Quality Management

Definition/Introduction
Quality in the traditional sense pertains to examining whether a product or service meets its
expected characteristics and satisfies the consumer—in other words, how well does a product or
a service do what it is meant to do. For healthcare, the Institute of Medicine (IOM) has defined
quality as “the degree to which health care services for individuals and populations increase the
likelihood of desired outcomes and are consistent with current professional knowledge.”

Healthcare Quality Domains

The goal of the healthcare system is to provide ideal care from a qualified provider in an
appropriate setting for a particular patient. In other words, the patient is to receive the best
possible care (i.e., standard of care based on evidence-based medicine) by a provider with the
right expertise in a setting that maximizes efficiency and minimizes risk and abuse of resources
—all the while treating the patient with respect and allowing involvement in care plan as the
patient desires. In recent years, six domains have been identified by IOM that help to achieve a
high degree of quality; health care must be safe, effective, patient-centered, timely, efficient, and
equitable. Meeting all these domains is at the core of quality management. “Safe” pertains to
preventing harm to patients stemming from the care they are receiving. “Effective” uses
evidence-based care with the correct utilization of resources. “Patient-centered” refers to care
that is receptive and considerate of the patient’s inclination, needs, and values to guide all
clinical decisions. “Timely” focuses on preventing delays in care. Efficient” relates to
minimizing or avoiding waste of resources such as supplies and time. Lastly, “equitable”
indicates providing care to all patients regardless of characteristics such as appearance,
socioeconomic status, and values. The success of health care in achieving these quality domains
can be measured by collecting data and evaluating “the five D’s:” death (mortality), disability
(morbidity), disease (resolution or persistence of disease following treatment), discomfort (the
process of providing medical care) and dissatisfaction (the patient’s experience during the
process of providing care).

Quality Management

In healthcare, quality management refers to the administration of systems design, policies, and
processes that minimize, if not eliminate, harm while optimizing patient care and outcomes. The
objective of quality management is to ensure that a particular product, service, or organization
will consistently fulfill its intended purpose. To achieve this, there is a constant collection of data
and alterations in process to create an optimal product or service that fulfills its intention and
satisfies the consumer. Further data is then collected to ensure that no additional changes are
necessary. Quality management systems (QMS) are tools used to implement quality management
and organize, standardize, and improve activities involving a product or service aimed at
customers. By measuring outcomes and effects of different factors via data collection, issues
within the system are identified, and evidence-based medicine and resources are used to develop
or alter processes to improve the quality of care. Information is then collected regarding new
outcomes to determine if the changes were beneficial or if other alterations are required. The
ultimate goal is to achieve consistent, high-level care with minimal morbidity, mortality, disease,
discomfort, and high patient satisfaction while meeting or exceeding all six of the IOM domains
(safe, effective, patient-centered, timely, efficient, and equitable care).

Here is the definition of quality and quality management as applied to a case scenario, noting
that all six IOM domains are easily identifiable. A trauma hospital offers a service: to safely and
efficiently assess and stabilize a patient after suffering a traumatic injury. Regardless of the
patient’s history or background, the patient is seen within a specific time frame based on the
acuity of the trauma. To achieve optimal care, all trauma providers are all trained in Advanced
Trauma Life Support (ATLS) to keep the evaluation of this patient organized and address the
most life-threatening injuries first. Despite the intensity of a trauma scenario, all efforts need to
respect a patient’s privacy and goals of care. After the patient’s hospital stay, quality
management teams measure data, including adverse events, patient outcomes, and experience
(i.e., the five D’s) to optimize future care and make changes and recommendations as needed.

Issues of Concern
Quality Management Models and Approaches

There are different Quality Management models and approaches. A recent review of existing
quality management models for inpatient healthcare identified 64 different models, 17 of which
gained recognition as significant to current healthcare practice. Below, we discuss a few of the
models and potential issues.

Total Quality Management (TQM). TQM is an “integrated process involving all systems and
employees in a continuous effort to improve quality, reduce cost, and enhance service to [the]
customer.” To identify essential elements of TQM in healthcare, researchers conducted a meta-
analysis to determine crucial aspects to the success of TQM in healthcare. Among these
were leadership, employee involvement, training, process management, support from
upper administration, and planning. Interestingly, another meta-analysis identified factors
contributing to the failure of TQM implementation in healthcare. These include lack of employee
involvement (specifically by physicians), lack of consistent upper- management support, poor
leadership, lack of a quality-oriented culture, insufficient education and training, and inadequate
resources. The similarity between the two studies indicates the essential elements of a healthcare
organization. The development of these features leads to success, but inadequacy will result in
the breakdown of TQM implementation.

Continuous Quality Improvement (CQI). CQI involves the systematic use of tools and processes
to identify and analyze strengths and barriers within an organization and continually test and
improve outcomes. CQI methods started in the business and engineering fields post World War
II and have been used in healthcare in the last few decades. In healthcare, CQI’s approach to
improvement allows for connecting the most recent best evidence with current practices to
achieve better patient outcomes. While finding success in different aspects of healthcare, some
areas have identified barriers with CQI. For example, implementation of CQI programs in
colonoscopy services found a significant knowledge gap concerning barriers and facilitators
pertaining to nurses, patients, and managers.

Joint Commission on Accreditation of Healthcare Organizations. Accreditation of healthcare

organizations has been another Quality Management pathway. An example is The Joint
Commission, which is a voluntary process that enforces, monitors, and improves upon the
quality of healthcare in the United States and internationally. It currently evaluates greater than
20,000 healthcare organizations and is the largest accreditation group in the nation. The Joint
Commission measures whether a facility is meeting accreditation standards for healthcare
quality, which includes incorporating programs that perform quality measurement, evaluation,
and improvement of patient outcomes. Accreditation also provides external validity to hospital
administration and increases transparency to patients and providers. The Joint Commission
hospital standards focus on the following areas:

 Patient-related issues such as care, education, and ethics

 Organization-related functions such as performance, leadership, surveillance, infection
control, and prevention
 Organizational structure such as governance, management, and medical staff

The question lingers: what is accreditation, and why is it important for hospitals? When a
hospital is accredited, its performance is within the range of nationally-accepted criteria based on
government guidelines; this means the hospital has its system of assessment and self-
improvement, resulting in compliance with the standard of care and, ideally, better outcomes.
Additionally, accredited hospital enhances public confidence (i.e., satisfies the consumer).

