Glossary for Food Testing Laboratories

 

Accreditation: The confirmation by a third-party accreditation body (usually governmental) that a laboratory meets the requirements of an accreditation standard, e.g., ISO/IEC 17025:2017.

Accuracy: The difference between an observed or measured value and the accepted or ‘true value’. Accuracy is affected by both random and systematic errors, and it can be defined as the sum of systematic plus random error.

Anomaly: An unexpected occurrence that has had (or had the potential to have) a negative effect on the work undertaken by the laboratory.

Audit Trail:   A chronological record that provides documentary evidence of the sequence of activities or changes that have occurred in a particular process, system, or piece of equipment. Audit trails enhance transparency, traceability, and accountability.

Batch:   The analysis of a group or "batch" of samples simultaneously, often used in production scenarios to ensure consistency and quality across a specific production run.

Biosecurity: A set of preventive measures designed and applied to reduce the risk of introducing a pathogenic agent into an enclosed laboratory.

Blank: A sample containing no added analyte or a sample treated in such a manner that the desired reaction does not take place (e.g., one of the reagents used to produce a reaction is omitted).

Calibration: The process of comparing a measurement instrument or system with a known standard to determine its accuracy and correct any deviations, ensuring the reliability of measurements.

Certification: The confirmation by an independent, third-party certification body that conformity is demonstrated with the specific requirements of a standard, e.g., ISO 9001. Certification may also be referred to as ‘Registration’.

Complaint: An expression of dissatisfaction from a customer regarding the quality of work performed by the laboratory.

Containment Level (CL): The bio-containment precautions that are to be taken when handling potentially harmful biological agents in an enclosed laboratory. These range from CL 1 (minimum level) to CL 4 (the highest).

Control of Data: The systematic management of data to ensure its accuracy, integrity, and confidentiality throughout its lifecycle, from collection to reporting.

Corrective and Preventive Action (CAPA): Corrective actions are actions taken when a process deviates outside the specification of the Quality Management System. Corrective Actions remove the ‘cause,’ and Preventive Action prevents recurrence. CAPA may be undertaken as a result of an anomaly, non-conformance, or customer complaint.

Certified Reference Material (CRM): A reference material accompanied by a certificate that provides information on its characteristics and properties, such as composition, homogeneity, and stability. The certification is issued by a recognized certification body or authority, and it attests that the material has been thoroughly analyzed and meets specific quality criteria. CRMs are particularly valuable in analytical chemistry and other fields where precise measurements and traceability to international standards are crucial. The use of CRMs enhances the accuracy and comparability of results among different laboratories and over time.

Critical Control Point (CCP):   A specific point in the food production process where control measures can be applied to prevent, eliminate, or reduce a potential hazard to an acceptable level. CCPs are crucial in Hazard Analysis and Critical Control Points (HACCP) systems.

Cross-Contamination:   The unintentional transfer of contaminants from one sample, substance, or surface to another, posing a risk to the accuracy and integrity of test results.

Decision Rule: A predefined criterion or set of rules that guide the laboratory in determining conformity or non-conformity based on measurement results and associated uncertainties.

Document: A controlled written policy, procedure, or work instruction that defines what operators do and how to do it. Controlled means that the document states who wrote and/or authorized the policy or procedure, when it was issued, and states a version number to avoid the use of a document that is no longer valid. Control of documentation will normally be the responsibility of the Quality Assurance Manager.

Gap Analysis: An audit with the purpose of establishing the current ‘gap’ between current activities and those which would meet the requirements of a standard or Management System.

Impartiality: The principle of neutrality and absence of bias in the decision-making process of a laboratory. It ensures that laboratory activities, including testing and calibration, are conducted objectively without any undue influence.

Internal Audits: Systematic and independent assessments conducted by the laboratory to evaluate its compliance with established policies, procedures, and standards, identifying areas for improvement.

Laboratory Information Management System (LIMS): A software-based system designed to manage and streamline laboratory processes, including sample tracking, data management, and reporting. LIMS enhances efficiency and data integrity within the laboratory.

Limit of Detection (LOD):   The lowest concentration of an analyte that can be reliably detected but not necessarily quantified. LOD is a critical parameter in assessing the sensitivity of an analytical method.

Limit of Quantification (LOQ):   The lowest concentration of an analyte that can be reliably measured and quantified with a defined level of precision and accuracy. LOQ is a key parameter in establishing the lower limit of a measurement range.

Matrix Effect:   The influence of the sample matrix on the accuracy and precision of analytical measurements. Understanding and mitigating matrix effects are essential in ensuring reliable and accurate results, especially in complex sample types.

