Ref.>> the main topics of QA.

pdf

The main topics in this lecture on quality assurance

Concepts in quality control and quality assurance

Revision of statistical methods (including experimental design)
QC tools (control charts, use of check samples)
Measurement uncertainty
Metrological traceability
Method validation
Interlaboratory studies (including proficiency testing)
Accreditation

Ref.>> GUIDE TO QUALITY IN ANALYTICAL CHEMISTRY.pdf

INTRODUCTION

The value of chemical measurements depends upon the level of confidence that
can be placed in the results. Increasingly, the chemical testing community is adopting QA
principles which, whilst not actually guaranteeing the quality of the data produced,
increases the likelihood of it being soundly based and fit for its intended purpose.
Appropriate QA can enable a laboratory to show that it has adequate facilities and
equipment for carrying out chemical analysis and that the work was carried out by
competent staff in a controlled manner, following a documented validated method. QA
should focus on the key issues which determine quality results, costs and timeliness and
avoid diversion of energies into less important issues.
Good QA practice, including its formal recognition by accreditation, certification
etc., help to ensure that results are valid and fit for purpose. However, it is important for
both laboratories and their customers to realise that QA cannot guarantee that 100% of
the individual results will be reliable. There are two reasons for this:
1. Mistakes/gross errors can occur, where, for example, the results for two samples are
mixed-up. In a well-run laboratory, the frequency of mistakes will be small, but not zero.
2. Random and systematic errors also occur, leading to uncertainty in a measured result.
The probability of a result lying within the stated uncertainty range depends on the level
of confidence employed, but again, even in a well ordered laboratory, deviant results will
occasionally occur and very occasionally the deviation will be large. The business of QA
is to manage the frequency of quality failures. The greater the effort taken, the smaller the
number of quality failures that can be expected. It is necessary to balance the cost of QA
against the benefit in reducing quality failures to an acceptable (non-zero) level.
The principles of QA have been formalised in a number of published protocols or
standards. Those most widely recognised and used in chemical testing fall into three
groups and are applied according to a laboratory's individual needs. The three groups are:
ISO/IEC 17025:1999: This standard addresses the technical competence of laboratories
to carry out specific tests and calibrations and is used by laboratory accreditation bodies
world-wide as the core requirements for the accreditation of laboratories;
 ISO 9001:2000: and its national and international equivalents. This standard relates
primarily to quality management, for facilities carrying out production, or providing
services, including chemical analysis;
OECD Principles of Good Laboratory Practice (GLP): 1998 (Ref B3) and its national
and sectorial equivalents. These guidelines are concerned with the organisational
processes and conditions under which laboratory studies related to certain regulatory
work are carried out.
A laboratory may decide to design its own QA procedures or it may follow one of
the established protocols. In the latter case it may claim informal compliance against the
protocol or ideally may undergo independent assessment from an official expert body,
with the aim of gaining independent endorsement of its quality system. Such independent
assessment / endorsement is variously known as accreditation, registration or certification
depending on which standard the assessment is made against. In particular areas of
analysis, accreditation is sometimes mandatory, however in most cases, the laboratory is
free to decide what sort of QA measures it wishes to adopt. The independent assessment
route has recognised advantages, particularly where the laboratory’s customers require
objective evidence of the technical competence of the laboratory. For clarification of the
term “accreditation” as used in this guide.

Ref.> Principles and Practice of Analytical Chemistry.pdf

Principles and Practice of Analytical Chemistry

Fifth Edition
F.W. Fifield
Kingston University
and
D. Kealey
University of Surrey

© 2000 by
Blackwell Science Ltd

2. The Assessment of Analytical Data 13

2.1 Definitions and Basic Concepts 13
2.2 The Nature and Origin of Errors 16
2.3 The Evaluation of Results and Methods 17
The Reliability of Measurements. The Analysis of Data. The
Application of Statistical Tests. Limits of Detection. Quality
Control Charts. Standardization of Analytical Methods.
Chemometrics.
Problems 34
Ref. > Quality-Control-Quality-Assurance-Quality-Improvement.pdf

QUALITY CONTROL,
QUALITY ASSURANCE,
QUALITY IMPROVEMENT
Prepared by :
Afizal Azzizan
Masni‐Azian Akiah
Mohd Faiz Md Rasid
Siti R dhi h Abd l A i
1
Rodhiah Abdul Aziz
Umi Kalsom Kamarul Ariffin

