Quality assurance cycle

Quality Assurance Cycle
BPH 4th year
HSM

Quality processes
Quality
Assurance
Quality
Control
Quality
Improvement
Total Quality
Management

Quality processes
• Quality Assurance: It is the process of assuring
compliance to specifications, requirements or
standards and implementing methods for
conformance.
• Quality Control: It is a management process where
actual performance is measured against expected
performance, and actions are taken on the
difference.

• Quality Improvement: It is an organized,
structured process that selectively identifies
improvement teams to achieve improvement in
products or services.
• Total Quality Management: It is a system of
continuous improvement employing
participative management and centered on the
needs of customers.
TQM includes QA, QC and QI.

Steps in Quality assurance cycle
1. Planning for quality assurance
2. Developing guidelines and setting standards
3. Communicating standards and specifications
4. Monitoring quality
5. Identifying problems and selecting opportunities for
improvement
6. Defining the problem operationally
7. Choosing a team
8. Analyzing and studying the problem to identify its root
causes
9. Developing solutions and actions for improvement
10. Implementing and evaluating quality improvement
efforts

Roles and responsibilities in quality
improvement
Decision makers
Health-service providers
Communities and
service users
Critical relationships in roles and responsibilities

a. Role and Responsibilities of Decision
Makers
• The main concern of quality improvement is policy and
strategy development.
• This critical activity will need to engage the whole
health system, this responsibilities is normally rest at
national and regional levels.
• The main concerns of decision-makers at these levels
will be
- to keep the performance of the whole system under
review
- to develop strategies for improving quality outcomes
which apply across the whole system.

Role and Responsibilities of Health
service providers
• The core responsibilities of health-service providers
for quality improvement are different.
• Providers may be seen as whole organizations,
teams, or individual health workers.
• In each case, they will ideally be committed to the
broad aims of quality policy for the whole system,
but their main concern will be to ensure that the
services they provide are of the highest possible
standard and meet the needs of individual service
users, their families, and communities.

Role and responsibilities of
Communities and health service users
• Improved quality outcomes are not, however,
delivered by health-service providers alone.
Communities and service users are the co-producers
of health.
• They have critical roles and responsibilities in
identifying their own needs and preferences, and in
managing their own health with appropriate support
from health-service providers.

Equally important to recognize the connections
between three parts of health system
• Decision-makers cannot hope to develop and implement
new strategies for quality without properly engaging
health-service providers, communities, and service users.
• Health-service providers need to operate within an
appropriate policy environment for quality, and with a
proper understanding of the needs and expectations of
those they serve, in order to deliver the best results.
• Communities and service users need to influence both
quality policy and the way in which health services are
provided to them, if they are to improve their own health
outcomes.

A process for building a strategy
for quality improvement
• It contains seven activities (“elements”) within the
three categories of analysis, strategy, and
implementation.
• As a cyclical process it reflects a frequently adopted
approach to quality improvement – understand the
problem, plan, take action, study the results, and
plan new actions in response.
• The main implication of this approach is that
strategies for quality improvement are not ’fixed’.

A process for building a strategy for
quality

Analysis
This first part of the cyclical process has three
elements.
Element 1. Stakeholder involvement
Element 2. Situational analysis
Element 3. Confirmation of health goals

Element 1. Stakeholder involvement
• Quality improvement is about change. For this
reason, an important early step is to determine who
are the key stakeholders and how they will be
involved.
• Key stakeholders - include political and community
leaders, service users and their advocates, health-
care delivery organizations, regulatory bodies, and
representative bodies for health workers. A further
central group of stakeholders would be the senior
officials responsible for quality within the ministry of
health.

• formation of a board or steering group drawn from
the stakeholder groups, that would remain involved in
all stages of the process, including implementation
and the review of progress.
• The board or steering group could provide the main
focus for accountability and preparing advice to
decision-makers, as well as wider communication with
all interested parties. Clear terms of reference would
be essential.
• To avoid confusion, those leading the process would
need to know clearly from the outset who would
make policy decisions and determine the range of
new quality interventions.

Element 2 Situational analysis
• Situational analysis is a mapping process which allows a
clear baseline to be established before any new
interventions are considered or existing ones adapted.
• The situational analysis will need to cover many areas,
such as
- Current structures and systems within the ministry of health
relating to quality improvement.
- Current policies in health and across sectors
- Current health goals and priorities.
- Current performance of the health system.
-Current quality interventions.

