QUALITY ASSURANCE

QUALITY ASSURANCE is the term most often used to describe a formal

system within a company for managing quality-control activities; in effect, it is
"quality control of the quality-control function".
A quality-assurance system formally defines and controls all company
activities that affect customer satisfaction with the quality of goods or
services.
Quality assurance became prominent in the late 1940's when the U. S. armed
services, particularly the Navy, began evaluating the effectiveness of the
inspection systems used by suppliers of materials.
A favorable evaluation permitted suppliers to perform their own inspections
without government supervision. Military specification MIL-1-45208,
"Inspection System Requirements", issued in 1961, formalized this program
for all U. S. armed services.
Basic quality-assurance requirements also have been written into such
documents as Military Specification MIL-Q-9858A, "Quality System
Requirements"; subarticles NA-3700 and NA-4000 of Section III of the ASME
Boiler and Pressure Vessel Code; and NASA NHB 5300.4 (1A).
Inspection alone does not assure quality or, more precisely, does not assure
conformance to requirements of the contract or customer order.
This applies not only to complex products such as satellites or nuclear
submarines, but also to simple products such as nails or pipe fittings.

Independence of Quality-Assurance Department

Responsibility for the development, operation and monitoring

of an effective quality-assurance program in a plant usually
rests with the quality-assurance manager.
Companies having several plants may have a corporate qualityassurance department that reviews-and-co-ordinates the
system for the entire organization.
To be effective, this department should be an independent staff
department that reports directly to an upper-level manager
such as a general superintendent, vice president or president.
The quality-assurance department should be free to devise and
recommend specific systems and procedures, and to require
corrective action at their discretion.

Establishment of Quality Standards

No single quality level is necessary or economically desirable for universal use;

the quality requirements of a paper clip are obviously quite different from those
of a nuclear reactor.
Many professional groups, trade associations and government agencies have
established national codes and standards.
However, these codes and standards generally cover broad requirements,
whereas a set of detailed rules for each product or class of products is required
for the control of quality.
In most plants, it is the responsibility of the quality-assurance manager to
interpret national codes and standards or terms of the purchase order, and from
these to devise process rules uniquely suited to the specific products and
manufacturing methods used in that particular plant.
The set of process rules thus devised may be known by various names; in this
article, it will be called an "operating-practice description".
There may be thousands of operating-practice descriptions in plant files, each
varying from the others as dictated by code or customer requirements, limits on
chemical composition or mechanical properties, or other special
characteristics.
Large plants may have computerized storage systems permitting immediate
retrieval of part or all of the operating practice descriptions at key locations
throughout .the plant.

Written Procedures
Written procedures are of prime importance
in quality assurance.
Oral instructions can be inadequately or
incorrectly given, and thus misunderstood
and incorrectly followed.
Clear and concise written instructions
minimize the likelihood of misinterpretation.
For instance, procedures should be specific
regarding the type and form of inspection
records, the identity of the individual who
keeps the records, and where records are
kept.

Control of Document Flow

The original purchase order, which is often less than one page in length, may
generate hundreds of other working papers before the ordered material or part
is shipped.
All paperwork must be accurate, and must reach each work station on time.
In some industries, where there may be an average of two or more specification
or drawing changes per order, an effective system of material tracking that is
separate and distinct from material identification is necessary.
Many large plants have computerized order systems, the heart of which is an
"active-order file".
This computer file receives periodic inputs to update information on
specifications,
drawings,
material sizes,
shop operations,
shipping, and
routing.
In turn, this file may be accessible from various terminals in the sales office,
home office or plant, when information is needed on material location, order
status, and the like.

Maintaining Identity and Traceability of

Materials

In high-speed manufacturing operations, particularly those

involving hot work, identity markings on the raw material, such
as paint marks, stencils or stamps, are usually destroyed
during processing.
In such instances, procedures must be devised for maintaining
identity not by marking alone but also by location and
count.
Ultimately, both producer and customer must be confident that
the goods actually delivered are described accurately in the
shipping papers, test reports and certificates of compliance.
This confidence is of great importance in certain applications in
the aerospace and nuclear industries.

