ADDIS ABABA MEDICAL AND BUSINESS

COLLEGE

Apply Quality Control for pharmacy 1st year regular

and ext.2012entry

LEARNING GUIDE

Unit of Competence : Apply Quality Control

Module Title : Applying Quality Control
LG Code : HLT NUA3 M015LO1
TTLM Code : HLT NUA3 TTLM 0112v1

LO1: Determine quality standards

LO2: Assess the quality of work
and product delivered
LO3: Record information

LO4: Study causes of quality deviations

LO5: Complete documentation

LO1: Determine quality standards

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
0
 Instruction Sheet Learning Guide 1

This learning guide is developed to provide you the necessary information

regarding the following content coverage and topics –
 Quality standards and procedures
 Quality standards documents

Learning Instructions

1. Read the information written in the “Information Sheets”.

2. If you earned a satisfactory evaluation proceed to next module. However, if

your rating is unsatisfactory, see your teacher for further instructions.

3. Read the “Operation Sheet” and try to understand the procedures discussed.

4. Practice the steps or procedures as illustrated in the operation sheet. Go to your

teacher if you need clarification or you want answers to your questions or you

need assistance in understanding a particular step or procedure

5. Do the “LAP test” (if you are ready). Request your teacher to evaluate your

performance and outputs. Your teacher will give you feedback and the

evaluation will be either satisfactory or unsatisfactory. If unsatisfactory, your

teacher shall advice you on additional work. But if satisfactory you can

proceed to the next Learning Guide.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
1
 Information sheet 1 Determine quality standards

1.1.Defining quality

The word quality, as you may already understand from the responses of different groups, is not
understood uniformly. What constitutes health care quality is different for different people
based on what is valued most. Due to this lack of standard understanding, quality particularly
when applied to the health sector is not simple to define.
With the greater emphasis given to quality of health care by patients, public health officials,
funding agencies and governments during the last few decades, different authors and
organizations have tried to define it. In this lesson, we will see some of the most frequently used
definitions.
Definition 1. Quality is the totality of characteristics of an entity that bear on its ability to
satisfy stated and implied needs. (ISO 8402)
Definition 2. Quality of health care is the application of medical science and technology in a
way that maximizes its benefits to health without correspondingly increasing
its risks. The degree of quality is, therefore, the extent to which care provided
is expected to achieve the most favorable balance of risks and benefits.
(AvedisDonabedian)
Definition 3. Quality health care is the proper performance (according to standards) of
interventions that are known to be safe, that are affordable to the society in
question, and that have the ability to produce an impact on mortality,
morbidity, disability, and malnutrition. (M.I. Roemer and C. Montoya Aguilar,
WHO)
Definition 4. Medical quality is the degree to which health care systems, services and supplies
for individuals and populations increase the likelihood for positive health
outcomes (AmericanCollege of Medical Quality)
Definition 5. The degree to which health services for individuals and populations increase the
likelihood of desired health outcomes and are consistent with current
professional knowledge. (IOM of the National Academies)
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
2
 1.2.Evolution of quality control
A brief look at the evolution of quality in modern health care systems may help understand the
need to improve performance measurement.
More than 30 years ago, a physician named AvedisDonabedian proposed a model for assessing
health care quality based on structures, processes and outcomes. He defined structure as the
environment in which health care is provided, process as the method by which health care is
provided, and outcome as the consequence of the health care provided. As a result, process
management is limited, and often temporary, when the structure isn't also improved.
Two decades later health care adopted continuous quality improvement, which uses teams to
improve processes. According to Donabedian's model, processes are constrained by the
structures in which they operate. To date, few health care organizations have addressed these
structures because health care senior managers have replicated the behavior of most industrial
senior managers by focusing on the process level.
The popularity of Robert S. Kaplan and David P. Norton's balanced scorecard method--
popularized in their book The Balanced Scorecard (1996, Harvard Business School Press)--
expanded health care organization measures beyond financial analysis. They led to the
development of measures in four or more areas, including patient/customer, financial, internal
operations and clinical. However, in creating a balanced scorecard, many organizations failed to
do the critical, difficult part: develop a cause-and-effect relationship among these measures.
Consequently, health care organizations typically generate lists of strategies and goals as if they
are independent of each other.
An additional impetus for health care organizations to adopt quality principles has been the
Joint Commission on Accreditation of Healthcare Organizations' standards. While the JCAHO
standards have evolved during the past decade, swayed in part by the Baldrige criteria, health
care organizations have been slow to use this organizational assessment as a way to drive
performance improvement.
The demand from JCAHO for performance improvement drove many health care organizations
to learn as much as possible about continuous quality improvement. They began implementing
ideas such as: teams and facilitators with training on conflict resolution; problem solving with
use of statistical tools and standardized problem-solving procedures; data collection, including
patient, physician and employee satisfaction surveys; process management using clinical
algorithms and practice guidelines with training on pathway development; and planning using
balanced scorecards and performance measurements. With continuous quality improvement
often delegated to levels below senior management, organizations struggled to integrate and
justify their many initiatives.

1.3. Quality standard procedures and organizational /work place policies

Policies and Procedures are two words frequently heard in the business world and there is often
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
3
 confusion between the two concepts.

What is an Organizational Policy?

A Policy defines an outcome; it is a premeditated rule set by a business to guide organizational

direction, employees and business decisions, and to regulate, direct and control actions and
conduct. Policies can range from a broad philosophy to a specific rule. They are the direct
connection between a company's Vision and its daily operations and the underpinnings to a
company's culture.

What is an Organizational Procedure?

A procedure is a means to an end. Procedures are step by step instructions, prescribing an exact
sequence of action. A procedure explains how to and who (which position) will implement the
policy. Procedures are specific, factual and succinct. They may include timelines, specific forms
to be used and template forms. Procedures assist in eliminating common misunderstandings
which can result in costly mistakes.

What is the difference?

Together Policies and Procedures empower a process by providing clear and concise direction
necessary for consistent operation. The essential differences are outlined below:

Policies
- General in nature
- Identify company rules
- Explain why rules exist
- Explain when the rule applies
- Describe to whom (what position) it applies
- Explain how it is enforced
- Describe consequences
- Provide guidance for managerial thought and action
- Flexible - allows for discretion

Procedures
- Identify specific and alternative actions
- Explain when to take actions
- Describe emergency procedures
- Include warnings and cautions
- Give examples
- Show how to complete a specific form
- Prescribe how to carry out the action through step by step instruction
- Less flexible - concise and exact sequence of activities

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
4
 Why does a company need Organizational Policies?

Policies and Procedures (P&Ps) are essential when a company requires consistency in its daily
operations. They provide clarity and direction re: accountability. P&Ps assist companies in
meeting legal requirements set out by the Employment Standards Act, the Human Rights Code,
the Occupational Health and Safety Act and numerous other compliance requirements.

A properly written policy and/or procedure allows employees to understand their roles and level
of responsibility and conduct their job by making decisions within predefined boundaries. By
implementing P&Ps, management can provide guidance to employees without needing to
micromanage, freeing managers to focus on strategic thought.

P&Ps allow the workforce to not only understand the accountabilities and responsibilities of
their own position, but also that of their co-workers, which can foster a cooperative work
environment.

How big should a company be to consider implementing Policies and Procedures?

With as few as six employees there will be recurring issues. Productivity and efficiencies both
from a legal and operational standpoint can be gained through the implementation of P&Ps.

ABOUT: Holly Ormsbee is a Human Resources Assistant at HR-Fusion, specializing in

Employee Relations, Recruitment and Compliance Issues

This dynamic Human Resources (HR) consulting firm focuses on strategic business and
organizational development through HR delivery and training. The integrated team approach
and 'full service' philosophy makes HR-Fusion a reliable resource and valuable business partner
when you need professional HR support.

HR-Fusion's Hamilton, Ontario location is uniquely positioned to provide services to Brantford,

Burlington, Oakville, and the surrounding Niagara region. HR requirements outside the
immediate geographic area are handled through the HR-Fusion partner network and provides
coast to coast coverage as required.

