Kaizen

KaizenFrom Wikipedia, the free encyclopedia

This article is about the continuous improvement philosophy. For the fantasy currency invented by Kaizen

Games with symbol "$K", see Priston Tale.

Kaizen (Japanese for "improvement" or "change for the better") refers to philosophy or practices that focus

upon continuous improvement of processes in manufacturing, engineering, supporting business processes,

and management. It has been applied in healthcare[1], government, banking, and many other industries.

When used in the business sense and applied to the workplace, kaizen refers to activities that continually

improve all functions, and involves all employees from the CEO to the assembly line workers. It also

applies to processes, such as purchasing and logistics, that cross organizational boundaries into the supply

chain.[2] By improving standardized activities and processes, kaizen aims to eliminate waste (see lean

manufacturing). Kaizen was first implemented in several Japanese businesses after the Second World

War, influenced in part by American business and quality management teachers who visited the country. It

has since spread throughout the world.[3]

Contents

 [hide]

1   Introduction

2   History

3   Implementation

o 3.1   The five main elements of kaizen

4   Criticisms

5   See also

6   References

7   Further reading

8   External links

[edit]Introduction

Kaizen is a daily song, the purpose of which goes beyond simple productivity improvement. It is also a

process that, when done correctly, humanizes the workplace, eliminates overly hard work ("muri"), and

teaches people how to perform experiments on their work using the scientific method and how to learn to

spot and eliminate waste in business processes. In all, the process suggests a humanized approach to

workers and to increasing productivity: "The idea is to nurture the company's human resources as much as

it is to praise and encourage participation in kaizen activities."[4] Successful implementation requires "the

participation of workers in the improvement."[5] The word "Kaizen" actually is from Chinese word "Gai 改"

and "zhen 正" rather than Japanese. People at all levels of an organization participate in kaizen, from the

CEO down to janitorial staff, as well as external stakeholders when applicable. The format for kaizen can

be individual, suggestion system, small group, or large group. At Toyota, it is usually a local improvement

within a workstation or local area and involves a small group in improving their own work environment and

productivity. This group is often guided through the kaizen process by a line supervisor; sometimes this is

the line supervisor's key role. Kaizen on a broad, cross-departmental scale in companies, generates total

quality management, and frees human efforts through improving productivity using machines and

computing power.[citation needed]

While kaizen (at Toyota) usually delivers small improvements, the culture of continual aligned small

improvements and standardization yields large results in the form of compound productivity improvement.

This philosophy differs from the "command and control" improvement programs of the mid-twentieth

century. Kaizen methodology includes making changes and monitoring results, then adjusting. Large-scale

pre-planning and extensive project scheduling are replaced by smaller experiments, which can be rapidly

adapted as new improvements are suggested.[citation needed]

In modern usage, a focused kaizen that is designed to address a particular issue over the course of a week

is referred to as a "kaizen blitz" or "kaizen event". These are limited in scope, and issues that arise from

them are typically used in later blitzes.[citation needed]

[edit]History

After World War II, to help restore Japan, American occupation forces brought in American experts to help

with the rebuilding of Japanese industry. The Civil Communications Section (CCS) developed a

Management Training Program that taught statistical control methods as part of the overall material. This

course was developed and taught by Homer Sarasohn and Charles Protzman in 1949 and 1950. Sarasohn

recommended William Deming for further training in Statistical Methods. The Economic and Scientific

Section (ESS) group was also tasked with improving Japanese management skills and Edgar McVoy is

instrumental in bringing Lowell Mellen to Japan to properly install the TWI programs in 1951. Prior to the

arrival of Mellen in 1951, the ESS group had a training film done to introduce the three TWI "J" programs

(Job Instruction, Job Methods and Job Relations)- the film was titled "Improvement in 4 Steps" (Kaizen eno

Yon Dankai). This is the original introduction of "Kaizen" to Japan. For the pioneering, introducing, and

implementing Kaizen in Japan, the Emperor of Japan awarded the Second Order Medal of the Sacred

Treasure to Dr. Deming in 1960. Consequently, the Union of Japanese Science and Engineering (JUSE)

instituted the annual Deming Prizes for achievements in quality and dependability of products in Japan. On

October 18, 1989, JUSE awarded the Deming Prize to Florida Power & Light Company (FPL), based in the

United States, for its exceptional accomplishments in its process and quality control management. FPL was

"the first company outside of Japan to win the Deming Prize."

Reference: US National Archives - SCAP collection - PR NewsWire

[edit]Implementation

The Toyota Production System is known for kaizen, where all line personnel are expected to stop their

moving production line in case of any abnormality and, along with their supervisor, suggest an

improvement to resolve the abnormality which may initiate a kaizen.

The PDCA cycles

The cycle of kaizen activity can be defined as:

Standardize an operation

Measure the standardized operation (find cycle time and amount of in-

process inventory)

Gauge measurements against requirements

Innovate to meet requirements and increase productivity

Standardize the new, improved operations

Continue cycle ad infinitum

This is also known as the Shewhart cycle, Deming cycle, or PDCA.

Masaaki Imai made the term famous in his book Kaizen: The Key to Japan's Competitive Success.

Apart from business applications of the method, both Anthony Robbins and Robert Maurer have

popularized the kaizen principles into personal development principles.

In their book The Toyota Way Fieldbook, Jeffrey Liker, and David Meier discuss the kaizen blitz and kaizen

burst (or kaizen event) approaches to continuous improvement. A kaizen blitz, or rapid improvement, is a

focused activity on a particular process or activity. The basic concept is to identify and quickly remove

waste. Another approach is that of the kaizen burst, a specific kaizen activity on a particular process in

the value stream.[6]

Key elements of kaizen are quality, effort, involvement of all employees, willingness to change, and

communication.

[edit]The five main elements of kaizen

This section does not cite any references or sources.Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed. (April 2010)

Teamwork

Personal discipline

Improved morale

Quality circles

Suggestions for improvement

[edit]Criticisms

Some critics of kaizen claim that the cost-cutting measures come at the expense of fair labor practices and

quality products. Examples include:

Accusations of death by overwork at Toyota that included unpaid "so-

called voluntary quality control meetings held after regular work hours" [7]

Suppliers refusing to accept orders from Toyota or its affiliates due to

successive price cuts[8]

A four-year-old memo from Japanese factory workers warning that safety

was being put at risk by aggressive cost-cutting[9]

In healthcare, direct-care providers such as nurses have gone on strike

over these streamlining procedures, because "procedure times can’t

always be standardized". Hospitals have used these streamlining

procedures as an excuse to cut patient-care staff. [10]

Although Kaizen is supposed to involve input from all employees, critics

claim that in reality front-line workers are not consulted.[11] Also see above,

re: memo from Japanese factory workers.

ISO 9000From Wikipedia, the free encyclopedia

This article may require cleanup to meet Wikipedia's quality standards. Please improve this article if you can. (June 2010)

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO,

the International Organization for Standardization and is administered by accreditation and certification

bodies. The rules are updated, as the requirements motivate changes over time. Some of the requirements

in ISO 9001:2008 (which is one of the standards in the ISO 9000 family) include

a set of procedures that cover all key processes in the business;

monitoring processes to ensure they are effective;

keeping adequate records;

checking output for defects, with appropriate and corrective action where necessary;

regularly reviewing individual processes and the quality system itself for effectiveness; and

facilitating continual improvement

A company or organization that has been independently audited and certified to be in conformance with

ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO

9001 standard does not guarantee any quality of end products and services; rather, it certifies that

formalized business processes are being applied.

Although the standards originated in manufacturing, they are now employed across several types of

organizations. A "product", in ISO vocabulary, can mean a physical object, services, or software.

Contents

[hide]

1 Contents of ISO 9001

o 1.1 1.0 Scope

o 1.2 4.0 Quality management system

1.2.1 4.1 General

1.2.2 4.2 Documentation requirements

1.2.2.1 4.2.1 General Specifications

1.2.2.2 4.2.2 Quality manual

1.2.2.3 4.2.3 Control of documents

1.2.2.4 4.2.4 Control of records

o 1.3 5.0 Management responsibility

1.3.1 5.1 Management commitment

1.3.2 5.2 Customer focus

1.3.3 5.3 Quality policy

1.3.4 5.4 Planning

1.3.4.1 5.4.1 Quality objectives

1.3.4.2 5.4.2 Quality management system planning

1.3.5 5.5 Responsibility, authority and communication

1.3.5.1 5.5.1 Responsibility and authority

1.3.5.2 5.5.2 Management representative

1.3.5.3 5.5.3 Internal communication

1.3.6 5.6 Management Review

1.3.6.1 5.6.1 General

1.3.6.2 5.6.2 Review input

1.3.6.3 5.6.3 Review output

o 1.4 6.0 Resource management

1.4.1 6.1 Provision of resources

1.4.2 6.2 Human resource Management

1.4.2.1 6.2.1 General

1.4.2.2 6.2.2 Competence, training, and awareness

1.4.3 6.3 Infrastructure

1.4.4 6.4 Work environment

o 1.5 7.0 Product realization

1.5.1 7.1 Planning of product realization

1.5.2 7.2 Customer- related processes

1.5.2.1 7.2.1 Determination of requirements related to the product

1.5.2.2 7.2.2 Review of requirements related to the product

1.5.2.3 7.2.3 Customer communication

1.5.3 7.3 Design and development

1.5.3.1 7.3.1 design and development planning

1.5.3.2 7.3.2 Design and development inputs

1.5.4 7.4 Purchasing

1.5.4.1 7.4.1 Purchasing process

1.5.4.2 7.4.2 Purchasing Information

1.5.4.3 7.4.3 Verification of purchased product

1.5.5 7.5 Production and service provision

1.5.5.1 7.5.1 Control of production and service provision

1.5.5.2 7.5.2 Validation of processes for production and service provision

1.5.5.3 7.5.3 Identification and traceability

1.5.5.4 7.5.4 Customer property

1.5.5.5 7.5.5 Preservation of product

1.5.6 7.6 Control of monitoring and measuring equipment

o 1.6 8.0 Measurement, analysis and improvement

1.6.1 8.1 General

1.6.2 8.2 Monitoring and measurement

1.6.2.1 8.2.1 Customer satisfaction

1.6.2.2 8.2.2 Internal Audits

1.6.2.3 8.2.3 Monitoring and measurement of processes

1.6.2.4 8.2.4 Monitoring and measurement of product

1.6.3 8.3 Control of nonconforming product

1.6.4 8.4 Analysis of data

1.6.5 8.5 Improvement

1.6.5.1 8.5.1 Continual improvement

1.6.5.2 8.5.2 Corrective action

1.6.5.3 8.5.3 Preventive action

o 1.7 1987 version

o 1.8 1994 version

o 1.9 2000 version

o 1.10 Certification

2 Auditing

3 Industry-specific interpretations

4 Effectiveness

o 4.1 Advantages

o 4.2 Problems

o 4.3 Summary

5 See also

6 References

7 Further reading

8 See Also

9 External links

[edit]Contents of ISO 9001

ISO 9001 certification of a fish wholesaler in Tsukiji

ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30

pages which is available from the national standards organization in each country. Outline contents are as

follows:

Page iv: Foreword

Pages v to vii: Section 0 Intro

Pages 1 to 14: Requirements

Section 1: Scope

Section 2: Normative Reference

Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)

Pages 2 to 14 132 1

Section 4: Quality Management System

Section 5: Management Responsibility

Section 6: Resource Management

Section 7: Product Realization

Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.

Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards

Page 23: Bibliography

The standard specifies six compulsory documents:

Control of Documents (4.2.3)

Control of Records (4.2.4)

Internal Audits (8.2.2)

Control of Nonconforming Product / Service (8.3)

Corrective Action (8.5.2)

Preventive Action (8.5.3)

In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual (which may or may not

include the above documents).

