“The opening meeting is Monday at 8 AM…” This notice can drive fear into the hearts of laboratory quality professionals and operational management alike. The auditor is coming to judge, to determine if you are worthy. This process, which is often viewed as adversarial, need not be that way, however. With a shift from conflict to partnership, the process can also shift from hurdle to a key element of laboratory improvement.
Ultimately, laboratories become accredited because it is critical to their business. Whether driven by regulatory pressure or a customer’s own internal quality program, the revenue profile of the laboratory requires it. Driven from the top, it is often viewed as necessary overhead. The expectation is to get it, keep it, and never let it be a problem.
The main event of the initial accreditation process is the onsite visit from an external auditor. In some industries, this is a government official. In others, it is a company whose business is to evaluate and accredit laboratories. They schedule a period of days to dig into the quality management system and all activities that support the scope of testing. There are associate interviews, documentation evaluation, and other deep-dive activities that can make a lab team feel like they are under the microscope.
After this initial event, laboratories fall into a cadence of periodic evaluations. Quality teams will begin preparing for these months in advance, buttoning up processes and ensuring records are accessible. In many quality systems, there is a time of catch-up for system elements that have not been properly maintained due to operational pressures. It is like the test in college that you have to cram for, maybe pull an all-nighter, and feel mixed emotions about preparedness.
When audit pressure creates the wrong incentives
Top-level leaders in the laboratory know that these audits must be successful for the continuation of the business. If accreditation is pulled by the assessor, it will shut down the flow of testing, stopping revenue. For this reason, success is expected. Unfortunately, this expectation often translates into fear of audit findings due to perceived impact on employment. If an employee, at whatever level, feels that their livelihood is at risk, they will find ways to avoid problems during an audit. A myriad of unhealthy practices can be found with this cause at the root, preventing any value from being found during the audit process.
At the core of modern QMSs is the idea of continuous improvement. A properly designed system relies on the system itself to ensure success. The ownness does not fall on individual employees if the system fails to prepare them appropriately for an audit. Further, it is much more common to discover that findings are an issue of improper training, inadequate documentation, or non-robust processes. Modern auditors know this and they typically seek to use the audit process to help laboratories find these gaps and close them.
So, how can laboratory leadership close this gap between performance expectations and deriving value from the audit process? It boils down to reframing the quality culture.
Build a culture that sees audits as opportunities
Laboratory leadership must realize the value of a robust, fully functioning QMS. The gap that often exists between operations and quality must be closed and a highly functional partnership be developed. Operational leaders must believe that the growth and improvement of their QMS correlates directly with growth and improvement of revenue and business strength.
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This shift is not merely an audit time discussion. With this focus throughout the year, the audit becomes something eagerly anticipated. A fresh perspective will drive improvement that could not have been achieved any other way. As a laboratory leader, I am thankful for every audit finding. I see the auditor as someone who just served my customers and strengthened my business.
Lab leaders can emphasize the right perspective in a few key ways. Emphasize with their staff that systematic improvement is always desired and welcome. Encourage discussion in meetings and among teams that seeks better ways to do the work. Provide avenues for staff to discuss pain points and challenges. Place constant emphasis on robust systems for lab staff to operate within. With these ideas as a framework, turning the view of the audit to one of evaluation and benefit will be natural.
Prepare staff before the audit—and involve them afterward
Including some key discussion points about the audit can also be beneficial. Prior to an audit, discuss the upcoming event with the staff. Explain what is happening, the purpose as leadership sees it, and the role of each individual. Encourage them to answer questions honestly, leaning on the system for support (documentation, their leadership, etc.). Explain that the purpose of the system is to ensure they are able to meet the requirements of the QMS effectively and efficiently. The audit, therefore, is the lab’s opportunity to test the system, identify gaps or weaknesses, and improve.
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After the audit, follow up with the staff, explaining what was found and how the system is benefiting from the recommended improvements. Include staff in the process of addressing the findings. Seek their input in solutions, stressing that the modifications to the existing system must be effective but also manageable in their workflow. Put ownership of the correction process into the areas the findings address along with providing all necessary support to any associates that might be new to operating within a QMS.
Make no mistake—working toward a culture that embraces audits is work for operational and quality leaders alike. I personally have a revulsion to any activity that does not provide value to the business, though. Without investing in the engagement of the quality system, it becomes perfunctory busy work. If I can create an environment where every activity—from laboratory technician to management to support functions—provides value and creates a rich value stream for my customers, I am serving them, my employees, and anyone with financial stake in the laboratory’s success.
