SCHOOL OF PUBLIC HEALTH

DEPARTMENT OF EPIDEMIOLOGY AND BIOSTATISITCS

(BSC. HEALTH SYSTEMS MANAGEMENT)

BPH4113: HEALTH SERVICES QUALITY MANAGEMENT

@2016

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BPH 4113 :HEALTH SERVICES QUALITY MANAGEMENT

COURSE OUTLINE

Week Topic Lectures

1 ,2 Perspectives and Concepts of 1 - Perspectives and concepts of quality
quality 2-Quality, Perceived quality, quality
attributes: Concepts of quality: quality
versus reputation, quality versus customer
satisfaction, the quality equation
3 Dimensions of quality 3-Dimensions of quality; Dimensions of
quality for product , dimensions of quality
for service
4 Total Quality Management 4- Total Quality Management
5 CAT1 CAT2
6,7 QualityManagement Sytems 5-Quality Management

6-Quality management systems:

Establishing a quality management
system according to ISO; ISO 9000 Family
of Standards, Principles of quality
management, elements of a quality
management system:

8,9 Quality models 7-Quality models : The Kenya Quality

Model For Health, 5S- KAIZEN GEMBA,
PDCA cycle, Ishikawa Diagram
10 Cost of Quality 8- Cost of Quality
11 CAT2 CAT2
12 Quality Improvement 9-Quality Improvement: Process
improvement:Root-Cause analysis, process

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 mapping, developing standard operating
procedures and documenting quality policies
and objectives
13 Quality Auditing and inspection 10-Quality auditing and inspection: internal
quality auditing, External recognition of
quality programs. Contemporary issues in
quality management
14 REVISION REVISION
15,16 EXAMS EXAMS

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 Lecture 1
Quality perspectives and concepts

Lecture Overview
Welcome to lecture one which will introduce you to various perscpectives and concepts of
quality.In this lecture we will discuss relevant terms as used in quality to help us understand
what is made of quality during the delivery of healthcare services
Course Purpose

To equip learners with knowledge and skills on establishing and maintaining effective quality
management systems that enhance customer satisfaction, operational efficiency and improved
business performance.

Expected Learning Outcomes

By the end of the course, learners should be able to

1. Define quality and related concepts

2. Explain the dimensions of quality for product and service
3. Describe the historical development of quality
4. Discuss the application of quality models in health care
5. Illustrate the use of quality management tools in planning for quality improvement in
the health sector
6. Discuss contemporary issues in continual quality improvement

By the end of this lecture, you should be able to:

i. Describe quality perspectives and concepts

ii. Explain the historical development of quality

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What is Quality?

It is a measure of how good something is. ―The Quality of technical care is the application of
medical science and technology in a way that maximizes its benefits for health without
increasing its risks‖ (Dr. A. Donabedian -1980) . ―…the proper performance - according to
standards - of interventions known to be safe, affordable for the society, and that have the
capacity to produce an impact on mortality, morbidity, disability and malnutrition.‖ (Roemer
and Montoya-Aguilar, WHO - 1988) . Quality of care should be defined in light of both
technical standards and patients' expectations. While no single definition of health service
quality applies in all situations, the following common definitions are helpful guides: ―Doing
the right thing, right, the first time, and doing it better the next time, with the resource
constraints and to the satisfaction of the community‖ (Ministry of Health and Population of
Malawi, 1997) ―Quality is conformance to requirements or specifications‖ (Crosby, 1979).
―Quality is compliance with standards.‖ – QA Contract, 1997 ―The quality of technical care
consists in the application of medical science and technology in a way that maximizes its
benefits to health without correspondingly increasing its risks. The degree of quality is,
therefore, the extent to which the care provided is expected to achieve the most favorable
balance of risks and benefits.‖ (Donabedian, 1980) ―…proper performance (according to
standards) of interventions that are known to be safe, that are affordable to the society in
question, and have the ability to produce an impact on mortality, morbidity, disability, and
malnutrition.‖ – M.I. Roemer and C. Montoya Aguilar, WHO, 1983 ―The totality of features
and characteristics of a product or service that bear on its ability to satisfy stated or implied
needs.‖ – International Standards Organization (ISO‘s) in Standard 8402. This definition
captures the customer perspective and notes that needs can be stated or implied.

The most comprehensive and perhaps the simplest definition of quality is that used by
advocates of total quality management (W. Edwards Deming, 1982): "Doing the right thing
right, right away."According to ISO9000:-Quality is defined as „the degree to which a set of
inherent characteristics fulfills requirements‟.It is both objective and subjective in
nature.According to WHO:-Quality of care is the level of attainment of health systems‟
intrinsic goals for health improvement and responsiveness to legitimate expectations of the
population.It also Meeting and/or exceeding the expectations of our customers.

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 Activity 1.1
Critititue the concept of quality and how we attacin it in our in
organizations?
________________________________________________________
________________________________________________________
_________________________________________________________

Perspectives of quality
What does quality of health care mean for the communities and clients that depend on it, the
clinicians who provide it, and the managers and administrators who oversee it?
The Client. For the clients and communities served by health care facilities, quality care
meets their perceived needs, and is delivered courteously and on time. In sum, the client wants
services that effectively relieve symptoms and prevent illness. The client‘s perspective is very
important because satisfied clients often are more likely to comply with treatment and to
continue to use primary health services. Thus, the dimensions of quality that relate to client
satisfaction affect the health and well-being of the community.
The Health Service Provider .From the provider‘s perspective, quality care implies that he or
she has the skills, resources, and conditions necessary to improve the health status of the
patient and the community, according to current technical standards and available resources.
The provider‘s commitment and motivation depend on the ability to carry out his or her duties
in an ideal or optimal way. Providers tend to focus on technical competence, effectiveness,
and safety.
The Health Care Manager Quality care requires that managers are rarely involved in
delivering patient care, although the quality of patient care is central to everything they do.
The varied demands of supervision and financial and logistics management present many
unexpected challenges and crises. This can leave a manager without a clear sense of priorities
or purpose. Focusing on the various dimensions of quality can help to set administrative
priorities. Health care managers must provide for the needs and demands of both providers
and patients.

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Client perspectives
Clients perspectives on quality means addressing clients‘ concerns is as essential as technical
competence. For clients, quality depends largely on their interaction with providers, with

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emphasis given to attributes such as waiting time, privacy, ease of access……and getting the

service they want!

Providers perspectives

For providers it means Service Providers: offering technically competent, effective services.
Programme managers: definition includes support services .Policy makers & donors:
additional elements include costs, efficiency, outcomes for population as a whole

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Quality assurance (QA)

It is the sum total of the organized arrangements made with the object of ensuring that
medicinal products are of the quality required for their intended use.Quality Assurance -
planned and systematic actions necessary to provide adequate confidence that a dosimetry
product or service will satisfy given requirements for quality.QA is mainly a matter of
common sense; the development of strategy for it, as well as setting the rules for the QA
programme and implementing them systematically in the service, require considerable
thought and effort.Quality assurance (QA), performed by personnel not directly involved
in the inventory compilation/development process, is a planned system of review
procedures.This involves using the minimum acceptable requirements for processes and
standards for outputs as the criteria for taking corrective action (Michele, 2009).Quality
Assurance entails:

• A process, not an end-point

• Must be independent of financial pressures

• Must ensure that quality policies are followed

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 • Must have final authority in product acceptance, rejection and release to public

• Integral to production, not an add-on

• Responsible for day-to-day operations and for longer term goal settings

• Quantitative discipline with specified parameters

What is the aim of Quality Assurance?

When good Quality Assurance is implemented there should be improvement in usability and
performance and lessening rates of defects
What does QA give?
 Quality‟ means your project is ‗useful‘ - without „quality‟ you may have little to offer

 „Quality‟ can help to future-proof projects

 But ‗quality assurance‟ needs documented standards and best practices to be

meaningful

 „Quality‟ & „Best Practice‟ can be considered in terms of being „Fit for Purpose‟

Quality Control
 Quality control (QC), performed by personnel compiling the inventory, is a system of
routine technical activities to assess and maintain the quality of the inventory as it is
being compiled. Quality Assurance - QA is defined as the overall program that ensures
that the final results reported by the laboratory are correct.A QA, QC and verification
system contributes to the objectives of good practice in inventory development,
namely to improve:

 Transparency

 Accuracy

 Consistency

 Comparability

 Completeness.

 QA/QC and verification activities should be integral parts of the inventory process.

What is the aim of QC?

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―The aim of quality control is simply to ensure that the results generated by the test are
correct. However, quality assurance is concerned with much more: that the right test is carried
out on the right specimen, and that the right result and right interpretation is delivered to the
right person at the right time‖

What is Quality Control?

Quality Control (QC) is the implementation of regular testing procedures against your
definitions of quality and more specifically the refinement of these procedures
• Formal use of testing

• Acting on the results of your tests

• Requires planning, structured tests, good documentation

• Relates to output - Quality Circle

• Standards - ISO 9000 & BS5750

• The goal of QC is to detect errors and correct them before patients‘ results are reported

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 You have come to the end of lecture one. In this lecture you have learnt the
following:
 Concepts and perspectives of quality
 Dimensions of quality
 Charactristics of service quality

1. Explain what you have understood in Quality

___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
2. Explain the importance of each perspective of quality
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

1.WHO. (2006). Basic concepts of quality. In WHO, Quality of care: a process for making
strategic choices in health systems (pp. 9-10). France: World Health Organization.

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 Lecture 2
Dimensions of Quality

Lecture Overview
Welcome to lecture teo where we shall discuss about the different dimentions of quality.

By the end of this lecture, you should be able to:

i. Desribe the dimensions of quality

Dimensions of quality

Dimensions of Quality
Technical Competence

Access to services
Effectiveness of services/standards
Efficiency of services

Interpersonal relations

Continuity of services

Safety
Amenities
Choice of services

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Technical Performance/Competence This is the degree to which the tasks carried out
by health workers and facilities meet expectations of technical quality (i.e., adhere to
standards). It refers to the skills, capability, and actual performance of health
providers, managers, and support staff. For example, to provide technically competent
services, a village health worker must have the skills and knowledge (capability) to
carry out specific tasks and to do so consistently and accurately (actual performance).
Technical performance relates to how well providers execute practice guidelines and
standards in terms of dependability, accuracy, reliability, and consistency. This
dimension is relevant for both clinical and nonclinical services.

Access to Services Access means that health care services are unrestricted by
geographic, economic, social, cultural, organizational, or linguistic barriers, and it
therefore influences utilization of services. The commonly referenced ―three delays
framework or model4‖ will also come into play among the access factors.

Geographic access may be measured by modes of transportation, distance, travel

time, and any other physical barriers that could keep the client from receiving care
(e.g. locating a health facility at the top of a mountain and expecting a woman who is
in labour to climb this mountain to come to deliver in the facility

Economic access refers to the affordability of products and services for clients.
Whether or not a client chooses to pay for a particular service can also be affected by
the client‘s assessment of this service‘s value. This implies that while a client may
have the ―hard cash‖ to pay for a service, s/he could choose not to pay for it because
the perceived value does not match the expenditure required.

Organizational access refers to the extent to which services are conveniently

organized for prospective clients and encompasses issues such as clinic hours and
appointment systems, waiting time, inappropriate eligibility criteria (e.g. no family
planning services for adolescents), arrangement of rooms, labeling, physical layout
and access (e.g. ramps for disabled persons), and the mode of service delivery.

Linguistic access means that the services are available in the local language or a
dialect in which the client is fluent. Apart from the obvious differences in the spoken
language, linguistic access comes into play in a major way where the client is deaf,
and therefore largely relies on sign language to communicate.

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Effectiveness (of care) Effectiveness is the degree to which desired results
(outcomes) of care are achieved. The quality of health services depends on the
effectiveness of service delivery norms and clinical guidelines. Assessing the
dimension of effectiveness answers the questions, ―Does the procedure or treatment,
when correctly applied, lead to the desired results?‖ and ―Is the recommended
treatment the most technologically appropriate for the setting in which it is delivered?‖
Effectiveness is an important dimension of quality at the central level, where norms
and specifications are defined. Effectiveness issues should also be considered at the
local level, where managers decide how to carry out norms and how to adapt them to
local conditions.

