This chapter discusses key concepts related to quality including definitions of quality, approaches to quality, quality characteristics, and quality management systems. It defines quality as conformance to requirements or specifications. There are various approaches to defining quality such as those based on products, users, manufacturing processes, and value. Standards and measurements are important for specifying quality requirements. Quality control involves operational techniques to ensure quality while quality assurance provides confidence that requirements will be met. A quality management system directs and controls an organization's quality activities through establishing policies, objectives, and processes.
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Tackling the challenges of single-use manufacturing for ADCsMilliporeSigma
Watch the full webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
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Tackling the challenges of single-use manufacturing for ADCsMilliporeSigma
Watch the full webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products in 2020. Adoption of SU systems has been slow due to concerns for safe handling of organic solvents and the toxic small molecule payload. Recent advances in Single-use technology have overcome these concerns and now provide understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how the single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
This is a three parts lecture series. The parts will cover the basics and fundamentals of reliability engineering. Part 1 begins with introduction of reliability definition and other reliability characteristics and measurements. It will be followed by reliability calculation, estimation of failure rates and understanding of the implications of failure rates on system maintenance and replacements in Part 2. Then Part 3 will cover the most important and practical failure time distributions and how to obtain the parameters of the distributions and interpretations of these parameters. Hands-on computations of the failure rates and the estimation of the failure time distribution parameters will be conducted using standard Microsoft Excel.
Part 1. Reliability Definitions
1.Reliability---Time dependent characteristic
2.Failure rate
3.Mean Time to Failure
4.Availability
5.Mean residual life
Authors: (i) Prashanth Lakshmi Narasimhan,
(ii) Mukesh Ravichandran
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The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
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Pe 6421 chapter @ quality and qaulity systems oct 5, 2014
1. CHAPTER TWO
Quality and Quality
Systems
Prof. Charlton S. Inao
Defence University
College of Engineering,
Bishoftu ,Ethiopia
1 10/6/2014
2. Topics
Quality Concepts and Related
Aspects
Quality Control and Quality
Assurance
Quality Management System
2 10/6/2014
3. Quality Concepts and Related
Aspects
What is quality?
Quality is conformance to requirements or
specifications.
Quality is fitness for use.
ISO 9000-2000( American Society of Quality)
Quality is a degree to which a set of inherent
characteristics fulfills requirements, with the
following notes:
1)The term quality can be used with adjectives such
poor, good and excellent.
2)Inherent means existing in something especially
3 10/6/2014
4. Product and Service Quality
(Feigenbaum)
The total composite product and
service marketing ,
engineering, manufacture and
maintenance through which the
product and service in use will
meet the expectations of the
customers
4 10/6/2014
5. Five Approaches to
Quality(Garvin)
1) Transcendent (inspiring, magnificent,
uplifting)
2) Product based
3) User based
4) Manufacturing based
5)Value based
5 10/6/2014
7. Quality Characteristics,
Specifications and Requirements
Specification - a concise statement of a set of
requirements to be satisfied.
Quality Characteristics- individual requirements
such as dimensions, appearance, strength ,
volume, errors in billing or posting of payments,
and product or service life.
What is Technical Specifications?
Document that prescribes technical requirements to
be fulfilled by a product, process or service. It
may be a standard, a part of standard or
independent of a standard.
7 10/6/2014
8. Standards and Measurements
What is a standard?
Document established by consensus and approved
by a recognized body, that provides , for common
and repeated use, rules , guidelines or
characteristics for activities of their results, aimed
at the achievement of the optimum degree of
order in a given context. (ISO 1991)
What is a Specification?
DOD-STD-480A
Specification. A document intended primarily for use
in procurement, which clearly and accurately
describes the essential technical requirements for
items, materials, or services including the
procedures by which it will be determined that the
8 10/6/2014
9. Example of Standards
The ASTM Standard Specification for Knitted
Fabrics, D3887-80 specify requirements on
properties on knitted fabrics:
Yield
Weight
Width
Length
Fabric count
Bursting strength
Extractable matter
Secondary Requirements
Moisture regain and thickness
The standard provides the necessary test
methods for the specified characteristics.
