This document discusses quality planning and ISO standards. It defines quality and outlines the key elements of quality planning, including determining customer needs, developing products and processes to meet those needs, and documenting quality systems. It also describes the ISO 9000 family of standards for quality management systems, which provide guidelines for organizations to ensure quality products and customer satisfaction. The steps for implementing a quality management system that meets ISO 9000 requirements are also summarized.
Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
A Review of the Concept of ISO Standard 9000 FamilySonali Chawla
In order to live in this period of customer oriented business every industry is endeavoring to slake the subsisting customers and additionally magnetize initial customers. One of the policies used is to maintain a quality standard of the products exceeding the client’s prospect. The software industry is no exclusion to identically tantamount. It is necessary for organizations to set up, manage and promote their quality control system and quality assurance systems and their integral standard operating functions and other quality documents to provide high-quality products and accommodations to plenarily gratify customer requirements and prospects. Quality control and quality assurance systems together form quality schemes. Quality management consists of both quality control as well as quality assurance. Quality control is engrossed on consummating quality requisites, whereas quality assurance is fixated on providing confidence that quality requisites are consummated.
6th sem b pharma QC,QA
pharmaceutical quality assurance
Quality Management System
Introduction to ISO 9000
Eight Quality Management Principles
ISO 9000 Series
Advantages
Clauses
Introduction to ISO 14000
Standards under ISO 14000 series
NABL accreditation ( National Accreditation Board for Testing and Calibration Laboratories)
Function of NABL
Process of NABL
A Review of the Concept of ISO Standard 9000 FamilySonali Chawla
In order to live in this period of customer oriented business every industry is endeavoring to slake the subsisting customers and additionally magnetize initial customers. One of the policies used is to maintain a quality standard of the products exceeding the client’s prospect. The software industry is no exclusion to identically tantamount. It is necessary for organizations to set up, manage and promote their quality control system and quality assurance systems and their integral standard operating functions and other quality documents to provide high-quality products and accommodations to plenarily gratify customer requirements and prospects. Quality control and quality assurance systems together form quality schemes. Quality management consists of both quality control as well as quality assurance. Quality control is engrossed on consummating quality requisites, whereas quality assurance is fixated on providing confidence that quality requisites are consummated.
6th sem b pharma QC,QA
pharmaceutical quality assurance
Quality Management System
Introduction to ISO 9000
Eight Quality Management Principles
ISO 9000 Series
Advantages
Clauses
Introduction to ISO 14000
Standards under ISO 14000 series
NABL accreditation ( National Accreditation Board for Testing and Calibration Laboratories)
Function of NABL
Process of NABL
Hybrid optimization of pumped hydro system and solar- Engr. Abdul-Azeez.pdffxintegritypublishin
Advancements in technology unveil a myriad of electrical and electronic breakthroughs geared towards efficiently harnessing limited resources to meet human energy demands. The optimization of hybrid solar PV panels and pumped hydro energy supply systems plays a pivotal role in utilizing natural resources effectively. This initiative not only benefits humanity but also fosters environmental sustainability. The study investigated the design optimization of these hybrid systems, focusing on understanding solar radiation patterns, identifying geographical influences on solar radiation, formulating a mathematical model for system optimization, and determining the optimal configuration of PV panels and pumped hydro storage. Through a comparative analysis approach and eight weeks of data collection, the study addressed key research questions related to solar radiation patterns and optimal system design. The findings highlighted regions with heightened solar radiation levels, showcasing substantial potential for power generation and emphasizing the system's efficiency. Optimizing system design significantly boosted power generation, promoted renewable energy utilization, and enhanced energy storage capacity. The study underscored the benefits of optimizing hybrid solar PV panels and pumped hydro energy supply systems for sustainable energy usage. Optimizing the design of solar PV panels and pumped hydro energy supply systems as examined across diverse climatic conditions in a developing country, not only enhances power generation but also improves the integration of renewable energy sources and boosts energy storage capacities, particularly beneficial for less economically prosperous regions. Additionally, the study provides valuable insights for advancing energy research in economically viable areas. Recommendations included conducting site-specific assessments, utilizing advanced modeling tools, implementing regular maintenance protocols, and enhancing communication among system components.
Sachpazis:Terzaghi Bearing Capacity Estimation in simple terms with Calculati...Dr.Costas Sachpazis
Terzaghi's soil bearing capacity theory, developed by Karl Terzaghi, is a fundamental principle in geotechnical engineering used to determine the bearing capacity of shallow foundations. This theory provides a method to calculate the ultimate bearing capacity of soil, which is the maximum load per unit area that the soil can support without undergoing shear failure. The Calculation HTML Code included.
