Qualioty management system

Namdeo Shinde
Namdeo ShindeAssistant Professor um Department of Pharmaceutics
Quality Management
System
• Mr. Namdeo G. Shinde
• Assistant Professor
• Department of Pharmaceutics,
• Satara College of Pharmacy, Degaon, Satara
• under
• Dr. Babasaheb Ambedkar Technological University,
Lonere Raigad, (MS) INDIA.
Basics of quality management system
Quality word oriented from Latin word ‘Qualitus’ it means General
excellence OR distinctive feature.
The customer or user is at focus.
If customer or user is happy and satisfied with our product or
service than product or service is called good quality.
Simply quality is ‘fitness for use’
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 statistical feature of organization.
Total Quality: The term total quality was used for first time in 1969
in Tokyo by Feigenbaum at first international conference of Quality
Control.
Total Quality Management (1980s-1990s): A new phrase of Quality
Control & Management coined in Japan as Total Quality Management.
In 1987, International Organization for Standardization take lead and
launched ISO 9000 is a series of quality management systems (QMS)
standards based on BS 5750 series of standard of BSI.
Dr. Joseph Juran:
Quality there are no shortcut of quality, it is neither an accidental
not it happens overnight. Quality must be planned.
Quality planning, Quality control, Quality improvement
Dr. W. Edward Deming:
Adopt a new policy a transformation of the style of management.
Create a structure of organization which allows every one to work
towards transformation.
Philip B. Crosby:
Quality is to conformation requirements.
The performance standard is zero defect.
Total Quality Management (TQM)
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/manner of handling , controlling, directing, etc.
TQM is the art of managing the whole to achieve
excellence
“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.”
TQM requires that the company maintain this quality standard in all
aspects of its business. This requires ensuring that things are done
right the first time and that defects and waste are eliminated from
operations.
Definition:
Total Quality Management(TQM) is a management strategy aimed
at embedding awareness of quality in all organizational processes.
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
6 Cs in TQM
1. Commitment
2. Culture
3. Control
4. Customer focus
5. Co-operation
6. Continuous improvements
Business success may simply be the extent to which your organization
can produce a higher-quality product or service than your
competitors are able to do at a competitive price.
When quality is the key to a company’s success, quality management
systems allow organizations to keep up with and meet current quality
levels, meet the consumer’s requirement for quality, retain
employees through competitive compensation programs, and keep
up with the latest technology.
WHY QUALITY IS IMPORTANT
Management systems are needed in all areas of activity, whether
large or small businesses, manufacturing, service or public sector.
A good QMS will:
• Set direction and meet customers’ expectations
• Improve process control
• Reduce wastage
• Lower costs
• Increase market share/ values
• Facilitate training
• Involve staff
• Raise morale
Quality Cost
Prevention Cost : Planning, Document, Control, Training Appraisal
cost- inspection test installation Calibration, M/c Depreciation,
Reports & Rejects.
Internal Failure Cost: Scraps, Repair Rework, Design Changes, Defect
Failure Analysis, Retests & Re-Inspection, Downgrading, Down Time.
External Failure Cost: Complaints, Goodwill, Failures, Services &
Replacement, Guarantee & Warranty, Compensation, Recall, Loss of
Sales, Seconds Sales.
Benefits of quality:
Improved quality
Employee participation
Less migration of employee
Team work
Internal external customer satisfaction
Productivity with connectivity
Profitability & increase market share
Continuous Quality Improvement (CQI)
It focus on the process of quality improvement
CQI implementation attempts to develop a quality system that is
never satisfied; it It strives for constant innovation to improve work
processes and systems by reducing time-consuming, low value-
added activities.
Find a process to improve.
Organize to improve a process.
Clarify what is known.
Understand variation.
Select a process improvement.
Then move through the process improvement plan:
Plan-Create a time line, including all resources, activities, dates, and
personnel training.
Do- Implement the plan and collect data.
Check—analyze the results of the plan.
Act—act on what was learned and determine the next steps.
 General elements of QMS includes:
 The organization’s quality policy and quality objectives
 Quality manual
 Procedures, instructions, and records
 Data management
 Internal processes
 Customer satisfaction from product quality
 Improvement opportunities
 Quality analysis
ELEMENTS AND REQUIREMENTS OF A QUALITY
MANAGEMENT SYSTEM
ESTABLISHING AND IMPLEMENTING QMS
Establishing a quality management system helps organizations run
effectively.
Before establishing a quality management system, the organization