Ref. > Development and use of reference materials and quality control materials. pdf

Development and use of

reference materials and
quality control materials

DEVELOPMENT AND USE OF REFERENCE MATERIALS AND

QUALITY CONTROL MATERIALS
IAEA, VIENNA, 2003
IAEA-TECDOC-1350
ISBN 92–0–103303–6
ISSN 1011–4289
© IAEA, 2003
Printed by the IAEA in Austria
April 2003

Ref. > VALIDATION OF ANAYTICAL METHODS. ppt

VALIDATION OF ANAYTICAL METHODS

http://en.wikipedia.org/wiki/Quality_control
Quality control

In engineering and manufacturing, quality control and quality engineering are used in
developing systems to ensure products or services are designed and produced to meet or
exceed customer requirements.

Quality control is the branch of engineering and manufacturing which deals with
assurance and failure testing in design and production of products or services, to meet or
exceed customer requirements.

Contents
• 1 Quality assurance
• 2 Failure testing
• 3 Statistical control
• 4 Company quality
• 5 Total quality control
• 6 Industrial resources
• 7 Scientific resources
• 8 Academic resources
• 9 See also
• 10 Notes & References

• 11 Further reading

Quality assurance

One of the most widely used paradigms for quality assurance management is the PDCA
(Plan-Do-Check-Act) approach, also known as the Shewhart cycle.

Failure testing

A valuable process to perform on a whole consumer product is failure testing (also

known as stress testing), the operation of a product until it fails, often under stresses such
as increasing vibration, temperature and humidity. This exposes many unanticipated
weaknesses in a product, and the data is used to drive engineering and manufacturing
process improvements.

Statistical control

Many organizations use statistical process control to bring the organization to Six Sigma
levels of quality, in other words, so that the likelihood of an unexpected failure is
confined to six standard deviations on the normal distribution. This probability is 3.4 one-
millionths. Items controlled often include clerical tasks such as order-entry as well as
conventional manufacturing tasks.

Traditional statistical process controls in manufacturing operations usually proceed by

randomly sampling and testing a fraction of the output. Variances of critical tolerances
are continuously tracked, and manufacturing processes are corrected before bad parts can
be produced.

Company quality

During the 1980s, eff the concept of “company quality” with the focus on management
and people came to the fore. It was realized that, if all departments approached quality
with an open mind, success was possible if the management led the quality improvement
process.

The company-wide quality approach places an emphasis on three aspects :-

1. Elements such as controls, job management, defined and well managed

processes[1][2], performance and integrity criteria and identification of records
2. Competence such as knowledge, skills, experience, qualifications
3. Soft elements, such as personnel integrity, confidence, organizational culture,
motivation, team spirit and quality relationships.

The quality of the outputs is at risk if any of these three aspects is deficient in any way.

Total quality control

Total Quality Control is the most necessary inspection control of all in cases where,
despite statistical quality control techniques or quality improvements implemented, sales
decrease.

If the original specification does not reflect the correct quality requirements, quality
cannot be inspected or manufactured into the product.

For instance, all parameters for a pressure vessel should include not only the material and
dimensions but operating, environmental, safety, reliability and maintainability
requirements.

Industrial resources
• Quality Progress [3][clarification needed]

Scientific resources
 • Accreditation and Quality Assurance: Journal for Quality, Comparability and
Reliability in Chemical Measurement, ISSN: 0949-1775 Print, eISSN: 1432-0517
[4]

Academic resources
• The Quality Assurance Journal, ISSN: 1087-8378 [5][clarification needed]

This section requires expansion.

