1. An Introduction to Quality Assurance in Analytical Science
Dr Irene Mueller-Harvey
Mr Richard Baker
Mr Brian Woodget

2. Part 3 - Quality systems Contents:
Introduction to quality systems (slides 3,4)
QA and QC systems (slides 5-9)
Measurement traceability (slides 10,11)
Reference materials and check samples (slide 12)
Keeping track of samples (slide 13)
Quality manual (slides 14-17)
Quality system filing (slide 18)
The presentation contains some animation which will be activated
automatically (no more than a 2 second delay), by mouse click or by use
of the ‘page down’ key on your keyboard.

3. Without a Laboratory Quality 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

4. 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

5. QA and QC systems Quality Control: Quality Assurance:
planned activities designed to 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)

6. 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

7. QC systems reagent blanks; verified standard solutions; blind samples
Quality control measures apply to each analytical
test in the laboratory by
use of:
Control chart
reagent blanks;
verified standard solutions;
check samples (from both within the lab and from outside);
blind samples
replicate analyses;
and control charts

8. Quality systems - control charts
A control chart is a means of ensuring that the method remains in ‘control’ - continues to perform in accordance with expectations. This usually
means that results from analysing standards fall within + 2 standard deviations of the accepted value (within the blue lines on the chart). Any results appearing outside the red lines (+ 3 standard deviations) indicate that the method is not longer in control and requires investigation.

9. Use of QC Samples
Step change
Regular analysis of a single control sample will identify a system in or out of control conditions
Bias
Target value
Drift
In control
Daily QC data

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

11. Measurement traceability (2)
The Sample
Analysed by
The SI units:
Kg, Metre, Mole
Secondary method:
e.g. lab. method
Calibrated by
Primary methods
(often gravimetric)
e.g. AOAC, EPA
Calibration Standards
Method routinely
checked by
Certified by
analysis
Primary methods are often based on gravimetric procedures (e.g. AOAC, EPA methods)
Secondary RMs
In-house QC materials
(fairly cheap, larger amounts,
matrix matched, short life)
Certified Reference Materials
(CRMs - expensive, small
amounts, best accuracy, long life)
Periodically
checked 1

12. Reference materials & check samples
SUPPLIED FOR
PROFICIENCY
TESTING
INTERNAL
QC SAMPLES
Internal QC samples
are prepared and
quantity values of
target components
are checked against
CRMs
An accredited
laboratory has to prove
its performance by
routinely analysing
samples supplied by
an independent
laboratory
CERTIFIED REFERENCE
MATERIALS (CRMs)

13. Keeping track of the samples
Lab. No. F7-002
Sample registration gives each sample a unique lab number.
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.
Sample integrity
Samples recorded on receipt 1

14. Quality Manual A quality manual defines the quality system under
Laboratory Quality System
Quality Manual
Admin
Page 1 of 1
Amiable Laboratory
Issue No.
Issue Date
Title of Section
Title Page
Issued by
QUALITY MANUAL
for
Amiable Laboratory
Benevolent Department
Well-intentioned Organisation
Usual Location
A quality manual
defines the quality
system under
which the
laboratory operates
This Manual is issued under the authority of
Issue Date
Issue No. 3
Copy No.
A Person
Holder
Head of Laboratory
Quality Manual - cover page

15. Quality Manual -
contents (1)

16. Quality Manual -
contents (2) -

17. Quality Manual -
contents (3)

18. Quality system files 1. Admin Audit reports System reviews Blank forms
Memos
Notices
Quality Manual
Record of anomalies
Preventive actions
1.2.1.(index)
General contract
2. Validation
Fibre
Milk
Proficiency test
3. Equipment
3.01 Equip records
3.02 Operating procedures
balance
ovens
muffles
thermometers
pH meters
List of General Procedures
4. Procedures
Quality control records
Reference standards
Result acceptability
Result reporting
Result uncertainties
Sample disposal
Sample reception
Sample registration
Staff records
System reviews
Training and competence
Recording and storing data
Document control
Calibration records
Complaints and anomalies
Equipment records
Method validation
Quality audits
5. Quality Control
Fibre analysis
Milk analysis
Feed analysis
N by combustion
Q.C. limits
Test reports & log
6. Staff Records
Job descriptions
7. Standard Methods
ADF
Dry matters
Fat, protein & lactose in milk
NDF 1