Efficiency (of Service Delivery) Efficiency is the ratio of the outputs of services to
the associated costs of producing those services. The efficiency of health services is an
important dimension of quality because it affects product and service affordability and
because health care resources are usually limited. Efficient services provide optimal
rather than maximum care to the patient and community; they provide the greatest
benefit within the resources available. Efficiency demands that necessary or
appropriate care is provided.

Interpersonal Relations: The dimension of interpersonal relations refers to the

interaction between providers and clients, managers and health care providers, and the
health team and the community. Good interpersonal relations establish trust and
credibility through demonstrations of respect, confidentiality, courtesy, responsiveness,
and empathy. Effective listening and communication are also important. Sound
interpersonal relations contribute to effective health counseling and to a positive
rapport with patients.

Continuity: Continuity means that the client receives the complete range of health
services that he or she needs, without interruption, cessation, or unnecessary repetition
of diagnosis or treatment. Services must be offered on an ongoing basis. The client
must have access to routine and preventive care provided by a health worker who
knows his or her medical history. A client must also have access to timely referral for
specialized services and to complete follow-up care.

Safety:As a dimension of quality, safety means minimizing the risks of injury,

infection, harmful side effects, or other dangers related to service delivery. Safety

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 involves the provider as well as the patient. For example, safety is an important
dimension of quality for blood transfusions, especially since the advent of HIV.
Patients must be protected from infection, and health workers who handle blood and
needles must be protected by safety procedures. Additional safety issues related to
blood transfusions include maintaining aseptic conditions and using proper techniques
for transfusing blood.

Amenities: (Physical infrastructure and comfort) Amenities refer to the features of

health services that do not directly relate to clinical effectiveness but may enhance the
client‘s satisfaction and willingness to return to the facility for subsequent health care
needs. Amenities are also important because they may affect the client‘s expectations
about and confidence in other aspects of the service or product.

Choice: Whenever appropriate, clients have a right to make a voluntary, well-

considered decision on provider, treatment, etc. that is based on options, information,
and understanding. It is the service provider‘s responsibility either to confirm that a
client has made an informed choice or to help the client reach an informed choice.

Activity 2.1
Expalain how we can apply the dimensions of qaulity to achieve the best
in our organizations
________________________________________________________
________________________________________________________
_________________________________________________________

Characteristics os service quality

1. Time and timeliness – customer waiting time, completion on time

2. Completeness – Costomers should get all they want

3. Courtesy – fair treatment from service providers/managers

4. Consistency – same level of service for all clients/customers

5. Accessibility and convenience – easy obtaining of a service

6. Accuracy – right performance always

7. Responsiveness – response/reactions at unusual times

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 Quality and customer satisfaction
A product (or service) is said to have quality when: Its features meet customer needs and
therefore provide customer satisfaction; and It is free from deficiencies or errors that require
doing work over again (rework) or that result in failures after (product or service) delivery,
customer dissatisfaction, customer claims, etc. Clients’ Rights + Staff Needs = Quality
A prerequisite for developing products that meet customer needs is identifying who the
customers are. The core purpose or mission of the organization is a guide in identifying the
customers.Recipients of health care services are not passive patients waiting to be seen by
experts.They are autonomous health care consumers, or clients. Who are responsible for
making decisions about their own health care and deserve—high-quality health care.Health
care staff desire to perform their duties well. However, if they lack administrative support and
critical resources, they will not be able to deliver the high-quality services to which clients are
entitled.
Clients’ needs
 Information

 Access to services

 Informed choice

 Safe services

 Privacy and confidentiality

 Dignity, comfort, and expression of opinion

 Continuity of care

Health care staff needs

 Facilitative supervision & management

 Information, training and development

 Supplies, equipment and infrastructure

There are two primary groups of customers: the external customers—those outside the
producing organization; and the internal customers—those inside the producing organization.
The term ―customer‖ can refer to an entire organization, a unit of a larger organization, or a
person.
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External Customers There are many types of external customers— some obvious, others
hidden. Below is a listing of the major categories to help guide complete customer
identification:
1. The purchaser Someone who buys the product for himself or herself or for someone else
2. The end user/ultimate customer Someone who finally benefits from the product, e.g., the
patient who goes to health care facility for diagnostic testing
3. Suppliers Those who provide input to the process, e.g., the manufacturer of the diagnostic
testing equipment and related supplies. Suppliers are also customers. They have information
needs with respect to product specification, feedback on deficiencies, predictability of orders,
and so on.
4. Potential customers Those not currently using the product but capable of becoming
customers
5. Hidden customers An assortment of different customers who are easily overlooked
because they may not come to mind readily. They can exert great influence over the product
design: regulators, critics, opinion leaders, testing services, payers, the media, the public at
large, those directly or potentially threatened by the product, corporate policymakers, labor
unions, and professional associations, etc.
Internal Customers Everyone inside an organization plays three roles: supplier, processor,
and customer. Each individual receives something from someone, does something with it, and
passes it to a third individual. Effectiveness in meeting the needs of these internal customers
can have a major impact on serving the external customers. Identifying the internal customers
will require some analysis because many of these relationships tend to be informal, resulting
in a hazy perception of who the customers are and how they will be affected. When the needs
of internal customers are not fully understood, communication among the functions breaks
down. This is why a major goal in the quality design process is to identify who the internal
customers are, discover their needs, and plan how those needs will be satisfied. This is also
another reason to have a multifunctional team involved in the planning; these are people who
are likely to recognize the vested interests of internal customers.

Identifying Customers It is most often helpful to draw a relatively high-level flow chart of
the processes related to the product being planned. Careful analysis of this flow chart often
will provide new insight, identifying customers that might have been missed and refining

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understanding of how the customers interact with the process. A review of the chart reveals
that the role of ―customer‖ is really two different roles—placing the order and using the
product. These may or may not be played by the same individuals, but they are two distinct
roles, and each needs to be understood in terms of its needs.

Other concepts used in quality

Accessibility Ability of a patient or population to utilize needed healthcare services
unrestricted by geographic, economic, social, cultural, organizational, or linguistic
barriers.
Effectiveness The degree to which program or system objectives are being achieved.
Efficiency The relationship of outputs (services produced) to inputs (resources used to
produce the services). Increasing efficiency is a matter of achieving the same outputs with
fewer resources or more outputs for the same amount of resources.
Customer Expectations The "needs" and "wants" of a customer that define "quality" in a
specified product or service. Customer Any person or group inside or outside the
organization who receives a product or service.
Cost of Quality A term used by many organizations to quantify the costs associated with
producing quality products. Typical factors taken into account are prevention costs
(training, work process analyses, design reviews, customer surveys), appraisal costs
(inspection and testing), and failure costs (rework, scrap, customer complaints, returns,
supplier negligence).
Continuous Quality Improvement (CQI) A management approach to improving and
maintaining quality that emphasizes internally driven and relatively continuous
assessments of potential causes of quality defects, followed by action aimed either at
avoiding decrease in quality or else correcting it an early stage.

You have come to the end of lecture one. In this lecture you have learnt the
following:
 Concepts and perspectives of quality

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  Dimensions of quality
 Charactristics of service quality

3. Discuss the application of the dimensions of quality

___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
_____________________________________________________________________

1.WHO. (2006). Basic concepts of quality. In WHO, Quality of care: a process for making
strategic choices in health systems (pp. 9-10). France: World Health Organization.

19
 Lecture 3
Total Quality Management (TQM)

Lecture Overview
In the previous lectures, we defined quality and its inter-related concepts.We shall now discuss
in depth what Total Quality Management is all about and how esential it is for any healthcare
organization that is operating in Quality systems.In this concept various elements of TQM are
key in propr operationalization quality management systems always

By the end of this lecture, you should be able to:

i. Describe the role of TQM in health services delivery

ii. Explain the elements of TQM

What is Total Quality Management?

Total: quality becomes a central focus in every phase of the company

Quality: seen from the customer‘s view NOT a parameter of production

Management: everybody is a manager by participation

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 success through customer
satisfaction, and benefits to all members of the organization and to society."
TQM: This is a management approach advocating the involvement of all employees in the
continuous improvement process, not just quality control specialists. An approach to quality
assurance that emphasizes a thorough understanding by all members of a production unit of
the needs and desires of the ultimate service recipients, a viewpoint of wishing to provide
service to internal, intermediate service recipients in the chain of service, and a knowledge of

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how to use specific data-related techniques to assess and improve the quality of their own and
the team‘s outputs

TQM is both a philosophy and methodology with a set of guiding principles that focuses on
managing the ‗whole‘ to achieve excellence. Not only does TQM encompass the entire
organization, but it stresses that quality is customer driven. TQM attempts to embed quality in
every aspect of the organization. It is concerned with technical aspects of quality as well as
the involvement of people in quality, such as customers, company employees, and suppliers.
―TQM is a set of systematic activities carried out by the entire organization to effectively and
efficiently achieve company objectives so as to provide products and services with a level of
quality that satisfies customers, at the appropriate time and price‖ (TQM committee 2002
cited in Fukui, et al., 2003, p 33). TQM is not a program. It is ―a strategy, a way of doing
businesses, a way of managing, a way of looking at the organization and its activities‖
(Anschutz 1995, 13 cited in Fukui, et al., 2003, p 34). Therefore, the success of TQM is
measured not only by its tangible outcome but also by both the way in which the
organizational structure is established and the processes by which corporate objectives are
achieved.

Rationale of TQM

 Improve internal operations by:

 Facilitating cost cutting;

 Improves employee morale

 Improves competitive position by commitments to quality customer demand it.

 Doing it right every time requires that everyone in the organizations is aware of the
need for TQM and is equipped with it. This involves that the personnel are qualified
and have necessary knowledge, skills and attitude.
Key concepts for TQM:-
 Defined and specific quality policies and objectives.
 Strong customer orientation.
 All the activities necessary to achieve these quality policies and objectives.
 Organizations wide integration of the activities.
 Clear personnel assignments for quality achievement.
 Specific vendor-control activities through quality equipment identification.
 Defined and effective quality information flow, processing and control
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Ways to create a quality culture
 Look inside;

 Promote teamwork;

 Adopt the language of quality;

 Promote employee ownership;

 Demonstrate commitment;

 Connect to customer;

 Let employees solve problems;

 Use symbols properly;

 Include employees at every level

Building TQM awareness

 Awareness- The first step is to build quality awareness among your people. If
everyone is thinking about quality, they will not only do their jobs better, they will
generate ideas that result to continuous quality improvement.

 Value-how do they view issues of quality, customers, teamwork, management,

honesty?

 Satisfaction-are they happy in their work? Do they feel there is sufficient opportunity
for advancement? How do they view compensation system?

 Quality- Do they understand basic quality concepts? How do they view quality? Are
they committed to it? What do they see as obstacles to quality?

 Training- Employees need skills. TQM not only emphasizes the importance of
effective implementation of traditional job training, but also requires training in quality
concepts, leadership and problem solving. At the same time, TQM guides you toward
quality in training-making your training investment pay off.

Ways to create quality culture

 Environment: in the simplest terms, an environment characterized by a Total Quality
culture is one where the obstacles to quality are removed. It is an environment where it
is easy for a person to do his/her job right.

Obstacles toward a quality culture

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  Short-term performance measures: Aim toward longer-range goals. Sometimes
customer orientation or team processes take time to pay off.

 Job insecurity: If cut backs have to be made in a company that is adopting TQM,
employees should know the reasons and should be given the information clear,
understandable terms.

Six ways to track customer quality perception

 Divide customers by market segment

 Identify priority customers;

 Collect data;

 Monitor customer complaints;

 Form quality partnerships;

 Set up a formal programme to use customer data.

