CHAPTER 7

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At the end of this chapter, students should be able to:

• define a Quality System and stated the benefit of a Quality

System to a Laboratory.
• identify types of quality standard for laboratory.
• explain how a laboratory selects a particular Quality System
Standard as being suitable for routine work.
• explain the difference between auditing a Quality System and
conducting a Quality System Review.
• define GLP, SOP, TQM, etc.
• list the necessary inputs for a laboratory to conduct a Quality
System Review.

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Definitions:
Quality System:
The collective plans, activities, and events that are
provided to ensure that a product, process, or services
will satify given needs.

The quality system is a combination of quality

management, quality control and quality assurance.

Quality management system:

The management system to direct and control an
organisation with regard to quality.

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 Overview

A laboratory’s Quality System is the formal structure set

up to encompass all aspects of quality in the laboratory.

The Quality system should cover everything:

• from the laboratory management’s statement of their

policy towards quality.

• the detail procedures used by the staff to ensure

quality in each and every analysis that they carry out.

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Three (3) Important Aspects of Quality Systems
(1) Planning of quality
Identify the customer needs, design the products and services.
Trainning of staff

(2) Control of quality

Included a systematic and independent examination whether
objectives are achieved and procedures implemented effectively.

(3) Improvement of quality

It should cover the management reviews such as activities to
determine the suitability, adequacy and effectiveness of the quality
system with regard to objectives and policies. The quality
improvement process such as corrective and preventive actions
are directed at long standing performance levels. The purpose of
such actions to eliminate the cause of a detected or potential non-
conformity

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Quality Management

PDCA Methodology

Plan Plan: establish the objectives and process

necessary to deliver results in
accordance with customer
requirements and organisations’s
Act Do policies.

Do: implement the process.

Check Check: monitor and measure process against

policies, objectives and requirements
for the product and report the results.

Act: take actions to continually improve

process performance.

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Quality System in Laboratory:

A set of procedures and responsibilities which a

organisation puts in force to make sure that their staff
(analytical chemists) have the faclilities and resources to
carry out measurements which satisfied the customer.

The procedures protect the laboratory and its staff, and

help to maintain credibility in the laboratory’s work.

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 QUALITY SYSTEMS DOCUMENTATION

Good Laboratory Practice (GLP):

GLP is concerned with the organizational process and the

conditions under which laboratory studies are planned,
performed, monitored, recorded and reported.

The principles of GLP in conjunction with principles of

Total Quality Management to ensure the quality and
reliability of laboratory results.

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 WHY GLP?

• Development of quality test data.

• Mutual acceptance of data.
• Avoid duplication of data.
• Avoid technical barriers to trade.
• Protection to human health and the environment.

GLP will ensure the generation of the high quality and

reliable test related to the safety of industrial chemicals,
pesticides, pharmaceuticals, food and feed additives, cosmetics
etc.

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 Terms Concerning the Organization

• Test facility
• Test site
• Test facility management
• Test site management
• Sponsor
• Study director
• Principle investigator
• Quality assurance program
• Standard Operating Procedures
• Master schedule

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Test facility: includes the person, premises and operational units
that are necessary for the operation of the laboratory.

Test sites: may be at different locations at which different phases

of study are conducted.

Sponsor is a laboratory customer , while the study director is the

person who responsible for the overall study conducted.

Principle investigator is the person who acts on behalf of the

study director in case of multi site studies.

Compilation of information to assist in the assessment of the

work and the tracking of studies at a test facility is called MASTER
SCHEDULE.

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Good manufacturing practice (GMP)

"GMP" is part of a quality system covering the manufacture

and testing of active pharmaceutical ingredients,
diagnostics, foods, pharmaceutical products, and medical
devices.

GMPs are guidelines that outline the aspects of production

and testing that can impact the quality of a product.

Many countries have legislated that pharmaceutical and

medical device companies must follow GMP procedures,
and have created their own GMP guidelines that correspond
with their legislation.

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 Benefit of a Quality System:

1. Reduce the mistake during the analysis, expecially for the bigger
laboratory.

2. Staff can refer the written operating procedures for carrying out
work as part of quality system.

3. Identifies staff’s responsibilities by setting out quality procedures

to be followed.

4. Improves customers’ perception of the laboratory and consistency

across the laboratory.

