Quality Control and Assurance in Health Care by Dr. Adam Silumbwe - Health Sciences_unza

Quality Control and Assurance in Health Care Dr. Adam Silumbwe What is quality control Process by which entities review the quality of all factors involved in production ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records Competence, such as knowledge, skills, experience, and qualifications Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed) Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints Method to address quality control issues Analytical quality control (AQC) : those processes and procedures designed to ensure that the results of laboratory analysis are consistent, comparable, accurate and within specified limits of precision. Constituents submitted to the analytical laboratory must be accurately described to avoid faulty interpretations, approximations, or incorrect results Initial control of the complete system can be achieved through specification of laboratory services, instrumentation, glassware, reagents, solvents, and gases systematic daily checks such as analyzing blanks, calibration standards, quality control check samples, and references must be performed to establish the reproducibility of the data Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a particular purpose. Common validation characteristics include accuracy, precision (repeatability), specificity, detection limit, quantitation limit, linearity, range, and robustness Because of the complex inter-relationship between analytical method, sample concentration, limits of detection and method precision The management of AQC is undertaken using a statistical approach to determine whether the results obtained lie within an acceptable statistical envelope Quality Assurance A way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers Part of quality management focused on providing confidence that quality requirements will be fulfilled This defect prevention in quality assurance differs subtly from defect detection and rejection in quality control and has been referred to as a shift left since it focuses on quality earlier in the process The terms "quality assurance" and "quality control" are often used interchangeably to refer to ways of ensuring the quality of a service or product For instance, the term "assurance" is often used as follows: Implementation of inspection and structured testing as a measure of quality assurance in a television set software project at Philips Semiconductors is described The term "control", however, is used to describe the fifth phase of the Define, Measure, Analyze, Improve, Control (DMAIC) model Quality assurance comprises administrative and procedural activities implemented in a quality system so that requirements and goals for a product, service or activity will be fulfilled. It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention This can be contrasted with quality control, which is focused on process output Principles of Quality Assurance Quality assurance includes two principles: Fit for purpose" (the product should be suitable for the intended purpose Right first time" (mistakes should be eliminated) QA includes management of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes Approaches to Quality Assurance Failure testing: In mechanical terms this is the operation of a product until it fails, often under stresses such as increasing vibration, temperature, and humidity Statistical control: Many organizations use statistical process control as a tool in any quality improvement effort to track quality data. Product quality data is statistically charted to distinguish between common cause variation or special cause variation Total quality management: The quality of products is dependent upon that of the participating constituents, some of which are sustainable and effectively controlled while others are not. The process(es) which are managed with QA pertain to Total quality management Models and standards: International standard that …