must identify and manage various connected, multifunctional
processes to ensure customer satisfaction is always the target
achieved.
The basic steps to implementing a quality management
system are as follows:
Design
Build
Deploy
Control
Measure
Review
Improve
The design and build portions serve to develop the structure of a
QMS, its processes, and plans for implementation.
Senior management must oversee this portion to ensure the needs
of the organization and the needs of its customers are a driving force
behind the systems development.
Deploy:
Deployment is best served in a granular fashion i.e. breaking each
process down into sub processes, and educating staff on
documentation, education, training tools, and metrics.
Control and measurement are two areas of establishing a QMS that
are largely accomplished through routine, systematic audits of the
quality management system.
The specifics vary greatly from organization to organization
depending on size, potential risk, and environmental impact.
CONTROL AND MEASURE
Review and improvement deal with how the results of an audit are
handled.
The goals are to determine the effectiveness and efficiency of each
process toward its objectives, to communicate these findings to the
employees, and to develop new best practices and processes based
on the data collected during the audit.
REVIEW AND IMPROVE
ISO 9001:2008
Quality Management
Systems
ISO 9000:2005 – Quality Management Systems, Fundamentals
and Vocabulary
ISO 9001:2008 – QMS – Requirements (required for certification)
Management Responsibility:
Resource Management
Product/Service realization
Measurement, analysis, improvement
ISO 9004-2009 – QMS – Guidelines for performance improvement
ISO FAMILY
ISO 9001:2008
ISO 9001 is for Quality Management.
Quality refers to all those features of a product (or service)
which are required by the customer.
Quality management means what the organization does to ensure
that its products or services satisfy the customer's quality
requirements, and Comply with any regulations applicable to those
products or services.
Quality management also means what the organization does to
enhance customer satisfaction, and
achieve continual improvement of its performance
ISO 9001 is an generic standards.
Generic means that the same standards can be applied:
to any organization, large or small, whatever its product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department
Management system means what the organization does to manage its
processes, or activities in order that its products or services meet the
organization’s objectives, such as,
satisfying the customer's quality requirements,
complying to regulations, or
meeting environmental objectives
Everyone is clear about who is responsible for doing
what, when, how, why and where.
MANAGEMENT SYSTEMS
Management system standards provide the organization with an
international, state-of-the-art model to follow.
ISO 9001 concerns the way an organization goes about its work.
They are not product /service standards.
They are process standards.
They Can be used by Product manufacturer and service providers.
ISO 9001 gives the requirements for what the organization
must do to manage processes affecting quality of its products
and services.
CERTIFICATION AND REGISTRATION
Certification is known as Registration in some countries.
An Independent, external body has audited an organizations
management system and verified that it conforms to the
requirements specified in the standard (ISO 9001).
The major reason why many companies want ISO 9001 certification is
that they want to portray themselves as a worthy company to do
business with, many of them do not really realize the benefits.
Direct Benefits:
• Improved customer satisfaction;
• Improved quality of products and services;
• Employees satisfaction and more commitment to the organization;
• Better management and a more effective organization;
• Improve relations with suppliers;
• Improved promotion of corporate image.
BENEFITS OF ISO CERTIFICATION
Indirect Benefits:
• Review business goals, and assess how well the organization is
meeting those goals;
• Identify processes that are unnecessary or inefficient, and then
remove or improve them;
• Review the organizational structure, clarifying managerial
responsibilities;
• Improve internal communication, and business and process
interfaces;
• Improve staff morale by identifying the importance of their output
to the business, and by involving them in the review and improvement
of their work.
QMS PRINCIPLES
Any organization can benefit from implementing ISO 9001 as its
requirements are underpinned by 8 management principles:
A customer focused organization
Leadership
The involvement of people
Ensuring a process approach
A systematic approach to management
A factual approach to decision making
Mutually beneficial supplier relations
Continuous improvement.
QUALITY MANUAL
Quality Manual is the main, top-level document which establishes
the quality policies and objectives of an organization.
It provides evidence of what specific controls are implemented to
ensure product/service quality.
Benefits to
• Customers
• Suppliers
• Employees
• The Company
1 von 32

