4 Steps to Avoid Common Compliance Audit Pitfalls
Nobody likes a compliance audit. But given the importance of testing water for pathogens, like E. coli and Legionella pneumophila, lab managers and employees should consider compliance audits — and the proper preparation leading up to them — a regular part of the job.
You need to ensure your lab is always prepared for an audit, so you don't get caught off guard and subsequently hit with poor inspection results. But even the most prepared labs can get dinged on an audit, so you should also familiarize yourself with the most common lab audit pitfalls and the best ways to avoid them.
With this two-tiered approach in mind, here are four steps you can take to ensure your lab is well on its way to being audit-ready.
Step 1: Conduct Internal Audits
Given the inevitable pressure water lab managers can come under during audit season, it's best to regard audit preparation as an ongoing process. As with anything, though, you can't be prepared without knowing what to expect.
By employing an outside inspector to conduct regular internal audits, you'll know what you're truly in for during the main event. That said, while internal audits are a great preparation method, they shouldn't be taken lightly, as your procedures for these are often assessed as part of the later compliance audit.
The primary goal of your preparation efforts should be to take some of the uncertainty out of the compliance audit process, explains Gregg Lundy, a laboratory auditor for the Environmental Protection Agency.
The best times to conduct internal audits are typically when your lab is either up for certification renewal or is experiencing a particularly light workload. But don't wait until the day before an audit to change procedures, organize records, or correct your standard operating procedure (SOP).
Step 2: Understand the Different Certifications
In addition to conducting internal audits, lab managers should further prepare for compliance audits by familiarizing themselves with the different certification statuses given during them.
Here's a refresher: A full certification means your lab has met all requirements; a provisional certification means some deficiencies were found, but your lab can still provide reliable, accurate, and defensible data. In the latter instance, your lab will have an opportunity to resolve these deficiencies. If the inspector is not able to complete the accreditation process for your lab in a timely manner, for one reason or another, an interim certification may be given.
Certification can also be denied if an inspector determines your lab has a "significant" number of deficiencies to be corrected.
Step 3: Steer Clear of Common Pitfalls
You should never do these three things during an audit: try to compile months worth of data from memory, answer auditor questions you don't fully understand, or give an answer you think the auditor will want to hear.
Additionally, your auditors will ask for materials beyond your SOP, so make sure you have documents, like method detection limit studies, as well as proficiency test results and raw data, at the ready.
According to The NELAC Institute, a nationwide nonprofit organization focused on environmental laboratory accreditation, two out of three laboratories do not demonstrate compliance with management standards for quality systems. Here are the most common offenses they cited from lab audit findings and ways you can avoid them:
- Inadequate records. Labs must maintain procedures to control quality and technical system records, as well as the proper identification of equipment used in analytical testing.
- Lacking equipment maintenance. Ensuring all equipment is in working order should be a routine part of your lab management. For audit purposes, you'll need to calibrate or verify the equipment annually for the entire range during which the equipment is used.
- Failure to implement quality and system management requirements. Your quality system manual should outline all data integrity policies and procedures in detail.
- Improper sample handling. Clearly define your lab's process for labeling containers to avoid confusing them physically or in documented references.
- Lack of documentation. As a lab manager, you need to make sure your entire staff — both new hires and seasoned employees — is regularly trained on data integrity, and that the training is fully documented.
- Failure to establish document review procedures. You must implement document review standards to keep a record of all approvals, issuances, and changes to documents, which should be included in your lab's quality system.
- Inadequate review of contracts. Your auditor will check that your contract review process includes defining the client requirements, the appropriate method to be used, and the lab's ability to perform the work.
Step 4: Learn From Each Audit
By proactively preparing for an audit, and identifying and addressing any shortcomings sooner rather than later, you can improve the health of your lab's quality management system — and, in turn, your chances of staying within compliance.
But keep in mind that even with the best preparations in place, it's nearly impossible to take into account everything a lab audit will involve. If your certification status isn't what you expected, remember, you have a chance to make it right and learn from this process. Your auditor will appreciate the prompt response to these findings almost as much as a squeaky clean initial report.
As with anything, feedback is always helpful, too. Auditors know better than anyone else what it takes to have the safest lab, so ask questions and take notes, in addition to employing these four steps before your next compliance audit.