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2. Define Quality?
Quality = Performance x Expectations
Five definitions of quality : Transcedent definition, product based definition , user
based definition ,manufacturing based definition, value based definition.
Quality characteristics : structural characteristics, sensory characteristics ,time
oriented characteristics ,ethical characteristics.
P = Performance
E = Expectations
DIMENSION OF QUALITY
1.
Performance
2.
Features
3. Conformance
4.
Reliability
5.
Durability
6. Service
7.
Response
8.
Aesthetics
9. Reputation
1. Customer Oriented
2. Long term commitment for continuous improvement of all process
3. Team work
4. Continuous involvement of top management
5. Continuous improving at all levels and all areas of responsibility
PRINCIPLES OF TQM:
1. Customers requirements - ( both internal & external) must be met first time & every time
2. Everybody must be involved
3. Regular two way communication must be promoted I
4. Identify the training needs and supply it to the employees
5. Top management commitment is must
BENEFITS OF TQM
Tangible Benefits
Intangible Benefits
Improved productivity
Increased profitability
Improved communication
Quality of design
Quality of design is the quality which the producer or supplier is intending to offer to the
customer. When the producer is making the quality of design of the product, he should take
into consideration the customer's requirements in order to satisfy them with fitness for use of
the product.
If the quality of design does not reflect the customer's requirements, the product which the
producer offers him would not probably satisfy the customer, even if it does sufficiently
conform to the design. Quality of design is usually indicated by completeness and correctness
of specifications, drawings, catalogues, etc. and is measured with fitness for use.
Design function should provide for the translation of customers' needs from the product brief
into technical specifications of products, materials, processes and services.
This should result in a product that provides customer satisfaction at an acceptable price that
enables a satisfactory return on investment for the organization and takes care of other
stakeholders' needs.
The product design and specification should be such that the product (including service) is
easily productable, verifiable and controllable under the proposed production, operational and
capable of being installed.
For translating the customer needs following aspects should be taken into consideration:
Accurately define the market demand and sector with details of grade, quantity, price
and time estimate of the product and service.
Product Brief
Product brief is formal statement or outline of the product requirements. It should be prepared
by the marketing function and provided to design function.
Product brief translates customer requirements and expectations to a preliminary set of
specifications as the basis for subsequent design work. Product brief should include:
Performance characteristics (environment and usage conditions, reliability, etc.);
Installation configuration;
Packaging requirements;
10. QUALITY
The word quality is often used indiscriminately for many different meanings. Quality can be defined
as fitness for use, customer satisfaction, doing things right the first time, or zero defects.
These definitions are acceptable because quality can refer to degrees of excellence. Websters
dictionary defines quality as an inherent characteristic, property or attribute. Quality Review will
define quality as a characteristic of a product or process that can be measured. Quality control is the
science of keeping these characteristics or qualities within certain bounds.
In a manufacturing or service environment, there are two major categories of quality: quality of
design and quality of conformance. A poorly designed product will not function properly regardless of
how well it meets its specifications. Conversely, a product that does not conform to excellent design
specifications will not properly perform its intended function.
1 Design Quality
Design quality refers to the level of characteristics that the designers specify for a product. Highgrade materials, tight tolerances, special features and high performance are characteristics associated
with the term, high quality product.
An example of design quality may be shown by the comparison between an expensive automobile and
an economy model. A Ferrari and a Ford Escort are compared. Both cars will perform the same basic
function of getting from point A to point B. Each will generally conform to its design specification.
The owners in both cases may be satisfied with the way their cars are put together. However, that is
where the similarity ends. The Escort owner does not expect his car to go 150 mph, have leather seats
and have twelve coats of paint, or be highly responsive. The Ferrari owner expects these
characteristics or qualities.
The cost of making a product will usually rise as more characteristics are specified to increase
product performance, improve comfort, improve ease of use and make the product look better. Highgrade materials usually command a premium price. However, in many cases, increased competition
creates an atmosphere of finding ways to make better and less expensive designs. This is true for
products such as computers, VCRs and televisions.