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TYPES OF QUALITY STANDARD FOR LABORATORIES
Different individuals and different laboratories can have different views of
which quality issues are important and what standards need to be set.

Three principal groups which have prepared and published standards for
Quality Systems which are relevant to analytical chemistry laboratories:

(i) The Organisation for Economic Co-operation and Development

(OECD), which has developed the Good Laboratory Practice (GLP) standard.

(ii) International and national standards organisation. Standards relevant to

quality in UK laboratories have been produced at 3 levels, International,
European and British.

(iii) National laboratory accreditation bodies produce more detailed

quality requirements for laboratories, usually based on the general criteria
set out in ISO, EN and any appropriate national standard, eg. NAMAS
(National Measurement Accreditation Services) in UK.

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 Auditing and Assesing Quality System
Accreditation – is the confirmation of the competence of a testing or
calibration laboratory by an independent third party, the accreditation
body, normally by the international standard ISO/IEC 17025.

Quality system documents generated by the laboratory should be

uniquely identified.

The laboratory should have a policy and procedure for the resolution
of complaints received from clients. Records should be maintained of all
complaints and of the investigations and corrective actions taken.

Internal audits are very important elements in ensuring that the quality
system is always up to date.

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Internal audits
The laboratory shall periodically and in accordance with a
predetermined shedule and procedure :

• to conduct internal audit activities

• to verify that its operations continue comply with the requirements
of the quality system and international standard

Laboratory’s executive management should conduct a review of

laboratory’s quality system testing/calibration activities
(periodically), to ensure their effectiveness and to introduce necessary
changes or improvement.

A typical period for conducting a management review is once a year.

Findings from these reviews and actions that are arise should be
recorded.

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 Introduction to ISO 9000

ISO 9000 is a series of quality standards published by the

International Organization for standardization (ISO) based
on “Quality Management System”.

Companies/organizations, comply with the requirements of

ISO 9000 in order to:

• improve the quality of their products,

• to make their processes more cost effective,
• to demonstrate to customers that their products are well
made,
• to increase the profitability of their company.

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 Introduction to ISO 9000 (continued)

ISO 9000 standards can also be applied to companies that

provide a service, for example, disposing of hazardous
waste or repairing equipment.

If the company/organization decides to comply with ISO

9000, then

1. they should develop and implement their own quality plan

in the form of a quality manual,
2. hires a certified auditor to evaluate whether they are
meeting their commitment based on their own plan.

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ISO 9000 is actually a series of standards with five documents:

ISO 9000 - provides general guide to quality management and quality

assurance standards.

ISO 9001 - covers all aspects of production ranging from research and
design, development, production, installation and servicing.

ISO 9002 - is a subset of ISO 9001 and does not deal with design or
servicing. It does deal with quality assurance, production and
installation capability.

ISO 9003 - addresses only quality assurance in final inspection and

testing capability.

ISO 9004 - is a supporting document to help a company implement

either 9001, 9002 or 9003 (Guide to generic quality system elements).

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ISO 14000

The ISO 14000 is a family of internationally recognized

standards for environmental management systems that
is applicable to any business or organization, regardless of
size, location or income.
The ISO 14000 family includes most notably the ISO 14001
standard, which represents the core set of standards used
by organizations for designing and implementing an
effective environmental management system.

ISO 14004 gives additional guidelines for a good

environmental management system, and more specialized
standards dealing with specific aspects of environmental
management.

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The major objective of the ISO 14000 series:

• to promote more effective and efficient environmental

management in organizations.

• to provide useful and usable tools - ones that are cost

effective, system-based, flexible and reflect the best
organizations and the best organizational practices
available for gathering, interpreting and communicating
environmentally relevant information.

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 ISO 14001:2004
The requirements of ISO 14001:2004 is a management
tool enabling an organization of any size or type to:

1) identify and control the environmental impact of its

activities, products or services, and
2) to improve its environmental performance
continually, and
3) to implement a systematic approach to setting
environmental objectives and targets, to achieving these
and to demonstrating that they have been achieved.

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ISO 17025
ISO 17025/IEC 17025 is an international standard for calibration
and testing labs.

It is divided into two principal parts, i.e. Management

requirements and Technical requirements. The management
requirements are similar to the ISO 9001 Quality Management
System.

ISO 17025 Laboratory Accreditation is the criteria for

laboratories to demonstrate the technical competence to carry
out specific test methods; generate valid calibration data, test
results, and operate an effective quality system.