See also
• Quality assurance
• Good Manufacturing Practice
• Good Automated Manufacturing Practice (GAMP)
• Corrective and Preventative Action (CAPA)
• Standing operating procedure (SOP)

Notes & References

1. ^ Adsit, D. (2007) What the call center industry can learn from manufacturing:
Part I, In Queue,
http://www.nationalcallcenters.org/pubs/In_Queue/vol2no21.html
2. ^ Adsit, D. (2007) What the call center industry can learn from manufacturing:
Part II, In Queue,
http://www.nationalcallcenters.org/pubs/In_Queue/vol2no22.html
3. ^ http://www.asq.org/qualityprogress/index.html
4. ^ http://www.springerlink.com/content/q922ehvpaq49pw6q/
5. ^ http://www3.interscience.wiley.com/journal/15634/home

• This article incorporates public domain material from the General Services
Administration document "Federal Standard 1037C" (in support of MIL-STD-
188).
• Godfrey, A. B., Juran's Quality Handbook, 1999. ISBN 007034003.
• Pyzdek, T., Quality Engineering Handbook, 2003. ISBN 0824746147.

Further reading
• OSDL Data Base Test Suite Backgrounder, Press releases, Open Source
Development Labs, 3 March 2003, archived from the original on 5 June 2004,
http://web.archive.org/web/20040605173457/http://www.osdl.org/newsroom/pres
s_releases/2003/2003_03_03_beaverton_backgrounder.html, retrieved on 29 June
2009
 • QACity: Resources for Busy Testers, LogiGear, archived from the original on 9
October 2004,
http://web.archive.org/web/20041009213226/http://www.qacity.com/front.htm,
retrieved on 29 June 2009
• Home, Saksoft, 29 May 2004, archived from the original on 10 August 2004,
http://web.archive.org/web/20040810002450/http://www.saksoft.com/sak_feb/test
ing_services.htm, retrieved on 29 June 2009

Retrieved from "http://en.wikipedia.org/wiki/Quality_control"

Quality assurance

From Wikipedia, the free encyclopedia

Jump to: navigation, search

Quality assurance, or QA for short, refers to planned and systematic production

processes that provide confidence in a product's suitability for its intended purpose. Refer
to the definition by Merriam-Webster for further information [1]. It is a set of activities
intended to ensure that products (goods and/or services) satisfy customer requirements in
a systematic, reliable fashion. QA cannot absolutely guarantee the production of quality
products, unfortunately, but makes this more likely.

Two key principles characterise QA: "fit for purpose" (the product should be suitable for
the intended purpose) and "right first time" (mistakes should be eliminated). QA includes
regulation of the quality of raw materials, assemblies, products and components; services
related to production; and management, production and inspection processes.

It is important to realize also that quality is determined by the intended users, clients or
customers, not by society in general: it is not the same as 'expensive' or 'high quality'.
Even goods with low prices can be considered quality items if they meet a market need.

Contents

• 1 History
o 1.1 Early efforts to control the quality of production
o 1.2 Wartime production
o 1.3 Postwar
• 2 Quality assurance versus quality control
o 2.1 Failure testing
 o 2.2 Statistical control
o 2.3 Total quality management
o 2.4 Quality awareness
• 3 QA in software development
o 3.1 Models and standards
• 4 Company quality
• 5 Using contractors and/or consultants
• 6 Industrial resources
• 7 Scientific resources
• 8 Academic resources
• 9 See also
• 10 Notes & References

• 11 External links

History

Early efforts to control the quality of production

When the first specialized craftsmen started manufacturing tools and materials for others
to purchase and use, the principle of quality was simple: "let the buyer beware" (caveat
emptor).

Early civil engineering projects needed to be built from specifications, for example the
four sides of the base of the Great Pyramid of Giza were required to be perpendicular to
within 3.5 arcseconds.

During the Middle Ages, guilds adopted responsibility for quality control of their
members, setting and maintaining certain standards for guild membership.

Royal governments purchasing material were interested in quality control as customers.

For this reason, King John of England appointed William Wrotham to report about the
construction and repair of ships. Centuries later, Samuel Pepys, Secretary to the British
Admiralty, appointed multiple such overseers.

Prior to the extensive division of labor and mechanization resulting from the Industrial
Revolution, it was possible for workers to control the quality of their own products.
Working conditions then were arguably more conducive to professional pride.

The Industrial Revolution led to a system in which large groups of people performing a
similar type of work were grouped together under the supervision of a foreman who was
appointed to control the quality of work manufactured.

Wartime production
Around the time of World War I, manufacturing processes typically became more
complex with larger numbers of workers being supervised. This period saw the
widespread introduction of mass production and piecework, which created problems as
workmen could now earn more money by the production of extra products, which in turn
led to bad workmanship being passed on to the assembly lines.

