qc and qa file practice school
qc and qa file practice school
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)
To the
Faculty of Pharmacy
DR. A.P.J. Abdul Kalam Technical University , Lucknow 2023-2024
MAA GAYATRI COLLEGE OF PHARMACY Page 1
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
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.
Declaration
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 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.
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)
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.
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.
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.
JIT
JIT helps achieves quality because it is a philosophy that
seeks to constantly improve production processes and
methods.
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,
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.
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
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.
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)
Standards Evaluates
of care care
Takes
action
Evaluate Identify
outcome of structure,
standards standard and
and criteria criteria
Plan Do
Act Check
Specific Approaches
Peer Review Committees (Staff Review Committees)
Standard as a device for quality assurance
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.
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
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.