 When corrective action is recommended by a

materials review board, it is usually "system
oriented" that is, intended to prevent recurrence
of the nonconformity by avoiding its cause.
In instances where a lot has been rejected because
the acceptance number for a sampling plan has been
exceeded, decisions concerning disposition of the
lot often are made on the basis of costs; the solution
that results in the least total loss to both producer
and customer is adopted. Sometimes, material that
is slightly out of tolerance and therefore not fit for
use by one customer may meet the specifications of
another customer.

Nonconforming Material and Corrective

Action

A system for detection and segregation of nonconforming material

requires
written inspection instructions that can be clearly understood;
identified, segregated holding areas for parts that have been rejected;
and
a structured group (sometimes called a materials review board) to
evaluate rejected material, make final judgment on its fitness for use,
decide what is to be done with nonconforming material, and prescribe
corrective action for the cause of rejection.
In many instances, rejected parts are only slightly out of tolerance and
their usefulness is not impaired.
Even so, all decisions of a materials review board to accept
nonconforming material must be unanimous.
In some companies, the authority of the materials review board is
limited to merely deciding whether or not nonconforming material is
fit for use.
However, in many companies the board also determines what is to be
done with nonconforming lots whether they are to be shipped "as
is", sorted, repaired or scrapped and fixes the accountability for
incurred losses.

Calibration of Equipment

The quality-assurance system must recognize that the accuracy and

repeatability of measuring and testing equipment may be affected by
continued use; maximum intervals between calibrations should be specified in
the written quality-assurance procedures.
Except perhaps for small hand instruments, such as micrometers, each testing
machine or instrument should be plainly labeled with the last date of
calibration.
Calibration standards should be traceable to recognized industry or national
standards of measurement.
It also is desirable to maintain a central file of calibration records for each plant
or department.
Retention of Records
A quality-assurance system must designate which records are to be retained,
and must set forth minimum time periods for retention of such records.
It is usual for important documents to be retained for 25 years or more; the
nuclear industry is required to maintain records for 40 years. Retention time,
however, should be consistent with real needs, as dictated by projected
lifetime of products or by legal requirements.
Besides satisfying certain contractual or other legal requirements, retained
records can provide important cost benefits to both producer and customer.

Personnel Training and

Qualification
National codes exist for the qualification of certain
specialized workers; for instance, welders and
inspectors.
Where applicable, codes should be incorporated as
minimum requirements for training and qualification
of key personnel.
All of these, however, must be supplemented by
local written procedures for both on-the-job and
classroom training.
Quality-assurance management must reduce
complex procedures to the simplest form that will
permit a trainee to understand exactly what the job
is and how it is to be performed.

Control of Purchased Material

All specifications and orders for outside
purchases of material whose performance may
affect product quality should be subject to approval
by quality-assurance management.
Inspection of incoming material should be
incorporated into the quality-assurance program.
The main purpose of receiving inspection is to check
for failures of vendor quality programs, but receiving
inspection should not be expected to compensate
for poor quality control by vendors.
The purchaser should evaluate and periodically
audit the quality-assurance system of each major
supplier to make sure that purchased material can
be expected to have the specified level of quality.

Periodic Audit

Periodic audit of system performance against written standards

is needed to detect corner-cutting, noncompliance and
intentional violations of established quality procedures.
To be as unbiased as possible, such audits should be
performed by persons not having responsibility in the area
being audited.
In companies having multiple plants, each individual plant may
conduct its own internals audits, but in addition should be
subject to audit by corporate-staff personnel.
The most important activities of a corporate staff, aside from
auditing, are review of the quality system with the highest level
of plant management, and follow-up to approve corrective
action for any discrepancies found during an audit.
Periodic review of the quality-assurance system and
reaffirmation of quality objectives by top management should
be part of company policy. This will, in part, ensure long-range
viability of the business enterprise.

ISO 9000 is sweeping the world. It is rapidly becoming

the most important quality standard. Thousands of
organization, companies and institutions in over 100
countries have already adopted it, and many more are in
the process of doing so. Why? Because:

It controls quality
It saves money
Customer expect it
And competitors uses it

ISO 9000 applies to all types of organization. It doesnt

matter what size they are or what they do.

ISO 9001, 9002, 9003, and 9004

ISO 9001:
ISO 9001 sets out the requirements for an organization whose
business processes range all the way from design and development, to
production, installation and servicing

ISO 9002:
This is the appropriate standard for an organization which does
not carry out design and development, since it does not include the design
control requirements of ISO 9001-otherwise, its requirements are identical.