Saudi Arabia stands as a titan in the global energy landscape, renowned for its abundant oil and gas resources. It's the largest exporter of petroleum and holds some of the world's most significant reserves. Let's delve into the top 10 oil and gas projects shaping Saudi Arabia's energy future in 2024.
Immunizing Image Classifiers Against Localized Adversary Attacksgerogepatton
This paper addresses the vulnerability of deep learning models, particularly convolutional neural networks
(CNN)s, to adversarial attacks and presents a proactive training technique designed to counter them. We
introduce a novel volumization algorithm, which transforms 2D images into 3D volumetric representations.
When combined with 3D convolution and deep curriculum learning optimization (CLO), itsignificantly improves
the immunity of models against localized universal attacks by up to 40%. We evaluate our proposed approach
using contemporary CNN architectures and the modified Canadian Institute for Advanced Research (CIFAR-10
and CIFAR-100) and ImageNet Large Scale Visual Recognition Challenge (ILSVRC12) datasets, showcasing
accuracy improvements over previous techniques. The results indicate that the combination of the volumetric
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Cosmetic shop management system project report.pdfKamal Acharya
Buying new cosmetic products is difficult. It can even be scary for those who have sensitive skin and are prone to skin trouble. The information needed to alleviate this problem is on the back of each product, but it's thought to interpret those ingredient lists unless you have a background in chemistry.
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The automated cosmetic shop management system should deal with the automation of general workflow and administration process of the shop. The main processes of the system focus on customer's request where the system is able to search the most appropriate products and deliver it to the customers. It should help the employees to quickly identify the list of cosmetic product that have reached the minimum quantity and also keep a track of expired date for each cosmetic product. It should help the employees to find the rack number in which the product is placed.It is also Faster and more efficient way.
Industrial Training at Shahjalal Fertilizer Company Limited (SFCL)MdTanvirMahtab2
This presentation is about the working procedure of Shahjalal Fertilizer Company Limited (SFCL). A Govt. owned Company of Bangladesh Chemical Industries Corporation under Ministry of Industries.
Final project report on grocery store management system..pdfKamal Acharya
In today’s fast-changing business environment, it’s extremely important to be able to respond to client needs in the most effective and timely manner. If your customers wish to see your business online and have instant access to your products or services.
Online Grocery Store is an e-commerce website, which retails various grocery products. This project allows viewing various products available enables registered users to purchase desired products instantly using Paytm, UPI payment processor (Instant Pay) and also can place order by using Cash on Delivery (Pay Later) option. This project provides an easy access to Administrators and Managers to view orders placed using Pay Later and Instant Pay options.
In order to develop an e-commerce website, a number of Technologies must be studied and understood. These include multi-tiered architecture, server and client-side scripting techniques, implementation technologies, programming language (such as PHP, HTML, CSS, JavaScript) and MySQL relational databases. This is a project with the objective to develop a basic website where a consumer is provided with a shopping cart website and also to know about the technologies used to develop such a website.
This document will discuss each of the underlying technologies to create and implement an e- commerce website.
Overview of the fundamental roles in Hydropower generation and the components involved in wider Electrical Engineering.
This paper presents the design and construction of hydroelectric dams from the hydrologist’s survey of the valley before construction, all aspects and involved disciplines, fluid dynamics, structural engineering, generation and mains frequency regulation to the very transmission of power through the network in the United Kingdom.
Author: Robbie Edward Sayers
Collaborators and co editors: Charlie Sims and Connor Healey.
(C) 2024 Robbie E. Sayers
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2. QUALITY PLANNING AND ITS
DEVELOPMENT
QUALITY
Quality is a relative term.
Degree of excellence.
Fitness for use.
It is based on the customers actual experience with
product or service, measured against his requirements.
The concept of quality concerns how well and for how
long a product meets requirements of the customer.
3. Definitions of quality
⚫Conformance to requirement- Philip B Crosby
⚫Continuous improvement- William Edwards Deming
⚫Fitness for use- Joseph Moses Juran
⚫Most economical, most useful and always satisfactory
to the customer- Kaoru Ishikawa
⚫As per ISO 9000 quality is defined as the totality of
features and characteristics of a product or service, that
bear on its ability to satisfy stated or implied needs
4. The word quality has variety of
meanings….
⚫Fitness for purpose.
⚫Conformance to requirements.
⚫Grade
⚫Degree of preference
⚫Degree of excellence
⚫Measure of fulfillment of promises.