1.4.The quality improvement in health care

Quality Improvement is a formal approach to the analysis of performance and
systematic efforts to improve it.
1.5.Factors influencing the quality movement in health care

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
5
 1.6.Legal and ethical implications

The malpractice litigation crisis affects all clinical health -care professionals. Providers are
sued by patients for professional (treatment-related) negligence, injury from defective products,
breach of contract, and/or intentional acts and omissions. Because orthotics and prosthetics
(O&P) focuses on both professional product and service delivery, prosthetists and orthotists
are particularly vulnerable to professional negligence and product liability claims. While it is
vital to maintain an altruistic focus in care delivery, clinicians and managers also must
practice effective malpractice risk management. Of particular importance is the generation of
legally acceptable incident reports when patients are injured during evaluation or treatment.

All health-care professionals (HCPs) are justifiably concerned about the potential risk of
exposure to situations in their clinical practices that could result in malpractice liability. The
United States is clearly experiencing a serious "litigation crisis," evidenced by the more than 19
million new civil lawsuits filed in 1992, the latest year for which statistics are available (1). The
healthcare malpractice crisis," although a small component of the litigation crisis (2), poses a
formidable threat to the participants in health-care delivery- providers, facilities, product
manufacturers, suppliers, insurers, and patients and their families

Although more and more patients with adverse treatment outcomes are resorting to the legal
system for redress, not all health-care malpractice claims can fairly be labeled as frivolous.
Evidence suggests a significant number of inadvertent adverse incidents associated with clinical
health-care delivery results from malpractice.

Health-care malpractice litigation exacts a devastating toll on provider defendants and their
families, just as it does on patient-plaintiffs. Some of the potential adverse consequences of
being sued include psychological stress, the prospect of an adverse money judgment in
settlement or at trial, the mandatory reporting of the names of licensed HCPs to the National
Practitioner Data Bank, and the potential for adverse employment consequences associated with
merely being named a defendant in a malpractice action.

Bases for Health-Care Malpractice

Legal Actions

Patients cannot successfully sue HCPs simply because they experience "bad" outcomes. Most
adverse outcomes result from normal complications of pathology. Many more occur due to non-
negligent errors in professional judgment.

To succeed in health-care malpractice litigation, a patient must prove to a judge or jury a

Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
6
 legitimate basis exists for imposing monetary liability. The legal bases of health-care
malpractice liability are professional negligence, intentional misconduct, breach of contract,
strict product liability for injury from providing dangerously defective products and strict
liability incident for abnormally dangerous activities. One or more of these legal bases of
liability must be present in addition to an adverse patient outcome (i.e., physical and/or
psychological injury to the patient) for a patient to prevail in a healthcare malpractice legal
action.

Health-care facilities may be named as malpractice defendants in lawsuits initiated by patients,

either for their own conduct (primary liability) or as entities vicariously (indirectly) liable for
the conduct of HCP employees acting within the scope of employment.

Individual HCP defendants are normally patient care providers legally recognized as "health-
care professionals." This group of potential individual defendants includes physicians, dentists,
registered nurses, physical and occupational therapists, and prosthetists and orthotists, among
other licensed and certified HCPs. O&P was formally recognized by the American Medical
Association as an allied health profession in 1992.

Professional Negligence

The vast majority of health-care malpractice claims and lawsuits are grounded exclusively in
allegations of professional negligence or substandard care. Because O&P is unique among the
health professions as a co-primary product and service profession, the incidence of product-
liability malpractice legal actions is greater than in other disciplines such as physical therapy,
nursing or medicine.

A patient-plaintiff in a professional negligence health-care malpractice legal action must prove

four elements by a preponderance of evidence. These elements of proof are as follows:

 The HCP owed the patient a legal duty of care.

 The HCP violated or breached the duty owed in some way.
 The breach of duty caused injury to the patient.
 The patient sustained the kinds of losses for which a court may award compensation in
the form of monetary "damages."

When is a duty owed to a patient? Normally, a specific duty of care is owed only when an HCP
agrees to provide professional treatment-related services or products to a patient. That special
duty is breached if the HCP fails to provide professional service or a product that at least
comports with minimally acceptable standards of practice and care.

There is no legal requirement that a professional service or product be superior to other

similarly situated HCPs' work products or even of average quality. The legal standard is
measured at "floor-level," not at the "ceiling" of comparative quality. "State-of-the-art'
technology is not necessary for compliance with the standard as long as what the HCP under
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
7
 inquiry did for a patient falls within acceptable standards of practice.

How is the standard of care established? With only a few isolated exceptions representing
judicial activism in the legal literature, every health-care profession has exercised the right to
establish its own standard of care. What is acceptable practice usually is determined by the
testimony of expert witnesses or those professionals from the same discipline as a defendant-
HCP or from a related discipline (provided the nonpeer possesses sufficient knowledge, training
and experience in the area under inquiry).

To qualify as an expert, a witness must:

1) possess in-depth knowledge about the product or service in issue

2) be familiar with the standard of care in the jurisdiction in which the patient was injured at the
time the injury occurred.

With these conditions in mind, physicians, physical and occupational therapists, nurses, and
others may or may not be legally competent in a malpractice case brought by a patient against a
prosthetist- or orthotist-defendant to testify about the standard of care. Prosthetists and
orthotists who are the subjects of legal claims should ensure their attorneys (personal legal
counsel and/ or professional liability insurance attorneys) investigate and, when appropriate,
challenge the competence of nonpeers to testify on the standard of care or O&P.

The legal standard of care also can be established by introducing into evidence authoritative
works such as textbooks and peer-reviewed professional journals (including the Journal of
Prosthetics and Orthotics). Profession-wide or institutional practice standards also may be used
to establish the legal standard of care. In addition, professional codes of ethics can serve as
reference documents for the standard of care. For O&P professionals, for example, certain
provisions in the Canons of Ethical Conduct (9) constitute practice standards that can be
introduced in a legal proceeding to establish the legal standard of care. Section 2.1 enunciates
two standards: 1) the diagnosis of patients' pathologies is considered to be outside the scope of
O&P professional practice, and 2) the making of a prosthesis or orthosis requires a prescription
from an appropriate licensed HCP. Section 2.3 states another practice standard: When requested
to do so by the referring entity, prosthetists and orthotists "shall monitor and observe a patient's
physical condition in connection with orthotic and prosthetic care...to make certain the patient is
responding appropriately." Section 2.5 spells out practice parameters for necessary
modifications by prosthetists and orthotists of prescribed devices. Section 3.2 employs another
practice standard that fixes primary (legal) responsibility for O&P evaluation and care delivery
on prosthetists and orthotists once they accept patients for care.

Intentional Conduct, Breach of Contract and Product Liability

Cases alleging intentional (mis)conduct are frequently highlighted by the media and include
such claims as battery (inappropriate touching of a patient without patient consent), sexual
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
8
 battery (battery intended to arouse or gratify sexual desires) and invasion of patient privacy.
Allegations of impropriety lodged against HCPs may give rise to legal actions in several
venues: civil court for malpractice, criminal court for felonious misconduct or an administrative
setting for adverse licensure or certification action. For example, the intentional wrong of
publicizing private information about a patient (invasion of privacy) also constitutes an ethics
violation for prosthetists and orthotists, potentially giving rise to both a civil legal action for
malpractice and an adverse administrative action that could affect certification.

Courts historically have been reluctant to permit patients to sue and win against HCPs for
breach of contract or injury from defective products because the legal system views the
HCP/patient relationship as something more than just an ordinary arms-length business
relationship. The courts traditionally view this relationship as special-akin to parent/child,
attorney/client and minister/parishioner relationships.

The problem with this quasi-immunity from product liability for prosthetists and orthotists is
the creation of a product is coequal in importance to professional service in the O&P profession.
Still, to minimize imposition of product liability, prosthetists and orthotists who are claimed
against or sued for product liability-related malpractice should ensure their attorneys argue
forcefully that their physical work products are integral components of professional health-care
service delivery.

Liability for Failing to Obtain Patient-Informed Consent

A special case of professional negligence liability involves failure to obtain patient-informed

consent for evaluation and treatment. Out of respect for patient autonomy, every HCP treating
patients has the legal and ethical duty to obtain informed consent from every patient (or
surrogate decisionmaker) before beginning treatment. Failure to make informed disclosure and
obtain patient consent to care is a breach of the duty of care owed to the patient. If the patient is
injured and can prove he or she would have declined treatment had informed disclosure been
made, the patient has an actionable healthcare malpractice case. The Patient Self-Determination,
a consumer-education federal statute that reiterates patient rights (but does not create new ones),
requires that federally funded healthcare facilities inform patients of their rights to make
advance directives and to control the treatment decision-making process generally. These
facilities must provide patients with written information about facility policies on patient-
informed decision-making and advance directives, including living wills and durable powers of
attorney for health-care decisions consistent with state law.

