Q U A LITY A SS U R A N C E IN

A N A LY TIC A L LA B O R ATO R Y

W hat is Q U ALITY
Quality is fitness for use ( Juran

1988)
Quality is conformance to

requirements or specifications
Quality is the degree to which a set

of inherent characteristics fulfills

requirements (ISO 9000-2000)

Q uality Assurance
Quality assurance is a system of

activities whose purpose is to

provide an assurance that the overall
quality control is in fact being done
effectively
One of the components in quality
system

H ow Q A and Q C is diff
erent?
Quality Control - planned activities

designed to provide a quality product.

Quality Assurance - planned activities

designed to ensure that the quality control

activities are being properly implemented.

Com ponents in Q A
Management
Management document that specify the

role of quality assurance within the

laboratory and clearly define who is
responsible for each area and activity
identify the records that should be kept
of routine operations ensuring that a
logical, coherent system of record
keeping is adopted
brought together as a single Quality
Manual which will act a reference text for
the whole quality assurance programme

Com ponents in Q A
Training
staff are adequately trained for the task

they have to perform

Training must be documented in order that
management and other personnel can
verify that staff are competent to conduct
the duties required of them
level of training required for each
procedure should also be clearly defined
to ensure that staff ability and training are
matched to procedural requirements

Com ponents in Q A
Standard Operating Procedures
Describe in detail every procedure
conducted by the laboratory
As an internal reference manual for the
particular procedure to which they are
dedicated

Com ponents in Q A
Sampling
Clear details should be given for

precautions to be taken while sampling

and the sampling strategies to be
employed
Provide relevant information on the
nature of the sample

Com ponents in Q A
Facilities and Equipment
Resources are required for regular laboratory

work
The environment in which the work is
conducted must be well controlled
All equipment must be maintained on a regular
basis, consistent with the documented criteria
of the laboratory
Apply standards which are well within the limits
normally established and recommended for the
care of the particular piece of equipment

Benefi
ts ofQ A
Customer satisfaction, and therefore, customer loyalty and

repeat business and referral;

Timely registration of drugs by eliminating waste and the
need for rework;
Operational results such as revenue, profitability, market
share and export opportunities;
Alignment of processes with achievement of better results;
Understanding and motivation of employees toward the
Company quality policy and business objectives, as well as
participation in continual quality improvement initiatives; and
Confidence of interested parties in the effectiveness and
efficiency of the Company as demonstrated by the financial
and social gains from Company performance and reputation.