Element 3. Confirmation of health
goals
The third element in the process of analysis is to
confirm the wider health goals of the health system.
This activity is important to deal as a separate
element because:
• it is critical for any new interventions in quality improvement
to be seen by stakeholders as aligned with and serving the
broader health goals of the system;
• the situational analysis may cause some health goals to be
called into question by policy-makers and other stakeholders;
• without clear and agreed health goals, the focus and purpose
of any new quality intervention is questionable.

• The health goals of any health system will normally
be set through a political process, and may be wide-
ranging. They might fall within the following broad
categories.
• Reducing mortality
• Reducing morbidity
• Reducing health inequalities
• Improving outcomes for a particular disease
• Making health care safer

Building the strategy: Choosing
interventions for quality
• The second part of the cyclical process is
concerned with the development of new
strategies in response to analysis,
Element 4 - development of quality goal
Element 5 -choosing interventions for quality
Element 6- planning for their implementation

Element 4 - the development of
quality goal
• The choice of quality goals will be driven by the agreed
health goals, and will relate to the different
dimensions of quality. The questioning process in
relation to the health goal will be to ask the following.
• What are the deficiencies in effectiveness?
• What are the deficiencies in efficiency?
• What are the deficiencies in accessibility?
• What are the deficiencies in acceptability?
• What are the deficiencies in equity?
• What are the deficiencies in safety?

The examples illustrate the connections
between broader health goals and related
quality goals
• .Health goal: improve health outcomes for rural populations.
Quality goals: improve local access to health services;
improve the acceptability of those services.
• Health goal: reduce avoidable mortality from preventable
risks.
Quality goals: reduce medication errors by 50%.
• Health goal: improve outcomes for people with cancer.
Quality goals: improve access to diagnostics and early
treatment; improve effectiveness through evidence-based
practice; ensure continuity of care.

Element 5 -choosing interventions for
quality
• This element moves attention from the “what” to the
“how”.
• It calls for judgements to be made about
interventions, and agreement to be reached about
the process of implementation.
• To assist this process, it is helpful to follow a simple
‘map’ of the domains where quality interventions
could be made (and where current quality problems
might be located).

Mapping the 'Domains'
• It identifies six domains, are intended to help policy-
makers address quality issues at a more strategic
level.
a. leadership
b. information
c. patient and population engagement
d. regulation and standard
e. organizational capacity
f. models of care

Six Domains of quality interventions

Element 6- planning for their
implementation
• Another important outcome to be achieved in this
part of the cycle is agreement about the plan for
implementation of the agreed interventions.
• Any implementation plan will need to meet local
considerations, but there are generic issues which
need to be considered, such as those suggested in
the following questions.
• Who will lead the change process?
• What resources will be available to support implementation?
• What technical expertise will be available to support
implementation?

• How will accountability work?
• Who has the authority to amend the implementation plan?
• Will the change process start with pilot projects?
• What will be the plan for scaling up?
• What will be the timetable for implementation?
• How will decision-makers communicate with stakeholders?
• What will be the key milestones?
• How will progress be monitored?

Implementation
• The third part of the cyclical process is concerned
with the management of agreed quality strategies,
and with reviewing progress and the impact of
changes as an input to the continuing activity of
ANALYSIS. It consists of
Element 7. Implementation process
Element 8. Monitoring progress

Element 6. Implementation process
• This element moves the focus to managing the
implementation process.
• The strategy will have identified a framework for
implementation and covered key issues such as
leadership and accountability, timescales and
milestones, and the monitoring of progress.
• The success of the interventions will then depend on
maintaining a clear focus on implementation,
sustaining interest and commitment, and having the
capacity to make tactical decisions to modify
activities in response to feedback.

The responsibilities of board for
sustainability
Having a programme board or steering group with
appropriate stakeholder representation and terms of
reference could be an effective way of sustaining a
intervention for quality strategy. The core responsibilities
of such a board might include:
• keeping under review progress on implementation,
adherence to timetables, and achievement of targets
and goals;
• redirecting resources;
• providing an account of progress to interested parties;
• modifying timetables and milestones;

• preparing the health system for scaling up where a
phased approach is planned;
• keeping new evidence under review and modifying
plans to take account of that evidence.

Element 7. Monitoring progress
• The final element is to maintain a focus on the
delivery of the improved outcomes and benefits
being sought. This focus is important because:
• if results are not those that were expected, it will be
important to make early decisions about how the
strategy and its selected interventions might be
modified to achieve better results;

• any investment of effort and resources in quality
improvement can only be justified in terms of
improved outcomes – giving proper account to
stakeholders for that investment can only be done
with information about changing outcomes; and
• maintaining the motivation and commitment of
stakeholders in the change process will be helped by
being able to point both to progress and
achievements, and to the delivery of the quality
goals to which they have subscribed.