Fiber composition 9 10/6/2014
10. Example 2 Beverage Company
Requirements and test instructions for the
following characteristics:
Syrup water ratio
Syrup Brix
Syrup age
Water(potable, free from off taste, odor,
suspended matter, max alkalinity, maximum
chlorine, iron and aluminum residual)
Max microbiological count limits on water,
Syrup, final product and washed bottle
10 10/6/2014
11. Product taste
Product appearance
Suspended matter or any other foreign material
Bottle cleaning
Crown crimp
NEW BOTLE INPUTS
Finish
Rocker
Leaner
Dimensions
Capacity
Pressure strength and thermal shock strength
11 10/6/2014
13. Severity Classification of Quality
Characteristics
Nonconformity- A departure from s specified
requirement
Defect-A sufficient departure from usage
requirements.
- nonfulfillment of a requirement related to
an
intended or specified use.
ISO 2859-1 Levels of Severity
Class A Very Serious =>severe injury or
catatrophic economic loss
Class B Serious => significant injury or significant
13 10/6/2014
14. Quality : A Maturing Concept
References to quality have become a
commonplace in the public media.
Consumer expectations for quality have
risen
significantly with respect to
performance, reliability, durability, price
and delivery.
An increasing quality awareness by
society has resulted in mass recalls of
automobiles and other manufactured
products. Such recalls were unheard of
14 10/6/2014
15. Class C Major => related to major problems
with respect o intended normal reasonable use
Class C Minor => related to minor problems
with respect to intended normal or reasonable
foreseeable use
AT & T uses common demerits weights like 100, 50, 10, 1. Demerits
classifications allows for the computation of a demerit index and the
possibility of charting.
A further example is the 3,5,15 point system used by Peugeuot in
auditing completed automobiles
3 Points Non comformity that will be accepted by average
consumer
5 Points Important nonconformity that most customers will not
accept
15 points Glaring and intolerable blunder that will be noticed by
all customers
15 10/6/2014
16. Measurement of Quality
Characteristics
Test methods and equipment for tests are
important parts of an overall quality systems.
INSTRUMENTS
Mechanical devices
Electronic instruments
Analytical chemistry
Visual inspections
Sensory evaluations
NDT- Non destructive
Testing
Radiographic Testing
Ultrasonic Testing
(for metals)
ATE- Automatic Test
Equipment if 100%
inspection is necessary;
to avoid further
processing of
nonconforming parts
16 10/6/2014
17. Metrology
Metrology =The logic or study or science of
measurement
NCSL= National Conference on Standard
Laboratories
ISO 10012-2002; Quality Assurance
Requirements for Measuring Equipment
International Bureau of Weights and
Measures( BIPM)
International Organization of Legal
metrology(OIML)
17 10/6/2014
18. Laboratory Accreditation
NATA- National Association of Testing
Authorities by Australia n Laboratory
Accreditation System
National Voluntary Accreditation Program
(NVLAP)
International Laboratory Accreditation
Conference(ILAC)
A new standard on laboratories is ISO 17025
based on the previous ISO/EC Guide 25,
General Requirements for the Technical
Competence of Testing Laboratories
18 10/6/2014
20. Quality Control
Quality control. The operational techniques and
the activities which sustain a quality of a product
or service that will satisfy given needs.
Also the use of such techniques and activities
(ANSI/ASQC Standard A3 )(1987)
Quality Control. Part of quality management
focused on fulfilling quality requirements
20 10/6/2014
21. Statistical Quality Control
(Deming 1971)
The Statistical Control of Quality is
the application of statistical
principles and techniques in all
stages of design, production,
maintenance and service, directed
toward the economic objective of
quality control.
21 10/6/2014
22. Quality Assurance
QA is a system of activities whose purpose is to
provide an assurance that the overall quality
control is in fact being done effectively.
All those planned or systematic actions
necessary to provide confidence that a product or
service will satisfy given needs,
Part of quality management, focused on providing
confidence that quality requirements will be
fulfilled.
22 10/6/2014
24. ISO 9000-2000 defined QMS
Quality Management System: management
system to direct and control an organization with
regard to quality
Quality System.: The collective plans, activities
and events that are provided to ensure that a
product, process or service will satisfy given
needs.
Quality Management. Coordinated activities to
direct and control an organization with regard to
quality . It includes establishment of quality policy
and quality objectives and quality control and
24 10/6/2014
25. Total Quality Management(TQM)
TQM is a process that integrates fundamental
management art and techniques with the
principles and methodologies of total strategic
quality to develop and implement successful
business strategies throughout the organization.
TQM Empahsizes:
Focus on customer needs
Empowerment and recognition of individuals
Sound planning for quality with fact based decision
making
Integration and cooperation with suppliers
Sensitivity to competition via benchmarking
Productivity, cost reduction and profitability
25 10/6/2014