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ISO 9001(2000) QMS (CLAUSE # 8) MEASUREMENT, ANALYSIS, AND IMPROVEMENT

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Lesson # 27
ISO 9001(2000) QMS (CLAUSE # 8) MEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.
Measurement, Analysis and Improvement
ISO 9001:2000 - Quality Management Systems - Requirements
8.
Measurement, Analysis and Improvement
8.1
General
The organization shall plan and implement the monitoring, measurement, analysis and improvement
processes needed
a)
To demonstrate conformity of the product,
b)
To ensure conformity of the quality management system, and
c)
To continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent
of their use.
8.1
General Guidance
Introduction
An organization should provide for the measurement and evaluation of its product, the capability of
processes, customer satisfaction and items required by other interested parties at appropriate intervals.
This includes the recording, collecting, analyzing, summarizing and communication of relevant data
needed to monitor and improve the organization's performance.
Measurements should be evaluated in terms of the added value provided to the organization, and should
be deployed only where the benefit can be identified. The measurement criteria and objectives should be
identified. These measurements should lead to consideration of appropriate action. They should not be
purely for the accumulation of information.
The results of measurement can show a level of achievement, but consideration should also be given to
trends and variation. The causes of trends and variation should be identified in order to ensure they are
understood. The organization should determine the need for the use of statistical techniques for
analyzing data, including verifying process operations and product characteristics. Statistical techniques
selected for use should be suitable for the application. The organization should control and monitor the
use of the statistical techniques selected.
The results of analysis of data from improvement activities should be one of the inputs to the
management review process. The information and data collected should be used throughout the
organization to support effective and efficient management.
The organization should promote the use of creative and innovative approaches for improvement
processes. Also, the organization should plan the implementation of the improvement action and
provide adequate resources. The organization should continually monitor and record the implementation
of improvement actions, which will also provide data for future improvements. Relevant comparative
data and information should be used to set realistic and challenging goals.
Continual improvement requires change within the organization. Evaluation of change requires
measurement. Measurement itself does not initiate change. Measurements should be taken for a clearly
defined purpose.
Issues to be Considered
Measurement, analysis and improvement include issues such as the following:
a)
Measurement, analysis and improvement should be used to establish appropriate priorities for
the organization;
b)
The measurements employed by the organization should be reviewed periodically, and data
should be verified on a continuum (basis for accuracy and completeness;
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c)
The benchmarking of individual processes as well as customer satisfaction should be employed
as .an improvement tool;
d)
The use of measurements and the generation of information are essential for good
communication and they should be the basis for improvement and involvement of all interested
parties; such information should be current, and be clearly defined as to its purpose;
e)
Appropriate tools for the communication of information resulting from the analyses of the
measurements should be implemented;
f)
The effectiveness of communication to interested par1ies should be measured to determine
whether the information is clearly understood;
g)
Self-assessment should be considered on a periodic basis to assess organizational performance
and to define improvement Opportunities (see annex A).
ISO 9001:2000 - Quality Management Systems - Requirements
8.2
Monitoring and Measurement
8.2.1  Customer Satisfaction
As one of the measurements of the performance of the quality management system, the organization
shall monitor information relating to customer perception as to whether the organization has met
customer requirements. The methods for obtaining and using this information shall be determined.
8.2
Measurement and Monitoring
8.2.1  Measurement and Monitoring of System Performance
General
The organization should identify the methodologies needed for identification of areas for improvement
in the overall efficiency and effectiveness of the quality management system.  Examples of
measurement and monitoring methodologies include customer satisfaction measurement,
·  Internals audits,
·  Financial measurements, and
·  Self-assessment methodologies.
8.2.1
Measurement and Monitoring of Customer Satisfaction
The organization should recognize that there are many sources of customer-related information, arid
should establish processes to gather analyze and deploy this information. The organization should
identify sources of customer and end-user information available in written and verbal forms, from
internal and external sources. Examples of customer- related information include
·  Feedback on all aspects of product.
·  Customer requirements and contract information, .marl<et needs.
·  Service delivery data, and
·  Information relating to competition.
