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An Introduction to Quality

Assurance in Labs

Azeem Dilawar
Manager Quality Operations
Approved Trainer for Food Safety and
Hygiene(High Field United Kingdom)
Learning objectives


At the end of the presentation,
participants should
Understand the principles of Quality Assurance in Labs
Understand the importance for internal and external quality
assurance schemes in labs
List the quality system essential elements
Describe the history of development of quality principles
Discuss relationship of this quality model to ISO and CLSI
standards
The Quality Assurance System in
Labs

What is Quality
Assurance

Laboratory
Quality
Assurance
System

too many mistakes
can make analysis
very costly; due to costs of analysis
expenses caused by wrong decisions, or
repeating analysis of samples
investigation of problems
revision of procedures
loss of good reputation
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
QA and QC systems


Quality
: activities designed to
planned
Control
provide a quality product.
Quality Assurance:
planned activities designed to ensure
that the quality control activities are
being properly
implemented.
(As defined by the Association of Official Analytical Chemists)
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
% Fat
3.30

QC systems
3.25

% fat
3.20

3.15


3.10
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Control chart
date

Quality control measures


apply to each analytical
test in the laboratory by
use of:

reagent blanks;
blind samples
verified standard
replicate analyses;
solutions;
check samples and control charts
(from both within
the lab and from
outside);
Quality systems -
control charts
A control chart is a means of
ensuring that the method remains in
3.30
% Fat control - continues to perform in
accordance with expectations. This
usually
3.25
means that results from analysing
standards fall within + 2 standard
deviations of the accepted value
% fat

3.20

(within the blue lines on the chart).


3.15 Any results appearing outside the
red lines (+ 3 standard
3.10
deviations) indicate that the
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date
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method is not longer in control and
requires investigation.
Use of QC Samples


Step change

Regular analysis of a Bias


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

In control

Daily QC data
Measurement
traceability

In an absolute sense,

the true value can be
defined only as being
that value directly SI
traceable to the base unit Transfers
Provides
system of measurement traceability accuracy
(SI) or their derivatives - Certified
ie: to national or reference material
international standards Laboratory
via an unbroken chain working standard
of comparisons

Analytical method
Measurement The Sample
traceability (2)
Analysed by
The SI units:
Kg, Metre, Mole Secondary method:
e.g. lab. method
Calibrated by
Primary methods
(often gravimetric)
Calibration Standards
e.g. AOAC, EPA
Method routinely
Certified by checked by
analysis

Secondary RMs
Certified Reference Materials In-house QC materials
(CRMs - expensive, small Periodically
(fairly cheap, larger amounts
checked
amounts, best accuracy, long life) matrix matched, short life)
Reference
materials & check
samples

SAMPLES
SUPPLIED FOR
INTERNAL PROFICIENCY
QC SAMPLES TESTING

Internal QC samples An accredited


are prepared and laboratory has to prove
quantity values of its performance by
target components CERTIFIED REFERENCE routinely analysing
are checked against MATERIALS (CRMs) samples supplied by
CRMs an independent
laboratory
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 samples passport,


you should not confuse any
sample with any other.

The history of the sample


should be traceable
throughout.
Samples recorded on receipt
Quality
Laboratory Quality System Quality Manual Admin 1.5.1.
Page 1 of 1
Amiable Laboratory
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
Holder
laboratory operates Head of Laboratory

Quality Manual - cover page


Quality
Laboratory Quality System - Quality manual Admin 1.5.1.
Index
Amiable Laboratory Page 1 of 2
Benevolent Department

Manual - Well-intentioned Organisation

Title of Section
Issue No. 3
Copy No.
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
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
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
Quality system files
1. Admin
Audit reports


System reviews 4. Procedures

Blank forms
Memos List of General Procedures
Notices 4.01 Calibration records
Quality Manual 4.02 Complaints and anomalies
Record of anomalies 4.03 Equipment records
Preventive actions 4.04 Method validation
1.2.1.(index) 4.05 Quality audits
5. Quality Control
General contract 4.06 Quality control records
5.01 R.M analysis
2. Validation 4.07 Reference standards 5.02 F.P analysis
R.M 4.08 Result acceptability 5.03 S.F.P analysis
F.P 4.09 Result reporting 5.04 N by combustion
Proficiency test 4.10 Result uncertainties 5.05 Q.C. limits
4.11 Sample disposal 5.06 Test reports & log
3. Equipment
4.12 Sample reception 6. Staff Records
3.01 Equip records Job descriptions
3.02 Operating procedures 4.13 Sample registration
3.2.1. balance 4.14 Staff records 7. Standard Methods
3.2.2. ovens 4.15 System reviews ADF
4.16 Training and competence Dry matters
3.2.3. muffles Macro Analysis
3.2.4. thermometers 4.17 Recording and storing data NDF
3.2.5. pH meters 4.18 Document control