⚫Assured performance and safety
⚫Proper packing and timely delivery
⚫Incorporating customer feedback
6. Quality planning
⚫Quality planning is one of the basic processes used in
managing for quality
⚫The process of establishing quality objectives and
developing the plans for meeting those objectives.
⚫Quality planning is the activity of developing the
products and processes required to meet customer’s
needs
7. Quality planning involves the following
steps
1. Determine who are the customers.
2. Determine the needs of the customers
3. Develop product features according to customers needs.
4. Develop processes which are able to produce those
product features.
5. Transfer the resulting plans to the operating forces.
8. Quality planning process
Identification of customers
Translate customer’sneedsinto supplier’slanguage
Discoveringcustomer needs
Transfer to operations
Develop the process
Develop the product that meetsthe customer’sneed
Optimize product design
9. Objectives of quality planning
which meet
⚫ To produce quality products and services
customer’s needs.
⚫ To define quality standards and to prepare product
specifications.
⚫ To prepare guidelines on various elements effecting quality.
⚫ To establish quality objectives and developing plans for
achieving these objectives.
10. ⚫ To review and evaluate product designs with a view to
improve quality and reduce the quality costs.
⚫ To develop quality control techniques and methods.
⚫ To build up a basis for total quality management culture
⚫ To identify opportunities for excellence
⚫ To create an excellent operating culture in the organization
11. Three prong approach to quality planning
⚫Planning is the activity of developing the product and
processes required to meet customers needs.
⚫Quality planning can be achieved by the three prong
approach
⚫1. Product planning
⚫2. Managerial and operational planning
⚫3. Documentation
12. 1. Product planning
⚫Product planning may be defined as – Evaluation of
the range, mix, specification and pricing of existing
and new products in relation to present and future
market requirements and competition.
⚫Planning of product range, mix, specification and
pricing to satisfy company objectives and specifying
the research, design and development support required.
⚫Product planning serves as an input to processes
design
13. 2. Managerial and operational planning
⚫ 1. Preparing organizational structure- involves responsibilities,
authorities and relationship arranged in pattern, through which
the organization performs its functions.
⚫ 2. Preparing organizational procedure- involves written
documentation of purpose and scope of each and every activity.
⚫ 3. Preparing process- involves set of inter- related resources and
activities which transform input into output in the most cost
effective and quality effective manners.
⚫ 4. Preparation of resources needed to implement quality
management- Includes the resources needed for all activities of
the over all management function that determine the quality
policy, objectives and responsibilities and prepare for
implementation such as quality control, quality assurance, quality
improvement
14. 3. Documentation
⚫All the elements requirements and provisions required
by company for its quality management system should
be documented in a systematic and orderly manner in
the form of written policies and procedures.
⚫Such documentation should ensure a common
understanding of quality policies and procedures.
⚫The quality management
adequate provision for
system should include
proper identification,
distribution, collection and maintenance of all quality
documents and records.
15. Types of quality documents
⚫ Drawing
⚫ Specifications
⚫ Blue prints
⚫ Inspection instructions
⚫ Test procedures
⚫ Work instructions
⚫ Operation sheet
⚫ Quality manual
⚫ Operational procedure
⚫ Quality control and quality assurance procedure
16. Quality management system
⚫ A management system to direct & control an organization
with regard to quality
⚫ System must clarify to the organization-what to do, who
will do it, how the work will be done, when to do it etc.
⚫ Systems in an organization must be focused towards a
direction i.e., there must exist a management system,
without which an organization would virtually collapse.
⚫ A system to establish quality policy & quality objectives &
to achieve those objectives
⚫ Quality management is also defined as A management
system to direct and control an organization with regard to
quality.
17. International standards organization -ISO
⚫ ISO is the international organization for standardisation, is
founded in 1946, with the objective of promotion and
development of international standards and related
activities, including conformity assessments such as
testing, inspection, laboratory accreditation, certification,
and quality assessments for facilitating international
exchange of goods and services.
18. ISO 9000
⚫ISO 9000 is a family of standards for quality
management systems, maintained by ISO based in
Geneva.
⚫Administrated by accreditation and certification
bodies.
⚫The ISO 9000 series of standards promotes the
adoption of process approach when developing,
implementing and improving the effectiveness of a
quality management system, to enhance customer
satisfaction by meeting customer requirements.
⚫ISO 9000 series standards have been adopted by some
45 countries.
19. ⚫ The first series of ISO 9000 standards were released in
1987.