Although the exact requirements for patient-informed consent vary from state to state, the
following is a general checklist of disclosure elements that prosthetists and orthotists should
impart to patients:

 the nature of the intervention ordered;

 whether any material (decisional) risks of serious injury or complications are associated
with the proposed plan of care;
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
9
  expected benefits of the proposed intervention, i.e., goals of treatment; and
 reasonable alternatives, if any, to the proposed course of treatment.

After disclosure of these consent elements, the O&P professional must solicit and satisfactorily
answer patient questions about the proposed care plan and then formally ask for patient consent
to proceed. Only after this process is complete has the patient given informed consent to O&P
intervention.

Ordinary Negligence ("Premises Liability")

One other form of negligence that can result in patient injury is "ordinary" negligence. Ordinary
negligence involves non-treatment-related negligence that results in patient injury, such as when
a patient slips and falls on a wet floor in the dressing room before or after evaluation or
treatment. The type of ordinary negligence described here also is called "premises liability", the
same kind of liability that can affect any landowner or occupant of business or residential
property. While there is a significant number of claims filed by patients for ordinary negligence,
this legal action does not equate "malpractice" and should not result in the same kinds of
adverse administrative and employment consequences for HCPs as professional negligence
often does.

Clinical Liability Risk Management

What steps in daily clinical practice can O&P professionals take to minimize the risk of being
claimed against or sued by patients for health-care malpractice or ordinary negligence? Simple
everyday practice patterns, including effective communication, friendliness and empathy for
patients' problems, go a long way toward preventing health-care-setting claims and lawsuits. So
does careful interpretation of physician and other HCP orders in patient records as well as
ongoing coordination with referring entities and co-providers.

Prosthetists and orthotists, like other HCPs privileged to document inpatient records, must
ensure their documents are accurate, clear, concise, objective and timely. Failure to document in
this manner is another form of professional negligence if other providers need vital information
concerning the patient and either fail to receive it in a timely manner or cannot decipher what is
contained therein.

Clinicians and clinic and facility managers must know the proper course of action following
patient injury in the clinic area. The first steps after patient injury are stabilizing the patient and
calling for medical assistance. An objective description of patient injuries and treatment should
be recorded in the patient's progress notes in the treatment record. A separate document-an
incident report-should then be generated and filed, through the clinic manager, with the facility
risk manager.

In the narrative section of an incident report, an objective description of everything the report
writer perceived should be documented, including relevant statements made by others about the
incident. Statements made by others (called "hearsay") are enclosed in quotes so there is never a
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
10
 later question about who said what. An incident report must never contain speculation as to the
cause(s) of patient injury, nor should it attribute blame to any specific HCP.

The dual purposes of an incident report are:

1) to alert management to possible safety deficiencies requiring immediate attention, and

2) to create an objective administrative and legal record of the incident for use in quality
improvement programs and as possible evidence in a legal proceeding. To ensure immunity
from disclosure, the generation of the incident report should not be mentioned nor should a
copy of the report be filed in the patient's treatment record.

1.7.Quality and cost

Two changes are needed to achieve effective economic competition to the health care industry:

 process enhanced insurance claim forms to gather cost and quality data on health care
providers, then make that data available to consumers via the Internet,
 change laws such that health care consumers have incentive to shop wisely for health
care, i.e. a high deductible.

In addition to effective economic competition, the government, and perhaps employers, could
limit the provided health care coverage to the current level of health care in 2008. Over time,
the cost of providing this level of health care should decline steadily as medical advances
continue. When the cost has declined enough, the coverage could remain constant in dollar
terms, but increase in effectiveness as medical advances continued.

Measuring Health Care Quality and Cost in Massachusetts is the first annual publication
developed by the Division of Health Care Finance and Policy on behalf of the Council. The
report provides a comparative view of hospitals based on performance measurements adopted
by the Council for use on its website. Section 1 of the report examines the quality and the cost
of care by procedure or condition; section 2 provides a summary of quality and cost information
for each hospital. However, data for comparing both the cost and quality of a given service
remains limitedly available.

Looking ahead, next year's report will include new quality measurements, including serious
reportable events, hospital acquired infections and surgical care infections, as well as new cost
measurements, including episodic costs associated with well baby and diabetes care. The
addition of these and other measures in the future will help refine our understanding of the
underlying causes of variations in the health care system and guide both policymakers and
providers in establishing an effective and cost-efficient health care system.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
11
 I-Essay: Explain briefly:

LEARNING GUIDE #2

Unit of Competence : Apply Quality Control

Module Title : Applying Quality Control
LG Code : HLT NUA3 M015LO2
TTLM Code : HLT NUA3 TTLM 0112v1

LO2: Assess the quality of work

Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
12
 and product delivered

LO2: Assess the quality of work and product delivered

Instruction
Learning Guide 2
Sheet

This learning guide is developed to provide you the necessary information

regarding the following content coverage and topics –
 Products/work outputs and work performance
 Work outputs and performance delivered
 Causes of any identified faults

Learning Instructions

1. Read the information written in the “Information Sheets”.

2. If you earned a satisfactory evaluation proceed to next module. However,

if your rating is unsatisfactory, see your teacher for further instructions.
3. Read the “Operation Sheet” and try to understand the procedures
discussed.
4. Practice the steps or procedures as illustrated in the operation sheet. Go to
your teacher if you need clarification or you want answers to your
questions or you need assistance in understanding a particular step or
procedure
5. Do the “LAP test” (if you are ready). Request your teacher to evaluate
your performance and outputs. Your teacher will give you feedback and
the evaluation will be either satisfactory or unsatisfactory. If
unsatisfactory, your teacher shall advice you on additional work. But if
satisfactory you can proceed to the next Learning Guide.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
13
 Information sheet Assess the quality of work and product delivered

2.1.Quality improvement

Quality Improvement (QI) refers to activities aimed at improving performance and is an

approach to the continuous study and improvement of the processes of providing services to
meet the needs of beneficiaries. This term generally refers to the overriding concepts of
continuous quality improvement and total quality management. These phrases in general are
used to describe the ongoing monitoring, evaluation, and improvement processes including
the management of the improvement process itself.
Contineous Quality Improvement (CQI) is an equivalent in health care for Total Quality
Management (TQM) in the industry. CQI is an ongoing, organization wide framework in
which HSOs and their employees and clinical staff are committed to and involved in
monitoring and evaluating all aspects of the HSO’s activities and outputs in order to
continuously improve them. (American Hospital Association)

2.1.1.Principles
Principles, we all use them (sometimes without knowing it) Whether in our personal lives or
in our professional environment, our action take place as a result of a inherent set of
principles. You could even define a principle of how we conform ourselves to the principles
we previous have set. Some stick to them a great deal, others change whatever seems to be
more convenient. In the book - 'the greatest salesman in the world' OgMandino elaborates a
set of principles that made him a successful salesman. What happens within a group of
people working together? Can you still define a common ground where they share the same
principles?

Principles within companies and organizations

Companies and groups, teams departments or domains within companies have there own
principles too. They are however less visible and the group might be less aware of the
principles they share. Never the less, how implicit they are, the principles can be
determined. By making the principles explicit, the driving power behind the organization

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
14
 becomes more clear and with that, the power to improve management of the organization.

2.1.2.Organizational structure for quality management

An organizational structure consists of activities such as task allocation, coordination and

supervision, which are directed towards the achievement of organizational aims. [1] It can also
be considered as the viewing glass or perspective through which individuals see their
organization and its environment.

Organizations are a variant of clustered entities

An organization can be structured in many different ways, depending on their objectives.

The structure of an organization will determine the modes in which it operates and performs.

Organizational structure allows the expressed allocation of responsibilities for different

functions and processes to different entities such as the branch, department, workgroup and
individual.

Organizational structure affects organizational action in two big ways. First, it provides the
foundation on which standard operating procedures and routines rest. Second, it determines
which individuals get to participate in which decision-making processes, and thus to what
extent their views shape the organization’s actions.

The set organizational structure may not coincide with facts, evolving in operational action.
Such divergence decreases performance, when growing. E.g., a wrong organizational
structure may hamper cooperation and thus hinder the completion of orders in due time and
within limits of resources and budgets. Organizational structures shall be adaptive to process
requirements, aiming to optimize the ratio of effort and input to output.

