Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a ‘zipped-tight’ posture toward the investigator?

The answer to approaching such a situation involves scenario planning and a true understanding of the company’s regulatory weak links during a compliance visit. Somehow, the investigator has a bloodhound sixth sense about ‘pokin’ around during an investigation visit. The job of an investigator is to find the weak links and ‘holes’ in the approach of an organization as to how the regulation is a part of the fabric of a company. On the day of the audit, there are some key factors needing consideration to successfully host a compliance investigator.

First, the company’s key representative should obtain a business card from the investigator upon arrival and ask him to be seated for a moment to allow for the initial ‘mobilization effort’ to occur.  This phase is important because the standard operating procedure (SOP) for hosting such an event should ‘go live’ at this point.  This is not a drill! The company representative should be a person familiar with the local compliance office staff who is comfortable helping the compliance officer perform the investigation. Simultaneously, the company’s ‘lieutenant’ or second in command should be sure that the  room of residence for the investigator is ready.

Concurrently, hold a team huddle before actually greeting the investigator.  Reassure the team.  Send text alerts to appropriate people (i.e. management, process owners, and quality team).  Review the SOP regarding:

• Who is in the room of residence with the investigator (i.e. Lead Quality Host, a ‘runner’ and a ‘scribe’)
• Who is in the ‘back room’ where key initial documents are available.
• Ensure the person who has the best understanding for accessing records, data, procedures and personnel (radios/cell phones as per the SOP) is always present
• A list of items to discuss with the investigator for a state of readiness (i.e. restrooms, Internet, anyone missing based on prior commitments and who will serve as alternates)
• Be sure the lieutenant is the ‘free-agent’ during the audit.  This person is a floater who will inform an area of a visit Inform key personnel to be ready for inquiry (i.e. onsite, when to come to interview)
• Assist in determining alternate escorts if needed (i.e. be the secondary escort).  A substitute for the point person might be needed during a temporary absence.
• Be sure that the lieutenant is operating in or near the backroom to review documents that the runner will request for the point person with the investigator.  The review will confirm the right document(s) are going in for review
• A standard notation sheet is available to communicate comments from the lieutenant to the point person (i.e. clarification, verification, need more time to locate, how much information to locate and verify). In most cases, the lieutenant will be the person operating the backroom during the audit

Once the investigator has been greeted and settled into the room of residence, he will begin requesting information.  The investigator will typically follow a ‘path’ of conformity for a selected process or method used to execute compliant components in meeting the intent of the regulation.  If the path he follows is not similar to previous visits, then it will follow the hierarchy components of the life science sector (i.e. Part 111, 211, 820, FSMA, ICH, etc.) It is critical to note that if such processes are not documented, or the records necessary are not captured, the host should try to explain best practice methods regardless of the omission of such documentation.  Note that it is important to be forthright and honest in the responses, providing only that information which is pertinent to the request.  It is important to understand that such an audit is not forward-path oriented. Its primary intent is the historical verification of effectiveness for execution of processes, practices and decisions that are substantiated by good documentation practices during daily operations.  Such evidence is substantiated by cursory observations in the operating areas of manufacturing according to process and product control (P&PC) sections of regulation.  These areas make up the lion’s share of sector compliance.  In closing, one must realized that the perception during an investigation is as important as the discovery of compliance in the beginning, during and at closure of the hosting process.

Note: This article is used with permission from GxP Lifeline and has been previously published.

Bio:

Walt Murray, is a specialist in the quality and regulatory professions with more than 25 years’ experience to his credit, working with nationally-recognized organizations including Aventis- Pasteur, Merck, Pfizer, Stryker, USANA, Del Monte Foods and the American Red Cross National Labs. He is certified in quality systems auditing, problem solving, and process control using Six Sigma principles that support lean enterprise, including kaizen improvement and advanced planning principles. His extensive audit experience covers several industries and he’s successfully brought several medical device companies to full registration under the ISO process model standard. Murray has also worked extensively in risk and supplier management.

A graduate of the University of Richmond, Murray is a member of the Society for Manufacturing Engineers (SME); Regulatory Affairs Professions (RAPS); the American Society for Quality (ASQ); and the Intermountain Biomedical Association (IBA). Walt may be reached at wmurray@mastercontrol.com.