Imagine this: it’s a typical morning, you’re completing your regular check-ins with the manufacturing plant manager when you suddenly get a Notice of Inspection (FDA Form 482) from an investigator. The investigator is waiting patiently in your front office. Immediately the panic starts to set in, and you think: are we ready?
Preparing for an FDA inspection and audit is one of the hardest tasks simply because there’s no warning. Inspectors can show up anytime they like, with little warning. If you’re not prepared, this can result in huge compliance issues and red flags for your operation. This means your organization must always be on alert and ready to be inspected at any time. That old Boy Scout motto ‘Be Prepared’ is especially apt.
However, imagine you get the notice of inspection and a wave of confidence comes over you. You think finally, my hours of hard work and preparation have paid off – we’re ready.
To help turn that second scenario into a reality, our EHS experts have a few tips to prepare.
The Process: What to Expect During an FDA Audit
An investigator will examine your production process, look at records, collect samples, ask for documentation, and more depending on the operations. At the end of the audit, they will discuss any significant red flags from the inspection, including observations and potential concerns. The inspector will provide a written report and list of Inspectional Observations (FDA Form 483) which outlines their observations, including any objectionable conditions or issues. This report will then act as a guide for implementing corrective and preventive actions (CAPAs).
How to Prepare: The Audit-Proof Checklist
Gather Co-Scouts
- A knowledgeable person at your organization – preferably the plant or production manager – should be present to help accompany you and the investigator during the inspection.
- This person should be designated beforehand and have a plan in place, and processes should be communicated and well-understood by all parties involved.
- In addition to the designated individual, there will need to be a back-up, in case the primary resource is out of the office when an inspector shows up. Training and prepping your team on a routine basis is key and will ensure that everyone knows what to expect.
Documentation
- Leverage a document control module within your EHS management system. This will ensure all documents, data, procedures, product sheets, non-conformances, incidents, etc. are all stored in one location.
- Drafting procedures is just one part of documentation. The procedures must align with the actual shop floor’s practices. In other words, “practice what you preach”. The inspector will make sure the procedures are documented, and in turn, that the plant is following them accordingly.
Incidents and Injuries
- Ensure previous issues, incidents, injuries, and fatalities are well documented and accessible 24/7. Showcase lessons learned from these events and demonstrate how corrective and preventative actions have been implemented to improve site health and safety and comply with applicable laws and regulations.
- Make sure incidents are time and date stamped. This demonstrates accuracy in reporting to inspectors.
Dress Rehearsal
- Conduct a bi-monthly self-audit. Set reminders in the EHS software so that time is carved out to practice with key stakeholders and perform an actual walk-through of the entire facility. Self-auditing is the single most effective way teams can identify and proactively close program and process gaps.
- Your organization’s internal audit process should be much more rigorous than the Agency’s. This will ensure that areas of concern and potential compliance issues are identified and corrected. Conducting an internal audit is also great for driving continuous improvement, which in turn helps your operations become safer and your health and safety programs become more effective over time.
- Walkthroughs are an opportunity for your team to interact with shop-floor team members and to reinforce processes and requirements for the shop-floor team members. Think of these interactions as mini-training moments as they might be asked questions during the audit process. This is a chance to prepare them in advance, so they are relaxed when an agency inspector is onsite.
The Secret Weapon
- Using a unified EHS platform to track programs and processes is the best defense. It creates a digital paper trail that can be used to showcase compliance with regulations, track CAPAs, and manage events and incidents.
Let’s walk through a case study that looks at how an EHS software solution can help food and beverage companies ace an FDA audit.
Case Study: How EHS Software Helped a Food Manufacturer Improve Risk Management
Food and beverage manufacturers need to consistently monitor quality across their entire facility in order to be compliant with stringent regulations. Tracking non-conformances, equipment calibration, and documentation all need to be properly managed in order to meet these requirements.
A food manufacturing company was working through regulatory checks, including a check of the FDA requirement for disease control. An employee suddenly tested positive for Hepatitis A during a routine check. Luckily, the manufacturer had implemented an EHS` software system that immediately flagged the positive test.
The Automated Process Kicked-In:
- The lab results were uploaded into the EHS system.
- An alert was sent out to Operations and Human Resources that employee X tested positive.
- The notification identified the areas of the plant to sanitize in which employee X worked.
- The notification also located the production lots and the contamination products that needed to be scrapped.
- Finally, the notification alerted involved key stakeholders that production needed to be stopped until the situation was controlled.
Through automation, the organization was able to quickly identify and proactively manage a critical health risk and quarantine the product before any of it left the facility. Their ability to trace their sampling efforts and leverage automation, allowed them to avoid a huge product recall that would have resulted in a significant impact to customer confidence, product sales, and brand reputation.
The automated workflow that was set-up within the EHS application worked perfectly. It alerted the correct people and provided them with actionable items to resolve the issues quickly. There was no need to wait for someone to react.
The following week, an FDA inspector came onsite to investigate the manufacturing plant. The EHS Manager and onsite Operations Officer were ready to demonstrate their response to the above event quickly and effectively. They also walked the inspector through all their original documentation and follow-up reports, and then shared how their system is handling future employee illness cases.
Concluding Remarks
Agency audits don’t have to be overwhelming. With the appropriate processes, technology, and people, these audits and inspections can be a relaxing and confident experience.
