Quality Assurance

Reference :
Quality assurance – the route to
efficiency and competitiveness 3rd
edition by Lionel Stebbing
Definition
Quality assurance requires the total integration
and control of all elements within a particular area
of operation so that none is subservient to the
other. These elements cover such aspects as
administration, finance, sales, marketing, design,
procurement, manufacture, installation,
commissioning, and even, as we have seen,
decommissioning.
Quality assurance department can produce a plan
for action and a system to be followed but its
implementation is a management responsibility.
Quality assurance is a philosophy of total
integration of the business to achieve the required
result.
Definition (cont’)
It is important, in the first place, to
understand what quality assurance is not :
It is not quality control or inspection.
It is not super-checking activity.
It is not responsible for engineering
decisions.
It is not a massive paper generator.
It is not a major cost area.
It is not a panacea for all ills.
What is quality assurance ??

It is cost-effective.
It is an aid to productivity.
It is means of getting it right first time
every time.
It is good management sense, and,
most importantly;
It is the responsibility of everyone.
The background to quality
assurance
The ultimate purpose of any quality system is to
ensure complete satisfaction by the customer with
the goods or services provided by the supplier.
Sometimes defects were not discovered until
manufacture was at an advanced stage, often
leading to costly repair work and sometimes
involving scrapping, with the inevitable schedule
days.
In today’s highly demanding environment of
quality, together with the concern by customers
and the costs restraints within a company, the
emphasis must now be proactive rather than
reactive. The question “have we got it right ?
” (quality control/inspection) must give way to “are
we doing it right ?” (quality assurance)
Objective evidence of quality
Objective evidence of quality is that which confirms that all
activities within each of the functions of a service or
manufacturing process and, in the case of large projects,
site construction and commissioning, have been carried out
in accordance with established working methods. These
methods are identified in documents which are known as
procedures & job instructions.
Procedures detail the purpose and scope of an activity and
also identify how, when, where, and by whom the activity is
to be carried out. Emanating from such will be documents
which will detail the results of these activities.
Job instructions direct personnel in carrying out a specific
task. Job instructions do not necessarily produce
documentation and, in such instances, can be audited only
by watching the person involved carry out the task.
Procedures and job instructions, together with the methods
for ensuring they work, make up a quality system.
The need for audit
Once procedures are established, how can
it be ensured that the procedures are being
implemented and are effective ? What
takes the place of inspection in the old
system of operation ? The answer is a
compliance audit.
An audit is undertaken to indicate whether
a procedure or job instruction is working
satisfactorily.
Principles, philosophies, standards
and procedures
In the main, quality system standards are issued
to cover three parts, levels, or categories, of
application, as follow :
Level 1 covering design, manufacture, and
installation.
Level 2 covering manufacture and installation.
Level 3 covering final inspection and/or test.
There are two types of quality assurance
standards : industry-related standards and general
standards
Principles, philosophies, standards
and procedures (cont’)
Industry-related standards are those developed by
purchasing bodies to enable suppliers to meet the
quality requirements of a particular industry.
General standards are those issued by national
bodies to give guidance to industry in general on
quality system development. They are normally for
guidance purposes only but are becoming
increasingly prevalent as a contract requirement.
Quality plan a document setting out the specific
quality practices, resources, and sequence of
activities relevant to a particular product, service,
contract, or project. (based on ISO 8402).
Setting up and developing the
appropriate quality system
Satisfying customer requirements and improving
overall business efficiency are generally
considered to be the two main reasons for
implementing a quality system. There are
however, a number of other objectives which could
be considered, such as :
To increase customer confidence
To enhance the company’s corporate image
To improve employee participation and morale.
To achieve registration as a quality-assured
company.
Establishing the appropriate quality
system
The objective of the working party is to establish
the appropriate quality system applicable to the
organization concerned. Before this can be done,
experience has shown that it is usually necessary
for certain actions to be taken, such as :
To define responsibilities and lines of
communication within each department or
discipline.
To establish interdepartmental interfaces.
To verify and agree the activities and functions
that are to be procedurally controlled.
To communicate to all employees the reason for,
and the benefits to be obtained from, the
implementation of a quality management system.
CORSET
It is used when identifying whether or not
an activity should be controlled one should
question, in the event that the activity
should go wrong, what would be the :
COst of putting it right ??
Resources required to put it right ??
Safety implications should it go wrong ??
Environmental impacts should it go
wrong ??
Time involved in putting it right ??
 In summary, the essence of a quality
system is simply :

Say what you do.

Do what you say.
Record that you have done it.
Audit for effective implementation.
Feedback and improve.
Quality Cost

Generally, quality costs can be

allocated to three distinct costing
centers, as follow :
Prevention costs
Appraisal (or inspection) costs
Failure/rectification costs
Prevetion costs
These are incurred to reduce the costs associated with the failure,
rectification and appraisal of the manufacturing or service process
and would normally be related to :
The activities of planning and implementing the quality system,
developing the quality system documentation, checking and
approving such documentation and distributing or communicating
the information contained within the documentation.
The activity involving the verification of the entire quality system, i.e.
internal audit.
The subsequent management review of the entire system.
The assessment and verification of suppliers organizations.
The costs associated with training and education, which will include
the development, implementation, operation and maintenance of in-
house and external training programmes.
The costs related to developing and implementing quality
improvement programmes, such as quality circles, performance
measurement, problem solving, statistical process control, and
others.
Appraisal costs
These are the costs incurred in verifying the conformance of
the product or process to requirements and would normally
include :
Verifying that purchased items are in conformance with
requirements.
Checking and verifying the manufacturing or service activity
throughout the process and then, finally, confirming the
quality of the completed work-for example, analysing and
reporting of verification results, which are conducted after
confirming that the activity has been satisfactorily
accomplished.
The costs associated with the storage of records as required
to confirm the quality of the items or service.
Failure/rectification costs

These are the costs associated with

“getting it wrong” and, subsequently
“putting it right”. Internally, these can
include such things as scrap,
corrective action, re-verification and
down-time.
The role of the quality assurance
department
• Verifying, by audit, that the quality system requirements are being
followed throughout the organization and that effective procedures and
job instructions are being implemented by all departments or disciplines.
• Verifying that those responsible for controlling and checking an activity
have done so in a systematic manner and that there is objective
evidence available to confirm such;
• Ensuring that all procedural non-conformances are resolved.
• Ensuring that fundamental working methods are established and that
fully approved procedures are developed to cover them and that all
departments and personnel are aware of, and have access to, current
versions of these procedures.
• Verifying that all procedures are regularly reviewed and updated as
necessary.
• Determining and reporting the principal causes of quality losses and non-
conformances;
• Determining, with senior management, where improvements are required
and, where necessary, recommending the corrective action.