Total quality means that there is continuous improvement in the ways the needs of these
internal customers are met

Activity 3.1
Explain how you can achieve TQM in your organization

Quality management principles

The eight principles have emerged as fundamental to the management of quality, regardless of
the approach or method of quality management that is adopted. These principles also form the
basis of the ISO 9000 family of standards and framework for a management system. An
important thing to note is that principles are not rules – they are simply guidelines or guides to
action, and help us determine the right things to do and gives us the rationale or basis for

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doing things. Working with principles gives us flexibility, because we decide how to apply the
principle given our circumstances.

Principle 1—Customer Focused Organization

Organizations depend on their customers and therefore should understand current
and future customer needs, meet customer requirements and strive to exceed
customer expectations. Far too often, a system is developed and people in that
system ―expect‖ customers to conform to the way things are done by the
organization. However, every person in the organization must understand that
customers are their reason for existence, not the other way around. Health services
exist to meet the health needs of clients, so the delivery of health services should be
designed to meet those needs. Customer focus means organizing work as a process
that converts customers‘ needs into satisfied customers. A focus on the client
examines how and whether each step in a process is relevant to meeting client needs
and eliminates steps that do not ultimately lead to client satisfaction or desired client
outcomes. It means that all processes have a customer focus. The organization
continually needs to examine its system to see if it is responsive to the ever-changing
customer requirements. Customer focus includes determination of customer needs
and expectations and measuring customer satisfaction.
Principle 2—Leadership
“Every operation looks exactly like the leaders.”
Leaders establish unity of purpose and direction of the organization. They should
create and maintain the infernal environment in which people can become fully
involved in achieving the organization's objectives. Leaders exist at all levels in an
organization, not simply at the top. Strong leadership will drive an organization
towards success. But leadership alone will not bring the right success; it needs to be
in combination with all the other principles. Leadership without customer focus will
drive organizations towards profit for its own sake. Leadership without involving
people will leave behind those who do not share the same vision. Indifference and
lack of involvement by senior management are frequently cited as the principal
reasons for the failure of quality improvement efforts. The senior managers should
not simply delegate the responsibility of quality to others, but must actually be
involved. The culture, vision, values, beliefs and motivation in an organization arise

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from leadership. Good leadership strives to bring about a set of shared values – a
shared vision so that everyone knows what the organization is trying to do and where
it is going.
―Senior management … can understand and cause zero defects to become routine.
But first they have to realize that getting everyone to “do it right the first time”
begins with the attitude of the management.‖

Principle 3—Involvement of People (Staff involvement and ownership)

People at all levels are the essence of an organization, and their full involvement
enables their abilities to be used for the organization's benefit. Every person has
knowledge and experience beyond the job where he or she has been assigned to
perform. Management should tap into this source of knowledge, encourage
personnel to make a contribution and utilize their personal experience. Additionally,
management should be open and not hide its discussions unless national or business
security could be threatened. Closed-door management leads to distrust among the
workforce. Quality management requires participation and teamwork to design,
measure and improve quality. The impact of quality management is greatest when
managers draw on the participation, experience, and knowledge of staff. The
manager should therefore use any mechanism or approach that will enhance the
participation, involvement and engagement of these critical stakeholders in the
quality management process. Employee involvement, an approach to improving
quality and productivity, can be enhanced by:
1. Creating an environment in which employees are able to motivate themselves;
2. Empowering the employees by creating an environment in which people have the
ability, confidence, and the commitment to take the responsibility and ownership to
improve the process and initiate the necessary steps to satisfy customer requirements
within well-defined boundaries in order to achieve organizational values and goals.
3. Advocating for the use of teams to solve problems and implement quality
solutions, recognizing that the impact of quality management activities is most
powerful when the participation, experience, and knowledge of major participants
and stakeholders is included. Processes consist of interdependent steps that are
executed by different people, so the group working within a process will understand

25
it better than any one person. Additionally, participation of major stakeholders
improves the ideas generated, builds consensus about changes, and reduces
resistance to change, leading to increased commitment to improvement. Such an
atmosphere of support discourages blaming others for problems. Finally, the
accomplishments of a team often increase the members‘ self-confidence. This
empowers staff to work towards the goal of quality by motivating them to contribute
their knowledge and skills to improve organizational and individual performance.
4. Creating an effective suggestion system to provide individuals with the
opportunity to be involved in contributing to the organization. For the suggestion
system to be effective, the management must be committed and must make it easy
for employees to suggest improvements, review them promptly, and implement
them.
5. Engaging employees in the planning and implementation of a recognition and
reward system that lets the employees know they are valuable members of the
organization. Recognition is acknowledgement by verbal or written praise and may
include symbolic items like certificates and plaques. Reward is something tangible
such as theatre tickets, dinner, or a cash award to promote desirable behaviour.
6. Implementing a performance appraisal system that lets employees know how
they are doing and that provides a basis for promotions, salary increases, counseling,
etc. Employees should be made aware of the appraisal process, what is evaluated,
and how often, and should be told how they‘re doing on a continuous basis, not just
at appraisal time. According to ISO 9000 (International Organization for
Standardization), applying the principle of involvement of people typically leads to:
 People understanding the importance of their contribution and role in the
organization.
 People identifying constraints to their performance.
 People accepting ownership of problems and their responsibility for solving
them.
 People evaluating their performance against their personal goals and
objectives.
 People actively seeking opportunities to enhance their competence,
knowledge and experience.

26
  People freely sharing knowledge and experience.
 People openly discussing problems and issues.

Principle 4—Process Approach

A desired result is achieved more efficiently when related resources and activities are
managed as a process.
A process is defined as "a sequence of steps through which inputs from suppliers are
converted into outputs for customers." All processes are directed at achieving one
goal or output. An effective process would be one where the results were those that
were required to fulfill the purpose of the organization. The organization exists to
create and satisfy customers and other interested parties; therefore the organization‘s
processes must serve the needs of these interested parties. There are different types
of processes in healthcare. These include:
 Clinical algorithms: The processes by which clinical deci
Information flow processes: The processes by which information is shared
across the different persons involved in the care
 Material flow processes: The processes by which materials (e.g., drugs,
supplies, food) are passed through the system
 Patient flow processes: The processes by which patients move through the
medical facility as they seek and receive care
 Multiple flow processes: Most processes are actually multiple flow
processes, whereby patients, materials, information, and others are involved
simultaneously in the same process of care. Processes perform exactly right
some of the time, yielding the results (outputs) expected of them. However,
processes may not perform exactly right all the time because things change,
including raw materials, worker morale, process parameters, customer
expectations, conditions of use, employee abilities, machine wear, legal
restrictions, the economy, the weather, etc. The processes that produce an
output are vulnerable to influence by many sources of variation, which are
often grouped into categories such as:
 Machine – e.g. speed variation, wear-related variation, lubrication schedule,
etc.
 Worker – e.g. skills, training, health, attitudes, etc.
27
  Methods – e.g. procedures and practices for operating the process
 Materials – raw materials (inputs) used in the process
 Measurement – variation in the measurement system
 Environment – e.g. temperature, humidity, and sometimes the
psychological environment of the workplace .A visual scheme portraying
these sources of variation is shown below in the fish-bone diagram, an
example of a cause-and-effect tool. In routine healthcare delivery, many
processes occur simultaneously and involve many professional functions in
the organization. Processes can cause inefficiencies due to problems that
occur in the execution or the transition of one step to the next. Inefficiency
in a process often results from unnecessary steps that add complexity, waste,
and extra work to a system, ultimately reducing the overall quality of care.
Processes also may have unclear and/or missing steps, and therefore require
clarification.

Since a process is as capable of producing wrong results as it is to produce right

results, processes need to be managed effectively for the required results to be
produced. Quality management recognizes that unclear, redundant, or incomplete
processes may be a source of problems in the delivery of quality care. Instead of
blaming the people implementing these processes for poor performance, quality
management activities involve people in the prevention, detection, and resolution of
problems within processes in order to improve the quality of care. The process
approach to management is about:

28
  Managing processes & ensuring that they have a clearly defined purpose and
objective that is based on the needs of the interested parties;

 Producing outputs that satisfy the needs and expectations of the stakeholders;
and

 Measuring, reviewing and continually improving process efficiency and

effectiveness.

Principle 5—System Approach to Management

―Identifying, understanding and managing a system of interrelated processes for a
given objective improve the organization's effectiveness and efficiency‖.
Quality management views all work in the form of processes and systems. A system
is:
 An arrangement of organizations, people, materials, and procedures that
together are associated with a particular function or outcome.
 A collection of interrelated, interdependent components or processes that act
in concert to turn inputs into some kind of outputs in pursuit of some goal
 ―A regularly interacting or interdependent group of items forming a unified
whole toward the achievement of a goal.‖ (The Association for Operations
Management Dictionary) Based on the above definitions, a system has two
primary features:
 It has a goal, and
 It has interactions among interdependent parts A system can be further
classified as (i) a subsystem, or (ii) a primary system. A primary system is
made up of subsystems. The subsystems come together to serve the ultimate
purpose of the primary system. A subsystem is a system in its own right, but
when aggregated with other systems under the umbrella of a primary system,
it‘s classified as a subsystem to clarify its relationship to the primary system.
The system approach recognizes that the behaviour of any part of a system
has some effect on the behaviour of the system as a whole. This implies that
when things don‘t seem to be going as expected, the effective manager
should first examine the systems and processes to determine what could be
causing the inefficiency, instead of quickly resorting to blaming people.
29
 Systems’ modeling (discussed in later modules) is an approach that a Health
Systems Manager can use to understand the interrelationships within a
system. As shown in the figure below, a system consists of inputs, processes,
and results, which include (outputs, outcomes & impacts).

(Inputs) (processes) (output)The (outcome) (Impact) Long-

Resources, Activities, products and Short-term & term effects on

tasks, actions services medium-term identifiable
needed to or work
undertake (deliverables) changes or population groups
performed to
activities to transform that result effects on produced by an
inputs into from the beneficiaries intervention
produce
specific
results completion of
outputs
activities

According to ISO 9000 (International Organization for Standardization), applying the

principle of system approach to management typically leads to:

 Structuring a system to achieve the organization's objectives in the most effective and
efficient way.

 Understanding the interdependencies between the processes of the system.

 Structured approaches that harmonize and integrate processes.

 Providing a better understanding of the roles and responsibilities necessary for

achieving common objectives and thereby reducing cross-functional barriers.

 Understanding organizational capabilities and establishing resource constraints prior to

action.

 Targeting and defining how specific activities within a system should operate.

 Continually improving the system through measurement and evaluation.

Principle 6—Continual Improvement

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Continual improvement should be a permanent objective of the organization.
Quality management is based on the premise that there is always room for
improvement. Customer needs and requirements keep changing, technology and
methods change, legislation changes, and all these and other things necessitate that
an organization continually improves to continue being relevant. Any improvement
is a change. As such, a health systems manager must be able to manage change
effectively in order for the quality management system (and therefore the
organization) to be successful. ISO 9000:2000 defines continual improvement as a
recurring activity to increase the ability to fulfill requirements. Performance,
methods and targets are the three key areas where improvement is necessary for
organizations to achieve and sustain success. Improvement can be targeted at
specific tasks or activities, specific processes, specific systems or to the whole
organization, each requiring a different scale of improvement. At each level,
continual improvement aims at improving efficiency and improving effectiveness.
Continual improvement can be achieved by:
1. Making all the processes effective, efficient, and adaptable;
2. Anticipating changing customer needs;
3. Eliminating waste and rework;
4. Investigating and eliminating activities that do not add value to the product or
service;
5. Using benchmarking to improve competitive advantage;
6. Innovating to achieve breakthroughs;
7. Maintaining constructive dissatisfaction with the present level of performance;
8. Encouraging continual learning, development and capacity building;
9. Incorporating lessons learned into future activities; and
10. Using technical tools and approaches to measure performance and identify areas
for improvement, among others. There are several models, approaches and
techniques that can be used for quality improvement, which will be discussed in the
module on Quality Improvement. According to ISO 9000 (International Organization
for Standardization), applying the principle of continual improvement typically leads
to:

31
  Employing a consistent organization-wide approach to continual improvement of the
organization's performance.
 Providing people with training in the methods and tools of continual improvement.
 Making continual improvement of products, processes and systems an objective for
every individual in the organization.
 Establishing goals to guide, and measures to track, continual improvement.
 Recognizing and acknowledging improvements.

