TQM Mod5@AzDOCUMENTS - in
TQM Mod5@AzDOCUMENTS - in
CONTENTS
1. Total Productive Maintenance (TPM):
2. Quality by Design (QbD)
3. Environmental Management Systems (EMS):
TPM (Total Productive Maintenance) is a unified approach used for equipment maintenance
TPM aims to make the production process free from breakdown, defect free, slowing down of
the production line, and setup time losses. It also aims to provide safe working conditions. TPM
ensures everyone works together in the industry to achieve peak performance and productivity.
• Keeping the current plant and equipment at the highest productive level through the
cooperation of all the areas of organization
• Total – everyone working together
• Productive – production of goods and services to meet or exceed the expectation of the
customer
• Maintenance – keep equipment in good or better than original condition at all times
Total Productive Maintenance (TPM) is a maintenance program which involves a newly defined
concept for maintaining plants and equipment.
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TPM seeks to maximize equipment‟s effectiveness throughout the life time of that equipment. It
strives to maintain optimum equipment conditions in order to prevent unexpected break downs, speed
loses, and quality defects arising from process activities.
Focused Improvement: In TPM, everyone focuses towards improvement. Small focus work
groups improve the quality continuously by removing root causes of errors. They work together
to reduce the number of defects.
Expected Questions
1) Explain the concept of product liability.
2) What measures are taken to prevent product failures? Explain.
3) What is total productive maintenance? What are its objectives?
4) Explain 8 pillars of TPM
5) How do you measure TPM? Explain.
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QUALITY BY DESIGN
Quality by Design (QbD): Definition, Key components of QbD,
Role of QbD in Pharmaceutical Industry,
Benefits and Challenges of QbD.
Introduction
Quality by design is the practice of using a multidisciplinary team to conduct conceptual thinking,
product design and production planning all at one time, it is also known as concurrent engineering,
simultaneous engineering or parallel engineering.
Quality by design has recently encouraged changes in management structures.
The major functions within an organization would complete their task by „„throwingit over the wall‟‟ to
the next department in the sequence and would not be concerned with any internal customer problems
that might arise, quality by design or concurrent engineering requires the major functions to be
performed at the same time. This system provides for immediate feedback, which prevents problems
with quality and productivity from occurring. Fig. 5.3. Shows the flow diagram for both sequential or
traditional engineering on the left and quality by design or concurrent engineering on the right.
When each of the specialists early input to the product definition and specifications, cost is minimized
and performance is maximized. Thus, better-quality products are manufactured for less cost with shorter
time to market.
The quality by design or concurrent engineering method combines all these steps into one. The product is
designed to be successful at each stage of its life cycle. It is designed correctly the first time, considering
all attributes and facets of its life, such as marketability, assembly and service ability, before release to
testing and small production.
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Fig. 5.3. Product development flow diagram. Source: Shoji shiba, et.al., A new American TQM, four
revolutions of Management,productivity press, 1990.
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Source: Shoji shiba, et.al., A new American TQM, four revolutions of Management,
productivity press, 1990.
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Expected Questions
1. What is quality by design? How is it different from sequential engineering?
2. Why do we need to implement quality by design?
3. What are the potential benefits of Quality by Design?
4. What are the barriers and misconceptions about Quality by Design?
2. ORGANIZATIONAL BENEFITS
• Assuring customers of a commitment to environmental management
• Meeting customer requirement
• Improve public relation
• Increase investor satisfaction
• Market share increase
• Conserving input material & energy
• Better industry/government relation
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• Low cost insurance, easy attainment of permits & authorization
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The best certification of a firm is through a third party.
A third-party company called a registrar is the only authorized entity that can award ISO 9000
certification.
Registrars are accredited by an authoritative national body and are contracted by companies for a fee to
evaluate their quality-management system to see if it meets the ISO 9000 standards.
A quality system certification involves the assessment and periodic surveillance audit of the adequacy of
a supplier‟s quality system by a registrar.
