What are you and your team doing to win on inspection day? Preparation for inspections is an ongoing process. You likely have a lengthy checklist of items that must go perfectly on the day of an inspection. However, many inspection readiness teams overlook the importance of first impressions. According to FDA inspectors, a positive first impression can result in quicker and smoother inspections. So, how do you prepare your team to make a great first impression?
Whether your team makes a great first impression is determined long before the inspector arrives. For instance, are the greeters well trained and prepared for inspection day? Greeters should welcome the inspector, take the inspector to your inspection room, and alert the team of the inspector’s arrival. If the inspector visited your organization in the past, a representative acquainted with the inspector should lead the opening meeting.
During the opening meeting, the team should keep to a time-appropriate script. Give an introduction, go over the scope and schedule, provide the inspector directions to the restroom, and discuss lunch plans. Being a gracious host should be number one on your inspection day checklist. One simple thing you can do to show respect is to ask if the inspector has any dietary restrictions and go through your scripted introduction. Considerate hosts appear more experienced and prepared, which can influence the outcome of an inspection. Suppose the inspector is unfamiliar with your operations. In that case, they may request a brief tour of the facility after settling into the inspection room.
Inspectors frequently arrive unannounced, and sections of the facility may be cluttered due to everyday work activity. At the beginning of the tour, the guide should lead inspectors through the cleanest areas of the building. Inspectors often associate a clean work environment with a cGMP compliant organization. Additionally, ensure that all employees are following your written and approved gowning procedures. As they are guided through the facility, inspectors watch for inconsistencies; so, personnel attire must be consistent and by the book. Practice giving the tour to your own staff “inspectors” to ensure your team is prepared for inspection day.
Furthermore, there are several common requests that the inspector will always make at the start of an inspection. These requests are often referred to as “pre-requests”. They can include the index for SOPs, maps of the facility, product flows for the facility, SOPs on training, etc. Quickly delivering the documents that are commonly requested at the onset of an inspection will give the inspector the impression that your facility and quality management system operate in a “State of Control.”
Inspection readiness is crucial to the success of organizations in highly regulated industries. In many cases, a favorable first impression is merely a great start but not enough to win on inspection day. However, implementing an Inspection Management System such as AuditUtopia® or ACE Inspection® can streamline your inspection processes. PSC’s Inspection Management Systems allow your team to take scribe notes, manage requests, collaborate on requests, and report on inspection data, all within a unified and secure platform. To help prepare documents and your team for inspection day, consider our consulting services at PSC Biotech.