CHAPTER 1

Introduction to Quality Assurance

1
References

Crosby, N.T., Day, J.A., Hardcastle, W.A., Holcombe, D.G. and

Treble, R.D. Quality in the Analytical Chemistry Laboratory. John
Wiley & Sons. 1995.

Funk, W., Dammann, V. and Donnevert, G. Quality Assurance in

Analytical Chemistry. John Wiley & Sons. 1995.

Elizaberth Prichard. Analytical Chemistry by Open Learning. Quality

in the Analytical Chemistry Laboratory.

Harrison M. Wadsworth, Kenneth S, Stephens, A.Blanton Godfrey.

Modern Methods for Quality Control and Improvement. John Wiley
& Sons. Inc. 2002.

B. W. Wenclawiak, M. Koch and E. Hadjicostas (Eds). Quality

Assurance in Analytical Chemistry.Springer-Verlag Berlin
Heidelberg. 2004.
2
STUDENT LEARNING OUTCOME:

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

• know what is the quality assurance all about.

• understand the need for a quality system and the
existence of standard organisations.
• differentiate the terms quality system, quality control and
quality assurance.

3
What is QUALITY?
General definition (Juran 1988)
“Quality is fitness for use”

Widely used definition

“Quality is conformance to requirements or
specifications”

Definition from ISO 9000-2000

“Quality is the degree to which a set of inherent
characteristics fulfils requirements”
4
What is QUALITY ASSURANCE?

General definition
Quality assurance is a system of activities
whose purpose is to provide an assurance
that the overall quality control is in fact being
done effectively.

(ISO 9000-2000)
Quality Assurance is part of quality management,
focused on providing confidence that quality
requirements will be fulfilled.
5
 Quality Assurance (QA)
QA describes the overall measures that a
laboratory uses to ensure the quality of its
operation.

Appropriate QA can enable a laboratory to show that

it has adequate facilities and equipment for carrying
out chemical analysis and the work was carried out by
competent staff in a controlled manner, following a
documented validated method.

Good QA practice, including its formal recognition by

accreditation, certification etc., help to ensure that
results are valid and fit for purpose. 6
 Quality Assurance in Laboratory
Refers to the total program that the laboratory uses to establish and
maintain high standards of performance.

Includes:
 licenced professional laboratory analysts employed by the lab.
 continuing training of the lab staff.
 the quality and unkeep of the instruments and glassware used in lab.
 specifications and certificates of analysis for the reagents and standards.
 records of reagent and standard preparation (SOP).
 instrument log and maintenance books.

Formalized in written form “QUALITY ASSURANCE MANUAL”

7
Quality in Analytical Laboratory:
is all about providing results, which:
• meet the specific needs of the customer
• attract confidence of the customer and all others who make use of the results
• represent value for money

Factors to be considered to ensure a quality result:

- correct sampling methods; is the sample representative of the total material?
- what level of uncertainty is acceptable?
- appropriate analytical method; is the sample representative of the total sample?
- measurements properly recorded; is there any possibility of a mistake, or a
measurement being lost, or a sample being wrongly identified?
- experimental procedure fully recorded; can someone repeat the work in the
future?
- report to the customer; is it understandable and does it answer the customer’s
question?
8
Quality Control (QC)

(Juran 1988)
Quality control is the regulatory process trough
which we measure actual quality performance,
compare it with standards, and act on the
difference.

(ISO 9000-2000)
Quality Control: part of quality management,
focused on fulfilling quality requirements

9
Foundations for Quality : Standards

Standard:
Document, established by consensus and
approved by a recognized body, that
provides, for common and repeated use,
rules, guidelines or characteristics for
activities or their results, aimed at the
achievement of the optimum degree of
order in a given context.

10
SIRIM Berhad, formerly known as the
Standards and Industrial Research
Institute of Malaysia (SIRIM) is the The Lloyd’s Register Group is
national organization of standardization one of the world leaders in
and quality. assessing business processes
and products to internationally
Main function: to develop recognised standards.
Malaysian standards and to
promote standardization and
quality assurance for greater
competitiveness
11
 DEFINITION
ACCREDITATION CERTIFICATION

Procedure by which an Procedure by which a

authoritative body gives third party gives written
formal recognition that a assurance that a
body or person is product, process or
competent to carry out service conforms to
specific task specific requirements

12
 QUALITY ASSURANCE

QUALITY

QUALITY CONTROL

STANDARDS

13
QA Systems
Quality Assurance measures apply to the
laboratory analytical work overall, which
includes;
• identifying the person having the overall
responsibility for quality

• having laboratory equipment calibrated

to recognised standards

• using reference materials

• joining proficiency testing schemes with

other laboratories doing similar tests

14
Without a
Laboratory
Quality System -
too many mistakes
can make analysis
costs of analysis
very costly; due to
expenses caused by wrong decisions, or
• repeating analysis of samples
• investigation of problems
• revision of procedures
• loss of good reputation 15
Prevention is Better
than cure!
‘It costs less to prevent a
problem than it does to
correct it’
A formal quality system in the
laboratory should prevent
mistakes by means of:

• quality assurance measures

• quality control of the analytical results
• thorough documentation of the system
• efficient maintenance of records
• regular audits of all aspects of the system
16
 % Fat
3.30

QC systems 3.25

% fa t
3.20

Is the single procedure used by the

laboratory on a regular basis to
3.15

obtain quantitative data about some

aspect of the validity of a specific
3.10

test procedure. 14/01/02 24/01/02 03/02/02 13/02/02 23/02/02 05/03/02

date
15/03/02 25/03/02 04/04/02 14/04/02 24/04/02

Control chart

Quality control measures apply to each analytical test in the laboratory

by use of:
• reagent blanks;
• verified standard solutions;
• check samples (from both within the lab and from outside);
• blind samples;
• replicate analyses;
• and control charts
17
Use of QC Samples
Step change

Regular analysis of a single

control sample will identify a Bias
system in or out of control
Target value
conditions

Drift

In control

18
Daily QC data
 Keeping track of the Lab. No. F7-002

samples

• Sample registration gives each

sample a unique lab number. Sample integrity

• The sample register records all

the information about the sample.

• Just like a sample’s passport, you

should not confuse any sample
with any other.

• The history of the sample should

be traceable throughout.
20
Samples recorded on receipt
Quality system files
1. Admin
Audit reports
System reviews 4. Procedures
Blank forms List of General Procedures
Memos 4.01 Calibration records
Notices
4.02 Complaints and anomalies
Quality Manual
4.03 Equipment records
Record of anomalies
Preventive actions 4.04 Method validation
1.2.1.(index) 4.05 Quality audits
4.06 Quality control records
General contract
4.07 Reference standards 5. Quality Control
2. Validation 4.08 Result acceptability 5.01 Fibre analysis
Fibre 4.09 Result reporting 5.02 Milk analysis
Milk 4.10 Result uncertainties 5.03 Feed analysis
Proficiency test 4.11 Sample disposal 5.04 N by combustion
5.05 Q.C. limits
3. Equipment 4.12 Sample reception
5.06 Test reports & log
3.01 Equip records 4.13 Sample registration
6. Staff Records
3.02 Operating procedures 4.14 Staff records Job descriptions
3.2.1. balance 4.15 System reviews
3.2.2. ovens 4.16 Training and competence 7. Standard Methods
3.2.3. muffles 4.17 Recording and storing data ADF
3.2.4. thermometers 4.18 Document control Dry matters
Fat, protein & lactose 21
in milk
3.2.5. pH meters NDF
Quality Laboratory Quality System Quality Manual
Amiable Laboratory
Admin 1.5.1.
Page 1 of 1
Issue No.

Manual Title of Section

Title Page
Issue Date
Issued by

QUALITY MANUAL
for
Amiable Laboratory
Benevolent Department
Well-intentioned Organisation
Usual Location

This Manual is issued under the authority of

A quality manual
defines the quality Issue Date ............................................................
system under Issue No. 3
which the Copy No. A Person
laboratory operates Holder
Head of Laboratory

Quality Manual - cover page 22

 Laboratory Quality System - Quality manual Admin 1.5.1.
Quality Amiable Laboratory
Index
Page 1 of 2
Benevolent Department
Manual - Well-intentioned Organisation Issue No. 3
Copy No.
Title of Section Issue Date
contents (1) Index of Contents Issued by

Section Para. Content

No.

1 QUALITY POLICY

2 QUALITY SYSTEM
2.1 Aims and Form of Quality System
2.2 Quality Manual
2.3 Quality Management
2.4 Documentation

3 ORGANISATION AND MANAGEMENT

3.1 Organisation
3.2 Organisational Chart
3.3 Staff - Qualifications and Training

23
Quality Section Para. Content

4
No.
QUALITY AUDIT AND QUALITY SYSTEM

Manual - 4.1
4.2
REVIEW
Purpose
Responsibility

contents (2) 4.3 Implementation

5 EQUIPMENT
5.1 Calibration and Testing Equipment
5.2 Operation and Maintenance of Equipment
5.3 Equipment Records

6 MEASUREMENT TRACEABILITY AND

CALIBRATION
6.1 Policy
6.2 Uncertainty of Measurement
6.3 Calibration

- 7 METHODS AND PROCEDURES FOR TESTS

7.1 Policy and Scope
7.3 Documentation of Methods and Procedures
7.4 Integrity of Data
7.5 Uncertainty of Results

24
 Section Para Content

Quality 8
No.
LABORATORY ACCOMMODATION AND
ENVIRONMENT

Manual - 9
9.1
9.2
HANDLING OF TEST ITEMS
Receipt and Handling of Items
Identification of Items
contents (3) 10 RECORDS
11 TEST REPORTS
11.1 Use of the UKAS Accreditation Mark
11.2 Validity of Reports
12 HANDLING COMPLAINTS AND ANOMALIES
12.1 Policy
12.2 Procedures
13 SUB-CONTRACTING OF TESTS
13.1 Policy
13.2 Register
14 OUTSIDE SUPPORT SERVICES AND
SUPPLIES
14.1 Policy
14.2 Records
15 SITE SECURITY
15.1 Security of Laboratory Premises

25
36