The reliability of a product must be considered in the design stage. Reliability is the probability that a
product will perform its intended function, without failure, for a specified length of time. Reliability is
dependent on the basic design, the quality of materials and the quality of components that go into the
final product. To achieve the required reliability, designers may need to specify higher priced
components. This may translate to higher prices but also higher value for the consumer.
Many products command a premium price because they provide value to the consumer. Others may
be expensive because of their role as status symbols. Expensive products do not always contribute to
better product performance or customer satisfaction. This is particularly true in the software industry.
Many low priced applications work just as well and sometimes better than expensive ones.
The designer may receive input from various sources when determining the level of design quality. In
addition to the designers own ideas, input concerning product performance, materials to be used and
various product characteristics may be received from management, marketing, sales, other
engineering organizations or directly from customers. The final design specification may or may not
be what the designer had in mind.
Although some quality engineers and other quality professionals get involved with product design,
their time and effort is usually spent in designing and maintaining systems to measure and control
process and product characteristics after the design is complete. A challenge to quality engineers is to
implement the statistical techniques used in manufacturing during the design stage. The goals would
be to enhance product design by eliminating problems early in the design process to ensure the ease of
manufacturing.
A quality system is a mechanism that coordinates and maintains the activities needed to
ensure that the characteristics of products, processes or services are within certain bounds. A
quality system involves every part of an organization that directly or indirectly affects these
activities. Typically, the quality system is documented in a quality manual and in the
associated documents that specify procedures and standards.
3.1 Basic Elements in a Quality System
There are three basic elements in a quality system: Quality Management, Quality Control, and
Quality Assurance.
Quality Management: Quality management is the means of implementing and carrying out
quality policy. They perform goal planning and manage quality control and quality assurance
activities. Quality management is responsible for seeing that all quality goals and objectives are
implemented and that corrective actions have been achieved. They periodically review the quality
system to ensure effectiveness and to identify and review any deficiencies.
Quality Control: The term quality control describes a variety of activities. It encompasses
all techniques and activities of an organization that continuously monitor and improve the
conformance of products, processes or services to specifications. Quality control may also include
the review of processes and specifications and make recommendations for their improvement.
Quality control aims to eliminate causes of unsatisfactory performance by identifying and helping
to eliminate or at least narrow the sources of variation. Quality control has the same meaning as
variation control of product characteristics.
The objective of a quality control program is to define a system in which products meet design
requirements and checks and feedback for corrective actions and process improvements. Quality
control activities should also include the selecting and rating of suppliers to ensure that purchased
products meet quality requirements.
Quality Assurance: The term quality assurance describes all the planned and systematic actions
necessary to assure that a product or service will satisfy the specified requirements. Usually this takes
the form of an independent final inspection. The distinction between quality control and quality
assurance is stated in an ANSI/ASQ standard: Quality control has to do with making quality what it
should be, and quality assurance has to do with making sure quality is what it should be. The quality
assurance function should represent the customer and be independent of the quality control function,
which is an integral part of the manufacturing operation.
Procurement process
The ultimate goal of procurement planning is coordinated and integrated action
to fulfil a need for goods, services or works in a timely manner and at a
reasonable cost. Early and accurate planning is essential to avoid last minute,
emergency or ill-planned procurement, which is contrary to open, efficient and
effective and consequently transparent procurement. In addition, most
potential savings in the procurement process are achieved by improvements in
the planning stages . Even in situations where planning is difficult such as
emergencies , proactive measures can be taken to ensure contingency planning
and be better prepared to address upcoming procurement requests.
Supplier evaluation
Assessment of existing or new suppliers on the basis of their delivery, prices,
production capacity, quality of management, technical capabilities, and service.
Supplier evaluation is not an easy process. Many different formulas and techniques can be
used. One effective method assigns suppliers to four basic categories based upon their level
of performance in key areas, such as delivery, quality and responsiveness.
A supplier is labeled a "full partner" if it meets all expectations. An "associate partner" is a
firm that needs a little work to bring it up to full partner status.
