Laboratory quality control (QC) and assurance are critical, particularly in highly regulated industries such as food, cosmetics, and pharmaceuticals. There are many definitions of quality, but in a laboratory setting, it generally refers to the accuracy and reliability of results. While inaccuracy is accepted to an extent, a strong quality management system will keep that level to a minimum.
Quality and compliance go hand in hand and can form the backbone of an organization's viability. Lack of QC and assessment can lead to dire consequences for organizations and their customers. Lab staff strive to meet quality and compliance standards to ensure outputs are reliable and conform to regulations.
Here, we examine the importance of lab quality and discuss the key factors managers and staff need to take into account to ensure quality standards are upheld.
The importance of lab quality
As noted by Ivan Krstic, PhD, head of Chemistry Solutions at Elsevier, lab work underpins all of the R&D life cycle and is vital to its progress. He adds that labs need to ensure scientists are able to capture and store data accurately and efficiently, and access and share existing data easily. “Lab quality is the approach to ensuring experiments and R&D conducted in a lab deliver accurate, reproducible, and reliable results, minimizing errors and removing duplicates,” explains Krstic.
Anca Ciobanu, Improving the Efficiency and Effectiveness of R&D lead at the Pistoia Alliance, asserts that quality assurance (QA) in the lab is critical for several reasons. “Research organizations firstly need to ensure their output is verifiable and reproducible to advance and support their own projects,” she explains. “Secondly, QA is essential to satisfy strict requirements from regulatory and inspection bodies so that a lab is approved and accredited for research.”
Krstic adds that QA is particularly important in the drug development process where it can take over a decade from discovery to market. “Organizations must be confident in the quality of their lab work and results, or risk losing many years of effort.”
The International Organization for Standardization (ISO) defines a quality management system (QMS) as “coordinated activities to direct and control an organization with regard to quality.” ISO outlines a framework for implementing a systematic and transparent QMS that’s designed to improve performance while addressing all organizational needs. Key principles involve understanding and meeting customer needs, establishing leadership aligned with the organization's objectives, and fully involving all members of the organization. ISO also notes the importance of taking a process approach to quality management and basing decisions on data analysis.
Lab staff must be well-equipped to ensure lab quality
Lab staff are the central driving force in ensuring quality in the laboratory and must be trusted to uphold best practices and adhere to all protocols. Staff should be fully trained in all aspects of their respective roles so that they can confidently fulfill their responsibilities. Within the organization, QC must be embedded into the culture through process and structure, as well as often overlooked components such as team morale and staff autonomy.
Krstic places emphasis on using a collaborative approach, noting that the research landscape of today is fragmented and dispersed. “To ensure quality, labs need to have integrated knowledge management. Many projects employ multiple internal and external laboratory partners (e.g., CRO, CMO), each of which may use their own electronic lab notebooks (ELNs) and record information in different file and data formats,” he says. This fragmentation prompts challenges, including difficulty in accessing, sharing, and fully exploring data.
Krstic advises that to ensure high quality lab results, organizations should standardize data capture formats throughout their cheminformatics ecosystem and make them available via various software packages. “Cheminformatics tools should integrate, or have access to, internal and external chemical and bioactivity data, so that researchers don’t have to go to multiple sources and platforms for information to support their use cases.”
Ciobanu recommends that leadership teams also venture outside of the organization to collaborate with other companies in the same industry. “A fundamental step in maintaining quality is good communication internally, but equally, organizations should look outside of their own lab to facilitate sharing best practices with companies facing similar challenges.” She reveals that the Pistoia Alliance fosters a non-competitive approach to establishing and maintaining lab quality, so companies can create common projects that improve quality across an industry. “Current initiatives look at several different aspects, such as naming conventions, enriching lab data, management of processes, consistent methods description, and communication between instrumentation,” says Ciobanu.
The lab manager’s role in quality assurance
QA can take on different forms depending on the industry and individual lab. “Labs can specialize in many different disciplines—chemistry, molecular biology, pharmacology, toxicology—to name just a few,” says Ciobanu. “Within each, there is a different understanding of how quality is implemented and what it should look like.”
But there are similarities within QA that span most types of laboratories. The lab manager is typically responsible for developing and overseeing a strict quality assurance program that enables laboratories to maintain high levels of accuracy at all times. This includes establishing standard operating procedures (SOPs) for every process, defining administrative requirements such as record keeping and audits, and specifying corrective actions when problems are identified.
Ciobanu explains that the manager responsible for QA must be confident that the lab meets its specific quality standards, not just on paper but in practice, and a key factor in this is proper training. “They must ensure all personnel have adequate training on the lab’s SOPs and work instructions, any deviations must be documented, and corrective and preventive plans should be implemented.”
Krstic adds that it is the responsibility of the lab manager to select and apply the best tools to help meet quality standards. “There is technology today to make the lab manager’s job easier, ensure that experimentation is less vulnerable to mistakes and human error, and maximize the value and accessibility of data.”
Indeed, many laboratory information management systems and other specialized software offer built-in quality and compliance features. These tools enable staff and managers to monitor and track KPIs and other data, ensuring compliance and providing insight into opportunities for improvement.