• Melita Ball

5 Steps to Better Audits

Do you struggle staying within the scope of your audit? Are you often overwhelmed by the volume of material to review during the course of an audit? Here are 5 steps you can take to help stay on track and confident during whatever type of audit you're conducting. Follow each step carefully and you will become a more confident, efficient, and effective auditor in no time. These tips work for all types of audits. It doesn’t matter if you are conducting a focused Internal Audit or a full system Supplier Audit, you will see results immediately. These tips work especially well for Mock FDA Inspections.

  1. Prepare with Focus

  2. Use QSIT as a Reference

  3. Practice Active Listening

  4. Follow Audit Trails to the End

  5. Be Realistic with Expectations

Prepare with Focus

Always prepare for your upcoming audit based on the audit scope. Gather as much information as possible within the scope of your audit and devote a block of time for the review of material. For Internal Audits, this means that you will likely have a fair amount of information and documentation at your fingertips. Internal Audits typically take more time for preparation than other types of audits because of the amount of information available; however, the purpose is the same. Stay focused on the defined scope and zero in on the important elements of device safety and compliance. Make notes and write out open-ended questions to get things started during the audit. With good preparation, your audit will get started quickly and you will gain the respect of the Auditee as you move through your agenda.

Use QSIT as a Reference

Many auditors never learn the QSIT approach and those that do, rarely use it for internal and supplier audits. I’ve never understood this because, for me, QSIT is my ace in the hole. It helps me stay focused on the important elements when I am running short on time, it provides me the tools to conduct a thorough system audit while sampling records in detail without losing time or focus, and it helps me correctly categorize, prioritize, and communicate my observations effectively. Even if you don’t follow the full QSIT process during your audit, you should use the QSIT guide as a reference for the areas that are in scope for your audit. This will keep you focused on the most important elements of any quality system.

Practice Active Listening

Do you know what active listening is? Do you practice it regularly? Active listening is consciously listening to what is being said without being distracted or preoccupied with your surroundings or your own thoughts. The ability of an auditor to listen during an audit is critical to the successful interpretation of the information received. Whenever interviewing personnel during an audit, it is very easy to misunderstand what is communicated. Listening is as important as asking the right questions. While conducting the audit, you may be subjected to a great deal of external noise. You may be receiving so much information during the performance of the audit that “non-listening” may occur. This makes it difficult to distinguish the important information from the less important. Active listening doesn’t just happen. You need to practice often to keep your skills up. The good news is that you don’t have to wait until you are in an audit to practice active listening. You have numerous opportunities each and every day.

Follow Audit Trails to the End

Your ability to pick up an audit trail and follow it to the end is directly dependent upon how well you listen to what the Auditee is telling you during your interview with her or him. If you’ve done a good job of asking the right questions, the Auditee will be explaining their process in their own words. If you have properly prepared and are actively listening to what is being said, the Auditee will give you many opportunities to pick an area to do a deep dive into the records to evaluate whether or not the processes that are documented are truly the processes that are implemented and practiced. Auditors must be able to sample enough records during an audit to be able to conclude whether or not people are following their processes on a regular basis and whether or not the overall system is effective. Roughly speaking, an auditor should strive to review approximately 3-5% of the records selected within the scope of the audit. If you are running tight on time, you can often balance that number with fewer records chosen but following those that you do choose through to their logical conclusion.

Be Realistic with Expectations

Let’s face it, anyone whose been auditing more than six months knows they can find little things in any medical device manufacturing environment. It’s important to understand and distinguish between what’s really important to the safety and efficacy of the device and what’s part of a normal manufacturing environment. The best auditors are able to make those distinctions as they are moving through the environment and interviewing personnel. The key here is to be realistic in your expectations while holding the Auditee to the high standards of medical device manufacturing. During an audit, remember, you are auditing real production and not idealized processes written in an SOP or Work Instruction. Don’t expect everything to be perfect but do expect the overall quality system to be effective in handling situations when things don’t go as planned or as written in the procedures.

Follow these simple steps and you will notice a positive difference in the way you conduct audits no matter what type of audit you are being asked to perform.

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