The organization's process for requesting, measuring and monitoring feedback of customer satisfaction
and dissatisfaction should provide information on a continual basis. It should address conformance to
requirements, meeting needs and expectations of customers, as well as price and delivery of product.
The organization should establish and use sources of customer information and should cooperate with
its customers in order to anticipate future needs. The organization should plan and establish processes
for implementing appropriate marketing activities to efficiently obtain the "voice of the customer".
The organization should specify the methodology and the measures to be used and the frequency of
gathering and analyzing data for review.
The organization should plan data collection methodologies. Examples of sources of information on
customer satisfaction include
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·
Customer complaints,
·
Direct communication with customers.
·
questionnaires and surveys, .focus groups,
·
Reports from consumer organizations,
·
Reports in various media, and .sector studies.
ISO 9001:2000 - Quality Management Systems - Requirements
8.2.2  Internal Audit
The organization shall conduct internal audits at planned intervals to determine whether the quality
management system:
a)
Conforms to the planned arrangements (see 7.1) to the requirements of this Internal Standards
and to the quality management system requirements established by the organization, and
b)
Is effectively implemented and maintained
An audit program shall be 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 shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and
impartiality of the audit process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting results and
maintaining records shall be defined in a documented procedure.
The management responsible for the area being audited shall ensure that actions are taken without under
delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the
verification of the actions taken and the reporting of verification results (see 8.5.2)
8.2.2
Internal Audit
An organization should establish an internal audit process to assess the strengths and weaknesses of the
Quality Management system. The internal audit process may also review the efficiency and
effectiveness of other activities and support processes in the organization. The internal audit process
should include the planning, implementation, reporting and follow-up activities related to internal
audits. Planning for internal audits should be flexible in order to permit changes in emphasis based on
findings and observations obtained during the audit Input from the area to be audited, as well as from
other interested parties, should be considered in the development of internal audit plans.
Examples for consideration by internal auditing include
·
existence of adequate documentation,
·
effective implementation of processes,
·
identification of nonconformance,
·
documentation of results, .competence of people,
·
opportunities for improvement,
·
capability of processes,
·
use of statistical techniques,
·
use of information technology,
·
analysis of quality cost data,
·
assigned responsibilities and authorities,
·
performance results and expectations,
·
adequacy and accuracy of performance measurement,
·
improvement activities, and
·
relationships with interested parties, including internal customers.
In addition to documenting non-conformances, internal audit reporting could also indicate areas for
improvement (with recommendations), as well as areas of outstanding performance.
Examples of follow-up activities include
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·
Verification of implementation.
·
timeliness and effectiveness of corrective action, and
·
Effectiveness of the internal audit process.
8.2.2
Self Assessment
Organizations should consider establishing and implementing a self-assessment process. The range and
depth d the assessment should be planned in relation to the organization's objectives and priorities. The
self-assessment methodology described in annex A, as well as existing quality awards criteria or other
appropriate methodologies may be used for self-assessment of the organization. Some of the advantages
of using the self-assessment methodology given in annex A are that .it is simple to understand,
·
it is easy to use,
·
it has minimal impact on the use of management resources, and
·
it provides input to enhance the performance of the organization's Quality management system.
The self-assessment methodology described in annex A focuses on determining the degree of efficiency
and effectiveness of implementation of the Quality management system defined in this International
Standard. Annex A is not intended to provide a self-assessment methodology to compete with existing
models. Self-assessment methodology should not be considered as an alternative to internal or external
quality auditing. Use of the methodology described in annex A can provide an overall view of the
performance of the organization and the degree of maturity of the quality management system. It can
also provide input for identifying areas in the organization requiring improvement and can help to
determine priorities.
8.2.3
Measurement and Monitoring of Processes
The organization should identify measurement methodologies and perform measurements to evaluate
process performance. The organization should consider how these measurements can be incorporated
into the product realization process and the role of measurement in process management.
Examples of measures of process performance include .accuracy,
·
timeliness,
·
dependability ,
·
reaction time of processes and people to special internal and external requests.
·
cycle time or throughput,
·
effectiveness and efficiency of people,
·
utilization of technologies, and
·
cost reduction.