A recent study determined whether patients admitted to accredited US hospitals have better
outcomes and whether accreditation by The Joint Commission has any additional benefits for
patients compared with other independent accrediting organizations.[18] Results indicated that
US hospitals accredited by independent organizations did not experience significantly lower
mortality but did demonstrate slightly reduced readmission rates for the fifteen common medical
conditions. Also, there was no indication that patients choosing a hospital accredited by The
Joint Commission had any healthcare benefits compared to a hospital accredited by another
independent accrediting organization. Of note, there were limitations to the study as it was
observational.

Clinical Significance
Principles of Quality Management

Regarding the study of quality management, the International Organization for Standardization
(ISO) identified seven basic principles that, when applied properly, can aid in the evaluation and
optimization of a service or product based on data collection, process improvement, and
coordination amongst involved parties.[5] ISO is an independent international group of voluntary
experts that develops consensus-based and market-relevant International Standards. These
quality management principles, or QMPs, include customer focus, leadership, engagement of
people, process approach, improvement, evidence-based decision making, and relationship
management.

Customer service/ customer satisfaction is essential to quality management. Without customers,

there is no one to offer a service or product. The goal is to keep customers returning by meeting
their expectations and building confidence in the offered product or service. While an
institution’s employees are each other’s customers, the ultimate customer is the patient. Both
patient experience and patient outcomes define healthcare quality. While we do not want the
patients cycling through a hospital more than needed, the hospital would like to be their provider
of choice if hospitalization is warranted. By taking into account the patient’s perception of care
—did they feel respected, were they included in the plan of care—and by fulfilling patient
expectations, the financial aspect of the healthcare system also will thrive. As an example,
patients coming into the emergency department expect to be seen and cared for in a timely
fashion. One example of a way to ensure a timely evaluation is to record when each member of
the team arrives to evaluate a patient. As mentioned, while the patient remains the ultimate
customer of healthcare institutions, it also should be emphasized that the people at every level of
the organization are one another’s customers, and each other’s performance is intertwined. The
goal is for each group/department to meet or exceed the needs and expectations of the
departments or groups they are serving. This approach allows the entire institution to deliver the
utmost care and safety to its patients. For example, the paramedics rely on the emergency
department to be ready for a patient, and, in turn, the emergency physician relies on quick test
results from the laboratory and radiology departments.

Leadership is necessary at all levels to reinforce the goals and purpose of an organization,
product, or service. Leadership at the top is needed to set the mission and vision of the
organization and to promote support, efficiency, and open communication by encouraging a
unified and attainable approach to reach objectives via pre-set process/policies. Returning to our
trauma scenario, the trauma surgeon ensures that the ATLS protocol is followed, and appropriate
interventions are taken, whether it be a chest tube insertion or exploratory surgery. Their job is to
encourage the team and communicate the needs of the patient to those within the trauma bay and
other involved parties such as the operating room or interventional radiology.

Engagement of people at all ranks is essential to reach the objective of an organization, product,
or service. Healthcare institutions are built on the strength and commitment of its people. It is
ideal to have enthusiastic workers who are competent in their particular role within the process.
By respecting those at all levels, there is an improvement in job satisfaction, motivation, and
collaboration; thus, better feedback for improvement within all stages of the process. As an
example, in the operating room (OR), all providers have a known, pre-identified role, whether it
is the scrub technician monitoring the sterile field, the anesthesiologist evaluating patient vitals,
or the OR nurse who is leading the pre-operative timeout. Feedback from all providers is
essential to ensure they can perform their job at the highest level possible.

Process approach is the key to achieving a consistent, desired outcome. While it is often multiple
interrelated processes that are required to achieve the ideal outcome, these all must function
consistently and as a unit to thrive. Once standardized, individual processes require continuous
assessment and appropriate optimization if areas needing improvement are identified. For a
cardiac arrest patient, the process begins the moment 9-1-1 is called and continues through
assessment by EMS, handoff to the emergency department team, performance of advance cardiac
life support protocol, and throughout the patient’s hospital stay. While each aspect of care
provides different services, each must be standardized and eventually optimized to achieve the
ultimate objective of getting the patient home safely with minimal morbidity.

Improvement is the key to success. By continually collecting data and assessing outcomes,
opportunities for improvement come to light and are addressable. The end result is better quality
through improved performance, outcomes, and customer satisfaction. Root cause analysis and
failure mode and effects analysis are two methods used to examine sentinel events and promote
improvement within a health care system. In the medical world, there are frequent morbidity and
mortality conferences and peer review sessions pertaining to a patient not having an ideal
outcome. What could have been done better throughout all stages of care? Was the patient seen
and evaluated in a timely fashion? Was there a missed diagnosis? Were the appropriate
interventions taken for the clinical picture? Was there a breach in the standard of care? What can
possibly remedy this?

Evidence-based decision making (i.e., evidence-based medicine) is the evaluation of facts,

evidence, cause-and-effect relationships, and other data that will allow for the delivery of the
best product or service. By basing decisions on facts, processes can be standardized, which is
more likely to produce consistent and desired results. After changing processes, it is important to
continue to monitor outcomes to determine whether corrective action is reaching the desired
endpoint. By repeating this cycle and sharing results with other health care intuitions, quality
care, and ideal outcomes can be widely replicated. For example, Level 1 trauma centers have in-
house trauma and neurosurgeons around the clock to ensure expedited care because studies and
clinical experience have shown that immediate access to these physicians reduced cost, time to
intervention, and hospital length of stay.[19]

Relationship management is essential for an organization to thrive. Supportive relationships with

suppliers, retailers, monetary providers, and partners must be maintained as well as a common
understanding of goals across all parties. Shared goals and understanding also ensures a reliable
supply chain to allow the institution to deliver high-quality care to its patients consistently. For
example, donations to a hospital allow a new interventional radiology suite to be built with the
highest level of technology so that patients can be accessed quicker, and providers have more
space and resources for treatment.