Recomendados

Quality control von
Quality controlQuality control
Quality controlJyoti Kathwariya
1.9K views11 Folien
Quality Assurance and Quality Control - Areas of Improvement von
Quality Assurance and Quality Control - Areas of ImprovementQuality Assurance and Quality Control - Areas of Improvement
Quality Assurance and Quality Control - Areas of ImprovementImran Jamil
5.1K views18 Folien
Quality Management von
Quality ManagementQuality Management
Quality ManagementSteven Cahill
27.6K views14 Folien
Quality assurance von
Quality assuranceQuality assurance
Quality assurancerohit kamboj
1.1K views24 Folien
Quality Assurance von
Quality AssuranceQuality Assurance
Quality AssuranceOlivier Yuval Minkowski
2K views21 Folien
Basic quality concepts(3) von
Basic quality concepts(3)Basic quality concepts(3)
Basic quality concepts(3)ngiyari
33.7K views11 Folien

Más contenido relacionado

Was ist angesagt?

Introdution of qa qc von
Introdution of qa qcIntrodution of qa qc
Introdution of qa qcMohammed Ayoub Nizamani
2.2K views7 Folien
Quality control and quality assurance von
Quality control and quality assuranceQuality control and quality assurance
Quality control and quality assuranceLeola Ramirez
62.1K views22 Folien
Quality Awareness Session.pptx von
Quality Awareness Session.pptxQuality Awareness Session.pptx
Quality Awareness Session.pptxssuser7e363f
925 views27 Folien
Quality Management System von
Quality Management SystemQuality Management System
Quality Management SystemKuldeep Yagik
3.1K views37 Folien
Presentation Quality Management von
Presentation Quality ManagementPresentation Quality Management
Presentation Quality ManagementPrizzl
8.2K views21 Folien
Concept of quality assurance and TQM von
Concept of quality assurance and TQMConcept of quality assurance and TQM
Concept of quality assurance and TQMAkhila Yadagani
25.6K views36 Folien

Was ist angesagt?(20)

Quality control and quality assurance von Leola Ramirez
Quality control and quality assuranceQuality control and quality assurance
Quality control and quality assurance
Leola Ramirez62.1K views
Quality Awareness Session.pptx von ssuser7e363f
Quality Awareness Session.pptxQuality Awareness Session.pptx
Quality Awareness Session.pptx
ssuser7e363f925 views
Quality Management System von Kuldeep Yagik
Quality Management SystemQuality Management System
Quality Management System
Kuldeep Yagik3.1K views
Presentation Quality Management von Prizzl
Presentation Quality ManagementPresentation Quality Management
Presentation Quality Management
Prizzl8.2K views
Concept of quality assurance and TQM von Akhila Yadagani
Concept of quality assurance and TQMConcept of quality assurance and TQM
Concept of quality assurance and TQM
Akhila Yadagani25.6K views
Quality Management System - ISO 9001-2015 von Abhishek Raj
Quality Management System - ISO 9001-2015Quality Management System - ISO 9001-2015
Quality Management System - ISO 9001-2015
Abhishek Raj5.6K views
Quality management concepts von Ashu0711
Quality management conceptsQuality management concepts
Quality management concepts
Ashu071114.7K views
Quality Management Presentation von brianbish10795
Quality Management PresentationQuality Management Presentation
Quality Management Presentation
brianbish1079574.2K views
Quality Management System PowerPoint Presentation Slides von SlideTeam
Quality Management System PowerPoint Presentation Slides Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides
SlideTeam6.2K views
Quality Assurance von Sagar Savale
Quality Assurance Quality Assurance
Quality Assurance
Sagar Savale4.7K views
Quality Assurance vs. Quality Control in Manufacturing von Monarch Metal
Quality Assurance vs. Quality Control in ManufacturingQuality Assurance vs. Quality Control in Manufacturing
Quality Assurance vs. Quality Control in Manufacturing
Monarch Metal 7.5K views

Similar a Qualioty management system

Qms von
QmsQms
QmsHANU DADHWAL
85K views37 Folien
TQM (Total Quality Management) von
TQM (Total Quality Management)TQM (Total Quality Management)
TQM (Total Quality Management)amarchand
18K views27 Folien
Section1 unit6 von
Section1 unit6Section1 unit6
Section1 unit6shailesh_65
248 views6 Folien
TOTAL QUALITY MANAGEMENT (TQM) von
TOTAL QUALITY MANAGEMENT (TQM)TOTAL QUALITY MANAGEMENT (TQM)
TOTAL QUALITY MANAGEMENT (TQM)AJITH MK
3.4K views40 Folien
qms.pptx von
qms.pptxqms.pptx
qms.pptxPankajSharma446574
36 views134 Folien
Definition of tqm von
Definition of tqmDefinition of tqm
Definition of tqmlabibmouri
8.3K views34 Folien