Additional categories include "high risk" and "incapable" suppliers. A high risk source might
continue to be utilized for current production only, based upon an internal risk assessment.
But, you might not want to award this supplier any future business. An incapable supplier
should be dropped as soon as possible.
PROCESS
A process is a unique combination of tools, materials, methods, and people
engaged in producing a measurable output; for example a manufacturing line for
machine parts. All processes have inherent statistical variability which can be
evaluated by statistical methods.
A process needs to be established with appropriate process controls in place. A control chart
analysis is used to determine whether the process is "in statistical control". If the process is
not in statistical control then capability has no meaning. Therefore the process capability
involves only common cause variation and not special cause variation.
Definitions
Process------: Process refers to any system of causes; any combination of conditions which worktogether
to produce a given result.
Process Capability ----Process capability refers to the normal behaviour of a process when operating in a state of
statistical control. It refers to the inherent ability of a process to produce similar parts for a
sustained period of time under a given set of conditions.
Process Capability Indices----Process capability can be expressed as percent nonconformingor in terms of the natural
spread related to the specification spread.
allows one to quantify how well a process can produce acceptable product. As a result, a
manager or engineer can prioritize
needed process improvements and identify those processes that do not need immediate
process improvements. Process capability studies indicate if a process is capable of
producing virtually all conforming product. If the process is capable, then statistical process
controls can be used to monitor the process and conventional acceptance efforts can be
reduced or eliminated entirely. This not only yields great cost savings in eliminating nonvalue added inspections but also eliminates scrap, rework and increases customer
satisfaction. The benefits of performing process capability studies are certainly worth the
effort in the long run. After a process capability study has been performed, a process will be
classified as either capable or incapable. When the process is not capable of producing
virtually all conforming product, the process is said to be incapable and acceptance sampling
procedures (or 100%inspection) must remain part of the process.
PROCESS CONTROL
Process control is a statistics and engineering discipline that deals with
architectures, mechanisms and algorithms for maintaining the output of a
specific process within a desired range.
Process control is the management of inputs to ensure a uniform output, no matter how many
times a process is repeated. This can involve everything from water purification procedures to
landing space shuttles safely and successfully. In process control, principles of statistics and
engineering are applied to a process to ensure regularity and repeatability. Automated systems are
capable of exerting process control and can be programmed for various advanced functions.
Technicians very clearly define an outcome in process control, such as a finished product or a
successful aircraft landing. This process may require batches; only one aircraft lands at once,
for example. It can also be continuous in nature. At an ice cream manufacturing facility, for
example, the facility can keep pumping out ice cream continuously, and does not need to take
a break between batches.
Awareness of an outcome allows the company to put measures in place to control the process,
and to ensure that the outcome will be reliable. The ice cream manufacturer needs controlled
temperatures for food safety and quality reasons, for example. It also needs ingredients,
personnel to operate the equipment, and supplies ready to package the ice cream for sale. All
of these become components of process control.
A control chart is a time-ordered diagram to monitor a quality characteristic, consisting of : A nominal value, or center line The average of several past samples
Two control limits used to judge whether action is require; an upper control limit (UCL)
and a lower control limit (LCL)
Data points, each consisting of the average measurement calculated from a sample taken
from the process, ordered over time. By Central Limit Theorem, regardless of the distribution
of the underlying individual measurements, the distribution of the sample means will follow a
normal distribution .The control limits are set based on the sampling distribution of the
quality measurement.
Steps Involved In Using Statistical Process Control
Proper Statistical Process Control starts with planning and data collection. Statistical
analysis on the wrong or incorrect data is rubbish, the analysis must be appropriate
for the data collected. Be sure to PLAN, then constantly re-evaluate your situation to
make sure the plan is correct. The key to any process improvement program is the
PDSA cycle described by Walter Shewart. Plan Identify the problem and the possible
causes. The QC tools described in this manual
can help organizations identify problems and possible causes, and to prioritize
corrective actions.
Do Make changes designed to correct or improve the situation.
