The following set of concepts groups laboratory management terminology into six thematic groups. Each concept should correspond to a screen, a space, or a relationship within a mature system.
1. Sample and Workflow
A sample is a substance delivered to a laboratory for analysis. It is recorded along with its source, time of collection, person who collected it, and storage conditions.
Sample Login: Registration of the sample in the system, assignment of a unique identifier and barcode, and determination of which analyses will be performed.
Aliquot: A subsample separated from the main sample. The relationship between the separated pieces and the main sample is maintained for different analyses.
Chain of Custody: A continuous record of who held the sample, where it was located, and under what conditions, from the moment it was collected until its destruction. It is mandatory for forensic and official analyses.
A witness/reference sample is a sample that is kept for a specific period as required by law and can be re-analyzed in case of dispute.
Sample Type Categories include raw materials, intermediate products, finished products, packaging, environmental, stability, complaints, and verification. It defines the workflow and required analyses.
A worklist is a set of analyses assigned to an analyst or instrument, with a defined sequence.
Turnaround Time : The time elapsed from sample acceptance to result confirmation. A key indicator of a laboratory's performance.
Priority/ Rush Samples: Samples that are awaiting production or are subject to customer commitment are moved to the front of the queue.
Sample Disposal: The disposal of samples whose storage period has expired, in accordance with waste regulations and in a properly recorded manner.
2. Method, Analysis and Results
Analysis Method (Test Method): A method that defines step-by-step how a parameter is measured. It can be a standard (TS, EN, ISO, ASTM, pharmacopoeia) or an internal method developed by the laboratory itself.
Method Validation : Proving that the method is suitable for its intended use: accuracy, precision, selectivity, linearity, detection and quantification limits, robustness.
Method Verification: Demonstrating that a standard method delivers the expected performance under the laboratory's own conditions.
A specification is a set of parameters and limits that a product or sample must meet. It serves as the reference for determining the conformity of the result.
Analysis Plan (Test Plan): A definition of which analyses will be applied to a specific sample type, in what order, and at what frequency.
Raw data is the unprocessed measurement data produced by the device. In audits, this data and the process of converting it to the final result are examined more than the final result itself.
Calculated Result: The final value derived from raw data using a formula. Having a system-defined and versioned formula eliminates manual calculation errors.
Limit of Detection/Quantitative Qualification (LOD/LOQ): The lowest concentration that the method can reliably detect and numerically measure.
Measurement Uncertainty: A numerical expression of the range within which a measurement result may vary. This is expected to be reported by accredited laboratories.
An Out-of-Specification (OOS) result is one that does not meet the acceptance criteria. This triggers a structured research process.
Out-of-Trend Result (OOT): A result that remains within the specification but deviates from past trends. It is an early indicator of a problem.
Retesting / Reanalysis: A second measurement taken according to specific rules. Unrecorded retesting is one of the most serious findings in audits.
3. Quality, Equipment and Resource Management
Calibration involves verifying the device's measurement against a traceable reference and adjusting it if necessary. The validity period is monitored in the system.
Qualification (IQ/OQ/PQ) is documentation demonstrating the device's suitability for its intended purpose in terms of installation, operation, and performance. It is mandatory in regulated sectors.
Metrological traceability refers to the ability to link a measurement result to a national or international standard through an uninterrupted comparison chain.
Reference Standard : Certified comparison agent of known purity. Traceable by lot, certificate, and expiry date.
Control Sample: A sample run within each batch whose result is known. It indicates that the analysis is under control on that day.
A control chart is a graph showing the trend of control sample results over time. It is used for the early detection of shifts and trends.
Proficiency Testing is an external quality assessment in which a laboratory is compared to other laboratories analyzing the same sample.
Personnel Competence: Demonstration, through training, observation, and record-keeping, that an analyst is competent in applying a particular methodology.
Consumable and Reagent Management: Tracking chemicals, solutions, and consumables by lot number, shelf life, opening date, and stock level.
Laboratory capacity is the ratio of equipment, analysts, and working hours to the demand for analysis. It identifies where the bottleneck is.
4. Data Integrity and Legislation
Data integrity means ensuring that data remains complete, consistent, and accurate throughout its lifecycle. It is a fundamental obligation for regulated laboratories.
