Handle Your Water Laboratory Audit with Confidence

In the recent IDEXX Water webinar "What Do Laboratory Auditors Look For?" third-party assessor Michelle Wade walked participants through each phase of the audit process. She shared practical strategies drawn from her years of experience conducting assessments for Florida, Minnesota, and the American Association for Laboratory Accreditation.

Let's dive into her guidance on preparing for a water laboratory audit, participating effectively, and following up with responses, documentation, and corrective actions once it's complete.

Preparing for an Audit: Start Early

Your preparation should begin well in advance of audit day. Depending on your accreditation, whether it's from a state or an independent accreditation body (IAB), the process may look a little different.

Clarify the type of audit planned: routine, scope addition, or unannounced. Routine audits typically follow a two- or three-year cycle, although IABs may do a one- or two-year follow-up assessment that's narrower in scope. If you're expanding your accreditation scope, an assessor will conduct a scope addition audit to ensure your lab possesses the required capabilities. At any time, an assessor may conduct an extraordinary or unannounced assessment.

For each, understand the expectations and documentation required. It's also critical to confirm that key personnel will be present, including your lab manager, QA officer, and primary analysts or supervisors.

"Communicate early with the assessor," Wade recommended. "Inevitably, something will go wrong: someone will get sick, a storm will hit, or a shipment will be delayed. But your best bet is to make sure everyone essential to the process is scheduled and ready."

You should receive a request for documentation, typically your quality manual and standard operating procedures (SOPs), to be sent by a specified deadline. Assessors need time to review them before they arrive.

Lab personnel should also review SOPs, quality manuals, past audit reports, and corrective actions. Ensure that everyone can easily access documents, such as training files, equipment logs, and data packages, and provide staff with a refresher on what to expect. Also, tidy up the lab and give an informal prep talk to help lab staff feel confident.

During the Assessment: Go with the Flow

The audit starts with an opening meeting. This sets the tone and clearly outlines who's involved, what the assessment covers, and how the day will unfold. Wade said assessors are often required to deliver specific information, so be prepared to listen and ask questions. You'll also want to finalize the schedule so assessors can observe your lab in action without disrupting the workflow.

"Here's a friendly tip: Consider having lunch suggestions ready for your assessors," Wade said. "If you're not providing lunch, it's helpful to offer options—both local favorites and chain restaurants—especially if your lab is in an unfamiliar area."

After the initial meeting, you'll give assessors a tour of the facility. Wade recommended starting with sample receiving and following the workflow, so assessors can get a sense of how your operations function.

Next, the assessor usually focuses on quality systems. "I always send a memo in advance so labs know what to prepare," Wade said. "It makes everything faster and easier if the records are pulled ahead of time, even if you don't get a specific list."

Documents that assessors typically request include Proficiency Testing reports, three data packages (either requested in advance or pulled on the spot), training files for all staff, and corrective action records. For ISO or TNI labs, assessors may also review complaint logs and any other items related to quality management.

Wade said she prefers access to records so she can explore documents at her own pace, but it's helpful if the lab manager or QA officer is available to answer questions. She also examines traceability—where data originates and how records flow through and align with systems.

When the technical portion begins, assessors observe staff working and may ask detailed questions. Wade emphasized that staff should feel comfortable checking SOPs or consulting a colleague when unsure, rather than guessing under pressure.

"We're checking for things like traceability of standards and reagents, calibration records, and whether your staff truly understand the tests they perform," Wade noted. "It's open book; they're allowed to reference their SOPs."

Assessors will typically review documents, such as calibration logs, certificates of analysis for standards and reagents, instrument data, temperature logs, pH meter calibrations, balance checks, and volumetric checks for pipettes and bottles.

Take notes as you move through the lab and track what the assessor is focusing on, which helps to avoid surprises during the closing meeting.

Responding to the Assessment: Resolve Problems Thoughtfully

Once the audit is complete, the assessor holds a closing meeting to review any deficiencies or nonconformances. You should come prepared with questions and seek clarification about citations and documentation requirements.

"Keep your tone professional and respectful," Wade advised. "Assessors are human, and while most are careful and fair, they can make mistakes too."

Assessors will cover the next steps, including when you can expect their report, the timeframe for your response, and the process for submitting corrective actions. Again, take notes and references from your SOPs, methods, or regulations.

Be sure to acknowledge receipt of the formal report and to respond within the set period. "Your response should address what you fixed, and also why the issue occurred and how you'll prevent it in the future," Wade said. You should conduct a root cause analysis to demonstrate that you've truly resolved a problem.

Speak up if the report contains errors or omissions, and request an extension in advance if needed. When submitting documentation, follow the requested format and include proof of implementation, such as updated SOPs, revised bench sheets, or screenshots that demonstrate you've implemented the correction.

Building on the Audit: Grow Strength and Skill

Audits are more than an administrative hurdle—they're a crucial part of ensuring your lab's operations are reliable, traceable, and defensible. By planning ahead, preparing your team, and engaging in the process with openness and clarity, each audit helps reinforce your lab's strengths and improve its systems.