process is in existence at your company but is not meeting customer specification or is not performing adequately.

When to Use DMADV

The DMADV methodology, instead of the DMAIC methodology, should be used when:
  • A product or process is not in existence at your company and one needs to be developed
  • The existing product or process exists and has been optimized (using either DMAIC or not) and still doesn't meet the level of customer specification or six sigma level

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Tuesday, March 29, 2011

Case Study :: how a process was digitized to produce fewer defects through the use of Six Sigma tools.

Case Study

A case study describing how a process was digitized (converting paper documents into electronic documents) to produce fewer defects through the use of Six Sigma tools.

This work described below was carried out in a large company based in the US and India. The project dealt with converting printed paper from US customers into electronic copies. The material was quite heterogeneous in nature - consisting of assorted magazines and legal papers. It is part of an ongoing operation that services several customers. The results obtained have wide applicability in the back rooms of industries processing large amounts of data - IT enabled services, banks, insurance companies, hospitals etc. - and computer based office processes.

This project was taken up as a demonstration example within the framework of building a Six Sigma mind-set in the organization, while training a core group in the use of the techniques and the teamwork required. The problem solving methodology consisted of seven steps, combined with quality tools to create a dramatic improvement in the quality of the output far beyond the expectations of anyone in the organization.

The narrative unfolds in the same sequence as the project followed - through each of the seven steps of problem solving accompanied by education in and application of the six sigma techniques relevant to the problem.

1. Selection of the Problem

1.1) A meeting of the senior management of the company was held and a brainstorming session produced a list of over 30 problems. These were classified into two categories:
  • "End result" problems faced by the external customers
  • Internal problems that were causes of customer problems rather than basic problems themselves.
The realization that the first category of problems was the one to be attacked (customer focus) came spontaneously.

Then prioritization was done to select the most important problem using the weighted voting system followed by a quick discussion to produce a consensus. The theme (CTQs) selected was "Consistency of Quality and Timeliness".

1.2) The problem area: Within the theme, intuitively the management recommended a particular customer line. When asked to collect data for different customer lines and present it, to their surprise they found that another major line had a bigger problem. This was the line selected. The realization of the importance of data based had begun!

1.3) Definition of the problem: Data (including errors) was collected for 30 days. During this exercise it was realized that different auditors were classifying the same error in two different ways, leading to measurement system discrepancies. This led to a reclassification of the errors, and training of the auditors.

From the data then collected and analyzed the problem was defined as follows:

Customer requirement: <50 ppm errors
 
Current process average errors: 510 ppm
 
Variability (sigma): 710 ppm
 
(Average + 3 sigma): 2640 ppm
 
Note: Errors were collected before rework to ensure that the root causes would be exposed.

Problem definition: Reduce error density to assure 3-sigma quality under 50 ppm from the current 2640 ppm (i.e. 98%).

2. Finding the Vital Few to Attack

The errors collected were categorized using a Pareto diagram. Prioritization was required at three levels:

Level 1: Four categories, C1 to C4 - one category (C1) constituted 85% of the errors
 
Level 2: C1 into 4 categories, C11 to C14 - one (C11) category constitutes 98% of the errors
 
Level 3: C11 into 4 categories, C111 to C114 - one (C111) constituted 85% of the errors
               Category C111 was attacked as it constituted approximately 65% of the total problem.

3. Idea Formulation for Countermeasures

Seven error types were found in C111 in two broad categories. They were examined to determine why each one could have occurred, and a brainstorm for possible countermeasures was done. The most likely measures to "Kill the Problems" were selected for trial implementation.

4. Idea Testing and Modification

 
The selected countermeasures were analyzed and tested for each error type and the successful countermeasure was short-listed for implementation.

5. Implementation of Countermeasures

Training instructions were prepared for the new procedures and all the operators were trained. Implementation of all the countermeasures was done across the system from a particular date.