Nursing, Allied Health, and Interprofessional Team

Interventions
Pioneers such as Ignaz Semmelweis and Florence Nightingale were among the first in medicine
to make changes to process based on observation and data collection.[20][21] Semmelweis was a
Hungarian physician who observed increased mortality in obstetric patients who were cared for
by physicians versus those cared for by nurse-midwives within the same institution. It was not
until one of his colleagues suffered an injury and death due to scalpel puncture while performing
an autopsy that Semmelweis noted an association. He instituted a policy of handwashing after
completing autopsies and prior to delivering babies, and, as a result, the mortality rate decreased
substantially to a level similar to that of midwives. As for Florence Nightingale, an English
nurse, she is known for her observation of poor healthcare conditions while serving the British
army. She also was an advocate for the development of standardized, formal nursing education
and was recognized as one of the earlier adopters of evidence-based medicine using data and
data visualization.[21]

Going forward, healthcare education should promote quality management as part of its
curriculum and interprofessional collaboration efforts. By introducing medical, healthcare, and
allied professions students and practitioners to quality improvement, they will be more likely to
reap the benefits of improved patient outcomes and satisfaction. Not to mention, knowledge of
the benefits of quality management will enhance compliance with and feedback from all areas
within the health care system. With insurance companies denying reimbursement for issues such
as foley catheter or central line-associated infections developed during a hospital stay, the push
for quality improvement increases. More than just meeting criteria for reimbursement, quality
management, when used to its full potential, will encourage optimal outcomes, supreme patient
satisfaction, reduce work by improving efficiency, and lower overall patient and hospital costs. It
all begins with collecting data to identify problems, evaluating possible causes, determining
potential solutions, and subsequently monitoring corrective actions for effectiveness. These
measures not only serve to improve patient outcomes, experience, and hospital performance, but
also fulfill requirements by joint commission and even insurance companies. Whether it is
evaluating a trauma M&M, a root-cause-analysis after a sentinel event, or the rate of catheter-
associated UTI, the importance of quality improvement cannot be under-emphasized. They
should continue to grow as a part of conventional health care education and practice.

Quality management in healthcare

Management
Patients sometimes find it difficult to determine whether their doctor is providing them with
high-quality treatment. Even doctors sometimes struggle to make this determination. Total
quality management in the healthcare industry aims to quantify the health benefits of hospitals’
and physicians’ work and enhance patient outcomes.

Quality management strives to lower mistakes and enhance patient care in the healthcare
industry. Two of the most important criteria for evaluating quality are the treatment efficacy and
safety.

Quality management aims to ensure that the goods or services a business offers are consistent,
appropriate for their intended use, and fulfill both internal and external standards. This includes
following the law and meeting consumer expectations.

What is quality management?

All required operations and tasks must be managed for quality to maintain the appropriate level
of excellence. Creating and implementing quality assurance and planning, as well as quality
control and improvement, are all included in this. Additionally, it is known as complete quality
management (TQM). Generally speaking, quality management prioritizes long-term objectives
while implementing short-term plans.

Total Quality Management (TQM) is a business philosophy that, at its core, supports the idea
that a company’s long-term success is generated from customer satisfaction and loyalty. Quality
management in healthcare requires collaboration amongst all company stakeholders to improve
operations, commodities, services, and corporate culture. Everything you should know about
quality control in healthcare.

Hospitals today operate like corporations. Hospital operations must be handled carefully and
executed well for efficient daily operations.

Significance of quality management in healthcare

The current health policies focusing on the quality of patient treatment include crucial pillars like
clinical governance and enhanced human resource management techniques. Enhancing the
accountability of healthcare professionals and managers, resource efficiency, identifying and
minimizing medical errors while maximizing the use of effective care, improving outcomes, and
aligning care to what users/patients want in addition to what they need are just a few of the
reasons why it is crucial to improve the quality of healthcare.

Quality also includes non-technical aspects of service delivery, such as client wait times and staff
attitudes, as well as programmatic components like policies, infrastructure, access, and
management. It can also relate to the technical quality of treatment.

Major quality management principles/standards in healthcare

Quality improvement aims to get the greatest results, and minimizing risks to the healthcare
organization is one way to do this. Risk managers may use incident reports and other sources of
information to manage risk, influence important decision-makers, and ultimately affect patient
safety and high-quality treatment by building a culture where healthcare personnel are
encouraged to speak out. Healthcare businesses should take five guiding principles into account
while using quality improvement tools and procedures in the industry.

 Improvement projects

Simply reviewing case studies and introducing doctors to concepts for quality improvement does
not inspire them to implement change. Applying quality improvement theory and methods to a
real clinical setting can help you understand it more effectively. Adoption will be facilitated by
choosing a topic that matters to physicians and setting up a platform for change.

 Define quality
In each given setting, establishing what to measure and how to gather data on those metrics
requires consensus on what quality is. The goals for healthcare systems form the basis for the
Institute of quality framework, but the most important goal for defining quality is that metrics
must be patient-centered.

 Improved measures, not accountability

Data and measurement fuel quality improvement, but healthcare faces greater challenges than
other sectors. Clinicians first associate performance measurements, which imply accountability,
with quality improvement measures. It’s crucial to distinguish between accountability and
performance measures.

 Learn from data variation

The team is better able to achieve the improvement target thanks to an extensive understanding
of the Model for Improvement framework. Understanding data variety and its causes help us get
some of this information. There are both deliberate and inadvertent variations in healthcare
processes. Intentional variety is choosing to carry out a task in a unique manner.

Patient-centered care is all about this. Since it is a part of their routine practice, clinicians may
object to minimizing variance. On purpose, they give one patient one dose of therapy and the
next patient a different dosage or treatment. A desired practice and a requirement of the job
description is intended variety.

How can I work in healthcare as a quality manager?

Although all graduates are eligible to pursue a job as a quality manager, having a degree in a
related field, like hospital administration, is an advantageous. However, companies frequently
prefer candidates with a master’s degree in healthcare management. In this position, experience
is extremely crucial.

To become a professional preparation for the future, learn about hospital planning and
infrastructure management, health informatics, and other important topics. Boost your income
potential and advance your career in healthcare administration by taking on a profitable new role
in the industry.

Objectives Results

Effective Delivering evidence-based healthcare to people who require it.

Safe Preventing damage to those who are receiving care

People Delivering treatment that takes into account each patient’s choices, requirements, and
Centric values

Equitable Delivering treatment that is equal in quality regardless of a patient’s gender, race, region,
 Objectives Results

or socioeconomic situation

The job involves producing data, reporting on performance, evaluating against predetermined
criteria, and monitoring and providing advice on the effectiveness of the quality management
system.

