July 12, 2018
As data integrity issues increasingly find their way into FDA Warning Letters and Form 483s, regulators are demanding companies determine the root cause of these problems by conducting in-depth, objective employee interviews.
This typically appears in FDA Inspectional Observations with the statement below.
“Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.”
In many cases, regulators expect the scope of these investigations to encompass laboratory and production areas in order to fully explain data irregularities and the causes for them, wherever they originated.
Because of the obvious challenge of encouraging personnel to divulge information about their work environments, colleagues, and practices for fear of their jobs (or those of their peers), FDA nearly always states that these investigations should be performed by an independent, qualified third party.
To ensure you're selecting a genuinely qualified third party professional and are well-prepared to help them plan and conduct an effective data integrity investigation, we've laid out the essential initial steps below.
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In general, outside consultants are considered "qualified" if they meet three general conditions:
The individual or team of consultants selected to conduct data integrity interviews must not be associated with your company. They must also be able to assure interviewees that any statements made will be kept confidential and not shared with the company. In cases where a translator is necessary, this person must also not be associated with your company in any way, nor to any current or former employee. In general, companies should dive as deep as they need to in order to ensure the individuals tasked with an investigation do not impose a conflict of interest in any way.
The person or people conducting interviews must be trained data gatherers. When determining the level of training for a prospective consultant, they should have experience in interviewing and be able to make inferences from subtle cues such as body language, facial expressions, and tone. They should also have experience dealing with contentious situations.
In addition to demonstrating technical expertise, qualified professionals should be brought up to speed with the relevant operations of your company as well as its organizational structure. This ensures interactions can be made with the appropriate sensitivities while no key people are missed in the shuffle. Lastly, make sure that any issues that have previously been identified through past inspections or audits have clearly been brought to the consultant's attention and enter into the investigation appropriately.
As with nearly every kind of deviation investigation, interviews need to accomplish two central goals:
In achieving these broad goals, your interview process should focus specifically on gathering relevant data and revealing unknown facts as well as the systems actually used for data capture (both official and unofficial). In addition, a successful interview will determine whether problems were due to management pressures, inappropriate actions, or genuine lapses in procedure.
Use and adapt the following step-by-step guide when planning your data integrity interviews.
Developing separate, standard checklists of questions for identifying the nature, scope, and root cause of data inaccuracies ensures consistency and completeness. These should include multiple types of questions (not just yes or no) and be further supplemented with any documents that can be used to support or draw issue with the matters discussed.
Specifically, the interview questions themselves should address the following subjects. (This is not an exhaustive list):
In most cases, a thorough interview should take anywhere from 30 minutes to an hour. These should be conducted in a private room where both parties feel they can have a completely confidential discussion.
Employees being interviewed should be clearly informed of the reason for the interview, as well as the assurance of confidentiality from the start.
All interviews should begin with simple, easy questions to confirm the basics, such as demographic information, work history, and responsibilities, while also building rapport early on. This trust-building is critical to enabling to a more honest and open conversation about contentious subjects as the discussion progresses.
Questions where details and employee observations are of significant importance should be left open-ended. A skilled interviewer will be able to naturally move to unscripted follow-up questions when necessary and pace their conversations slowly to avoid adding unneeded pressure.
In order to accurately determine a root cause, investigators must be able to understand which individuals hold the power of influence and how much influence executives and department leaders have over the actions of supervisors and frontline staff. This should be a core component of your interview.
While this should in no way influence decisions specific to your investigation, the following issues often lie at the heart of many data integrity problems:
Following any data integrity investigation, all responses should be stripped of personally identifiable information and analyzed into a report summarizing the key takeaways of the investigation and the root causes identified.
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