This blog post is continued from Preparing for an Inspection or Accreditation Survey –  Part 1. Read part 1 for more information on preparing for an on-site visit by a third-party organization or regulatory agency for an inspection, survey, or review of your operations.  

Conduct Mock On-site Visits 

One of the best ways to prepare your team for an on-site visit is to do a test run by conducting a mock inspection or accreditation survey. There are 4 main activities in an inspection or accreditation survey:  

  1. Tour of the facility
  2. Interview staff
  3. Review processes
  4. Records review

Here are some ideas that may be helpful to you when conducting a mock inspection or accreditation survey: 

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Icon of two people working and communicating together
Notepad icon with checkboxes to signify that you are in compliance with your policies and procedures
Icon showing a report of the care assessment and a checkmark next to the report

When conducting the tour of your facility, make sure to:  

  • Visit all spaces within the entire licensed facility, including all suites and buildings 
  • Look for cleanliness and general appearance
  • Evaluate whether you have any security breaches or concerns or if confidentiality needs improvement 

Interview your staff to help prepare them for the types of questions they may be asked

  • Interviews can be done in both a formal, sit-down environment and in an informal setting
  • Ask typical questions, in plain language, so the staff can gain confidence in how to answer questions
  • Provide feedback at the conclusion of the interview so improvements can be made

Review processes from start to finish, based on each type of business activity or scope of services

  • For a pharmacy, review how prescriptions are received. Then, walk through each step of the practice of pharmacy such as data entry; drug utilization review; compounding; final association between the drug, the prescription, and the label (eg, the dispensing act); and patient counseling. Go through each step in the process until the prescription is picked up, mailed, or delivered to the patient.
  • For a wholesale distributor or a third-party logistics (3PL) company, review how orders are received for a prescription drug/device and walk through each step in the process such as picking, storage, handling, inventory, packing, billing and other communication with the customer, and shipment.
  • For each of these business models, you should also review processes for the movement of a prescription drug or device from ordering, receiving, stocking, inventory management and accountability, security systems, selecting, packaging, labeling, and delivering to the customer.
  • A review of processes should be done for each scope of service or business activity to encompass the entire operations. For example:
    • For a pharmacy, processes are likely different for dispensing prescription drugs from a manufacturer’s container than for compounded drugs.
    • For a business that has both wholesale distribution activities as well as repackaging, the movement of drugs throughout the facility may look different.
    • For each of these business models, be sure to also look at maintenance of required records, required internal and external reporting (such as theft or significant loss), and quality management.
  • Facilities may find the technique of “tracer methodology” to be helpful.

Review each type of record an inspector or surveyor may request. These may include, but are not limited to:

  • Employee files
  • Patient records
  • Facility storage and maintenance records (such as temperature control or cleaning records)
  • Movement of the prescription drug throughout facility (such as invoices, inventory, or shipping)

By completing a mock inspection or survey, you will have increased knowledge of the process, will fully evaluate areas for improvement, and can develop a training plan. If you have compliance or quality management personnel, they are a great resource to independently conduct this type of evaluation and internal assessment. 

If you’re interested in obtaining an accreditation, NABP can help. Browse our accreditations page to find information on accreditations we provide to pharmacies, online businesses, and distributors. You can also explore our portfolio of inspection programs to find a program that is right for you. If you’re interested in learning more about how NABP can help your business stay DSCSA compliant, check out Pulse by NABP™. 

All of the ideas listed in this article are intended to be helpful tools for facilities to prepare for an on-site visit. This article does not contain legal advice and should not be construed to be so, nor official NABP Guidance for applicants or accredited facilities. These ideas are not requirements prior to on-site visits.