To ensure that quality management in healthcare is operating effectively, the quality manager
must communicate with other managers and employees across the firm. The position must
emphasize improvements and how to apply them, as well as offer instruction, equipment, and
methods to help others meet quality requirements.

The effort to enhance quality is crucial due to the complexity of healthcare operations and the
wide range of healthcare options. When used within a framework founded on principles, it
became possible with healthcare quality managers.

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Quality management in healthcare

Introduction 1.
A Health Care Organization (HCO) is a complex organization by nature owing to the intangible
outcome of service and a blend of diverse professional personnel. Quality management in
healthcare is a critical requirement in health sector. The principles of quality have been implicit
in health care. However, quality is not a physical attribute service. Use of the term ‘Health Care
Service’ in place of ‘Medical Care’ further defines the field and puts it as an entity that can be
assessed, monitored and improved. A quality healthcare system can be defined as “one that is
accessible, appropriate, available, affordable, effective, efficient, integrated, safe, and patient
related”.1 Health care is delivered by practitioners in allied health services, dentistry, midwifery,
obstetrics, medicine, nursing, optometry, pharmacy, psychology and other care providers.

Quality management in health care is a wide term. Initially it was perceived as directing the
healthcare personnel to what to do. However, its current interpretation is to manage the process
of care.2 It refers to observing the organizational functions as an interaction of procedures and
processes that can be addressed individually and collectively. Although various models have
been put forth, however, the concept of triad of structure, process and outcome proposed by
Donabedian remains the foundation of quality assessment today.3
Quality management has emerged as the dire need more fiercely than ever in light of the new
definition of the quality with patient satisfaction as the outcome of service. The quality of
services being provided to patients is highly crucial. The traditional view of quality control
aimed at defect detection while the current concept aims at the defect prevention, continuous
process improvement, and outcome driven system guided by patients’ needs. Hence there is a
crying need to bring about a paradigm shift in quality of health care delivery.4 The authorities
need to step forward to get involved in quality.5 Currently, the quality has been addressed more
in medical field than in the allied fields such as dentistry and nursing and also more in the
developing country context.

Quality 2.
‘Quality’ has different definitions, ranging from traditional to those that are strategic. The
American National Standards Institute (ANSI) and American Society for Quality (ASQ) defines
quality as the totality of features and characteristics of a care or service that bears on its ability to
satisfy given needs. W Edwards Deming, the father of concept of TQM has defined quality as a
strategy aimed at the needs of the customer. This strategic definition has received widest
international acceptance. Joseph M Juran, another authority on quality, has defined quality as
conformance to requirements.

Quality is a unit less value system interpreted as diverse view-points. It has been conceived as
superiority of excellence or lacing patient care and service defect or conformance to
requirements i.e. zero defects. The precise meaning of quality of care in HCO is ambiguous. It
involves more than the earlier perception of ‘clinical quality’. The technical component is also
included. The content quality in health care is determined and evaluated by the expectations of
the health care professionals. The delivery quality of the health care service is determined by the
patient satisfaction, is based on the patient expectations and linked with training and human
interpersonal relations.6

2.1. Quality in health care

Medicine is a learned profession and it decides its own content quality. The focus for quality in
health care is on simple preventive maintenance rather than total service maintenance.
Donabedian proposed the use of triad of structure, process, and outcome to evaluate the quality
of health care.3 The structure component includes the infrastructure, skill and qualifications of
health care professionals and administrative systems to deliver the health care. The process
encompasses the individual components of care and their interactions. The outcome is the
recovery, restoration of function, and survival.

To understand quality the key features are reliability, assurance and responsiveness. The seven
pillars of quality as presented by Donabedian are efficacy, efficiency, optimality, acceptability,
legitimacy, equity, and cost. According to the Institute of Medicine, services are of quality, when
they are safe, effective, patient centered, timely, efficient, and equitable. 7

Quality management in health care has observed a paradigm shift from expecting errors and
defects to considering that perfect patient experience is achievable. Philip Crosby supports the
same principle that the system for causing quality is prevention and not the appraisal. Literature
indicates that the cause of death for a large number of patients in hospitals is medical negligence
and nosocomial infections. These deaths can be easily avoided by incorporating quality
assurance programs.

System designs are important but are not enough in health care management. High value clinical
care results from the most efficient expenditure of resources to achieve an established high level
of clinical quality. Six Sigma design produces a yield of virtually zero defects. No single model
has been established as superior to others in quality management. However, any mechanism
would work if top management and the team are committed to quality.

Patient satisfaction is the desirable outcome of quality assurance program that requires patient-
centered care delivery and also compliance with the standards and efficient protocols. The
Institute of Medicine defines patient-centered care as a type of care that is respectful of and
representative to individual patient preferences, needs, and values ensuring that patient values
guide all clinical decisions. Another approach is the shared decision-making where clinicians and
patients make decisions together using the best available evidence.

Patient satisfaction, a blurred term that lacks a clear and agreed-upon definition, is a
multidimensional entity and is subjective to great extent.2 Majority of the studies to understand
the intricacies of relationship between the three key components of service quality have been
carried out in the developed country context, which cannot be generalized in the developing
country context due to culture differences. The overall quality of the service provided is one of
the key factors that patients consider important when choosing a dentist.8

Tools can be utilized to continually improve the effectiveness of quality management system.
These include internal quality audit, subject feedback and corrective/preventive actions to meet
applicable standards. IT-Integrated Health Management Information System and committed
leadership facilitates the implementation. The four-step quality model, the plan-do-check-act
(PDCA) cycle, also known as the Deming Cycle, is the most widely used tool for continuous
quality improvement (CQI). (Fig. 1) Other methods are Six Sigma, Lean and total quality
management (TQM). The Kano model has been adopted to identify patient requirements or
enhance their satisfaction with healthcare services. Well defined protocols following standard
operating procedures and continually trained staff are the internal measures to control quality,
while accreditation is the external evaluation of quality.
Fig. 1

Quality Control Flow Chart in Health Care Organization.

Total quality management

The aim of the quality assurance programs in HCOs is to implement a system that is capable of
managing the health care service to deliver a high quality service in a measurable way. The
answer lies in TQM, a system that can address all the challenges of the organization. Total
Quality Management (TQM) is defined as a management philosophy concerned with people and
work processes that focuses on customer satisfaction and improves organizational performance. 9
It encompasses Content Quality and Delivery Quality both. It decreases burden of errors, ensures
optimal utilization of infrastructure and medical personnel and manages quality control.