Principle 7—Factual Approach to Decision Making

Effective decisions are based on the analysis of data and information.
Quality management emphasizes the need to improve processes by understanding
how they function. This principle promotes decision-making based on accurate and
timely data, rather than on assumptions. Understanding and using data also means
understanding variation: whether variation is a normal part of the process or whether
it indicates a real change. In quality management, data are used to analyze processes,
identify problems, test solutions, and measure performance. Data are important
because they ensure objectivity. For example, the collection and analysis of data
allow us to develop and test hypotheses. Comparing data from before and after a
change can allow us to verify that the changes have actually led to improvements.
Specifically, measurement and data are used in QM to:
 Identify opportunities for improvement to initiate QM efforts
 Detect and assess problems
 Verify possible causes of problems
 Inform decision making
 Show if a quality intervention yielded improvement and by how much
Monitor processes over time to see if the change or improvement is maintained The degree to
which data are collected and analyzed varies with different quality management tasks. Data
may be quantitative in nature, such as service statistics, or qualitative, such as customer
feedback or comments of healthcare workers. According to ISO 9000 (International
Organization for Standardization), applying the principle of factual approach to decision
making typically leads to:
 Ensuring that data and information are sufficiently accurate and reliable.
32
  Making data accessible to those who need it.
 Analyzing data and information using valid methods.
 Making decisions and taking action based on factual analysis, balanced with
experience and intuition.

Principle 8—Mutually Beneficial Supplier Relationships

―An organization and its suppliers are interdependent and a mutually beneficial
relationship enhances the ability of both to create value.‖

Organizations depend on their suppliers in order to satisfy the needs and expectations
of their customers, on whom they depend. Suppliers provide the materials, resources
and services that are crucial inputs in the production of products and services for an
organization‘s external customers. Prior to the 1980s, procurement decisions were
typically based on price, thereby awarding contracts to the lowest bidder, regardless
of q uality. Today, strategic partnerships and alliances are being formed between
suppliers and organizations, thus reducing the costs of acquiring new suppliers.
Partnering is a long -term commitment between two or more organizations for the
purpose of achieving specific business goals and objectives by maximizing the
effectiveness of each participant‘s resources. The relationship is based upon trust,
dedication to common goals and objec tives, and an understanding of each other‘s
expectations and values. A partnering relationship has three key elements: long -term
commitment, trust, and shared vision. The benefits of partnering include improved
quality, increased efficiency, lower cost, in creased opportunity for innovation, and
the continuous improvement of products and services.
An organization and its suppliers are interdependent, and a mutually beneficial
relationship enhances the ability of both to create value.

Characteristics of service quality.

33
 a. Time & Timeliness - customer-waiting time, completed on time
b. Completeness - customer gets all they ask for
c. Courtesy - treatment by employees and or managers
d. Consistency - same level of service for all customers
e. Accessibility & Convenience - ease of obtaining service
f. Accuracy - performed right every time
g. Responsiveness - reactions to unusual situations

The Eight Elements Of TQM

Eight elements are key in ensuring the success of TQM in an organization.

Total Quality Management is a management approach that originated in the 1950′s and has
steadily become more popular since the early 1980′s. Total Quality is a description of the
culture, attitude and organization of a company that strives to provide customers with
products and services that satisfy their needs. The culture requires quality in all aspects of the
company‘s operations, with processes being done right the first time and defects and waste
eradicated from operations.

To be successful implementing TQM, an organization must concentrate on the eight key

elements:

1. Ethics

2. Integrity

3. Trust

4. Training

5. Teamwork

6. Leadership

7. Recognition

8. Communication

This paper is meant to describe the eight elements comprising TQM.

34
 Key Elements
TQM has been coined to describe a philosophy that makes
quality the driving force behind leadership, design, planning,
and improvement initiatives. For this, TQM requires the help of
those eight key elements. These elements can be divided into
four groups according to their function. The groups are:

I. Foundation – It includes: Ethics, Integrity

and Trust.
II.Building Bricks – It includes: Training, Teamwork and Leadership.
III.Binding Mortar – It includes: Communication.
IV. Roof – It includes: Recognition.

Foundation

TQM is built on a foundation of ethics, integrity and trust. It fosters openness, fairness and
sincerity and allows involvement by everyone. This is the key to unlocking the ultimate
potential of TQM. These three elements move together, however, each element offers
something different to the TQM concept.

1. Ethics – Ethics is the discipline concerned with good and bad in any situation. It is a two-
faceted subject represented by organizational and individual ethics. Organizational ethics
establish a business code of ethics that outlines guidelines that all employees are to adhere to
in the performance of their work. Individual ethics include personal rights or wrongs.

2. Integrity – Integrity implies honesty, morals, values, fairness, and adherence to the facts
and sincerity. The characteristic is what customers (internal or external) expect and deserve to
receive. People see the opposite of integrity as duplicity. TQM will not work in an atmosphere
of duplicity.

3. Trust – Trust is a by-product of integrity and ethical conduct. Without trust, the framework
of TQM cannot be built. Trust fosters full participation of all members. It allows
empowerment that encourages pride ownership and it encourages commitment. It allows
decision making at appropriate levels in the organization, fosters individual risk-taking for
continuous improvement and helps to ensure that measurements focus on improvement of

35
process and are not used to contend people. Trust is essential to ensure customer satisfaction.
So, trust builds the cooperative environment essential for TQM.

II. Bricks
Basing on the strong foundation of trust, ethics and integrity, bricks are placed to reach the
roof of recognition. It includes:

4. Training – Training is very important for employees to be highly productive. Supervisors

are solely responsible for implementing TQM within their departments, and teaching their
employees the philosophies of TQM. Training that employees require are interpersonal skills,
the ability to function within teams, problem solving, decision making, job management
performance analysis and improvement, business economics and technical skills. During the
creation and formation of TQM, employees are trained so that they can become effective
employees for the company.

5. Teamwork – To become successful in business, teamwork is also a key element of TQM.

With the use of teams, the business will receive quicker and better solutions to problems.
Teams also provide more permanent improvements in processes and operations. In teams,
people feel more comfortable bringing up problems that may occur, and can get help from
other workers to find a solution and put into place. There are mainly three types of teams that
TQM organizations adopt:

A. Quality Improvement Teams or Excellence Teams (QITS) – These are temporary teams
with the purpose of dealing with specific problems that often re-occur. These teams are set up
for period of three to twelve months.
B. Problem Solving Teams (PSTs) – These are temporary teams to solve certain problems
and also to identify and overcome causes of problems. They generally last from one week to
three months.
C. Natural Work Teams (NWTs) – These teams consist of small groups of skilled workers
who share tasks and responsibilities. These teams use concepts such as employee involvement
teams, self-managing teams and quality circles. These teams generally work for one to two
hours a week.

6. Leadership – It is possibly the most important element in TQM. It appears everywhere in

organization. Leadership in TQM requires the manager to provide an inspiring vision, make
strategic directions that are understood by all and to instill values that guide subordinates. For
36
TQM to be successful in the business/organisation, the supervisor must be committed in
leading his employees. A supervisor must understand TQM, believe in it and then demonstrate
their belief and commitment through their daily practices of TQM. The supervisor makes sure
that strategies, philosophies, values and goals are transmitted down throughout the
organization to provide focus, clarity and direction. A key point is that TQM has to be
introduced and led by top management. Commitment and personal involvement is required
from top management in creating and deploying clear quality values and goals consistent with
the objectives of the company and in creating and deploying well defined systems, methods
and performance measures for achieving those goals.

III. Binding Mortar

7. Communication – It binds everything together. Starting from foundation to roof of the
TQM house, everything is bound by strong mortar of communication. It acts as a vital link
between all elements of TQM. Communication means a common understanding of ideas
between the sender and the receiver. The success of TQM demands communication with and
among all the organization members, suppliers and customers. Supervisors must keep open
airways where employees can send and receive information about the TQM process.
Communication coupled with the sharing of correct information is vital. For communication
to be credible the message must be clear and receiver must interpret in the way the sender
intended.

There are different ways of communication such as:

A. Downward communication – This is the dominant form of communication in an
organization. Presentations and discussions basically do it. By this the supervisors are able to
make the employees clear about TQM.
B. Upward communication – By this the lower level of employees are able to provide
suggestions to upper management of the affects of TQM. As employees provide insight and
constructive criticism, supervisors must listen effectively to correct the situation that comes
about through the use of TQM. This forms a level of trust between supervisors and
employees. This is also similar to empowering communication, where supervisors keep open
ears and listen to others.
C. Sideways communication – This type of communication is important because it breaks
down barriers between departments. It also allows dealing with customers and suppliers in a
more professional manner.

37
IV. Roof
8. Recognition – Recognition is the last and final element in the entire system. It should be
provided for both suggestions and achievements for teams as well as individuals. Employees
strive to receive recognition for themselves and their teams. Detecting and recognizing
contributors is the most important job of a supervisor. As people are recognized, there can be
huge changes in self-esteem, productivity, quality and the amount of effort exhorted to the
task at hand. Recognition comes in its best form when it is immediately following an action
that an employee has performed. Recognition comes in different ways, places and time such
as,

 Ways – It can be by way of personal letter from top management. Also by award
banquets, plaques, trophies etc.

 Places – Good performers can be recognized in front of departments, on performance

boards and also in front of top management.

 Time – Recognition can given at any time like in staff meeting, annual award
banquets, etc.

TQM Implementation Approaches

You can't implement just one effective solution for planning and implementing TQM concepts
in all situations. Below we list generic models for implementing total quality management
theory:
1- Train top management on TQM principles.

2- Assess the current: Culture, customer satisfaction, and quality management system.
3- Top management determines the core values and principles and communicates them.

4- Develop a TQM master plan based on steps 1,2,3.

5- Identify and prioritize customer needs and determine products or service to meet those
needs.
6- Determine the critical processes that produces those products or services.
7- Create process improvement teams.
8- Managers supports the efforts by planning, training, and providing resources to the team.

38
9- Management integrates changes for improvement in daily process management. After
improvements standardization takes place.
10- Evaluate progress against plan and adjust as needed.

11- Provide constant employee awareness and feedback. Establish an employee reward/
recognition process.

You have come to the end of this lecture. Having worked through this lecture,
you should be able to state the basic elements TQM in your organization continously.

Now take a break the answer the questions below.

1. Explain the importance of well established TQM systems in healthcare systems
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

1. Crosby, P. B. Management gets the quality it causes. Florida: Philip Crosby Associates
II, Inc.
2. Gehres, R. (2001). Quality is free when leadership picks up the tab. CPCU Society
Leadership & Managerial Excellence Interest Group.

39
 Lecture 4
Quality Management

Lecture Overview
Welcome to lecture five. In this lecture, we shall discuss about quality management in
healthcare organizations. Quality Management is the core business of all managers in
healthcare systems.They should apply the principles of quality management always and
continously

By the end of this lecture, you should be able to:

i. Discuss quality management systems

What is quality management all about?

Two aspects of quality:

1. Features: more features that meet /exceed customer needs = higher quality

2. Freedom from trouble: fewer defects = higher quality

“High quality depends primarily on good management, not worker motivation”.

In most instances workers within a health care system have inherent personal pride in the
work they do. The achievement of a particular level of quality is more a result of the systems
under which they work than a problem with commitment or motivation. Quality is a function
of process. Process depends on the systems by which the organization operates. These systems
are directly structured and controlled by management. Therefore, the starting place for quality
in any organization is top management. Organizations that attempt to establish quality by
focusing exclusively on the end product and front-line workers, while ignoring the underlying
management systems and their critical impact on quality, will fail to achieve high quality and
the full range of secondary cost benefits it brings over time.

