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Quality Control in Retail Pharmacies Practice
Pharmacist: Emad Shafik Ghoneim,
B. Sc. Pharma, MBA
Introduction
Pharmaceutical organizations are socio-economically structured as
any organization. The social structure is focusing mainly on the
pharmacist who is the cornerstone of any pharmaceutical business, at the
same time we can not ignore the importance of assistant pharmacists as
well as paramedical social structure in such field. Assistant Pharmacists
are supporting the pharmacist in tasks that do not need high technical
experiences, prescriptions filling, documentation, expiration date
monitoring, and managing pharmaceutical items storage conditions are
examples of these tasks. Paramedical support is very important in the
pharmaceutical field, Human Resource, Accounting, labors, and
maintenance, have a role in sustaining pharmaceutical business growth.
On the other hand, the economic structure in the pharmaceutical business
is managed through many areas. Supply chain management is the most
important area of the pharmaceutical business economy, while
operational cost is in the second priority.
Although, most of pharmaceutical businesses owners are focusing
in the economical structure, the growth of their business could not be
sustained without focusing in both the social and the economic structure.
I conducted a study in 2008 about "Application of Balanced
Scorecard Approach in the Saudi Private Retail Pharmacies" that
covered the majority of Saudi private retail pharmacies at this time. It
revealed that, performance evaluation is based mainly on the financial
section, while other sections as customers focus, internal businesses
processes, and learning and growth had been ignored.
Recently, Pharmaceutical organizations especially chain of
pharmacies have recognized the importance of the social structure in their
growth. They started focusing in the personnel training and development,
at the same time they started believing on the customers focusing
importance. The inter-pharmaceutical chains competition became in the
human resource development as well as attracting, retaining and
satisfying customers.
Quality Management
In 1980`s Philip B. Crosby defined the quality as a conformance to
requirements wit zero defects. This phenomenon was rapidly changed to
the concept of "Fitness for use" by Joseph M. Juran, where customers
who can define the quality that he perceived. The recent definition of
quality is the products and / or services that meet or exceed customers'
expectations.
Quality management is the processes directed by the management,
through which a company continuously tries to improve the quality of
processes, services and products. Quality Management System is a
system that outlines the policies and procedures necessary to control and
improve various processes that will ultimately lead to improved business
performance.
Quality profession grew from simple control (from 1940`s to
1960`s) to quality engineering (in 1970`s) and in 1990`s quality
management system became an emerging field. From this time, quality
management practicing consists of two correlated processes, quality
assurance and quality control.
There are
many benefits for the
organization
from applying
quality management
system; one of these
benefits is directing
organization
activities to be customers oriented, the other one is ensuring the continual
PLAN
DO
CHECK
ACT
improvement in the organization. Recognized best practice, continuous
readiness for any inspection and reduction of working stress could be
other benefits.
Although, Deming created the cycle for improvement which
consists of Plan, Do, Check and Act (PDCA), and Juran introduced his
trilogy of quality which consists of quality planning, quality
improvement, and quality control, the general management concept
consists of four main processes planning, organizing, influencing
(motivating) and controlling.
Management cycle started by the planning and ended by
controlling which is the input of future planning. Planning and controlling
are called the twins of management, where there is no controlling without
good planning and no planning without the results of controlling. In the
Quality Management System as an approach of management, planning,
organizing, and influencing processes are usually applied in one process,
it is the Quality Assurance. On the other hand, the Quality Control is the
second process.
A. Quality Assurance
Quality assurance refers to activities that are planned and executed
to ensure high quality products or services. From this definition we can
conclude that quality assurance consists of quality planning and
execution. Quality planning includes converting the plan into procedures
that should be applied by each department (organizing). Execution of the
planned procedures is done through implementation of these procedures
to each department members (influencing).
Quality assurance is important not only because it leads to the
correction of problems encountered during the plan execution, but also
because it gives organizational owners and customers' confidence that the
introduced products and / or services are free of defects. Correcting
problems can lead to greater efficiency, decreased cost and higher quality
of products.
Quality Assurance in Retail Pharmaceutical practice
Quality assurance is consisting of planning, organizing, and
executing (implementing) the quality management system. Although,
there are many differences between single retail pharmacies, chain of
retail pharmacies, hospital pharmacies, governmental hospital pharmacies
and not for profit organizations pharmacies in the organizational
hierarchy, mission and scope, all are considered as organizations working
in the same field and they can apply the same quality management
strategy with their own concepts.
Quality planning starts with defining the organization mission and
vision. The corporate mission clarifies the organizational strategy which
is the main source of the organizational goals. Based on the
organizational mission, vision, strategy and goals, organizational
structure is established to achieve the organizational goals. Job design,
analysis and profile should be done for each job.
