A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
The detailed synopsis of QMS. It will definitely surpass, your desire to streamline, implement and brainstorm Quality Management in your organization. Perhaps, the 8 core principles of QMS is applicable for everyone and everywhere .
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
The detailed synopsis of QMS. It will definitely surpass, your desire to streamline, implement and brainstorm Quality Management in your organization. Perhaps, the 8 core principles of QMS is applicable for everyone and everywhere .
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
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1. Basic of quality management
Riya rai
T1622PQA008
1st Semester
M.Pharm QA
Guided by
Dr.avni khristi
M.Pharm, PhD
Assistant
professor
PARUL INSTITUTE OF PHARMACY
2. contents
Quality management
Component of quality management
Principle of quality management
Purpose of quality management
Benefits of quality management
Process improvement
Techniques of quality management
references
3. Quality : “Measure of excellence or the
state of being free from defects ,
Deficiencies and significant variations .”
4. Quality management
A system to make sure that a product or service meets
standards of excellence, and that the process by which the
product or service is created is efficient and effective as
well.
5. Component of quality management
Quality planning
Quality assurance
Quality control
Quality improvement
6. Quality planning
Quality control planning is the first step .
Requirements must be identified , a criteria needs to
be set, and important procedure must be recognized
as a part of plan.
Quality control
Quality control is needed to review the quality
of the product or service.
Quality control focused on fulfilling quality
requirements.
7. Quality assurance
Companies need to assure defects and Mistake
are avoided in the manufacturing of good or the
delivery of service, and quality assurance
guarantees consistent results.
Quality improvement
The is always room for improvement Through
Quality improvement ,the results can be measured
and possible improvements in products or services
can be made.
8. Principle of quality management
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
9. Purpose of quality management
Ease the processes of production,
Make the workflow more efficient,
Ensure a quick and airtight delivery mechanism, and
Significantly improve the quality of deliverables (both
service and product)
10. The Benefits of Quality Management
1. Improved customer satisfaction
2. Reduced costs
3. Increased efficiency
4. Improved competitiveness
5. Increased compliance with regulations.
6. Increased employee satisfaction
11. Process improvement
PDCA :It is a cyclic method for continuous
improvement of processes
•Test potential
solutions
•Study results
•Identify your
problems
•Implement the
best solution
Act Plan
Do
Check
12. Techniques of Quality Management
1.Total quality management
It is the approach of the management to achieve long-term
success by focusing on customer satisfaction. The
organization works towards a steady improvement in
quality at all stages of production.
13. 2. Six Sigma
Six sigma :Six Sigma is a systematic approach to
eliminating errors.
A business process for improving quality , reducing
costs , and increasing customer satisfaction
Six Sigma is a set of techniques and tools for process
improvement.
Statistically
Having no more than 3.4 defects per million.
Program designed to reduce defects.
14. Methodology for six sigma:
There are two methodologies used in the six-sigma project.
1. DMAIC: It is a method for improving current business
operations.
DMAIC (Define—Measure—Analyze—Improve—
Control)
Develop, test, and implement solutions to improve the
process.
15. 2. DMADV: It is a technique for developing a new
product or process design that results in more
predictable, mature, and defect-free efficiency
DMADV (Define—Measure—Analyze—Design—
Verify)
Measure and identify critical-to-quality characteristics
of the product, service or process. This includes risk
and production capabilities.
16. 3.ISO
It is the “International organization for
standardization” a body which gives the certification of
quality to the products and also to various type of
companies.
This ISO certification also works as an assurance to the
customer that the product is genuine and safe to
consume.
The ISO tag is there on every product. There are very
hard formalities which are to be followed to get the
status of ISO approved.
17. This ISO tag is also the sign of good quality and every
industry is running to get this mark to make its product
as a genuine product.
18. 4. Cost of Quality
cost of quality is the difference between the cost of the
production including manufacturing, sale and other
expenses and cost incurred without any defect during the
production.
The main idea behind the cost of quality is to make the
product cheaper and defect-free.
The manager basically focuses on cost reduction and
quality improvement so that there is a benefit of the
customer and as well of the company.
19. Quality of cost=Cost of conformance + cost of non-
conformance