When it comes to a variety of products and services, quality is often defined by the consumer. While certain criteria might be established, quality is frequently interpreted by each customer. In a laboratory setting, quality is defined by compliance with specifications. Rather than being determined by each consumer, quality is measurable in laboratories.
Mass Production and Quality Control
During the days when goods were produced by individuals, quality was in the eye of the beholder. Mass production lead to the creation of quality control standards. Evaluations were continually performed to ensure the goods were consistent and viable. As laboratories were developed and evolved, they transformed from a place where one or two people experimented to huge facilities that did everything from testing to production and more.
The Establishment of Quality Management
Quality is specifically important in a laboratory to ensure the highest level of accuracy and safety. Quality management is an organizational approach to developing a quality policy beyond quality assurance and quality control. A wide variety of factors is considered and measured. Equipment must be managed, ranging from overhead laboratory stirrers to sanitary strainers and more. Supplies are evaluated, from software to chemicals used for laboratory protocols. Management of capital is a considering as well as ongoing compliance training and achieving optimum customer service.
Accuracy is Imperative
The goal is to ensure the final laboratory results are correct and accurate. Systematic activities encourage the highest level of accuracy during testing. The management team at a laboratory must verify standard operating procedures and documentation are key components of their quality assurance programs. A laboratory is a controlled environment where accurate documentation is a requirement as well as an analytical method for further validation. Testing results must be verified and medical personnel validated.
The Audit as a Tool
Audits are a tool used to verify compliance and maintain a quality system that works all the time. Audits can also show where improvements can be made, ranging from personnel performance to laboratory processes. The audit results include preventative actions that can be taking as well as corrective ones to continually improve the quality system. The three major items addressed by a quality assurance program include proficiency testing, uncertainty, and traceability. Performance can also be measured by accreditation and measured against the International Organization for Standardization, which was created in 1947 to address quality measurement issues. These quality standards are now recognized in a variety of industries people depend on each day, including testing laboratories, the food and beverage industry, and the pharmaceutical industry.
Another way of boosting productivity and ensuring greater accuracy is the integration of cutting edge robotics for microplate handling related to ELISA testing and other common functions. Quality goes beyond what consumers can see in these industries which make quality assurance and compliance essential for greater peace of mind.