To counter bad workmanship, full time inspectors were introduced into the factory to
identify, quarantine and ideally correct product quality failures. Quality control by
inspection in the 1920s and 1930s led to the growth of quality inspection functions,
separately organised from production and big enough to be headed by superintendents.

The systematic approach to quality started in industrial manufacture during the 1930s,
mostly in the USA, when some attention was given to the cost of scrap and rework. With
the impact of mass production, which was required during the Second World War, it
became necessary to introduce a more appropriate form of quality control which can be
identified as Statistical Quality Control, or SQC. Some of the initial work for SQC is
credited to Walter A. Shewhart of Bell Labs, starting with his famous one-page
memorandum of 1924.

SQC came about with the realization that quality cannot be fully inspected into an
important batch of items. By extending the inspection phase and making inspection
organizations more efficient, it provides inspectors with control tools such as sampling
and control charts, even where 100 per cent inspection is not practicable. Standard
statistical techniques allow the producer to sample and test a certain proportion of the
products for quality to achieve the desired level of confidence in the quality of the entire
batch or production run.

Postwar

In the period following World War II, many countries' manufacturing capabilities that
had been destroyed during the war were rebuilt. The U.S. sent General Douglas
MacArthur to oversee the re-building of Japan. During this time, General MacArthur
involved two key individuals in the development of modern quality concepts: W.
Edwards Deming and Joseph Juran. Both individuals promoted the collaborative concepts
of quality to Japanese business and technical groups, and these groups utilized these
concepts in the redevelopment of the Japanese economy.

Although there were many individuals trying to lead United States industries towards a
more comprehensive approach to quality, the U.S. continued to apply the QC concepts of
inspection and sampling to remove defective product from production lines, essentially
ignoring advances in QA for decades.

Quality assurance versus quality control

Quality control emphasizes testing of products to uncover defects, and reporting to

management who make the decision to allow or deny the release. Whereas quality
assurance attempts to improve and stabilize production, and associated processes, to
avoid, or at least minimize, issues that led to the defects in the first place.[citations needed] To
prevent mistakes from arising, several QA methodologies are used. However, QA does
not necessarily eliminate the need for QC: some product parameters are so critical that
testing is still necessary. QC activities are treated as an integral part of the overall QA
processes.[citation needed]

Failure testing

A valuable[citation needed] process to perform on a whole consumer product is failure testing or

stress testing. In mechanical terms this is the operation of a product until it fails, often
under stresses such as increasing vibration, temperature, and humidity. This exposes
many unanticipated weaknesses in a product, and the data are used to drive engineering
and manufacturing process improvements. Often quite simple changes can dramatically
improve product service, such as changing to mold-resistant paint or adding lock-washer
placement to the training for new assembly personnel.

Statistical control

Many[citation needed] organizations use statistical process control to bring the organization to
Six Sigma levels of quality, in other words, so that the likelihood of an unexpected failure
is confined to six standard deviations on the normal distribution. This probability is less
than four one-millionths. Items controlled often include clerical tasks such as order-entry
as well as conventional manufacturing tasks.[citation needed]

Traditional statistical process controls in manufacturing operations usually proceed by

randomly sampling and testing a fraction of the output. Variances in critical tolerances
are continuously tracked and where necessary corrected before bad parts are produced.

Total quality management

The neutrality of this section is disputed. Please see the discussion on the talk
page. Please do not remove this message until the dispute is resolved. (February
2009)
This section does not cite any references or sources. Please help improve this
article by adding citations to reliable sources. Unsourced material may be
challenged and removed. (February 2009)
See also: Total Quality Management

Deep analysis of QA practices and premises used about them is the most necessary
inspection control of all in cases, where, despite statistical quality control techniques or
quality improvements implemented, sales decrease.
The major problem which leads to a decrease in sales was that the specifications did not
include the most important factor, “What the specifications have to state in order to
satisfy the customer requirements?”.

