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qc and qa file practice school

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qc and qa file practice school

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lOMoARcPSD|50313900

Rohit yadav practice school project final

Bachelor of pharmacy (Dr. A.P.J. Abdul Kalam Technical University)

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lOMoARcPSD|50313900

A REPORT
on
“PRACTICE SCHOOL (BP706PS)”
Submitted in Practical Fulfillment of the
requirements For the Degree of
Bachelor of Pharmacy
By
Rohit Yadav
B.Pharm. IV Year, VII Semester
Roll No.:2009150500017
Enrollment No.: 200915050067681
Maa Gayatri College of Pharmacy (Prayagraj)

Under the Supervision of


Ms. Shivani Sharma
Asst. Prof. Department of Pharmacy

To the
Faculty of Pharmacy
DR. A.P.J. Abdul Kalam Technical University , Lucknow 2023-2024
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A REPORT FILE OF
“PRACTICE SCHOOL
(BP706PS)”

(2023-2024)

Quality control
and
Quality assurance

ROHIT YADAV
B. PHARM IVth YEAR
ROLL NO.: 2009150500021
MAA GAYATRI COLLEGE OF PHARMACY
NAINI, PRAYAGRAJ

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Certificate
This is to certify that Mr. ROHIT YADAV is a student of B.Pharm (IVth year) of
Maa Gayatri College Of Pharmacy Mawaiya road Naini Prayagraj. They have
prepared ‘A report on Practice School’ under the guidence of Ms. SHIVANI
SHARMA.

Guidence: Ms. SHIVANI SHARMA


External Examiner-
Name- Maa Gayatri College Of
Date- Pharmacy
Signature- Mawaiya Road,Naini,
Prayagraj

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Declaration

I hereby declare that the project entitled “Report on Practice School”,


embodies my own unaided work.

Place:PRAYAGRAJ ROHIT YADAV


Date:

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ACKNOWLEDGEMENT
Firstly, I would like to thank the management of our institute MAA GAYATRI
COLLEGE OF PHARMACY, MAWAIYA ROAD NAINI PRAYAGRAJ for my work.

I would also like to think our Ms. SHIVANI SHARMA for providing his
guidance thought the work.

I would like to acknowledgement the continuous encouragement and help


extended to me by my friends for preparing this review work.

I would like to thank my teachers for providing guidance and giving the article
regarding my work.

My thanks are due to my Parents and my Family whose moral support has
been always showered upon all the steps.

Last but not the least I thank “GOD” who has patronized me with
consciousness and love to ladder the success.

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PRACTICE SCHOOL Quality Control & Quality Assurance

Quality
 “Quality is defined as the degree to which health services
for the individuals and populations increase the likelihood
of the desired health outcomes and are consistent with
current professional knowledge”.
-Joint commission on Accreditation of
Healthcare Organizations (2002)

 “Quality of a servies is defined as the totality of features


and characteristics of a service that bear on its ability to
satisfy the stated and implied needs of the patients”.
-International Organization for
Standardization (ISO 8402)

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MEANING OF QUALITY CONTROL


 Quality control is the traditional way of managing quality.
 Quality control is concerned with checking and reviewing
work that has been done.
 For example, this would include lots of inspection, testing
and sampling.
 Quality control is mainly about “detecting” defective
output-rather than preventing it. Quality control can also
be a very expensive process. Gence, in recent years,
business have focused on quality management and quality
assurance.

DEFINITION OF QUALITY CONTROL


 “Quality control means the recognition and removal of
identifiable causes and defects, and variables from the set
standards”.
- J.A. Shubin

Basic examples of Quality Control


 Manufacturers of food products often have employees
who test the finished products for taste and other
qualities.
 Manufacturers have workers inspect clothing rments to
ensure that they are properly swn.
 Service-oriented companies often have representatives
who observe the services being performed or who do
follow-up checkes to ensure that everything was done
properly.
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PRACTICE SCHOOL Quality Control & Quality Assurance

When does Quality Control occur?