Study the effect of these changes on the situation. This is where control charts are
used they show the effects of changes on a process over time. Evaluate the results
and then replicate the change or abandon it and try something different.
Act If the result is successful, standardize the changes and then work on further
improvements or the next prioritized problem. If the outcome is not yet successful,
look for other ways to change the process or identify different causes for the
problem. Control charting is one of a number of steps involved in Statistical Process
Control. The steps include discovery, analysis,clarification, and then charting. Before
using Statistics QC software, appropriate data must be collected for analysis. Then,
you need to begin again and do it over and over and over. Remember, quality is a
CYCLE of continuous improvement.
1.PLAN
2.DO
3.STUDY
4.ACT
QUALITY AUDIT --Quality audit is the process of systematic examination of a quality system carried out by an internal or external
quality auditor or an audit team. It is an important part of organization's quality management system and is a key
element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly
defined internal system monitoring procedures linked to effective action. This can help determine if the
organization complies with the defined quality system processes and can involve procedural or results-based
assessment criteria.
OBJECTIVE OF INTERNAL QUALITY AUDIT SYSTEM
the Quality System of Company complies with all clauses of the ISO 9001
standard and applicable contractual/legal requirements;
the Quality System is understood and used through all levels of the
organization;
the Quality System is functioning efficiently and has the ability to achieve
defined quality objectives;
Period of validity
Liability of manufacturer
Procedure of submitting guarantee claims
Condition which makes the guarantee invald
Unit 2
Definition of quality management:
Definition of organization:
Definition
A social unit of people that is structured and managed to meet a need
or to pursue collective goals. All organizations have a management
structure that determines relationships between the different activities
and the members, and subdivides and assigns roles, responsibilities,
and authority to carry out different tasks. Organizations are open
systems--they affect and are affected by their environment.
Definition of nature
bureaucratic structures
Functional structures
Divisional structures
Matrix structures
Divisional structures
Bureaucratic structure
Design of an organization
Depends on 1. Hierarchical systems 2. Design process 3. Organization
design decisions
Hierarchical systems:
A human-built system with complex behaviour is often organized as a hierarchy.
For example a command hierarchy has among its notable features the
organizational chart of superiors, subordinates, and lines of organizational
communication. Hierarchical control systems are organized similarly to divide the
decision making responsibility.
QUALITY FUNCTION :
It is a method to transform user demands into design quality, to deploy the
functions forming quality, and to deploy methods for achieving the design quality
into subsystems and component parts, and ultimately to specific elements of the
manufacturing process. DIVIDED INTO TWO DISTINCT GROUPS
Product line : A product line refers to a number of products that are related
and developed by the same manufacturer. Product lines are not to be confused
with product bundling, which combines various items into one type of product.
Items within a product line generally share the same basic theme, and with the
help of a successful marketing plan these products can be entirely effective.
Quality costs can be broken down into four broad groups. These four groups are also
termed as four (4) types of quality costs. Two of these groups are known as prevention
costs and appraisal costs. These are incurred in an effort to keep defective products from
falling into the hands of customers. The other two groups of costs are known as internal
failure costs and external failure costs. Internal and external failure costs are incurred
because defects are produced despite efforts to prevent them
Four types of quality cost are briefly explained below :-
Prevention Costs: Generally the most effective way to manage quality costs is to avoid
the defects in the first place. It is much less costly to prevent a problem from ever happening
than it is toad and correct the problem after it has occurred. Prevention costs support
activities whose purpose is to reduce the number of defects. Companies emplo y many
techniques to prevent defects for example statistical process control, quality engineering.
training, and a variety of tools from quality TQM .Prevention costs include activities relating
to statistical process control.
PARTS OF PREVENTION COSTS
1. SYSTEMS DEVELOPMENT
2. Qualtiy engineering
3. Quality training
4. Quality circles
5. Statistical process control
6. Supervision of prevention activities
7. Quality data gathering analysis
APPRAISAL COST:
1. Test and inspection of incoming materials
2. Test and inspection of inprocess goods
3. Final product testing
4. Supply used in testing and inspection
5. Supervision of testing and inspection activities
EXTERNAL FAILURE COST
Fig: motivation for workers few factors in workers motivation and retention.
