The description of the methodology will be explained by two factors: Analyte Accuracy Certain Score (AACS) and System Maturity Score (SMS).
Analyte Accuracy Certain Scores. AACS
AACS is a specific score influenced by 4M criteria (Manpower, Method, Machine and Material). Manpower is related to the analyst’s qualification, competency and experience; method refers to the validated or verified method; the machine depends on measuring instruments and the analytical instruments, which are well calibrated and maintained. Material is all kinds of reference standards used in the proper procedure and proves the metrological traceability, add on for the participation in the proficiency testing or interlaboratory comparison, consumable, reagent used, and sample receiving. A combination of these 4M will develop the formulation of AACS.
Score based on pre-defined criteria:
Manpower:
Focus on the analyst who runs the testing, divided into two sections: the interview section and record tracking. The interview section covers the technique of sample running, either divided by section or run by one person. Followed by pre-treatment sampling, sample preparation – extraction process, sample analysis by instrument, resulting from the interpretation and report writing, those based on qualification, which was qualified based on Sijil Peperiksaan Malaysia, SPM, Diploma, Degree, Master and Ph.D. The experience is divided into four categories: less than one year, 1-5 years, 6-10 years and more than ten years. Years of experience directly affect the performance of the analysis. Practice helps us increase our ability to access information rapidly and automatically; thus, practice makes perfect. If the personnel do the things daily, they must start doing the right thing to obtain good performance. The method was introduced in the right way for any analysis or experiments. The training module, competency method and competency test were considered for the record tracking section. The training module was important to understand how the laboratory trained personnel, was it trained by method approach, instruments or analyst? After training, competency is needed either before case handling or during case handling. A competency test is compulsory to ensure the validity of the results (clause 7.7.2); the period of test can be done within three months, six months or annually. The total score from this section is 28 points. It covers 25% overall of 4M.
Method:
The type of method influences the validation or verification study. The method can be divided into International, regional/national standards, reputable technical organisations’ methods, relevant scientific texts or journals to treat as the laboratory’s method, the method based on the specified by the equipment manufacturer or laboratory-developed or modified method. Method validation criteria based on selectivity, robustness, linearity/calibration model, working range, the limit of detection (LOD), the limit of quantitation (LOQ), precision, trueness and uncertainty, whereas for method verification based on precision, trueness, LOD, LOQ and uncertainty only. Ten methods were selected from the laboratory, which covers food preservatives, proximate food analysis, contaminants in food, mycotoxin, drug residue and food standard. The total score from this section is 16 points and covers 15% overall of 4M.
Machine:
Referring to measuring instruments such as balance, oven and thermometer; and analytical instruments such as gas chromatography (GC), liquid chromatography (LC), ultraviolet spectrometry (UVS), atomic absorption spectroscopy (AAS) and others. The status of the instrument, type of calibration and maintenance schedule were mandatory for observation. Calibrated record and maintained records of the analytical instruments and measuring equipment. The total score from this section is 33 points and covers 30% overall of 4M.
Material:
Reference material or certified reference material based on the type and purity of the substances. Add more proficiency testing or interlaboratory comparison based on the schemes' frequency, matrices, analytes and performance. The total score from this section is 30 points and covers 30% overall of 4M, which is the same as “Machine”. Both of them are equally important; under clause 6.4, equipment including but not limited to measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary apparatus that are required for the correct performance of laboratory activities and that can influence the results [2].
System Maturity Score, SMS
SMS will cover scores from overall audit findings and Overall Proficiency Testing (OPT) performance. Overall audit findings include internal audits and external assessments. Internal audits are thorough reviews by an independent team that arises in findings and recommendations. An internal audit assesses performance in relation to predetermined standards. Findings are the outcomes regarding each condition; they could be a compliance or non-compliance finding verified by the evidence. A laboratory's requirement to maintain a certain task is evaluated through external assessments. These fit the strict definition of an assessment, but the assessor's expertise and experience considerably more strongly influence the findings. Assessments also result in a finding, although this conclusion is mostly based on the assessor's judgement as opposed to a set of precise requirements, based still based on the standard used. The success of the auditing program depends significantly upon selecting the right person for the task, and not everyone can be a good auditor. A proficient assessor must communicate effectively, encourage others, write and explain, be a good listener, and use a good combination of appropriate language while questioning accredited lab staff. Overall, an assessor must be a good manager, planner and situation handler. Proper knowledge, experience, and additional qualities of the assessor/auditor [16]. On the other side, the OPT covers all the proficiency testing and inter-lab comparison, which are provided by accredited or non-accredited PT providers, either at local or international levels; pre-defined criteria were based on the performance of the Z score.
Score based on pre-defined criteria:
Audit/Assessment, A score:
The finding was collected from 2 cycles of assessment covering 1st cycle (2016-2018) and 2nd cycle (2019-2021) from internal audit and external assessment; criteria are defined based on the Non – Compliance Record, NCR category 1 to 3, and category 4 is observation. The scoring system applied as follows: -
- NCR Cat 1 with 4 points
- NCR Cat 2 with 3 points
- NCR Cat 3 with 2 points
- Observation Cat 4 with 1 point
Index A was obtained by comparing the marks of the current year with the previous year, continuing for two cycles, and then averaging all the marks. The formulation of the index A (I) is based on equation (1), and the calculation of A score (A) is based on equation (2).
Overall Proficiency Testing score, OPT score:
Overall schemes for the data collection from 2016 – 2021, criteria based on the performance of Z score.
- Z<1 with 4 points
- 1≤ Z < 2 with 3 points
- 2 ≤ Z < 3 with 2 points
- Z ≥ 3 with 1 point
- Not submitted the result with no points.
OPT score is obtained by summarising all the schemes carried out in the chemical testing between the two cycles; the score is divided by the highest points and then gets the percentage average.
Maturity Model, MM
A combination of AACS and SMS with a ratio of 20:80 obtained a maturity score, which was calculated as MM. Referring to Figure 1, the scoring system started from 40% to 49%, which is declared as the Beginning level. The minimum score for an accredited laboratory is 40%. The second level is the developing level which covers 50% to 59%. The emerging level covered 60% to 69%. Followed by the fourth level, the accelerating level started from 70% to 79%. The highest level is above 80%, which is the leading level. The laboratory with this level can lead the firm without doubt or query. The laboratory achieved all the criteria from 4 M and obtained a higher score, most probably can compete at a world-class level.