Similar a Qualioty management system(20)

TQM (Total Quality Management) von amarchand
TQM (Total Quality Management)TQM (Total Quality Management)
TQM (Total Quality Management)
amarchand18K views
TOTAL QUALITY MANAGEMENT (TQM) von AJITH MK
TOTAL QUALITY MANAGEMENT (TQM)TOTAL QUALITY MANAGEMENT (TQM)
TOTAL QUALITY MANAGEMENT (TQM)
AJITH MK3.4K views
Definition of tqm von labibmouri
Definition of tqmDefinition of tqm
Definition of tqm
labibmouri8.3K views
CONCEPT OF TOTAL QUALITY MANAGEMENT(Roll No-8).pptx von VivekWagh13
CONCEPT OF TOTAL QUALITY MANAGEMENT(Roll No-8).pptxCONCEPT OF TOTAL QUALITY MANAGEMENT(Roll No-8).pptx
CONCEPT OF TOTAL QUALITY MANAGEMENT(Roll No-8).pptx
VivekWagh13268 views
Total quality management and six sigma von DhrutiPatel61
Total quality management and six sigmaTotal quality management and six sigma
Total quality management and six sigma
DhrutiPatel61129 views
Total Quality Management (Ankit Rana) von Ankit Rana
Total Quality Management (Ankit Rana)Total Quality Management (Ankit Rana)
Total Quality Management (Ankit Rana)
Ankit Rana542 views
quality management system von RiyaRai26
quality management system quality management system
quality management system
RiyaRai26111 views
Pharmaceutical Quality Management System von Dhawal_Raghuvanshi
Pharmaceutical Quality Management SystemPharmaceutical Quality Management System
Pharmaceutical Quality Management System
Dhawal_Raghuvanshi34.8K views
Total quality management von satya pal
Total quality managementTotal quality management
Total quality management
satya pal3.8K views
Total Quality Management (TQM) von Sheetal Wagh
Total Quality Management (TQM)Total Quality Management (TQM)
Total Quality Management (TQM)
Sheetal Wagh140.2K views

Más de Namdeo Shinde

Pharmacokinetic models von
Pharmacokinetic models Pharmacokinetic models
Pharmacokinetic models Namdeo Shinde
551 views22 Folien
GPAT 2022 Preparation Strategies by Pharma Scholars Academy von
GPAT 2022 Preparation Strategies by Pharma Scholars AcademyGPAT 2022 Preparation Strategies by Pharma Scholars Academy
GPAT 2022 Preparation Strategies by Pharma Scholars AcademyNamdeo Shinde
1.3K views37 Folien
GPAT highlights 2021 von
 GPAT highlights 2021 GPAT highlights 2021
GPAT highlights 2021Namdeo Shinde
390 views108 Folien
Concept of health and disease von
Concept of health and disease  Concept of health and disease
Concept of health and disease Namdeo Shinde
2.8K views41 Folien
Practice school session: Preformulation von
Practice school session: PreformulationPractice school session: Preformulation
Practice school session: PreformulationNamdeo Shinde
602 views23 Folien
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by... von
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...Namdeo Shinde
127 views45 Folien

Más de Namdeo Shinde(20)