ISO 9001:2000 - Quality Management Systems - Requirements
8.2.3  Monitoring and Measurement of Processes
The organization shall apply suitable methods for measurement and, where applicable, measurement of
the quality management system processes. These methods shall demonstrate the ability of the processes
to achieve planned results. When planned results are not achieved, correction and corrective action shall
be taken, as appropriate, to ensure conformity of the product
8.2.4
Monitoring and Measurement of Products
The organization should establish and specify the measurement requirements (including acceptance
criteria) for its products. The measurement of product should be planned and performed to verify
conformance to specified requirements.
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The organization should consider the following when choosing a methodology to measure products:
a)
The conformance to specified requirements of its products, and those provided by suppliers;
b)
The location of each measurement point in its process sequence;
c)
Characteristics to be measured at each point, the documentation and acceptance criteria to be
used;
d)
Equipment and tools required;
e)
Customer established points for witness or verification of selected characteristics of a product;
f)
Inspections or testing that are required to be witnessed or performed by statutory and regulatory
authorities;
g)
Where, when and how the organization intends, or is required by the customer or statutory and
regulatory authorities, to engage qualified third parties to perform
-
type testing.
-
In-process inspections or testing,
-
Product verification,
-
Product validation;
h)
Qualification of material, product, process, people or the quality management system;
i)
Final inspections to confirm that all specified inspections and testing are completed and
accepted;
j)
Outputs of the measurement process of the product.
The measurement of product should be performed prior to delivery to verify that the product is in
conformance with requirements. The organization should review the approach used for measuring
products and the records of verification and make appropriate improvement.
Typical examples of product measurement records include
·
inspection and test reports,
·
material release notices,
·
certificates as required, and
·
electronic data.
ISO 9001:2000 -Quality Management Systems - Requirements
8.2.4  Monitoring and Measurement of Product
The organization shall monitor and measure the characteristics of the product to verify that requirements
have been met. This shall be carried out at appropriate stages of the product realization process in
accordance with the planned arrangement (see 7.1).
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the
person(s) authorizing release of product.
Product release and service delivery shall 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.
8.2.4
Measurement and Monitoring of Satisfaction of Interested Parties
The organization should identify the measurement information required to meet the needs of other
interested parties at appropriate stages of product realization. Such information should include
measurements relating to people, owners, suppliers and society.
8.2.4
People in the Organization
The organization should
·  gather the opinion of its people regarding the manner in which the organization satisfies their
needs and expectations, and
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assess individual and collective performances and their contribution to organizational results.
8.2.4
Owners
The organization should
·
assess its capacity to attain the defined goals,
·
measure financial performance,
·
measure the impact of external factors on results, and
·
identify the value contributed by the actions taken.
8.2.4
Suppliers
The organization should
·
monitor the performance of suppliers and their compliance with the purchasing policy,
·
measure or monitor the quality of the product purchased, and
·
measure the performance of the purchasing processes of the organization.
8.2.4
Society
The organization should
·  define appropriate measurements relative to its objectives, for interaction with society, and
·  periodically assess the efficiency of its actions and the perceptions of the results by relevant
parts of society.
8.3
Control of Nonconformance
General
All people within the organization should have the authority to report non-conformances at any stage of
a process. This is particularly true for those people engaged in monitoring processes and process output
verification. Prompt attention to non-conformances permits the initiation of prompt corrective action.
Authority for reaction to non-conformances should be defined to maintain achievement of product
requirements. The organization should control product identification, segregation and disposition in
order to prevent misuse. The organization may also need to consider recording information on those
non-conformances which are corrected in the normal course of work. Such data can provide valuable
information for process improvement It is essential that all non-conformances be recorded, together with
their disposition, to assist learning and provide data for analysis and improvement activities.
8.3
Nonconformance Review and Disposition
The organization should have a process to provide for review and disposition of all non-conformances.
Review of non conformances should be conducted by designated persons to determine if any trends or
patterns of occurrence exist. These trends should be considered for improvement and as input to
management review. People carrying out the review should be competent to evaluate the effects of the
non-conformance and should have the authority and resource to define corrective action. Customer
acceptance of the disposition may be a contractual requirement.
