When I served in the military there was a term used that is still pretty familiar today: “sound general quarters!” When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.
Many companies in the life science sector hear their own version of “sound general quarters!” from FDA and anxiously await the ultimate examination:
An inspection visit by the FDA. One of the key components of hosting such an inspection is the preparation and use of a “war room” during the visit. It can be referred to as the primary line of defense in the success of such a visit.
This strategic office should be devoted and organized to provide the necessary objective evidence requested during such an inspection. One of the key observations the inspector will make is the timeliness of the turnaround of a request. A speedy response is always favorably acknowledged and a well-organized war room makes that possible.
WAR ROOM COMPONENTS
Three war room components should be easily accessible during the inspection: desktop documentation; records of data and recorded information; and pre-selected auditees and their backups.
Making these items quickly available requires some pre-planning. Choose a war room location in an office area that is not in the traffic mainstream. It should be in close proximity to the room hosting the inspection. All electronic venues should be available, including email, cell phone and a reliable devoted printer (e-documentation). Be cognizant of the nature of documents to be made available in terms of sign-offs for review and approvals of documents and records. Conducting a dry run for war room readiness as part of a mock audit would be very prudent.
Pre-selected auditees should be “processed” through the war room before entering the “inspection arena.” Coaching in the war room before entering an inspection interview will be very effective in setting the appropriate tone for the auditee. Also, if last minute plans for availability change, then the war room can regroup, preparing the backup auditees before the inspector’s interview.
The strategic person in the war room should have certain items at their finger tips at the start of the inspection:
- A quality system manual and/or site master plan.
- An organization chart showing the relationship of quality and regulatory management.
- Key SOPs that manage quality and compliance system: CAPA, record control, internal audits, change control, master batch or actual batch records and associated process flow diagrams.
- Permissions for file access, or person(s) who can access critical information when “on-deck”.
This inspection moment for a company should be a call to “general quarters” but the war room should be prepared under the motto “Semper Paratus,” meaning always ready. When the call to duty comes, everyone should know their positions. All will await the orders from the war room while the company continues to navigate its business affairs. No one should be lackadaisical until the order comes to “stand-down” from the war room.
Bio:
Walt Murray has performed and hosted many audits in his 30-year career. He is a veteran of the U.S. Coast Guard and has obtained certified Lead Auditor and Six Sigma Black Belt statuses during his tenure in the quality management field. He currently consults for MasterControl, based in Salt Lake City, Utah.
Reprinted with permission from MasterControl and GxP Lifeline.
Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.
For more information about MasterControl workshops, go to:
http://www.cvent.com/events/2012-quality-management-workshops/event-summary-66ee283ff4c042c38a8a5aa607205e61.asp