GPAT 2022 Preparation Strategies by Pharma Scholars Academy von Namdeo Shinde
GPAT 2022 Preparation Strategies by Pharma Scholars AcademyGPAT 2022 Preparation Strategies by Pharma Scholars Academy
GPAT 2022 Preparation Strategies by Pharma Scholars Academy
Namdeo Shinde1.3K views
Concept of health and disease von Namdeo Shinde
Concept of health and disease  Concept of health and disease
Concept of health and disease
Namdeo Shinde2.8K views
Practice school session: Preformulation von Namdeo Shinde
Practice school session: PreformulationPractice school session: Preformulation
Practice school session: Preformulation
Namdeo Shinde602 views
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by... von Namdeo Shinde
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
Namdeo Shinde127 views
Regulatory requirements for drug approval von Namdeo Shinde
Regulatory requirements for drug approval Regulatory requirements for drug approval
Regulatory requirements for drug approval
Namdeo Shinde26.2K views
Pharmaceutical industrial safety von Namdeo Shinde
Pharmaceutical industrial safetyPharmaceutical industrial safety
Pharmaceutical industrial safety
Namdeo Shinde66.6K views
HVAC SYSTEM IN PHARMACEUTICAL INDUSTRY von Namdeo Shinde
HVAC SYSTEM IN PHARMACEUTICAL INDUSTRYHVAC SYSTEM IN PHARMACEUTICAL INDUSTRY
HVAC SYSTEM IN PHARMACEUTICAL INDUSTRY
Namdeo Shinde78.3K views
Design of gastroretentive bilayer floating films of propranolol hydrochloride... von Namdeo Shinde
Design of gastroretentive bilayer floating films of propranolol hydrochloride...Design of gastroretentive bilayer floating films of propranolol hydrochloride...
Design of gastroretentive bilayer floating films of propranolol hydrochloride...
Namdeo Shinde4.3K views
PHARMACIST in patient counseling von Namdeo Shinde
PHARMACIST in patient counselingPHARMACIST in patient counseling
PHARMACIST in patient counseling
Namdeo Shinde19.2K views
Routes of drug administration von Namdeo Shinde
Routes of drug administration Routes of drug administration
Routes of drug administration
Namdeo Shinde88.5K views
recent advances in vesicular drug delivery system. von Namdeo Shinde
recent advances in vesicular drug delivery system.recent advances in vesicular drug delivery system.
recent advances in vesicular drug delivery system.
Namdeo Shinde8K views

Último

GCSE Music von
GCSE MusicGCSE Music
GCSE MusicWestHatch
45 views50 Folien
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx von
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptxPharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptxMs. Pooja Bhandare
113 views51 Folien
How to empty an One2many field in Odoo von
How to empty an One2many field in OdooHow to empty an One2many field in Odoo
How to empty an One2many field in OdooCeline George
87 views8 Folien
Java Simplified: Understanding Programming Basics von
Java Simplified: Understanding Programming BasicsJava Simplified: Understanding Programming Basics
Java Simplified: Understanding Programming BasicsAkshaj Vadakkath Joshy
322 views155 Folien
STRATEGIC MANAGEMENT MODULE 1_UNIT1 _UNIT2.pdf von
STRATEGIC MANAGEMENT MODULE 1_UNIT1 _UNIT2.pdfSTRATEGIC MANAGEMENT MODULE 1_UNIT1 _UNIT2.pdf
STRATEGIC MANAGEMENT MODULE 1_UNIT1 _UNIT2.pdfDr Vijay Vishwakarma
70 views68 Folien
Purpose of maths student display.pptx von
Purpose of maths student display.pptxPurpose of maths student display.pptx
Purpose of maths student display.pptxchristianmathematics
87 views9 Folien

Último(20)

Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx von Ms. Pooja Bhandare
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptxPharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Ms. Pooja Bhandare113 views
How to empty an One2many field in Odoo von Celine George
How to empty an One2many field in OdooHow to empty an One2many field in Odoo
How to empty an One2many field in Odoo
Celine George87 views
CUNY IT Picciano.pptx von apicciano
CUNY IT Picciano.pptxCUNY IT Picciano.pptx
CUNY IT Picciano.pptx
apicciano54 views
Classification of crude drugs.pptx von GayatriPatra14
Classification of crude drugs.pptxClassification of crude drugs.pptx
Classification of crude drugs.pptx
GayatriPatra14101 views
ISO/IEC 27001 and ISO/IEC 27005: Managing AI Risks Effectively von PECB
ISO/IEC 27001 and ISO/IEC 27005: Managing AI Risks EffectivelyISO/IEC 27001 and ISO/IEC 27005: Managing AI Risks Effectively
ISO/IEC 27001 and ISO/IEC 27005: Managing AI Risks Effectively
PECB 623 views
Monthly Information Session for MV Asterix (November) von Esquimalt MFRC
Monthly Information Session for MV Asterix (November)Monthly Information Session for MV Asterix (November)
Monthly Information Session for MV Asterix (November)
Esquimalt MFRC72 views
AUDIENCE - BANDURA.pptx von iammrhaywood
AUDIENCE - BANDURA.pptxAUDIENCE - BANDURA.pptx
AUDIENCE - BANDURA.pptx
iammrhaywood117 views
Narration lesson plan von TARIQ KHAN
Narration lesson planNarration lesson plan
Narration lesson plan
TARIQ KHAN61 views
Create a Structure in VBNet.pptx von Breach_P
Create a Structure in VBNet.pptxCreate a Structure in VBNet.pptx
Create a Structure in VBNet.pptx
Breach_P78 views
Pharmaceutical Inorganic Chemistry Unit IVMiscellaneous compounds Expectorant... von Ms. Pooja Bhandare
Pharmaceutical Inorganic Chemistry Unit IVMiscellaneous compounds Expectorant...Pharmaceutical Inorganic Chemistry Unit IVMiscellaneous compounds Expectorant...
Pharmaceutical Inorganic Chemistry Unit IVMiscellaneous compounds Expectorant...
Ms. Pooja Bhandare133 views