[edit]1.0 Scope

Designing Manufacturing Installation (DMI) has developed and implemented this quality management

system to demonstrate its ability to consistently provide an FRP product that meets customer and statutory

and regulatory requirements, and to address customer satisfaction through the effective application of the

system.

1.3 QUALITY POLICY DMI accepts responsibility for the complete satisfaction of its customers. We

exercise this responsibility through adequate training of our employees, adherence to proven procedures,

and total commitment to meeting and exceeding customer requirements.

[edit]4.0 Quality management system

[edit]4.1 General

The Company documents, implements, and maintains a quality management system and continually

improves its effectiveness in accordance with the requirements of the ISO 9001:2008 International

Standard, that comprises of:

(Company Name):

determines the processes needed for the quality management system and their application

throughout (Company Name),

determines the sequence and interaction of these processes,

determines criteria and methods needed to ensure that both the operation and control of these

processes are effective,

ensures the availability of resources and information necessary to support the operation and

monitoring of these processes,

monitors, measures where applicable and analyzes these processes,

implements actions necessary to achieve planned results and continual improvement of these

processes.

These processes are managed by (Company Name) in accordance with the requirements of the ISO

9001:2008 International Standard. Where (Company Name) chooses to outsource any process that affects

product conformity with requirements, (Company Name) ensures control over such processes. The type

and extent of control of such outsourced processes are identified within the quality management system.

NOTE: Processes needed for the quality management system referred to above include processes for

management activities, provision of resources, product realization, measurement, analysis, and

improvement.

[edit]4.2 Documentation requirements

[edit]4.2.1 General Specifications

The quality management system documentation includes:

documented statements of a quality policy and quality objectives,

a quality manual,

documented procedures and records required by the ISO 9001:2008 International Standard, and

documents, including records determined by (Company Name) to be necessary to ensure the

effective planning, operation and control of its processes

NOTE 1: Where the term “documented procedure” appears within the ISO 9001:2008 International

Standard, means that a procedure is established, documented, implemented and maintained.

NOTE 2: Documentation can be in any form or type of medium.

[edit]4.2.2 Quality manual

(Company Name) establishes and maintains a quality manual that includes

the scope of the quality management system, including details of and justification for any

exclusions,

the documented procedures established for the quality management system, or reference to them,

and

a description of the interaction between the processes of the quality management system.

[edit]4.2.3 Control of documents

Documents required by the quality management system are controlled. Records required by the quality

management system are controlled according to the requirements given in 4.2.4. A documented procedure

is established to define the controls needed:

to approve documents for adequacy prior to issue,

to review and update as necessary and re-approve documents,

to ensure that changes and the current revision status of documents are identified,

to ensure that relevant versions of applicable documents are available at points of use,

to ensure that documents remain legible and readily identifiable,

to ensure that documents of external origin determined by the organization to be necessary for the

planning and operation of the quality management system are identified and their distribution

controlled, and

to prevent the unintended use of obsolete documents, and to apply suitable identification to them if

they are retained for any purpose.

Supporting Documentation

QOP-42-01 Control of Documents

[edit]4.2.4 Control of records

Records established to provide evidence of conformity to requirements and or the effective operation of the

quality management system shall be controlled. (Company Name) will establish a documented procedure

to define the controls needed for the identification, storage, protection, retrieval, retention time and

disposition of records. Records will remain legible, readily identifiable, and retrievable. Supporting

Documentation QOP-42-02 Control of Records

[edit]5.0 Management responsibility

[edit]5.1 Management commitment

Top management is committed to the development and implementation of the quality management system

and continually improves its effectiveness by:

communicating to (Company Name) the importance of meeting customer as well as statutory and

regulatory requirements,

establishing a quality policy,

establishing quality objectives,

conducting management reviews, and

ensuring the availability of resources.

[edit]5.2 Customer focus

Top management ensures that customer requirements are determined and are met with the aim of

enhancing customer satisfaction. (see 7.2.1 and 8.2.1)

[edit]5.3 Quality policy

“(Company Name) is committed to Exceeding Customer Expectations through Implementation and

Continuous Improvement of our Quality Management System. Absolute Customer Satisfaction is the

expectation and, will be achieved through supplying a Superior Product, On-time, at a Competitive Price.”

Top management ensures that the quality policy

is appropriate to the purpose of the quality policy,

includes a commitment to comply with requirements and continually improve the effectiveness of

the quality management system,

provides a framework for establishing and reviewing quality objectives,

is communicated and understood within (Company Name), and

is reviewed for continuing suitability.

[edit]5.4 Planning

[edit]5.4.1 Quality objectives

Top management ensures that quality objectives, including those needed to meet requirements for product

[see 7.1 a], are established at relevant functions and levels within (Company Name). The quality objectives

are measurable and consistent with the quality policy. 1. Meet or exceed customer expectations by

effective communication and review of customer requirements. 2. Provide our customers high quality

products and services, on time delivery, and at a reasonable cost. 3. Effectively manage our products,

processes, and services to provide superior customer satisfaction. 4. Promote the safety, awareness, and

well being of employees through training and education.

[edit]5.4.2 Quality management system planning

Top management ensures that:

the planning of the quality management system is carried out in order to meet the requirements

given in 4.1, as well as the quality objectives, and

the integrity of the quality management system is maintained when changes to the quality

management system are planned and implemented.

[edit]5.5 Responsibility, authority and communication

[edit]5.5.1 Responsibility and authority

Top management ensures that responsibilities and authorities are defined and communicated within

(Company Name) to promote effective management of the quality system. An Organizational Chart

illustrates the responsibility and relative authority of the personnel who manage, perform, and verify the

activities affecting the QMS. Changes to the quality system are planned within the framework of

management reviews. These changes may be in response to changing circumstances, such as product,

process, capacity, or other operational or organizational changes; or to improve the effectiveness and

efficiency of the quality system. Supporting Documentation Organizational Chart

[edit]5.5.2 Management representative

Top management has appointed a member of the organization’s management who, irrespective of other

responsibilities, has the responsibility and authority that includes

ensuring that processes needed for the quality management system are established, implemented

and maintained,

reporting to top management on the performance of the quality management system and any need

for improvement, and

ensuring the promotion of awareness of customer requirements throughout (Company Name).

NOTE The responsibility of a management representative can include liaison with external parties on

matters relating to the quality management system.

[edit]5.5.3 Internal communication

Top management ensures that appropriate communication processes are established within (Company

Name) and that communication takes place regarding the effectiveness of the quality management system.

[edit]5.6 Management Review

[edit]5.6.1 General

Top management reviews (Company Name)’s quality management system, at planned intervals, to ensure

its continuing suitability, adequacy and effectiveness. The review includes assessing opportunities for

improvement and the need for changes to the quality management system, including the quality policy and

quality objectives. Records from management reviews are maintained (see 4.2.4). Supporting

Documentation QOP-56-01 Management Review

[edit]5.6.2 Review input

The input to management review includes information on:

results of audits,

customer feedback,

process performance and product conformity,

status of preventive and corrective actions,

follow-up actions from previous management reviews,

changes that could affect the quality management system, and

recommendations for improvement.

[edit]5.6.3 Review output

The output from the management review includes any decisions and actions related to:

improvement of the effectiveness of the quality management system and its processes,

improvement of product related to customer requirements, and

resource needs.

[edit]6.0 Resource management

[edit]6.1 Provision of resources

(Company Name) determines and provides the resources needed

to implement and maintain the quality management system and continually improve its

effectiveness, and

to enhance customer satisfaction by meeting customer requirements.

[edit]6.2 Human resource Management

[edit]6.2.1 General

Personnel performing work affecting conformity to product requirements are competent on the basis of

appropriate education, training, skills and experience.

[edit]6.2.2 Competence, training, and awareness

(Company Name) :

determines the necessary competence for personnel performing work affecting conformity to

product requirements,

where applicable, provides training or takes other actions to achieve the necessary competence,

evaluates the effectiveness of the actions taken,

ensures that its personnel are aware of the relevance and importance of their activities and how

they contribute to the achievement of the quality objectives, and

maintains appropriate records of education, training, skills and experience (see 4.2.4).

Supporting Documentation QOP-62-01 Competence, Training, and Awareness

[edit]6.3 Infrastructure

(Company Name) determines, provides for, and maintains the infrastructure needed to achieve conformity

to product requirements. Infrastructure includes, as applicable:

buildings, workspace and associated utilities,

Process equipment (both hardware and software), and

Supporting services (such as transport, communication or information systems).

Supporting Documentation QOP-63-01 Equipment Maintenance.

[edit]6.4 Work environment

(Company Name) determines and manages the work environment needed to achieve conformity to product

requirements.

[edit]7.0 Product realization

[edit]7.1 Planning of product realization

(Company Name) plans and develops the processes needed for product realization. Planning of product

realization is consistent with the requirements of the other processes of the quality management system

(see 4.1). In planning product realization, (Company Name) determines the following, as appropriate:

quality objectives and requirements for the product,

the need to establish processes, and documents, and provide resources specific to the product,

required verification, validation, monitoring, measurement, inspection and test activities specific to

the product and the criteria for product acceptance, and

records needed to provide evidence that the realization processes and resulting product meet

requirements (see 4.2.4).

The output of the planning is in a form suitable for (Company Name)s method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product

realization processes) and the resources to be applied to a specific product, project or contract, is referred

to as the quality plan.

NOTE 2 (Company Name) also applies the requirements given in 7.3 to the development of product

realization processes. Supporting Documentation

QOP-71-01 Planning of Product Realization

[edit]7.2 Customer- related processes

[edit]7.2.1 Determination of requirements related to the product

(Company Name) determines:

requirements specified by the customer, including the requirements for delivery and post-delivery

activities,

requirements not stated by the customer but necessary for specified or intended use, where

known,

statutory and regulatory requirements applicable to the product, and

any additional requirements considered necessary by (Company Name).

Supporting Documentation

QOP-72-02 Order Processing & Review

[edit]7.2.2 Review of requirements related to the product

(Company Name) reviews the requirements related to the product. This review is conducted prior to

(Company Name)s commitment to supply a product to the customer (e.g. submission of tenders,

acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that:

product requirements are defined,

contract or order requirements differing from those previously expressed are resolved, and

(Company Name) has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review are maintained (see 4.2.4). Where

the customer provides no documented statement of requirement, the customer requirements are confirmed

by (Company Name) before acceptance. Where product requirements are changed, (Company Name)

ensures that relevant documents are amended and that relevant personnel are made aware of the changed

requirements.

NOTE In some situations, a formal review is impractical for each order. Instead the review can cover

relevant product information such as catalogues or advertising material.

Supporting Documentation

QOP-72-02 Order Processing & Review

[edit]7.2.3 Customer communication

(Company Name) determines and implements effective arrangements for communicating with customers in

relation to:

product information,

enquiries, contracts or order handling, including amendments, and

customer feedback, including customer complaints.

Supporting Documentation

QOP-72-02 Order Processing & Review

QOP-85-02 Customer Complaints

[edit]7.3 Design and development

[edit]7.3.1 design and development planning

(Company Name) plans and controls the design and development of product. During the design and

development planning, (Company Name) determines:

the design and development stages.

the review, verification and validation that are appropriate to each design and development stage,

and

the responsibilities and authorities for design and development.

[edit]7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained. these inputs shall

include

functional and performance requirements.

applicable statutory and regulatory requirements.

where applicable information derived from previous similar designs, and

other requirements essential for design and development.

the inputs shall be reviewed for adequacy, requirements shall be complete, unambiguous and not in conflict

with each other.

