TQM can have a beneficial effect on employee and organizational development. By having all employees focus on quality management and continuous improvement, companies can establish and uphold cultural values that create long-term success for both customers and the organization. TQM's focus on quality helps organizations identify skill deficiencies in employees, along with the necessary training, education or mentoring required to address those needs.
2. ■ Introduction The pharmaceutical industry is key part of the health care
system. The regulation of this industry is very important because one
mistake in production or design can cause more severe condition in
relation to health care system. So, the maintenance of the quality of the
drugs is so important in pharmaceutical industries because the poor
quality of drugs can cause health hazards and economical burden for both
the government and patients. Total quality management is improvised in
the industries to maintain the quality and safety of the drugs and
prevention of the defects rather than the detection. The pharmaceutical
quality system is described under ICH guideline Q10. The concepts, key
points of quality improvement of TQM were proposed by several
eminents like Edward Deming, Joseph Juran, Philip Crosby, Genichi
Taguchi, etc
3. ■ Definition : As per International Organization of Standard (ISO), TQM is
defined as: “A management approach of an organization centered on quality,
based on participation of all its members and aiming at long term benefits to all
members of the organization and society”.
■ Focus of TQM
There are three main key components of TQM:
1. Consumer/Customer focus
2. Involvement of employee
3. Continuous improvement
TQM is controlled by customer focus, process (planning, management and
improvement) and total participations.
According to previous literature (Mazumder et al, 2011), the key
ingredients of TQM are: 1. Strategic commitment by the
management 2.
Employee involvement
3. Materials used in the organizations
4. Precise techniques used by the organizations
4. Statistical Quality Control To achieve accuracy, statistics play an important role in
quality management systems. The seven major tools used for statistical process
control are:
1. Histogram: A histogram is an accurate representation of the distribution of
numerical data (related with one variable).
2. Pareto chart: A Pareto chart is a type of chart that contains both bars and a line
graph, where individual values are represented in descending order by bars, and the
cumulative total is represented by the line.
3. Cause and effect diagram (Fish bone diagram): It helps to identify the possible
causes of a specific problem or quality characteristic.
4. Defect concentration diagram.
5. 5. Control chart: The control chart is a graph used to study how a process
changes over time. Data are plotted in time order. A control chart always has a
central line for the average, an upper line for the upper control limit and a
lower line for the lower control limit.
6. Scatter diagram: The scatter diagram graphs pairs of numerical data, with
one variable on each axis, to look for a relationship between them. If the
variables are correlated, the points will fall along a line or curve.
7. Check sheet: The check sheet is a form or document used to collect data in
real time at the location where the data is generated.
6. ■ Advantages
1. Improve in quality and safety of the drugs.
2. Improvement of customer satisfaction.
3. Improvement of reputation of industry.
4. Total involvement of employee with higher moral and responsibilities.
5. Lower economic burden.