Shai's Quality Management 1

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Standardization • Various natural phenomena reflect a definite pattern • For variety reduction and interchangeability • An orderly approach considering economy, function and safety • Result of standardization efforts approved by a recognized authority

Quality Management Systems (ISO 9001 QMS) It is a set of quality assurance standards formulated by International Organization for standardization (ISO) applicable to all types of industries and organizations irrespective of they are manufacturing or service. The implementation leads to a certification.

ISO 9001 Quality Standards • Provides International Evaluating Processes.

• Has Facilitated Operations

Basis

for

Global

• Focus on Processes not Products • Vast Majority of Companies are European 5-17

QMS Requirements • General requirements Establishing, documenting, implementing and maintaining QMS • Documentation General, quality manual, Control of documents, control of records

Elements of ISO 9001 • Management Responsibility Management commitment, Customer focus, Quality Policy, Planning, Responsibility and Authority, communication and management review • Resource Management Provision of resources, Human resources, Infrastructure, Work environment • Product Realization Planning Product realization, Customer related processes, Design and development, Purchasing, Production and service provision, Control and monitoring of measuring devices • Measurement, Analysis and Improvement General, Monitoring and measurement, Control of non conforming product, Data analysis, Quality audit, Improvement

Steps in ISO 9001 1. 2. 3. 4. 5. 6. 7. 8. 9.

Formulation of Quality Policy Documentation of Procedures Verification and compliance with ISO Implementation of procedures Reviewing Implementation thru Internal Quality Audit Compliance Audit by Third Party Taking of Corrective actions Assessment and certification by certification body. Continuous surveillance

Implementation of ISO 9001 • • • • • • •

Top management commitment Appointment of management representative Awareness Appoint implementation team Training Time schedule Select element owners

Implementation of ISO 9001 • • • • • • •

Review the present system Write the documents Install the new system Internal audit Management review Preassessment Registration

Documentation • Policy Document that defines what will be done and why • Procedure Document defining who should perform specific tasks, when the task should be done, and where the documentation will be made • Work Instructions Machine, task or product oriented and spell how the job will be done • Records Evidence for the following of procedures and work instructions

Quality Audits • After the implementation of ISO 9001 system checks are to be made to ensure that system is being followed and expected results are achieved • This is accomplished through Internal quality audits done by people within the organization cross functional and external audits by the certifying agencies

Objectives of Quality audits • Determine that the actual performance conforms to the documented QMS • Initiate corrective actions in response to deficiencies • Follow-up on non compliance items from previous audits • Provide continued improvement in the system through feedback to management • Cause the auditee to think about the process, thereby encouraging possible improvements.

Quality Audit

Benefits of ISO 9001 • • • • • • • • • • •

Clarity of customer requirements Clarity of roles and responsibilities Clear business objectives and company targets Control over quality operations Assurance on quality of outsourced materials Continued up gradation of knowledge & skills of people Efficient and effective work methods Efficient review of process Independent audit of all operations Improved confidence and pride Increased efficiency, productivity and profitability

Environmental Management Systems (ISO 14001 EMS) The ISO 14001 Environmental Management systems are a set of comprehensive management system that addresses how the overall business activities including its products and services impact the environment.

Requirements of ISO 14001 • General requirements • Environmental policy – management commitment, leadership and direction for environmental activities • Planning – Environmental aspects, legal and other requirements, Objectives and targets, Environmental management programme

Requirements of ISO 14001 • Implementation and operation – Structure and responsibility, training, awareness and competency, communication, documentation, document control, operational control,emergency preparedness and response • Checking and corrective action – monitoring and measuring, non conformance and corrective and preventive action, records, EMS audit, • Management review -

Benefits of ISO 14001 • Global Facilitate trade, improve environmental performance, building consensus on need for environmental management • Organizational Assuring customers a commitment to environmental management, maintain good public relations image, obtaining insurance at reasonable cost, improve competitive advantage, reducing liability, conserving input materials and energy

Malcolm Baldrige Award • The Baldrige Award was established in 1987 to promote quality awareness, understand the requirements for quality excellence, and share information about successful quality strategies and benefits. • There are three eligibility categories: manufacturing, services, and small firms. • According to its principles, the role of quality data collection and analysis as the basis for managerial decisions is paramount. • Furthermore, quality efforts should not concentrate only on the elimination of defects but also encompass creative activities that will influence customer satisfaction.

