Audits are serious business, wrought with regulations to remember, policies and procedures to follow, and documents to organize and analyze. Traditionally, food, beverage, and supplement manufacturers and distributors endured months of pre-audit planning, inspection day stress, and post-inspection day recovery. Audits under these conditions often feel like nightmares that last for months. But they don’t have to be.
Audits can be more comfortable with these five strategies:
Digitize your documents. Don’t waste time sifting through paper documents stuffed in a filing cabinet. Be proactive with your documents by digitizing each one upon receipt, making them searchable within your system. So next time you have an audit and the auditor asks to see a particular document, you’ll be able to find it within seconds, instead of hours or days.
Implement an automated solution to convert your documents into actionable data, alerting you to any compliance issues proactively. It’s essential to keep in mind that not all solutions are created equal. Some will solve your need to digitize documents and house them in a searchable format, but then won’t allow you to analyze the data and take action. Other solutions will weigh heavily on your company’s IT department, possibly drawing back that department’s pushback and a drain on company resources. An ideal solution would be to digitize your documents, make them searchable, and analyze those records to extract critical business elements and automatically issue alerts for any non-compliance. This type of solution – like TraceGains – provides companies with the transparency and action they need to ensure all certificates and documents are up to date and ready for an audit 365 days a year.
Organize your inspection team. Your inspection team will be responsible for handling the inspection when the FDA is onsite and should include an accountable person, inspection escort, subject matter expert(s), and recordkeeper.
Be as prepared as possible for inspection day. Whether planned or spontaneously, FDA inspections typically follow a specific format from greetings and credentials exchanged to the walkthrough and substantive inspection. Each of these inspection-day milestones comes with specific considerations to help keep the audit moving smoothly.
Develop a strong sense of humor. No matter how much we plan, mishaps can still happen – as some food professionals learned and shared with us — so learn to laugh at yourself and the situation. You can’t prepare for everything; sometimes you have to roll with it.
Take the nightmare out of future food audits by employing these five tactics – digital documents, automated solution, organized team, 365 audit-ready preparations, and, last but not least, have a sense of humor.
Discover how to automate your audit program here.