[edit]7.4 Purchasing

[edit]7.4.1 Purchasing process

(Company Name) ensures that purchased product conforms to specified purchase requirements. The type

and extent of control applied to the supplier and the purchased product is dependent upon the effect of the

purchased product on subsequent product realization or the final product.

Supporting Documentation

QOP-74-01 Purchasing

[edit]7.4.2 Purchasing Information

Purchasing information describes the product to be purchased, including where appropriate

requirements for approval of product, procedures, processes and equipment,

requirements for qualification of personnel, and

quality management system requirements.

(Company Name) ensures the adequacy of specified purchase requirements prior to their communication

to the supplier.

Supporting Documentation

QOP-74-01 Purchasing

[edit]7.4.3 Verification of purchased product

(Company Name) establishes and implements the inspection or other activities necessary for ensuring that

purchased product meets specified purchase requirements. Where (Company Name) or its customer

intends to perform verification at the supplier’s premises, (Company Name) states the intended verification

arrangements and method of product release in the purchasing information.

Supporting Documentation

QOP-74-02 Verification of Purchase Product

[edit]7.5 Production and service provision

[edit]7.5.1 Control of production and service provision

As applicable, (Company Name) plans and carries out production and service provisions under controlled

conditions. Controlled conditions include:

the availability of information that describes the characteristics of the product,

the availability of work instructions, as necessary,

the use of suitable equipment,

the availability and use of monitoring and measuring equipment,

the implementation of monitoring and measurement activities, and

the implementation of product release, delivery and post-delivery activities.

Supporting Documentation

QOP-75-01 Work Order and Production Records

QOP-63-01 Equipment Maintenance

QOP-76-01 Measuring and Monitoring Equipment

QOP-84-02 Final Inspection

QOP-75-06 Shipping

[edit]7.5.2 Validation of processes for production and service provision

(Company Name) validates any processes for production and service provisions where the resulting output

cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become

apparent only after the product is in use or the service has been delivered. Validation demonstrates the

ability of these processes to achieve planned results. As applicable, (Company Name) establishes

arrangements for these processes including:

defined criteria for review and approval of the processes,

approval of equipment and qualification of personnel,

use of specific methods and procedures,

requirements for records (see 4.2.4), and

e) revalidation.

Note: (Company Name) has no Special Processes at this time.

[edit]7.5.3 Identification and traceability

Where appropriate, (Company Name) identifies the product by suitable means throughout product

realization. (Company Name) identifies the product status with respect to monitoring and measurement

requirements throughout product realization. Where traceability is a requirement, (Company Name)

controls the unique identification of the product an maintain records (4.2.4). Supporting Documentation

QOP-75-04 Product Identification and Traceability

[edit]7.5.4 Customer property

(Company Name) exercises care with customer property while it is under (Company Name)s control or

being used by (Company Name). (Company Name) identifies, verifies, protects and safeguards customer

property provided for use or incorporation into the product. If any customer property is lost, damaged or

otherwise found to be unsuitable for use, (Company Name) will report this to the customer and maintain

records (see 4.2.4).

Note: Customer property can include intellectual property and personal date.

Note: (Company Name) has no Customer Property at this time.

[edit]7.5.5 Preservation of product

(Company Name) preserves the product during internal processing and delivery to the intended destination

in order to maintain conformity to requirements. As applicable, preservation includes identification,

handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product.

[edit]7.6 Control of monitoring and measuring equipment

(Company Name) determines the monitoring and measurement to be undertaken and the monitoring and

measuring equipment needed to provide evidence of conformity of product to determined requirements.

(Company Name) establishes processes to ensure that monitoring and measurement can be carried out,

and is carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results measuring equipment is:

calibrated, verified or both 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,

adjusted or re-adjusted as necessary,

have identification in order to determine it’s calibration status,

safeguarded from adjustments that would invalidate the measurement result, and

protected from damage and deterioration during handling, maintenance and storage.

In addition, (Company Name) assesses and records the validity of the previous measuring results when the

equipment is found not to conform to requirements. (Company Name) takes appropriate action on the

equipment and any product affected. Records of the results of calibration and verification are maintained

(see 4.2.4).

Note: Confirmation of the ability of computer software to satisfy the intended application will typically

include its verification and configuration management to maintain its suitability for use Supporting

Documentation

QOP-76-01 Monitoring and Measuring Equipment

[edit]8.0 Measurement, analysis and improvement

[edit]8.1 General

(Company Name) plans and implements the monitoring, measurement, analysis and improvement

processes needed:

to demonstrate conformity to product requirements,

to ensure conformity of the quality management system, and

to continually improve the effectiveness of the quality management system.

This includes determination of applicable methods, including statistical techniques, and the extent of their

use.

[edit]8.2 Monitoring and measurement

[edit]8.2.1 Customer satisfaction

As one of the measurements of the performance of the quality management system, (Company Name)

monitors information relating to customer perception as to whether (Company Name) has met customer

requirements. The methods for obtaining and using this information are determined. Supporting

Documentation QOP-82-01 Customer Satisfaction

[edit]8.2.2 Internal Audits

(Company Name) conducts internal audits at planned intervals to determine whether the quality

management system:

conforms to the planned arrangements (see 7.1), to the requirements of ISO 9001:2008 and to the

quality management system requirements established by (Company Name), and b)is effectively

implemented and maintained.

An audit program is planned, taking into consideration the status and importance of the processes and

areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and

methods are defined. The selection of auditors and conduct of audits ensure objectivity and impartiality of

the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning

and conducting audits, and for reporting results and maintaining records (see 4.2.4) are defined in a

documented procedure. The management responsible for the area being audited ensures that any

necessary correction and corrective actions are taken without undue delay to eliminate detected

nonconformities and their causes. Follow-up activities include the verification of the actions taken and the

reporting of verification results (see 8.5.2). Supporting Documentation QOP-82-02 Internal Quality Audits

[edit]8.2.3 Monitoring and measurement of processes

(Company Name) applies suitable methods for monitoring and where applicable, measurement of the

quality management system processes. These methods demonstrate the ability of the processes to

achieve planned results. When planned results are not achieved, correction and corrective action is taken,

as appropriate.

[edit]8.2.4 Monitoring and measurement of product

(Company Name) monitors and measures the characteristics of the product to verify that product

requirements have been met. This is carried out at appropriate stages of the product realization process in

accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria is

maintained. Records indicate the person(s) authorizing release of product for delivery to the customer (see

4.2.4). The release of product and delivery of service to the customer does not proceed until the planned

arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant

authority and where applicable, by the customer. Supporting Documentation QOP-82-03 In Process

Inspections QOP-82-04 Final Inspection

[edit]8.3 Control of nonconforming product

(Company Name) ensures that product which does not conform to product requirements is identified and

controlled to prevent its unintended use or delivery. A documented procedure is established to define the

controls and related responsibilities and authorities for dealing with nonconforming products. Where

applicable (Company Name) deals with nonconforming product by one or more of the following ways:

by taking action to eliminate the detected nonconformity,

by authorizing its use, release or acceptance under concession by a relevant authority and, where

applicable, by the customer, and

by taking action to preclude its original intended use or application.

by taking action appropriate to the effects, or potential effects, of the nonconformity when

nonconforming product is detected after delivery or use has started.

When nonconforming product is corrected the product is subject to re-verification to demonstrate

conformity to the requirements. When nonconforming product is detected after delivery or use has started,

(Company Name) takes action appropriate to the effects, or potential effects, of the nonconformity. Records

of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are

maintained (see 4.2.4). Supporting Documentation QOP-83-01 Control of Nonconforming Product

[edit]8.4 Analysis of data

(Company Name) determines, collects and analyzes appropriate data to demonstrate the suitability and

effectiveness of the quality management system and to evaluate where continual improvement of the

effectiveness of the quality management system can be made. This includes data generated as a result of

monitoring and measurement and from other relevant sources. The analysis of data provides information

relating to:

customer satisfaction (see 8.2.1),

conformity to product requirements (see 8.2.4),

characteristics and trends of processes and products including opportunities for preventive action

(see 8.2.3 and 8.2.4),

suppliers (see 7.4),

Supporting Documentation QOP-56-01 Management Review

[edit]8.5 Improvement

[edit]8.5.1 Continual improvement

(Company Name) continually improves the effectiveness of the quality management system through the

use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions

and management reviews. Supporting Documentation QOP-85-01 Continual Improvement

[edit]8.5.2 Corrective action

(Company Name) takes action to eliminate the causes of nonconformities in order to prevent recurrence.

Corrective actions are appropriate to the effects of the nonconformities encountered. A documented

procedure is established to define requirements for:

reviewing nonconformities (including customer complaints),

determining the causes of nonconformities,

evaluating the need for action to ensure that nonconformities do not recur,

determining and implementing action needed,

records of the results of action taken (see 4.2.4), and

reviewing the effectiveness of the corrective action taken.

Supporting Documentation QOP-85-02 Customer Complaints QOP-85-03 Corrective and Preventive

Actions

[edit]8.5.3 Preventive action

(Company Name) determines actions to eliminate the causes of potential nonconformities in order to

prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. A

documented procedure is established to define requirements for:

determining potential nonconformities and their causes,

evaluating the need for action to prevent occurrence of nonconformities,

determining and implementing action needed,

records of results of action taken (see 4.2.4), and

reviewing the effectiveness of the preventive action taken.

Supporting Documentation QOP-85-03 Corrective and Preventive Actions

[edit]1987 version

ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality

management systems, the selection of which was based on the scope of activities of the organization:

ISO 9001:1987 Model for quality assurance in design, development, production, installation, and

servicing was for companies and organizations whose activities included the creation of new products.

ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically

the same material as ISO 9001 but without covering the creation of new products.

ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final

inspection of finished product, with no concern for how the product was produced.

ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so

was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures

rather than the overall process of management—which was likely the actual intent.[citation needed]

[edit]1994 version

ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product,

and continued to require evidence of compliance with documented procedures. As with the first edition, the

down-side was that companies tended to implement its requirements by creating shelf-loads of procedure

manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving

processes could actually be impeded by the quality system.[citation needed]

[edit]2000 version

ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and

development procedures are required only if a company does in fact engage in the creation of new

products. The 2000 version sought to make a radical change in thinking by actually placing the concept

of process management front and center ("Process management" was the monitoring and optimizing of a

company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands

involvement by upper executives, in order to integrate quality into the business system and avoid

delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process

performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of

continual process improvement and tracking customer satisfaction were made explicit.

The ISO 9000 standard is continually being revised by standing technical committees and advisory groups,

who receive feedback from those professionals who are implementing the standard.[1]

ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some

changes intended to improve consistency with ISO 14001:2004. There are no new requirements.

Explanation of changes in ISO 9001:2008. A quality management system being upgraded just needs to be

checked to see if it is following the clarifications introduced in the amended version.

[edit]Certification

ISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize

certification bodies, which audit organizations applying for ISO 9001 compliance certification. Although

commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality

management can be certified is ISO 9001:2008. Both the accreditation bodies and the certification bodies

charge fees for their services. The various accreditation bodies have mutual agreements with each other to

ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted worldwide.

The applying organization is assessed based on an extensive sample of its sites, functions, products,

services and processes; a list of problems ("action requests" or "non-compliance") is made known to the

management. If there are no major problems on this list, or after it receives a satisfactory improvement plan

from the management showing how any problems will be resolved, the certification body will issue an ISO

9001 certificate for each geographical site it has visited.

An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended

by the certification body, usually around three years. There are no grades of competence within ISO 9001:

either a company is certified (meaning that it is committed to the method and model of quality management

described in the standard), or it is not. In this respect, it contrasts with measurement-based quality systems

such as the Capability Maturity Model.