40
The establishment of quality in an organization is a top-down process. Quality should
therefore be a major concern of the chief executive officer of the corporation. While a
committee or some other officer may be assigned day-to-day oversight of specific quality-
monitoring operations, the CEO should have a direct, day-to-day responsibility to manage that
process

A quality organization recognizes that most workers are motivated by pride in their job, and
builds systems that allow them to express that pride in terms of high quality. It recognizes that
front-line workers best understand the problems involved in serving customers and producing
health care products. It recognizes that most workers are already motivated, and only need an
outlet for their innovative ideas. Finally, it recognizes that attitudes held by employees
regarding the organization are often transferred directly to customers as health care services
are delivered. If an employee believes that the organization strongly supports high quality,
then this viewpoint will be conveyed to the customers served by the employee. All workers in
the organization:
• Should know that they can have a direct impact on the structure of the systems used by the
organization (that is, their concerns will be promptly and competently addressed)
• Should not fear overt or covert reprisal for criticizing the systems used by the organization
• Should he encouraged by the structure and operation of the organization to be oriented to the
needs of their true customers rather than to those of their supervisors
Ultimately, quality is delivered by the employee who builds the product or interacts with the
customer. "At the interface" employees have the best understanding of customers' needs and
expectations on an individual basis and are directly responsible for meeting them.
The remaining structure of the organization—including management—exists to support front-
line employees in their critical rote. Successful organizations find ways to stimulate, test, and
implement the quality improvement ideas that their front-line employees generate. They also
recognize that every employee of the organization is, in one sense, a front-tine employee—it
is just that managers work on the "front-line" of producing management systems, rather than
the traditional products envisioned by the company's leaders. The same quality principles that
apply to improvements in operational processes may also be applied to achieve improvements
in management processes.
Management's principal tasks are to:

41
1. Commit
• Demonstrate constancy of purpose
• Imbue the organization with a stable long-term strategic vision
• Establish an organization-wide quality mission statement
• Show top-down management commitment to quality in actions as well as words (quality
starts with the board and CEO)
2. Understand
• Know the business of the company (sometimes called substantive or fundamental
knowledge); management must have hands-on experience with the processes and products
upon which the organization depends for its continued existence
• Learn the following principles of quality measurement, and teach them throughout the
organization:
Specification, data collection, and process measurement
The nature of random ("common") versus attributable ("specific") variation
Enumerative versus analytic techniques
3. Identify
• Customers, products, and processes (i.e., generate valid specifications)
4. Educate and train
• Employees, in their jobs and in quality principles
• Customers (at all levels, as defined above), in order to guide their expectations
5. Measure
• Customer expectations, process outputs, and outcomes
6. Manage
• Eliminate quality waste
• Increase productivity
7. Test
• Use the Shewhart cycle (PDCA) and front-line employees to constantly improve the
organization‘s production and management processes
8. Establish appropriate incentives
• Most improvement is team based; reward teams, not individuals

Quality management principles

Principle 1—Customer Focused Organization

42
Organizations depend on their customers and therefore should understand current
and future customer needs, meet customer requirements and strive to exceed
customer expectations.
Principle 2—Leadership
Leaders establish unity of purpose and direction of the organization. They should
create and maintain the infernal environment in which people can become fully
involved in achieving the organization's objectives.

Principle 3—Involvement of People

People at all levels are the essence of an organization, and their full involvement
enables their abilities to be used for the organization's benefit.

Principle 4—Process Approach

A desired result is achieved more efficiently when related resources and activities are
managed as a process.

Principle 5—System Approach to Management

Identifying, understanding and managing a system of interrelated processes for a
given objective improve the organization's effectiveness and efficiency.

Principle 6—Continual Improvement

Continual improvement should be a permanent objective of the organization.

Principle 7—Factual Approach to Decision Making

Effective decisions are based on the analysis of data and information.

.Principle 8—Mutually Beneficial Supplier Relationships

An organization and its suppliers are interdependent, and a mutually beneficial
relationship enhances the ability of both to create value.

43
 Activity 4.1
Critique the role of quality manager in the operationalization of quality
management
________________________________________________________
________________________________________________________
________________________________________________________

Using the Principles of Quality Management

Now that you understand the principles of quality management, how can you apply them to
ensuring a high-performing health system? The principles can be used in validating the design
of processes, in validating decisions, in auditing system and processes. For instance, you can
look at a process and ask:
 Where is the customer focus in this process?
 Where in this process are there leadership, guiding policies, measurable objectives and
the environment that motivate the workforce to achieve these objectives?
 Where in this process is the involvement of people in the design of the process, the
making of decisions, the monitoring and measurement of performance and the
improvement of performance?
 Where is the process approach to the accomplishment of these objectives?
 Where is the systems‘ approach to the management of these processes, the
optimization of performance, the elimination of bottlenecks and delays?
 Where in the process are decisions based on fact?
 Where is there continual improvement in performance, efficiency and effectiveness of
this process?
 Where is there a mutually beneficial relationship with suppliers in this process?
Also you can review the actual measures used for assessing leadership, customer
relationships, personnel, processes, systems, decisions, performance, and supplier
relationships for alignment with the principles.
Reasons for Adopting a Quality Management Approach
Why should a health care institution bother with implementing a quality management system?
What are the benefits of adopting a quality management approach? There are several reasons
to adopt a quality management approach and improve quality:
 It safeguards clients‘ & staff‘s health
44
  It leads to savings through more efficiency, less repeated work, and less waste
 It helps to add service features that can attract new customers (clients, donors, etc.)
 It helps to maintain existing strengths, which all organizations have
 Understanding that there is always room for improvement, no matter how good
services are
 Working in an organization known for quality builds the morale of staff

Barriers to Adopting a Quality Management Approach

Activity 4.2
Explain barriers that can be experienced when institutionlizing
quality management in health care systems
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Core Quality Management Activities

What exactly does the implementation of a quality management system entail? What activities
are carried out? The QA Project uses the term ―quality assurance‖ where I generally use
―quality management‖ (although in reality, quality management encompasses more aspects
than the QA activities below – think more along the lines of the framework for
institutionalizing quality you looked at above). In the QAP approach, three core quality
assurance activities (each with a range of sub-activities) have been identified
 Defining quality
 Measuring quality
 Improving quality

45
The greatest impact on quality of care can be achieved only when all three activities are
implemented in a coordinated fashion. The triangle shape appropriately suggests that there is
no "correct" or even optimal sequence to initiate QA activities. The order will depend on the
capacity of the healthcare system or facility and the interest of the providers. In practice, QA is
a cyclical, iterative process that must be applied flexibly to meet the needs of a specific
program or organization. The three key processes above are based on the Juran Trilogy which
comprises three managerial processes:
 Quality planning (referred to as quality design in the QAP triangle)
 Quality control (referred to as quality measurement in the QAP triangle)
 Quality improvement

46
 Congratulations. You have come to the end of this lecture.In this lecture,we have
discussed on the importance quality management principles and that there are various
challenges when institutionalizing change. You should now be able to assess challenges faced
healthcare systems when implementing change and the intervetions you can propose to
overcome. Remember to use models to help you understand the main problem

47
1. Make observations in your healthcare system and critique the extent of quality management
institutionalization
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
2. Explain the application of the aspects of the principles of quality management
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
__________________________________________________________________________

That was a long session! You should now be able to work on your assignment.

1. ASQ. (2009). Overcoming barriers to quality improvement. In C. M. Borror (Ed.), The

certified quality engineer handbook. Milwaukee: American Society for Quality,
Quality Press.
2. Crosby, P. B. (1988).Quality Without Tears: The Art of Hassle-Free Management.
New York City: New American Library

48
 Lecture 5
Quality Management Systems

Lecture Overview
Welcome to this lecture on quality management Systems of ISO 9000
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is
normally carried out through ISO technical committees. Each member body interested in a
subject for which a technical committee has been established has the right to be represented
on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

By the end of this lecture, you should be able to:

i. Describe various models of quality management

The adoption of a quality management system is a strategic decision for an organization that
can help to improve its overall performance and provide a sound basis for sustainable
development initiatives.
The potential benefits to an organization of implementing a quality management system based
on this International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system
requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.

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Evolution of Quality Management Systems

The development of Quality management is clustered in 4 stages:

1. Quality Inspection (1920s)

2. Quality Control (1950s)

3. Quality Assurance (1970s)

4. Total Quality Management (1980s)

ISO System and Quality Management System Concept

 Who is ISO
 How ISO started
 What ISO has done
 ISO Membership
 Member Bodies

 Correspondent Bodies

 Subscriber Bodies

 How ISO works

 Standards identification

50
 Evolution of ISO 9000 standards

BS 5750:1979

ISO adopts BS 5750 as the basis for ISO

standard

ISO 9001:1994 – Minor

updates

ISO 9001:2000 – Major update - proce

ISO 9001:2008 – Mino

ISO 9001:2015
update

Structure of management system standards

 In order to seek consistency and compatibility across all the management system
standards, it is the intent of ISO to have all management systems standards having the
same basic structure, format and wording.

 To address this issue ISO has published an Annex SL which describes the framework
for a generic management system.

The structure of all ISO management system standards shall be as follows:-

0. Introduction
1. Scope
2. Normative references

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 3. Terms and Definitions
Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation (discipline specific requirements)
9. Performance Evaluation
10. Improvement

Activity 5.1
Explain the application ISO 9000 standards in an organization that is
operating under the quality management system.
________________________________________________________
________________________________________________________

Benefits
1. Avoid inconsistencies, duplications and misunderstanding of standards.
2. The management systems standards will have the same look and feel
3. Easier to implement multiple management systems
4. Auditors and implementers will have a core set of generic requirements that need to be
addressed no matter the discipline. This shall make work easier for both implementers
and auditors.
The ISO 9000 Family
Four Primary standards

 ISO 9000:2015, QMS – Fundamentals and Vocabulary

 ISO 9004:2009, Managing for the sustained success of an organization - A quality

management approach

 ISO 19011:2011, Guidelines for auditing management systems

 ISO 9001:2015, QMS – Requirements

52
Benefits of Implementing a QMS

 Clarity in objectives and identification of opportunities by assessing the context of the

organization

 Customer focus

 Efficiency - all your processes will be aligned and understood by everyone in the
organization.

 Meet the necessary statutory and regulatory requirements

 Identify and address the risks associated with your organization

You have now come to the end of this lecture.

1.Explain how you can apply the use of the QMS to improve the quality of service in your
organization.
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

1. International Standards ISO 90001 (2015), 2015-09-15

53
54
 Lecture 6
Quality Management Models

Lecture Overview
Welcome to this lecture on quality management models.We shall discuss the application of
various models of quality management.These models help us understand how to about
managing quality in a systematic manner.