Standard operations procedures should be established to outline the
procedures that should be applied by each job to introduce high quality
products and services to the customers.
Although, retail pharmacies are not manufacturing products that
they are selling, they have to plan for introducing the most effective
products to their customers through the following procedures:
1. Planning for purchasing the pharmaceutical products from the
qualified suppliers especially products sole agents. Purchasing of
products from unknown or unqualified supplier could lead to selling of
ineffective or could be toxic products.
2. Planning of storing the product in the most suitable storage
condition as mentioned by the manufacturer is of extreme importance.
Storage conditions of many pharmaceutical products especially insulin
and hormones are very important to maintain its effectiveness.
3. Planning for recruiting professional pharmacists and giving them
continuous training renders them aware by the recent pharmaceutical
practice. It could minimize the accidental errors in dispensing medicines.
On the other hand it ensures that customers shall receive the professional
counseling.
4. Planning of continuously providing of skills training and
coaching for the pharmacy staff and their managers shall improve the
customers' satisfaction and consequently sales growth.
5. Planning for customers education for certain precautions,
dealing with chronic, pandemic, and endemic diseases, handling of
certain medications and returning policy definitely improve customers'
satisfaction as well as standardize customers' related procedures.
Standard operation procedures should cover all the planned
processes as well as jobs that already planned in the organizational chart.
Based on the corporate goals and department standard procedures, each
departmental head shall prepare his department quality objectives that
continuously improve his department performance.
Planning how to control each process is very important; it starts
with identifying the criteria of the introduced products and services that
shall meet customers' expectations. The second step is the identification
of the quality improvement indicators which monitor the effectiveness of
the planned quality management system. They are the measures that used
in the quality control process.
Executing or implementing the quality management system is the
most important step in the quality assurance. In this step each member in
the organization shall know his role in the company quality management
system. The pharmacist, the assistant pharmacist, the cashier, the labor
and the other supporting staff should be aware about the quality
management system and their roles. Everyone should know the impact of
his tasks on the overall company goals and how he can improve his
organizational performance.
After planning, organizing and implementing the organization
quality management system, the role of quality control starts to close the
cycle.
B. Quality Control
Quality control system monitors the planned quality management
system effectiveness and gauge whether the end results conform to the
planned quality standards or not.
The required product or service quality standards should be
identified in the quality plan, while the process of introducing the
required product or service should be allocated in the standard
procedures. Consequently, quality control monitors the final product or
service and the procedures that lead to their production, while both are
specified in the quality assurance as shown in the following figure.
Juran defined the quality control as a process of evaluating the
actual performance, comparing performance to the goals, and taking
actions on the difference. He revealed that after the improvements have
been made, a new level of performance has been achieved. Now, it is
important to establish new controls at this level to prevent the
performance level from deteriorating to previous level or even worse.
For establishing quality control in the retail pharmaceutical
practice, two important tools shall be used, the quality control team and
the quality control measures.
1 .Quality control team
Quality controllers are group of the working employees selected to
control the application of the quality management system. In some
organizations especially ISO 9001 certified, quality controllers are called
internal quality auditors. Quality control team should be well trained for
doing their tasks efficiently. They should be aware of their organizations
mission, vision, goals and procedures that they will control.
Quality control team should evaluate the effectiveness of the
standard procedures as well as the introduced products and / or services.
They should compare what have been achieved with that planned in the
procedures objectively.
Based on the quality controllers' reports, the quality assurance team
shall prepare the new quality plan. The new plan shall correct the
reported defects in the previous one.
In retail pharmaceutical practice, quality controllers should be
pharmacists to be aware of the related technical points. Their activities
should be planned and documented. The positive attitude of the quality
controller is of extreme importance, where by his attitude can direct the
pharmacist to the way of improvement. Mutual respect and benefits are
the basis of quality controllers and pharmacist relation ship. On the other
hand, other organizational levels as the middle management and even the
top management should be controlled. Quality control should be a
company norm that not excluding any member in the organization.
Quality controller shall spend enough time with the staff to
evaluate all their working tasks, for example spending one full shift with
the pharmacist to evaluate the introduced services and his relations with
customers.
Quality control team activities should be also evaluated through
360 degree performance evaluation method. Double visits with an expert
and direct coaching are the tools for improving quality control team
members.
2 .Quality control measures
Quality control measures are driven from the standard operations
procedures that shall accomplish the company goals to realize the
company mission. Without these measurements, there is no way to know
how processes are performing. Mikle Harry said " It is only by measuring
we can know the value of something and we can't improve what we don't
measure".
Quality control measures are specified in the quality plan. They
should measure the standard procedures application not the people who
apply it. Quality measures should be used as tools of improvement, not
for defense or catching mistakes. They should measure only what could
be controlled by the employees. Data collected from the quality measures
should represent reality, based on facts not assumptions. Quality control
measurements should be objective not subjective.