ISO 9001:2000-Quality Management Systems ­ Requirements
8.3
Control of Nonconforming Product
The organization shall ensure that product which does not conform to product requirements is identified
and controlled to prevent unintended use or delivery. The controls and related responsibilities and
authorities for neither dealing with nor conforming product shall be defined in a documented procedure.
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The organization shall deal with nonconforming product by one or more of the following ways:
a)
By taking action to eliminate the detected nonconformity;
b)
By authorizing its use, release or acceptance under concession by a relevant authority and,
where applicable, by the customer;
c)
By taking action to preclude its original intended use or application.
Records of the nature of nonconformities and any subsequent actions taken, including concessions
obtained, shall be maintained (see 4.2.4)
When nonconforming product is corrected it shall be subject to re-verification to demonstrate
conformity to the requirements. When nonconforming product is detected after delivery or use has
started, the organization shall take action appropriate to the effects, or potential effects, of the
nonconformity.
operational performance
customer satisfaction and dissatisfaction,
satisfaction level of other interested parties,
effectiveness and efficiency of - organization,
supplier contribution,
economics of quality and financial and market-related performance and,
bend1marrking of performance.
8.4
Analysis of Data for Improvement
The organization should analyze data from various sources to assess performance against plans and
goals and to identify areas for improvement. The organization should plan to use statistical
methodologies for data analysis, which can help in assessing, controlling, and improving performance of
processes.
The analysis of data can help deten11ine the cause of problems, and therefore guide effective corrective
and preventive action. This may require analysis of the product specifications, as well as analysis of
relevant processes, operations and quality records.
Information and data from all parts of the organization should be integrated and analyzed to evaluate the
overall performance of the organization. The overall performance should be presented in a forma that is
suitable to different levels of management.
The results of analysis can be used to deten11ine
trends,
operational performance
customer satisfaction and dissatisfaction,
satisfaction level of other interested parties,
effectiveness and efficiency of - organization,
supplier contribution,
economics of quality and financial and market-related performance and,
bend marking of performance.
ISO 9001; 2000 - Quality Managements -Requirements
8.4
Analysis of Data
The organization shall determine collect and analyze 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 shall include data generated as a
result of monitoring and measurement and from other relevant sources.
The organization shall analyze this data to provide information on:
a)
Customer satisfaction (see 8.2.1)
b)
Conformity to product requirements (see 7.2.1)
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c}
characteristics and trends of processes and products including opportunities for preventive
action,
d)
Suppliers
ISO 9001:2000- Quality Management Systems - Requirements
8.5
Improvement
8.5.1  Continual Improvement
The organization shall continually improve 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 review.
8.5
Improvement
8.5.1
General
The organization should continually seek to improve its processes, rather than wait for a problem to
reveal opportunities for improvement. Potential improvements can range from continual activities to
long-term improvement projects. The organization should have a process in place to identify and
manage improvement projects.
The efficiency and effectiveness of processes should be emphasized when actions are taken. These
actions should be monitored to ensure that desired goals are met. Identification of causes of deviations
may result in changes to, the product, processes and even revision of the quality management system.
8.5.2
Corrective Action
The organization should plan and establish a process for corrective action. Corrective action planning
should include evaluation of the significance of problems affecting quality. The evaluation should be in
terms of the potential impact on such aspects as operating costs, costs of nonconformance, performance,
dependability, safety and customer satisfaction. Appropriate functions should be represented in the
corrective action process.
The organization should identify sources of information, collect information and define the necessary
corrective - actions. The defined corrective action should be focused on eliminating causes of non-
conformances and defects in order to avoid recurrence.
Examples of sources of information include
·  customer complaints,
·  non-conformance reports,
·  outputs from management review,
·  internal audit reports,
·  outputs from data analysis,
·  relevant quality management system records,
·  outputs from satisfaction measurements,
·  process measurements, and .results of self-assessment
The corrective action process should include
·  a definition of the causes of non-conformances and defects,
·  elimination of causes of non-conformances and defects,
·  appropriate actions to avoid recurrence of problems, and
·  a record of the activity and results.