The major characteristics, ignored during the search to improve manufacture and overall
business performance were:

• Reliability
• Maintainability
• Safety
• Strength

As the most important factor had been ignored, a few refinements had to be introduced:

1. Marketing had to carry out their work properly and define the customer’s
specifications.
2. Specifications had to be defined to conform to these requirements.
3. Conformance to specifications i.e. drawings, standards and other relevant
documents, were introduced during manufacturing, planning and control.
4. Management had to confirm all operators are equal to the work imposed on them
and holidays, celebrations and disputes did not affect any of the quality levels.
5. Inspections and tests were carried out, and all components and materials, bought
in or otherwise, conformed to the specifications, and the measuring equipment
was accurate, this is the responsibility of the QA/QC department.
6. Any complaints received from the customers were satisfactorily dealt with in a
timely manner.
7. Feedback from the user/customer is used to review designs.
8. Consistent data recording and assessment and documentation integrity.
9. Product and/or process change management and notification.

If the specification does not reflect the true quality requirements, the product's quality
cannot be guaranteed. For instance, the parameters for a pressure vessel should cover not
only the material and dimensions but operating, environmental, safety, reliability and
maintainability requirements.

Quality awareness

Widespread awareness of quality issues throughout the organization increases the

probability that product quality will be taken into account at every stage of the production
process.[citation needed]

QA in software development

See also: Software quality assurance The following are examples of QA models relating
to the software development process.
Models and standards

ISO 17025 is an international standard that specifies the general requirements for the
competence to carry out tests and or calibrations. There are 15 management requirements
and 10 technical requirements. These requirements outline what a laboratory must do to
become accredited. Management system refers to the organization's structure for
managing its processes or activities that transform inputs of resources into a product or
service which meets the organization's objectives, such as satisfying the customer's
quality requirements, complying with regulations, or meeting environmental objectives.

The CMMI (Capability Maturity Model Integration) model is widely used to implement
Quality Assurance (PPQA) in an organization. The CMMI maturity levels can be divided
in to 5 steps, which a company can achieve by performing specific activities within the
organization.

Company quality

During the 1980s, the concept of “company quality” with the focus on management and
people came to the fore. It was realized that, if all departments approached quality with
an open mind, success was possible if the management led the quality improvement
process.

The company-wide quality approach places an emphasis on four aspects :-

1. Elements such as controls, job management, adequate processes, performance and

integrity criteria and identification of records
2. Competence such as knowledge, skills, experience, qualifications
3. Soft elements, such as personnel integrity, confidence, organizational culture,
motivation, team spirit and quality relationships.
4. Infrastructure (as it enhances or limits functionality)

The quality of the outputs is at risk if any of these aspects is deficient in any way.

The approach to quality management given here is therefore not limited to the
manufacturing theatre only but can be applied to any business or non-business activity:

• Design work
• Administrative services
• Consulting
• Banking
• Insurance
• Computer software development
• Retailing
• Transportation
• Education
 • It comprises a quality improvement process, which is generic in the sense it can
be applied to any of these activities and it establishes a behaviour pattern, which
supports the achievement of quality.

This in turn is supported by quality management practices which can include a number of
business systems and which are usually specific to the activities of the business unit
concerned.

In manufacturing and construction activities, these business practices can be equated to

the models for quality assurance defined by the International Standards contained in the
ISO 9000 series and the specified Specifications for quality systems.

Still, in the system of Company Quality, the work being carried out was shop floor
inspection which did not reveal the major quality problems. This led to quality assurance
or total quality control, which has come into being recently.

Using contractors and/or consultants

It has become customary to use consultants and contractors when introducing new quality
practices and methods, particularly where the relevant skills and expertise are not
available within the organization. In addition, when new initiatives and improvements are
required to boost the current quality system, or perhaps improve upon current
manufacturing systems, the use of temporary consultants becomes a viable solution when
allocating valuable resources.

There are various types of consultants and contractors available in the market; most will
have the skills needed to facilitate improvement activities such as Quality Management
Systems (QMS) auditing and procedural documentation writing. More experienced
consultants are likely to have knowledge of specialized quality improvement activities
such as CMMI, Six Sigma, Measurement Systems Analysis (MSA), Quality Function
Deployment (QFD), Failure Mode and Effects Analysis (FMEA), Advance Product
Quality Planning (APQP).

Industrial resources

• Quality Progress [2][clarification needed]

Scientific resources

• Accreditation and Quality Assurance: Journal for Quality, Comparability and

Reliability in Chemical Measurement, ISSN: 0949-1775 Print, eISSN: 1432-0517
[3]

• Quality Assurance in Education, ISSN 0968-4883, Emerald Publishing

Group[clarification needed]
• Food Quality and Preference, ISSN: 0950-3293 [4][clarification needed]
Academic resources

• The Quality Assurance Journal, ISSN: 1087-8378 [5][clarification needed]

This section requires expansion.

