Written by: Crystal Booth, M.M.- Regional Manager, Southeast USA at PSC Biotech
We’ve probably all heard the phrase “audit ready state”. But what does it really mean? How do you get to and maintain an audit ready state? An audit ready state is simply operating in a way where you are ready for an audit at any time. This may be a client audit or a regulatory audit.
One of the best ways to get into an audit ready state is to perform internal audits and self-audits on a frequent basis. Have different individuals and quality assurance look over operations, processes, and physically walk-down areas e.g., Gemba Walks, etc. Take findings seriously and implement corrective and preventative actions. During self-audits look at labeling, cleanliness, expiration dating, documentation, logbooks, equipment calibrations, reagents, blocked isles, waste bastes, incubators, etc. You want to systematically look at your area of responsibility and pretend you are a regulatory auditor. What would the auditor see? Your goal is to find and correct potential findings. What you find and fix are audit observations proactively dealt with. It is better that your internal audit systems find potential observations and implement solutions than for clients or regulators to find your weaknesses.
Tools, such as 6S (Sort, Set In Order, Shine, Standardize, Sustain, and Safety), will help to ensure that everything is clean and in place. Frequent self-auditing and adherence to 6S principles gives you constant feedback and allows you to adjust processes where needed to ensure you are consistently audit ready. Remember, don’t wait for “them” to find your weaknesses.
Another tip is to be in an “audit state of mind”. This means developing the mindset to pursue top-notch quality on a daily basis and embrace the concept of continual improvement.
Need help getting started? PSC Biotech™ provides custom programs to help companies get to a compliant audit ready state. Experienced consultants are available to perform audits of your facility and processes to help ensure your current processes and quality systems are compliant.
PSC Biotech™ offers a wide variety of solutions to ensure success for any size company, including consulting, risk assessment, writing standard operating procedures, protocols, and white papers, project management or complete turnkey project services to execute projects to free up your company’s valuable resources. Whatever your needs may be, PSC Biotech™ is here to help. Give us a call today!
