Editor’s Note: This story was originally posted here. Reprinted with permission.
We are introducing a new recurring blog series called the “Inspection Series” to provide information and tips for surviving your next inspection or audit. Regardless of whether it’s an unannounced inspection or a scheduled audit, there is a lot of preparation that can be done before and during an inspection. Throughout the series, we’ll be interviewing regulatory experts, providing proven techniques and proposing new ideas for upcoming regulatory activities!
Our first topic is about Generating Logs. One of the first things RAQA teams do when they learn about an upcoming inspection is to generate logs of key quality sub-systems:
CAPAs — Be able to produce a list of all CAPAs for the last 2 years with a short description and status of each one. If you have open CAPAs that are more than 2 years old, the inspector may ask for older ones, but 2 years is a good start.
Complaints — Depending on how many complaints your company receives in a year, provide at least 1 or 2 years worth of complaints to the inspector. For each complaint provide a short description and whether an MDR was filed for that complaint. The inspector will likely skim through the complaints looking for high-risk ones to investigate further.
Non-conforming Product — Create a log of all non-conforming product that was documented. This can include any NCs that were identified in-process or in the field. Be able to answer what occurred after the non-conforming product conforming
Suppliers — Keep a log of approved suppliers on hand and make sure your team can identify what goods each supplier supplies. Again, take note of all high-risk or critical suppliers and be able to produce documentation for approval. As a bonus log, it would be even better if you had all suppliers that are pending approval or have been rejected.
Calibration — Generate a log of all equipment that requires calibration and be able to identify and locate the equipment in the building. The log should include when the next calibration of each equipment is required.
Service Records — Be able to produce a list of all service activity that has occurred in the last year. This is not just a list of service calls, this should be a list of actions and dispositions when servicing occurred either in-house or in the field.
Why are logs important?
Logs are incredibly important during inspections because it is often the first thing that agents will look at. It’s a window into your documentation and activities. Spend extra time to make sure the logs are complete, formatted correctly and easy to read. The last thing you want is for an inspector to question missing lines or be confused about item descriptions.
Ideally, these logs are consistently updated and maintained regardless of whether there is an upcoming inspection, however sometimes it’s difficult to do so. You don’t want to be rushing to create these logs during an inspection, so a little bit of preparation goes a long way. Don’t wait for the inspector to ask for them! Prepare these logs beforehand and have them ready whether they ask for them or not.