The key principles of TQM are customer focus, obsession with quality, scientific approach, long-
term commitment, teamwork, continual improvement systems, education, and training, freedom
through control, and unity.10 It addresses not only the direct medical services of diagnosis and
treatment but indirect operations as administration and purchase also. The nurses are the main
personnel that contribute to achieve the success of implementation of this program.11
The TQM implementation is strengthened by the specific quality department.12 Various
instruments have been developed to measure the healthcare service quality. Improved quality
benefits all, reduces cost and it identifies problems before they actually cause harm. TQM helps
reduce quality waste and imparts a continuous improvement of quality services and the
employees. Research on the implementation of TQM has been limited, particularly in developing
countries including India.13

Health care is a sacred and scientific enterprise and not fundamentally a commercial one. The
competent authorities should enforce the responsibility for ensuring high quality standards and
quality of care in healthcare facilities. The authority should consider shaping the curricula to
ensure training of future professionals to increase patient satisfaction. To gain the desired
momentum, HCOs need to initiate a new Quality Movement to achieve total quality in health
care service. It is the need, the challenge and the future direction.

Implementing Quality Process in Public

Sector Hospitals in India
Quality in healthcare is a relatively novel concept in public health in our country. The notion of
enforcing quality care in medical profession can be traced back to early 1900s in the form of
“Medical Audit” in the United States of America (USA). The medical audit gradually moved to
“Hospital Standardization Program” in 1918 and finally took the form of “Quality Assurance
activities” (i.e., delivery of relevant and effective medical care in accordance with the standards)
with the formation of “Joint Commission on Accreditation of Hospitals” later named as “Joint
Commission on Accreditation of Health Care Organizations” in 1960. The Geneva-based
International Organization for Standardization (ISO) was raised in 1946. The ISO 9000 series of
standards have generated maximum interest worldwide.(1) In India, National Accreditation
Board for Hospital and Health Care Providers (NABH), a constituent board of Quality Council
of India (QCI), has been set up to establish and operate accreditation program for healthcare
organizations.(2)

Quality in Healthcare: What is it?

The quality in healthcare system implies that the patients receive high level of care, have access
to a qualified and competent medical staff and to a quality-focused organization, receive
understandable education and communication and that their feedback (satisfaction) is evaluated
continuously. It also benefits patient through appropriate healthcare decisions and
standardization of healthcare processes, focus on patient safety, vulnerable patient, safe
transport, and continuity of care, which is paramount.(3)

Role of the Quality System in a Healthcare Facility

The primary role of any quality system is to provide effective means to assuring that the
customer (patient) requirements are met fully.(1) Some of the key elements/components of
quality that accomplish the patient requirements are patient's safety, staff behavior toward the
patients, correct and timely treatment, compliance to treatment protocols, seeking patient
feedback, and adequate response to it, complete record keeping, acceptable quality care at
affordable prices, clear communication to the patients with respect to the services, best practices
for fixing appointment and service delivery, reliable diagnostic and laboratory support, reliable
support services like canteen, ambulance, pharmacy, etc. safe and pleasant environment,
technical competence, courtesy, and attitude of staff.

The establishment of a quality system in a healthcare organization facilitates the standardization

of the systems and processes (both clinical and administrative). This standardization further
ensures improving the performance of the hospital with respect to above-stated key
elements/components of quality. The quality system thus acts as a vehicle for healthcare
organizations to focus on patient and provider needs and expectations.

Public Health System in India: Quality Issues under

National Rural Health Mission
In our country the healthcare setup can be viewed as government and private/corporate
organizations. The private/corporate hospitals by the virtue of their objectives typically have an
inbuilt quality culture and these have been undergoing certification for various accreditation
standards. These hospitals have gained importance in recent past due to sheer increase in their
numbers and the quality of services they provide.

Still, the governmental setup comprising district hospitals, community health centers, primary
health centers and subcenters are the main stay of healthcare all over the country. Under National
Rural Health Mission (NRHM), with accredited social health activist in place, there is bound to
be a groundswell of demands for health services and the system needs to be geared to face the
challenge. Not only does the system require upgradation to handle higher patient load, but
emphasis also needs to be given to quality aspects to increase the level of patient satisfaction.(4)

Quantitative improvement in services having been achieved in majority of states, the quality
needs scrutiny. In fact a disproportionate increase in quantity without a proportionate increase in
manpower and physical facility has led to a compromise in quality. One of the biggest challenges
under NRHM is to meet the human resource requirement for the services to be delivered. There
is deficit of the staff across the board, specialist doctors, male multipurpose workers, and
laboratory technicians. The area that lags behind most significantly is the health management
information system. Emphasis on interpersonal communication and utilization of the health
facility visit for health awareness has been negligible as the time spent by the doctor per patient
is limited. The other areas still to be addressed are regular patient feedback and its evaluation,
standardization of care processes, patient safety, safe transport, and continuity of care.(5)

Quality Standards in India

Various standards in India that can facilitate the public healthcare facilities to establish quality
system are the Bureau of Indian Standards, NABH standards and Indian Public Health Standards
(IPHS). In order to ensure quality of services IPHS have been set up for public health facilities so
as to provide a yardstick to measure the services being provided there.(4)

Why ISO 9001:2008?

IPHS largely addresses the structural lacunae such as availability of infrastructure, equipment,
and manpower; there are a few components that measure processes and none that measure
outcomes.(6) On the other hand ISO 9001: 2008 (earlier version 9001:2000) promotes the
adoption of a process approach for developing, implementing, and improving effectiveness of a
quality management system (QMS) while enhancing customer satisfaction by meeting customer
requirement. Furthermore ISO 9001: 2008 can act as a stepping stone for implementation of
more resource intensive and stringent standards such as NABH.

