An Introduction to Quality Assurance in Analytical
ScienceDr Irene Mueller-Harvey
Mr Richard Baker
Mr Brian Woodget
University of Reading
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)
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expenses caused by wrong decisions, or
Without a Laboratory Quality System -
costs of analysis
too many mistakes can make analysis very costly; due to
• 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 Control: planned activities designed to provide a quality product.
Quality Assurance:
planned activities designed to ensure that the quality control activities are being properlyimplemented.
(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
QC systems
• reagent blanks;
• verified standard solutions;
• check samples (from both within the lab and from outside);
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• blind samples
• replicate analyses;
• and control charts
Quality control measures apply to each analytical test in the laboratory byuse of:
Control chart
Quality systems - control charts
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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.
Use of QC Samples
Regular analysis of a single control sample will identify a system in or out of control conditions
Target value
Daily QC data
Step change
Bias
Drift
In control
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
SIunit
Certifiedreference material
Laboratoryworking standard
Analytical method
Transfersaccuracy
Providestraceability
The SI units: Kg, Metre, Mole
Primary methods (often gravimetric)
e.g. AOAC, EPA
Certified Reference Materials (CRMs - expensive, small
amounts, best accuracy, long life)
Secondary RMs In-house QC materials (fairly cheap, larger amounts,
matrix matched, short life)
Secondary method:e.g. lab. method
Calibration Standards
The SampleMeasurement traceability (2)
Analysed by
Calibrated by
Method routinelychecked by
Periodicallychecked
Certified byanalysis
Reference materials & check samples
CERTIFIED REFERENCEMATERIALS (CRMs)
INTERNALQC SAMPLES
SAMPLESSUPPLIED FORPROFICIENCY
TESTING
Internal QC samplesare prepared andquantity values oftarget components
are checked againstCRMs
An accredited laboratory has to prove
its performance byroutinely analysing
samples supplied byan independent
laboratory
Keeping track of the
samples
• 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.
Samples recorded on receipt
Lab. No. F7-002
Sample integrity
Laboratory Quality System Admin 1.5.1.
Quality Manual
Amiable Laboratory Page 1 of 1
Issue No.
Title of Section Issue Date
Title Page Issued by
QUALITY MANUALfor
Amiable LaboratoryBenevolent Department
Well-intentioned OrganisationUsual Location
This Manual is issued under the authority of
............................................................
A Person
Head of Laboratory
Issue Date Issue No. 3 Copy No. Holder
QualityManual
Quality Manual - cover page
A quality manualdefines the quality
system underwhich the
laboratory operates
Laboratory Quality System - Quality manual Admin 1.5.1.Index
Amiable Laboratory Page 1 of 2Benevolent Department
Well-intentioned Organisation Issue No. 3Copy No.
Title of Section Issue Date
Index of Contents Issued by
Section Para.No.
Content
1 QUALITY POLICY
2 QUALITY SYSTEM2.1 Aims and Form of Quality System2.2 Quality Manual2.3 Quality Management2.4 Documentation
3 ORGANISATION AND MANAGEMENT3.1 Organisation3.2 Organisational Chart3.3 Staff - Qualifications and Training
QualityManual -contents (1)
Section Para.No.
Content
4 QUALITY AUDIT AND QUALITY SYSTEMREVIEW
4.1 Purpose4.2 Responsibility4.3 Implementation
5 EQUIPMENT5.1 Calibration and Testing Equipment5.2 Operation and Maintenance of Equipment5.3 Equipment Records
6 MEASUREMENT TRACEABILITY ANDCALIBRATION
6.1 Policy6.2 Uncertainty of Measurement6.3 Calibration
7 METHODS AND PROCEDURES FOR TESTS7.1 Policy and Scope7.3 Documentation of Methods and Procedures7.4 Integrity of Data7.5 Uncertainty of Results
QualityManual -contents (2)
-
Section ParaNo.
Content
8 LABORATORY ACCOMMODATION ANDENVIRONMENT
9 HANDLING OF TEST ITEMS9.1 Receipt and Handling of Items9.2 Identification of Items
10 RECORDS
11 TEST REPORTS11.1 Use of the UKAS Accreditation Mark11.2 Validity of Reports
12 HANDLING COMPLAINTS AND ANOMALIES12.1 Policy12.2 Procedures
13 SUB-CONTRACTING OF TESTS13.1 Policy13.2 Register
14 OUTSIDE SUPPORT SERVICES ANDSUPPLIES
14.1 Policy14.2 Records
15 SITE SECURITY15.1 Security of Laboratory Premises
QualityManual -contents (3)
1. AdminAudit reports
System reviewsBlank formsMemosNoticesQuality ManualRecord of anomalies
Preventive actions1.2.1.(index)General contract
2. ValidationFibreMilkProficiency test
3. Equipment3.01 Equip records3.02 Operating procedures
3.2.1. balance3.2.2. ovens3.2.3. muffles3.2.4. thermometers3.2.5. pH meters
List of General Procedures
4. Procedures
4.06 Quality control records4.07 Reference standards4.08 Result acceptability4.09 Result reporting4.10 Result uncertainties4.11 Sample disposal4.12 Sample reception4.13 Sample registration4.14 Staff records4.15 System reviews4.16 Training and competence4.17 Recording and storing data4.18 Document control
4.01 Calibration records4.02 Complaints and anomalies4.03 Equipment records4.04 Method validation4.05 Quality audits
5. Quality Control5.01 Fibre analysis5.02 Milk analysis5.03 Feed analysis5.04 N by combustion5.05 Q.C. limits5.06 Test reports & log
6. Staff RecordsJob descriptions
7. Standard MethodsADF Dry mattersFat, protein & lactose in milkNDF
Quality system files
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