CHAPTER 9:

QUALITY MANAGMENT
 CONCEPT
Quality Management is the assembly
and management of all activities aimed at
the production of quality by organizations of
various kinds. In the present case this
implies the introduction and proper running
of a QUALITY SYSTEM in laboratories.
 QUALITY ASSURANCE
Proper Quality Management implies
consequent implementation of the next
level: Quality Assurance. The ISO definition
reads: The assembly of all planned and
systematic actions necessary to provide
adequate confidence that a product,
process or services will satisfy given quality
requirements.
 QUALITY CONTROL
A major part of the quality assurance is the
Quality Control defined by ISO as the
operational techniques and activities that
are used to satisfy quality requirements.
Quality control is primarily aimed at the
prevention of errors. Yet, despite all efforts, it
remains inevitable that errors are be made.
Therefore, the control system should have
checks to detect them.
 When errors or mistakes are suspected or
discovered it is essential that the 5 Ws are trailed:

1. What error was made?

2. Where was it made?
3. When was it made?
4. Who made it?
5. Why it is made?
 The techniques and activities involved in Quality
Control can be divided into four levels of operation:

1. First-line control: Instrument performance

check.
2. Second-line control: Check of calibration
or standardization.
3. Third-line control: Batch control.
4. Fourth-line control: Overall check.
 This designation is used throughout the
present Guidelines:
First-line control: Instrument check/calibration
Second-line control: Batch control
Third-line control: External check.

It will be clear that producing quality in the

laboratory is a major enterprise requiring a
continuous human effort and input of money.
 Therefore, for quality work at least four condition
should be fulfilled:

1. Means are available.

2. Efficient use of time and means
3. Expertise is available
4. Upholding and improving level of output
GOOD LABORATORY PRACTICE
When properly applied, Good Laboratory Practice
should then:
1.Allow better laboratory management
2.Improve efficiency
3.Minimize errors
4.Allow quality control
5.Stimulate and motivate all personnel
6.Improve safety
7.Improve communication possibilities, both internally
and externally.
The result of GLP is that the performance of a laboratory is improved
and its working effectively controlled. An important aspect is also that
the standards of quality are documented and can be demonstrated to
authorities and clients. This results to an improved reputations for the
laboratory. In short, the message is:

1.Say what you do

2.Do what you say
3.Do it better
4.Be able to show what you have done.
 QUALITY MANUAL
This comprises then all relevant information on:
1.Organization and Personnel
2.Facilities
3.Equipment and Working materials
4.Analytical or testing systems
5.Quality Control
6.Reporting and filing of results
 CONCEPT OF QUALITY
Quality in business, engineering and
manufacturing has a pragmatic interpretation as
the non-inferiority or superiority of something.
Quality is a perceptual, conditional and somewhat
subjective attribute and may be understood
differently by different people. Consumers may
focus on the specification quality of a
product/service, or how it compares to competitors
in the marketplace.
 CONCEPT OF QUALITY
Producers might measure the
conformance quality or degree to which
the product/service was produced
correctly. Numerous definitions and
methodologies have been created to
assists in managing the quality-
affecting aspects of business
operations.
 CONCEPT OF QUALITY
Many different techniques and concepts
have evolved to improve products or service
quality. There are two common quality-
related functions within a business. One is
quality assurance which is the prevention of
defects, such a by the deployment of a
quality management system and
preventative activities like FMEA.
 DEFINITIONS
The business meanings of quality have developed over
time. Various interpretation are:
ISO 9000: Degree to which a set of inherent
characteristics fulfills requirements.
SIX SIGMA: Number of defects per million opportunities.
Subir Chowdhury: Quality combines people power and
process power
Philip B. Crosby: Conformance to requirements.
Joseph M. Juran: Fitness for use
 DEFINITION
Noriaki Kano and others, present in two-
dimensional model of quality: Must be
quality and attractive quality
Robert Pirsig: The result of care
Ginichi Taguchi. With two definitions:
Uniformity around a target
The loss a product imposes on society after it
is shipped
 DEFINITION
American Society for Quality: A subjective term for which
each person has his or her own definition in technical
usage, quality can have two meanings:
The characteristics of a product or service that bear on its ability to
satisfy stated or implied needs;
A product of service free of deficiencies
Peter Drucker: Quality in a product or service is not what
the supplier puts in. it is what the customer gets out and is
willing to pay for.
W. Edwards Deming: The efficient production of the
quality that the market expects
Gerald M. Weinberg: Value to some person
 MARKET SECTOR PERSPECTIVE