Organizational structure types

Pre-bureaucratic structures

Pre-bureaucratic (entrepreneurial) structures lack standardization of tasks. This structure is

most common in smaller organizations and is best used to solve simple tasks. The structure
is totally centralized. The strategic leader makes all key decisions and most communication
is done by one on one conversations. It is particularly useful for new (entrepreneurial)
business as it enables the founder to control growth and development.

They are usually based on traditional domination or charismatic domination in the sense of
Max Weber's tripartite classification of authority

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
15
 Bureaucratic structures

Weber (1948, p. 214) gives the analogy that “the fully developed bureaucratic mechanism
compares with other organizations exactly as does the machine compare with the non-
mechanical modes of production. Precision, speed, unambiguity, … strict subordination,
reduction of friction and of material and personal costs- these are raised to the optimum
point in the strictly bureaucratic administration.”Bureaucratic structures have a certain
degree of standardization. They are better suited for more complex or larger scale
organizations, usually adopting a tall structure. The tension between bureaucratic structures
and non-bureaucratic is echoed in Burns and Stalker's distinction between mechanistic and
organic structures.

The Weberian characteristics of bureaucracy are:

 Clear defined roles and responsibilities

 A hierarchical structure
 Respect for merit.

Post-bureaucratic

The term of post bureaucratic is used in two senses in the organizational literature: one
generic and one much more specific.[7] In the generic sense the term post bureaucratic is
often used to describe a range of ideas developed since the 1980s that specifically contrast
themselves with Weber's ideal type bureaucracy. This may include total quality
management, culture management and matrix management, amongst others. None of these
however has left behind the core tenets of Bureaucracy. Hierarchies still exist, authority is
still Weber's rational, legal type, and the organization is still rule bound. Heckscher, arguing
along these lines, describes them as cleaned up bureaucracies, [8] rather than a fundamental
shift away from bureaucracy. Gideon Kunda, in his classic study of culture management at
'Tech' argued that 'the essence of bureaucratic control - the formalisation, codification and
enforcement of rules and regulations - does not change in principle.....it shifts focus from
organizational structure to the organization's culture'.

Another smaller group of theorists have developed the theory of the Post-Bureaucratic
Organization.,[8] provide a detailed discussion which attempts to describe an organization
that is fundamentally not bureaucratic. Charles Heckscher has developed an ideal type, the
post-bureaucratic organization, in which decisions are based on dialogue and consensus
rather than authority and command, the organization is a network rather than a hierarchy,
open at the boundaries (in direct contrast to culture management); there is an emphasis on
meta-decision making rules rather than decision making rules. This sort of horizontal
decision making by consensus model is often used in housing cooperatives, other
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
16
 cooperatives and when running a non-profit or community organization. It is used in order
to encourage participation and help to empower people who normally experience oppression
in groups.

Still other theorists are developing a resurgence of interest in complexity theory and
organizations, and have focused on how simple structures can be used to engender
organizational adaptations. For instance, Miner et al. (2000) studied how simple structures
could be used to generate improvisational outcomes in product development. Their study
makes links to simple structures and improviser learning. Other scholars such as Jan Rivkin
and Sigglekow,[9] and Nelson Repenning[10] revive an older interest in how structure and
strategy relate in dynamic environments.

Functional structure

Employees within the functional divisions of an organization tend to perform a specialized

set of tasks, for instance the engineering department would be staffed only with software
engineers. This leads to operational efficiencies within that group. However it could also
lead to a lack of communication between the functional groups within an organization,
making the organization slow and inflexible.

As a whole, a functional organization is best suited as a producer of standardized goods and

services at large volume and low cost. Coordination and specialization of tasks are
centralized in a functional structure, which makes producing a limited amount of products
or services efficient and predictable. Moreover, efficiencies can further be realized as
functional organizations integrate their activities vertically so that products are sold and
distributed quickly and at low cost. For instance, a small business could make components
used in production of its products instead of buying them.

Divisional structure

Also called a "product structure", the divisional structure groups each organizational
function into a division. Each division within a divisional structure contains all the
necessary resources and functions within it. Divisions can be categorized from different
points of view. One might make distinctions on a geographical basis (a US division and an
EU division, for example) or on product/service basis (different products for different
customers: households or companies). In another example, an automobile company with a
divisional structure might have one division for SUVs, another division for subcompact
cars, and another division for sedans.

Each division may have its own sales, engineering and marketing departments.

Matrix structure
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
17
 The matrix structure groups employees by both function and product. This structure can
combine the best of both separate structures. A matrix organization frequently uses teams of
employees to accomplish work, in order to take advantage of the strengths, as well as make
up for the weaknesses, of functional and decentralized forms. An example would be a
company that produces two products, "product a" and "product b". Using the matrix
structure, this company would organize functions within the company as follows: "product
a" sales department, "product a" customer service department, "product a" accounting,
"product b" sales department, "product b" customer service department, "product b"
accounting department. Matrix structure is amongst the purest of organizational structures, a
simple lattice emulating order and regularity demonstrated in nature.

 Weak/Functional Matrix: A project manager with only limited authority is

assigned to oversee the cross- functional aspects of the project. The functional managers
maintain control over their resources and project areas.
 Balanced/Functional Matrix: A project manager is assigned to oversee the project.
Power is shared equally between the project manager and the functional managers. It brings
the best aspects of functional and projectized organizations. However, this is the most
difficult system to maintain as the sharing power is delicate proposition.
 Strong/Project Matrix: A project manager is primarily responsible for the project.
Functional managers provide technical expertise and assign resources as needed.

2.1.3.Organizational culture

Organizational culture is the collective behavior of humans who are part of an

organization and the meanings that the people attach to their actions. Culture includes the
organization values, visions, norms, working language, systems, symbols, beliefs and habits.
[1]
It is also the pattern of such collective behaviors and assumptions that are taught to new
organizational members as a way of perceiving, and even thinking and feeling. [2]
Organizational culture affects the way people and groups interact with each other, with
clients, and with stakeholders.

Ravasi and Schultz (2006) state that organizational culture is a set of shared mental
assumptions that guide interpretation and action in organizations by defining appropriate
behavior for various situations. At the same time although a company may have "own
unique culture", in larger organizations, there is a diverse and sometimes conflicting cultures
that co-exist due to different characteristics of the management team.The organizational
culture may also have negative and positive aspects.

Schein (2009), Deal & Kennedy (2000), Kotter (1992) and many others state that
organizations often have very differing cultures as well as subcultures.

Usage
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
18
 Organizational culture refers to culture in any type of organization be it school, university,
not-for-profit groups, government agencies or business entities. In business, terms such as
corporate culture and company culture are sometimes used to refer to a similar concept.

Although the idea that the term became known in businesses in the late 80s and early 90s is
widespread, in fact corporate culture was already used by managers and addressed in
sociology, cultural studies and organizational theory in the beginning of the 80s.

The idea about the culture and overall environment and characteristics of organization, in
fact, was first and similarly approached with the notion of organizational climate in the 60s
and 70s, and the terms now are somewhat overlapping.

2.1.4.Work force diversity

We want to accomplish a workforce that is representative of the American people and work
sites that are highly effective due to the contributions of the variety of American people that
we employ. We want the National Park Service to continue to be a strong organization into
the 21st century despite the changing demographics of this country.

We must continue to work toward creating an environment where workforce diversity is

understood, valued and embraced, where there is an absence of bias, and where the mission
is achieved through collaboration and teamwork. We must continue to move vigorously
toward a workforce that reflect the diversity of American society at large and employs the
best talents of all groups. This is good business for America and it is good business for the
National Park Service.

Diversity is a strategic business imperative essential to Allstate's success in today's

marketplace.

A Competitive Advantage

We aggressively pursue diversity in our workforce and our workplace, challenging ourselves
to be appropriately represented by women and people of color in our general employee
population, agency owners and within our leadership ranks; the percentage of procurement
dollars spent with companies owned by minorities and women; our customer experience;

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
19
 our multi-cultural marketing efforts; our inclusive work environment and ultimately, our
business results.

Workforce Mission

Our Workforce Diversity Mission is to sustain an effective organization that drives a high-
performance culture, which in turn enables higher productivity, higher morale, more
innovation, collaboration and risk taking. Our policies, procedures and programs are
designed to promote inclusion, work/life balance, dignity and respect, commitment to
appropriate representation and leveraging differences to maximize innovation and creativity.