By the end of this lecture, you should be able to:

ii. Describe various models of quality management

Quality models

1. The Kenya Quality Model For Health

What is Kenya Quality Model for Health (KQMH ) ?
This is a conceptual framework for an integrated approach to improved quality of healthcare.
It provides a framework for: holistically and systematically addressing a range of
organizational quality issues with the main aim of delivering positive health impacts.
KQMH aims at :
 improving adherence to standards and guidelines based on evidence-based medicine
 improving structure – process – outcome by applying quality principles and tools
 satisfying patient / client needs in a culturally appropriate way

55
Evidence-Based Medicine
Doing the right thing the right way: Using best available evidence on disease
patterns, diagnosis and treatment and using Standards and Guidelines that are proven to be:
effective,efficient, affordable and accepted

56
 KQMH principles
This model is applying the principles of quality maangement as follows:
1. Systems approach to management
2. Process orientation
3. Leadership to provide guidance and motivation to quality improvement
4. Customer orientation (external and internal)
5. Involvement of people and stakeholders
6. Continuous quality improvement
7. Evidence-based decision making

1. Systems Approach
Identifying, understanding and managing interrelated steps and processes as a system
contribute to the organization‘s effectiveness and efficiency in achieving its objectives.
Example:
• Without providing supplies, measures to motivate staff may have no effect.
• Processes (adherence to guidelines) cannot be improved without availability of required
inputs
• Patient satisfaction survey results need to be linked to QI processes
2. Process Orientation
• Addressing all steps required to achieve a desired result
• Managing activities and related resources as a process
Example:
• Objective to reduce time spent at OPD (Entry – Registration – Examinations –
Treatment – Discharge) i.e. think of the process and stations from the time client enters up to
discharge
• Sterilisation:
Think of the whole chain of sterilisation, packing, storage and movement of sterilized
equipment
3. Leadership
Leadership is a process that provides guidance and motivation to improve quality care.
Leaders should—
• Create unity in the objective and the directions of the organization

57
• Maintain a team environment in which staff can become fully involved in achieving the
organization‘s objectives
• Demonstrate commitment to the organization
• Help to overcome workers natural resistance to change and to convince staff that quality is
important

Qualities:
• Be a personal and professional
example
• Motivate staff in a difficult work environment
• Have good communication skills
4. Customer Orientation
Organizations depend on their customers and therefore should—
• understand current and future needs
• meet customer requirements
• strive to exceed expectations
• build up a relationship and show commitment
• provide feedback, M&E
• display and communicate patients‘ rights
4. Customer Orientation
Example:
• Assess the needs of customers
• Some female patients may prefer to be seen by a female health worker
• Be friendly and greet cheerfully, referring to patient‘s names
5. Involvement of People
• People of all levels (staff, professionals and managers)
•People are the essence of an organization
•Their full involvement enables their abilities to be used for the organization‘s benefit
• Other stakeholders
•Co-ordination and co-operation
Example:
• Staff meetings help reveal problems that may otherwise not be known to the in-charges
• Involve community for outreach activities

58
6. Continuous Quality Improvement (CQI)
• Continuous improvement of the organization and its overall performance should be the
permanent objective of the organization. This is achieved through the 5S–Kaizen (CQI)
approach. This approach aims to improve working environment and create foundation of
quality, productivity and safety improvement.

7. Evidence-Based Decision Making

Effective decisions are based on the analysis of data and information.
Therefore, we need to—
•Ensure that data and information are available, sufficiently accurate and reliable
•Make data accessible to those who need it
•Analyze data by using valid methods
•Make decisions and take action based on facts balanced with experience and intuition
Example:
• Using records for planning outreach activities, buying supplies, etc.
• Using results from staff satisfaction survey for appropriate human resource management
measures
2. 5S- KAIZEN GEMBA
What is 5S in Quality Management?
5S is short for: Sort, Set in Order, Shine, Standardize and Sustain.5S represents 5 disciplines
for maintaining a visual workplace (visual controls and information systems).These are
foundational to Kaizen (continuous improvement) and a manufacturing strategy based "Lean
Manufacturing" (waste removing) concepts.5S is one of the activities that will help ensure our
organization‘s survival.

1. Sort - All unneeded tools, parts and supplies are removed from the area

2. Set in Order - A place for everything and everything is in its place

3. Shine - The area is cleaned as the work is performed

4. Standardize - Cleaning and identification methods are consistently applied

5. Sustain - 5S is a habit and is continually improved

What is KAIZEN in Quality Management?

59
KAIZEN means improvement. Moreover it means continuing improvement in personnel
life, home life, social life and working place.When applied to the workplace KAIZEN
means continuing improvement involving everyone – managers and workers alike.

Why KAIZEN?

Elements of KAIZEN

 Appreciate the process, not the result (Always appreciate ―human effort‖)

 Encourage ‗Team Work‘ for problem solving and decision making;

 Go search for the problem. Do not let it come to you;

 Identify and eliminate waste;( anything that doesn’t add value;changing form
fit or function and anything that doesn’t help meet customer requirements and
anything our customers would not be willing to pay us to do

 Deliver best service possible. Make the workers aware of productivity and quality;
and

 Clean, orderly and safe working environment.

Reasons of using KAIZEN

 Lower Cost;

60
  Immediate Results;

 Less Waiting;

 Energize Employees;

 Improve Productivity; and

 Creativity and Innvation

Benefits

 Process Improvement;

 Short Time;

 Zero / Less Defect;

 Human Resource Development; and

 Profits and Sharing.

Benefits for Organization

 Eliminates hidden costs

 Service to customer will be highest quality, lowest cost and shortest time possible

 Major changes quickly and minimum loss of production time

Benefits for you

 Can work with ease and comfort by reducing delay and wasted motion

 You think what you do and contribute ideas

 Work as a team

Stages of Kaizen

 Planning and Preparation

 Event

 Report out

 Follow-up

61
 What is Kaizen?
Kaizen
• is a tool to rapidly improve work as part of the PDCA cycle
• is a tool for implementing Rule 4 of the Rules-In-Use
• goals must align with the business objectives

2. Design 3. Do
(Plan)

1. Customer
Needs
5. Improve 4. Feedback
(Act) (Check)

Meeting Customer Needs:

• Internal/External
• Shareholders
• Employees
• Community

Ten basic rules for practicing kaizen in the workplace

 Discard conventional rigid thinking about production / service;

 Think how to do it, and not why it cannot be done;

 Do not make excuses. Start by questioning current practices;

 Do not seek perfection. Do it right away even if for only 50% of target;

 Correct mistakes at once;

 Do not spend money for kaizen;

 Wisdom is brought out when faced with hardship;

 Ask ‗Why?‘ five times and seek the root cause;

 Seek the wisdom of ten people rather the knowledge of one; and

 Remember that opportunities for Kaizen are infinite.

62
 Activity 6.1
How can you apply the 5s-KAIZEN model in your healthcare system?
________________________________________________________
________________________________________________________

3. PDCA cycle,

Plan – Do – Check – Act vs Plan – Do – Study – Act

This model has been termed as simple because it‘s a very basic, 4-phase cycle and it is
powerful because it follows the scientific method of essentially understanding a problem,
developing potential solutions, testing the solution and analyzing the results. PDCA, or
PDSA are the same thing, and arose from an issue of translation that occurred after the
work had been introduced and refined in Japan. For our purposes, however, it‘s essentially
a matter of semantics.

1. Plan- The purpose of this phase is to investigate the current situation, fully understand
the nature of any problem to be solved, and to develop potential solutions to the
problem that will be tested. There are several steps involved in the ―Plan‖ phase, and
the first is to identify all of the opportunities for quality improvement, and prioritize
63
 them. We can‘t do everything at once, and we have tools to help us, as a group,
identify what needs to come first. An aim statement is essentially a specific,
measurable objective, that answers the questions what, when, how much and for whom
are we looking to improve? Data to be collected can take many forms. The important
thing in this step is to carefully consider the measurable objective we set in the aim
statement. We need to ensure that we can measure any improvements, and therefore
we need to think carefully about baseline data. For example, if we‘re seeking to
improve the number of adults who receive an annual influenza vaccine, we‘d need to
know the percentage of adults who received it this year. This is a critical step in quality
improvement – one where we will carefully examine the problem we choose and
identify the root cause. Another name for this step is to conduct a root cause analysis.
A popular tool for this step is the use of a cause-and-effect diagram, also known as a
fishbone diagram. Once we‘ve identified the root cause, it‘s time to determine what
interventions to test – what improvement or improvements to try out. We‘ll come up
with improvements, and consider their costs and impacts. We‘ll also think about what
could go wrong, and countermeasures we can take to minimize problems and
maximize our chance of success.

2. Do- The ―Do‖ phase is as it sounds – just do it! This marks the implementation of the
improvement, and during this phase it‘s important to not only collect and document
data around the improvement, but also to document the other things listed. QI efforts
generate many learnings and it‘s important to capture these.

3. Check/Study- This phase involves analyzing the effect of the intervention. Compare
the new data to the baseline data to determine whether an improvement was achieved,
and whether the measures in the aim statement were met. And again – document!

4. Act- This phase marks the culmination of the planning, testing, and analysis regarding
whether the desired improvement was achieved as articulated in the aim statement, and
the purpose is to act upon what has been learned. If the improvement was achieved,
it‘s time to adopt it as standard practice. If the improvement wasn‘t quite achieved, but
we feel it was close, we will adapt our ―test,‖ and either extend the testing period or
revise something and repeat the testing cycle. If the improvement simply wasn‘t
achieved, we need to start back at the planning phase and reconsider the problem at
hand.Once we have adopted and standardized the improvement, we still need to
monitor the situation and make sure the improvement holds.
64
You have now come to the end of this lecture. In this lecture, we have discussed various
models of quality management. These models are generic and so easily applied in our
helathcare systems.

1.Explain how you can apply the various models of quality management discussed above in
your healthcare organization.
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

1. 1. COPE Handbook: A process of improving Quality in Health Services,

EngenderHealth

2. Kenya Quality Model for Health manual

3.
65
 LECTURE 7
Cost of Quality

Lecture Overview
Welcome to lecture this lecture on qaulity and cost.We are curious to know whether quality is
expensive and if so how much it costs.

By the end of this lecture, you should be able to:

Describe the relationship of cost and quality

Quality costs are the costs associated with preventing, finding, and correcting defective work.
Many of these costs can be significantly reduced or completely avoided.
A quality cost is considered to be any cost that the company would not have incurred if the
quality of the product or service were perfect.

 Quality costs are defined as costs associated with non-achievement of product/service

quality. In simple terms, quality cost is the cost of poor products/services.

 The cost of poor quality can add to other costs such as design, production,
maintenance, inspection, sales, etc. Quality costs cross department boundaries by
involving all activities of the organization – marketing, purchasing, design,
manufacturing, service, etc.

66
 The price of nonconformance (Philip Crosby) or the cost of poor quality (Joseph
Juran), the term 'Cost of Quality', refers to the costs associated with providing poor
quality product or service.

 Phillip B. Crosby (Quality is free . . . ):The system for causing quality is prevention,
not appraisal – Quality is Free.The performance standard must be Zero Defects, not
"that's close enough"The measurement of quality is the Price of Non-
conformance.Cost of quality is only the measure of operational performance.―Quality
is free. It‘s not a gift, but it is free. What costs money are the unquality things -- all the
actions that involve not doing jobs right the first time.‖

 Total quality costs are the sum of prevention costs, appraisal costs, and internal and
external failure costs.

Total Quality Management (TQM)

Customers will seek Improved quality that exceeds

out the highest quality customer expectations will
product. generate more revenues that
exceed the cost of quality.

Therefore,
quality is
“free”.
Total Quality Management - Spring 2010 - IUG 8

67
Quality costs increase over
time
Liability costs
Failure Costs

Failure found by customer

Field repair costs

Failure found at installation

Failure found at final inspection

Failure found at onset of manufacture
Failure found during design phase
Prevention Costs

Time when failure found

Cost of Quality

Hidden Costs of Poor

Quality
Reprocessing
Customer returns
Rejects
Warranty expenses

Lost sales Loss of goodwill

Overtime to correct errors
Process downtime
Extra inventory Delays
Premium freight costs Extra process capacity
Extra inventory

Cost of Quality

 Quality costing is one of the tools

◦ to provide initial assessments and hard evidence that improvement is needed or

had been made

◦ To monitor the effectiveness of quality improvement initiatives

68
 ◦ To be used in a generic term by senior management, shareholders and financial
institutions, so that they can readily understand implication of quality in the
term of money

Benefits of quality costing

 Greater accuracy in the evaluation and forecasting of resource use

 Justification for investment in the prevention and appraisal of failures

 Ability to cost and compare performance across all departments functions and
activities

 Identification and prioritization of activities, processes and departments in terms of

corrective action, investment, or quality improvement initiatives

 Ability to set cost-reduction targets and then to measure and report progress

 Ability to produce ―local‖ data which improves understanding of resource utilization

objectives and targets at all levels throughout the company

 Provision of data to support formal quality management system (including, especially;

those based upon the ISO9000)