ALCOA+ Data must possess the following qualities: attributable, legible, concurrent, original, accurate; also complete, consistent, persistent, and accessible.
An Audit Trail is an indelible record for each record detailing who changed what, when, from which old value to which new value, and why.
Electronic signatures are linked to individuals; they contain identity verification and a statement of purpose that have the same legal validity as a wet signature.
Computerized System Validation (CSV) is documented proof that software is suitable for its intended use. It is conducted using a risk-based approach.
Good Laboratory Practice (GLP) is a quality system for planning, conducting, and reporting safety-related studies.
Good Manufacturing Practices (GMP) are mandatory quality rules for the production and control of pharmaceuticals and similar products; laboratories are an integral part of this.
ISO/IEC 17025 is an international standard concerning the competence of testing and calibration laboratories. It forms the basis of accreditation.
Deviation and CAPA: Recording of deviations from expectations and implementing corrective and preventive actions.
Change Control refers to ensuring that changes to a method, device, specification, or system are made in an approved and traceable manner.
5. Chemical Safety and GHS
GHS is the United Nations' Globally Harmonized System for the Classification and Labelling of Chemicals. Also known as the "Purple Book," it is revised every two years.
Substance: A single chemical component and its unavoidable impurities. It is identified by its CAS and EC numbers.
A mixture is two or more substances that come together without reacting chemically. Many commercial products are mixtures.
Hazard Class: Type of physical, health, or environmental hazard: flammable liquid, skin corrosive, acute toxicity, harmful to aquatic life, etc.
Harm Category: The degree of severity within the class. Category 1 generally represents the most severe level.
Hazard Statement (H statement) : A standard textual description of the harm; for example, it causes skin irritation.
Precautionary Statement (P statement): Standard instructions regarding prevention, intervention, storage, and disposal.
The pictogram is a warning symbol inside a red-framed rhombus. It is assigned according to the pest class.
The signal word on the label is a "Danger" or "Caution" statement indicating the severity of the damage.
Cut-off Value / Concentration Limit: The minimum concentration at which a component begins to affect the classification of a mixture. This can be general or substance-specific.
Additivity Method: Calculating the harmfulness of a mixture by summing the concentrations and harmfulness contributions of its components.
Acute Toxicity Estimation (ATE) : Calculation of the acute toxicity of the mixture from the ATE values of the components using a formula.
The M factor is a multiplier that increases the weight of substances that are very harmful to the aquatic environment in the mixture calculation.
Bridging Principles are rules that allow classification derivation from data on similar mixtures even when the mixture itself has not been tested: dilution, production batch, concentration, interpolation, essentially similar mixtures and aerosols.
A Safety Data Sheet (SDS) is a standard document containing 16 entries about the hazards and safe use of a substance or mixture.
Exposure Scenario: A section added to the expanded safety data sheet that describes the conditions of use of the substance and risk management measures.
The Unique Formula Identifier (UFI) is a code linked to the composition of the mixture in poison control center notifications; it appears on the label.
6. Formulation and Product Development
A recipe is a description of which raw materials will be used, in what proportions, and through which process steps to produce a product.
Formulation is the process of combining the components in a recipe to produce the intended physical, chemical, and performance characteristics of the product.
Formulation Definition : The functional role of formula components: active ingredient, solvent, filler, preservative, emulsifier, pigment, additive. It allows for the identification of alternative substances performing the same function.
Theoretical Recipe (Ideal Recipe): A formula defined at the laboratory scale but not yet transferred to production.
Trial: Testing a prescription on a laboratory or pilot scale; recording and comparing the results.
Scale-up: Transferring the laboratory recipe to pilot and mass production scale.
Recipe Version: Each change to the formula is stored as a separate version; allowing tracking of which batch was produced with which version.
Recipe Cost: The unit cost derived from component prices. It is the commercial aspect of formulation decisions.
Alternative Raw Material : A substitute material that performs the same function. Used to compensate for supply disruptions, increased costs, or reduced harmful effects.
Specification Card: A document outlining the characteristics that a raw material or finished product must meet; a reference shared with both the supplier and the customer.