Allstate aims to attract professionals who collectively embrace an inclusive value system
that leverages diversity, equal opportunity, talent development, lifelong learning and
work/life balance. Allstate’s workplace diversity strategy helps us attract and retain the best
talent, drive high performance, provide tailored service and products to a diverse customer
base and strengthen our corporate brand in the marketplace and labor market.

2.1.5.Scientific approach for quality management

ISO defined quality management as a set of activities that organizations use to direct,

control, and coordinate quality. Depending on different organizational factors including the
nature of products/services produced, different approaches could be applied to manage
quality in different organizational setups. The commonly known approaches include:
1. Standardization
2. Accreditation
3. Quality Assurance
4. Quality Improvement
All of them share a common goal which is production and provision of better
products/services to beneficiaries. Theoretically their difference is in their approach but in
practice none of them exist as a standalone approach. Most of the time, organizations
implement multiple approaches, or create a hybrid of multiple approaches. For this reason,
people usually use some of these phrases interchangeably. In this lesson, we will briefly
discuss each of these approaches.

1. Standardization
Standardization is the process of developing and agreeing upon technical specifications,
criteria, methods, processes, or practices to establish uniformity in the characteristics of
products or services. When applied to quality standards in health care, standardization could
be considered as an approach to set the “minimum requirement” or “best” structure or
processes which health facilities should try to achieve.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
20
 In order for a standardization process to be effective in improving quality of services,
meeting standards should be either enforced by law or should be linked with some kind of
incentives.
Standardization could be considered as a good alternative to manage quality of health care
provided that two conditions are fulfilled:
 Quality standards are set based on scientific recommendations to achieve
maximum benefit for beneficiaries
 Meeting standards will be aspired by all service providers either enforced by
law or voluntarily
Examples of standards in health care:
 Setting minimum requirements to establish a medium clinic
 Developing and agreeing on a standard procedure to conduct a laboratory test

2. Accreditation
Accreditation is a process in which certification of competency, authority, or credibility is
presented. In the health care set up, it is considered as a self-assessment and external peer
assessment process used to accurately assess level of performance in relation to established
standards and to implement ways to continuously improve.
It is expected to be performed by organizations or associations with recognized competency
to implement testing and certification for participating organizations. Usually, the motive
behind participation of health facilities in an accreditation process is recognition, and
participation is most of the time voluntary based.
For this reason, in developing countries like Ethiopia, where there are very limited
alternative health care providers in communities, accreditation may not be effective as
compared to situations where there are competitive providers.
Standards used by different accreditation agencies include:
 the standards of governance
 commitment to internal quality improvement
 medical ethical standards
 quality of clinical staff
 quality and ethical standards of management
 clinical record management
 infection prevention
 client/patient feedback utilization and complaint handling
3. Quality Assurance
Quality assurance is a process intended to ensure that products or services will satisfy
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
21
 expected needs. It refers to a broad spectrum of activities aimed at ensuring compliance with
minimum quality standards.
It can not absolutely guarantee the production of quality production/services; however, the
likelihood of producing such products or providing such services will be increased if there is
a well functioning quality assurance.
Serving intended purpose and eliminating errors are two principles characterizing quality
assurance. The focus of quality assurance is on structure and processes of service provision
including:
 controlling the quality of inputs (human, material, technology)
 activities during care provision or production
 management and inspection process

4. Quality Improvement
Quality Improvement (QI) refers to activities aimed at improving performance and is an
approach to the continuous study and improvement of the processes of providing services to
meet the needs of beneficiaries. This term generally refers to the overriding concepts of
continuous quality improvement and total quality management. These phrases in general are
used to describe the ongoing monitoring, evaluation, and improvement processes including
the management of the improvement process itself.
Contineous Quality Improvement (CQI) is an equivalent in health care for Total Quality
Management (TQM) in the industry. CQI is an ongoing, organization wide framework in
which HSOs and their employees and clinical staff are committed to and involved in
monitoring and evaluating all aspects of the HSO’s activities and outputs in order to
continuously improve them. (American Hospital Association)

2.1.6.Nursing’s role in quality

2.1.6.1 Nursing Quality standards

"Standards are professionally developed expressions of the range of acceptable variations

from a norm or criterion"-AvedisDonabedian.

Standards may be defined as "Benchmark of achievement which is based on a desired

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
22
 level of excellence.

Criteria are pre-determined elements against which aspects of the quality of medical
service may be compared.

What are Nursing Standards?

All standards of practice provide a guide to the knowledge, skills, judgment & attitudes
that are needed to practice safely.

They reflect a desired and achievable level of performance against which actual
performance can be compared. Their main purpose is to promote, guide and direct
professional nursing practice. (Registered Nurses Association of BC (2003) & the College
of Nurses of Ontario (2002)

Why are Standards Important?

 Outlines what the profession expects of its members.

 Promotes guides and directs professional nursing practice – important for self-
assessment and evaluation of practice by employers, clients and other stakeholders.
 Provides nurses with a framework for developing competencies
 Aids in developing a better understanding & respect for the various &
complimentary roles that nurses have. ( Registered Nurses Association of BC (2003) &
the College of Nurses of Ontario (2002)

What is a profession?

Characteristics of a Profession according to Houle (1980)

1. Concept of mission open to change.

2. Mastery of theoretical knowledge.
3. Capacity to solve problems.
4. Use of theoretical knowledge.
5. Continued seeking of self-enhancement by its members.
6. Formal training.
7. Credentialing system to certify competence.
8. Creation of subculture.
9. Legal reinforcement of professional standards.
10. Ethical practice.
11. Penalties against incompetent or unethical practice.
12. Public acceptance.
13. Role distinctions that differentiate professional work from that of other vocations
and permit autonomous practice.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
23
 14. Service to society.

Professionalization of nursing

Professionalization is the process by which an occupation achieves professional status.

The status of nursing as a profession is important because it reflects the value society
places on the work of nurses and the centrality of this work to the good of society. a
profession is characterized by prolonged education that takes place in a college or
university. Values, beliefs, and ethics relating to the profession are an integral part of the
educational preparation. By definition, a professional is autonomous in decision making
and is accountable for his or her own actions. Personal identification and commitment to
the profession are strong, and individuals are unlikely to change professions. In contrast,
an occupation is characterized by training that may occur on the job for varying lengths of
time. The training does not incorporate, as a prominent feature, the values, beliefs, and
ethics of the occupation. The workers are supervised, and ultimate accountability rests
with the employer. Thus commitment is not always strong, and individuals often changes
jobs (Chitty, 1993).

Professional nursing practice involves “specialized skills essential to the performance of a

unique, professional role” the two main concepts that are in the forefront of professional
nursing and its services ideal are accountability and autonomy.

Accountability is the state of being responsible and answerable for one’s own behavior.
The sphere of a nurse’s accountability is to self, the client, the employing agency, and the
profession. The standards of clinical nursing practice by ANA and standards of the
various specialty nursing practices document the professional nurse’s scope and limits of
accountability. By virtue of these standards, society holds nurses and those under their
supervision accountable for their actions.

Autonomy in nursing is the freedom and the authority to act independently. It implies
control over one’s practice, and it applies to both decisions and actions.

An accountability based governance system is a predominant feature of professional

practice models. Responsibility and authority are established in specified processes rather
than in particular individuals who, in turn, determine the placement of accountability. The
nurse is central to the organization and is supported by major service components such as
standards, quality assurance, continuing education, and peer process. Nursing
management has no legitimate role in practice-related decisions; rather, management
facilitates, integrates, and co-ordinates nursing operations to support the practitioner.

Professional standards and nursing process

Professional standards ensure that the highest level of quality nursing care is promoted.
Excellent nursing practice is a reflection of sound ethical standards. Client care requires
more than just the application of scientific knowledge. A nurse must be able to think
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
24
 critically, solve problems, and find the best solution for client’s needs to assist clients in
maintaining, regaining, or improving their health. Critical thinking requires the use of
scientifically based and practice-based criteria for making clinical judgments. These
criteria may be scientifically based on research findings or practice based on standards
developed by clinical experts and quality improvement initiatives.

