STATISTICAL QUALITY CONTROL

(S.Q.C)
Statistical Quality Control is one of the
important application of statistical techniques
in field of Pharmaceutical industries.
It is noted that quality control is specialized
professional technique which is used to
maintain the technical efficiency of the
process of production.
The term “statistical process control (S.P.C)” is
often used interchangeably with “statistical
quality control”, although S.Q.C includes
acceptance sampling as well as S.P.C.
S.Q.C aims at achieving the target of
conformance of the end products to the
standards and expectations laid down by the
customer.
It is the application of quantitative techniques
to determine how far the product conforms to
the standards of quality and precision and to
what extent its quality deviates from the
standard quality.
In other words, it is a simple statistical method
for determining the extent to which quality
goals are being met without necessarily
checking every item produced and for
indicating whether or not the variations which
occur are exceeding normal expectations.
S.Q.C enables us to decide whether to accept
or reject a particular product.
Variations in manufacturing:
No two products or characteristics are ever
exactly the same, because any process
contains many sources of variability.
In mass-manufacturing, traditionally, the
quality of a finished article is ensured by post-
manufacturing inspection of the product.

Each article (or a sample of articles from a

production lot) may be accepted or rejected
according to how well it meets its design
specifications.
In contrast, SPC uses statistical tools to
observe the performance of the production
process in order to detect significant variations
before they result in the production of a sub-
standard article.
Any source of variation at any point of time in
a process will fall into one of two classes.
1) COMMON CAUSES: It is also referred to
as non-assignable, normal sources of
variation. It refers to many sources of
variation that consistently acts on
process. These types of causes produce a
stable and repeatable distribution over
time.
2) SPECIAL CAUSES: It is also referred to as
assignable sources of variation. It refers
to any factor causing variation that
affects only some of the process output.
They are often intermittent and
unpredictable.
 Most processes have many sources of
variation; most of them are minor and may
be ignored.
If the dominant assignable sources of
variation are detected, potentially they can
be Identified and removed.
When they are removed, the process is said
to be "stable".
When a process is stable, its variation should
remain within a known set of limits.
That is, at least, until another assignable
source of variation occurs.
BENEFITS OF S.Q.C:
 Easy to identify operators that are
producing defects and may require
additional training.
 Accurately reports defects at the operator,
cut, job and style level.
 Defects analysis in either summary or
detail versions.
 Up-to-the-minute operator accountability
for quick and accurate repair and control.
  Improved quality levels within the plant
and reduced expense involved in
reworking garments.
 It is useful for the customers for purchasing
quality product with minimum risks.
 It is beneficial for the producers since the
product gets maximum demands in the
market.
TECHNIQUES OF S.Q.C
1) PROCESS CONTROL:
(a) Variables:
(i)X-Chart (ii)R-Chart
(b) Attributes:
(i)C-Chart (ii)hp-Chart (iii)P-Chart
2) PRODUCT CONTROL:
(a) Attributes
(b) Variables
Process control is used during production
while the product is being made. The main
decision in this case whether to continue the
process or to stop production and look for an
assignable cause of defects which could be
attributed to the materials, operators or the
machines.
Whereas product control (acceptance
sampling) applies to lot inspection where a
decision to accept or reject a lot of materials is
made on basis of a random sample drawn from
the lot. This type of inspection is done after
production is completed.
Acceptance sampling is defined as taking one
or more samples at random from a lot of items
inspecting each of the items in the samples
and deciding on the basis of inspection results
whether to accept or reject the entire lot.
CONTROL CHARTS
A control chart is a graphical representation of
an ongoing process for its quality. The quality
is a measurable character.
A control chart for mean (𝑋̅) can help in
assessing whether the average of the process
is in control or not. A control chart for range
(R-Chart) can help in assessing whether the
variability or the spread of the process is in
control or not.
CONTROL CHART

UPPER CONTROL LIMIT

CHARACTERISTIC

CENTRAL LINE

LOWER CONTROL LIMIT

SAMPLE NUMBER

It has a central line which indicates the desired