Driving Excellence: The Role of Internal Lab Audits

Like trips to the doctor’s office, laboratory managers should routinely schedule internal audits (IA) to assess the overall well-being of their laboratory. IAs serve as the physical examination report card on the status of laboratory health, which can identify areas of improvement, uncover potential issues, and create any needed action plans to resolve cited observations before they become bigger problems.

In this article, we’ll provide some suggestions and guidelines for planning and conducting an audit, assessing the results, and taking any necessary corrective actions.

Auditing for quality and compliance

Some lab managers may ask, “Why audit my operations at all?” The simplest answer is that most laboratories, regardless of the industry, are measured against regulations. While not all companies require formal quality units (QAU), laboratories operate within and test materials to regulatory standards. For example, OSHA and the EPA safety regulations require recordkeeping, metrics, and corrective action. Compliance exposes laboratories to external scrutiny and potential citations. Adherence provides sufficient reason to perform IAs to assure your laboratories are meeting these standards. The goal of any IA is to assess the level of control and to determine the “health” of laboratory operations.

Where to begin?

If the goal is to assess operational control of the lab, then the lab manager should develop an IA process that measures the level of compliance. This can become the lab’s medical “shot record”, where the lab manager can update critical information based on events, metrics, or previous audit findings. Many years ago, an OSHA auditor provided this advice: “Are you trying to audit-proof yourself or looking to make real change here? If the former, the audit is over, and it was nice to meet you. If the latter, then I look forward to working with you.” Avoid just going through the process. Set expectations in advance that will guide the process, provide tangible results, a baseline for change, and build a better program.

IAs serve as the physical examination report card on the status of laboratory health.

Pre-audit meetings

To start, consider holding a pre-audit meeting. This provides lab managers an opportunity to set the agenda, timeframe, and tone of the upcoming audit. It offers a chance for all parties to ask questions, provide input, adjust the agenda, identify auditors, and determine staff availability. Most importantly, it facilitates team buy-in to the process. Limit the audit scope to only a few operational areas. For example, during the first audit, the scope might be data storage/integrity and computer systems. Next time, you could focus on documentation and instrument qualifications. Regardless, limit the scope, set boundaries, and keep the audit to only a few days. Setting boundaries is critical, as the audit process may unexpectedly move to other areas of your operations. As a lab manager, you must define the audit sandbox to prevent the audit from spiraling, which can extend an already complicated process.

Involve staff members at all levels to gain insight into actual operations. Keep audit review to reasonable past timeframes. Look toward corporate document retention policies as a guide. Request needed documents, archived data, or electronic records in advance to help expedite the audit process. Always review requested documentation prior to providing it to an auditor. This serves to familiarize you with the data, find errors before they do, and gives you a chance to properly answer any questions.

For the audit team, select impartial personnel, if possible. Since audits can become confrontational, the opening meeting can build cohesion instead of developing a “lab versus the quality unit” mentality. Determine methods to acquire requested data, who will answer questions, and provide escorts and other procedural steps. As the lab manager, you should take the lead on these concerns.

Actions post-audit

As part of the post-audit assessment, recognize that auditors are not required to be subject matter experts. Quality auditors are trained in asking good questions and finding trends. Holding a post-audit meeting can assist in clarifying discrepancies and is a chance to ask questions or resolve items before having to respond.

Nobody likes to hear bad news. It’s only human nature to initially discount the findings of an audit. As a lab manager, accept the results of the audit at first glance, then take time to do a more critical review. Remediate observations related to safety, health, or HazMat immediately, as these directly impact the well-being of your staff. These types of issues come with monetary implications if found or cited during formal external regulatory audits.

As a lab manager, you must define the audit sandbox to prevent the audit from spiraling, which can extend an already complicated process.

Corrective actions are not expected to remain open or unresolved. Critical items can become outdated, forgotten, no longer relevant or, worse yet, escalate into a serious quality issue if not managed properly. A well-executed corrective action/preventative action plan (CAPA) fosters an environment of continuous improvement. Be realistic and commit resources to the effort based on a thoughtful plan. Use the post-audit meeting as a method of setting goals and realistic timeframes for completion.

Summary

A few simple guidelines, along with the motivation to regularly check the pulse of your lab’s operations can establish a solid audit program.

First, manage the emotional aspect of the process for yourself and the team. It is common that staff will react in different ways, but negative energy can plague your team and lead to unnecessary confrontations.

Next, limit the scope of audits to one or two topics. Auditing is time consuming and complicated. Focus on finding areas that require change, if needed, instead of a quick review of all areas. Then, empower staff members to participate, which will provide opportunities to build trust in the systems and experience for future audits. Hold pre- and post-audit meetings, which can define audit goals, set boundaries, foster teamwork, and help define any needed corrective actions.

Conducting internal audits can demonstrate that your systems are in control, which builds confidence in your lab and enhances its reputation for quality work.