[edit]Auditing

Two types of auditing are required to become registered to the standard: auditing by an

external certification body (external audit) and audits by internal staff trained for this process (internal

audits). The aim is a continual process of review and assessment, to verify that the system is working as

it's supposed to, find out where it can improve and to correct or prevent problems identified. It is considered

healthier for internal auditors to audit outside their usual management line, so as to bring a degree of

independence to their judgments.

Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance

auditing":

Tell me what you do (describe the business process)

Show me where it says that (reference the procedure manuals)

Prove that this is what happened (exhibit evidence in documented records)

The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote

"compliance" by focusing on risk, status and importance. This means they are expected to make more

judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference

from the previous standard can be explained thus:

Under the 1994 version, the question was broadly "Are you doing what the manual says you

should be doing?", whereas under the 2000 version, the question is more "Will this process help

you achieve your stated objectives? Is it a good process or is there a way to do it better?"

[edit]Industry-specific interpretations

The ISO 9001 standard is generalized and abstract. Its parts must be carefully interpreted, to make

sense within a particular organization. Developing software is not like making cheeseor

offering counseling services; yet the ISO 9001 guidelines, because they are business, management

guidelines can be applied to each of these. Diverse organizations—police departments (US),

professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO

9001:2000 systems.

Over time, various industry sectors have wanted to standardize their interpretations of the guidelines

within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their

specific requirements, but also to try and ensure that more appropriately trained and experienced

auditors are sent to assess them.

The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit

the processes of the information technology industry, especially software development.

AS9000  is the Aerospace Basic Quality System Standard, an interpretation developed by major

aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine,

Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop

Grumman, Pratt & Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current

version is AS9100.

PS 9000 is an application of the standard for Pharmaceutical Packaging Materials. The

Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA) has developed

PS 9000:2001. It aims to provide a widely accepted baseline GMP framework of best practice

within the pharmaceutical packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical

printed and contact packaging materials.

QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford,

Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS

16949.

ISO/TS 16949:2009  is an interpretation agreed upon by major automotive manufacturers

(American and European manufacturers); the latest version is based on ISO 9001:2008. The

emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009

contains the full text of ISO 9001:2008 and automotive industry-specific requirements.

TL 9000  is the Telecom Quality Management and Measurement System Standard, an

interpretation developed by the telecom consortium, QuEST Forum. The current version is 4.0

and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product

measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality

Management System to meet the supply chain quality requirements of the worldwide

telecommunications industry.

ISO 13485:2003  is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it

replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO

13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean

compliance with ISO 9001:2000.

ISO/IEC 90003:2004  provides guidelines for the application of ISO 9001:2000 to computer

software.

ISO/TS 29001  is quality management system requirements for the design, development,

production, installation and service of products for the petroleum, petrochemical and natural gas

industries. It is equivalent to API Spec Q1 without the Monogram annex.

[edit]Effectiveness

The debate on the effectiveness of ISO 9000 commonly centers on the following questions:

1. Are the quality principles in ISO 9001:2000 of value? (Note that the version date is

important: in the 2000 version ISO attempted to address many concerns and criticisms of

ISO 9000:1994).

2. Does it help to implement an ISO 9001:2000 compliant quality management system?

3. Does it help to obtain ISO 9001:2000 certification?

Effectiveness of the ISO system being implemented depends on a number of factors, the most

significant of which are:

1. Commitment of Senior Management to monitor, control, and improve quality. Organizations

that implement an ISO system without this desire and commitment, often take the cheapest

road to get a certificate on the wall and ignore problem areas uncovered in the audits.

2. How well the ISO system integrates into their business practices. Many organizations that

implement ISO try to make their system fit into a cookie-cutter quality manual rather than

create a manual that documents existing practices and only adds new processes to meet

the ISO standard when necessary.

3. How well the ISO system focuses on improving the customer experience. The broadest

definition of quality is "Whatever the customer perceives good quality to be". This means

that you don't necessarily have to make a product that never fails, some customers will have

a higher tolerance for product failures if they always receive shipments on-time, or some

other dimension of customer service. Your ISO system should take into account all areas of

the customer experience, the industry expectations, and seek to improve them on a

continual basis. This means taking into account all processes that deal with the three

stakeholders (your customers, your suppliers, and your organization), only then will you be

able to sustain improvements in your customer experience.

4. How well the auditor finds and communicates areas of improvement. Now, ISO auditors may

not provide consulting to the clients they audit, however, there is the potential for auditors to

point out areas of improvement. Many auditors simply rely on submitting reports that indicate

compliance or non-compliance with the appropriate section of the standard, however, to

most executives, this is like speaking a foreign language. Auditors that can clearly identify

and communicate areas of improvement in language and terms executive management

understands allows the companies they audit to act on improvement initiatives. When

management doesn't understand why they were non-compliant and the business

implications, they simply ignore the reports and focus on what they do understand.

[edit]Advantages

It is widely acknowledged that proper quality management improves business, often having a positive

effect on investment, market share, sales growth, sales margins, competitive advantage, and

avoidance of litigation.The quality principles in ISO 9000:2000 are also sound, according to Wade

and Barnes, who say that "ISO 9000 guidelines provide a comprehensive model for quality

management systems that can make any company competitive implementing ISO often gives the

following advantages:

1. Create a more efficient, effective operation

2. Increase customer satisfaction and retention

3. Reduce audits

4. Enhance marketing

5. Improve employee motivation, awareness, and morale

6. Promote international trade

7. Increases profit

8. Reduce waste and increases productivity.

[edit]Problems

A common criticism of ISO 9001 is the amount of money, time and paperwork required for

registration.[1] According to Barnes, "Opponents claim that it is only for documentation. Proponents

believe that if a company has documented its quality systems, then most of the paperwork has

already been completed."[2]

ISO 9001 is not in any way an indication that products produced using its certified systems are any

good. A company can intend to produce a poor quality product and providing it does so consistently

and with the proper documentation can put an ISO 9001 stamp on it. According to Seddon, ISO 9001

promotes specification, control, and procedures rather than understanding and improvement.[3]

[4] Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to

mislead companies into thinking that certification means better quality, ... [undermining] the need for

an organization to set its own quality standards." [5] Paraphrased, Wade's argument is that reliance on

the specifications of ISO 9001 does not guarantee a successful quality system.

While internationally recognized, most US consumers are not aware of ISO 9000 and it holds no

relevance to them. The added cost to certify and then maintain certification may not be justified if

product end users do not require ISO 9000. The cost can actually put a company at a competitive

disadvantage when competing against a non ISO 9000 certified company.

The standard is seen as especially prone to failure when a company is interested in certification

before quality.[3] Certifications are in fact often based on customer contractual requirements rather

than a desire to actually improve quality.[2][6] "If you just want the certificate on the wall, chances are,

you will create a paper system that doesn't have much to do with the way you actually run your

business," said ISO's Roger Frost.[6] Certification by an independent auditor is often seen as the

problem area, and according to Barnes, "has become a vehicle to increase consulting services." [2] In

fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality

benefits that can be achieved.[7]

Another problem reported is the competition among the numerous certifying bodies, leading to a

softer approach to the defects noticed in the operation of the Quality System of a firm.

Abrahamson[8] argued that fashionable management discourse such as Quality Circles tends to follow

a lifecycle in the form of a bell curve, possibly indicating a management fad.

[edit]Summary

A good overview for effective use of ISO 9000 is provided by Barnes: "Good business judgment is

needed to determine its proper role for a company. Is certification itself important to the marketing

plans of the company? If not, do not rush to certification Even without certification, companies should

utilize the ISO 9000 model as a benchmark to assess the adequacy of its quality programs."

[edit]See also

Conformity assessment —Containing ISO published standards

ISO 10006 —Quality management—Guidelines to quality management in projects

ISO 14001 —Environmental management standards

ISO 19011 —Guidelines for quality management systems auditing and environmental management

systems auditing

ISO/TS 16949 —Quality management system requirements for automotive-related products

suppliers

ISO/IEC 27001 —Information security management

AS 9100  - aerospace industry implementation of ISO 9000/1

List of ISO standards

Quality management system

Test management

Verification and Validation

[edit]References

1. ̂  "So many standards to follow, so little payoff". Stephanie Clifford. Inc Magazine, May 2005.

2. ^ a b c "Good Business Sense Is the Key to Confronting ISO 9000" Frank Barnes in Review of

Business, Spring 2000.

3. ^ a b "The 'quality' you can't feel", John Seddon, The Observer, Sunday November 19, 2000

4. ̂  "A Brief History of ISO 9000: Where did we go wrong?". John Seddon. Chapter one of "The

Case Against ISO 9000", 2nd ed., Oak Tree Press. November 2000. ISBN 1-86076-173-9

5. ̂  "Is ISO 9000 really a standard?" Jim Wade, ISO Management Systems – May-June 2002

6. ^ a b "ISO a GO-Go." Mark Henricks. Entrepreneur Magazine Dec 2001.

7. ̂  The ISO Survey – 2005 (abridged version, PDF, 3 MB), ISO, 2005

8. ̂  Abrahamson, E. (1996). "Managerial fashion." Academy of Management Review. 21(1):254-

285.

[edit]Further reading

Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and Systems Providers: An

Engineering Approach (1st ed.). CRC-Press. ISBN 0849320631, ISBN 978-0849320637

Naveh. E., Marcus, A. (2004). "When does ISO 9000 Quality Assurance standard lead to

performance improvement?", IEEE Transactions on Engineering Management, 51(3), 352–363.

http://www.iso.org/iso/survey2007.pdf  - An abstract of the 2007's ISO survey of certificates

http://www.iso.org/iso/survey2008.pdf  - An abstract of the 2008's ISO survey of certificates

[edit]See Also

International Organization for Standardization

[edit]External links

ISO 9000  at the Open Directory Project

Introduction to ISO 9000 and ISO 14000

International Organization for Standardization

ISO's Technical Committee 176  on Quality Management and Quality Assurance

Technical Committee No. 176, Sub-committee No. 2 , which is responsible for developing

ISO 9000 standards.

Basic info  on ISO 9000 development

ISO 9000 FAQs

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Six SigmaFrom Wikipedia, the free encyclopedia

Not to be confused with Sigma 6.

The often-used six sigma symbol.

Part of a series of articles on

Industry

Manufacturing methods

Batch production • Job production

Continuous production

Improvement methods

LM • TPM • QRM • VDM

TOC • Six Sigma • RCM

Information & communication

ISA-88 • ISA-95 • ERP

SAP • IEC 62264 • B2MML

Process control

PLC • DCS

Six Sigma is a business management strategy originally developed by Motorola, USA in 1981.[1] As of

2010, it enjoys widespread application in many sectors of industry, although its application is not without

controversy.

Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of

defects (errors) and minimizing variability inmanufacturing and business processes.[2] It uses a set of quality

management methods, including statistical methods, and creates a special infrastructure of people within

the organization ("Black Belts", "Green Belts", etc.) who are experts in these methods.[2] Each Six Sigma

project carried out within an organization follows a defined sequence of steps and that not only has

quantified financial targets (cost reduction or profit increase) but also has other benefits such as reduction

in errors or [mistake proofing] resulting in better controls on the business processes.[2]

The term six sigma originated from terminology associated with manufacturing, mining, specifically terms

associated with statistical modelling of manufacturing processes. The maturity of a manufacturing process

can be described by a sigma rating indicating its yield, or the percentage of defect-free products it

creates. A six-sigma process is one in which 99.99966% of the products manufactured are

statistically expected to be free of defects (3.4 defects per million). Motorola set a goal of "six

sigmas" for all of its manufacturing operations, and this goal became a byword for the management

and engineering practices used to achieve it.