When a hospital is certified as complying with ISO 9001: 2008 standards it implies that it is able
to provide services that meet patient's requirements and complies with statutory and regulatory
requirements applicable to the services and aims to enhance patient satisfaction through effective
application of the quality management system and through processes for continual improvement.
(7)

The Indian Initiative

National Health System Resource Centre (NHSRC), a technical support group with NRHM, has
taken up an initiative to facilitate the improvement of service delivery in the public healthcare
facilities to meet the laid down quality process in line with ISO 9001: 2008 standard
requirements, and also to develop a methodology of quality improvement as applicable to public
health facilities.(3)

The Methodology for Quality Improvement

At commencement of the project, a survey is carried out to create a baseline document called the
“As- Is Situation Analysis” which includes the infrastructure, manpower, and equipment survey
of the facility as per quality standards such as the IPHS. Thereafter, analysis and evaluation of
gaps are carried out and an action plan is developed to fill the gaps. The next step is the
preparation of QMS documents which involves preparation of the “To be” process documents.
The “To be” documents entail the processes which are intended to be implemented in the facility.
These include the quality manual, procedure manual, forms and format manual and standard
operating procedures.(3)

A basic orientation and training is provided to the hospital managers and to the existing staff at
the healthcare facilities for facilitating the implementation of action plan. The development of
QMS documents follows in coordination with hospital, local, and state agencies which also
support the effective implementation of documented processes.

After reviewing the status of process implementation, internal audits (IA) are conducted to
elucidate remaining gaps. This is followed by measures/actions for closing these gaps and
ensuring consistency in performance. The efforts are made to improve the processes and service
quality aimed at improving the quality of treatment and end-user-related parameters such as
patient satisfaction, waiting time for registration and examination, indoor illumination levels,
promptness of care, cleanliness of toilets and surroundings, complaint resolution time,
establishment of sturdy admission and discharge process, institution of system for medical and
death audits, timely reporting of investigation results, compliance to statutory rules such as bio-
medical waste (management and handing) rule and regulatory guidelines such as AERB (atomic
energy regulatory board) norms, calibration of measuring equipments, establishment of the
verification system of results of the laboratory test, sterilization and infection control measures,
maintenance of records and documents, review of internal process for continual improvement,
stores and inventory management functions, etc. Efforts are also made to improve internal
process parameters such as timely and adequate availability of equipments and optimization of
store inventories, managerial, administrative, and technical capacity.

After a robust implementation of QMS, a final audit (for certification) is carried out by external
certifying agencies. Once the hospital is certified as ISO compliant, it undergoes yearly
surveillance audit for assessing the compliance to the standards and a 3 yearly recertification
audit for retaining the certificate.

In the journey so far the hospitals facilitated by NHSRC and their certification status are as
follows:(8)

1. Korba District Hospital, Chhattisgarh, certified to ISO 9001:2000 and successfully

completed first surveillance audit.
2. Duffrin Hospital, Allahabad, U.P, certified to ISO 9001:2000 and surveillance audit
completed.
3. Doon Hospital, Dehradun, Uttarakhand, certified to ISO 9001:2008.
4. Deoghar Hospital, Deoghar, Jharkhand, certified to ISO 9001:2008.
5. Karauli District Hospital, Karauli, Rajasthan, certified to ISO 9001:2008.
6. Puri District Hospital, Puri, Orissa, certified to ISO 9001:2008.
7. Ara District Hospital, Bihar, Pending certification.
8. Katni District Hospital, Madhya Pradesh, Pending certification.

Effective implementation of the QMS will address the major quality issues such as the staff
deficit; implementation of the health management information system, interpersonal
communication, and other important unaddressed areas such as regular patient feedback and its
evaluation, standardization of care processes, patient safety, safe transport, and continuity of care
and will thus facilitate improvement in public sector hospital as envisaged under NRHM. Once
the hospital is certified, it is important that it focuses on maintaining the quality and that the
hospital staff is continuously motivated for continual and ongoing quality enhancement to higher
levels of quality of healthcare.

The 8 universal principles of quality

management
Chances are, if someone asks you about the ISO 9001 certification, you’ll look at them blankly.
But the principles set out by this certification are actually in use in pretty much every modern
business – you probably draw upon at least two of them in your average working day.

So, what are universal quality management principles and

where do they come from?
They're set out by the International Standard for Organisations (ISO), which has been developing
guiding principles to protect businesses from fatal errors since its foundation in 1947. ISO 9001
is the catchy name for its Quality Management System (QMS) Standards model, which was
introduced in 1994.

The most current version, which came into force in 2015, was adopted to address new regulatory
requirements and improve on the previous model.

The QMS standards apply worldwide, and their application is overseen by the ISO’s Technical
Committee, 176. All these numbers are starting to make sense now, right? The committee also
decides when to update the standards and writes new guidelines roughly every three years.

The principles set out by the ISO 9001 were invented in the 1990s by a small group of experts,
who created them using the philosophical teachings and business knowhow of the previous
century. Let’s take a look at each of them in detail.

Principle 1: Customer focus

The first, and arguably most important principle, argues that a business wouldn’t exist without its
customers. Therefore, organisations should strive to understand their current and future
customers, in order to better meet their requirements and expectations.

Key benefits of cultivating good customer relationships include an increased market share and
boost to revenue, as well as improved customer loyalty. If you are seen as understanding and
reacting appropriately to consumer demand, the success of your business is pretty much
guaranteed, so it’s worth paying close attention to this principle.

Principle 2: Leadership

This principle extols the virtues of strong, purposeful and unifying leadership. Leaders are
responsible for creating a productive and progressive business environment. They also are in
charge of ensuring that future hires maintain that atmosphere.

Implementing this principle in your workplace relies upon having an established vision for the
business, as well as the right leaders in place to promote that vision to the rest of the team.
Spending some time getting this right from the get-go will save you time and stress in the future.
Principle 3: People involvement

Just as your business would be nowhere without a customer base, it also wouldn’t get very far
without a balanced, multi-skilled team either. Employees at every level of the organisation are
crucial to its success, and this principle is all about recognising that.

As an employer it's vital to ensure that your team are motivated and engaged, not just in their
day-to-day responsibilities, but also in the company as a whole. For this to happen, staff need to
understand the importance of their role and how it fits into wider company objectives, as well as
take responsibility for any problems that might impede them from doing their job to the best of
their abilities.

Principle 4: Process approach

A process-driven approach can help companies to avoid logistical problems that often stem from
confusion over the right way to go about things. It also future-proofs your business, as having set
processes ensures that there’s no moment of flat panic when a key team member moves on,
leaving everyone in the dark about key elements of their job.

Developing processes for every area of your business, from sales to marketing, finance to HR,
will ensure that resources are used most effectively, resulting in cost-effective and consistent
results. It also allows you to dedicate time and attention to bigger and more exciting tasks!