See also
• American Society for Quality
• Best practice
• CQE
• Data quality
• Data integrity
• Farm assurance
• GxP
• ISO 9000
• NCSL International
• Quality control
• Quality infrastructure
• Quality management
• Quality Management System
• Society of Quality Assurance
• Software Testing
• Software quality assurance
• Total Quality Management
• Common Test Cases

Notes & References

1. ^ Merriam-Webster. "quality assurance". http://www.merriam-

webster.com/dictionary/quality+assurance. Retrieved on 12 April 2009.
2. ^ http://www.asq.org/qualityprogress/index.html
3. ^ http://www.springerlink.com/content/q922ehvpaq49pw6q/
4. ^
http://www.elsevier.com/wps/find/journaldescription.cws_home/405859/descripti
on
5. ^ John Wiley & Sons. "The Quality Assurance Journal".
http://www3.interscience.wiley.com/journal/15634/home. Retrieved on 15 Jyly
2009.

External links

• Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0-8247-4614-7

• Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 0-07-034003-X
 • http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-appb.html

Ref.> Pure Appl. Chem., Vol. 74, No. 5, pp. 835–855, 2002.pdf

HARMONIZED GUIDELINES FOR SINGLELABORATORY

VALIDATION OF METHODS OF
ANALYSIS

Ref.> Attempting to Make QA Interesting to Uninterested Undergraduates.pdf

Attempting to Make QA Interesting to Uninterested Undergraduates

Training Courses on Quality Assurance and Quality

Control Activities

The Quality Staff develops a variety of traditional training courses on quality assurance
(QA) and quality control (QC) activities and the EPA quality system. For each course,
there is a facilitator guide with slides and speaker notes, suggested activities, and
supplementary materials for student handouts. Instructors should have an applied
knowledge in quality system management, as well as quality assurance and quality
control activities. Since these courses are generic in nature, instructors should supplement
these courses with program-specific activities or material to give context, emphasis, and
relevance to your training event.

Assessing Quality Systems

This one-day course is designed to prepare those who will either assess or
be assessed as part of an EPA or EPA-supporting quality system.
The focus of the course is to improve quality systems and conserve
resources through careful planning. Knowledge of the principles and
documentation of the quality system is a prerequisite for the course.

Detecting Improper Laboratory Practices

This one and a half day course presents tools and techniques for
identifying improper practices in environmental laboratories during
routine technical assessments. The course identifies "red flags" in
each step of the assessment process which can indicate improper
practices in the laboratory.

Interpreting Monitoring Data

This half day course teaches partipants how to deal with monitoring data
using statistics. At the end of the course the participants will
understand the need to incorporate systematic planning into
monitoring activities, realize the importance of representativeness,
be able to graphically view the data, and gain an insight into the
complexities of statistical analyses of monitoring data.

Interpreting Multivariate Analysis

This half day course covers multivariate analysis technques to explore

relationships among several variables in an effort to understanding
an environmental problem. A prerequisite of the course is a general
understanding of data collection and elementary statistical analysis.

Introduction to Data Quality Assessment

This one-day course demonstrates how to perform a data quality

assessment (DQA) to evaluate data and provides detailed
information on graphical and statistical tools. This course will
familiarize participants with the process for performing a data
quality assessments. It does not involve detailed instructions on the
statistics involved in the process. The course is intended for
managers or analysts that either use (analyze) data themselves or
review the use of data by others.

Introduction to Data Quality Indicators

This one-day course discusses the principal data quality indicators (DQIs):
precision, bias (accuracy), representativeness, comparability,
completeness, and sensitivity. It also includes information on
verification, validation, and integrity which, although not classified
 as indicators, directly influence data quality. This course may also
be taught in a half-day by following the instructions in the speakers
guide.

Introduction to Data Quality Objectives

This one-day course teaches participants the basic elements of the Data
Quality Objectives (DQO) Process. In the first part of the course, the
participants learn about the Agency's Quality System and the
elements of the DQO Process, how the process applies to a
regulatory program at EPA, and how to interpret the consequences
of potential decision errors. In the latter half of the course,
participants are divided into groups and work together as teams to
apply the process to some real-life examples.

