This document provides an overview of quality management systems and Six Sigma. It discusses basics of quality management including definitions of quality, dimensions of quality, and the scope of pharmaceutical quality management systems. It then introduces Total Quality Management (TQM) and its principles of continuous improvement. Six Sigma is defined as a statistical approach to process improvement, and its DMAIC methodology is explained. The key principles of Six Sigma are outlined as focusing on customer requirements, using data to identify process variation, improving processes to eliminate variation, involving multidisciplinary teams, and maintaining flexibility.
1. Basics Of Quality Management. Total Quality
Management. Principles Of Six Sigma
SUBMITTED BY,
RAJ PATIL QUIDED BY,
FIRST YEAR M.PHARMACY ( QAT ) K.V.DHAMAK
DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE PRAVARA RURAL COLLEGE OF PHARMACY
SEMESTER 1
ROLL NO : 13
PRAVARA RURAL COLLEGE OF PHARMACY
2. Contents
Quality Management System
Basics Of Quality Management System
Dimension Of Quality
Scope Of Pharmaceutical QMS
Introduction Of Total Quality Management (TQM)
Total Quality Management and Continuous Improvement:-
Six SIGMA
Principal OF Six SIgma
3. Quality Management System (QMS)
Quality Management System (QMS) is an important aspect for the pharmaceutical industry for
maintaining the quality and safety for their products and services. QMS relies on the regulations
and guidelines to maintain the effective quality in pharmaceutical industries. According to US
FDA, the international harmonized guidance is intended to assist pharmaceutical manufacturers by
describing a model for an effective quality management system for the pharmaceutical industry.
This guidance is referred as ICH (International Council for Harmonization) guideline.
Quality:- Quality can be defined according to US FDA as; "A measure of a product's or service's
ability to satisfy the customer's stated or implied needs."
4. Basics of quality management system
Quality word oriented from Latin word 'Qualitus' it means General excellence OR
distinctive feature.
Quality- a standard of how good something is as measured against other similar
things.(by OXFORD dictionary)
If we try to analyse definition some common words like...
5. 1. Standard
2. Measurement
3. Goodness
4. comparison
Most simple definition of quality is 'fitness for use'
The customer or user is at focus. if customer or user is happy and satisfied with our product or
service then product or service is called good quality.
It must be remember that the quality is not the job of only a single person or single department but,
it is responsibility of whole organization.
Quality of Product and service is measurable, managerial, technological and stastical feature of
organization.
7. Quality Assurance (QA):- According to WHO, QA is a wide-ranging concept covering all matters that
individually or collectively influence the quality of a product. It is the totality of the arrangements made
with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
Quality assurance therefore incorporates GMP and other factors. including those outside the scope of this
guide such as product design and development.
Quality Control (QC):- QC is that part of GMP concerned
with sampling, specification, testing, documentation and release procedures which ensure that the
necessary and relevant tests are performed and the product is released for use only after ascertaining its
quality.
8. Scope of Pharmaceutical QMS:-
1. Phamaceutical Development:-
Drug substance development. Formulation development (including container/closure
system). Manufacture of investigational products.
Delivery system development (where relevant).
Manufacturing process development and scale-up. Analytical method development.
2. Technology Transfer:
New product transfers during development through manufacturing.
Transfers within or between manufacturing and testing sites for marketed product
9. Introduction:-
Total-Made up of the whole (or) Complete.
Quality-Degree of Excellence a product or
service provides to the customer in present and future.
Management -Act, art, or manner of handling, controlling, directing, etc.
TQM is the art of managing the whole to achieve excellence
Definition:- "TQM is a management approach for an organization, centered on quality,
based on the participation of all its members and aiming at long-term success through
customer satisfaction, and benefits to all members of the organization and to society."
10.
11. Characteristics :
•Technological strength, hardness,
•Time - oriented, Reliability, maintainability - availability
•Contractual Guarantee
Six basic concepts of TQM:-
1. A committed and involved management to provide long term top - to - bottom organization support.
2. An unwavering focus on the customer, both internally and externally.
3. Effective involvement and utilization of the entire work force.
4. Continuous improvement of the business and production
5. Treating suppliers of the business and production process.
6. Establishing the performance measures
12. Total Quality Management and Continuous
Improvement:-
TQM is the management process used to make continuous improvements to all functions.
TQM represents an ongoing, continuous commitment to improvement.
