Quality Assurance (QA) is a framework aimed at ensuring the quality of products or services through planned and systematic approaches. Laboratory Quality Assurance (QA) includes the implementation of procedures within a laboratory to ensure the accuracy, reliability, and validity of laboratory test results.
Laboratory QA encompasses standard operating procedures, regular audits, and continuous improvement practices. Quality assurance in laboratories is important for ensuring the quality, accuracy, and reliability of test results, which are critical for informed decision-making in medical, environmental, and scientific fields.
The key components of a laboratory QA include Internal Quality Control (IQC), External Quality Assessment (EQA), and Total Quality Management (TQM).
To conduct QA activities systematically, laboratories implement what is generally referred to as a QA system. A QA system is a system designed to ensure that a product or service consistently meets predefined quality standards and customer and regulatory requirements.
Laboratory QA system’s main processes include document control and records management, change control, training and competency management, equipment calibration and maintenance, audit and inspection management, and others.
It is important to differentiate QA from Quality Control (QC), as they represent different aspects of ensuring and maintaining product or service quality. The main differences between QA and QC lie in their focus and objectives. QA is implemented to ensure product or service quality. QC is conducted to test and control the presence of quality on products or services.
Quality Management System (QMS) software streamlines and automates laboratory QA system processes.
SimplerQMS provides QMS software solutions designed for Life Science companies, including laboratories. Book a personalized demo to learn how SimplerQMS can streamline QA system processes in the laboratory.
This article covers the following topics in more detail:
- What Is Quality Assurance (QA) in the Laboratory?
- Why Is Quality Assurance Important in Laboratories?
- What Are the Key Components of the Laboratory Quality Assurance Framework?
- What Are the Processes of a Laboratory Quality Assurance System?
- What Is the Difference Between Quality Assurance and Quality Control in the Laboratory?
- What Is the Role of QMS Software in Supporting Laboratory QA System Processes?
What Is Quality Assurance (QA) in the Laboratory?
Quality assurance (QA) in the laboratory is the framework supported by systematic approaches that ensure the quality, accuracy, reliability, and validity of laboratory testing processes, results, and overall operations.
Laboratory QA encompasses standard operating procedures, regular audits, and continuous improvement practices. Effective clinical and medical laboratory QA practices help identify and remove errors, maintain compliance with requirements, and improve the credibility of laboratory data.
A quality assurance system is a system for handling relevant processes aimed at ensuring that products and services meet predefined quality standards and comply with customer and regulatory requirements.
QA in the laboratory is part of the quality management system, based on processes such as document control and records management, equipment calibration and maintenance, audit and inspection management, and management of suppliers, among others.
Why Is Quality Assurance Important in Laboratories?
Quality assurance is essential for helping informed decision-making in medical, environmental, and scientific fields by ensuring the accuracy, reliability, and consistency of test results.
The purpose of QA in the laboratory is to ensure that laboratories deliver uniform and high-quality test results, ensure patient safety directly or indirectly, and comply with customer and regulatory requirements.
What Are the Key Components of the Laboratory Quality Assurance Framework?
The three key components of the laboratory quality assurance framework are Internal Quality Control, External Quality Assessment, and Total Quality Management.
- Internal Quality Control (IQC): IQC involves procedures and controls within a laboratory to ensure result accuracy and consistency.
- External Quality Assessment (EQA): EQA involves external evaluation comparing a laboratory’s performance with other laboratories and standards.
- Total Quality Management (TQM): TQM is a management approach involving all members to continuously improve quality and meet customer expectations.
Internal Quality Control (IQC)
Internal Quality Control (IQC) involves the routine monitoring and verification of testing processes within the laboratory to ensure the reliability and accuracy of results. IQC involves using control charts, standard reference materials, control samples, and statistical analysis software.
The purpose of IQC is to detect and correct errors or deviations in testing procedures promptly, ensuring the quality and consistency of laboratory results.
For example, in a clinical laboratory conducting blood tests, IQC involves running known control samples alongside patient samples to verify the accuracy of the test results. Deviations from expected values trigger investigations and corrective actions.
External Quality Assessment (EQA)
External Quality Assessment (EQA) involves laboratories participating in external proficiency testing programs or inter-laboratory comparison studies to assess the accuracy and reliability of their testing methods. EQA encompasses proficiency testing materials, reference laboratories, and statistical analysis software.
EQA benchmarks a laboratory’s performance against other laboratories and requirements, ensuring the reliability and comparability of results across different facilities.
For instance, a medical laboratory participating in an EQA program for cholesterol testing receives blind samples from an external provider. The laboratory then analyses these samples and compares their results with the expected values provided by the EQA scheme.
Total Quality Management (TQM)
Total Quality Management (TQM) is a comprehensive management approach that focuses on continuous improvement in all aspects of laboratory operations.
TQM promotes the improvement of product and service quality and safety. TQM includes employee training programs, customer feedback mechanisms, process mapping tools, performance metrics, and more.