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ISO 17025 – (continued)

ISO 17025 applies to any organization that wants to

assure its customers of its precision, accuracy and
repeatability of results.
It requires labs to demonstrate that they:

• Operate a quality system covering processes,

documentation and management.
• Generate technically valid results taking account of the
equipment, procedures, and personnel.

This standard is an evolution of the former ISO Guide 25

replacing EN45001 in Europe and has been adopted in
the U.S.

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 Assuring the Quality of the Test and Calibration Results- ISO 17025

The laboratory shall have quality control procedures for monitoring

the validity of the tests and the calibration undertaken.

The resulting data shall be recorded in such a way that trends are
detectable and where practicable, statistical techniques shall be
applied to the reviewing of the results.

The monitoring shall be planned and reviewed and may include:

i) regular use of certified reference materials,
ii) participation in inter-laboratory comparison,
iii) replicate tests or calibrations using the same or different methods,
iv) correlation results for different characteristic of an item.

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 Document Changes: ISO/IEC 17025

Where applicable, the altered or new text shall be identified in

the document or the appropriate attachment

If the laboratory’s documentation control system allows for the

amendment of the documents by hard pending the re-issue of
the documents, the amendment procedure shall be define.

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 FOUR ASPECTS OF ISO 17025
In the context of a laboratory making measurement,
accreditation is a formal recognition that a laboratory is
competent to carry out specific calibration.

1. process-compliant laboratory

2. accredited laboratory

3. conformant service

4. accredited service

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1. ISO 17025 process-compliant laboratory
This satisfies the needs of people who just need to be
confident that the lab is competent and has adequate
quality built into its processes.

An internal audit program is necessary to claim process-

compliance, but no external review is required.

2. ISO 17025 accredited laboratory

Being accredited is a prerequisite for selling an accredited

service.

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3. ISO 17025- conformant service

This is a service which delivers to the requirements of ISO

17025 and includes measurement uncertainties which
expose the adequacy of measurements.

If a statement of specification-compliance is made, it

should take those uncertainties into account.

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4. ISO 17025 accredited service

All measurements are performed using processes that

have been assessed by the external auditing body,
and audit process will have also ratified the measurement
uncertainties displayed on the calibration certificate.

This gives the highest degree of confidence that the

measurements are trustworthy.

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Benefits of ISO 17025 series.

• Helps in maintaining the quality of calibration by governing

calibration laboratory operations procedures, as well as the technical
quality data provided by calibration service suppliers.
• The enhancement and standardization of calibration data provides
companies an increased level confidence in their test instrument
accuracy.
• It helps calibration service providers by reducing the need of
customer audits.
• Increased effectiveness laboratory quality standard to enhance
customer satisfaction.
• Improved, consistent and predictable results.
• Performance advantage through improved laboratories capabilities.

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Main purpose of ISO series:

The main purpose of ISO is to obtain a structured

controlled system for consistent quality products/services
in meeting customers’ requirements. Also to provide
greater confidence to the market place to gear up the
business for competitive world.

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STANDARD OPERATING PROCEDURES (SOP)

"A Standard Operating Procedure is a document which

describes the regularly recurring operations relevant
to the quality of the investigation. The purpose of a SOP
is to carry out the operations correctly and always in the
same manner”

A SOP should be available at the place where the work is

done.

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A number of important SOP types are:

- Fundamental SOPs. These give instructions how to make

SOPs of the other categories.
- Methodic SOPs. These describe a complete testing system
or method of investigation.
- SOPs for safety precautions.
- Standard procedures for operating instruments, apparatus
and other equipment.
- SOPs for analytical methods.
- SOPs for the preparation of reagents.
- SOPs for receiving and registration of samples.
- SOPs for Quality Assurance.
- SOPs for archiving and how to deal with complaints.

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 Preparation of SOPs:
1. Each page should have a heading and/or footing mentioning:
a. date of approval and/or version number;
b. a unique title (abbreviated if desired);
c. the number of the SOP (preferably with category);
d. page number and total number of pages of the SOP.
e. the heading (or only the logo) of originals should preferably be
printed in another colour than black.