OPERATION MANAGEMENT
The dimensions of quality refer to the
attributes that quality achieves in Operation
Management:
1. Quality supports Dependability
2. Dependability supports Speed
3. Speed supports Flexibility
4. Flexibility supports Cost.
 MANUFACTURING
In the manufacturing industry it is
commonly stated that Quality drives
productivity. Improved productivity is a
source of greater revenues, employment
opportunities and technological advances.
The best way to think about quality is in
process control. If the process is under
control, inspection is not necessary.
 CUSTOMERS
The most progressive view of quality is that it
is defined entirely by the customer or end user and
is based upon that persons evaluation of his or
her entire customer experience. The customer
have with the companys product and services,
and is by definition a combination of these. For
examples, any time one buys a product one forms
an impression based on how it was sold, how it
was delivered, how it was performed, how well it
was supported, etc.
QUALITY MANAGEMENT
TECHNIQUES
 INSPECTION
An inspection is a formal examination or evaluation
exercise. It normally involves measurements, gauges, and
tests to determine whether the characteristics of the object
or activity being inspected confirm to pre-decided
standards.
Inspection are usually not destructive; rather,
inspection is required at all levels in society to ensure that
most ordinances are enforced as fairly and efficiently as
possible, thus ensuring safety and security for everyone.
 INSPECTION
Inspections such as home inspections and
building inspections are highly beneficial to
owners as well as to buyers who plan to
make huge investments. In all inspections,
standards of compliance in accordance with
the state are ensured. Therefore a good
inspection guarantees public safety by
enforcing municipal and state regulations
typically for construction activities.
 QUALITY CONTROL
Quality control is a process employed to ensure a
certain level of quality in a product or service. It
may include whatever actions a business deems
necessary to provided for the control and
verification of certain characteristics of a product or
service. The basic goal of quality control is to
ensure that the product, services or processes
provided to meet specific requirements and are
dependable, satisfactory and fiscally sound.
 QUALITY CONTROL
If a problem is identified, the job of a quality
control team or professional may involve
stopping production temporarily. Depending
on the particular service or product as well
as the type of problem identified, production
or implementation may not cease entirely.
Quality control is concerned with the
product, while quality assurance is process-
oriented.
 QUALITY ASSURANCE
The four quality assurance steps within the Plan, Do,
Check, Act (PDCA) model stands for:
1.Plan: Establish objectives and processes required to
deliver the desired results.
2.Do: Implement the process developed.
3.Check: Monitor and evaluate the implemented process by
testing the results against the predetermined objectives
4.Act: Apply actions necessary for improvement if the result
requires changes.
ACCURACY OF QUALITY ASSURANCE

There is an extensive process of trial

and error in order to ensure quality
assurance. By the end of the trials you
arrive at an acceptable process that helps
you decide the reliability and efficiency of
the sample. The process involves meeting
specifications such as performance
measure and depends on environment
operation.
 STEPS FOR QUALITY
ASSURANCE PROCESS
Plan to improve
Design to include improvements and
requirements
Manufacture with improvements
Review new item and improvements
Test new item
 QUALITY ASSURANCE VERSUS
QUALITY CONTROL
Quality control emphasize testing of
products to uncover defects, and reporting
to management who make the decision to
allow or deny the release, whereas quality
assurance attempts to improve stabilize
production, and associated processes, to
avoid or at least minimize, issues that led to
the defects in the first place.
 FAILURE TESTING
A valuable process to perform on a
whole consumer product is failure testing or
stress testing. In mechanical terms, this is the
operation of a product until it fails, often
under stresses such as increasing vibration,
temperature, and humidity. This exposes
many unanticipated weaknesses in a product,
and the data are used to die engineering and
manufacturing process improvements.
 STATISTICAL CONTROL
Many organizations use statistical process
control to bring the organization to Six Sigma
of quality, in other words, so that the likelihood
of an unexpected failure is confined to six
standard deviations on the normal distribution.
Traditional statistical process controls in
manufacturing operations usually proceed by
randomly sampling testing a fraction of the
output.
TOTAL QUALITY MANAGEMENT