Contents

 [hide]

1   Historical overview

2   Methods

o 2.1   DMAIC

o 2.2   DMADV

o 2.3   Quality management tools and methods used in Six Sigma

3   Implementation roles

o 3.1   Certification

4   Origin and meaning of the term "six sigma process"

o 4.1   Role of the 1.5 sigma shift

o 4.2   Sigma levels

5   Software used for Six Sigma

6   List of Six Sigma companies

7   Criticism

o 7.1   Lack of originality

o 7.2   Role of consultants

o 7.3   Potential negative effects

o 7.4   Based on arbitrary standards

o 7.5   Criticism of the 1.5 sigma shift

8   See also

9   References

10   Further reading

[edit]Historical overview

Six Sigma originated as a set of practices designed to improve manufacturing processes and eliminate

defects, but its application was subsequently extended to other types of business processes as well.[3] In

Six Sigma, a defect is defined as any process output that does not meet customer specifications, or that

could lead to creating an output that does not meet customer specifications.[2]

Bill Smith first formulated the particulars of the methodology at Motorola in 1986.[4] Six Sigma was heavily

inspired by six preceding decades of quality improvement methodologies such as quality control, TQM,

and Zero Defects,[5][6] based on the work of pioneers such

as Shewhart, Deming, Juran, Ishikawa, Taguchi and others.

Like its predecessors, Six Sigma doctrine asserts that:

Continuous efforts to achieve stable and predictable process results (i.e.,

reduce process variation) are of vital importance to business success.

Manufacturing and business processes have characteristics that can be

measured, analyzed, improved and controlled.

Achieving sustained quality improvement requires commitment from the

entire organization, particularly from top-level management.

Features that set Six Sigma apart from previous quality improvement initiatives include:

A clear focus on achieving measurable and quantifiable financial returns

from any Six Sigma project.[2]

An increased emphasis on strong and passionate management leadership

and support.[2]

A special infrastructure of "Champions","Master Black Belts","Black

Belts","Green Belts", etc. to lead and implement the Six Sigma approach.[2]

A clear commitment to making decisions on the basis of verifiable data,

rather than assumptions and guesswork.[2]

The term "Six Sigma" comes from a field of statistics known as process capability studies. Originally, it

referred to the ability of manufacturing processes to produce a very high proportion of output within

specification. Processes that operate with "six sigma quality" over the short term are assumed to produce

long-term defect levels below 3.4 defects per million opportunities (DPMO).[7][8] Six Sigma's implicit goal is

to improve all processes to that level of quality or better.

Six Sigma is a registered service mark and trademark of Motorola Inc.[9] As of 2006 Motorola reported over

US$17 billion in savings[10] from Six Sigma.

Other early adopters of Six Sigma who achieved well-publicized success include Honeywell (previously

known as AlliedSignal) and General Electric, where Jack Welch introduced the method.[11] By the late

1990s, about two-thirds of the Fortune 500 organizations had begun Six Sigma initiatives with the aim of

reducing costs and improving quality.[12]

In recent years, some practitioners have combined Six Sigma ideas with lean manufacturing to yield a

methodology named Lean Six Sigma.

[edit]Methods

Six Sigma projects follow two project methodologies inspired by Deming's Plan-Do-Check-Act Cycle. These

methodologies, composed of five phases each, bear the acronyms DMAIC and DMADV.[12]

DMAIC is used for projects aimed at improving an existing business

process.[12] DMAIC is pronounced as "duh-may-ick".

DMADV is used for projects aimed at creating new product or process

designs.[12] DMADV is pronounced as "duh-mad-vee".

[edit]DMAIC

The DMAIC project methodology has five phases:

Define the problem, the voice of the customer, and the project goals,

specifically.

Measure key aspects of the current process and collect relevant data.

Analyze the data to investigate and verify cause-and-effect relationships.

Determine what the relationships are, and attempt to ensure that all

factors have been considered. Seek out root cause of the defect under

investigation.

Improve or optimize the current process based upon data analysis using

techniques such as design of experiments, poka yoke or mistake proofing,

and standard work to create a new, future state process. Set up pilot runs

to establish process capability.

Control the future state process to ensure that any deviations from target

are corrected before they result in defects. Implement control

systems such as statistical process control,production boards, and visual

workplaces, and continuously monitor the process.

[edit]DMADV

The DMADV project methodology, also known as DFSS ("Design For Six Sigma"),[12] features five phases:

Define design goals that are consistent with customer demands and the

enterprise strategy.

Measure and identify CTQs (characteristics that are Critical To Quality),

product capabilities, production process capability, and risks.

Analyze to develop and design alternatives, create a high-level design and

evaluate design capability to select the best design.

Design details, optimize the design, and plan for design verification. This

phase may require simulations.

Verify the design, set up pilot runs, implement the production process and

hand it over to the process owner(s).

[edit]Quality management tools and methods used in Six Sigma

Within the individual phases of a DMAIC or DMADV project, Six Sigma utilizes many established

quality-management tools that are also used outside of Six Sigma. The following table shows an

overview of the main methods used.

5 Whys

Analysis of variance

ANOVA Gauge R&R

Axiomatic design

Business Process Mapping

Catapult exercise on variability

Cause & effects diagram (also known as fishbone or Ishikawa diagram)

Chi-square test  of independence and fits

Control chart

Correlation

Cost-benefit analysis

CTQ tree

Design of experiments

Failure mode and effects analysis  (FMEA)

General linear model

Histograms

Homoscedasticity

Quality Function Deployment

Pareto chart

Pick chart

Process capability

Quantitative marketing research

Management (EFM) systems

Regression analysis

Root cause analysis

Run charts

SIPOC  analysis (Suppliers,

Stratification

Taguchi methods

Taguchi Loss Function

TRIZ

[edit]Implementation roles

One key innovation of Six Sigma involves the "professionalizing" of quality management functions. Prior to

Six Sigma, quality management in practice was largely relegated to the production floor and

to statisticians in a separate quality department. Formal Six Sigma programs borrow martial arts ranking

terminology to define a hierarchy (and career path) that cuts across all business functions.

Six Sigma identifies several key roles for its successful implementation.[13]

Executive Leadership includes the CEO and other members of top

management. They are responsible for setting up a vision for Six Sigma

implementation. They also empower the other role holders with the

freedom and resources to explore new ideas for breakthrough

improvements.

Champions take responsibility for Six Sigma implementation across the

organization in an integrated manner. The Executive Leadership draws

them from upper management. Champions also act as mentors to Black

Belts.

Master Black Belts, identified by champions, act as in-house coaches on

Six Sigma. They devote 100% of their time to Six Sigma. They assist

champions and guide Black Belts and Green Belts. Apart from statistical

tasks, they spend their time on ensuring consistent application of Six

Sigma across various functions and departments.

Black Belts operate under Master Black Belts to apply Six Sigma

methodology to specific projects. They devote 100% of their time to Six

Sigma. They primarily focus on Six Sigma project execution, whereas

Champions and Master Black Belts focus on identifying projects/functions

for Six Sigma.

Green Belts are the employees who take up Six Sigma implementation

along with their other job responsibilities, operating under the guidance of

Black Belts.

Some organizations use additional belt colours, such as Yellow Belts, for employees that have basic

training in Six Sigma tools.

[edit]Certification

In the United States, Six Sigma certification for both Green and Black Belts is offered by the Institute of

Industrial Engineers [14]  and by the American Society for Quality.[15]

In addition to these examples, there are many other organizations and companies that offer certification.

There currently is no central certification body, either in the United States or anywhere else in the world.

[edit]Origin and meaning of the term "six sigma process"

Graph of the normal distribution, which underlies the statistical assumptions of the Six Sigma model. The Greek letter σ

(sigma) marks the distance on the horizontal axis between the mean, µ, and the curve's inflection point. The greater this

distance, the greater is the spread of values encountered. For the curve shown above, µ = 0 and σ = 1. The upper and

lower specification limits (USL, LSL) are at a distance of 6σ from the mean. Because of the properties of the normal

distribution, values lying that far away from the mean are extremely unlikely. Even if the mean were to move right or left

by 1.5σ at some point in the future (1.5 sigma shift), there is still a good safety cushion. This is why Six Sigma aims to

have processes where the mean is at least 6σ away from the nearest specification limit.

The term "six sigma process" comes from the notion that if one has six standard deviations between the

process mean and the nearest specification limit, as shown in the graph, practically no items will fail to

meet specifications.[8] This is based on the calculation method employed inprocess capability studies.

Capability studies measure the number of standard deviations between the process mean and the nearest

specification limit in sigma units. As process standard deviation goes up, or the mean of the process moves

away from the center of the tolerance, fewer standard deviations will fit between the mean and the nearest

specification limit, decreasing the sigma number and increasing the likelihood of items outside

specification.[8]

[edit]Role of the 1.5 sigma shift

Experience has shown that processes usually do not perform as well in the long term as they do in the

short term.[8] As a result, the number of sigmas that will fit between the process mean and the nearest

specification limit may well drop over time, compared to an initial short-term study.[8] To account for this

real-life increase in process variation over time, an empirically-based 1.5 sigma shift is introduced into the

calculation.[8][16] According to this idea, a process that fits six sigmas between the process mean and the

nearest specification limit in a short-term study will in the long term only fit 4.5 sigmas – either because the

process mean will move over time, or because the long-term standard deviation of the process will be

greater than that observed in the short term, or both.[8]

Hence the widely accepted definition of a six sigma process as one that produces 3.4 defective parts per

million opportunities (DPMO). This is based on the fact that a process that isnormally distributed will have

3.4 parts per million beyond a point that is 4.5 standard deviations above or below the mean (one-sided

capability study).[8] So the 3.4 DPMO of a "Six Sigma" process in fact corresponds to 4.5 sigmas, namely 6

sigmas minus the 1.5 sigma shift introduced to account for long-term variation.[8] This takes account of

special causes that may cause a deterioration in process performance over time and is designed to prevent

underestimation of the defect levels likely to be encountered in real-life operation.[8]

[edit]Sigma levels

A control chart depicting a process that experienced a 1.5 sigma drift in the process mean toward the upper

specification limit starting at midnight. Control charts are used to maintain 6 sigma quality by signaling when quality

professionals should investigate a process to find and eliminate special-cause variation.

See also: Three sigma rule

The table[17][18] below gives long-term DPMO values corresponding to various short-term sigma levels.

Note that these figures assume that the process mean will shift by 1.5 sigma toward the side with the

critical specification limit. In other words, they assume that after the initial study determining the short-term

sigma level, the long-term Cpk  value  will turn out to be 0.5 less than the short-term Cpk value. So, for

example, the DPMO figure given for 1 sigma assumes that the long-term process mean will be 0.5

sigma beyond the specification limit (Cpk = –0.17), rather than 1 sigma within it, as it was in the short-term

study (Cpk = 0.33). Note that the defect percentages only indicate defects exceeding the specification

limit to which the process mean is nearest. Defects beyond the far specification limit are not

included in the percentages.

