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

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Presentation on theme: "An Introduction to Quality Assurance in Analytical Science Dr Irene Mueller-Harvey Mr Richard Baker Mr Brian Woodget."— Presentation transcript:

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 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

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: 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; check samples (from both within the lab and from outside); blind samples replicate analyses; and control charts Quality control measures apply to each analytical test in the laboratory by use of: Control chart

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 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

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 Certified reference material Laboratory working standard Analytical method Transfers accuracy Provides traceability

11 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 Sample Measurement traceability (2) Analysed by Calibrated by Method routinely checked by Periodically checked Certified by analysis

12 Reference materials & check samples CERTIFIED REFERENCE MATERIALS (CRMs) INTERNAL QC SAMPLES SAMPLES SUPPLIED FOR PROFICIENCY TESTING 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

13 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 samples 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

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

15 Quality Manual - contents (1)

16 Quality Manual - contents (2) -

17 Quality Manual - contents (3)

18 1. Admin Audit reports System reviews Blank forms Memos Notices Quality Manual Record of anomalies Preventive actions (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 4.06 Quality control records 4.07 Reference standards 4.08 Result acceptability 4.09 Result reporting 4.10 Result uncertainties 4.11 Sample disposal 4.12 Sample reception 4.13 Sample registration 4.14 Staff records 4.15 System reviews 4.16 Training and competence 4.17 Recording and storing data 4.18 Document control 4.01 Calibration records 4.02 Complaints and anomalies 4.03 Equipment records 4.04 Method validation 4.05 Quality audits 5. Quality Control 5.01 Fibre analysis 5.02 Milk analysis 5.03 Feed analysis 5.04 N by combustion 5.05 Q.C. limits 5.06 Test reports & log 6. Staff Records Job descriptions 7. Standard Methods ADF Dry matters Fat, protein & lactose in milk NDF Quality system files

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