Laboratory quality control and assurance (QC) is essential, especially in highly regulated industries such as food, cosmetics and pharmaceuticals. There are many definitions of quality, but in a lab setting it usually refers to the accuracy and reliability of results. Although inaccuracy is accepted to some extent, a strong quality management system will keep this 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 have disastrous consequences for organizations and their customers. Laboratory staff strive to meet quality and compliance standards to ensure that results are reliable and comply with regulations.
Here, we examine the importance of laboratory quality and discuss key factors that managers and staff should consider to ensure quality standards are met.
Lack of QC and assessment can have disastrous consequences for organizations and their customers.
The importance of laboratory quality
As noted by Ivan Krstic, PhD, Head of Chemistry Solutions at Elsevier, laboratory work underpins the entire R&D lifecycle and is critical to its evolution. He adds that labs need to ensure scientists are able to capture and store data accurately and efficiently, and easily access and share existing data. “Lab quality is the approach to ensuring that experiments and R&D conducted in a laboratory provide accurate, reproducible and reliable results, minimizing errors and eliminating duplication,” Krstic explains.
Anca Ciobanu, R&D Efficiency and Effectiveness Improvement Manager at Alliance Pistoia, says quality assurance (QA) in the lab is essential for several reasons. “Research organizations must first ensure that their results are verifiable and reproducible to advance and support their own projects,” she explains. “Second, QA is essential to meet the stringent requirements of regulatory and inspection bodies for a laboratory to be approved and accredited for research.”
Krstic adds that quality assurance is especially important in the drug development process, where it can take more than a decade from discovery to commercialization. “Organizations need to be confident in the quality of their lab work and results, otherwise they risk wasting 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 respect to quality”. ISO describes a framework for implementing a systematic and transparent quality management system designed to improve performance while meeting all organizational needs. Key principles involve understanding and responding to customer needs, establishing leadership aligned with organizational goals, and fully involving everyone in the organization. ISO also notes the importance of taking a process approach to quality management and basing decisions on data analysis.
Laboratory staff should be well equipped to ensure laboratory quality
Laboratory personnel are the central driving force for ensuring quality in the laboratory and must be trusted to maintain best practices and adhere to all protocols. Staff should be fully trained in all aspects of their respective roles so that they can discharge their responsibilities with confidence. Within the organization, QC must be built into the culture through process and structure, as well as often overlooked elements such as team morale and staff autonomy.
Laboratory quality is the approach to ensuring that experiments and R&D conducted in a laboratory provide accurate, reproducible and reliable results, minimizing errors and eliminating duplication.
Krstic emphasizes using a collaborative approach, noting that today’s research landscape is fragmented and dispersed. “To guarantee quality, laboratories must have integrated knowledge management. Many projects employ multiple internal and external lab partners (e.g. CRO, CMO), each of which can use their own electronic lab notebooks (ELNs) and save information in different file and data formats,” he says. This fragmentation leads to challenges, including difficulties in accessing, sharing and fully exploring the data.
Krstic advises that to ensure high-quality lab results, organizations should standardize data capture formats across their cheminformatics ecosystem and make them available through various software packages. “Chemoinformatics tools must integrate or have access to internal and external chemistry and bioactivity data, so that researchers do not have to consult multiple sources and platforms to obtain information to support their cases. of use. »
Ciobanu recommends that leadership teams also venture outside the organization to collaborate with other companies in the same industry. “A fundamental step in maintaining quality is good internal communication, but equally, organizations need to look outside their own lab to facilitate the sharing of best practices with companies facing similar challenges.” She reveals that the Pistoia Alliance promotes a non-competitive approach to establishing and maintaining laboratory quality, so that companies can create joint projects that improve quality in an industry. “Current initiatives address several different aspects, such as naming conventions, lab data enrichment, process management, consistent method description, and communication between instruments,” Ciobanu explains.
The role of the laboratory manager in quality assurance
Quality assurance can take different forms depending on the industry and the individual laboratory. “Labs can specialize in many different disciplines – chemistry, molecular biology, pharmacology, toxicology – to name 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 labs. The laboratory manager is usually 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 each 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 needs to 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 that all staff have adequate training on the laboratory’s SOPs and work instructions, that any deviations must be documented, and that corrective and preventive plans must be implemented.”
Krstic adds that it is the lab manager’s responsibility to select and apply the best tools to help meet quality standards. “There is technology today to make the job of the lab manager easier, to ensure that experimentation is less vulnerable to error and human error, and to 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 allow staff and managers to monitor and track key performance indicators and other data, ensuring compliance and providing insight into opportunities for improvement.