In the rush to provide services and products, the Quality Assurance department can often go overlooked despite its fundamental importance to the overall success of any organization.
Particularly when it comes to medical and science-based services, a properly functioning QA team can provide critical feedback and problem-solving that can ensure a client has a positive experience and feels they received the level of expected quality. Here’s an overview of why spending some time and money on a great QA team is more than worth it in the long run.
Scrutinizing lab policies and procedures
Like with many fields, laboratories put together procedures designed to ensure that the process creates a very high level of quality. However, no matter how good these policies might appear on paper or in meetings, you won’t fully know how successful they are until there is a thorough and objective review. That’s where the Quality Assurance department comes into play. Instead of gauging how procedure is intended to work, a good QA team assesses how the established procedure is working in a real-world setting, which can provide invaluable insight into everyday operations.
With a competent QA department backing up lab technicians, every service can be independently verified and the organization can maintain confidence that procedures are being followed and are working as expected. Appropriate quality assurance will also help an organization determine whether the staff is performing up to its ability and providing further insight into how the organization is functioning as a whole. The importance of a QA team isn’t to mirror the intentions of a lab but to provide an objective overview that can guarantee that everything (and everyone) is working correctly.
Correcting small issues before they turn into major problems
According to the Code of Federal Regulations, every lab “must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process.” Perhaps more than anything, rigorous QA can help a lab avoid significant trouble down the road, especially in case of an FDA audit that can overwhelm an inferior QA team.
Even well trained and highly qualified lab technicians are capable of error, which can be problematic for any lab built upon providing accuracy and results that can be duplicated.
While the first goal of any lab is to provide the highest possible quality to the client, a small issue that goes uncorrected by QA can fester into a much bigger problem when it comes to FDA oversight. However, with the correct internal oversight, a lab can avoid both minor and major citations as well as the need to respond to a Form 483.
In many ways, a lab is only as strong as its system of documentation, as it’s an essential component of being able to authenticate results down the road. This is why it’s important for QA to follow-up and ensure that standard procedures are being followed for each and every study. If there is any change from standard procedure, it’s also important for this to be documented and explained thoroughly, as failing to do so can be very problematic in the future. Even though most scientists don’t get into their field to be expert record keepers, the QA department is tasked with making sure that every test and service provided can be verified thanks to appropriate records.
For information about our full range of laboratory services, from histology and pathology to specimen storage at a state-of-the-art facility, please contact our experienced professionals at HSRL with any questions or comments.