Quality Indicators in retail pharmaceutical practice
Quality improvement is an internally driven process without end. It
embraced by all employees jobs and focuses on processes as well as the
introduced products and / or services. Improvement is added on process
and customers focus.
Quality improvement indicators in the retail pharmaceutical
practice could be financial indicators, customers' related indicators and
process improvement indicators. There are many other indicators that
could be suitable for other organizations depending on the nature of the
organization, its mission and goals.
Financial Indicators
Retail pharmaceutical business as any business seeks for the
maximum profit excluding the not for profit organizations. Quality
management system should have positive impact on cost reduction and
increase of profits.
For every 1 (one) dollar an organization spends to prevent a quality
problem, it would have to spend 10 (ten) dollars to inspect and correct the
mistake after the product was made, and it would have to spend 100 (one
hundred) dollars to rectify the problem after it has reached the customers
(1-10-100 rule by G.H. Loabovitiz and Y. S .Chang). The relation
between quality control and the cost of quality is illustrated in the
following diagram.
Financial quality improvement indicators could be sales growth,
increase of the net profit, resources saving, cost reduction and improving
the organization market share in the whole market. Financial
improvement is the most favorable indicator especially for the owners of
the organization and definitely it will be reflected on the whole staff.
Customers related indicators
The value of any organization is usually measured by the growth of
the number of its customers. It depends on its capability to retain its loyal
customers and they are in continuous growth.
Retail pharmaceutical business is mainly based on the introduced
services, so customers related indicators are of extreme importance.
Many pharmacies chain in the Kingdome of Saudi Arabia are striving to
attract more customers. The competition between them becomes on the
customers. For these reasons, customers related indicators should be
continuously evaluated.
Customers related indicators could be the level of customers'
satisfaction, customers' loyalty, customers flow (number) and the average
purchase per customer. There are many customers loyalty programs
applied based on the customers points of sales. The value of customers'
data is still not yet well utilized in the Arabic countries which could be
one of the most powerful competitive advantages.
Processes improvement indicators
Innovations are important tools in the organizations processes
improvement. Reducing working steps and minimizing rework
procedures are the scope of the organization quality management system.
Reduction of working errors is the main indicator of the quality
improvement. Pharmaceutical practices errors could be fatal because it is
directly related to people health.
Reduction of operation time shall directly improve productivity
and reduce the cost.
Personal development indicators
Staff training and development became one of important strategies
for the majority of organizations. It is one of the important competitive
advantages especially in the retail pharmaceutical business.
Pharmaceutical organizations are not manufacturing the products
that they sell, while they are responsible for the level of the introduced
services. Employees' selection before hiring and the continuous training
they are receiving are the indicators for the introduced services.
Suppose you have hired the best employee possible for a particular
job. If that employee begins work without receiving the basic skills and
orientation training as well as he is not receiving the continuous training.
What is the expected level of service he shall provide to the customers?
Definitely it will be poor and many mistakes could be happened during
his working practices.
Work force retention and employees satisfactions are could be used
as indicators for quality improvement. Organizations staff are considered
as internal customers and their satisfaction shall be reflected on the
external customers' satisfaction. Employees' loyalties and their turnover
are very important indicator for quality improvement.
There are many other indicators that suit each organization
depending on the nature of the organization, its mission and goals.
Technological improvement could be used as an indicator for quality
improvement in technology driven organizations.
Conclusion
Retail pharmacy practice as any other business seeks the maximum
profit, customers' satisfaction, retention, and increase, and gaining
competitive advantage in the whole market. On the other hand
pharmaceutical practice is differ from other practices in dealing with
people's health and should free from mistakes. For balancing this
equation the quality improvement strategy could be the most effective
way. Quality improvement as emphasized by Juran in 1980 is starting
with planning, improvement and control (Juran trilogy). Quality practice
consists of two correlated divisions, quality assurance and quality control.
There is no controlling without plan and no planning without control. For
controlling quality in the pharmaceutical field, we have to identify the
quality control team, measures, and indicators for ensuring the system
effectiveness and evaluating the improvement.
Finally, we have to know that quality is not just about
implementing a system or working towards a set of standards. It is an
attitude, a way of working that not only improves an organization, but
also the way the organization works.
Quality is not an act. It is a habit.
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The author:
Pharmacist: Emad Shafik Ghoneim, B. Sc. Pharma, MBA, PhD
candidate.
Bachelor degree in pharmaceutical science, Egypt 1990, MBA in HR,
Malaysia 2008, and Candidate in PhD program, quality excellence,
Malaysia.
Quality officer in Al-Dawaa Medical Services Company (DMSCO),
Khuber, KSA.
E-mail ([email protected]) and ([email protected])
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