Efficiency and effectiveness of processes should be emphasized when actions are taken and the actions
should be monitored to ensure that desired goals are met.
Corrective actions should be considered for inclusion in the management review process. For example,
corrective actions with high financial impact or those that have significant potential impact on customer
satisfaction should be considered.
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Root because analysis results should be verified by testing, where appropriate, in order to define
effective corrective action.
ISO 9001:2000 -Quality Management Systems -Requirements
8.5.2  Corrective Action
The organization shall take corrective action to eliminate the cause of nonconformities in order to
prevent recurrence. Corrective action shall be appropriate to the effects of the nonconformities
encountered.
The documented procedure shall be established to define requirement for
a)
Reviewing nonconformities (including customer complaints);
b)
Determining the causes of nonconformities;
c)
Evaluating the need for actions to ensure that nonconformities do not recur;
d)
Determining and implementing the corrective action needed;
e)
Recording results of action taken;
f)
Reviewing of corrective action taken.
8.5.3
Preventive Action
The organization should use preventive methodologies to identify the causes of potential non-
conformances. Examples of such methodologies include risk analyses, .trend analyses, statistical
process control, fault tree analysis, failure modes and effects and criticality analyses.
Appropriate organizational representatives should participate in the preventive actions.
The organization should identify sources of information for planning and prioritizing preventive actions.
Examples of sources are
·  customer needs and expectations,
·  market analysis,
·  management review output,
·  outputs from data analysis,
·  satisfaction measurements,
·  process measurements,
·  systems that consolidate many sources of customer information,
·  relevant quality management system records,
·  results of self-assessment, and
·  processes that provide early warning of approaching out-of-control operating conditions.
Preventive actions should be considered for inclusion in the management review process. This is
especially true for preventive actions with high financial impact or those that have significant potential
impact on satisfaction of customers and other interested parties.
ISO 9001:2000-Quality Management Systems -Requirements
8.5.3 Preventive Action
The organization shall determine preventive action to eliminate the causes of potential nonconformities
in order to prevent occurrence. Preventive actions shall be appropriate to the effects of the potential
problems. A documented procedure shall be established to define requirements for:
a)
Determining potential nonconformities and their causes;
b)
Evaluating the need for action to prevent occurrence of nonconformities
c)
Determining and implementing action needed,
d)
Records of results of action taken and
e)
Reviewing preventive action taken.
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8.5.4
Process for Improvement
In addition to the improvement actions described in the previous sub-clauses, the organization should
define and implement a methodology for process improvement that can be applied to all processes and
activities. Such a standard methodology for process improvement can become a tool for improving
internal effectiveness and efficiency, as well as improving the satisfaction of customers and other
interested parties.
Examples of inputs to the improvement process include
·  validation data,
·  test data,
·  requirements and feedback from interested parties,
·  financial data,
·  product performance data, and
·  service delivery data.
The organization should undertake small step improvement activities integral to routine operations in
order to maintain continual improvement through involvement of people. Improvement should also be
planned for breakthrough projects to achieve specific objectives.
