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CHAPTER 7

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• 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.

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

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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.

Training 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

Plan

Do

Check

Act

PDCA Methodology

Plan: establish the objectives and process

necessary to deliver results in

accordance with customer

requirements and organisations’s

policies.

Do: implement the process.

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):

The principles of GLP in conjunction with principles of

Total Quality Management to ensure the quality and

reliability of laboratory results.

GLP is a quality system concerned with the organizational

process and the conditions under which laboratory studies

are planned, performed, monitored, recorded and reported.

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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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GLP

REQUIREMENTS

1. MANAGEMENT 3. QUALITY

ASSURANCE

PROGRAMME

2. FACILITIES

4. TEST FACILITIES

WORKING PROCEDURE

5. EQUIPMENT 6. PLANNING AND

CONDUCT OF STUDY

7. FINAL REPORT

8. DATA

STORAGE

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1. MANAGEMENT

The responsibilities of personnel and the laboratory’s management

structure must be clearly defined (eg: organisational charts, job

description, updated records of qualification, staff training to show their

competency to carry out work. Appointment of Study Director.

2. FACILITIES

Must be appropriate for the work being carried out (receipt of test

materials, their handling and storage, how the substances are issues

for use thus the record of the use of the test materials can be audited.

3. QUALITY ASSURANCE PROGRAMME

There must be a system in place to monitor the study while it is in

progress to check that all systems are working in accordance with GLP

requirement, to record any problems identified and to ensure that

remedial action is taken.

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4. TEST FACILITIES WORKING PROCEDURE

SOPs should be properly autorised, documented and available to the

staff carrying out the work. It should be regularly reviewed to ensure

that they are still appropriate for their purpose.

Reagents and test substances must be clearly identified including shelf

lives, purity, properties and storage conditions if required.

5. EQUIPMENT

Equipment must be suitable , mantained and calibrated.

6. PLANNING AND CONDUCT OF STUDY

A study plan should make clear the purpose of the study, schedule for

the study and test system which is to be used. The type of test should

be documented as well as statistical methods to analysed the data (if

required).

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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 (SOPs) 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

results 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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Quality Audit and Quality System Reviews

Quality Audit (QA)

Is a continuing process of testing the Quality Systems in use in

laboratory to check if the system are effective and documented

(responsibility of the Quality Manager)

Quality System Review (QSR)

Is the periodic re-examination of the Quality Systems to check if the

systems are still appropriate (changes of staff, procedures, equipment,

sample type, etc. (responsibility of the Laboratory Management)

To provide a consistent standard of quality both QA and QSR should

be conducted.

To ensure standards of quality are maintained, a laboratory must

operate its own internal audit to test its Quality System.

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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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INTERNAL AUDIT VERIFICATION

1. Staff - academic qualification, experience and job training. Tests are

only conducted by authorised analysts.

2. Environment – laboratory environment is suitable (clean and tidy) for

the work carried out. Adequate of sample reception, preparation,

clean-up and measurement areas

3. Equipment – is suited to its purpose. Instruments are maintained

and calibrated. Instrument performance checks and calibration

procedures arte carried out at appropriate intervals (eg, day to day)

4. Method and Procedures

5. Chemical and physical standards, CRMs and reagents

6. Quality control – an appropriate QC should be conducted for each

test (eg using control chart, QC check samples)

7. Sample management – Samples are properly labelled and stored,

effective documented system of receiving and analysis of samples.

8. Records

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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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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.

Introduction to ISO 9000 (continued)

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

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).

ISO 9000 - provides general guide to quality management and quality

assurance standards.

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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

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.

ISO 17025/IEC 17025 is an international standard for calibration

and testing labs.

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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.

This standard is an evolution of the former ISO Guide 25

replacing EN45001 in Europe and has been adopted in

the U.S.

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.

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

The laboratories 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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1. process-compliant laboratory

2. accredited laboratory

3. conformant service

4. accredited service

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.

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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.

1. ISO 17025 process-compliant laboratory

Being accredited is a prerequisite for selling an accredited

service.

2. ISO 17025 accredited laboratory

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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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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.

Preparation of SOPs (continued)

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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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• 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.

TQM emphasis (continued)

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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).