When a supplier‟s system conforms to the registrar‟s interpretation of the standard, the registrar issues a
certification to that effect to the supplier.
This certification ensures customers or potential customers that a supplier has a quality system in place
and it is being monitored.
Once passed by the third-party audit, a firm is certified and may be registered and recorded as having
achieved ISO 9000 status and it becomes part of a registry of certified companies recognized throughout
the world.
Sector-specific standards
AS 9000 (The Aerospace Standards)
The aerospace industry requires that all elements of production and supply chain operate to levels of quality
and performance that assure safe and reliable products. The Americas Aerospace Quality Group (AAQG) in
cooperation with many aerospace companies developed specific requirements for quality systems that are to
be implemented and maintained by the complete production and supply chain in the manufacture of products
used in aviation and space applications.
AS9000/AS9100
AS9100 includes ASQ9001:2000 quality system requirements and specifies additional requirements for the
quality system of the aerospace industry.
Examples of common and unique aerospace requirements found in AS9000/AS9100 are as follows:
• Identification and Control of Key Characteristics
• Stamp Control
• Foreign Object Detection (FOD)
• Requirements Flow Down
• Tooling Control
• Customer and Regulatory Agency Involvement and Approval
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AS9101A Quality System Assessment
The checklist corresponding to AS9100 Revision A.
AS9102 Aerospace First Article Inspection Requirement
Established the requirements for First Article Inspection. The purpose of First Article Inspection is to
provide objective evidence that all engineering design and specification requirements are properly
understood, accounted for, verified and documented.
AS9103 Variation Management of Key Characteristics
Established variation management requirements for key characteristics. This standard also specifies general
requirements and provides a process to achieve those requirements.
AS9120
This standard includes ISO 9001:2000 quality management system requirements and specifies additional
requirements for a quality management system for the aerospace industry applicable to stockiest distributors.
AS9131 Quality Systems Non-Conformance Documentation
This document defines to supplier/subcontractor common information and documentation required to inform
customers, when applicable about nonconformity (Customer-provider use).
ISO 9001 Requirements
CLAUSES (ELEMENTS) OF ISO 9000 (During the year 2000)
1. Scope 2. Normative Reference 3. Terms and Definitions
4. Quality Management System (QMS)
General Requirements
Documentation
5. Management Responsibility
Management Commitment
Customer Focus
Quality Policy
Planning
Responsibility, Authority and Communication
Management Review
6. Resource Management
Provision of Resources
Human Resources
Infrastructure
Work Environment
7. Product Realization
Planning of Product Realization
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Customer related processes
Design and Development
Purchasing
Production and Service Provision
Control of Monitoring and Measuring devices
8. Monitoring and Measurement
General
Monitoring and Measurement
Control of Non-Conforming Product
Analysis of Data
Improvement
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A study of 100 Italian manufacturing firms was undertaken to determine if there was any improvement in
performance after registration. Significant improvement was noted in the following areas:
Internal quality as measured by the percent of scrap, rework and nonconformities at final inspection.
Production reliability as measured by the number of breakdowns per month, percent of time dedicated to
emergencies and percent of downtime per shift
External quality as measured by product accepted by customers without inspection,claims of
nonconforming product and returned product
Time performance as measured by time to market, on-time delivery and throughput time
Cost of poor quality as measured by external nonconformities, scrap and rework
On the negative side, prevention and appraisal costs increased.
DOCUMENTATION
In every organization, the quality system must be documented properly. The documentation of the system can be
seen as a hierarchical format as shown.
1 POLICY
2 PROCEDURES
3 PRACTICES
4 PROOFS
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following ways:
• Fewer on-site audits by customers
• Increased market share
• Improved quality, both internally and externally (fewer complaints)
• Improved product and service quality levels from suppliers
• Greater awareness of quality by employees
• A documented formal system
• Reduced operating costs
Environmental Management System
The overall aim of the Environmental Management systems is to provide protection to the environment
and to prevent pollution.
The success of ISO 9000 along with increased emphasis on Environmental issues were instrumental in
ISO‟s decision to develop Environmental Management Standards.