 Nursing profession and essential components

 Nursing is a helping, independent profession that provides services that contribute to the
health of people. Three essential components of professional nursing are care, cure and
co-ordination. Caring aspect is rational and requires as nurse to understand the patient’s
needs at a level that permits individualization of nursing therapies. To cure is to assist
patients in understanding their health problems and to help them to cope. The cure aspect
involves the administration of treatments and the use of clinical nursing judgment in
determining, on the basis of patient outcomes, whether the plan is effective. Co-ordination
of care involves organizing and timing the medical and other professional and technical
services to meet the holistic needs of the patient. And often a patient requires many other
services simultaneously in order to be well cared for. A professional nurse also supervises,
teaches, and directs all of those involved in nursing care. So there are some guidelines are
essential to check how the nurses perform professionally and how they exercise the care,
cure and co ordination aspects of nursing. As an independent profession, nursing has
increasingly set its own standards for practice. This is called standards of nursing care.

Clinical, administrative, and academic experts have developed standards of nursing

practice. The most widely accepted one is American Nurses Association (ANA) 2004
within this document there are standards of professional performance and standards of
practice.

Nursing as a profession

Nursing is not simply a collection of specific skills, and the nurse is not simply a person
trained to perform specific tasks. Nursing is a profession. No one factor absolutely
differentiates a job or a profession, but difference is important in terms of how nurse
practice. When one can say a person acts “professionally”, for example, we imply that the
person is conscientious in actions, knowledgeable in the subject, and responsible to self

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
25
 and others.

As explained before a profession as have some characteristics, one among this is the
profession has a code of ethics and standards.

Standards of Professional Performance

 The ANA Standards of professional Performance describes a competent level of behavior

in the professional role, including activities related to quality of care, performance
appraisal , education, collegiality, ethics, collaboration, research, and resource utilization,
this document serves as objective guidelines for nurses to be accountable foe their actions,
their patients, and their peers . the standards provide a method to assure clients that they
are receiving high-quality care, that the nurses know exactly what is necessary to provide
nursing care, and that measure are I n place to determine whether the care meets the
standards.

2.1.6.2.Parameters

2.1.6.3.Basic information on quality performance

2.1.6.4.Records of work quality indicators

2.1.8 Quality assurance practice system

2.1.8.1 Features of a quality assurance system
Anyone who works in the health care industry can attest to the regulations and mandates
that permeate the system. Due to the exorbitant amount of protocols, health care
organizations rely on quality assurance programs to develop ways to monitor and ensure
that mandatory standards are being met.
Features
Quality assurance programs in health care industries are usually overseen by the
organization's medical director, and are run out of a dedicated department. These
programs are designed to analyze health care requirements, determine ways of ensuring
that protocols are followed throughout the organization, have a system in place to audit
the protocols for compliance and institute performance improvement plans when
standards are not met. Quality assurance programs use a quantitative approach to
gathering and generating statistics used to determine areas of progress and deficiency.
Function
Many departments rely on quality assurance programs to keep things in check, identify
areas for improvement and work with other staff to make sure that regulations are clearly
interpreted and followed. Quality assurance programs begin by creating policy and
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
26
 procedure manuals that exhibit all the clinical and business processes in the company.
From there, the program develops monitoring or audit tools that capture quantitative data
to measure compliance. Each compliance point is associated with a performance standard,
which is what quality assurance programs use as a benchmark in audits. When
deficiencies are discovered, the quality assurance program will assign performance
improvement projects to bring the area into compliance.

Directions: Answer all the questions listed below. Use the answer sheet provided in the
next page.
I-True or False: Write TRUE if the statement is correct and write FALSE if the statement
is wrong. (2pts. Each)

Unit of Competence : Apply Quality Control

Module Title : Applying Quality Control

LG Code : HLT NUA3 M015LO1

TTLM Code : HLT NUA3 TTLM 0112v1

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
27
LEARNING GUIDE #3
 LO3: Record information

LO3: Record information

Information sheet-3 Record information

3.1.Manuals and documentation

An important part of any operating system is documentation, the technical manuals

that describe the operation and use of programs. As part of its efforts to create a high-
quality free operating system, the Debian Project is making every effort to provide all
of its users with proper documentation in an easily accessible form.

Do have these at hand when you make your first Debian installation, it will probably
answer many questions and help you work with your new Debian system.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
28
 Types of documentation

Most of the documentation included in Debian was written for GNU/Linux in general.
There is also some documentation written specifically for Debian. These documents
come in these basic categories:

manuals
HOWTOs
FAQs
other shorter documents

Manuals

The manuals resemble books, because they comprehensively describe major topics.

HOWTOs

The HOWTO documents, like their name says, describe how to do something, and they
usually cover a more specific subject.

Some of the most important Linux HOWTOs are:

Hardware Compatibility HOWTO,

Unix and Internet Fundamentals HOWTO,
Filesystems HOWTO,
Configuration HOWTO,
Networking HOWTO,
and many others

FAQs

FAQ stands for frequently asked questions. A FAQ is a document which answers those
questions.

Other, shorter documents

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
29
 The following documents include quicker, shorter instructions:

manual pages
Traditionally, all Unix programs are documented with manual pages, reference
manuals made available through the man command. They usually aren't meant
for beginners. .

info files
Many GNU software is documented through info files instead of manual pages.
These files include detailed information of the program itself, options and
example usage and are available through the info command.

3.2.Auditing and audits

The general definition of an audit is an evaluation of a person, organization, system,
process, enterprise, project or product. The term most commonly refers to audits in
accounting, but similar concepts also exist in project management, quality
management, water management, and energy conservation.

3.3.Standard operating procedures (sops)

A Standard Operating Procedure (SOP) is a set of directions that should (must) be

followed to ensure food safety when completing certain tasks such as cooking chicken,
cooling a food, or sanitizing a work surface. These SOP's should be used as a guide to
establishing a food safety program for your operation.

The National Food Service Management Institute (NFSMI) has developed food safety
SOPs in conjunction with USDA and FDA. Although the NFSMI SOPs include
HACCP-based principles, you should remember that SOPs are only one component of
an overall food safety program. Food safety SOPs include the following principles:

 Corrective actions
 Monitoring procedures
 Verification procedures
 Record keeping procedures

3.4.Controlling the process

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
30
 The control process is a continuous flow between measuring, comparing, and action.
The following contains four parts of the process.

The four steps in the control process are establishing performance standards,
measuring actual performance, comparing measured performance against established
standards, and taking corrective action.

Setting Objectives

Establishing performance standards are when objectives are set during the planning
process. Its standard is a guideline established as the basis for measurement. It is a
precise, explicit statement of expected results from a product, service, machine,
individual, or organizational unit. It is usually expressed numerically and is set for
quality, quantity, and time (Plunkett, et al.). There are several sub-controls in this step:
time controls, material controls, equipment controls, cost controls, and budget controls,
financial controls, and operations controls (like total quality management).

Observing and Measuring Performance

During step two, measuring actual performance, supervisors collect data to measure
actual performance to determine variation from the standard. Personal observation,
statistical reports, or oral reports can be used to measure performance. Observation of
employees working provides hands on information, extensive coverage, and the ability
to read between the lines. While providing insight, this method of management by
walking around might be misinterpreted by employees as mistrust (Plunkett, et al.).

Comparing Results

The third step of comparing measured performance against an established standard is

comparing the results with the standards to discover variations. Some variation can be
expected in all activities and the range of variation has to be established (Plunkett, et
al.). Management usually lets operations continue as long as they are within the
defined control limits. Deviations that exceed this range alerts the manager to a
problem and leads to the last step.

Corrective Action

The last step, taking corrective action, is when a supervisor finds the cause of the
deviation. Then he or she takes action to remove or minimize the cause. If the source
of the variation in performance is from a deficit activity, then the supervisor can take
immediate corrective action and get performance back on track. Also, the manager can
opt to take basic corrective action, which determines how and why performance has
deviated, and correct the source of the deviation. Immediate corrective action is more

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
31
 efficient, while basic corrective action is more effective

3.5.Regulations and legislation

Legislation The process of making or enacting laws.
Act Primary legislation that has been passed by
both houses of Parliament.
Regulation The practical details and rules made under
s Acts.
Codes A collection of rules on a given subject.
Legislation is a directive placed by a government or governing body on either an
industry, a section of community or placed on people of a country which must be
complied with in order to remain within the legal boundaries of that particular country,
community or industry. In industry, legislation acts as an external driver which must
be met by all players in order to be compliant. Legislation is passed as laws by a
parliament of a country or some other legislative arm of a government. After
legislation is passed, there will be regulators, usually government bodies, who will
examine the laws passed and work out the details that need to be enforced so that they
are followed. For instance a parliament may pass a legislation that enforces a uniform
interconnection fee for telecommunication service providers in a country, and then a
government department (regulator) of communications will detail the nitty-gritty of the
legislation and enforce it. At times before a part of legislation becomes a law, it may
be referred to as a bill. Some countries require legislation to be validated by the
executive (usually President) before it could be enforced as law. Commonly a member
of the governing body or legislature will propose legislation or by the executive, which
then becomes open for debate by legislators. Amendments are usually made before it is
finally passed. Government legislative priorities often determine whether a given bill is
proposed and enforced as law.