Introduction to EPA Quality System Requirements

This one-day course is designed with a "how-to" approach for individuals

who write, review, and/or approve QA Project Plans. It provides an
overview of QA Project Plan development which stresses the need
for systematic planning and EPA's graded approach to project plan
development, and describes in detail, the twenty-four elements of the
QA Project Plan. Participants are expected to have some basic
experience in quality assurance.

Introduction to Quality Assurance Project Plans

This half-day course is intended to introduce the EPA policies and

specifications of Quality Management Plans. This course presents
information to be used in writing a Quality Management Plan that
satisfies EPA CIO 2105.0 and EPA Requirements for Quality
Management Plans (QA/R-2). Participants receive instruction in how
to address each element of the specifications. Participants are taught
how to describe their organization's approach to each element and
to identify the documentation required to develop a Quality
Management Plan. A 1-hour briefing that contains presentation
materials and a factsheet is also available. This briefing can be used
to educate managers on EPA's policies for Quality Management
Plans
 Introduction to Quality Management Plans (with Briefing
Materials)

This one-day course is intended to introduce the concepts of quality

management. The course contains an overview of the Agency's
Quality System, an overview of basic QA concepts, and a description
of the application of these concepts to environmental programs
involving the collection or use of environmental data. Topics covered
include terms and nomenclature, roles and responsibilities, and
principal QA activities.

Overview of the EPA Quality System

This is an abbreviated version of the Introduction to the EPA Quality

System Requirements course that focuses on the policies and
specifications of the EPA Quality System. This course describes the
EPA Quality System and the specific elements that managers and
project personnel must address to comply with EPA policy.

Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A

Regulatory Compliance Primer

Who Should Attend

This two-day course is designed for all persons who work in, supervise, or are involved in the
management of pharmaceutical, biopharmaceutical, and biologics Quality Control Analytical
Laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and
others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance. This
course will also provide participants with an understanding of how to effectively handle out-of-
specification results, deviations, laboratory investigations, Corrective and Preventive Actions.

Learning Objectives

Upon completion of this course, you will:

 • Be conversant in the specialized language of laboratory compliance
• Be very familiar with the cGMPs and other regulations as they impact QC labs
• Know the current compliance “hot spots” that FDA and other regulatory authorities look for
when inspecting QC labs
• Understand how to effectively deal with laboratory deviations and OOS results
• Understand the what, how and why of laboratory equipment qualification and methods
validations
• Understand how to properly prepare your QC lab for audits and inspections

Course Description

This course is intended to give participants a thorough overview and practical understanding of
Current Good Manufacturing Practices for laboratory compliance including:

• General requirements for design and construction of analytical laboratories

• Calibration and Qualification of instrumentation and equipment
• Documentation, records-keeping and change control
• Management of reagents, test solutions and reference standards
• Personnel development and training

View Course Agenda

Past Participant's Comments:

“Dynamic presentation style kept my interest. Practical examples were really useful in making
course material relevant. Length of course was good; not too long and not too condensed. Course
material was well developed and nicely presented for attendees.”
Diana B., QC Chemistry Manager, Allergan

“The instructor was extremely energetic and maintained focus of the entire group at all times.
Never once did I look at my watch to see how much longer we had to go. He was extremely well
versed in all areas and offered appropriate examples to drive home all key concepts.”
Lauren B., Project Manager, Chiron

“The course was very informative and lots of useful information was presented. The instructor
handled a number of difficult questions and I learned a great deal from others in the course.”
John M., Quality Manager, Berlex

“The material and speaker was great. I liked the examples that he used to convey the material. I
appreciated allowing as many students’ questions as he did. The recommendation given to read the
secondary materials; such as website literature, court cases, and guidance documentation was very
helpful. I would look for more classes to take from this course director and company again.”
Kristi C., Lab Technician
Pharmaceutical and Biopharmaceutical Quality Control
Laboratories - A Regulatory Compliance Primer
COURSE AGENDA

