Just as the human body needs a skeletal structure to maintain its shape, a laboratory needs a set of guidelines that provide the framework for activities.
A Quality Management System (QMS) is a framework that is used to ensure that all activities performed by a laboratory meet or exceed customer and regulatory requirements and conform to the organization's policies and procedures. Developing this system can be challenging for laboratories because it requires them to transform their current operating methods and integrate quality into every aspect of their operation.
What is a QMS?
A QMS is a framework that provides the lab with a set of essential building blocks. These building blocks are well-defined objectives, standards, and procedures concerning quality management, such as employee training and education, calibration and maintenance of lab equipment, raw material or test sample handling, instrumentation and control processes, laboratory safety, and records management and reporting.
These building blocks are divided into two distinct areas:
- The quality assurance (QA) program is a set of planned activities within the product manufacturing process that ensure the product’s safety and quality. QA is the policies and procedures implemented before or during production that help prevent problems with the finished product.
- The quality control (QC) program is a systematic set of processes to ensure the product meets the required quality standards. QC means testing the processes involved in creating a product and testing the product itself to ensure the correct parameters are met. QC is a subset of QA.
The purpose of QA is to prevent any defects before they occur when manufacturing the product, while the purpose of QC is to verify the quality of the output. QA is a proactive activity, planned throughout the whole product development life cycle, looking to reduce the number of defects, while QC is a reactive activity, usually planned at the final stages when the output is produced. .
QA processes include SOPs, supplier management, training management, change control, project audits, documentation practices, and process checklists, while QC processes include testing processes, peer review, inspections, and product sampling.
A quality management system can be used in any organization where quality data needs to be generated or analyzed, including laboratories in R&D, product development, process control, QA/QC testing, clinical trials, production processes, and manufacturing lines.
What should be included in the QMS?
A QMS can be tailored to fit any lab's goals for quality. The program should be customized to fit your lab's needs, but the most common elements of a QMS include:
- Standard operating procedures (SOPs) involving the use of hazardous chemicals
- Criteria to implement control measures to reduce employee exposure to hazardous chemicals
- Requirements to ensure that control measures perform properly
- Employee training
- Medical consultation and examinations
- Designation of chemical hygiene officers
- Requirements for handling particularly hazardous chemicals
- Identification of designated areas (laboratories, storage rooms, and disposal areas
- Containment equipment
- Procedures for safe removal of contaminated waste
- Decontamination procedures
Why is QMS in laboratories important?
The US FDA requires laboratory Quality Management Systems for all laboratories performing regulated activities under the Good Laboratory Practice regulations. In addition to this regulation, other federal agencies have established similar requirements for their regulated laboratories. For example, the Environmental Protection Agency requires that environmental laboratories adopt a QMS that meets the minimum requirements of ISO 17025 (“General requirements for the competence of testing and calibration laboratories”).
A QMS is a way for a laboratory to show that it is dedicated to quality and conforms to regulatory requirements. As these policies and procedures are followed, they assure that the data generated by the lab is accurate and reliable.
Without a QMS to provide the necessary guidance for an effective management system, the laboratory is more likely to experience problems with consistency and accuracy. That can lead to costly re-testing by clients in addition to unhappy customers who have to deal with results they do not understand or trust. Without a QMS in place at the start of your operation, you run the risk of having to overhaul your entire operation later on.
How can a QMS be integrated into lab culture and practices?
For the laboratory, implementing a QMS means creating a culture of quality, which includes:
- Awareness: Your employees must be aware of the standards and expectations for them. You can't expect employees to be responsive to quality issues if they don't understand their expectations.
- Commitment: Quality must be built into your organization's culture at every level. It must come from the top-down and the bottom up. Top management must show commitment by setting the tone and providing the resources needed to accomplish goals. Employees at every level need to embrace quality as part of their job roles.
- Planning: A good plan is crucial to achieving quality objectives in the workplace. Laboratories need to develop a strategy for achieving quality objectives and creating plans for specific areas, such as training and equipment maintenance.
A good QMS should be developed with short-term and long-term goals. Management typically sets short-term goals, but long-term goals are more frequently determined by a quality committee or the laboratory director.
The quality committee should be composed of at least one representative from each department within the lab and a representative from management. The committee's primary function is to continually evaluate the state of your QMS and make sure it is on track to fulfill its objectives. Committee members should meet at least once every two weeks and discuss everything from new policies to the training needs of each staff member.
The quality management system is an easy way for the lab to ensure control over all of its processes. A QMS requires a lot of data, so many labs need to adjust record-keeping and data analysis. This can be disruptive to lab processes, but impacts such as these typically only last for the first year. All of the improvements soon outweigh the disruption QMS brings.
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