6. Confirming the Results

The team was trained in control charts and the X bar-sigma charts were introduced to monitor the results. A dramatic reduction occurred from the day of implementation ,and the first three weeks confirmed that a drop of 90% in error density had been achieved from 2640 ppm to around 300 ppm.
Tremendous enthusiasm was generated in the team as the result of this project far exceeded their expectation
.
7. Maintenance of Improvement - Continuous Small Improvements

Standard operating procedures (SOP) were drawn up for the process changes. A special session with the operating personnel emphasizing regular review, and killing any abnormal peaks that may have occurred in the control chart was explained. An SOP covered the frequency of review meetings for each level of supervision and management and a review format was introduced. The line supervisor who was part of the team became the enthusiastic owner of quality and the control chart, as well as the leader of the team charged with maintaining quality and continuously improving it. The slogan "If you do not improve, you deteriorate" was introduced.

This effort gradually brought down the (average + 3 sigma) error density further from 300 ppm to <50ppm.

The Quality Improvement (QI) Story

A QI Story was prepared for presentation to senior management detailing the improvements that occurred:

Tangible
  • Customer delight: Customer reported 100% quality in his sampling consistently over six months. He could not find errors at such a low density.
  • Productivity and Cost: Inspection and rework reduced to almost zero. 99.7% first pass efficiency. Sampling sizes were reduced. These resulted in savings of US $ 50000 per annum at Indian wage levels (in US equivalent US $ 300,000 per annum).
  • Volume Increase: Approximately 50% by the customer. The production went through without increased manpower.
  • Turnaround of the documents was improved dramatically due to no rework and started meeting customer requirements.
Intangible
  • Senior management time saved
  • Motivation of the operations personnel very high
  • Team work between Operations, Instruction and tool development and QA personnel
  • Mind-set Changes
  • Producing quality saves money
  • The importance of data and six sigma techniques.
  • If you don't improve, you deteriorate
Future plans for improving the turnaround by 50% using just in time methods are being implemented now.

Conclusion, Six Sigma - Techniques and Mind-set

The case here emphasizes the importance of Six Sigma techniques implementation being accompanied by building a culture and mind-set of continuous improvement and change in all employees. In the author's view and experience it is the creation of synergy between people and techniques that ensures maximum and continuing benefits from a Six Sigma/TQM initiative.

Sunday, March 27, 2011

Bill Smith :: Father of Six Sigma

 A Tribute to Bill Smith

Born in Brooklyn, New York, in 1929, Bill Smith graduated from the U.S. Naval Academy in 1952 and studied at the University of Minnesota School of Business. In 1987, after working for nearly 35 years in engineering and quality assurance, he joined Motorola, serving as vice president and senior quality assurance manager for the Land Mobile Products Sector.

Bill Smith, the Father of Six Sigma, introduced the statistical approach while working at Motorola, where it garnered the company financial benefits and numerous awards.

Bill Smith spent years convincing higher-ups that he really had invented a better mousetrap. Then he spent the rest of his life spreading the word to business professionals, government leaders and educators.

Smith's mousetrap? It was Six Sigma, the TQM spin off that has generated billions of dollars for Motorola, the company where Smith introduced his statistical approach aimed at increasing profitability by reducing defects. Smith, who earned the appellation, Father of Six Sigma, would probably be tickled to know Six Sigma has become so important that it even appears periodically in the widely syndicated comic strip, Dilbert.

As a Motorola employee, Smith did not share directly in the profits generated by the company's Six Sigma applications. However, over the years, he and Motorola garnered numerous awards and recognition for his vital work to improve profitability in America's manufacturing sector. He was especially proud of his role in Motorola's winning the prestigious Malcolm Baldrige National Quality Award. The Baldrige Award came in 1988, two years after Motorola implemented Smith's Six Sigma principles.

Smith's death, only five years later, caught everyone by surprise. He died of a heart attack at work.

