A laboratory is a critical part of industries such as medical technologies, pharmaceuticals, etc., and is regulated by various standards and regulations to ensure the quality of its operations. Standards and regulations such as ISO 15189:2022, ISO 17025:2017, and FDA 42 CFR Part 493 provide guidelines for the implementation of a Laboratory Quality Management System (LQMS) to manage the quality of laboratories. It covers the policies, procedures, and practices that a laboratory employs to manage laboratory processes such as:
- Calibration
- Testing
- Documentation
- Quality control
- Personnel competency
Broadly, these cover ensuring the equipment accuracy in performing the tests, safe handling of samples, validating and verifying the methodology, quality control and assurance, ensuring personnel competency through assessments and training, documentation, and customer satisfaction.
Given the complexity of laboratory operations, manual management of laboratory quality can be challenging. A cloud-based laboratory quality management system helps automate workflows, provide visibility and traceability, enable risk management, change control, CAPA management, and ensure compliance.
It empowers employees, managers, and quality leaders with data and tools that help with proactive risk identification, monitoring and tracking the effectiveness of processes and mitigation strategies in controlling risks, improving resource efficiency, and ensuring the quality of outcomes. This helps lower the cost of lab operations, improve customer satisfaction, and enhance brand reputation.
8 Key Elements of Integrating Quality Management Principles in Laboratory Practices
By implementing a cloud-based Quality Management System such as ComplianceQuest, built on Salesforce, laboratories can improve operational efficiency, manage risks better, and reduce potential errors. Some of the key elements that can enable this include:
- Equipment Calibration and Maintenance: Laboratory equipment plays a key role in providing accurate readings that enable the developing products that deliver on the promise. Therefore, keeping them calibrated and having a regular maintenance schedule is important. Planned downtime also minimizes disruptions due to failure, causing production schedules to be delayed. An automated calibration solution helps with preventive maintenance that can improve the quality of the outcomes.
- Auditing and Inspections: Periodic audits and inspections can help identify potential risks through timely interventions in case any deviations or noncompliance are detected in operations. This is also important for demonstrating compliance to regulatory bodies in highly regulated industries. Automating the scheduling, reporting of findings, and follow-up action becomes simpler with a quality management solution.
- Documentation: This is a critical aspect of compliance requirements as it demonstrates the alignment of the operations with the internal and external standards. Policies and procedures are also important documents that need to clearly delineate the organization’s quality management systems, procedures and processes and be shared with all employees to enable them to understand their roles and responsibilities. A centralized system helps all stakeholders with authorization to access these documents and ensure compliance.
- Training: Given the sensitive nature of the inputs used in a laboratory, safe handling to prevent spillage and contamination is critical. Lab personnel must be given periodic training to constantly upgrade their skills and align with evolving regulatory requirements. The organization must also ensure that only trained personnel handle these chemicals or biological materials. A training management system ensures that all staff receive relevant training periodically to become competent.
- Supplier: The quality of the raw material also plays an important role in the quality of the final product. The storage and transportation of raw materials also play an important role in ensuring the purity and integrity of the material. Therefore, choosing the right suppliers and periodically conducting supplier audits becomes important to ensure quality.
- Management Review: All the data can be converted to valuable insights for strategy planning and implementation, continuous improvement of processes and the quality management system, and informed decision-making. A cloud-based solution such as ComplianceQuest provides a unified view of the laboratory operations to ensure compliance and efficiency. Any non-compliance needs to be addressed quickly. Root cause analysis must be performed to understand the real cause for any issues. If required, CAPA must be initiated to take corrective and preventive action.
- Risk Management: All regulatory bodies recommend a risk-based approach to quality management and creating a quality culture. A cloud-based solution helps laboratories identify risks, rank them based on frequency and severity, and address high-ranked risks through proper mitigation strategies to eliminate or reduce the impact.
- Monitoring and Tracking: A quality management system is only as good as it is effective. To measure effectiveness, identifying KPIs and having quantifiable measures is critical. These KPIs must be tracked, and corrective action must be taken in case of deviations or errors. An integrated quality management system enables tracking and measuring KPIs for continuous improvement.
Furthermore, the Compliancequest solution is scalable and flexible and integrates with other enterprise systems, providing an enterprise-wide view of processes for end-to-end integration of all operations. Laboratories can also use a plan-do-check-act approach to implementing changes for greater efficiency. It allows the integration of quality management principles in everyday laboratory practices to improve the efficiency, effectiveness, and productivity of resources.
The ComplianceQuest solution delivers on the core quality promise, delivering customer satisfaction by making them core to the design and development process. It facilitates customer success, driving the manufacturing company’s end-to-end quality and compliance needs across all processes at all times. Further, it enables data-driven business decision-making, using data as the core of the quality process, making it easy to drive insights from quality data.
To know more, visit www.compliancequest.com.