 Enable decisions about quality to be made in an objective and systematic manner

 Promoting TQM and a company-wide quality improvement culture

Difficulties in using quality costing

 Management have not believed in the possibilities of improvement

 Quality costing is demanding

◦ It requires a lot of data of each activity related to quality

◦ Other limitations

◦ Does not resolve quality problems

◦ Does not provide specific actions

◦ vulnerable to short-term mismanagement

◦ difficult to match effort and accomplishment

◦ subject to measurement errors

69
 ◦ may neglect important or include inappropriate costs

Steps in implementing quality cost

1. Involve accountants right from the start

2. Decide purpose and objectives

3. Decide how to deal with overheads

4. Distinguish between basic work and quality related activities

5. Collection data which offers the prospect of real gains

6. Start by examining failure costs

7. Evaluate the costs of inspection

8. Analyze and use the data

9. Collecting and reporting quality cost data

Assessing Cost and Quality

Is quality expensive?
Is it worth it implementing a quality management system?
Does it make a difference?
Does it add any value?
According to Crosby, ―The only performance measurement is the cost of quality, which is the
expense of nonconformance‖ and ―quality is free” (Crosby, 1979). What costs money is
failure to do things right the first time. Juran (1951) agrees in his definition of quality costs as
―the sum of all costs that would disappear if there were no quality problems‖. Poor quality is
care that falls short of customer expectations. The cost of poor quality is equivalent to the
time and money spent on something that does not help the client and is the cost of not
doing things right the first time and having to do them over. Waress, Pasternak, and Smith
(1994) describe this idea by saying that ―costs associated with quality are those costs that
would not be expended if quality was perfect.‖ The cost of quality (COQ) system includes:
1. Costs incurred in achieving/maintaining quality standards:
a. Prevention costs are the costs of all activities specifically designed to prevent poor quality
in products and services. In other words, it is the cost of ―doing things right the first time‖.
Typical costs include direct and indirect costs related to quality training and education, pilot
studies, quality circles, quality engineering, procedure writing, development of protocols,
70
rating of vendors, suppliers & subcontractors, process or equipment automation, quality
design (QD) activities, etc.. These costs are incurred in order to build awareness of the quality
management program and to keep the costs of appraisal and failure to a minimum.
b. Appraisal costs are the costs associated with measuring, evaluating, or auditing products or
services to assure conformance to quality standards and performance requirements. They are
costs incurred while performing inspections, checking, testing, or other planned activities to
detect defective units of services and determine how well they comply with requirements
before they are given to clients. Think of these costs as the ―inspection‖ costs – the costs you
will incur while inspecting the quality of the service or product. Typical costs include
inspection of drug stocks, calibration, supplier surveillance, etc.).
2. Costs resulting from not achieving/maintaining quality standards. This component is
not always obvious or easy to know.
c. Internal failure costs are the costs resulting from products or services not conforming to
requirements or customer/user needs (which) occur prior to delivery or shipment to the
customer. For instance, if the laboratory technician was running an ELISA test on a batch of
samples, and then discovers that something is wrong (e.g. the machine was incorrectly set),
s/he would have to repeat the whole process (hoping s/he still has the serum or whatever fluid
he‘s using to run the test!). Analyzing this, you‘ll see that there is the lost of time, electricity,
reagents, etc. due to this failure, but the faulty results have not yet been reported to the client.
So the mistake is still ‗within the system‘ or internal. Typical costs in this category are
therefore related to waste and rework, correction of documentation, cost of downtime – e.g.
if the lab technician had to wait for the machine to be calibrated, that would constitute time
when that work cannot proceed, etc.
d. External failure costs are the costs resulting from products or services not conforming to
requirements or customer/user needs (which) occur after delivery or shipment of the product,
and during or after furnishing of a service to the customer. They are the costs incurred when
services are identified as defective after they reach the client. This cost affects the
reputation of the organization because it implies that the customer has already experienced
the failure. Typical costs include those related to adverse reaction to drugs, or administration
of wrong drugs, customer dissatisfaction, complaint handling, loss of good will, litigation, etc.
In addition, you can also include the costs of having to correct the mistake after the client has
received the first wrong service. Prevention costs and part of appraisal costs can be viewed as
an investment, or an input, while part of appraisal costs and all of internal and external failure

71
costs can be viewed as the cost of poor quality, or an output (Fargher and Morse, 1998).
Appraisal costs should be minimized as they are non-value added since they don‘t change the
quality of the product or service being evaluated. The more inspections and verifications
conducted, the less likely that poor quality will be delivered to the customers. However, these
activities do not prevent the poor quality from being produced. By spending more money on
prevention activities, appraisal activities can be reduced and this should also lead to lower
failure costs. Ideally, an organization should have zero failure costs (Beecroft, 2000). In
summary:
The Cost of Quality = Cost of Prevention + Cost of Appraisal + Cost of Failure
One reason for tracking COQ is to translate the ―language of things‖ that quality professionals
use (e.g. defects, units) to the ―language of dollars‖ that managers use (e.g. costs, financial
performance). The use of dollars instead of defect rates also makes it easier to aggregate
performance measures across departments or divisions and to compare to other dollar
measures (Evans and Lindsay, 2002). Tracking COQ also makes it easier to use quality
information in the budgeting process and cost control activities.

Activity 7.1

Consider critiquing the situation of quality cost in your organization

Cost of poor quality

72
Preventing poor quality
• Would it not make sense to prevent poor quality products from happening?

• How can this be done?

• Whose responsibility is this?

How to prevent poor quality

• Prepare to measure costs of quality

– Determine categories of quality costs

– Create measurement system that captures categories of quality costs

• Assign responsibility to collect data

• Analyse collected data

Determine quality cost categories

• Understand your product

73
 • Understand your process

• Understand where problems occur

• Determine precisely what goes wrong

• Determine what costs represents each problem

Create data collection system

• Create measurement system

– Attempt to harness existing financial accounting system

– Manipulate existing financial data

– Collect costs as they occur

• Whatever you do ensure costs are accurate

Assign responsibilities

• Make individuals at all levels responsible for collecting quality cost data:

– If quality cost data is required then make it the responsibility of the person who
creates the cost to collect the data

• If no one is responsible no one will bother

Analyse data collected

• Data on its own is useless

• You must have it analysed to be able to extract meaning

• Determine what knowledge you require

• Develop an analysis system that provides the knowledge you require

Congratulations. You have completed this lecture on cost of quality . I hope you
can now make an informed decision on the relationship of cost and quality. It is expensive?
And are there implications of cost of poor quality:Find out!

74
Read more on the impact of cost of quality in health care systems
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

1. Hardy, T. L. (2010). Using cost of quality approaches to improve safety. Great Circle
Analytics.
2. Harrington, H. J. (1999). Performance improvement: a total poor-quality cost system.
The TQM Magazine , 11 (4), 221 - 230.

75
 Lecture 8
Quality improvement

Lecture Overview
Welcome to this lecture about quality improvement. One of the principles of quality
management is continous improvement. This principle emphasizes that Quality is continous
always and there is no stoppin point and that there is alwys room for improvement

By the end of this lecture, you should be able to:

i. Describe the need for quality improvement and its impact on process improvement

Introduction to Quality Improvement

Improving quality (QI) refers to the application of quality management methods and tools to
close the gap between current (actual) and expected (desired) levels of quality by
understanding and addressing system deficiencies and strengths to improve, or in some cases,
re-design healthcare processes. This activity leads to improved performance according to
defined standards of quality. An opportunity for improvement need not stem from a major
deficiency. It may represent simply a desire to improve a process that is operating in a
satisfactory manner in order to reach a higher level of acceptable quality.QI entails combined
and unceasing efforts of everyone – health care professionals, patients & families,
researchers, payers, planners and educators – to make the changes that will lead to better
patient outcomes (health), better system performance (care) and better professional
development (learning) Quality improvement (QI) in public health is the use of a
deliberateand definedprocess which is focused on activities that are responsive to community
needs and improving population health. (QI). Systematic and continuous actions that lead to
measurable positive changes in health care services and health status of target patients
(HRSA, 2011).

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Goal of Quality Improvement

Continous Quaality Improvement (CQI).It refers to a continuous and ongoing effort to

achieve measurable improvements in
-Efficiency

-Effectiveness

-Performance

-Accountability

-Outcomes and other indicators of quality services or processes which achieve equity and
improve the health of the community.
CQI:An approach to quality management that builds upon traditional quality assurance
methods by emphasizing the organization and systems: focuses on ―process‖ rather than the
individual; recognizes both internal and external ―customers‖; promotes the need for objective
data to analyze and improve processes. Source: Graham, N.O. Quality in Health

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Quality Improvement Steps and Tools
A variety of quality improvement approaches exist, ranging from individual performance
improvement to redesign of entire systems/processes to organizational restructuring/re-
engineering. These approaches differ in terms of time, resources, and complexity, but share
the same four basic steps in quality improvement:
1. Identify what you want to improve,
2. Analyze the problem or system,
3. Develop potential solutions or changes that appear likely to improve the problem or system,
and
4. Test and implement the solutions. Step 4 uses the ―plan, do, study, act‖ (PDSA or
Shewhart‘s) cycle to determine whether the solutions under consideration would really yield
improvement and whether they should be abandoned, modified, or scaled up.

1: Identify :The first step of quality improvement begins when someone recognizes that an
opportunity for improvement exists. Problems can be identified in a number of different ways.
A patient might express dissatisfaction with quality of care provided, an adverse event might
draw attention to a flawed process, or an organization might systematically capture and
monitor statistical information it believes to be important. The following questions are helpful
in problem identification.
 What is the problem?
 How do you know that it is a problem?
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  How frequently does it occur, or how long has it existed?
 What are the effects of this problem?
 How will you know when it is resolved? Criteria for Selecting Problems
 Problem is important
 Support for change exists in this area
 The project has emotional appeal/visibility
 There are risks associated with not addressing this area
 The project is within your sphere of influence
Problem Statements Problem statements are concise statement about a problem to be
addressed. While it is not always necessary to begin with a problem statement, the practice of
creating a problem statement is very helpful in bringing about a shared understanding of the
improvement opportunity. Therefore, the creation of a problem statement is highly
recommended when more than one person will be working to solve the problem or improve a
process.
2: Analyze: The second step of quality improvement begins once an opportunity for quality
improvement has been identified. Like Step 1 - Identify, Step 2 will vary based upon the size
and complexity of the process improvement effort. Analysis is performed to better understand
the process that needs to be improved or the system in which the improvement effort will be
based. Listed below are some objectives of the problem analysis stage:
 Clarify why the process or system produces the effect that needs to be improved
 Measure the performance of the process or system that produces the effect
 Learn about internal and external clients
 Formulate research questions, including:
 Who is involved or affected?
 Where does the problem occur?
 When does the problem occur?
 What happens when the problem occurs?
 Why does the problem occur?
To achieve these objectives, the analysis stage involves the use of data. Some of the data may
already exist, or new data can be collected.
3: Develop: The third stage begins when enough data has been collected to develop
hypotheses about what changes or interventions might improve the existing problem. A

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hypothesis is an educated guess about the underlying cause of a problem. Because it has not
been tested, it is only a theory at this point.
4: Test and Implement:The fourth and final stage of the quality improvement process
focuses on testing and implementation of hypothesized solutions. As with the other stages of
the quality improvement effort, the nature of this step will be influenced by the size and
complexity of the quality improvement effort. For example, in some situations it might make
sense to conduct several small tests of the solution(s), while in other situations it might make
sense to make one large test of all the solutions. The process that is used to test and implement
hypothesized solutions is known as the PDSA Cycle

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After Successful Results
 Document your work
 Celebrate
 Consider how to disseminate information
 Consider how to build support for further improvement activities
 Consider how to tackle larger, more complex problems
If Results Did Not Improve
 Examine your process - how could it have been improved? Was the problem statement
focused on a process? Was there clarity about the goals for improvement? Was
reasoning accurate about the current process and theories of cause? Were data
accurate and correctly interpreted?
 Should the same team try solving the problem again?
 Celebrate! Identify what you have learned about the current process, your work as a
team, your QA knowledge
 Document your work!
 Consider another QA activity – setting standards, monitoring, quality assessment, or
another problem solving effort

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 A quality improvement storyborad is a communication vehicle to display improvement
efforts to alert others of changes being tested or carried out.