Sigma level DPMO Percent defectivePercentage

yieldShort-term Cpk Long-term Cpk

1 691,462 69% 31% 0.33 –0.17

2 308,538 31% 69% 0.67 0.17

3 66,807 6.7% 93.3% 1.00 0.5

4 6,210 0.62% 99.38% 1.33 0.83

5 233 0.023% 99.977% 1.67 1.17

6 3.4 0.00034% 99.99966% 2.00 1.5

7 0.019 0.0000019% 99.9999981% 2.33 1.83

[edit]Software used for Six Sigma

Main article: List of Six Sigma software packages

[edit]List of Six Sigma companies

Main article: List of Six Sigma companies

[edit]Criticism

[edit]Lack of originality

Noted quality expert Joseph M. Juran has described Six Sigma as "a basic version of quality improvement",

stating that "[t]here is nothing new there. It includes what we used to call facilitators. They've adopted more

flamboyant terms, like belts with different colors. I think that concept has merit to set apart, to create

specialists who can be very helpful. Again, that's not a new idea. The American Society for Quality long ago

established certificates, such as for reliability engineers."[19]

[edit]Role of consultants

The use of "Black Belts" as itinerant change agents has (controversially) fostered an industry of training

and certification. Critics argue there is overselling of Six Sigma by too great a number of consulting firms,

many of which claim expertise in Six Sigma when they only have a rudimentary understanding of the tools

and techniques involved.[2]

[edit]Potential negative effects

A Fortune article stated that "of 58 large companies that have announced Six Sigma programs, 91 percent

have trailed the S&P 500 since". The statement is attributed to "an analysis by Charles Holland of

consulting firm Qualpro (which espouses a competing quality-improvement process)."[20] The summary of

the article is that Six Sigma is effective at what it is intended to do, but that it is "narrowly designed to fix an

existing process" and does not help in "coming up with new products or disruptive technologies."

Advocates of Six Sigma have argued that many of these claims are in error or ill-informed.[21][22]

A BusinessWeek article says that James McNerney's introduction of Six Sigma at 3M may have had the

effect of stifling creativity. It cites two Wharton School professors who say that Six Sigma leads to

incremental innovation at the expense of blue-sky work.[23] This phenomenon is further explored in the

book, Going Lean, which describes a related approach known as lean dynamics and provides data to show

that Ford's "6 Sigma" program did little to change its fortunes.[24]

[edit]Based on arbitrary standards

While 3.4 defects per million opportunities might work well for certain products/processes, it might not

operate optimally or cost effectively for others. A pacemaker process might need higher standards, for

example, whereas a direct mail advertising campaign might need lower standards. The basis and

justification for choosing 6 (as opposed to 5 or 7, for example) as the number of standard deviations is not

clearly explained. In addition, the Six Sigma model assumes that the process data always conform to

the normal distribution. The calculation of defect rates for situations where the normal distribution model

does not apply is not properly addressed in the current Six Sigma literature.[2]

[edit]Criticism of the 1.5 sigma shift

The statistician Donald J. Wheeler has dismissed the 1.5 sigma shift as "goofy" because of its arbitrary

nature.[25] Its universal applicability is seen as doubtful.[2]

The 1.5 sigma shift has also become contentious because it results in stated "sigma levels" that reflect

short-term rather than long-term performance: a process that has long-term defect levels corresponding to

4.5 sigma performance is, by Six Sigma convention, described as a "6 sigma process."[8][26] The accepted

Six Sigma scoring system thus cannot be equated to actual normal distribution probabilities for the stated

number of standard deviations, and this has been a key bone of contention about how Six Sigma measures

are defined.[26] The fact that it is rarely explained that a "6 sigma" process will have long-term defect rates

corresponding to 4.5 sigma performance rather than actual 6 sigma performance has led several

commentators to express the opinion that Six Sigma is a confidence trick.[8]

[edit]See also

Business process

Design for Six Sigma

Total quality management

Total productive maintenance

[edit]References

1. ̂  Tennant, Geoff (2001). SIX SIGMA: SPC and TQM in Manufacturing

and Services. Gower Publishing, Ltd.. p. 6. ISBN 0566083744.

2. ^ a b c d e f g h i j k Antony, Jiju. "Pros and cons of Six Sigma: an academic

perspective". Retrieved August 5, 2010.

3. ̂  "Motorola University - What is Six Sigma?". Retrieved 2009-09-14. "[...]

Six Sigma started as a defect reduction effort in manufacturing and was

then applied to other business processes for the same purpose."

4. ̂  "The Inventors of Six Sigma". Retrieved January 29, 2006.

5. ̂  Stamatis, D. H. (2004). Six Sigma Fundamentals: A Complete Guide to

the System, Methods, and Tools. New York, New York: Productivity

Press. p. 1. ISBN 9781563272929.OCLC 52775178. "The practitioner of

the six sigma methodology in any organization should expect to see the

use of old and established tools and approaches in the pursuit of

continual improvement and customer satisfaction. So much so that even

TQM (total quality management) is revisited as a foundation of some of

the approaches. In fact, one may define six sigma as "TQM on steroids.""

6. ̂  Montgomery, Douglas C. (2009). Statistical Quality Control: A Modern

Introduction (6 ed.). Hoboken, New Jersey: John Wiley & Sons.

p. 23. ISBN 9780470233979. OCLC 244727396. "During the 1950s and

1960s programs such as Zero Defects and Value Engineering abounded,

but they had little impact on quality and productivity improvement. During

the heyday of TQM in the 1980s, another popular program was

the Quality Is Free initiative, in which management worked on identifying

the cost of quality..."

7. ̂  "Motorola University Six Sigma Dictionary". Retrieved January 29,

2006.

8. ^ a b c d e f g h i j k l Tennant, Geoff (2001). SIX SIGMA: SPC and TQM in

Manufacturing and Services. Gower Publishing, Ltd..

pp. 25. ISBN 0566083744.

9. ̂  "Motorola Inc. - Motorola University". Retrieved January 29, 2006.

10. ̂  "About Motorola University". Retrieved January 29, 2006.

11. ̂  "Six Sigma: Where is it now?". Retrieved May 22, 2008.

12. ^ a b c d e De Feo, Joseph A.; Barnard, William (2005). JURAN Institute's

Six Sigma Breakthrough and Beyond - Quality Performance

Breakthrough Methods. Tata McGraw-Hill Publishing Company

Limited. ISBN 0-07-059881-9.

13. ̂  Harry, Mikel; Schroeder, Richard (2000). Six Sigma. Random House,

Inc. ISBN 0-385-49437-8.

14. ̂  "Institute of Industrial Engineers Six Sigma certifications". Norcross,

Georgia: Institute of Industrial Engineers. Retrieved 2010-01-05.

15. ̂  "Certification - ASQ". Milwaukee, Wisconsin: American Society for

Quality. Retrieved 2010-01-05.

16. ̂  Harry, Mikel J. (1988). The Nature of six sigma quality. Rolling

Meadows, Illinois: Motorola University Press.

p. 25. ISBN 9781569460092.

17. ̂  Gygi, Craig; DeCarlo, Neil; Williams, Bruce (2005). Six Sigma for

Dummies. Hoboken, NJ: Wiley Publishing, Inc.. pp. Front inside cover,

23. ISBN 0-7645-6798-5.

18. ̂  El-Haik, Basem; Suh, Nam P.. Axiomatic Quality. John Wiley and Sons.

p. 10. ISBN 9780471682738.

19. ̂  Paton, Scott M. (August 2002). Juran: A Lifetime of Quality. 22. pp. 19–

23. Retrieved 2009-04-01.

20. ̂  Morris, Betsy (2006-07-11). "Tearing up the Jack Welch playbook".

Fortune. Retrieved 2006-11-26.

21. ̂  Richardson, Karen (2007-01-07). "The 'Six Sigma' Factor for Home

Depot". Wall Street Journal Online. Retrieved October 15, 2007.

22. ̂  Ficalora, Joe; Costello, Joe. "Wall Street Journal SBTI Rebuttal" (PDF).

Sigma Breakthrough Technologies, Inc.. Retrieved October 15, 2007.

23. ̂  Hindo, Brian (6 June 2007). "At 3M, a struggle between efficiency and

creativity". Business Week. Retrieved June 6, 2007.

24. ̂  Ruffa, Stephen A. (2008). Going Lean: How the Best Companies Apply

Lean Manufacturing Principles to Shatter Uncertainty, Drive Innovation,

and Maximize Profits. AMACOM (a division of American Management

Association). ISBN 0-8144-1057-X.

25. ̂  Wheeler, Donald J. (2004). The Six Sigma Practitioner's Guide to Data

Analysis. SPC Press. p. 307. ISBN 9780945320623.

26. ^ a b *Pande, Peter S.; Neuman, Robert P.; Cavanagh, Roland R.

(2001). The Six Sigma Way: How GE, Motorola, and Other Top

Companies are Honing Their Performance. New York: McGraw-Hill

Professional. p. 229. ISBN 0071358064.

[edit]Further reading

Adams, Cary W.; Gupta, Praveen; Charles E. Wilson (2003). Six Sigma

Deployment. Burlington, MA: Butterworth-Heinemann. ISBN 0750675233.

Breyfogle, Forrest W. III (1999). Implementing Six Sigma: Smarter

Solutions Using Statistical Methods. New York, NY: John Wiley &

Sons. ISBN 0471265721.

De Feo, Joseph A.; Barnard, William (2005). JURAN Institute's Six Sigma

Breakthrough and Beyond - Quality Performance Breakthrough Methods.

New York, NY: McGraw-Hill Professional. ISBN 0071422277.

Hahn, G. J., Hill, W. J., Hoerl, R. W. and Zinkgraf, S. A. (1999) The Impact

of Six Sigma Improvement-A Glimpse into the Future of Statistics, The

American Statistician, Vol. 53, No. 3, pp. 208–215.

Harry, Mikel J.; Schroeder, Richard (1999). Six Sigma: The Breakthrough

Management Strategy Revolutionizing the World’s Top Corporations. New

York, NY: Doubleday.ISBN 0385494378.

Keller, Paul A. (2001). Six Sigma Deployment: A Guide for Implementing

Six Sigma in Your Organization. Tucson, AZ: Quality

Publishing. ISBN 0930011848.

Pande, Peter S.; Neuman, Robert P.; Roland R. Cavanagh (2001). The

Six Sigma Way: How GE, Motorola, and Other Top Companies are

Honing Their Performance. New York, NY: McGraw-Hill

Professional. ISBN 0071358064.

Pyzdek, Thomas and Paul A. Keller (2009). The Six Sigma Handbook,

Third Edition. New York, NY: McGraw-Hill. ISBN 0071623388.

Snee, Ronald D.; Hoerl, Roger W. (2002). Leading Six Sigma: A Step-by-

Step Guide Based on Experience with GE and Other Six Sigma

Companies. Upper Saddle River, NJ: FT Press. ISBN 0130084573.

Taylor, Gerald (2008). Lean Six Sigma Service Excellence: A Guide to

Green Belt Certification and Bottom Line Improvement. New York, NY: J.

Ross Publishing. ISBN 978-1604270068.

Tennant, Geoff (2001). SIX SIGMA: SPC and TQM in Manufacturing and

Services. Aldershot, UK: Gower Publishing, Ltd. ISBN 0566083744.

Categories: Industry | Business terms | Evaluation methods | General Electric | Motorola | Process

management | Production and manufacturing | Quality | 1981 introductions

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Six SigmaFrom Wikipedia, the free encyclopedia

Not to be confused with Sigma 6.

The often-used six sigma symbol.

Part of a series of articles on

Industry

Manufacturing methods

Batch production • Job production

Continuous production

Improvement methods

LM • TPM • QRM • VDM

TOC • Six Sigma • RCM

Information & communication

ISA-88 • ISA-95 • ERP

SAP • IEC 62264 • B2MML

Process control

PLC • DCS

Six Sigma is a business management strategy originally developed by Motorola, USA in 1981.[1] As of

2010, it enjoys widespread application in many sectors of industry, although its application is not without

controversy.

Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of

defects (errors) and minimizing variability inmanufacturing and business processes.[2] It uses a set of quality

management methods, including statistical methods, and creates a special infrastructure of people within

the organization ("Black Belts", "Green Belts", etc.) who are experts in these methods.[2] Each Six Sigma

project carried out within an organization follows a defined sequence of steps and that not only has

quantified financial targets (cost reduction or profit increase) but also has other benefits such as reduction

in errors or [mistake proofing] resulting in better controls on the business processes.[2]

The term six sigma originated from terminology associated with manufacturing, mining, specifically terms

associated with statistical modelling of manufacturing processes. The maturity of a manufacturing process

can be described by a sigma rating indicating its yield, or the percentage of defect-free products it

creates. A six-sigma process is one in which 99.99966% of the products manufactured are

statistically expected to be free of defects (3.4 defects per million). Motorola set a goal of "six

sigmas" for all of its manufacturing operations, and this goal became a byword for the management

and engineering practices used to achieve it.

Contents

 [hide]

1   Historical overview

2   Methods

o 2.1   DMAIC

o 2.2   DMADV

o 2.3   Quality management tools and methods used in Six Sigma

3   Implementation roles

o 3.1   Certification

4   Origin and meaning of the term "six sigma process"

o 4.1   Role of the 1.5 sigma shift

o 4.2   Sigma levels

5   Software used for Six Sigma

6   List of Six Sigma companies

7   Criticism

o 7.1   Lack of originality

o 7.2   Role of consultants

o 7.3   Potential negative effects

o 7.4   Based on arbitrary standards

o 7.5   Criticism of the 1.5 sigma shift

8   See also

9   References

10   Further reading

[edit]Historical overview

Six Sigma originated as a set of practices designed to improve manufacturing processes and eliminate

defects, but its application was subsequently extended to other types of business processes as well.[3] In

Six Sigma, a defect is defined as any process output that does not meet customer specifications, or that

could lead to creating an output that does not meet customer specifications.[2]

Bill Smith first formulated the particulars of the methodology at Motorola in 1986.[4] Six Sigma was heavily

inspired by six preceding decades of quality improvement methodologies such as quality control, TQM,

and Zero Defects,[5][6] based on the work of pioneers such

as Shewhart, Deming, Juran, Ishikawa, Taguchi and others.

Like its predecessors, Six Sigma doctrine asserts that:

Continuous efforts to achieve stable and predictable process results (i.e.,

reduce process variation) are of vital importance to business success.

Manufacturing and business processes have characteristics that can be

measured, analyzed, improved and controlled.

Achieving sustained quality improvement requires commitment from the

entire organization, particularly from top-level management.

Features that set Six Sigma apart from previous quality improvement initiatives include:

A clear focus on achieving measurable and quantifiable financial returns

from any Six Sigma project.[2]

An increased emphasis on strong and passionate management leadership

and support.[2]

A special infrastructure of "Champions","Master Black Belts","Black

Belts","Green Belts", etc. to lead and implement the Six Sigma approach.[2]

A clear commitment to making decisions on the basis of verifiable data,

rather than assumptions and guesswork.[2]

The term "Six Sigma" comes from a field of statistics known as process capability studies. Originally, it

referred to the ability of manufacturing processes to produce a very high proportion of output within

specification. Processes that operate with "six sigma quality" over the short term are assumed to produce

long-term defect levels below 3.4 defects per million opportunities (DPMO).[7][8] Six Sigma's implicit goal is

to improve all processes to that level of quality or better.

Six Sigma is a registered service mark and trademark of Motorola Inc.[9] As of 2006 Motorola reported over

US$17 billion in savings[10] from Six Sigma.

Other early adopters of Six Sigma who achieved well-publicized success include Honeywell (previously

known as AlliedSignal) and General Electric, where Jack Welch introduced the method.[11] By the late

1990s, about two-thirds of the Fortune 500 organizations had begun Six Sigma initiatives with the aim of

reducing costs and improving quality.[12]

In recent years, some practitioners have combined Six Sigma ideas with lean manufacturing to yield a

methodology named Lean Six Sigma.

[edit]Methods

Six Sigma projects follow two project methodologies inspired by Deming's Plan-Do-Check-Act Cycle. These

methodologies, composed of five phases each, bear the acronyms DMAIC and DMADV.[12]

DMAIC is used for projects aimed at improving an existing business

process.[12] DMAIC is pronounced as "duh-may-ick".

DMADV is used for projects aimed at creating new product or process

designs.[12] DMADV is pronounced as "duh-mad-vee".

[edit]DMAIC

The DMAIC project methodology has five phases:

Define the problem, the voice of the customer, and the project goals,

specifically.

Measure key aspects of the current process and collect relevant data.

Analyze the data to investigate and verify cause-and-effect relationships.

Determine what the relationships are, and attempt to ensure that all

factors have been considered. Seek out root cause of the defect under

investigation.

Improve or optimize the current process based upon data analysis using

techniques such as design of experiments, poka yoke or mistake proofing,

and standard work to create a new, future state process. Set up pilot runs

to establish process capability.

Control the future state process to ensure that any deviations from target

are corrected before they result in defects. Implement control

systems such as statistical process control,production boards, and visual

workplaces, and continuously monitor the process.

[edit]DMADV

The DMADV project methodology, also known as DFSS ("Design For Six Sigma"),[12] features five phases:

Define design goals that are consistent with customer demands and the

enterprise strategy.

Measure and identify CTQs (characteristics that are Critical To Quality),

product capabilities, production process capability, and risks.

Analyze to develop and design alternatives, create a high-level design and

evaluate design capability to select the best design.

Design details, optimize the design, and plan for design verification. This

phase may require simulations.

Verify the design, set up pilot runs, implement the production process and

hand it over to the process owner(s).

[edit]Quality management tools and methods used in Six Sigma

Within the individual phases of a DMAIC or DMADV project, Six Sigma utilizes many established

quality-management tools that are also used outside of Six Sigma. The following table shows an

overview of the main methods used.

5 Whys

Analysis of variance

ANOVA Gauge R&R

Axiomatic design

Business Process Mapping

Catapult exercise on variability

Cause & effects diagram (also known as fishbone or Ishikawa diagram)

Chi-square test  of independence and fits

Control chart

Correlation

Cost-benefit analysis

CTQ tree

Design of experiments

Histograms

Homoscedasticity

Quality Function Deployment

Pareto chart

Pick chart

Process capability

Quantitative marketing research

Management (EFM) systems

Regression analysis

Root cause analysis

Run charts

SIPOC  analysis (Suppliers,

Stratification

Taguchi methods

Failure mode and effects analysis  (FMEA)

General linear model

Taguchi Loss Function

TRIZ

[edit]Implementation roles

One key innovation of Six Sigma involves the "professionalizing" of quality management functions. Prior to

Six Sigma, quality management in practice was largely relegated to the production floor and

to statisticians in a separate quality department. Formal Six Sigma programs borrow martial arts ranking

terminology to define a hierarchy (and career path) that cuts across all business functions.

Six Sigma identifies several key roles for its successful implementation.[13]

Executive Leadership includes the CEO and other members of top

management. They are responsible for setting up a vision for Six Sigma

implementation. They also empower the other role holders with the

freedom and resources to explore new ideas for breakthrough

improvements.

Champions take responsibility for Six Sigma implementation across the

organization in an integrated manner. The Executive Leadership draws

them from upper management. Champions also act as mentors to Black

Belts.

Master Black Belts, identified by champions, act as in-house coaches on

Six Sigma. They devote 100% of their time to Six Sigma. They assist

champions and guide Black Belts and Green Belts. Apart from statistical

tasks, they spend their time on ensuring consistent application of Six

Sigma across various functions and departments.

Black Belts operate under Master Black Belts to apply Six Sigma

methodology to specific projects. They devote 100% of their time to Six

Sigma. They primarily focus on Six Sigma project execution, whereas

Champions and Master Black Belts focus on identifying projects/functions

for Six Sigma.

Green Belts are the employees who take up Six Sigma implementation

along with their other job responsibilities, operating under the guidance of

Black Belts.

Some organizations use additional belt colours, such as Yellow Belts, for employees that have basic

training in Six Sigma tools.

[edit]Certification

In the United States, Six Sigma certification for both Green and Black Belts is offered by the Institute of

Industrial Engineers [14]  and by the American Society for Quality.[15]

In addition to these examples, there are many other organizations and companies that offer certification.

There currently is no central certification body, either in the United States or anywhere else in the world.

[edit]Origin and meaning of the term "six sigma process"

Graph of the normal distribution, which underlies the statistical assumptions of the Six Sigma model. The Greek letter σ

(sigma) marks the distance on the horizontal axis between the mean, µ, and the curve's inflection point. The greater this

distance, the greater is the spread of values encountered. For the curve shown above, µ = 0 and σ = 1. The upper and

lower specification limits (USL, LSL) are at a distance of 6σ from the mean. Because of the properties of the normal

distribution, values lying that far away from the mean are extremely unlikely. Even if the mean were to move right or left

by 1.5σ at some point in the future (1.5 sigma shift), there is still a good safety cushion. This is why Six Sigma aims to

have processes where the mean is at least 6σ away from the nearest specification limit.

The term "six sigma process" comes from the notion that if one has six standard deviations between the

process mean and the nearest specification limit, as shown in the graph, practically no items will fail to

meet specifications.[8] This is based on the calculation method employed inprocess capability studies.

Capability studies measure the number of standard deviations between the process mean and the nearest

specification limit in sigma units. As process standard deviation goes up, or the mean of the process moves

away from the center of the tolerance, fewer standard deviations will fit between the mean and the nearest

specification limit, decreasing the sigma number and increasing the likelihood of items outside

specification.[8]

[edit]Role of the 1.5 sigma shift

Experience has shown that processes usually do not perform as well in the long term as they do in the

short term.[8] As a result, the number of sigmas that will fit between the process mean and the nearest

specification limit may well drop over time, compared to an initial short-term study.[8] To account for this

real-life increase in process variation over time, an empirically-based 1.5 sigma shift is introduced into the

calculation.[8][16] According to this idea, a process that fits six sigmas between the process mean and the

nearest specification limit in a short-term study will in the long term only fit 4.5 sigmas – either because the

process mean will move over time, or because the long-term standard deviation of the process will be

greater than that observed in the short term, or both.[8]

Hence the widely accepted definition of a six sigma process as one that produces 3.4 defective parts per

million opportunities (DPMO). This is based on the fact that a process that isnormally distributed will have

3.4 parts per million beyond a point that is 4.5 standard deviations above or below the mean (one-sided

capability study).[8] So the 3.4 DPMO of a "Six Sigma" process in fact corresponds to 4.5 sigmas, namely 6

sigmas minus the 1.5 sigma shift introduced to account for long-term variation.[8] This takes account of

special causes that may cause a deterioration in process performance over time and is designed to prevent

underestimation of the defect levels likely to be encountered in real-life operation.[8]

[edit]Sigma levels

A control chart depicting a process that experienced a 1.5 sigma drift in the process mean toward the upper

specification limit starting at midnight. Control charts are used to maintain 6 sigma quality by signaling when quality

professionals should investigate a process to find and eliminate special-cause variation.

See also: Three sigma rule

The table[17][18] below gives long-term DPMO values corresponding to various short-term sigma levels.

Note that these figures assume that the process mean will shift by 1.5 sigma toward the side with the

critical specification limit. In other words, they assume that after the initial study determining the short-term

sigma level, the long-term Cpk  value  will turn out to be 0.5 less than the short-term Cpk value. So, for

example, the DPMO figure given for 1 sigma assumes that the long-term process mean will be 0.5

sigma beyond the specification limit (Cpk = –0.17), rather than 1 sigma within it, as it was in the short-term

study (Cpk = 0.33). Note that the defect percentages only indicate defects exceeding the specification

limit to which the process mean is nearest. Defects beyond the far specification limit are not

included in the percentages.