1. When raw materials are received prior to entering
production.
2. Whilst products are going through the production process.
3. When products are finished – inspection or testing takes
place before products are dispatched to customers.
4. Evaluating people. (Applicable with service-oriented
companies.)

Benefits of Quality Control


1) It provides a means of detecting error at inspection.
2) It leads to more uniform quality of production.
3) It improves the relationship with the customer.
4) It reduces inspection costs.
5) It reduces the number of rejects and saves the cost of
material.
6) It provides a basis for attainable specifications.
7) It points out the bottlenecks and trouble spots.
8) It provides a means of determining the capability of the
manufacturing process.
9) It promotes the understanding and appreciation of quality
control.

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PRACTICE SCHOOL Quality Control & Quality Assurance

Objectives of Quality Control


1. Improvement of quality.
2. Reduction of scrap and rework
3. Efficient use of men and machines
4. Economy in use of materials
5. Removing production bottle-necks
6. Decreased inspection coasts
7. Reduction in cost per unit
8. Scientific evaluation of quality and production
9. Quality caution at all levels

7 Basic tools of Quality Control


1. Check sheet
2. Control chart
3. Histogram
4. Ishikawa diagram
5. Pareto chart
6. Scatter diagram
7. Flow chart

1. Check sheet -
It is a form used to collect data in real time
at the location where the data are generated. The data it
captures can be quantitative or qualitative. When the
information is quantitative, the check sheet is sometimes called
a tally sheet.

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PRACTICE SCHOOL Quality Control & Quality Assurance

2. Control Chart -
Also known as she whart charts or process-
behavior charts, in statistical process control are tools used to
determine if a manufacturing or business process is in a state of
statistical control.

3. Histogram –
Is a graphical representation showing a visual
impression of the distribution of data.

4. Ishikawa Diagram –
Common uses of the ishikawa diagram
are product design and quality defect prevention, to identify
potential factors causing an overall effect. Each cause or reason
for imperfection is a source of variation. Causes are usually
grouped into major categories to identify these sources of
variation.

5. Pareto Chart –
Is a type of chart that contains both bars
and a line graph, where individual values are represented in
descending order by bars, and the cumulative total is
representated by the line.

6. Scatter diagram –
Is a type of mathematical diagram using
Cartesian coordinates to display values for two variables for a
set of data.

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7. Flow chart –
Is a type of diagram that represents an
algorithm or process, showing the steps as boxes of varios
kinds, and their order by connecting them with arrows.

Quality control through production systems


 Inputs – Raw materials – acceptance tests – quality of
inputs
 Conversion – production processes – control charts –
monitoring quality of partially completed products
 Outputs – goods & services – acceptance tests – quality of
outputs

Quality control Techniques


 JIT
 Quality at source
 Inspection
 SQC
 QC
 TQM

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JIT
 JIT helps achieves quality because it is a philosophy that
seeks to constantly improve production processes and
methods.

 JIT contributes to high product quality in the following


ways
- Production is highly standardized. Workers perform
standards tasks every day. They are familiar with their
tasks. Familiarity ensures high quality
- In process inventories are drastically reduces by
cutting lot sizes. Any interruption, therefore causes
production to stop until the problem has been solved.
- Suppliers of materials, under JIT system, supply
materials of perfect quality. Many companies do not
even inspect suppliers’ deliveries of materials; rather,
the emphasis is on working with suppliers to produce
perfect parts and materials.
- Workers are responsible for producing parts of
perfect quality.

Quality of the source


 The worker is put in the driver’s seat in controlling product
quality. The principles underlying quality at the source are:
- Every worker’s job becomes a quality control station.
The worker is responsible for inspecting his own
work.