Categories can be denoted with a letter or combination of letters, e.g.:

- F for fundamental SOP
- A or APP for apparatus SOP
- M or METH for analytical method SOP
- P or PROJ for procedure to carry out a special investigation (project)
- PROT for a protocol describing a sequence of actions or operations
- ORG for an organizational document
- PERS for describing personnel matters
- RF for registration form (e.g. chemicals, samples)
- WS for worksheet (related to analytical procedures)

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2. The first page, the title page, should mention:

a. general information, including the complete title;

b. a summary of the contents with purpose and field of application (if these
are not evident from the title); if desired the principle may be given,
including a list of points that may need attention;
c. any related SOPs (of operations used in the present SOP);
d. possible safety instructions;
e. name and signature of author, including date of signing.
f. name and signature of person who authorizes the introduction of the SOP
(including date).

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 Preparation of SOPs (continued)

3. The necessary equipment, reagents (including grade) and other

means should be detailed.

4. A clear, unambiguous imperative description is given in a

language mastered by the user.

5. It is recommended to include criteria for the control of the

described system during operation.

6. It is recommended to include a list of contents particularly if the

SOP is lengthy.

7. It is recommended to include a list of references.

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 TOTAL QUALITY MANAGEMENT (TQM)

Total quality management: a process that integrates

fundamental management art and technique with the principles
and methodologies of total strategic quality to develop and
implement successful business strategies throughout the
organization.
Or
TQM is a philosophy and involves company practices that aim
to hardness the human and material resources of an
organization in the most effective way to achieve the objectives
of the organization.
(British Standard 7850)

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The process of TQM consists of three major activities:

1. Setting the policy and strategy of the organization

2. Effectively and efficiently managing the organization
3. Seeking continuous improvement

Policy and strategy of the organization

• Mission
• Leadership and commitment
• Divisional objectives

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Management of organization:
• Organization structure
• Management structure
• Information system
• Communication

Improvement of the organization:

• Working environment
• Measurement of performance
• Improvement objectives
• Improvement plans
• Monitor and review
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 Fundamental Concepts Commitment to TQM

• Commitment of TQM by the highest level of management

• Promotion of this concept at all levels and activities of the organization

• Individual involvement
• Devotion to continuous improvement

Management commitment involves every department, function and the

active commitment of everyone in organization in meeting customer
needs and seeking continuous improvement.

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TQM emphasis on the following:
• clear focus on customer needs
• continuous improvement and innovation of all processes,
services, and products.
• effective empowerment and recognition of individuals under a
team involvement approach, including essential programs of
education and training.
• productivity, cost reduction, and profitability enhancements.
• strong leadership by management at all levels.

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 TQM emphasis (continued)

• initiating a cultural change with strong management support

establishing a customer focused organization.
• analyzing and improving work processes to improve efficiency
and reduce waste.
• designing quality in products and processes and establishing
quality criteria.
• providing training and placing emphasis of lifelong learning.
• providing leadership style of management which supports and
encouraging new ideas and rewarding success.
• creating a structure and climate which reinforces quality
improvement and customer service.

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Benefits of TQM…
• continuous improvement of processes and products, and enhance efficiency of
people and machines leading to improved quality.
• process efficiency leading to improved profit per product or service fiscal
discipline through elimination of unnecessary steps and wasteful expenditure
focused, systematic and structured approach to enhancing customer's
satisfaction.
• Process improvement methods that reduce or eliminate problems i.e. non
conformance costs.
• Delivering what the customer needs in terms of service, product and the
whole experience.
• Intrinsic motivation and improved attitudes throughout the workforce.
• Workforce is proactive - prevention orientated.
• Enhanced communication.
• Reduction in waste and rework.
• Increase in process ownership- employee involvement and empowerment.
• Everyone from top to bottom educated.
• Improved customer/supplier relationships (internally & externally).

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 CHM561: Assignment 2

You are appointed as a chemist in a pharmaceutical laboratory. Your

company has launched a plant-based supplement product. Basically, the
active compounds of the product have been extracted using the USEPA
3545 method with slightly modification. The target compounds were
separated using liquid chromatography-mass spectrometry (LC-MS).

(a) Method validation is the process used to confirm that the analytical
procedure employed for a specific test is suitable for its intended use.
Results from method validation can be used to judge the quality,
reliability and consistency of analytical results. As a chemist, outline
and justify your strategy in validating the extraction and analytical
methods to produce the supplement. Include all the necessary
validation parameters in your discussion.

(b) Explain about the Quality Systems. Discuss the three important
aspects of Quality Systems.

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