Laboratory Quality Control: Food Agricultural Products Quality Development Control Project (Fapqdcp)

FOOD AGRICULTURAL PRODUCTS QUALITY DEVELOPMENT CONTROL PROJECT (FAPQDCP)
Laboratory Quality Control

Francis Beaudry, Ph.D., Chemist Assistant Professor Faculty of Veterinary Medicine University of Montreal
Definitions (1)
Quality Control - QC refers to the measures that must be included during each assay run to verify that the method is working properly. Quality Assurance - QA is defined as the overall program that ensures that the final results reported by the laboratory are correct. The aim of quality control is simply to ensure that the results generated by the method are reliable. However, quality assurance is concerned with much more: that the right method is carried out on the right specimen, and that the right result and right interpretation is delivered to the right person at the right time
Definitions (2)
Quality Assessment - quality assessment (also known as proficiency testing) is a means to determine the quality of the results generated by the laboratory. Quality assessment is a challenge to the effectiveness of the QA and QC programs. Quality Assessment may be external or internal, examples of external programs include regulatory agencies and reference laboratories.
Variables that affect the quality of results
The educational background and training of the laboratory personnel The condition of the specimens The controls used in the test runs Reagents Equipment The interpretation of the results The transcription of results The reporting of results
Errors in measurement
True value - this is an ideal concept which cannot be achieved. Accepted true value - the value approximating the true value, the difference between the two values is negligible (within acceptance criteria). Error - the discrepancy between the result of a measurement and the true (or accepted true value).
Sources of error
Input data required - such as standards used, calibration values, and values of physical constants. Inherent characteristics of the quantity being measured Instruments used - accuracy, repeatability. Observer fallibility - reading errors, blunders, equipment selection, analysis and computation errors. Environment - any external influences affecting the measurement. Theory assumed - validity of mathematical methods and approximations.
Random Error
An error which varies in an unpredictable manner, in magnitude and sign, when a large number of measurements of the same quantity are made under effectively identical conditions. Random errors create a characteristic spread of results for any test method and cannot be accounted for by applying corrections. Random errors are difficult to eliminate but repetition reduces the influences of random errors. Examples of random errors include errors in pipetting and changes in incubation period. Random errors can be minimized by training, supervision and adherence to standard operating procedures.
Random Errors
x x True Value x x x x x x x x x x x x
x x x
Systematic Error
An error which, in the course of a number of measurements of the same value of a given quantity, remains constant when measurements are made under the same conditions, or varies according to a definite law when conditions change. Systematic errors create a characteristic bias in the test results and can be accounted for by applying a correction. Systematic errors may be induced by factors such as variations in incubation temperature, blockage of plate washer, change in the reagent batch or modifications in testing method.
Systematic Errors
Systematic + BIAS
x x True Value x x x x x x x
Strongly suggest a process error
Internal Quality Control Program
An internal quality control program depend on the use of internal quality control (IQC) specimens and the use of statistical methods for interpretation. Internal Quality Control Specimens IQC specimens comprises either (1) in-house sera (single or pooled samples), or (2) Reference samples provided by a reference laboratory with values within significant analytical ranges (MRL minimally but Idealy; 0.5*MRL, MRL and 2*MRL).
Quality Control Scheme

The quality control scheme depend on the use of IQC specimens and is developed in the following manner:
Use IQC specimen analysed in duplicate for each analytical runs and record the individual values. Weekly/Monthly/yearly, Calculate the mean and standard deviations (SD) of the individual values obtained Make a plot with the assay run number on the x-axis, and measured values on the y axis. Draw the following lines across the y-axis: mean, -3SD, -2SD, -2SD, 1SD, 2SD, and 3 SD. (based on normal gaussian distribution) Plot the concentration obtained for the IQC specimen for all analytical runs (trend analysis)
Statistical Basis for Evaluation

Mean
Objectives of an analytical procedure

s
Able to quantify as accurately as possible each unknown quantity to be determined. After analysis: the difference between returned result x and the unknown true value T be small or < acceptance limit : - < x - T < x - T <
: depends on objective of analytical procedure e.g, Generally accepted BIAS is 15 %
14
Mesured Accuracy profile

bias (%) + + BIAS
acceptance limits
Acceptable BIAS 0 concentration - BIAS C1 LLQ C2 C3 C4 ULQ 15
RANGE
dosage interval
Intra Batch Quality Control Estimator
+15%
-15%
0.5*MRL MRL 2*MRL
Inter Batch Quality Control Trend Analysis

1.98 SD
95%CI
- 1.98 * SD
Trend analysis and performance evaluation are vital to assess if the method performed with an acceptable accuracy.
Warning rules
Warning 1 : It is violated if 1/3 of IQC bias exceeds 15% Warning 2 : It detects systematic. BIAS is systematicaly negative or positive. Warning 3 : It is violated if consecutive IQC bias lead from a positif to a negative Bias of from a negative to a positive bias. This observation may indicate the need to perform instrument verification or maintenance.
Mandatory rules
Mandatory 1 : It is violated when the IQC bias exceeds the mean by 2SD (1.98SD). The assay run is regarded as out of control. Mandatory 2 : This rule is violated when the last 2 or 3 consecutive runs show IQC bias on the same side of the mean or target value (Systematic + or bias).
Follow-up action in the event of a violation

There are three options as to the action to be taken in the event of a violation of a pre-established QC rules:
Accept the test run in its entirety - this usually applies when only a warning rule is violated. Reject the whole test run - this applies only when a mandatory rule is violated. Accept only results that are within the analytical range that is not affected by a violation of either a warning or mandatory rule. Re-analyse samples that are affected by rule violation (this is always risky)

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FOOD AGRICULTURAL PRODUCTS QUALITY DEVELOPMENT CONTROL PROJECT (FAPQDCP)

Laboratory Quality Control

Variables that affect the quality of results

Strongly suggest a process error

Internal Quality Control Program

Quality Control Scheme

Statistical Basis for Evaluation

Objectives of an analytical procedure

: depends on objective of analytical procedure e.g, Generally accepted BIAS is 15 %

Mesured Accuracy profile

Acceptable BIAS 0 concentration - BIAS C1 LLQ C2 C3 C4 ULQ 15

Intra Batch Quality Control Estimator

Inter Batch Quality Control Trend Analysis

Follow-up action in the event of a violation

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