Measurement Uncertainty: The parameter associated with the variability of measurement results, encompassing both systematic and random errors. It provides a quantitative estimate of the confidence level in a measurement.

Metrological Traceability: The ability to trace measurement results to a recognized reference standard through an unbroken chain of comparisons, ensuring the reliability and accuracy of measurements.

Nonconforming Work: Work that does not meet specified requirements or standards, requiring corrective actions to address the non-conformity and prevent its recurrence.

Opinions and Interpretations: Subjective judgments or explanations provided by laboratory personnel in the context of their expertise, especially when dealing with complex or ambiguous situations.

Provision of Objective Evidence: The presentation of tangible and verifiable data or information that demonstrates compliance with specified requirements.

Proficiency Testing:   An external assessment of a laboratory's competence to perform specific tests or calibrations. Proficiency testing involves the laboratory analyzing samples with unknown concentrations and comparing its results with those of other competent laboratories.

Quality Control (QC):  A systematic process within the laboratory that monitors and verifies the consistency and reliability of analytical procedures, ensuring that the results meet specified quality criteria.

Quality Control Chart:   A graphical tool used to monitor and analyze the performance of a process over time. Control charts help identify trends, patterns, or shifts that may indicate variations in the process.

Quality Control Sample:  A sample with a known concentration of an analyte, used to assess the precision and accuracy of analytical methods and equipment. It helps ensure the reliability of test results over time.

Quality Objectives:   Specific and measurable goals set by the laboratory to achieve and maintain the desired level of quality in its operations. Quality objectives support the organization's overall quality policy.

Quality Records:   Documents and data that provide evidence of the implementation, monitoring, and performance of the QMS. Quality records include, but are not limited to, calibration records, test results, and audit reports.

Quality Policy:  A statement of the organization's commitment to quality, outlining its overall intentions and direction for achieving and maintaining quality in its operations.

Quality Assurance (QA):  A set of planned and systematic activities implemented within the QMS to provide confidence that the laboratory will fulfill quality requirements.

Quality Manual:  A documented set of policies, procedures, and guidelines that define and describe the laboratory's QMS and its structure.

Records: Can be electronic or paper. Examples include chain of custody paperwork, sample results, worksheets, QA/QC data, audit results, calibration records, etc.

Reference Material: A material or substance with well-characterized properties, used as a standard or benchmark in laboratory analyses. Reference materials provide a basis for calibration, quality control, and validation of measurement methods. They are essential for ensuring the accuracy and reliability of test results by allowing laboratories to compare and verify their measurements against a known and established reference.

Reproducibility:   The degree of agreement between results obtained by different laboratories, analysts, or instruments when analyzing the same sample under the same conditions. Reproducibility is a measure of the method's robustness and reliability.

Risk Assessment: The systematic process of identifying, analyzing, and evaluating potential risks associated with laboratory activities. Risk assessment helps prioritize risk management strategies to minimize the likelihood of adverse events.

Root Cause Analysis:   A systematic process of identifying and addressing the underlying causes of problems or non-conformities, aiming to prevent their recurrence.

Sampling: The process of selecting and collecting representative portions of a material or substance for analysis, often crucial in ensuring the accuracy and reliability of test results.

Sampling Plan:  A structured approach to selecting samples for testing, outlining the procedures and criteria for collecting representative portions of materials.

Standard Operating Procedure (SOP): A document describing specified steps taken in a method. This method can be a specific analytical procedure or a policy controlling a more generic aspect of the work performed (e.g., training records, handling complaints, or using balances). SOPs may be paper or electronic but must be controlled and available at the point of use.

Test: A procedure for critical examination; a means of determining the presence, quality, or truth of something; a trial.

Traceability: The property of the result of a measurement whereby it can be related to stated references, usually international standards, through an unbroken chain of comparisons.

Trainee: A person receiving training in the workplace.

Trainer: A person who is trained and competent in a procedure and is training another.

Uncertainty Budget:  A detailed breakdown of the sources and magnitudes of uncertainties associated with a measurement process, helping to quantify and manage the overall measurement uncertainty.

Uncertainty Measurement:   The process of evaluating and quantifying the uncertainties associated with a measurement result. It involves considering factors such as instrumentation, method variability, and environmental conditions.

Validation: The robust process of demonstrating and documenting that a procedure is fit for purpose and establishing the limits of testing that may apply.

Verification: The process of confirming that specified requirements have been met through the examination of objective evidence, often applied to equipment, methods, or procedures.

Work Instruction:  A detailed set of step-by-step instructions that guide laboratory operators on how to perform a specific task or activity within the laboratory.