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- Statistical quality control techniques are used to


monitor the quality of parts produced at each work
station/ and easy-to-understand charts and graphs
are used to coomunicate progress to workers and
managers.
- Each worker is given the right to stop the production
line to avoid producing defective parts.
- Workers and managers are organized into quality
circles- groups of people who analyse quality
problems, work to solve the problems, and
implement programmes to improve product quality.

Inspection
 The act of determining conformance or non-conformance
of the expected performance is the function of inspection.
By inspection, a manager seeks to determine the
acceptability or non-acceptibility of the parts,

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ISO 9000
 ISO 9000 standard represents an international consensus
on good management practices with the aim of ensuring
that the organization can time and again deliver the
product or services that meet the client’s quality
requirements. These good practices have been distilled
into a set of system, regardless of what the organization
does, its size, or whether it is private or public sector.

ISO
 Objectives:
- To promote the development of standardiastion and
related activities in the world with a view to
facilitating international exchange of goods and
services, and to developing cooperation in the
spheres of intellectual, scientific, technological and
economic activity.

Principle
 Demonstrate ability to consistently provide product to
meet customer and applicable regulatory requirements
 Enhance customer satisfaction
 Improve the quality of its own operations
 Provide confidence to internal management and
interested parties that the requirements of a quality
management system are being effectively implemented.

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PRACTICE SCHOOL Quality Control & Quality Assurance

Benefits
 ISO 9000 certification has become the de facto minimum
requirement for entering inti global markets
 It provides an opportunity to increase value to the
activities of te organization, by streamlining quality
management system.
 Improves the performance of processes/activities
continually thereby reducing the cost of production
 It gives importance to customer satisfaction
 It helps to improve customer relations by providing quality
product or servie
 It also acts an incentive to develop employee relations,
employee empowerment and organizational development

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Conclusion
 Quality Control (QC) is a procedure or set of procedures
intended to ensure that a manufactured product or
performed service adheres to a defined set of quality
criteria or meets the requirements of the client or
customer.
 Quality Control is a product-oriented process.
 Quality Control makes sure the end product meets the
quality requirements
 Quality control can be noted as a reactive process.

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Quality Assurance
 “Quality Assurance is an on-going, systematic
comprehensive evaluation of health care services and the
impact of those services on health care services.
- Kozier.
 Quality Asuurance is defined as all activities undertaken to
predate and prevent poor quality.
- Neetvert (1992)

Key terms related to quality assurance


 Quality improvement
 Total Quality Management/ Continuous Quality
improvement
 Quality Control
 Quality circles

Objectives of Quality Assurance


According to Jonas (2000), the two main objectives are;
 To ensure the delivery of quality client care
 To demonstrate the efforts of the health care providers to
provide the best possible results

Other specific objectives are;


 Formulate plan of care
 Attend the patients physical and non-physical needs
 Evaluate achievement of nursing care

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 Support delivery of nursing care with administrative and


managerial services

Principle of Quality Assurance


 Customer focus
 Leadership
 Involvement of people
 Process approach
 System approach to management
 Continual improvement
 Factual approach to decision making
 Mutually beneficial supplier relationship

Functios of Quality Assurance

Standards Evaluates
of care care

Takes
action

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Components of Quality Assurance


 Structure Evaluation
 Process Evaluation
 Outcome Evaluation

Quality Assurance process


1. Establishment of standards or criteria
2. Identify the information relevant to criteria
3. Determine ways to collect information
4. Collect and analyze the information
5. Compare collected information with established criteria
6. Make a judgment about quality
7. Provide information and if necessary, take corrective
action regarding findings of appropriate sources

Models of Quality Assurance

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ANA Quality Assurance Model

Evaluate Identify
outcome of structure,
standards standard and
and criteria criteria

apply the process,


standards and
criteria

Plan, Do, Study, Act cycle

Plan Do

Act Check

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Levels of evaluation of Quality of care


 National Level
 Trust or organization level
 Local level

Approaches of Quality Improvement


General Approaches
 Credentialing
 Licensure
 Accreditation
 Certification
 Charter
 Academic Degrees

