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Quality control is a critical element in laboratory monitoring that helps ensure product integrity and process accuracy. Without quality control procedures in the laboratory, there may be no means of determining whether a product or process meets regulatory standards.
Laboratories are often sensitive facilities that demand high regard for accuracy in all processes. For example, a medical lab may conduct tests on human samples to establish pathological anomalies to ultimately inform a doctor's prognosis for a patient. As such, it is of utmost importance that reagents used in the laboratory are of the right concentration and quantity.
The process itself necessitates documentation to prevent variations that may induce errors. Without proper quality control in the laboratory, the outputs may likely be erroneous. In a worse case scenario, misleading information may be provided to a doctor who may then prescribe a fatal medication to a patient. The same applies to pharmaceutical labs, where experts manufacture medicines and vaccines.
The nature of products used and produced in the labs often necessitates stringent control measures. There must be a quality control program to validate the accuracy of the production process and ensure it meets regulatory standards. The scope of quality control includes system and process efficiency. One can maximize a lab's productivity by having the means to control quality by minimizing waste.
The concept of quality control began in the early 20th century, where the first guidelines for statistical control were applied to production lines. Early on, quality control experts realized the fallacy of focusing only on the product and ignoring the process. The first proponents of quality control advocated for the inclusion of the process in all quality control procedures to achieve better outcomes. ELPRO solutions help enable companies to carry on that quality control tradition in laboratories worldwide.
In the 1950s, Levey and Jennings introduced quality control in the medical laboratory. At a basic level, the procedure involved multiple measurements on a single patient’s sample. Although the mean showed significant variations from patient to patient, the range offered a more reliable precise measurement. As time went on, quality control in the laboratory developed to become increasingly important. Modern methods provide more accurate results and offer sophisticated techniques for analysis and interpretation.
The Science of Quality Control in the Laboratory
In a broader sense, quality control is a means to ensure that the product quality remains the same or improves. It denotes the construction of control protocols to standardize production processes to achieve consistent quality outputs.
The laboratory's quality control seeks to streamline lab processes and set control measures to detect and rectify discrepancies. The end goal is to minimize errors, which consequently ensures improved results quality.
In that regard, quality control is a measure of precision. It determines how consistent a system is in producing accurate results under varying conditions.
Quality control processes in a laboratory are often conducted at the beginning of every shift as staff interchange. It is also essential to run quality checks after equipment undergoes service or calibration before putting it back into service. This helps determine accurate results before entrusting the equipment to patient use.
GxP-Compliant Calibration
Calibrated sensors ensure precise, reliable measurements. Find answers to basic questions about GxP-compliant calibration. Learn more in this practical guide.
Detailed analysis can help determine how close output is to an expected value. The precision value determines how consistently the instrument can reproduce the same value, for the same test sample, under the same test conditions.
Quality control and quality assurance are both part of quality management. However, they differ in purpose and application. Quality assurance puts in place mechanisms and systems to instill confidence in management and stakeholders that the output will fulfill all requirements. However, quality control has to do more with inspection, to determine compliance with quality requirements.
A few elements are mandatory for an excellent quality control system. The system must be easy to use and reproduce over many groups of control samples. It must also have minimal vial-to-vial variations. If not, these discrepancies will appear as systemic errors arising from the measurement system. Moreover, its stability should be dependable for extended periods and not susceptible to interferences in the short term.
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