DAY ONE

Regulations – Guidance’s - Problems

Session 1 – Introduction to GMP/GLP

• Introduction
• Overview of CFR Title 21, Parts 58, 210 and 211, an abbreviation and acronym primer
• Overview of 21 CFR 58 Good Laboratory Practices
• The Quality Control Laboratory:
o Design and construction considerations - Part 211 Subpart C: Buildings and
Facilities
o Utilities
o Equipment and Instrumentation - Subpart D: Equipment
o Safety and security

Session 2 – The GMP/GLP Laboratory

• The Essentials of CGMP compliance

• Documentation, records-keeping and change control - Subpart J: Records and Reports
• Management of reagents, test solutions and reference standards
• Sample management - Subpart E: Control of Components and Drug Product Containers and
Closures
• Personnel development and training- Subpart B: Organization and Personnel

Session 3 - Other Regulations and Guidance’s

• Overview of essential industry and FDA guidance documents to guide your lab compliance
efforts
• The International Conference on Harmonization: what it is and why you need to keep up
with its activities reference material

Session 4 - When things go wrong

• Deviations and test failures, Subpart F: Production and Process Controls; Subpart J:
Records and Reports
• Essential Documentation
• Conducting Effective Investigations
• Effective handling of Deviations and Out Of Specification Results: how to stay out of
regulatory hot water
• A basic root cause analysis primer
• Corrective and Preventative Actions
o Develop, Implement, Track Effectiveness Change control in the QC laboratory

DAY TWO

Auditing – Validation - Improvement

Session 5 - Auditing the laboratory

• Audit Planning, techniques, reporting and follow-up actions

• Self-Inspection and Self-Auditing
• Auditing external QC labs
• References and Resources

Session 6

• Analytical method validation

• Equipment Qualification Requirements
o Qualification of QC lab equipment: D/I/O/PQ
o Design Qualification
o Installation Qualification
o Operational Qualification
o Performance Qualification
• System Suitability Testing: an essential component of lab compliance
• Calibration and maintenance of QC lab equipment
• Stability
• 21 CFR Part 11 and QC lab data

Session 7 - The cost of non-compliance

• FDA enforcement powers

• Top CGMP problems FDA sees in QC labs
• Review of important FDA Notices of Deficiency (483s) and Warning Letters Current hot
topics in lab compliance

Session 8 - Wrap Up

• How to use FDA inspection results to audit, enhance, and maintain CGMP compliance
• Improving operations
• Tracking and trending
• Programs and methods for improvement
• Discussion Forum:
o Question and Answer Period, Course wrap-up and conclusions
o What are your top lab compliance challenges, issues, and problems?
o Discussion of participant questions, problems, and issues

Quality Management and Design of Analytical Systems, an Introduction; Westgard Quality

Corporation

This course provides the background for understanding QC Design, with emphasis on available
guidelines, quality goals, QC Design tools, and practical directions concerning the information
needed to perform QC Design.

Quality Control is not something to be performed without thought. There is no single way to "do
QC", and the notion that 2 SD limits are the standard QC practice is both out-dated and wasteful.
Performing QC requires careful consideration and planning. This course is concerned with the
establishment of logical specifications for precision and accuracy of methods and with the
selection of control rules for statistical QC.

Portions of this course are taken from the chapters in the Westgard book, Assuring the Right
Quality Right. Purchasing the book is not mandatory to complete this course.

SUMMARY
Few analyses are so straightforward that high-quality results are easily
obtained. Good analytical work requires careful planning and an
attention to detail. Creating and maintaining a quality assurance
program is one way to help ensure the quality of analytical results.
Quality assurance programs usually include elements of quality control
and quality assessment.

Quality control encompasses all activities used to bring a system into

statistical control. The most important facet of quality control is written
documentation, including statements of good laboratory practices,
good measurement practices, standard operating procedures, and
protocols for a specific purpose.

Quality assessment includes the statistical tools used to determine

whether an analysis is in a state of statistical control and, if possible, to
suggest why an analysis has drifted out of statistical control. Among
the tools included in quality assessment are the analysis of duplicate
samples, the analysis of blanks, the analysis of standards, and the
analysis of spike recoveries.

Another important quality assessment tool, which provides an ongoing

evaluation of an analysis, is a control chart. A control chart plots a
property, such as a spike recovery, as a function of time. Results
exceeding warning and control limits, or unusual patterns of data
indicate that an analysis is no longer under statistical control.