ISO 9003:
This is the appropriate standard for an organization whose
business do not include design control, process control, purchasing or
servicing, and which basically uses inspection and testing to ensure that the
final products and services meet specific requirements.

ISO 9004:
ISO 9004 provides guidance on implementing a quality
management system. ISO 9004 should not be viewed as a requirements
document, but rather a guidance document for companies wishing to move
beyond the requirements of ISO 9001.
There is no difference of quality ranking between the three standards. An
organization chooses ISO 9001, ISO 9002 or ISO 9003 according to the
business processes covered by the quality system.

ISO 9000:2000

ISO first published its quality standards in 1987, revised them in 1994, and
then republished an updated version in 2000. These new standards are
referred to as the ISO 9000:2000 Standards

The 2000 version of the standard focuses more on management, the

customer, and continuous improvement.

ISO 9000 currently includes three quality standards: ISO 9000:2000, ISO
9001:2000, and ISO 9004:2000. ISO 9001:2000 presents requirements, while
ISO 9000:2000 and ISO 9004:2000 present guidelines. All of these are
process standards not product standards.

Applications of 9000:2000:

The ISO 9000:2000 standards apply to all kinds of organizations in

all kind of areas.

Some of these areas include manufacturing, processing, servicing,

printing, forestry, electronics, steel, computing, legal services,
financial services, accounting, trucking, banking, retailing, drilling,
recycling, aerospace, construction, textiles, oil & gas, pulp & paper,
petrochemicals, publishing, shipping, energy, plastics, metals,
research, health care, hospitality, recreation, customer products,
transportation, insurance and so on.

ISO 9000:2000 PRINCIPLES

ISO 9000:2000 standards are based on eight quality management principles.

These principles were derived from the experience of experts on the technical
committees and represent the main elements that a good quality system must
have. These principles are:

1. Customer Focus : Organizations depends on their customers and

therefore have to understand the current and future customer needs, meet
their customers' requirements and strive to exceed their customers
expectations.

2. Leadership: Leaders establish a unity of purpose and the direction of the

organization. They need to create and maintain an internal environment in
which people can become fully involved in achieving the organizations
objectives.

3. People Involvement: People at all levels are the essence of an

organization. Their full involvement creates opportunities for their abilities to
be used for the organizations benefit.

4. Process Approach : A desired result is achieved more efficiently when

activities and related resources are managed as a process.

5. System Approach to Management

Identifying, understanding and managing interrelated processes as
a system define the organizations effectiveness at achieving its
objectives.
6. Continual Improvement
Continuous overall performance improvement is the objective of a
successful long term organization.
7. Factual Approach to Decision Making
Effective decisions are based on solid information and objectives
data analysis.
8. Mutually Beneficial Supplier Relationship
An organization and its suppliers are interdependent and a mutually
beneficial relationship enhances the ability of both to create value.

The official changes to the ISO9000 standards has

shifted to the Plan-Do-Check-Act improvement cycle
used in ISO14000 standards. The basic tenants of
quality remains the same.

PLAN:
While making the plan following four
steps are to be considered:
1. select and define the problem
2. analyse current situation
3. identity root causes
4. select improvement opportunity.
DO:
Implementing the process or put the
plan into operation by implementing
pilot solution.
CHECK:
Monitor and measure processes and
product against policies objectives
and requirement for the
improvement of the product and
report the results.
Act:
take actions to continually improve
process performance by holding
the gains and to ensure that
improvement is part of the job.

ISO 14000
ISO 14000 series is a family of environmental management
standards developed by the international organization for
standardization (ISO).
The ISO 14000 standards are designed to provide an
internationally recognized framework for environmental
management, measurement, evaluation and auditing. They do not
prescribe environmental performance targets, but instead provide
organizations with the tools to assess and control the environmental
impact of their activities, products or services. They address the
following subjects:

Environmental Management System (EMS)

Environmental Auditing (EA)
Environmental Labelling (EL)
Environmental Performance and Evaluation (EPE)
Life Cycle Assessment (LCA)
Environmental Aspects in Products Standards (EAPS)

Audit by certification agency

Award of certificate

Audit by certification agency

Award of certificate