For example, TQM initiatives in a laboratory may involve regular employee training on quality requirements, conducting internal audits to identify areas for improvement, and implementing process optimization to increase efficiency and accuracy.
What Are the Processes of a Laboratory Quality Assurance System?
A laboratory quality assurance system comprises nine primary processes, as described below.
- Document Control and Records Management: Processes to ensure the accuracy, accessibility, and integrity of laboratory documents and records.
- Change Control: A systematic approach to manage and document changes to procedures, equipment, and processes.
- Training and Competency Management: Processes to ensure laboratory staff are adequately trained and competent to perform their tasks.
- SOP Management: The process for the development, approval, and maintenance of Standard Operating Procedures (SOP) to ensure consistent laboratory practices.
- Equipment Calibration and Maintenance: Systematic approaches to regular calibration and maintenance of laboratory equipment to ensure accuracy and reliability.
- Audit and Inspection Management: Processes to manage audits and inspections to ensure compliance with regulatory and customer requirements.
- Supplier Management: Process to evaluate and monitor suppliers to ensure the quality and reliability of materials and services.
- Deviation Management and Nonconformance Management: The process of identification and management of deviations and nonconformances from quality standards to prevent recurrence.
- CAPA Management: The process of implementing Corrective and Preventive Actions (CAPA) to address and prevent issues affecting quality.
Laboratory QA processes are integral parts of the laboratory quality management system.
A Laboratory QMS refers to a set of policies, processes, and procedures implemented in a laboratory to ensure consistent quality and accuracy in its operations. Laboratory QA activities ensure that specific quality tasks are performed effectively.
The following sections further explain each laboratory QA system process and provide examples of how SimplerQMS software streamlines each process.
Document Control and Records Management
Document control and records management involves the systematic management of laboratory documents and records, ensuring their accuracy, accessibility, and compliance with relevant requirements.
In a laboratory setting, accurate documentation is essential for maintaining traceability, ensuring compliance with regulatory requirements, and facilitating effective decision-making. Document control ensures that procedures, protocols, and data records are up-to-date, accessible to authorized employees, and properly controlled.
SimplerQMS software offers document management capabilities to help streamline document control and records management processes by facilitating document creation, review, approval, storage, and distribution. SimplerQMS provides features for version control, electronic signatures, and audit trails, ensuring compliance with regulatory requirements and improving document traceability and accessibility.
Change Control
Change control is the process of managing and documenting changes to QA documents, products, procedures, work instructions, and processes within the laboratory to ensure changes are implemented effectively and without introducing additional risk.
Effective change control helps mitigate the risks associated with changes by ensuring that changes are properly evaluated, documented, communicated, and implemented.
QMS software, like SimplerQMS, provides predefined workflows for initiating, reviewing, approving, and implementing changes. SimplerQMS change management module automatically creates records of changes within time-stamped audit trails and informs relevant employees of change control-related tasks through notifications and reminders.
Training and Competency Management
Training and competency management involves assessing, documenting, and tracking employees’ training and competencies. Training and competence management ensures that employees are adequately qualified and proficient to perform their tasks within the laboratory.
Proper training and competency management are essential for ensuring the accuracy, reliability, and consistency of laboratory testing processes and results. Well-trained and competent employees are better equipped to perform their duties effectively, mitigate errors, and support compliance.
SimplerQMS simplifies the creation and management of training plans, quiz assignments, competency assessments, and training records for laboratory personnel. The SimplerQMS training management module tracks training completion and certification statuses. SimplerQMS provides reminders for upcoming training assignments, ensuring that employees remain qualified and competent in their roles.
SOP Management
Standard Operating Procedure (SOP) management involves creating, reviewing, approving, distributing, and updating SOPs to ensure the consistent and accurate execution of laboratory processes and protocols.
SOPs provide high-level guidelines for a process, ensuring that all employees follow the same procedures to maintain consistency, accuracy, and reliability in test results. Proper SOP management helps minimize errors, support compliance, and improve overall laboratory efficiency and quality.
QMS software facilitates the entire lifecycle of SOPs, from creation and approval to distribution and periodic review. SimplerQMS includes features for drafting and editing SOPs using Microsoft Office Word, tracking document versions, ensuring controlled distribution and controlled printing, and providing easy access to the latest versions of SOPs.
Equipment Calibration and Maintenance
Equipment calibration and maintenance involves the systematic scheduling, execution, and documentation of calibration and maintenance activities for laboratory equipment. Equipment calibration and maintenance ensure equipment accuracy, reliability, and proper functioning.
In a laboratory, accurate and reliable equipment is essential for producing trustworthy test results. Proper equipment calibration and maintenance help minimize measurement errors, ensure consistency in test results, prolong the lifespan of expensive laboratory instruments, and ensure compliance with requirements.
SimplerQMS streamlines equipment calibration and maintenance processes by providing tools for scheduling, tracking, and documenting calibration and maintenance activities. The SimplerQMS equipment management module simplifies identifying quality critical equipment, setting up calibration schedules, recording calibration results, tracking equipment history, and managing equipment inventory.