⚫ There were 5 core standards and various guidance
standards for interpretation of mandatory requirements for
the specific industries.
⚫ As part of continual improvement, ISO 9000 series of
standards are reviewed and revised once in five years.
20. Whom does ISO-9000 HELP?
⚫ Organizations, whom want to promote their products in
international markets.
⚫ Organizations in creating confidence to the customers
regarding the product quality, which improves profits.
⚫ Organizations, in withstanding the competitions from other
producers of product in the global market.
⚫ Suppliers, in improving the quality of raw materials, semi
finished and finished products.
⚫ Customers, in getting good quality products.
⚫ Organizations, in expanding their business throughout the
world wide.
21. ISO 9000 SERIES
⚫ There are five standards in the ISO 9000 series, ISO 9000 to ISO
9004. They are,
⚫ 1. ISO 9000: Quality management and quality assurance
standards guidelines for selection and use.
⚫ Describes fundamentals of QMS,QCS,QAS etc
⚫ It includes fundamentals & vocabulary used in 9000 series
⚫ 2. ISO 9001: Quality systems- Model for quality assurance in
design, production, installation and servicing.
• Contains the actual requirements an organization must comply with
to become ISO 9001 Registered. It basically deals with certification
• Basically for business dealing with design, production,
Installation & servicing eg: jewellery
⚫ 3. ISO 9002: Quality systems model tor quality assurance in
production and installation.
⚫ It used to deal with mainly organisation which do not design or
develop products
22. ⚫ 4. ISO 9003: Quality systems - model for quality assurance
in final inspection and test.
⚫It is model for quality assurance in final inspection &
testing of products
⚫ 5. ISO 9004 : Quality management and quality system
elements –guidelines
⚫Provides guidelines on technical administration & human
factors affecting the quality of product & it provides
guidance for sustaining the success of an organization’s
objectives.
23. Elements of ISO 9000
⚫ A quality system for design, development, production, installation
and service has twenty requirements (elements) which has to be
established and compiled for ISO 9000 certification. They are,
⚫ 1. Management responsibility
⚫ 2. Quality system
⚫ 3. Contract review
⚫ 4. Design control
⚫ 5. Document control
⚫ 6. Purchasing
⚫ 7. Purchaser-supplied product
⚫ 8. Product identification and traceability
⚫ 9. Process control
⚫ 10. Inspection and testing
24. ⚫ 11. Inspection, measuring and testing equipment
⚫ 12. Inspection and test status
⚫ 13. Control of non-conformity product.
⚫ 14. Corrective action
⚫ 15. Handling, storage, packing and delivery
⚫ 16. Quality records
⚫ 17. Internal quality audits.
⚫ 18. Training
⚫ 19. Servicing
⚫ 20. Statistical techniques.
25. Steps for installation of ISO 9000
⚫3 steps are there
⚫1) Preparatory step
⚫2) Implementation step
⚫3) Registration & certification step
26. 1. PREPARATORY STEP
⚫ Make everybody aware of quality
⚫ Necessary quality document to be prepared for – Top
managerial groups – Department heads – Junior level
executives
⚫ Analyze present status & take corrective actions
⚫ Design & develop standard procedures of
manufacturing
⚫ Document everything in form of policy, procedures
etc
27. 2. IMPLEMENTATION STEP
⚫Implementing the documented quality system into
practice in the organization.
⚫ Internal audit
⚫ External audit
⚫ Conducting Pre-registration
28. 3. Registration and certification step
⚫Apply for registration
⚫Audit by certification body
⚫Certificate will be issued by certification body
29. QUALITY AUDIT
⚫A Systematic & independent examination to determine
whether quality objectives are as par the plans &
whether these plans are implemented effectively in
achieving quality objectives with the maintenance of
quality standards.
30. Objectives of quality audit
⚫To study the quality of the existing systems and find
out the non conformity with the quality system.
⚫To suggest the corrections to be done in different areas
and operations.
⚫To propose and implement methods as per ISO
standards.
⚫To evaluate a supplier before entering a contract with
him.
⚫To suggest best procedures and practices.
⚫To reduce the loss of money due to duplication of
activities, high repairs, high scraps, and so on.
31. Types of audit
⚫1. Adequate audit – Also called documentation review
or Intent audit. Office exercise to compare
documentation with applicable standard
⚫2. Compliance audit – Also called implementation or
effectiveness audit. It is an audit to establish the extend
to which the documented system is complied or not.
