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Signs of a Well-Managed Laboratory

An experienced assessor shares key factors to ensure labs follow a robust quality management system

by
Charles Newton

Charles Newton has more than 24 years of experience as an environmental chemist and a highly experienced project manager with expertise in analytical chemistry and quality programs for environmental applications....

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As evidence that a laboratory is operating a robust quality management system, the lab must show compliance with recognized consensus standards, such as TNI or ISO 17025. Experienced assessors can quickly tell whether the laboratory processes function effectively or not.   Although the role of the assessor is to verify compliance or noncompliance with a standard, there are several common trends that assessors have identified   that indicate whether the laboratory has a well-managed operation and rigorous quality management program.

All organizations, whether intentional or not, have inherent behaviors and habits that evolve over time, and establish a culture unique to the facility and organization. A laboratory’s culture does not solely indicate quality level but can signal if potential issues are on the horizon. The following are a few examples of cultures that emerge:

  • The black box: These are laboratories where information seems to flow in, but with little to no communication outward. Management in these types of facilities tend to be direct and communicate with “yes” or “no” answers. The assessment process should be more communicative, as the goal of an assessor is to aid laboratories in continuous improvement, not to seek out just the findings. A healthy dialogue of how the laboratory operates and discussion of areas where labs may be struggling is encouraged, as it shows that the management values continuous improvement.
  • Active engagement by leadership: An assessor is often escorted to a conference room, and aside from introduction with the lab director during the opening conference, there is little to no engagement with the management team. It is understandable that a manager’s time is limited, but in laboratories where the management team is actively engaged in quality activities, such as assessments, the assessor quickly understands that the leadership understands the quality system requirements and is committed to operating a top-notch laboratory.
  • Production versus quality driven: In commercial labs, one cannot ignore production goals and profitability, as any business only exists to be profitable for the ownership. Client expectations often suffers in a laboratory where production demands supersede quality system requirements. When the balance between production and quality has become unbalanced, the assessor can expect to find excessive short-cuts and omissions of quality system requirements.
  • Innovative versus status quo: For a laboratory to survive, management must always be evolving and seeking out better ways to achieve data collection. As technology and method requirements change, a well-managed lab proactively accepts these challenges by keeping systems updated and always looking for a better, more efficient way of performing the task.
  • Should versus shall: These words are used in the methods or standards to indicate a requirement (Shall) verses a recommendation (Should). In general, “should” represents good laboratory practices, and often become a requirement in future versions of the standards. Laboratories that proactively adopt “should” statements into their procedures as a requirement struggle less with implementation of change.

The TNI and ISO 17025 standards both place the responsibility for ensuring that the quality system is supported and that the requirements are communicated and understood by all employees in the laboratory on the management. As such, management sets the tone for the laboratory. When quality and adherence to quality system requirements are important to the management, it is important to the staff. The first job of any employee is meet expectations and goals.  When the expectation on quality is understood, the staff make quality important as well. Management must be visible in the operation and understand the quality system requirements to ensure compliance in day-to-day activities of the staff. 

Consistent and clear communication on the quality objectives must be delivered on a regular basis by  lab leadership. Lab managers that understand these requirements and recognize both compliance and noncompliance are proactive in identifying issues and correcting them before they become out of control. Active listening by management to staff concerns can be an effective way to recognize opportunities for improvement. There are several pitfalls that lab mangers can become trapped in and are quickly seen by anyone outside of the operation. Laboratories struggle with quality system requirements where  management fails to delegate activities to appropriate staff members. Managers often believe that if the task must be done right, it must be done by them. By empowering staff to make decisions as appropriate for the assigned duties, it allows the manager to focus attention on areas of the lab that may be more problematic. Although the responsibility for maintaining the quality system rests on management, the manager cannot be everywhere or see everything that happens in the lab. When staff bring issues forward, managers must avoid ignoring the issue or imposing punitive action on the staff. A good manager will encourage staff to aid in identifying issues and work to resolve them as quickly as possible. A well-managed laboratory is staffed appropriately to support the scope of services and production demands. A well-developed staffing plan allows labs to identify gaps in training and ensure that quality data is being collected.

No one enjoys receiving or hearing bad news, and complaints come from both clients and from within the laboratory. A well-managed laboratory will encourage feedback, both positive and negative, and take the time to dissect the issue and understand what actions are needed to resolve the issue. Labs that ignore complaints are doomed to suffer repeated issues and struggle with compliance.

As much as technology and automation improve, the reality is that people make up the laboratory. Staff attrition is a major problem for the laboratory to address to support a robust quality management system. Laboratories with high employee attrition are susceptible to quality issues. The most obvious issue is loss of knowledge of the requirements and expectations. Even when staff are replaced, the new employee only “knows what he knows”. Laboratories with high turnover must have well written SOPs and be dedicated to training new staff to minimize the impact of staff changes.

Motivating, stimulating, and recruiting staff can be difficult. Managers must recognize what drives employee engagement, such as salary, flexible scheduling, achievement, and recognition. Asking the question, “How do I make this a career as opposed to just a job?” will aid in finding the answers to solving employee retention.

There are a few tell-tell signs an assessor can readily identify, and which will lead the assessor down lines of inquiry and audit trails during an assessment. Facilities and equipment that are not well maintained is an immediate red flag and often lead to nonconformity. Additionally, the lab’s quality system documentation should be kept current, and not reviewed or revised in the days and weeks just prior to the assessment. When issues are discovered, laboratories must fully understand the root causes and develop a sustainable action plan to resolve them. Repeat nonconformities are common in labs with ineffective root cause/corrective action procedures.

Internal audits are essential in a well-managed laboratory to ensure both technical and quality system compliance. Having staff that are trained and experienced in conducting audits is essential to the process. By taking the internal audit seriously and not just a “check the box” exercise, laboratories can identify nonconformance issues and resolve them proactively. Laboratories should avoid waiting on external assessors to identify issues. 

In summary, quality starts with the lab leadership. It’s in the name, quality management system. Laboratories must stay current with technology, regulations, and people. The cost of quality is high, so budget appropriately to support a quality system, and never forget that we are scientists, and not just number generators!