Inspection Readiness

Staffing the GXP Inspection Team

Post by
Denise Lacey
Staffing the GXP Inspection Team

A colleague recently asked, "How many people are usually on an inspection team?" I've worked with teams as small as two people (would not recommend) and teams as large as fifty (REALLY would not recommend). When staffing an inspection team, it helps first to think about the jobs that need to be performed, then the  mechanisms being used to deliver information, and finally the capabilities of the available team members.

Any inspection team needs people to perform the following tasks:

  • Capture requests
  • Assign requests to subject matter experts
  • Retrieve requested documents and provide information
  • QC documents
  • Release documents and information to the inspector
  • Take notes during the inspection

The mechanisms used to deliver information can add to the list of jobs.  For example, if you're capturing requests or delivering documents in paper, then you may need people to print, copy, stamp, and run documents between rooms. If the team has remote staff, especially if you're using a number of different electronic tools to effect your workflow, then you may need additional IT support to ensure that every remote team member has each tool properly installed and running. Generally, the simpler your solutions are, the fewer people are needed to manage them.

The knowledge, experience, and capabilities of available team members also affect staffing decisions. People who capture requests and write scribe notes need to type fast and have a good understanding of the product under inspection and the associated processes. If the host has to dictate requests word for word, that will slow down the inspection. The person assigning requests also has to have a thorough understanding of the inspected product and team roles and responsibilities. People retrieving documents need to have access to the documents, of course, and a good understanding of the filing structure. If documents are filed in a single repository, a small number of retrievers can perform much of the work. If documents are scattered among different restricted repositories, though, or if  inspection team members have to reach out to a vendor to retrieve every document, this will also slow things down.

In Ready Room, we break down the roles as follows:

  • Communicator:  Capture requests
  • Assigner:  Assign requests to subject-matter experts
  • Subject-Matter Experts:  Retrieve requested documents
  • Ready Room Reviewer:  Retrieve documents
  • Host:  Release documents and information to the inspector
  • Scribe:  Take notes
  • Observer: Observe the inspection without being able to move requests

The system is designed to be flexible, though, so a user can both capture and assign requests, or QC and release requests - no configuration required. Conversely, the system also lets the team double or triple up on roles, to field a separate team for each inspector. Labels, filters, and color cues help keep each person focused on their tasks.

For the team that absolutely requires fifty people to retrieve documents, we've implemented the "restricted SME" role, which gives users a view of the inspection restricted to requests that are assigned to them. This enables vendors to provide documents without being privy to all inspection activity.

Regardless of the team's tools or experience, well-defined roles and responsibilities help the inspection team function efficiently. A productive inspection team resembles an assembly line, with most team members focused on discrete tasks, and the front and back room leaders - in our world, the Host and Assigner - keeping an eye on the overall flow.

Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations.  Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development.  She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.