Principle 5: Systematic approach to management

This principle is linked to the previous one, and argues that identifying, understanding and
managing processes using a clear system will help to streamline your business. By ensuring that
team members are dedicating the right amount of attention to key tasks, you’ll eliminate wasted
time and make your business more efficient.

A systematic approach also allows everyone to have access to every stage of certain processes
and stay up to date with progress. Plus, it looks great for prospective new clients when your
business is organised. Win-win.

Principle 6: Continual improvement

As the old adage goes, if you’re not going forwards, you’re going backwards. A business should
always be pushing for improvements, because if you’re not, you can bet that your competitors
will be.

Continual progress is a permanent goal of any successful organisation. Take a look at the world’s
top 10 most prosperous organisations and you can guarantee that they have entire teams
dedicated to ensuring that they are always onto the next thing. Commitment to improvement also
allows you to be the market leader, as you’ll be the ones setting the agenda, rather than playing
catch-up to your competitors.
Principle 7: Factual Approach to Decision Making

This principle states that effective decisions are made based on rational analysis of data. Whilst a
gut feeling can be useful in some situations, it won’t really stand up when you’re explaining to
your board of investors why your profits are down by 10% this year.

Before making any business decisions, big or small, ensure that you have all the facts. That way,
if you’re ever questioned about why you made a certain decision, or asked to prove how that
decision benefits your business, you’ll have all the data at your fingertips to fall back on. This
principle also relies upon having access to reliable and accurate data, another vital aspect for a
modern-day business.

Principle 8: Mutually Beneficial Supplier Relations

Okay, so you’ve got a fantastic management system, excellent customer relationships and a
comprehensive business plan. There’s one thing missing – what are you delivering to your
customers?

Whether your business provides goods or services to customers, it’s likely you’ll rely on some
sort of supplier. This principle dictates that relationships between your company and any
suppliers must be mutually beneficial in order to add value to both parties. It allows both of you
to react more quickly and flexibly to customer demands if things are smooth and harmonious
between you, as well as making it easier to negotiate on costs.

These principles are designed to be the basis for a host of other subsidiary standards including
the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory
Practices (GLP). The ISO really does love its acronyms, doesn’t it?

Joking aside, the QMS principles don’t just underpin quality systems across the globe – they’re
also the foundation of good business practice, regardless of industry or sector. By following
them, you can ensure that your business is well-organised and efficient – the very definition of
total quality management.

In Summary
The 8 universal principles of quality management are:

1. Customer focus
2. Leadership
3. People involvement
4. Process approach
5. Systematic approach to management
6. Continual improvement
7. Factual approach to decision making
 8. Mutually beneficial supplier relations

Define, Measure, Analyze, Improve, Control

(DMAIC) Methodology as a Roadmap in
Quality Improvement
LEARNING OBJECTIVES
1. Know the history of Lean, Six Sigma, and DMAIC
2. Describe the applicability of DMAIC methodology to healthcare
3. Describe the steps and process tools used in DMAIC

HISTORY OF LEAN, SIX SIGMA, AND DMAIC

METHODOLOGY
The term DMAIC, which stands for “define, measure, analyze, improve, and control,” represents
a method for process analysis used in Lean Six Sigma. To understand DMAIC methodology, one
must first know the history of Lean and Six Sigma. “Lean” production originates from the
Toyota Production System introduced in Japan by engineer Taiichi Ohno in the 1950s through
1980s. Lean principles (aspects of which are shaped by Japanese culture and Japanese Zen
Buddhism) are designed to permeate every aspect of an organization from company culture and
philosophy down to leadership, technology, teamwork, and task standardization.[1] Ultimately,
the goal of Lean is to improve efficiency of a process and deliver the best product by eliminating
waste.[1] Six Sigma is a Western concept that originated from statistical modeling of
manufacturing processes themselves. In the 1920s, Walter Shewhart created the basis for
statistical process control with the concept that observed variation in a manufacturing process
leads to deviation which results in an unideal product.[2] Furthermore, changing a manufacturing
process without proper analysis can worsen variation and result in more defects. Shewhart went
on to work with physicist Edwards Deming to develop the “Plan Do Study Act” (PDSA) cycle in
the 1930s.[3] These concepts were applied by engineer Bill Smith in the 1980s to reduce process
variation at Motorola and were coined, “Six Sigma.” [2] “Lean Six Sigma” combines the
principles of both Lean and Six Sigma with the overarching goal to reduce both waste and
variation within a system using data and continuous quality improvement. To reduce variation in
a process, Six Sigma utilizes statistical analysis through a 5-step approach called the DMAIC
method.

APPLICATION OF SIX SIGMA AND DMAIC IN

HEALTHCARE
Six Sigma and the DMAIC method originated in the manufacturing industry; however, by the
late 1990s several healthcare organizations had adopted these concepts to improve patient safety
and healthcare delivery.[4] Challenges exist when implementing DMAIC methodology into a
dynamic multifaceted health system. Unlike the production line in a factory, a health system is
not delivering a singular standardized product and patients are not the only consumers.
Healthcare professionals may bristle at the notion of standardization, believing it will limit their
autonomy to make decisions.[5] Gold-standards and medical recommendations may exist, but
often with variation in strength of evidence; these are meant not as hard rules but rather as a
guide in conjunction with clinical judgment. These qualities of patient care make removal of
variation difficult; however, ample opportunities appropriate for standardization still exist. Lean
Six Sigma concepts have been applied successfully to improve these various aspects of patient
care. In a recent systematic review from 2020, Ninerola and colleagues identified 196
manuscripts outlining Six Sigma use in the healthcare sector.[6] Most of these originated from
the United States and were published case studies. Multiple specialties and services have used
these methods to standardize and improve one or more processes. For example, Six Sigma
methodologies using DMAIC have been used to reduce wait times for radiology results, improve
the safe administration of medications, and decrease unnecessary antibiotic use.[7–9]

STEPS OF DMAIC
Figure 1 is adapted from recent publications discussing the use of DMAIC in healthcare and
outlines the steps and process tools involved.[9,10] One advantage to DMAIC methodology
compared to PDSA cycles (also known as the Deming or Shewhart cycle) is that a more robust
preparation of measurement and analysis occurs before any change or improvements are
proposed. Change is not proposed until step 4 of 5 (as opposed to step 2 of the PDSA cycle).
Additionally, process control is required as a built-in final step, which may help impart lasting
change regardless of whether the cycle is repeated.
Figure 1

Define, measure, analyze, improve, control (DMAIC) methodology and process tools[9,10]

Step 1: Define

In the define phase, stakeholders must clearly define the project objective, scope, and if possible,
the time frame. Stakeholders must agree on what the target of the project is, as well as its
duration. This may include a process map or other analysis (Financial, Stakeholder, or Kano
analysis), to develop an aims statement.