Plan for monitoring
• The quality measures to be used will have been
agreed earlier in the process,when health goals and
related quality goals were set.
• Wherever possible, existing information sources
should be used to monitor progress and outcomes;
the
• Implementation plan should include arrangements
for collecting new data if required.
• Tools such as questionnaires, matrix can be used

Example-A matrix for mapping quality
interventions at country level

Quality Control
• Quality control (QC) has a narrower focus than
quality assurance. Quality control focuses on the
process of producing the product or service with
the intent of eliminating problems that might
result in defects.
• QC includes the operational techniques and the
activities which sustain a quality of product or
service that will satisfy given needs; also the use
of such techniques and activities.

• Quality control is the function of ensuring that
the product or service quality conforms to
predetermined standard.
• Once the standard have been determined, the
acceptability of the actual work can be compared
with expected standard.
• If there is a serious lack of conformity, corrective
measures may be neccery.

Five activities implies in Quality
Control Process
• Determining tolerance i.e. range within which
deviation in actual quality from standard will be
acceptable.
• Conducting inspection and tests of materials,
processes and products.
• Isolating acceptable units from those, which do not
conform to quality standards.
• Bringing causes of deviations to the attention of the
concerned manager
• Suggesting ways and means of improving the
quality

Methods/ Techniques of Quality
Control
• Two main techniques of quality control -
a. Inspection- involves periodic checking and
measuring before, during and after the production
process, aims to detect and isolate defective work
and prevent it occurring in future.
b. Statistical quality control-statistical techniques is
applied for the maintenance of quality standard. It is
based on the theory of sampling and laws of
probability.

Total Quality Management:
• Total Quality Management or Quality
management is a system of continuous
improvement employing participative
management and centered on the needs of
customers. TQM includes QA, QC and QI.
• It is the totality of functions involved in the
determination and achievement of quality

• Total quality management is a management approach
centred on quality, based on the participation of an
organisation's people and aiming at long term success
(ISO 8402:1994). This is achieved through customer
satisfaction and benefits all members of the organisation
and society.
• In other words, TQM is a philosophy for managing an
organisation in a way which enables it to meet
stakeholder needs and expectations efficiently and
effectively, without compromising ethical values.
• TQM is a way of thinking about goals, organisations,
processes and people to ensure that the right things are
done right first time. This thought process can change
attitudes, behaviour and hence results for the better.

Definitions
• TQM is a cooperative form of doing business that relies
on the talents and contributions of both labour and
management to continually improve quality and
productivity using teams.
Josep R. Jablonski 1991
TQM is creating an organizationl culture committed to the
continuous improved of skills, teamwork, process,
product and service quality and consumer satisfaction.
Arthur R. Tenner and Irving J. DeToro 1997
• TQM is continuous, customer-oriented, employee-driven
improvement.
Richard Schonberger 2002

The principles of quality
management
There are eight principles and elements of quality
management:
• customer-focused organization
• leadership
• involvement of people
• process approach
• system approach to management
• continual improvement
• factual approach to decision making
• mutually beneficial supplier relationships

TQM Techniques
• Benchmarking -process of continually comparing.
Two types of benchmarking.
i. Internal ii. External
• ISO Standards - series of number 9000 to 9004. In
the 1990s, another system introduced-ISO 1400. In
Nepal, the Nepal Bureau of Standards and Metrology
NBSM, ISO 9000 has adopted, as a international
assessment criteria, 'ISO 9000 certification'
• Quality circles- viewed as increase of worker
involvement and powerful method of employee
empowerment

• Responsiveness- responds over their competitors. If
The organization responds quickly, it is faster than
competition. Faster organizations are more likely to
be the winners, better and smarter.
• Outsourcing- process of contracting out for some
functions of an organization to outside firms. It
increases efficiency, reduces cost and time, enhances
productivity of resources and improve quality.

• SIX SIGMA- is a statistical model coupled with specific
quality tools. It is fact-based, data driven philosophy
of quality improvement that values defect prevention
over defect detection.
• Six sigma attempts to design quality rather than
measuring the quality after production, the premise
behind Six Sigma is to design, measure, analyze and
control the input of production process to achieve
the goal of no more than 99. 99% defects per million
procedure.
• Kaizen- is a Japanese term, is the elimination of
waste.