The foundation of total quality is a management philosophy that supports meeting
customer requirements through continuous improvement.
13. What is six sigma..????
Six sigma is a business statistical Strategy.
Is to identifying defects and removing them from the process of products to
improve quality.
A defect is defined as any process output that does not meet customer
specifications.
Statistical measure to objectively evaluate processes.
14. History of six sigma
The Six sigma was founded by Motorola in the 1970s.
Out of senior executive Art Sundry's criticism of Motorola's bad quality.
They founded a connection between increases in quality and decreases in
costs of production.
Bill Smith, "Father of six sigma" introduce this quality improvement
Methodology to Motorola
15. Six Sigma Definition
Quality management program developed by Motorola in the 1980s.
• Management philosophy focused on business process improvements to:
✓Eliminate waste, rework, and mistakes
✓Increase customer satisfaction
✔Increase profitability and competitiveness
19. Six Sigma Technique
Define process goals in terms of key critical parameters (i.e. critical to quality or critical to
production) on the basis of customer requirements or Voice Of Customer (VOC)
Measure the current process performance in context of goals
Analyze the current scenario in terms of causes of variations and defects
Improve the process by systematically reducing variation and eliminating defects
Control future performance of the process
21. 1. Focus on Customer Requirements:
The initial phase in Six Sigma process is defining the "quality" from the
point of customers. Every customer defines quality differently. A business
needs to measure quality in a similar way its customers do. By addressing
the needs of the customer business can define the quality to the customer.
22. 2. Use data to identify the variation in the process:
Variations in the process are of two types; Special cause variation and
Natural variation. Special cause variation is caused by external factors.
Natural variation is random variation present in the process. Six Sigma aims
to reduce the special cause variation. To identify the root cause of the
variation, understating the process is necessary. The understanding of the
process should be deep and extensive.
To collect detailed data:
23. Define the goals for data collection clearly Identification of the data.
Define the reason for the data collection Define the expected insight
Define the data collection method
Eliminate the error in the data collection
Data collection in the Six Sigma process includes interviewing with people, taking
observations, and asking questions.
Once the data collection is finished, check whether the collected data gives the required
knowledge to meet the objectives which were set up. If not, repeat the data collection plan
and get more information
24. The process is repeated to find answers. Identify the potential root causes for
the variation in the process and try to eliminate it with the help of collected
data. After identifying the potential root causes, analyze it. To identify the
significant root cause that makes the variation, use Statistical analysis.
25. 3. Continually improving the process to eliminate the variation:
After identifying root causes, make changes to eliminate variation in the
process. Thus the defects in the process are removed. Additionally, search for
ways to remove steps that do not add value to the customer. This will
eliminate waste in the process.
Identify variation and eliminate it. Don't wait for the variation to show itself.
Collect data, talk to people, and study the data to identify variations in the
process. variation may have become the routine because "that's the way we've
always done things."
26. 4. Involve people from different levels of management and process:
Six Sigma is formed on the foundation of good teams. The good teams comprise of
peoples who take responsibility for the Six Sigma processes.
The people on the team need training in Six Sigma's methods. Forming a cross-
functional team with peoples from different backgrounds will help identify variation.
For example, six sigma team from health care project consists of top management
people, doctors, nurses, managers, people from operations and purchasing.
27. 5. Be flexible and thorough:
Six Sigma requires adaptability from various points of view. The business's
management system needs to acknowledge positive changes. People should be
motivated to accept the changes in the system to eliminate the variation. To motivate
the employee, the benefits of the six sigma system should be made clear to all levels of
employees. This will make the changes easily acceptable.
Six Sigma also requires reducing variation to be thorough. So understand all the
aspects of a process the steps, stakeholders, and methods involved. This will help to
ensure that any new or updated process works.
28. Importance of Six Sigma Principles:
Six Sigma is such a popular approach for process management as it forms a way through
which one can improve their processes. It is centrally a customer and product-driven
approach.
The main purpose of this approach is to avoid waste and delivering the product by
meeting all the requirements of the customer thereby increasing customer satisfaction
To accurately analyze the process, Six Sigma requires precise data. The below goals also
known as business success facts can be achieved by implementing Six Sigma in a
company.
29. Importance of Six Sigma Principles
Increased Quality
Increased Productivity
Reduced Operation Cost
High Customer Satisfaction
Improved Employee Morale
Efficient Work environment