Audit and Inspection Management
Audit and inspection management involves planning, executing, and documenting internal and external audits, supplier audits, and inspections to assess compliance with regulatory and customer requirements.
Audits and inspections help ensure that laboratory operations follow established procedures, identify areas for improvement, and verify the effectiveness of quality management systems. Proper audit and inspection management help identify and address issues, mitigate risks, and maintain confidence in laboratory operations.
SimplerQMS audit management module provides tools for planning, scheduling, conducting, and documenting audits and inspections. The system facilitates creating audit checklists, assigning audit tasks, and documenting audit findings. SimplerQMS integrates QMS modules to simplify relating audit findings to products, equipment, and persons, as well as escalating audit findings to the CAPA process.
Supplier Management
Supplier management is the process of evaluating, selecting, monitoring, and assessing the performance of suppliers. Supplier management ensures the uniform and high quality and reliability of services, materials, reagents, and equipment acquired for laboratory operations.
Effective supplier management helps ensure that suppliers deliver products and services on time, maintain consistency in product quality, and comply with requirements.
Electronic QMS software, such as SimplerQMS, streamlines the purchasing and inventory processes by providing tools for supplier qualification and approval and managing supplier-related documentation.
SimplerQMS supplier management module helps laboratories maintain a reliable approved suppliers list (ASL), identify quality-critical suppliers, and automatically send reminders and notifications regarding supplier-related assignments as scheduled.
Deviation Management and Nonconformance Management
Deviation and nonconformance management involve identifying, documenting, investigating, and resolving deviations and nonconformances from established laboratory procedures or customer and regulatory requirements.
A well-structured deviation or nonconformance management process helps companies identify the root causes of issues and prevent potential problems in product or service quality.
SimplerQMS deviation management and nonconformance management modules offer predefined workflows for documenting, reviewing, investigating, and closing issues. The QMS software integrates with other QMS processes, such as corrective and preventive actions (CAPA), to ensure comprehensive issue resolution.
CAPA Management
CAPA management is the systematic process of identifying, investigating, and addressing issues. Effective CAPA management process helps prevent recurring deviations and nonconformances, ensuring continuous improvement and compliance.
Effective CAPA management helps laboratories identify, address, and prevent the recurrence of issues related to quality.
SimplerQMS CAPA management module provides tools for initiating CAPA directly from any recorded issue (deviation, complaint, audit finding), creating and implementing corrective and preventive actions, tracking CAPA progress, and assessing CAPA effectiveness.
What Is the Difference Between Quality Assurance and Quality Control in the Laboratory?
The differences between Quality Assurance (QA) and Quality Control (QC) lie in their focus and objectives. QA encompasses processes and systems to ensure consistent quality throughout operations, while QC involves activities that verify the quality of specific products or services.
QA in a laboratory involves implementing and maintaining processes to ensure that reliable and accurate results are consistently achieved. For example, QA in a laboratory involves validating analytical methods, calibrating equipment, and maintaining robust document control.
QC in a laboratory encompasses the operational techniques and activities used to verify the quality of products and services. For instance, QC in a laboratory involves running quality control samples alongside patient samples to ensure the accuracy and precision of test results.
Quality assurance and quality control are integral components of the overall quality management system, as illustrated in the image below.
What Is a Laboratory Quality Control (QC) System?
A laboratory quality control system is a system designed to monitor, assess, and ensure the reliability, accuracy, and validity of test results. The laboratory quality control system involves a set of procedures designed to monitor and maintain the quality of analytical procedures, instruments, and personnel performance.
Laboratory QC system includes using reference materials, proficiency testing, and instrument calibration, among others. A laboratory QC system aims to identify and correct errors, ensure the consistency of test results, and maintain the overall quality and reliability of laboratory testing processes.
What Is the Role of QMS Software in Supporting Laboratory QA System Processes?
QMS software supports the laboratory QA system processes by automating documentation and streamlining workflows.
The laboratory QMS software solution improves overall efficiency and accuracy in quality assurance processes. QMS software helps ensure compliance with regulatory and customer requirements.
SimplerQMS offers an eQMS solution designed for the Life Science industry, including medical and clinical laboratories. SimplerQMS supports laboratories in achieving operational excellence, ensuring safe and effective products and services, and complying with relevant requirements.
SimplerQMS provides features and capabilities designed for managing QMS processes, including document control, change control, training management, equipment management, audit management, supplier management, and CAPA management.
SimlperQMS offers comprehensive QMS process support, helping companies comply with Life Science requirements, such as ISO 15189:2022, ISO 17025:2017, GxP, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, MDR, IVDR, EU Annex 11, and others.
SimplerQMS is fully validated according to ISPE GAMP 5 guidelines. Our QMS software undergoes ongoing validation whenever new versions or updates are implemented, preserving its validated status.
Learn more about how the SimplerQMS solution can streamline quality assurance processes. Book a demo and talk with our Quality Solution Consultants experts to better understand how SimplerQMS can support your laboratory operations.