A regulation refers to a specific requirement that can take on various forms, such as
industry specific regulation or regulations that are much broader in scope. They are
basically the way the legislation is enforced by regulators and they support the
requirements of the legislation. In industry, they specify the particular formal (legal)
requirements that need to be followed by organizations, workers and employers alike
so as to create a level playing field within the competitive environment of the
organizations as well as within a particular organization. This is so because regulations
address product safety, consumer protection and other factors in public interest. The
thing with regulations is that they could either be internally or externally developed so
as a means of compliance, they may be developed through technical specifications or
may be through some standards in the private sector.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
32
 3.6.Control points

A control point (CP, also control and checkpoint and passport control) is a marked
waypoint used in orienteering and related sports such as rogaining and adventure
racing. It is located in the competition area; marked both on an orienteering map and in
the terrain; and described on a control description sheet. The control point must be
identifiable on the map and on the ground. A control point has three components: a
high visibility item, known as a flag or kite; an identifier, known as a control code; and
a recording mechanism for contestants to record proof that they visited the control
point. The control point is usually temporary, except on a permanent orienteering
course.

For events held under IOF Rules the kite has a triangular form with each face being
about 30 cm x 30 cm and coloured white and orange. Most national governing bodies,
and related sports, use the same design. The earlier specification used white and red.

The location of control points is kept secret from the competitors until the start of the
competition, when they receive the map. The map may be pre-printed with the control
points, or the competitor may be required to copy control points onto the map from a
master map. Control points are selected and prepared anew for each competition.
Permanent courses, with their permanent control points, are used primarily for training
and recreation, but rarely for competition.

In the early days, control points were staffed. Often the competitors were given at the
outset only the location of the first control point, and were given the next location by
the control point staff, who also stamped the control cards.

The first public orienteering competition, in Norway in 1897, had three controls, at the
farms Finnerud, Bjørnholt and Slakteren, while start and finish were on the farm
Grøttum (see map in ref). The first Swedish public orienteering competition, near
Stockholm in 1901, used two churches (Bromma and Spånga Church) and two large
farms as control points. Control description sheet

Control description sheet for an orienteering course in Poland

In orienteering competitions the locations of the control points are described on a

control description sheet (or clue sheet). It is sometimes incorrectly referred to as a
"Course Description Sheet". For beginners, and the younger competitors, the
description is written in a simple text format, but for advanced orienteers the
descriptions use symbols (pictorial), in accordance with the IOF Control descriptions.
These symbols eliminate any language-based confusion, vital for international
competition. The control descriptions are fixed to or printed on the map, and separate
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
33
 control description sheets may be available at the prestart. Some competitors wear the
extra control description sheet in a holder strapped onto their forearm, so that they can
read it while running.

A popular software program for producing control description sheets is Clue, available
free from the Delaware Valley Orienteering Association

Control card and punching

Each competitor is required to carry a control card, and to present it at the Start and
hand it in at the Finish. The control card is marked by some means at each control
point to show that the competitor has completed the course correctly.

In both trail orienteering and North American style mounted orienteering, it may not
be feasible, safe, or permitted for the competitor to go to the control point itself.
Instead, the competitor views the control point from a short distance and marks the
control card with a pen. Several marking schemes are in use, including a pre-printed
multiple choice form, and a "secret word" posted at the control point that the
competitor must copy down.

In foot orienteering, the oldest form of orienteering, the first control cards were card
stock with a perforated stub, the stub to be handed in at the Start as a safety check. At
each control, originally, the control staff or the competitor rubber stamped the control
card using a rubber stamp and inkpad kept at that control. Rubber stamps soon were
replaced with ticket punches, usually with a different punch shape (circular, square,
diamond, star, etc.) at each control. Card stock control cards are in limited use today,
having been mostly replaced by weatherproof stock such as Tyvek. Ticket punches
have been replaced by needle punches that punch a pattern of small holes in the control
card (similar to a perfin).

3.7.Variation
3.7.1.Reasons for variation

3.7.2.Measuring variation

Variation is not simple to measure, as by its nature is random and individual events
cannot be predicted. Despite this, a degree of measurement can be achieved by
looking at how a number of measurements group together. Usually these items are

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
34
 selected with sampling methods.

The spread of measurements within a group enables special causes of variation to be

distinguished from common causes of variation. Beyond this, the characteristics of
how these random events are spread out can allow improvements in seemingly
random chaos to be simply measured.

Distribution of results

It is common in processes for most measurements to cluster around a central value,

with less and less measurements occurring further away from this center. For
example, the distribution of holes across the target will gradually spread out from a
central, most common placement, as below:

The Normal distribution

The bell-shaped curve in the figure above occurs surprisingly often and is
consequently called a Normal distribution (or Gaussian distribution, after its
discoverer) and has some very useful properties which can be used to help variation
be understood and controlled.

Other distributions

A Normal distribution of measurement values does not always occur, and other
distributions may be caused by various factors, conditions and combinations. Several
of these are discussed in Chapter 23. It is a trap to use tools that expect a Normal

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
35
 distribution, such as Process Capability, when the distribution is not Normal.

3.8.Problem solving basic steps

Edwards Deming, who is among the pioneers in the field of quality

improvement, organized this idea as a problem solving cycle – also called
Deming’s Cycle or Shewhart’s Cycle. The cycle includes four interrelated
activities leading to continuous improvement of identified gaps: Plan, Do,
Study and Act.
Plan – planning a change thought to bring about improvement
Planning is the first step in the problem solving cycle linking quality measurement
with quality improvement. It involves a set of activities including:

- investigation of observed quality problems to Plan

• Based on fi ndin gs o f
pe rforma nce mea su re men t

– In ve st ig ate th e r oo t ca us es of
pe rfo rm anc e ga p

– Come u p w ith a p rior it ize d list

of fe asi bl e so lu ti on s

– Se to bj ecti ves f or im pr ov eme nt

– Pl an im p le men ta ti on (wh o,
what , wh er e, whe n)
Pl an

identify their root causes

- come up with a prioritized list of feasible solutions
- set objectives for improvement
- plan implementation of selected solutions (who will do what, how, where and
when?)
At this step, quality improvement teams need to think that not all changes implemented
in a health facility will lead to improvements. Therefore, planning should focus on
small scale changes to be tested if they work. • Car ry o ut the
pla n – sm all
s cale

• Doc ume nt
pro blem s and
unex pe cted
obs ervations

• Beg in a nalys is
of t he d ata
Do

Do – implement planned change on a small scale

Quality improvement teams implement planned changes only on a small scale. This is
like a pilot testing of an intervention which will be studied to see what has worked and Study
what hasn’t. Smaller scale of implementation at this stage will allow improvement
teams to have more frequent cycles through which more will be learned. At this stage, Study

QI teams are expected to:

Why do we need this step?out planned changes on small scale
- Carry
because all improvements need changes but not all changes result in
improvement - Document problems and unexpected observations
- Begin analysis of the data
Study – see the results of implementing small scale changes
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
36
 Small scale implementation of changes (pilot phases) should be studied so as to know:
- if improvement goals are achieved
- what worked and what didn’t
- is there evidence to implement the change at a larger scale
- if additional testing cycles are required
- if there is a need to modify the implemented change

This requires a complete analysis of data from the pilot implementation and
comparison of findings with expectations to draw conclusions on what to expand and
what to further improve.
Act – expend effective changes and modify those in need of improvement
Once data collected from the pilot phase is analyzed and achievements are
• E
p a
x
a b
th
• o

• F
p ro
im
M ify
d
a n
th
d
o
m
rin g
b
p o
m
d
in
lu tio
o
s
ith n
w
c h
d
n
u g
ro
me
e
v
h a
c
d
e
t io
a
ifc
o re
m
mo
e
trv
u
g e
n
a
t
h
ts

s fo
n
o
n
Act
g e
n
s to
n
s
rn
e
th
s

ra re
s
a
Ac t

documented, quality improvement teams will be able to

p ro
im me
e
v t
n

decide on what to expand

• S r th
ta e n t c
x
e le
y

and what to modify. At this stage, QI teams:

