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