Malcolm Baldrige Criteria for Performance Excellence • Category 1—Leadership • Category 2—Strategic Planning • Category 3—Customer and Market Focus • Category 4—Information and Analysis • Category 5—Human Resource Focus • Category 6—Process Management • Category 7—Business Results

120 points 85 points 85 points 90 points 85 points 85 points 450 points

Malcolm Baldrige Criteria for Performance Excellence

• • • • • • •

Leadership—Leadership system, values, expectations, and public responsibilities Strategic Planning—The effectiveness of strategic and business planning and deployment of plans, focusing on performance requirements Customer and Market Focus—How the company determines customer and market requirements and achieves customers satisfaction Information and Analysis—The effectiveness of information systems to support customer driven performance excellence and marketplace success Human Resource Focus—The success of efforts to realize the full potential of the work force to create a high-performance organization Process Management—The effectiveness of systems and processes for assuring the quality of products and services Business Results—Performance results and competitive benchmarking in customer satisfaction, financials, human resources, suppliers, and operations

The Deming Prize • The Deming Prize is Japan’s national quality award for industry. It was established in 1951 by the Japanese Union of Scientists and engineers (JUSE) and it was named after W. Edwards Deming. • Its principles are a national competition to seek out and commend those organizations making the greatest strides each year in quality, or more specifically, TQC. • The prize has three award categories. They are Individual person, the Deming Application Prizes, and the Quality Control Award for factory. • The Deming Application prizes are awarded to private or public organizations and are subdivided into small enterprises, divisions of large corporations, and overseas companies.

Criteria for Deming Prize • • • • • • • • • •

Policy and Objectives Organization and its Management Education and dissemination Collection, Dissemination and Use of Information on Quality Analysis Standardization Control Quality Assurance Results Planning for the Future

Topic

Baldrige Award

Deming Prize

Definition of Quality

“customer-driven quality” it views quality as defined by the customer

“conformance to specifications” it views quality as defined by the producers

Primary Focus

customer satisfaction and quality

statistical quality control

Overall Approach

quality of management

management of quality

Purpose

promote competitiveness through total quality management

promote quality assurance through statistical techniques

Types of Organization

manufacturing, service and small business

essentially private or public manufacturing

Orientation

60% result, 40% process

60% process, 40% results

Scoring Weight

different weight for each criteria

equal weight in 10 criteria

Consideration

less concern

concern in productivity, delivery, safety, and environment

Information Management

heavily concern

less concern

Winners

Maximum of two per category

All firms meeting standard

Scope

U.S. firms only

Firms for any country

Grading time

six months

one year

First Award

1987

1951

Sponsor

National Institutes Standards and Technology

Union of Japanese Scientists and Engineers

Total Productive Maintenance (TPM)  TPM is keeping the current plant and equipments at the highest productive level through co operation of all areas of organization.  It consists of action programmes for improving the overall equipment effectiveness which is a product of the Availability, Efficiency and Quality.

Total Productive Maintenance (TPM) • A movement towards ZERO breakdowns • Breakdown occurs due to Equipment stops performing its function Equipment deteriorates Equipment has hidden defects • All the above are to be eliminated. All the earlier maintenance approaches are reactive and what is required is a proactive approach

Objective of TPM - Overall Equipment Effectiveness - OEE • OEE = Availability x Efficiency x Quality • Availability = Running time – Down Time Running time • Efficiency = Cycle time x number of units Operation time • Quality = Number of Good units Total No of units produced

TPM Involves • Optimizing equipment effectiveness by elimination of all breakdowns, speed losses and defects • Autonomous Maintenance by Operators • Organization wide involvement through small group activities • TPM covers Breakdown Maintenance, Preventive Maintenance, Maintenance prevention, Maintainability improvement, and company wide involvement

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