Sigma level DPMO Percent defectivePercentage

yieldShort-term Cpk Long-term Cpk

1 691,462 69% 31% 0.33 –0.17

2 308,538 31% 69% 0.67 0.17

3 66,807 6.7% 93.3% 1.00 0.5

4 6,210 0.62% 99.38% 1.33 0.83

5 233 0.023% 99.977% 1.67 1.17

6 3.4 0.00034% 99.99966% 2.00 1.5

7 0.019 0.0000019% 99.9999981% 2.33 1.83

[edit]Software used for Six Sigma

Main article: List of Six Sigma software packages

[edit]List of Six Sigma companies

Main article: List of Six Sigma companies

[edit]Criticism

[edit]Lack of originality

Noted quality expert Joseph M. Juran has described Six Sigma as "a basic version of quality improvement",

stating that "[t]here is nothing new there. It includes what we used to call facilitators. They've adopted more

flamboyant terms, like belts with different colors. I think that concept has merit to set apart, to create

specialists who can be very helpful. Again, that's not a new idea. The American Society for Quality long ago

established certificates, such as for reliability engineers."[19]

[edit]Role of consultants

The use of "Black Belts" as itinerant change agents has (controversially) fostered an industry of training

and certification. Critics argue there is overselling of Six Sigma by too great a number of consulting firms,

many of which claim expertise in Six Sigma when they only have a rudimentary understanding of the tools

and techniques involved.[2]

[edit]Potential negative effects

A Fortune article stated that "of 58 large companies that have announced Six Sigma programs, 91 percent

have trailed the S&P 500 since". The statement is attributed to "an analysis by Charles Holland of

consulting firm Qualpro (which espouses a competing quality-improvement process)."[20] The summary of

the article is that Six Sigma is effective at what it is intended to do, but that it is "narrowly designed to fix an

existing process" and does not help in "coming up with new products or disruptive technologies."

Advocates of Six Sigma have argued that many of these claims are in error or ill-informed.[21][22]

A BusinessWeek article says that James McNerney's introduction of Six Sigma at 3M may have had the

effect of stifling creativity. It cites two Wharton School professors who say that Six Sigma leads to

incremental innovation at the expense of blue-sky work.[23] This phenomenon is further explored in the

book, Going Lean, which describes a related approach known as lean dynamics and provides data to show

that Ford's "6 Sigma" program did little to change its fortunes.[24]

[edit]Based on arbitrary standards

While 3.4 defects per million opportunities might work well for certain products/processes, it might not

operate optimally or cost effectively for others. A pacemaker process might need higher standards, for

example, whereas a direct mail advertising campaign might need lower standards. The basis and

justification for choosing 6 (as opposed to 5 or 7, for example) as the number of standard deviations is not

clearly explained. In addition, the Six Sigma model assumes that the process data always conform to

the normal distribution. The calculation of defect rates for situations where the normal distribution model

does not apply is not properly addressed in the current Six Sigma literature.[2]

[edit]Criticism of the 1.5 sigma shift

The statistician Donald J. Wheeler has dismissed the 1.5 sigma shift as "goofy" because of its arbitrary

nature.[25] Its universal applicability is seen as doubtful.[2]

The 1.5 sigma shift has also become contentious because it results in stated "sigma levels" that reflect

short-term rather than long-term performance: a process that has long-term defect levels corresponding to

4.5 sigma performance is, by Six Sigma convention, described as a "6 sigma process."[8][26] The accepted

Six Sigma scoring system thus cannot be equated to actual normal distribution probabilities for the stated

number of standard deviations, and this has been a key bone of contention about how Six Sigma measures

are defined.[26] The fact that it is rarely explained that a "6 sigma" process will have long-term defect rates

corresponding to 4.5 sigma performance rather than actual 6 sigma performance has led several

commentators to express the opinion that Six Sigma is a confidence trick.[8]

[edit]See also

Business process

Design for Six Sigma

Total quality management

Total productive maintenance

[edit]References

1. ̂  Tennant, Geoff (2001). SIX SIGMA: SPC and TQM in Manufacturing

and Services. Gower Publishing, Ltd.. p. 6. ISBN 0566083744.

2. ^ a b c d e f g h i j k Antony, Jiju. "Pros and cons of Six Sigma: an academic

perspective". Retrieved August 5, 2010.

3. ̂  "Motorola University - What is Six Sigma?". Retrieved 2009-09-14. "[...]

Six Sigma started as a defect reduction effort in manufacturing and was

then applied to other business processes for the same purpose."

4. ̂  "The Inventors of Six Sigma". Retrieved January 29, 2006.

5. ̂  Stamatis, D. H. (2004). Six Sigma Fundamentals: A Complete Guide to

the System, Methods, and Tools. New York, New York: Productivity

Press. p. 1. ISBN 9781563272929.OCLC 52775178. "The practitioner of

the six sigma methodology in any organization should expect to see the

use of old and established tools and approaches in the pursuit of

continual improvement and customer satisfaction. So much so that even

TQM (total quality management) is revisited as a foundation of some of

the approaches. In fact, one may define six sigma as "TQM on steroids.""

6. ̂  Montgomery, Douglas C. (2009). Statistical Quality Control: A Modern

Introduction (6 ed.). Hoboken, New Jersey: John Wiley & Sons.

p. 23. ISBN 9780470233979. OCLC 244727396. "During the 1950s and

1960s programs such as Zero Defects and Value Engineering abounded,

but they had little impact on quality and productivity improvement. During

the heyday of TQM in the 1980s, another popular program was

the Quality Is Free initiative, in which management worked on identifying

the cost of quality..."

7. ̂  "Motorola University Six Sigma Dictionary". Retrieved January 29,

2006.

8. ^ a b c d e f g h i j k l Tennant, Geoff (2001). SIX SIGMA: SPC and TQM in

Manufacturing and Services. Gower Publishing, Ltd..

pp. 25. ISBN 0566083744.

9. ̂  "Motorola Inc. - Motorola University". Retrieved January 29, 2006.

10. ̂  "About Motorola University". Retrieved January 29, 2006.

11. ̂  "Six Sigma: Where is it now?". Retrieved May 22, 2008.

12. ^ a b c d e De Feo, Joseph A.; Barnard, William (2005). JURAN Institute's

Six Sigma Breakthrough and Beyond - Quality Performance

Breakthrough Methods. Tata McGraw-Hill Publishing Company

Limited. ISBN 0-07-059881-9.

13. ̂  Harry, Mikel; Schroeder, Richard (2000). Six Sigma. Random House,

Inc. ISBN 0-385-49437-8.

14. ̂  "Institute of Industrial Engineers Six Sigma certifications". Norcross,

Georgia: Institute of Industrial Engineers. Retrieved 2010-01-05.

15. ̂  "Certification - ASQ". Milwaukee, Wisconsin: American Society for

Quality. Retrieved 2010-01-05.

16. ̂  Harry, Mikel J. (1988). The Nature of six sigma quality. Rolling

Meadows, Illinois: Motorola University Press.

p. 25. ISBN 9781569460092.

17. ̂  Gygi, Craig; DeCarlo, Neil; Williams, Bruce (2005). Six Sigma for

Dummies. Hoboken, NJ: Wiley Publishing, Inc.. pp. Front inside cover,

23. ISBN 0-7645-6798-5.

18. ̂  El-Haik, Basem; Suh, Nam P.. Axiomatic Quality. John Wiley and Sons.

p. 10. ISBN 9780471682738.

19. ̂  Paton, Scott M. (August 2002). Juran: A Lifetime of Quality. 22. pp. 19–

23. Retrieved 2009-04-01.

20. ̂  Morris, Betsy (2006-07-11). "Tearing up the Jack Welch playbook".

Fortune. Retrieved 2006-11-26.

21. ̂  Richardson, Karen (2007-01-07). "The 'Six Sigma' Factor for Home

Depot". Wall Street Journal Online. Retrieved October 15, 2007.

22. ̂  Ficalora, Joe; Costello, Joe. "Wall Street Journal SBTI Rebuttal" (PDF).

Sigma Breakthrough Technologies, Inc.. Retrieved October 15, 2007.

23. ̂  Hindo, Brian (6 June 2007). "At 3M, a struggle between efficiency and

creativity". Business Week. Retrieved June 6, 2007.

24. ̂  Ruffa, Stephen A. (2008). Going Lean: How the Best Companies Apply

Lean Manufacturing Principles to Shatter Uncertainty, Drive Innovation,

and Maximize Profits. AMACOM (a division of American Management

Association). ISBN 0-8144-1057-X.

25. ̂  Wheeler, Donald J. (2004). The Six Sigma Practitioner's Guide to Data

Analysis. SPC Press. p. 307. ISBN 9780945320623.

26. ^ a b *Pande, Peter S.; Neuman, Robert P.; Cavanagh, Roland R.

(2001). The Six Sigma Way: How GE, Motorola, and Other Top

Companies are Honing Their Performance. New York: McGraw-Hill

Professional. p. 229. ISBN 0071358064.

[edit]Further reading

Adams, Cary W.; Gupta, Praveen; Charles E. Wilson (2003). Six Sigma

Deployment. Burlington, MA: Butterworth-Heinemann. ISBN 0750675233.

Breyfogle, Forrest W. III (1999). Implementing Six Sigma: Smarter

Solutions Using Statistical Methods. New York, NY: John Wiley &

Sons. ISBN 0471265721.

De Feo, Joseph A.; Barnard, William (2005). JURAN Institute's Six Sigma

Breakthrough and Beyond - Quality Performance Breakthrough Methods.

New York, NY: McGraw-Hill Professional. ISBN 0071422277.

Hahn, G. J., Hill, W. J., Hoerl, R. W. and Zinkgraf, S. A. (1999) The Impact

of Six Sigma Improvement-A Glimpse into the Future of Statistics, The

American Statistician, Vol. 53, No. 3, pp. 208–215.

Harry, Mikel J.; Schroeder, Richard (1999). Six Sigma: The Breakthrough

Management Strategy Revolutionizing the World’s Top Corporations. New

York, NY: Doubleday.ISBN 0385494378.

Keller, Paul A. (2001). Six Sigma Deployment: A Guide for Implementing

Six Sigma in Your Organization. Tucson, AZ: Quality

Publishing. ISBN 0930011848.

Pande, Peter S.; Neuman, Robert P.; Roland R. Cavanagh (2001). The

Six Sigma Way: How GE, Motorola, and Other Top Companies are

Honing Their Performance. New York, NY: McGraw-Hill

Professional. ISBN 0071358064.

Pyzdek, Thomas and Paul A. Keller (2009). The Six Sigma Handbook,

Third Edition. New York, NY: McGraw-Hill. ISBN 0071623388.

Snee, Ronald D.; Hoerl, Roger W. (2002). Leading Six Sigma: A Step-by-

Step Guide Based on Experience with GE and Other Six Sigma

Companies. Upper Saddle River, NJ: FT Press. ISBN 0130084573.

Taylor, Gerald (2008). Lean Six Sigma Service Excellence: A Guide to

Green Belt Certification and Bottom Line Improvement. New York, NY: J.

Ross Publishing. ISBN 978-1604270068.

Tennant, Geoff (2001). SIX SIGMA: SPC and TQM in Manufacturing and

Services. Aldershot, UK: Gower Publishing, Ltd. ISBN 0566083744.

Categories: Industry | Business terms | Evaluation methods | General Electric | Motorola | Process

management | Production and manufacturing | Quality | 1981 introductions

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