TQM Tools include:
• Pareto analysis
• Control chart
• Cause and effect diagrams
• Flowcharting
• Others-
- histogram/ bar graph
- check list
-check sheets

Pareto Principle
• Pareto Principle

• The Pareto principle suggests that most effects come
from relatively few causes.
• In quantitative terms: 80% of the problems come
from 20% of the causes (machines, raw materials,
operators etc.);
• 80% of the wealth is owned by 20% of the people
etc. Therefore effort aimed at the right 20% can solve
80% of the problems.
• Double (back to back) Pareto charts can be used to
compare 'before and after' situations. General use, to
decide where to apply initial effort for maximum
effect.

• Control charts are a method of Statistical Process
Control, SPC. (Control system for production
processes).
• They enable the control of distribution of variation
rather than attempting to control each individual
variation.
• Upper and lower control and tolerance limits are
calculated for a process and sampled measures are
regularly plotted about a central line between the
two sets of limits. The plotted line corresponds to
the stability/trend of the process.

Cause and Effect , Fishbone, Ishikawa
Diagram

• The cause-and-effect diagram or fishbone diagram is
a method for analyzing process dispersion.
• The diagram's purpose is to relate causes and
effects.
• Three basic types: Dispersion analysis, Process
classification and cause enumeration.
• Effect = problem to be resolved, opportunity to be
grasped, result to be achieved.
• Excellent for capturing team brainstorming output
and for filling in from the 'wide picture'.
• Helps organize and relate factors, providing a
sequential view.
• Deals with time direction but not quantity. Can not
demonstrate interrelationships.

Flow Charts
• A Flow charts is a pictorial representation that shows
pictures, symbols or text coupled with lines, arrows
on lines show direction of flow.
• This chart can be used when the managers are trying
to identify problems/opportunities and decision
points.
• This chart presents ideal path of a work. Any
deviation from ideal path is detected.
• A flow charts is useful tools for planning and control
of quality

Measurements
• After using the tools and techniques an organisation
needs to establish the degree of improvement.
• Any number of techniques can be used for this
including self-assessment, audits and SPC.

TQM Process
• TQM processes are divided into four sequential
categories: plan, do, check, and act (the PDCA cycle).
Act Plan
Check Do

• Plan -In the planning phase, people define the
problem to be addressed, collect relevant data, and
ascertain the problem's root cause;
• Do - in the doing phase, people develop and
implement a solution, and decide upon a
measurement to gauge its effectiveness;
• Check- in the checking phase, people confirm the
results through before-and-after data comparison;
• Actin the acting phase, people document their
results, inform others about process changes, and
make recommendations for the problem to be
addressed in the next PDCA cycle.

Advantages of Quality Studies in
Health Care
1. Accomplishments of the programme will be listed.
2. Weak points in the programme will be identified.
3. Process of quality assessment itself will improve
quality of care.
4. Health care financing will be more focused.
5. Determines the utilization pattern of health care
services.
6. Aspects of care that can maximize effectiveness
may identified.
7. Reflects changing and emerging needs in health
care.

Steps in Conducting A Quality
Assessment Study
1. Identify the objectives of the programme to be
evaluated
2. Identify the indicators of quality for the objectives
3. Develop standards for the indicators
4. Identify the methods of assessing quality
5. Sampling in quality assessment need not be strictly
representative.
6. After data collection organize the data in terms of
the indicators.
7. Compare it with standards developed

Techniques of Conducting Quality
Assessment
• Review of statistics
• Review of records
• Special studies
• Patient surveys
• Household surveys
• Assessment of consumer satisfaction
• Observation

Types of Quality
• Product based quality: product’s attributes e.g.
sweet mangoes, soft silk etc.
• User based quality: the ability of the product to
meet the user’s needs and expectations.
• Value based quality: cost benefit relationship. It
is the ratio of what the customer gets and gives.
• Manufacturing based quality: Conformance to
established standards.
• Transcendent based quality: It is inherent
value apparent to the customer. “Beauty lies in the
beholder’s eyes”

STANDARDS
• A Standard is a statement of expected level of
quality.
• It states clearly the inputs required to deliver a
service, how things should be done (process) and
what the output or outcome should be.
• When we compare what is expected in the standards
to what we do, we shall be able to identify any
quality gaps and then make plans to improve upon it.