- Expand changes that brought improvements
- Modify changes that need modifications to bring more improvements
- Find out other solutions for areas with no improvement
- Start the next cycle
2

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
37
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
38
 LEARNING GUIDE #4

Unit of Competence : Apply Quality Control

Module Title : Applying Quality Control

LG Code : HLT NUA3 M015LO4

Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
39
 TTLM Code : HLT NUA3 TTLM 0112v1

LO4: Study causes of quality deviations

LO4: Study causes of quality deviations

Information sheet-4 Study causes of quality deviations

LO4- Study causes of quality deviations

4.1.causes of quality deviation
A Deviation is a departure from standard procedures or specifications resulting in non-conforming
material and/or processes or where there have been unusual or unexplained events which have the
potential to impact on product quality, system integrity or personal safety. For compliance to GMP
and the sake of continuous improvement, these deviations are recorded in the form of Deviation
Report (DR).
Types of Deviations:
Following are some examples of deviations raised from different functional areas of business:
1. Production Deviation - usually raised during the manufacture of a batch production.
2. EHS Deviation - raised due to an environmental, health and safety hazards.
4. Quality Improvement Deviation - may be raised if a potential weakness has been identified and
the implementation will require project approval.
5. Audit Deviation - raised to flag non-conformance identified during internal, external, supplier
or corporate audits.
6. Customer Service Deviation - raised to track implementation measures related to customer
complaints.
7. Technical Deviation - can be raised for validation discrepancies. For example: changes in
Manufacturing Instruction.
8. Material Complaint - raised to document any issues with regards to non-conforming, superseded
or obsolete raw materials/components, packaging or imported finished goods.
9. System Routing Deviation - raised to track changes made to Bill of materials as a result of an
Artwork change.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
40
 When to Report Deviation:
A Deviation should be raised when there is a deviation from methods or controls specified in
manufacturing documents, material control documents, standard operating procedure for products
and confirmed out of specification results and from the occurrence of an event and observation
suggesting the existence of a real or potential quality related problems.
A deviation should be reported if a trend is noticed that requires further investigation.
All batch production deviations (planned or unintended) covering all manufacturing facilities,
equipment, operations, distribution, procedures, systems and record keeping must be reported and
investigated for corrective and preventative action.
Reporting deviation is required regardless of final batch disposition. If a batch is rejected a
deviation reporting is still required.
Different Levels of Deviation Risks:
For the ease of assessing risk any deviation can be classified into one of the three levels 1, 2 & 3
based on the magnitude and seriousness of a deviation.
Level 1: Critical Deviation
Deviation from Company Standards and/or current regulatory expectations that provide immediate
and significant risk to product quality, patient safety or data integrity or a combination/repetition
of major deficiencies that indicate a critical failure of systems
Level 2: Serious Deviation
Deviation from Company Standards and/or current regulatory expectations that provide a
potentially significant risk to product quality, patient safety or data integrity or could potentially
result in significant observations from a regulatory agency or a combination/repetition of "other"
deficiencies that indicate a failure of system(s).
Level 3: Standard Deviation
Observations of a less serious or isolated nature that are not deemed Critical or Major, but require
correction or suggestions given on how to improve systems or procedures that may be compliant
but would benefit from improvement (e.g. incorrect data entry).
How to Manage Reported Deviation:
The department Manager or delegate should initiate the deviation report by using a standard
deviation form as soon as a deviation is found. Write a short description of the fact with a title in
the table on the form and notify the Quality Assurance department within one business day to
identify the investigation.
QA has to evaluate the deviation and assess the potential impact to the product quality, validation
and regulatory requirement. All completed deviation investigations are to be approved by QA
Manager or delegate. QA Manger has to justify wither the deviation is a Critical, Serious or
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
41
 Standard in nature. For a deviation of either critical or serious nature QA delegate has to arrange a
Cross Functional Investigation.
For a standard type deviation a Cross functional Investigation (CFI) is not necessary. Immediate
corrective actions have to be completed before the final disposition of a batch. Final batch
disposition is the responsibility of Quality Assurance Department.
If a critical or serious deviation leads to a CFI, corrective and preventive actions should be
determined and follow up tasks should be assigned to area representatives. Follow up tasks should
be completed within 30 business days of the observation of deviation. If a deviation with CFI can
not be completed within 30 business days, an interim report should be generated detailing the
reason for the delay and the progress so far.
After successful completion of the Follow up tasks Deviation should be completed and attached
with the Batch Report /Audit report/ Product complaint report /Safety investigation report as
appropriate.

4.2. investigation and report

The purpose of this guidance document is intended to provide information on the
management and documentation of deviations from SOPs and study protocols under the
direction of the University of Texas Medical Branch-Galveston (UTMB-Galveston)
personnel participating in Good Laboratory Practices (GLP) facility operations and
studies. Individual laboratories may establish internal business operations to handle
such deviations, but the minimum requirements are stated within this document.
Responsibilities
Associate
· Reports deviation from protocols and/or SOPs.
· Submits the Deviation Reporting Form to the Study Director.
Study Director
· Assures deviations from study protocol and/or SOPs are reported and
documented.
· Assures corrective actions are taken and documented.
· Investigates unforeseen circumstances that may affect the quality and
integrity of the GLP study.
· Acknowledges the deviation after the completion of the deviation
reporting process.
· If the deviation involves another GLP regulated area, notifies the Study
Director/Unit Management responsible for the area involved in the
deviation.
Upon receiving the Deviation information, it is suggested that the Study
Director shall:
· Identify the root cause of the deviation.
· Identify the scope of the deviation.
· Assess the impact of the deviation on the GLP study.
· Evaluate the protocol or SOP involved in the deviation.
· Assess the adequacy of the study’s support components such as
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
42
 SOPs, training, staffing, and equipment if necessary.
· Document the findings.

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
43
 LEARNING GUIDE #5
Unit of Competence : Apply Quality Control
Module Title : Applying Quality Control
LG Code : HLT NUA3 M015LO5
TTLM Code : HLT NUA3 TTLM 0112v1

LO5: Complete documentation

LO5: Complete documentation

Instruction Sheet-5 Learning Guide 5

This learning guide is developed to provide you the necessary information

regarding the following content coverage and topics –
 information on quality and Indicators of service
 recorded service process and out come

Set by:Mr. Natnael Daniel Bed.Degree in CSIT

BA Degree in BMgt.
44
Information sheet-5 Complete documentation

5.1.informotion on quality and Indicators of service

1. Definition of Indicator
An indicator, in the context of quality management, is an aspect of patient care
measured to determine an organization’s performance with regard to a particular
element of care. An indicator may measure a particular structure, process or outcome.
Quality of care indicators are usually derived from clinical guidelines, standard
operating procedures and other manuals stating what types of services need to be
provided to a patient/client/population with specific needs. Such guides provide the
standard against which performance will be measured. These manuals could be
developed by government bodies, professional associations, or any other authorized
body.

Examples of clinical guidelines and manuals:

 Guideline for the management of severe and complicated malaria
 Guideline for the management of opportunistic infections and
antiretroviral therapy for adults and adolescents in Ethiopia
 National Tuberculosis and Leprosy Control Program Manual
 Guideline for the Prevention of Mother to Child Transmission of HIV
 Procedure Manuals for Health Management Information System
What are the characteristics of a
good indicator? 2. Selecting health care quality indicators

 Evidence of importance Quality improvement is not expected to happen

as a result of a single institution. It requires the
 Degree of control at the participation of all relevant stakeholders so as
specific level of care to ensure, from the beginning, that
measurement results will be accepted by
 Measurability different actors. Therefore, whenever possible
it is advisable to use indicators which are
 Sensitivity widely used by different groups. But, if there is
a need to develop new indicators, all relevant
 Specificity stakeholders need to be involved. This will
guarantee acceptability of measures and help
 Validity address the information needs of stakeholders
with no additional cost to collect and report
 Reliability data.
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
During selection of health care quality
 Understandability BA Degree in BMgt.
indicators, quality improvement teams need to
45
 Comparability consider characteristics of a good indicator.
These characteristics are:
2.1. Evidence of importance/Relevance/:
Set by:Mr. Natnael Daniel Bed.Degree in CSIT
BA Degree in BMgt.
46