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

PLA D
organization from N O
applying quality

management system; one

AC CHEC
of these benefits is T K

directing organization

activities to be customers

oriented, the other one is ensuring the continual 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.

Quality control team .1

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.
 Quality control measures .2

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 (Ghonam@al-dawaa.com.sa) and (emad_ghoneim@hotmail.com)

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