Specific Approaches
 Peer Review Committees (Staff Review Committees)
 Standard as a device for quality assurance

Factors Affecting Quality Assurance in Nursing


Practice
 Lack of resources
 Personnel problem
 Imporper maintenance
 Unreasonable patients and attendants
 Absence of well-informed population
 Absence of accreditation laws
 Lack of incident review procedure
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 Lack of good hospital information system


 Absence of patient satisfaction surveys
 Lack of nursing care research
 Miscellaneous factors

Barriers of Quality Improvement Efforts


 The nurse manager might become pre occupied with
quality assessment
 It is impossible to identify all factors that influence nursing
care quality
 Difficulty in defining outcome criteria that result solely
from nursing intervention
 Nurse’s documentation of care measures is at times vague,
incomplete and lacking in objectivity
 There is still no single, all purpose, all site quality
assessment tool that is universally appropriate for all
health agencies.
 High cost

Role of Nurses in Quality Assurance


 Nurses are the active participant of interdisciplinary
quality improvement team
 Develop mechanism for continually monitoring the
effectivesness of nursing care both a collaborative and an
individual professional activity.
 Contribute innovation and improvement of patient care
 Participating in improvement projects and patient safety
initiatives
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 Participate continuing educational programs and in-service


educational programs for continuing professional
development
 Periodic and continuing appraisal and evaluation of health
care situation of patient
 Participate research works related to quality assurance
 Identify any area of needed improvement in delivery of
care.

Advantages of nursing audit


 It can be used as a method of measurement in all areas of
nursing.
 Scoring system is fairly simple.
 Results easily understood.
 Assesses the work of all those involved in recoring care.
 May be useful tool as part of a quality assurance
programme in areas where accurate records of care are
kept.

Disadvantages of nursing audit


 Appraises the outcomes of the nursing process, so it is not
so useful in areas where the nursing process has not been
implemented.
 Many of the components overlap making analysis difficult.
 Time consuming.
 Requires a team of trained auditors.

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The Eight elements of QAM


Ethics
It is a discipline concerned with good or bad in any situation.
Thses can be organizational or individual ethics

Integrity
Integrity implies honesty, morals, values, fairness, & adherence
to the facts & sincerity.

Trust
It is the by- product of integrity & ethical conduct. Trust allows
decision – making at appropriate levels in the organization

Training
Training of the employees includes interpersonal skills, the
ability to function within teams, problem solving, decision
making, job management performance analysis.

Teamwork
Teams provides more permanent improvement in processes &
operations.

Leadership
Leadership in total quality management(TQM) provides an
inspiring vision; make all and to instill values that guide
subordinates.

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Communication
It acts as a vital link between all elements of the TQM. It can be
upward communication, downward communication, or
sideways communication

Recognition
It should be provide for both suggestions and achievements for
teams as well as individuals

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Community health nursing standards


 Promoting health: incorporates practice strategies in
health promotion, prevention, protection and
maintenance, restoration and palliation.
 Building individual/community capacity: Reflects the
integral role of work with individuals, groups,
organizations and communicates in developing skills,
knowledge and readiness to take action in support of
health.
 Building relationship: Emphasizes development of
caring relationships, networks and supportive
environments
 Facilitating access and equity: Integrates application of
the principles of primary helath care in working with
others to facilitate universal and equitable access to
service and addressing determinants of health.
 Demonstrating professional responsibility and
accountability: acknowledges the autonomy of
community health nursing practice and the practitioner’s
responsibility in providing competent care within a
complex environment.

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Conclusion
 Good Manufacturing Practices are the basis of the
prodction and preparation of safe food.
 Good Hygienic Practices deal with safety and suitability
requirements to be follow world-wide.
 Each food operation should adapt existing codes to their
specific set of conditions
 Food operations should also decide which practices are
critical for the safety of a product and thus have to be
included in the HACCP plan.

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