In 1991, ISO formed the Strategic Advisory Group on the Environment (SAGE) which led to the formation
of Technical Committee (TC) 207 in 1992.
Mission of TC207 is to develop standards for an Environmental Management System (EMS) which was
identified as ISO 14000.
TC 207 has established six sub-committees
1. Environmental Management System (EMS)
2. Environmental Auditing (EA)
3. Environmental labelling (EL)
4. Environmental Performance Evaluation (EPE)
5. Life-Cycle Assessment (LCA)
6. Terms & Definitions
EMS has two Evaluation Standards. They are
1. Organization Evaluation Standards 2. Product Evaluation Standards
REQUIREMENT OF ISO 14001
There are six elements
1. GENERAL REQUIREMENTS
EMS should include policy, planning implementation & operation, checking & corrective action,
management review.
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2. ENVIRONMENTAL POLICY (Should be based on mission)
• The policy must be relevant to the organization‟s nature.
• Management‟s Commitment (for continual improvement & preventing pollution).
• Should be a framework (for Environmental objectives & Targets).
• Must be Documented, Implemented, & Maintained.
3. PLANNING
• Environmental Aspects
• Legal & other Requirements
• Objectives & Targets
• Environmental Management Programs
4. IMPLEMENTATION & OPERATION
• Structure & Responsibility
• Training, Awareness & Competency
• Communication
• EMS Documentation
• Document Control
• Operational Control
• Emergency Preparedness & Response
5. CHECKING & CORRECTIVE ACTION
• Monitoring & Measuring
• Nonconformance& Corrective & Preventive action
• Records
• EMS Audit
6. MANAGENMENT REVIEW
• Review of objectives & targets
• Review of Environmental performance against legal & other requirement
• Effectiveness of EMS elements
• Evaluation of the continuation of the policy
2. ORGANIZATIONAL BENEFITS
• Assuring customers of a commitment to environmental management
• Meeting customer requirement
• Improve public relation
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• Increase investor satisfaction
• Market share increase
• Conserving input material & energy
• Better industry/government relation
• Low cost insurance, easy attainment of permits & authorization
QFD TEAM:
There are two types of teams namely
1. Team for designing a new product
2. Team for improving an existing product
BENEFITS OF QFD:
1. Improves Customer satisfaction
Creates focus on customer requirements
Uses competitive information effectively
Prioritizes resources
Identifies items that can be acted upon
2. Reduces Implementation Time
Decreases midstream design changes
Limits post introduction problems
Avoids future development redundancies
3. Promotes Team Work
Based on consensus
Creates communication
Identifies actions
4. Provides Documentation
Documents rationale for design
Adds structure to the information
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Adapts to changes (a living document)
HOUSE OF QUALITY
The primary planning tool used in QFD is the house of quality. The house of quality converts the voice of
the customer into product design characteristics. QFD uses a series of matrix diagrams, also called „quality
tables‟, resembles connected houses.
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competing product measures, and the technical ability of the organization to meet each customer
requirement.
Getting good data from the customer in Phase 1 is critical to the success of the entire QFD process.
Phase 2, Product Design: This phase 2 is led by the engineering department. Product design requires
creativity and innovative team ideas. Product concepts are created during this phase and part specifications
are documented. Parts that are determined to be most important to meeting customer needs are then deployed
into process planning, or Phase 3.
Phase 3, Process Planning: Process planning comes next and is led by manufacturing engineering. During
process planning, manufacturing processes are flowcharted and process parameters (or target values) are
documented.
Phase 4, Process Control: And finally, in production planning, performance indicators are created to
monitor the production process, maintenance schedules, and skills training for operators. Also, in this phase
decisions are made as to which process poses the most risk and controls are put in place to prevent failures.
Significance of QFD
QFD is a way to assure the design quality while the product is still in the design stage.
is a planning tool used to fulfil customer expectations.
focuses on customer expectations or requirements, often referred to as voice of the customer.
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