• Standards can be set for any level of the healthcare
system i.e. national, regional, district, sub-district.
• There are also international standards e.g. those
developed by the WHO that can be adapted to that
of the country.
• They can be developed for use in public health,
clinical care and support services

Types of Standard
• Input Standards- Input or structure standards define
the resources that must be supplied for the activities
to be carried out.
• Process Standards -Process standards describe the
tasks or steps that must be carried out until the
activity is completed.
• Output/ Outcome Standards -Output/ Outcome
standards describe the outputs or results of the
activities carried out.

Input standards for antenatal Clinic
Physical structure Equipment and
supplies
Staff

Process standards
• National Reproductive Health Policy, Standards and
Protocols
• Laboratory standard operating procedures; and
• Medical records procedures.

Output/ Outcome standards
• Pregnant women will attend at least four times
during pregnancy.
• Ninety percent (90%) of women attending antenatal
clinic will report satisfaction with care given (client
survey).

Uses of Standards
Standards are used to:
• Define quality
• Determine, inputs, processes and outcomes, and
• Develop indicators to monitor quality.

example
• standards for antenatal care using the three
(3) areas namely,
• input,
• process and
• outcome

Input standards
• These are measured in terms of quality of physical
structure, equipment, supplies and staff.
• Physical structure-
- The antenatal clinic should have a reception and
waiting area with adequate seating for women.
- A separate examination room for history and
examination
• Staff
• Qualified nurse midwife(s)
• Support staff

• Equipment and supplies
• Standing scale with Height measure
• Sphygmomanometer
• Maternal health records
• Fetoscope
• Dipstick for urinalysis
• Measuring tape
• Examination table
• Immunization equipmentsseparate examination room for
history and examination
• Drugs- Folic acid, Iron, anti-malarials
• Laboratory for basic tests

Methods used for communication to staff
about Standard
• Training of health workers (in service and on the job
training)
• Launching of the standard
• Seminars/ conferences
• Developing job aids
• Support supervision.

Barriers of quality health services
• The health system environment
• The health system infrastructure
• Cost of services
• Socio/cultural constraints
• Service user's perception regarding medical care
• Language and education
• Trust by users in health care providers and procedures
• Service provider's attitudes and skills
• Lack of assertiveness and low self-esteem by users
• Lack of information/knowledge of available health
services in community

• monitoring quality of care;
• comparing and ranking performance of facilities
• providing technical support to regional QA teams;
• mobilizing resources for quality assurance.

Issues and challenges in quality of
health care
• Inequity due to mal distribution of scarce health
resources
• Shortage of trained personnel and skewed distribution
• Increasing expenditure in health
• Expansion of health business in health center
• Continuity of services
• Quality assessment, techniques and tools
• Monitoring and reporting system

Roles and responsibilities of
organizational levels in Quality
• The role of national level is to give direction and
support to regions in the implementation of quality
assurance. A national QA team for the establishment
of a quality assurance unit will serve the following
functions:
• developing policies and strategies;
• co-ordinating countrywide quality assurance
program;
• developing clinical guidelines and protocols;
• setting national standards ;

• Socioeconomics plays an important role in a family's
decision to seek medical assistance The uncertainty
regarding the ability to pay for medical cost may
discourage one to seeking medical help. For example,
cost and prices of services, transport cost, wages of
quality of staff, price of quality of drugs and other
consumables.
• Waiting for a long period e.g. two or three-month
doctor’s appointment, facing long lines, and long
hours discourages individuals seeking healthcare
services.

• Language and literacy can be a barrier to healthcare.
Lack of information on available health care
choice/providers, the embarrassment of sharing
personal information or admitting ones lacks of
reading and writing skills can be a barrier to entering
a medical facility.
• Community's culture, attitudes and norms plays a
significant role in healthcare barriers through
negative perceptions or fears regarding medical care.
For example, culturally, patients may have difficulty
with a doctor of the opposite. Another cultural
barrier to medical services is an individual’s religious
belief.

• Trust plays a major role in seeking medical attention.
Lack of trust by users in health care providers, making
people reluctant to use the respective services.
• Staff absenteeism, limited opening hours that do not
allow for dealing with emergencies or working times
are not convenient for patients, especially working
people.
• Negative experiences with medical staff may
influence patients to postpone medical attention. For
example unwelcoming staff attitude or poor
interpersonal skills as well as complex billing systems
at hospitals play barrier in quality of care.

• Lack of assertiveness and low self-esteem by users
from among the poor, which increased the difficulty
of accessing services.
• The effect of non-financial barriers, such as lack of
health awareness, apparent unfelt need or lack of
opportunity (defined as exclusion from social and
health providers) are important hindering factors to
assure of quality improvement of health services.

Quality assurance cycle

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