By Wanda Eng, Principal Consultant, PAREXEL® Consulting and David W. Husman, Ph.D., RAC, CPGP, Principal Consultant, PAREXEL® Consulting
FDA Warning Letters are now demanding that companies conduct interviews of current and former employees to determine the root causes of data integrity issues.
As part of Data Integrity Remediation, the FDA Warning Letter states:
“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.”
These interviews are expected to cover both laboratory and production areas (including maintenance and support staff) to explain data irregularities and their causes.
But what should the interviews look like, and how should they be conducted considering that personnel may be reluctant to reveal the details of their work environment. Employees may fear for their jobs or the health of the company. If there is any underlying wrong-doing, the interviewee may be reluctant to divulge information or may become defensive in his or her answers.
The FDA understands these problems, which is why it recommends that an independent “qualified third party” perform the interviews. However, this raises the question of what qualifies a third party? In our experience, to fulfill the FDA’s expectations and requirements, the third party must be:
Independent. The person or persons conducting the interviews must not be associated with the company and must be able to provide assurance to the interviewee that any statements he or she makes will be kept confidential, not shared with the company. If the interviews are conducted in a non-English speaking country, a translator should be used. The translator also must be independent, with no connection to the company, or to any current or former employees. This is to guarantee that there will be no conflicts of interest.
Trained. The interviewer must be trained and qualified to gather data from personnel. He or she should have experience in interviewing techniques and be able to make inferences from body language, facial expressions, and tone of the reply. As these conversations could become contentious, having FDA Investigator training and experience is a plus.
Knowledgeable. The interviewer should be familiar with the operations of the company and the company’s organizational chart to be sensitive to the interviewees’ position. Additionally, if previous issues have been identified – for example, during a regulatory inspection or internal audit – the interviewer should be aware of these matters.
How the interview should be conducted
Interviews for deviation investigations are intended to identify variances between observed and standard processes or outcomes. They are designed to suggest improvements in processes or procedures. Interviews to identify the nature, scope, and root cause of data inaccuracies are not the same. These data integrity interviews are conducted to gather data, uncover hidden facts, identify both official and unofficial systems deployed for data capture, and to determine whether data integrity issues have been caused by management applying undue pressure on employees, withholding resources, or otherwise acting in an inappropriate manner.
To guide the data integrity interview process, create a questionnaire (or checklist) ahead of time to ensure consistency among interviews. (See the sample questionnaire below.) The key things to establish are who the interviewee is, where in the organization they reside, and what their primary responsibilities are. A variety of question types (open-ended and yes-no) should be asked to gather and confirm information. Where appropriate, obtain documents that could be used to ground discussions with interviewees.
It is important to schedule adequate time to perform the interview and allow for transitions between personnel. Typically, this should be between 30 minutes to an hour. You’ll want a confidential space where both interviewer and interviewee can speak freely.
When conducting the interviews, the interviewees should be first told why they are being interviewed. They should be reminded that what they say will be kept confidential: no names will be attached to the interview; no names will accompany any quotes.
As the sample questionnaire/checklist suggests, begin by establishing basic demographic information about the interviewee: his or her name, job title, number of years in organization, and responsibilities. This line of questioning can help create comfort and trust, and has the additional benefit of getting the interviewee talking. From there, move on to open-ended questions about the interviewee’s job. Don’t rely solely on the questionnaire; follow-up questions, based on what the interviewee provides, are equally important. The interviewer should not rush the interviewee, pausing to allow the interviewee to fill the silence with more information. There will be a few interviewees who will be eager to provide answers; with others, it will be necessary to draw them out.
The interviewer must learn which people within the company are in positions of influence. It is important to determine what and how much influence on data integrity the CEO, the Head of QA, the Head of Production, and Head of the QC laboratory have. And the interviewer must be sensitive to the corporate culture. Is it one of rigorous compliance, perfect HPLC and GC chromatograms, and neat laboratory notebooks? Is it acceptable for the QC Laboratory Analyst to manipulate and delete data? What is the culture within the laboratory? Is it relatively independent, or responsive to pressures from the top?
Common root causes
Some of the root causes of data integrity issues we see include a lack of resources (encompassing equipment, time, and supervision), systems that lack robust checks and balances, the undue and inappropriate influence of company leaders, and sometimes rogue employees. It should be noted that the FDA-mandated interview is not (and should not) be the end of the process. Responses must be analyzed, with any individually-identifiable information removed. A summary report must be prepared that clearly captures the number of personnel interviewed, their roles and responsibilities, and any general themes that emerged, as well as any root causes determined.
Companies do not always know that their processes and procedures are not in compliance with regulatory requirements. At other times, there are people who intentionally manipulate systems to achieve the outcomes they want. Ultimately, when the interviews have been conducted and the report has been written, it may be accepted by the company leadership, or defiantly rejected.
The goal of this process is always the same: to identify what led to a data integrity issue and to ensure it does not recur.
Conclusion
Data Integrity findings have become widespread in the industry with agencies requesting companies undergo extensive interviews with their employees (frequently employing independent third parties) to understand how the data integrity failures occurred and develop actions to correct them to ensure they do not recur in the future. This article discussed the process for conducting these interviews and provided a sample questionnaire that addresses the areas that frequently are the source of data irregularitities. As noted, one of the key aspects of this process is analyzing the data collected to determine root causes (e.g. resources, any policy, procedure or practice deficiencies as well as any undue influences exerted by people in authority).
David W. Husman, Ph.D., RAC, CPGP
Principal Consultant
Wanda Eng
Principal Consultant
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