⚫3. System audit – Evaluates quality aspects of various
system in organization such a production and planning,
research and development, purchasing, design &
development assembly, inspection etc
32. ⚫4. Product audit – Evaluates or examines the
acceptance level of the finished product made by
inspection and testing department.
⚫5. First party audit – also called internal audit. Done by
persons within the organization to determine whether
the quality management system conforms to the
requirement of the ISO std, whether quality
management system has been effectively implemented
and maintained.
⚫6. Second party audit – Done by parties who have
interest in the organization such as customers.
⚫7. Third party audit – Conducted by external
independent organizations – ISO Certificate is issued
33. BENEFITS OF BECOMING ISO COMPANY
⚫ISO 9000 provide a competitive edge in the domestic
and global market
⚫Platform for Consistent improvement
⚫Reduces wastage & increases profit
⚫Maintains streamlined records
⚫Maintains streamlined material handling & storage
⚫It changes attitude of workers, working atmosphere etc
⚫ISO 9000 gives international recognition of ability,
credibility and expertise, thereby increasing the
number of customers.
34. Total quality management
⚫ Means Quality in every aspect of company operation
⚫ AIM
⚫ Long term success
⚫ Benefit to all
⚫ Zero defect
⚫ Customer satisfaction
⚫ TQM involves effective decision making, problem solving,
quality planning, quality implementation and quality
improvement strategies of all the departments of an organization.
⚫ In TQM, the needs of Customers are constantly monitored to
improve the products and processes to meet their requirements.
⚫ Effective TQM results in greater customer satisfaction, fewer
defects, less waste, reduced costs, improved profitability and
increased productivity
35. TQM is defined as,
⚫ Management approach of an organisation 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 an organisation and to
society.
⚫ Cost effective system for integrating continuous quality
improvement efforts of people at all levels in an
organisation, to deliver products and services which ensure
customer satisfaction.
⚫ TQM is a building, housing quality assurance system. The
foundation of this system is consciousness of employees,
walls of this building are employees involvement and
commitment, roof of the building is quality policy of the
top management.
36. ⚫ Q M
T-Total
In all functional areas
⚫
⚫
- at all levels
- all the people who haveshare in the organisation.
Q – Quality
⚫ - to meet customer requirements
M- Management
- effective utilisation of resources
- to maintain existing levels
T
37. all major areas of
TQM involves consideration of
production activities such as
(a)Engineering design development
(b)Sales
(c)Marketing
(d)Information system
(e) Purchasing service
(f) Distribution etc
38. TEN MANTHRAS OF TQM
⚫ 1) Quality is never accident, it is always the result of untiring and
intelligent effort
⚫ 2) Quality is like a prayer to god, which never comes out without
hard work and devotion
⚫ 3) Quality is everybody’s work
⚫ 4) Take care of quality , it will take care of everything
⚫ 5) Document is dependable but not memory
⚫ 6) Quality is achieved through team work
⚫ 7) Quality begins with cleanliness of the work place
⚫ 8) quality is begins and ends with education
evaluate
⚫ 9) Quality is the attribute that a customer uses to
products and services
⚫ 10)Make it right first time & all time
39. Link between ISO 9000 and TQM with the
help of TQM model
⚫ TQM is a mechanism to change the culture of the company to
achieve its goals, ISO certification.
⚫ ISO may be called as the subset of TQM.
⚫ Focused on employee involvement and product improvement
Quality in 4 dimension:
⚫ (a) Requirement of customer
⚫ (b) Management commitment
⚫ (c)Countrywide participation
⚫ (d)Analysis of quality problems
40. ⚫ ISO 9000is a quality management system
⚫ Organization has to prepare quality manual
⚫ Quality manual deals with organizations activities, procedures so
that organization can supply quality products and services
⚫ Organization which have decided to adopt TQM, will produce
quality products and services today and in near future.
⚫ Organization has to produce better quality products and services
than competitors.
⚫ Focused on consistency and record keeping
42. Vision and mission
⚫Mission: Declaration of what an organisation should
like in future.
⚫To design, manufacture and supply high quality and
reliable products.
⚫Mission statement should be easy to understand,
describe the functions of the organisation, purposes
for employees ,customers , supplier.
⚫Vision: It must find expression in the strategic quality
plan
43. Quality policy
⚫ A quality policy is a brief statement that aligns with your
organization's purpose and strategic direction, provides a
framework for quality objectives, and includes a
commitment to meet applicable requirements.
⚫ It is a brief statement or document that defines
your quality goals and objectives, a commitment.
⚫ It should provide an outline for creating, stating, and
measuring your performance of the quality objectives.