How to Deliver the Elements of a Lab Quality Management System

All labs need to deliver correct scientific output. Scientists are heavily motivated to learn and share the results from their experiments in the lab. The best way to enable a systematic and robust process ensuring that the lab meets these quality requirements is to implement some type of quality management system (QMS). The American Society of Quality (ASQ) defines a QMS as “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.” There are many different approaches to a QMS. Depending on the type of lab and the needs of the broader organization, anything from an internally developed system to a formally accredited and audited standard-based system can deliver the appropriate level of quality. Independent of the system chosen, it is vital for the lab manager to be fully committed to the chosen quality process and integrate the elements of the quality system into the culture of the lab.

Key Benefits of a QMS

The QMS is much more than a set of documents and procedures. A properly functioning QMS provides significant benefits to the lab, along with its lab staff, stakeholders, and customers. 

Stakeholder Needs—The primary benefit is building trust with the lab’s stakeholders. This is accomplished through a combination of delivering accurate results that address the needs of the stakeholders. An important part of the QMS is ensuring that there is a process to listen to, understand, and document the stakeholder needs. The trust developed with stakeholders is crucial to the ongoing support of the lab.

The QMS also provides a structure to address stakeholder complaints and disappointment. By following some form of corrective action/preventive action (CAPA) process, issues with stakeholders can be effectively addressed, and the lab will learn and improve from taking these actions. Sometimes the strongest stakeholder relationships come from the way that problems are addressed and resolved.

Organizational Needs—The QMS also serves to align the lab with the broader quality strategy of the organization. This ensures that the lab’s approach to quality is consistent with the expectations of senior management, the culture of the organization, and the needs of any internal stakeholders. This alignment prevents internal conflicts that waste time and resources and builds trust with the broader organization.

Staff Needs—Lab staff can thrive when they fully understand what is expected of them. An effective QMS defines and clarifies how the lab work will be approached and completed. Building a lab culture that supports the QMS engages staff, drives quality compliance, and delivers improved technical outcomes.

Lab Processes—The most recognized standards defining the requirements for a lab QMS are found in the International Organization for Standardization (ISO) 9001:2015 guidelines. These guidelines are also included in standards that apply to different kinds of labs, such as ISO 14001 for environmental labs and ISO 17025 for testing labs. A well-defined QMS will deliver multiple benefits to the lab across a wide range of lab activities, such as catching and preventing mistakes, improving consistency of results, ensuring the right questions are asked and the right experiments are done, reducing waste in both materials and people time, reducing rework, improving the effectiveness of training, and reducing costs. 

Elements of a QMS

Building an effective QMS includes all of the important elements which mutually support one another and ensure that the system delivers the intended benefits. The ASQ lists eight key elements that all must be included for the lab quality system to deliver the expected benefits.

Quality Policy and Objectives—Document the intent and goals of the lab quality program which support the strategic direction of the lab. These will define the scope of the program and ensure that staff, stakeholders, and customers understand the commitment to quality. Having specific quality goals also help the staff aspire to improvement and drive the lab toward excellence.

Quality Manual—Document the high-level components of the QMS, including clear roles and responsibilities, and the lab’s intentions around delivering quality outcomes, meeting regulatory requirements, providing high customer satisfaction, and practicing effective quality management. The quality manual needs to be accessible to staff and to answer the key questions around why different decisions regarding the lab processes have been made.

Procedures, Instructions, and Records—Provide explicit instructions via standard operating procedures (SOP), so that lab staff clearly understand the expected behaviors around quality activities, experimental methods, lab instruments and equipment, how to handle samples, and engaging in customer interactions. Keep clear records to document decisions that could impact experiments, like staff involved, methods and instruments used, training records, and purchases. The QMS also defines the review process to keep these documents up to date and useful to lab staff. 

Data Management—Ensure the right experiments are conducted following any appropriate SOPs and that the data are unaltered and protected. Preserve observations and experimental results. Ensure appropriate review of results prior to reporting. Archive data and results in a traceable way. Provide a clear understanding of measurement uncertainty. Appropriate data management allows scientists to return to older experiments and re-evaluate outcomes as new knowledge is gained.

Internal Processes—Build the internal processes that can deliver on the scope, objectives, and intent of the QMS. Include overall lab quality SOPs to define important processes, internal audits, effective training, objective review of methods and data, and a leadership-driven CAPA plan to address and learn from any issues. These internal processes must be driven from lab leadership, including the lab manager and the quality manager.

Customer Satisfaction—Delivering effective customer satisfaction requires lab processes that will clearly understand the customer’s needs, deliver clear and timely communication, and follow up with any issues or questions. It is important to engage with customers with curiosity to fully understand their needs, issues, and desired outcomes. The lab must also understand how to deliver the right skills, tools, time, and scientific process to meet the expected requirements.

Improvement Opportunities—Delivering an effective QMS requires the desire and inclination to improve. This can be done through regular review of procedures and processes, monitoring and evaluating the lab’s effectiveness, reviewing customer feedback, identifying and reducing nonconformities, ongoing staff training, and delivering on CAPA actions.

Quality Analysis—Analyze the QMS as a system. Evaluate and measure the different elements, conduct external round-robin testing, and perform internal audits to find opportunities for improvement. Lab managers should conduct active management review of the system on a regular basis.

Implementing an effective QMS can be a challenge, but the benefits of a well-run quality program are significant. The best QMS become part of the culture of the lab and contribute in large and small ways to the delivery of outstanding science to the key stakeholders.