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Table of Contents:
  1. OVERVIEW OF QUALITY MANAGEMENT:PROFESSIONAL MANAGERIAL ERA (1950)
  2. TOTAL QUALITY MANAGEMENT AND TOTAL ORGANIZATION EXCELLENCE:Measurement
  3. INTEGRATING PEOPLE AND PERFORMANCE THROUGH QUALITY MANAGEMENT
  4. FUNDAMENTALS OF TOTAL QUALITY AND RATERS VIEW:The Concept of Quality
  5. TOTAL QUALITY MANAGEMENT AND GLOBAL COMPETITIVE ADVANTAGE:Customer Focus
  6. TOTAL QUALITY MANAGEMENT AND PLANNING FOR QUALITY AT OFFICE
  7. LEADERS IN QUALITY REVOLUTION AND DEFINING FOR QUALITY:User-Based
  8. TAGUCHI LOSS FUNCTION AND QUALITY MANAGEMENT
  9. WTO, SHIFTING FOCUS OF CORPORATE CULTURE AND ORGANIZATIONAL MODEL OF MANAGEMENT
  10. HISTORY OF QUALITY MANAGEMENT PARADIGMS
  11. DEFINING QUALITY, QUALITY MANAGEMENT AND LINKS WITH PROFITABILITY
  12. LEARNING ABOUT QUALITY AND APPROACHES FROM QUALITY PHILOSOPHIES
  13. TOTAL QUALITY MANAGEMENT THEORIES EDWARD DEMING’S SYSTEM OF PROFOUND KNOWLEDGE
  14. DEMING’S PHILOSOPHY AND 14 POINTS FOR MANAGEMENT:The cost of quality
  15. DEMING CYCLE AND QUALITY TRILOGY:Juran’s Three Basic Steps to Progress
  16. JURAN AND CROSBY ON QUALITY AND QUALITY IS FREE:Quality Planning
  17. CROSBY’S CONCEPT OF COST OF QUALITY:Cost of Quality Attitude
  18. COSTS OF QUALITY AND RETURN ON QUALITY:Total Quality Costs
  19. OVERVIEW OF TOTAL QUALITY APPROACHES:The Future of Quality Management
  20. BUSINESS EXCELLENCE MODELS:Excellence in all functions
  21. DESIGNING ORGANIZATIONS FOR QUALITY:Customer focus, Leadership
  22. DEVELOPING ISO QMS FOR CERTIFICATION:Process approach
  23. ISO 9001(2000) QMS MANAGEMENT RESPONSIBILITY:Issues to be Considered
  24. ISO 9001(2000) QMS (CLAUSE # 6) RESOURCES MANAGEMENT:Training and Awareness
  25. ISO 9001(2000) (CLAUSE # 7) PRODUCT REALIZATION AND CUSTOMER RELATED PROCESSES
  26. ISO 9001(2000) QMS (CLAUSE # 7) CONTROL OF PRODUCTION AND SERVICES
  27. ISO 9001(2000) QMS (CLAUSE # 8) MEASUREMENT, ANALYSIS, AND IMPROVEMENT
  28. QUALITY IN SOFTWARE SECTOR AND MATURITY LEVELS:Structure of CMM
  29. INSTALLING AN ISO -9001 QM SYSTEM:Implementation, Audit and Registration
  30. CREATING BUSINESS EXCELLENCE:Elements of a Total Quality Culture
  31. CREATING QUALITY AT STRATEGIC, TACTICAL AND OPERATIONAL LEVEL
  32. BIG Q AND SMALL q LEADERSHIP FOR QUALITY:The roles of a Quality Leader
  33. STRATEGIC PLANNING FOR QUALITY AND ADVANCED QUALITY MANAGEMENT TOOLS
  34. HOSHIN KANRI AND STRATEGIC POLICY DEPLOYMENT:Senior Management
  35. QUALITY FUNCTION DEPLOYMENT (QFD) AND OTHER TOOLS FOR IMPLEMENTATION
  36. BASIC SQC IMPROVEMENT TOOLS:TOTAL QUALITY TOOLS DEFINED
  37. HOW QUALITY IS IMPLEMENTED? A DIALOGUE WITH A QUALITY MANAGER!
  38. CAUSE AND EFFECT DIAGRAM AND OTHER TOOLS OF QUALITY:Control Charts
  39. STATISTICAL PROCESS CONTROL (SPC) FOR CONTINUAL QUALITY IMPROVEMENT
  40. STATISTICAL PROCESS CONTROL….CONTD:Control Charts
  41. BUILDING QUALITY THROUGH SPC:Types of Data, Defining Process Capability
  42. AN INTERVIEW SESSION WITH OFFICERS OF A CMMI LEVEL 5 QUALITY IT PAKISTANI COMPANY
  43. TEAMWORK CULTURE FOR TQM:Steering Committees, Natural Work Teams
  44. UNDERSTANDING EMPOWERMENT FOR TQ AND CUSTOMER-SUPPLIER RELATIONSHIP
  45. CSR, INNOVATION, KNOWLEDGE MANAGEMENT AND INTRODUCING LEARNING ORGANIZATION