Qualioty management system

  • 1. Quality Management System • Mr. Namdeo G. Shinde • Assistant Professor • Department of Pharmaceutics, • Satara College of Pharmacy, Degaon, Satara • under • Dr. Babasaheb Ambedkar Technological University, Lonere Raigad, (MS) INDIA.
  • 2. Basics of quality management system Quality word oriented from Latin word ‘Qualitus’ it means General excellence OR distinctive feature. The customer or user is at focus. If customer or user is happy and satisfied with our product or service than product or service is called good quality. Simply quality is ‘fitness for use’
  • 3. 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 statistical feature of organization.
  • 4. Total Quality: The term total quality was used for first time in 1969 in Tokyo by Feigenbaum at first international conference of Quality Control. Total Quality Management (1980s-1990s): A new phrase of Quality Control & Management coined in Japan as Total Quality Management. In 1987, International Organization for Standardization take lead and launched ISO 9000 is a series of quality management systems (QMS) standards based on BS 5750 series of standard of BSI.
  • 5. Dr. Joseph Juran: Quality there are no shortcut of quality, it is neither an accidental not it happens overnight. Quality must be planned. Quality planning, Quality control, Quality improvement Dr. W. Edward Deming: Adopt a new policy a transformation of the style of management. Create a structure of organization which allows every one to work towards transformation. Philip B. Crosby: Quality is to conformation requirements. The performance standard is zero defect.
  • 6. Total Quality Management (TQM) 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/manner of handling , controlling, directing, etc. TQM is the art of managing the whole to achieve excellence
  • 7. “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.” TQM requires that the company maintain this quality standard in all aspects of its business. This requires ensuring that things are done right the first time and that defects and waste are eliminated from operations. Definition: Total Quality Management(TQM) is a management strategy aimed at embedding awareness of quality in all organizational processes.
  • 8. 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
  • 9. 6 Cs in TQM 1. Commitment 2. Culture 3. Control 4. Customer focus 5. Co-operation 6. Continuous improvements
  • 10. Business success may simply be the extent to which your organization can produce a higher-quality product or service than your competitors are able to do at a competitive price. When quality is the key to a company’s success, quality management systems allow organizations to keep up with and meet current quality levels, meet the consumer’s requirement for quality, retain employees through competitive compensation programs, and keep up with the latest technology. WHY QUALITY IS IMPORTANT
  • 11. Management systems are needed in all areas of activity, whether large or small businesses, manufacturing, service or public sector. A good QMS will: • Set direction and meet customers’ expectations • Improve process control • Reduce wastage • Lower costs • Increase market share/ values • Facilitate training • Involve staff • Raise morale
  • 12. Quality Cost Prevention Cost : Planning, Document, Control, Training Appraisal cost- inspection test installation Calibration, M/c Depreciation, Reports & Rejects. Internal Failure Cost: Scraps, Repair Rework, Design Changes, Defect Failure Analysis, Retests & Re-Inspection, Downgrading, Down Time. External Failure Cost: Complaints, Goodwill, Failures, Services & Replacement, Guarantee & Warranty, Compensation, Recall, Loss of Sales, Seconds Sales.
  • 13. Benefits of quality: Improved quality Employee participation Less migration of employee Team work Internal external customer satisfaction Productivity with connectivity Profitability & increase market share
  • 14. Continuous Quality Improvement (CQI) It focus on the process of quality improvement CQI implementation attempts to develop a quality system that is never satisfied; it It strives for constant innovation to improve work processes and systems by reducing time-consuming, low value- added activities.
  • 15. Find a process to improve. Organize to improve a process. Clarify what is known. Understand variation. Select a process improvement. Then move through the process improvement plan: Plan-Create a time line, including all resources, activities, dates, and personnel training. Do- Implement the plan and collect data. Check—analyze the results of the plan. Act—act on what was learned and determine the next steps.
  • 16.  General elements of QMS includes:  The organization’s quality policy and quality objectives  Quality manual  Procedures, instructions, and records  Data management  Internal processes  Customer satisfaction from product quality  Improvement opportunities  Quality analysis ELEMENTS AND REQUIREMENTS OF A QUALITY MANAGEMENT SYSTEM
