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ISO 9001(2000) QMS (CLAUSE # 7) CONTROL OF PRODUCTION AND SERVICES

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Total Quality Management ­ MGT510
VU
Lesson # 26
ISO 9001(2000) QMS (CLAUSE # 7) CONTROL OF PRODUCTION AND SERVICES
7.5
Production and Service Operations
ISO 9001:2000 - Quality Management Systems - Requirements
7.5
Production and Service Operations
7.5.1  Control of Production and Service Provision
The organization shall plan and carry out production and service provision under controlled conditions.
Controlled conditions shall include, as applicable.
a)
The availability of information that the characteristics of the product;
b)
The availability of work instructions, as necessary,
c)
The use of suitable equipment,
d)
The availability and use of monitoring and measuring devices,
e)
The implementation of monitoring and measurement, and
f)
The implementation of release, delivery and post-delivery activities.
7.5.1
Control of Production and Service Provision
The organization should identify requirements for operations that realize products or deliver services in
order to ensure compliance with specifications and satisfy the needs and expectations of interested
parties. To meet these needs and expectations, the organization should review its
·
ability to comply with contractual requirements,
·
training and competence of people,
·
communication.
·
problem prevention, and
·
relevant statutory and regulatory requirements.
Further considerations may include .capacity planning,
·
logistics.
·
intended use,
·
post- realization activities.
·
preservation.
·
training required, A
·
product flow and yield.
·
automation, and
·
electronic monitoring.
The infrastructure should be appropriately maintained and adequately protected in and between use in
order to maintain operational capability.
ISO 9001:2000-Quality Management Systems -Requirements
7.5.2
Validation of Processes for Production and Service Provision
The organization shall validate any processes for production and service provision where the resulting
output cannot be verified by subsequent monitoring or measurement. This includes any processes where
deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangement for these processes including, as applicable
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Total Quality Management ­ MGT510
VU
a)
Defined criteria for review and approval of the processes,
b)
Approval of equipment and qualification of personnel,
c)
Use of specific methods and procedures,
d)
Requirements for records (see 4.2.4), and
e)
Revalidation.
ISO 9001:2000- Quality Management Systems -Requirements
7.5.3  Identification and Traceability
Where appropriate, the organization shall identify the product by suitable means throughout product
realization. To organization shall identify the product status respect to monitoring and measurement
requirements. Where traceability is a requirement, the organization shall control and record the unique
identification of the product
NOTE in some industry sectors, configuration management is a means by which identification and
traceability are maintained.
7.5.3
Identification and Traceability
The organization should establish a process and documentation for identification and traceability for
control of products to satisfy customer and other interested party requirements.
The need for identification and traceability may be due to
·
status of products, including component parts,
·
contract requirements,
·
relevant statutory and regulatory requirements,
·
intended use or application
·
hazardous materials, and
·
risk mitigation.
ISO 9001:2000- Quality Management Systems -Requirements
7.5.4  Customer Property
The organization shall exercise care with customer property while it is under the organization's control
or being used by the organization. The organization shall identify, verify, protect and safeguard
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, this shall be reported to the customer and records
maintained
NOTE Customer property can include intellectual property.
7.5.4
Customer Property
The organization should identify responsibilities in relation to property and other assets owned by
customers and other interested parties and under the control of the organization, in order to protect the
value of the property. Examples of such property are:
·
ingredients or components supplied for inclusion in a product,
·
product supplied for repair, maintenance or upgrading,
·
packaging materials supplied directly by the customer,
·
customer materials handled by service operations such as storage,
·
services supplied on behalf of the customer such as transport of customer property to a third
party,
·
protection of customer intellectual property including specifications, such as drawings.
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Total Quality Management ­ MGT510
VU
ISO 9001:2000 - Quality Management Systems - Requirements
7.5.5  Preservation of Product
The organization shall preserve conformity of product during internal processing and delivery to the
intended destination. This preservation shall include identification, handling, packaging, storage and
protection. Preservation shall also apply to the constituent parts of a product.
7.5.5
Preservation of Product
The organization should define and implement processes for handling, packaging, storage, preservation
and delivery that are designed to prevent damage, deterioration or misuse during internal processing and
final delivery of the product. The organization should consider the need for any special requirements
arising from the nature of the product. Special requirements may be associated with software, electronic
media, hazardous materials, specialist personnel, and products or materials which are unique or
irreplaceable. The organization should identify resources needed to maintain the product throughout its
life cycle to prevent damage, deterioration, or misuse. The organization should communicate
information to the interested parties involved about the resources needed to facilitate preservation
actions.
ISO 9001:2000 - Quality Management Systems ­ Requirements
7.6 Control of Monitoring and Measuring Devices
The organization shall determine the monitoring and measurement to be undertaken and the monitoring
and measuring devices needed to provide evidence of conformity of product to determined requirements
The organization shall establish processes to ensure that monitoring and measurement can be carried out
and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall
a)
Be calibrated or verified 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;
b)
Be adjusted or re-adjusted as necessary;
c)
Be identified to enable the calibration status to be determined;
d)
Be safeguarded from adjustments that would invalidate the measurement result;
e)
Be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when
the equipment is found not to conform to requirements. The organization shall take appropriate action
on the equipment and any product affected. Records of the results of calibration and verification shall be
maintained.
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial
use and reconfirmed as necessary.
7.6
Control of Measuring and Monitoring Devices
The organization should define and implement methodologies for verification of products and validation
of processes to ensure interested party satisfaction. These methodologies could include surveys,
simulations, measurement and monitoring.
Measuring and monitoring devices can be used for the verification of outputs of processes against
specified requirements. The organization should ensure that where measuring and monitoring devices
are used fur verification, they are calibrated and maintained to accepted standards, giving confidence to
the results.
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Total Quality Management ­ MGT510
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The organization should consider other means to eliminate all potential errors from processes (known as
"fool-proofing"), for verification of process outputs to minimize the need for control of measurement
and monitoring devices, and to add value for interested parties.
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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