HOUSE OF QUALITY:
Every successful company has always used data and information to help in its
planning processes. In planning a new product, engineers have always
examined the manufacturing and performance history of the current product.
They look at field test data, comparing their product to that of their
competitor's product. They examine any customer satisfaction information that
Unit -3
What is a control chart?
A control chart is a statistical tool used to distinguish between variation in a process
resulting from common causes and variation resulting from special causes. It
presents a graphic display of process stability or instability over time.
One goal of using a control chart is to achieve and maintain process stability.
Process stability is defined as state in which
A process head displayed a certain degree of consistence in the past and is
expected to continue to do so in the future
Unit-5
WHAT IS ISO 9000?
ISO 9000 describes fundamentals of quality management systems and specifies
the terminology for quality management systems.
INTRODUCTION:
Two of the most important objectives in the revision of the ISO 9000 series of
standards have been a) to develop a simplified set of standards that will be
equally applicable to small as well as
medium and large organizations, and b) for the amount and detail of
documentation required to be more relevant to the desired results of the
organizations process activities.
ISO 9001:2008 Quality management systems Requirements has achieved these
objectives, and the purpose of this additional guidance is to explain the intent of
the new standard with specific regard to documentation. ISO 9001:2008 allows
an organization flexibility in the way it chooses to document its quality
management system (QMS). This enables each individual organization to develop
the minimum amount of documentation needed in order to demonstrate the
effective planning, operation and control of its processes and the implementation
and continual improvement of the effectiveness of its QMS.
The quality policy is understood and followed at all levels and by all
employees. Each employee works towards measurable objectives.
The business makes decisions about the quality system based on recorded
data.
The quality system is regularly audited and evaluated for conformance and
effectiveness.
Records show how and where raw materials and products were processed to
allow products and problems to be traced to the source.
The business has created systems for communicating with customers about
product information, inquiries, contracts, orders, feedback, and complaints.
The business deals with past problems and potential problems. It keeps
records of these activities and the resulting decisions, and monitors their
effectiveness.
The business has documented procedures for dealing with actual and
potential nonconformances (problems involving suppliers, customers, or
internal problems).
The business:
1.
2.
3.
4.
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.
2000 version
ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. Design
and development procedures were 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 optimisation of a
company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded
involvement by upper executives in order to integrate quality into the business system and avoid delegation of
quality functions to junior administrators. Another goal was 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.
2008 version
ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the
existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO
14001:2004. There were no new requirements. For example, 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.
ISO 9001 is supplemented directly by two other standards of the family:
ISO 9004:2009 "Managing for the sustained success of an organization. A quality management
approach"
Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality
system.
Certification
ISO does not certify organizations itself. Numerous certification bodies exist, which audit organizations and, upon
success, issue ISO 9001 compliance certificates. Although commonly referred to as 'ISO 9000' certification, the
actual standard to which an organization's quality management system can be certified is ISO 9001:2008. Many
countries have formed accreditation bodies to authorize ("accredit") the certification bodies. 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. Certification bodies themselves operate under another quality standard,
ISO/IEC 17021,[28] while accreditation bodies operate under ISO/IEC 17011.
An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites,
functions, products, services and processes. The auditor presents a list of problems (defined as
"nonconformities", "observations" or "opportunities for improvement") to management. If there are no major
nonconformities, the certification body will issue a certificate. Where major nonconformities are identified, the
organization will present an improvement plan to the certification body (e.g. corrective action reports showing
how the problems will be resolved); once the certification body is satisfied that the organisation has carried out
sufficient corrective action, it will issue a certificate. The certificate is limited by a certain scope (e.g. production of
golf balls) and will display the addresses to which the certificate refers.
A product (or service) performance variation can be reduced by examining the non-linear
effects of factors (parameters) on the performance characteristics. Any deviation from a
target leads to poor quality.