  • 17. ESTABLISHING AND IMPLEMENTING QMS Establishing a quality management system helps organizations run effectively. Before establishing a quality management system, the organization must identify and manage various connected, multifunctional processes to ensure customer satisfaction is always the target achieved.
  • 18. The basic steps to implementing a quality management system are as follows: Design Build Deploy Control Measure Review Improve
  • 19. The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation. Senior management must oversee this portion to ensure the needs of the organization and the needs of its customers are a driving force behind the systems development. Deploy: Deployment is best served in a granular fashion i.e. breaking each process down into sub processes, and educating staff on documentation, education, training tools, and metrics.
  • 20. Control and measurement are two areas of establishing a QMS that are largely accomplished through routine, systematic audits of the quality management system. The specifics vary greatly from organization to organization depending on size, potential risk, and environmental impact. CONTROL AND MEASURE
  • 21. Review and improvement deal with how the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit. REVIEW AND IMPROVE
  • 23. ISO 9000:2005 – Quality Management Systems, Fundamentals and Vocabulary ISO 9001:2008 – QMS – Requirements (required for certification) Management Responsibility: Resource Management Product/Service realization Measurement, analysis, improvement ISO 9004-2009 – QMS – Guidelines for performance improvement ISO FAMILY
  • 24. ISO 9001:2008 ISO 9001 is for Quality Management. Quality refers to all those features of a product (or service) which are required by the customer. Quality management means what the organization does to ensure that its products or services satisfy the customer's quality requirements, and Comply with any regulations applicable to those products or services.
  • 25. Quality management also means what the organization does to enhance customer satisfaction, and achieve continual improvement of its performance ISO 9001 is an generic standards. Generic means that the same standards can be applied: to any organization, large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department
  • 26. Management system means what the organization does to manage its processes, or activities in order that its products or services meet the organization’s objectives, such as, satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives Everyone is clear about who is responsible for doing what, when, how, why and where. MANAGEMENT SYSTEMS
  • 27. Management system standards provide the organization with an international, state-of-the-art model to follow. ISO 9001 concerns the way an organization goes about its work. They are not product /service standards. They are process standards. They Can be used by Product manufacturer and service providers. ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services.
  • 28. CERTIFICATION AND REGISTRATION Certification is known as Registration in some countries. An Independent, external body has audited an organizations management system and verified that it conforms to the requirements specified in the standard (ISO 9001).
  • 29. The major reason why many companies want ISO 9001 certification is that they want to portray themselves as a worthy company to do business with, many of them do not really realize the benefits. Direct Benefits: • Improved customer satisfaction; • Improved quality of products and services; • Employees satisfaction and more commitment to the organization; • Better management and a more effective organization; • Improve relations with suppliers; • Improved promotion of corporate image. BENEFITS OF ISO CERTIFICATION
  • 30. Indirect Benefits: • Review business goals, and assess how well the organization is meeting those goals; • Identify processes that are unnecessary or inefficient, and then remove or improve them; • Review the organizational structure, clarifying managerial responsibilities; • Improve internal communication, and business and process interfaces; • Improve staff morale by identifying the importance of their output to the business, and by involving them in the review and improvement of their work.
  • 31. QMS PRINCIPLES Any organization can benefit from implementing ISO 9001 as its requirements are underpinned by 8 management principles: A customer focused organization Leadership The involvement of people Ensuring a process approach A systematic approach to management A factual approach to decision making Mutually beneficial supplier relations Continuous improvement.
  • 32. QUALITY MANUAL Quality Manual is the main, top-level document which establishes the quality policies and objectives of an organization. It provides evidence of what specific controls are implemented to ensure product/service quality. Benefits to • Customers • Suppliers • Employees • The Company