Quality Control, Assurance, and Management Systems

• Quality Control (QC) focuses on operational techniques and activities to fulfill quality requirements.
• Quality Assurance (QA) covers systematic activities and planned measures to ensure product or service requirements are met.
• Quality Management System (QMS) is the overarching system encompassing QA and QC to maintain and improve quality.
• Compliance involves adhering to regulatory requirements, standards, and guidelines.
• Quality Management focuses on continuous improvement and customer satisfaction, exceeding mere compliance.
• A quality management system includes policies, processes, and procedures for planning and execution in an organization's core business area.
• Organization, customer service, facilities and safety, personnel, purchasing and inventory, and equipment are QMS essentials.
• Process Management, documents and records, information management, nonconformance management, assessments, and continual improvement are QMS essentials.
• A flow chart visually represents process steps, showing how activities flow into each other.
• Validation ensures new processes achieve desired outcomes consistently.
• Calibration, equipment maintenance, quality control samples, SOP adherence, and environment monitoring are laboratory process controls.
• A form is a document used to capture data.
• A record is a completed form containing data.
• Document control for procedures ensures accuracy, updates, and accessibility.
• Remedial action provides immediate fixes to stop non-conformities.
• Corrective action implements long-term measures to prevent recurrence.
• Auditing assesses compliance, effectiveness, and opportunities for improvement in a QMS.
• Customer feedback, audit results, performance data, employee suggestions, incident reports, and benchmarking are sources for process improvement.
• Problem identification, root cause analysis, solution development, implementation, and review are activities in a problem-solving process.

Key Terms

• Accreditation standards are criteria by accrediting bodies ensuring labs meet quality and competency requirements.
• Analytic activity is the phase where actual sample testing takes place.
• Compliance is adhering to laws, regulations, guidelines, and specifications relevant to lab operations.
• Continual improvement involves ongoing efforts to enhance processes, products, or services.
• Corrective action involves steps to eliminate the root cause of nonconformance to prevent recurrence.
• Document control manages and maintains documents for accuracy, accessibility, and consistency.
• A flow chart visually represents process steps, showing the sequence and relationship between tasks.
• Information management involves collecting, storing, and using data to ensure efficient and effective operations.
• An internal audit is an independent assessment to evaluate processes and compliance with standards.
• Management review is a periodic evaluation of the QMS by top management
• Nonconformance is a deviation from standards, procedures, or specifications.
• Opportunities for improvement are identified and addressed to enhance lab processes, products, or services.
• The path of workflow is the sequence of activities from test request to result reporting.
• Post-analytic activity occurs after testing, including result validation, reporting, and interpretation.
• Pre-analytic activity occurs before testing, including sample collection, handling, and preparation.
• A process is a series of actions or steps taken to achieve a particular outcome.
• A procedure is a detailed, written description of a specific process.
• Process control uses techniques and activities to ensure processes are performed within set parameters.
• Proficiency testing assesses the performance of testing processes by comparing results with other labs.
• Quality is the degree to which a product, service, or process meets requirements and expectations.
• Quality assurance ensures products or services meet requirements through planned activities.
• Quality control uses operational techniques and activities to monitor and control processes.
• Quality indicators are metrics used to measure the performance and effectiveness of processes.
• Quality management is the overall approach to managing and improving the quality of operations.
• A quality management system is the framework of policies, processes, and procedures ensuring quality.
• Quality system essentials are the key components of a QMS necessary for effective operations.
• Records provide evidence of activities performed and results achieved.
• Regulatory requirements are laws, regulations, and standards that labs must comply with.
• Remedial action involves immediate steps taken to correct a nonconformance.
• Validation confirms that a method, process, or system performs as intended.