Step 2: Measure

Measurable data to serve as quality or safety indicators are identified. This may require
conducting data collection to establish baseline metrics. Data extracted from aggregate databases
should be analyzed for accuracy. Data should be able to be displayed visually for subsequent
analysis. Box plots, pareto charts, control charts, or histograms may be used which will
subsequently be used in further steps. An exemption from the institutional review board can
usually be obtained for data being used for quality improvement.

Step 3: Analyze

This step merges what is known about the process as well as the baseline data to identify and
validate the causes of errors, deviation, delays, waste, or other etiologies of defects in the
process. Analysis may include pareto diagrams, histograms, pie charts, Ishikawa (fishbone)
diagrams, a 5-whys analysis, or other tools to explore cause and effect.

Step 4: Improve

In this phase, the team works to address the root cause and make changes to eliminate the issues
leading to variability and waste in the process. Communication with team members and team
involvement and commitment is parament. Stakeholders should be comfortable brainstorming
and using clear and regular communication about potential solutions. Various stakeholders may
disagree about who or what needs to change to reach the targeted goal. National benchmarking
and discussion of established best practices may be needed. Keep in mind that interventions
relying on human memory (education, pocket cards, policy changes, email reminders) may be
appropriate, but will be weaker than those that are tied directly to process flow (hard stops in
ordering, electronic alerts). The concept of Kaizen (a Japanese term meaning, “change for the
better”) can help ground the group in the idea that improved operations should involve all
employees and are continuous and methodical process.[11]

Step 5: Control

The control phase is crucial to achieving sustainable change and requires tracking process
performance. A process control plan usually builds on the new ideal process map indicating who
is responsible for each aspect of the new process. The team must be aware of new potential
problems that could arise because of work arounds, design flaws, or resistance to process change.
Ongoing control charts can monitor variation. Team members must be aware of the metrics on a
regular basis so that “out of control” performance can be corrected, and the control plan can be
updated. How often team members are updated (daily, weekly, annually, etcetera) is dependent
on the metric being tracked and the amount of time required to gather and/or verify the data.

Go to:
DMAIC can serve as a roadmap to apply the Lean Six Sigma philosophy and improve a process
even in a complex field such as healthcare. Involving the relevant stakeholders and building in
long-term plans for process control are crucial to its applicability and sustainability.

5 most widely used types of Quality

Management indicators

Using quality indicators to measure and check a company's performance are the best friends of
those who monitor and analyze the operation, because they point the way and are a great
benchmark.

The quality indicators can be diversified and have the function, by means of standards pre-
established by the company, of measuring the expected final result in a reliable manner.

It’s worth remembering that monitoring the operation’s results regularly through goals and
numbers is very important, because they will be proof that the process is operating efficiently.

To help you structure this monitoring in your company, we have listed the 5 Quality
Management indicators used the most by PariPassu's customers.

But do you know what the main

advantages of quality management
indicators are?
 Obtain information to help in the decision making process
 Contribute to strategic planning
 A view of the business that is more critical
 Distribute and make better use of resources
 Avoid and eliminate errors
 Continuous improvements to the process
check out the highlights of the
indicators

1. Efficiency indicator

The efficiency indicator allows you to detect waste of resources, which will reduce your
productivity.

Efficiency focuses on the process and reflects indirectly on the customers. We can mention a few
points that interfere with this indicator:

 Work hours per product produced

 Amount of money spent for the execution of a certain activity
 Number of hours a team’s work is interrupted or a machine is shutdown

But do you calculate it? This can be measured through production management software that
allows the control of raw material purchases, cost control, disposals, among other points.

2. Safety/Quality Indicator
This indicator is critical in order to prevent damage to the customers' health or physical integrity,
for example.

A simple way of measuring this is by performing inspections and controls of the production, of
the final products, of the raw materials, and also of the critical points of the operation’s control,
through checklists and analyses.

It’s important to check that the safety measures and requirements of national and international
certifications and standards are being met in your product.

CLICQ automated checklist application

3. Efficiency indicator
Efficiency measures the level to which results are achieved, i.e. focus is on the accomplishment
and not on the resources spent to reach such a result.
Thus, efficiency indicators focus on the product and the result obtained, and are directly related
to customer satisfaction. This is precisely why they relate more to issues, such as customer
service, satisfaction, punctuality, reliability, etc.

As an example of efficiency indicators, we have:

 Percentage of customer complaints;

 Product durability;
 Quick completion of a call;
 Reliability of the product, service or team;
 Product or service or team performance.

And it’s worth remembering that these efficiency indicators are linked directly to the company's
profit increase.

4. Effectiveness Indicator
Effectiveness is merely the combination of efficacy and efficiency. This indicator shows the
consequences of a product or service.

Effectiveness indicators can measure whether the proposed objectives have been achieved.

In other words, an effective company performs processes that provide good results for
customers, with reduced costs and increased profitability. Effectiveness indicators answer
questions, such as:

 Is the service offered relevant to the customer?

 Has the project contributed to increase revenue?
 Does the project reduce employee mistakes.

5. Customer Service indicator

Among the quality indicators, the customer service indicator will show whether your company is
really delivering what it promises when offering a certain product or service to consumers.

A very important factor here is the need for the after-sales process, to follow up with customers
very closely.

You’ve probably heard that the best customer satisfaction index is the word of mouth strategy,
right? Well, monitoring the customer service indicator is very important so you can know if your
brand has customers who will promote your company for you.
Implementing quality indicators
It’s worth remembering that quality indicators vary from company to company, and according to
the organizational goals of each one.

The indicators mentioned here tend to be general for any type of business. Our tip is to always
evaluate what makes sense in terms of monitoring at this time for your company; to do so, the
indicators must be 100% related to your company's goals, for example:

 Be used in the decision-making process;

 Be a strategic point;
 Adhere to the company's business;
 Be relevant across all levels and sectors;
 Be based on reliable and measurable data;
 Serve as input for an action plan.