Kaizen

Kaizen
From 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 9000
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
• 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).
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.
[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.
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.
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.
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.
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.
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
[show]
v • d • e
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Six Sigma
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
[ 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  Histograms
 Analysis of variance  Homoscedasticity
 ANOVA Gauge R&R  Quality Function D
 Axiomatic design  Pareto chart
 Business Process Mapping  Pick chart
 Catapult exercise on variability  Process capability
 Cause & effects diagram (also known as fishbone or Ishikawa diagram)  Quantitative mark
 Chi-square test of independence and fits Management (EFM) sy
 Control chart  Regression analys
 Correlation  Root cause analys
 Cost-benefit analysis  Run charts
 CTQ tree  SIPOC analysis (Sup
 Design of experiments  Stratification
 Failure mode and effects analysis (FMEA)  Taguchi methods

 Taguchi Loss Fun
 General linear model
 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 defective Percentage yield Short-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.
 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.
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Six Sigma
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
[ 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  Histograms
 Analysis of variance  Homoscedasticity
 ANOVA Gauge R&R  Quality Function D
 Axiomatic design  Pareto chart
 Business Process Mapping  Pick chart
 Catapult exercise on variability  Process capability
 Cause & effects diagram (also known as fishbone or Ishikawa diagram)  Quantitative mark
 Chi-square test of independence and fits Management (EFM) sy
 Control chart  Regression analys
 Correlation  Root cause analys
 Cost-benefit analysis  Run charts
 CTQ tree  SIPOC analysis (Sup
 Design of experiments  Stratification
 Taguchi methods
 Failure mode and effects analysis (FMEA)  Taguchi Loss Fun
 General linear model  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 defective Percentage yield Short-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.
 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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Kaizen

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From Wikipedia, the free encyclopedia

o 3.1 The five main elements of kaizen

Reference: US National Archives - SCAP collection - PR NewsWire

The PDCA cycles

The cycle of kaizen activity can be defined as:

 Gauge measurements against requirements

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

[edit]The five main elements of kaizen

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

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

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

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

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

This article may require cleanup to meet

 monitoring processes to ensure they are effective;

 keeping adequate records;

 facilitating continual improvement

• 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

 1.3.6.1 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