Baldrige Award winners agree to share their quality programs with anyone who is interested. Hook said that since Motorola was the first company to win, others were eager to learn more about Six Sigma. 

He used to spend the last few years of his life traveling around, teaching and introducing Six Sigma to people. He was so appreciated wherever he went and people were really interested in it. Not surprisingly, the man behind the methodology was a passionate visionary and a great communicator. Bill Smith was also a perfectionist. Even at home.

In honor of Smith's talents and dedication, Northwestern University's Kellogg Graduate School of Management established an endowed scholarship in Smith's name. Dean Donald P. Jacobs of the Kellogg School notified Motorola's Robert Galvin of the school's intention less than a month after Smith died. It was a fitting tribute to a man who influenced business students and corporate leaders worldwide with his innovative Six Sigma strategy.

As the one who followed most closely in his footsteps, Marjorie Hook is well-positioned to speculate about Bill Smith's take on the 2003 version of Six Sigma. "Today I think people sometimes try to make Six Sigma seem complicated and overly technical," she said. "His approach was, 'If you want to improve something, involve the people who are doing the job.' He always wanted to make it simple so people would use it."
.

Tuesday, March 22, 2011

ISO 9001:2008 Quality management systems

Introduction
Two of the most important objectives in the revision of the ISO 9000 series of standards have been
  • to develop a simplified set of standards  that will be equally applicable to small as well as medium and large organizations, and
  • for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities.
ISO 9001:2008, Quality management systems – Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documentation. 

ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. 

It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a “system of documents”.

What is a “document”? - Definitions and references
The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;
a)    Communication of Information
It is used as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.
b)    Evidence of conformity
It takes care of the provision of evidence that was planned, has actually been done.
c)    Knowledge sharing
It is important to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

ISO 9001:2008 Documentation Requirements 

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

  • documented statements of a quality policy and quality objectives;
  • a quality manual
  • documented procedures required by this International Standard
  • documents needed by the organization to ensure the effective planning, operation and control of its processes, and
  • records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:

  • the size of organization and type of activities;
  • the complexity of  processes and their interactions, and
  • the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

Guidance on Clause 4.2 of ISO 9001:2008 

The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard. 

a)    Documented statements of a quality policy and objectives:
  • Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.
    Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
  • Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
·      
b)    Quality Manual:
  • Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
  • A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
  • Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
  • The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c)    Documented procedures: 

  • ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
    4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
  • These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
  • Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
  • Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
  • Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d)    Documents needed by the organization to ensure the effective 
        planning, operation and control of its processes:
  •         In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:
    - Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
  • There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:
  •   Process maps, process flow charts and/or process descriptions
    - Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
·         All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e)    Records:
·         Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
·         Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
·         Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.
Organizations preparing to implement a QMS
For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.
·         For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:
- Identifying the processes necessary for the effective implementation of   the quality management system
- understanding  the interactions between these processes.
- documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)
·         These processes include the management, resource, product realization and measurement processes that are relevant to the effective operation of the QMS.
·         Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.
Organizations wishing to adapt an existing QMS
For organizations that currently have a QMS the following comments are intended to assist in understanding the changes to documentation that may be required or facilitated by the transition to ISO 9001:2008
  • An organization with an existing QMS should not need to rewrite all of its documentation in order to meet the requirements of ISO 9001:2008. This is particularly true if an organization has structured its QMS based on the way it effectively operates, using a process approach. In this case, the existing documentation may be adequate and can be simply referenced in the revised quality manual.
  • An organization that has not used a process approach in the past will need to pay particular attention to the definition of its processes, their sequence and interaction.
  • An organization may be able to carry out some simplification and/or consolidation of existing documents, in order to simplify its QMS.
Demonstrating conformity with ISO 9001:2008
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
  • Organizations may be able to demonstrate conformity without the need for extensive documentation.
  • To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
  • Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.  
  • here the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.