Activity 8.1

Critique the current status of Quality Improvement in your healthcare system

Core steps of CQI

1. Form a team with knowledge on system

2. Define clear aim

3. Understand the needs of the people

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 4. Identify and define measures of success

5. Brainstorm strategies for improvement

6. Plan, collect and use data for decision making

7. Apply scientific method to test and refine changes

Principles of CQI
1. QI works as systems and processes

 To make improvements, an organization needs to understand its own delivery system

and key processes. Both resources (inputs) and activities carried out (processes) are
addressed together to ensure or improve quality of care (outputs/outcomes). QI can be
individualized to meet the needs of a specific organization‘s health service delivery
system.

Example

2. Focus on patients/beneficiaries

An important measure of quality is the extent to which patients‘ needs and expectations
are met. Services that are designed to meet the needs and expectations of patients and their
community include:

 Systems that affect patient access

 Care provision that is evidence-based

 Patient safety

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  Support for patient engagement

 Coordination of care with other parts of the larger health care system

 Cultural competence, including assessing health literacy of patients, patient-centered

communication, and linguistically appropriate care

3. Focus on the implementing team

QI is a team process .The right team harnesses the knowledge, skills, experience, and
perspectives of different individuals within the team to make lasting improvements

A team approach is most effective when:

 The process or system is complex

 No one person in an organization knows all the dimensions of an issue

 The process involves more than one discipline or work area

 Solutions require creativity

 Staff commitment and buy-in are needed

 A team effort helps an organization to achieve significant and lasting improvements.

 It is the responsibility of each individual to be an active and contributing member of

the team.

 Each person on a team brings a unique perspective to the process; i.e., how things
work; what happens when changes are made, and how to sustain improvements during
daily work.

4. Focus on efficient use of resources

Emphasize the need for efficient use of resources in the organization among all
providers

5. Focus on use of the data

 Separates what is thought from the reality

 Establishes a baseline

 Identifies ineffective solutions

 Allows monitoring of procedural changes

 Indicates whether changes lead to improvements

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  Allows comparison across sites

6. Focus on implementing continuous improvement (e.g. through capacity building)

You have come to the end of another lecture where we discussed.The lecture was
all about Quality Improvement. It requires the efforts of all to successfully improve
QUALITY

Read on Quality Improvement tools and expalin how you can use them in your health care
system for purposes of improving quality
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
____________________________.

1. Berwick, D. (1991). Improving health care quality. Boston: Institute for Health
Improvement.
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2. Crosby, P. B. (2000). The circle of doing something about quality: A mini-history of
managing quality in the 20th century and a solution for the future.

86
87
 Lecture 9
Quality audit and inspection

Lecture Overview
Welcome to this lecture on quality auditing .You now have a solid background on what quality
entails and therefore in any healthcare organization that is operating on quality systems it is
impertative that the quality systems are audited and regulary inspected. Quality is continous
and there is alwys room for improvement

By the end of this lecture, you should be able to:

i. Describe quality audit and inspection

Quality Audit
It is the process by which an independent body assures itself and the stakeholders that an
educational institution has adequate and appropriate mechanisms set up to ensure quality of
educational provisions. It is not an exercise to determine quality per se. It is therefore
concerned with an evaluation of the way in which quality is assured by an institution.
Institutional Accreditation is another term used to denote more or less the same thing as an
academic audit or quality audit.
Quality Audit: A systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these
arrangements are implemented effectively and are suitable to achieve objectives.
Quality Audit: Quality audit is the process of ensuring that the quality control arrangements
in an institution are satisfactory. In practice, prime responsibility for quality audit lies
individually or collectively with institutions, and it extends to the totality of quality assurance
in an institution including staff development

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Quality Audit: Is an objective assessment,performed at the defined intervals and at sufficient
frequency of a company‘s quality system to operate against a given criteria.
It should be:
 systematic,independent and documented
 Provide factual, unfiltered information to manage the quality system
 A tool for use by management
 Regulatory requirement
 Help minimize risk
 ―Close the loop‖ for other elements of the quality system
 Detect program defects and through isolation of unsatisfactory trends and correction of
factors that cause defective products, prevent the production of unsafe or
nonconforming devices.
 Assure the manufacturer is consistently in a state-of-control.
 Audits are not a quick look

 Audits are preventive, not detective

 Audits are planned, organized, and coordinated

 Audits are carried out for the benefit of the company, not the auditor

 A single audit will not find all noncompliant issues or potential problems

Purpose of quality audit

 assessing the strength of the quality culture;
 determining the commitment to continuous improvement;
 appraising the systems in place to determine standards;
 evaluating the systems in place to ensure that measures taken to maintain and enhance
quality are appropriate and effective; and
 establishing whether the institution is embracing the concept of fitness for purpose as
well as fitness of purpose through fulfilling its mission and achieving its objectives in
an efficient and effective manner and demonstrating relevance of its undertakings.
An audit is a systematic, independent and documented process for obtaining audit evidence
and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
from ―ISO 19011: 2011 – Guidelines for auditing management systems‖ Such an activity can
assume different features (objectives, internal vs external auditors, …) Common trait of the
different types of auditing is the purpose of check and review in order to improve The results

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include a summary of the objectives, reason for conducting review, individuals involved
(including external advice), list of recommendations, list of areas and proposals for
improvement (with priorities where possible)
Quality dimensions Audit
The focus is on the products/outputs and the quality components
•Relevance

•Accuracy

•Timeliness and Punctuality

•Accessibility and Clarity

•Coherence and comparability .System of standard quality measures and internal or external
quality targets (e.g. from regulations)

Audit based ISO norms

ISO 19011:2011 These audits can be conducted either internally or externally:
•The internal audits are conducted with the purpose of reviewing the quality system and
internal objectives, and are led by a team of internal quality auditors;

•The external audits are conducted either by stakeholders or other parts that have interest in
the organisation, or by an external and independent auditing organisation that certifies that the
quality and/or environmental systems are according to the prerequisites of the ISO 9001 and
ISO 14001, respectively (in this last case it might mean that the organization is applying for a
quality certification according to the ISO standards).

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 Audit Process

Chart & Coded Data Hospital Staff

Audit
Process

Auditor

Activity 9.1

Explain reasons of auditing a quality system in healthcare systems

_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________

Types of Audits
Internal and External audits
There are three main types of audits:
First party audits
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The first party audit is the mechanism by which the company monitors adherence to the
documented quality system. It carries little weight externally, except as confirmation that the
quality management system is operating correctly. Its benefit is to the company. It provides
objective data used to highlight the potential improvement and a basis on which to plan
improvements .The audits re carried out by people who understand both the company and its
activities
Second party audits
The second party audits are usually performed by the customer or a representative of the
customer when the customer needs to establish confidence in the process3w contributing to a
particular product or service

Third Party audits

The third party audits are performed by agencies, independent of both customer and supplier,
recognized as competent to assess quality management systems against a standard. In
recognition of meeting the requirements of the standards, the supplier will achieve
certification to the standard. Certification has the benefit of reducing if not completely
removing, the need to perform second party audits

Framework for Audit Quality

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External Evaluation of Quality
There are three primary approaches for external evaluation of healthcare quality: Licensure,
Accreditation, and Certification. All three approaches use standards to determine the level of
quality achieved by an individual or organization. External quality evaluations can generate
objective data to:
 Support comparisons of performance between the public and private health sectors and
more appropriate government oversight of the health sector
 Shape healthcare services delivery in new settings by monitoring access, quality, and
risk
 Demonstrate whether a predetermined rate of beneficiary coverage for preventive
services is being achieved
 Ensure efficient use and allocation of limited healthcare resources
 Identify and create centers of excellence (e.g., those facilities that can provide greater
volume of services, greater efficiency, and lower per case costs)
 Integrate structures and services of several organizations to improve coordinati on and
efficiency of care and reduce administrative costs

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Inspection and quality
Self- insepection
The purpose of self-inspection is to evaluate the manufacturer‘s compliance with GMP
(General Mangement Practice) in all aspects of production and quality control. It also
assists in ensuring quality improvement. There should be a programme that covers all
aspects of production and quality control. It should be designed to detect shortcomings in
the implementation of GMP and recommend corrective actions. The company should set a
timetable for corrective action to be completed. You can verify this during your
assessment.

Self-inspections should be performed routinely, and may, in addition, be performed on

special occasions, e.g. in the case of product recalls or repeated rejections, or when an
inspection of the health authorities is announced.

The team responsible for self-inspection should consist of personnel who can evaluate the
implementation of GMP objectively; all recommendations for corrective action should be
implemented. The procedure for self-inspection should be documented, and there should
be an effective follow-up programme. It can also be a good training exercise to involve
operators in the process. It is also possible to bring in people from other parts of the
company, or even outside the company, if it will add value to the process.

The informal self-inspection that takes place on a daily basis is carried out by operators
and managers. If something is seen to be wrong, it is immediately put right.Next is the
formal self-inspection process that takes place on a regular basis. The purpose of this is
to take a step back from the day-to-day activities to review for compliance to GMP and to
look for ways in which the system can be improved. There may also be a need to conduct
self-inspections as a result of a specific problem such as frequent rejections. The next
stage may or may not take place, depending on the size of the organization. It involves the
use of QC staff as ―internal auditors‖ to review the system for compliance. (In a smaller
company, this step and the previous one may blend into one).

Items for self inspection

There should be written instructions for self-inspection detailing what is to be inspected

and at what frequency. It should be used to ensure that a consistent approach is achieved.
The areas to be inspected will include (but will not be limited to):

• personnel
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 • premises including personnel facilities

• maintenance of buildings and equipment

• storage of starting materials and finished products

• equipment

• production and in-process controls

• documentation

• sanitation and hygiene

• validation and revalidation programmes

• calibration of instruments or measurement systems

• recall procedures

• complaints management

• labels control

• results of previous self-inspections and

any corrective steps taken

Inspection team

The self-inspection team is appointed by the management of the company and is made up
of a mixture of people, including experts in GMP and persons familiar with the area to be
inspected. It is useful to have people from production, QC (Quality Control) and
engineering on the team, as they will bring different perspectives to the inspection. The
team leader needs to be someone who has access to the resources to produce a report at the
end of the process, and with the authority and experience to organize and manage a team
activity. Hence it is usually, but not always, a manager or supervisor.

The leader should be from a different department so that he/she can take a more impartial
viewpoint. It is important that the team members are encouraged to be objective in their
evaluation. The frequency with which self-inspections are carried out will depend on the
company. For a small company that can cover all its operations in one inspection, a three
or six-monthly review might be sufficient. However, for a larger company that needs to
split the inspection into a number of sections, a programme of monthly inspections
covering the whole factory in three to six months might be more appropriate.

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 Contemporary Issues in Quality management

Activity 9.2

Provision of health care services in a devolved function of the County government in

Kenya.Discuss the challenges in quality management in this context.

_________________________________________________________________________

_________________________________________________________________________

_________________________________________________________________________

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 Congratulations. You are now done with lecture 10. We have discussed the
quality audit process and inspection. Now that you understand what quality audit entails,Does
your healthcare systems have quality audit systems?

As a health systems manager quality auditing is essential.If you have quality audits in your
organization critique the procedure and document it current state
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
______________________________________________________________________.

1. Woodhouse David (1995), Audit Manual: Handbook for Institutions and Members of
Audit Panels, New Zealand Universities Academic Audit Unit.
2. A Guide to Quality Assurance in The Open University (1997), The Open University,
UK.

Self Assessment Questions

1) Discuss the application of Quality management in healthcare syrsems

2) Differentiate the following concepts
 Quallity Control
 Quality Assurance
 Qaulity Management
 Quality Audit

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 3) Explain the dimensions of quality with relevant examples in health care systems
4) Write short notes on the details of quality audit
5) Crittque the importance of quality measurement and monitoring in healthcare
ssytems
6) Discuss the application of atleast two quality models
7) Explain the use of various quality measurement tools in healthcare systems

EVALUATION
We appreciate your evaluation of the course. Please give us comments in the following areas
and forward them to the ODLM office at your earliest convenience.

Circle the most appropriate response

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Trimester Year

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