You are more than halfway through conducting your pivotal clinical trial when all of a sudden it hits you: something is missing. As you review the study expenses, you realize that the study budget does not have a line item for the conduct of quality audits at your clinical vendors! Momentarily you consider skipping this important quality step but instead you send out an email to all of your colleagues asking for the name of a good Quality Assurance auditor (QA auditor). What do you do? How do you select the right QA auditor? And what do you look for? If you don’t know where to begin here are some things to consider when choosing the right QA auditor.
- Do they have the right experience? There may be unique areas in your clinical trial that require a QA auditor who has the appropriate experience to understand and interpret if there are any gaps in given auditee’s profile as well as be able to ask probing questions that will uncover potential concerns.
- What are their credentials? Does the QA auditor need to have a bachelor’s degree or equivalent in a life science field, at least three years QA experience in GxP audits where X is the specific need for your audit (GCP, GCLP for example), accreditations or certifications (e.g., RQAP-GCP/GLP) or even membership in a professional organization like Society for Quality Assurance?
- Interview and Gut Feel, is it everything? Once you’ve defined a set of minimum hiring requirements, you consider bringing in the potential candidates for an interview, but is that enough? The candidates may sound great but how you will evaluate the auditor’s knowledge or uncover if the auditor has an ability to identify issues and offer solutions to problems in a pragmatic way? Can an interview indicate if the auditor has good attention to detail, with the ability to see the ‘big picture’, is highly professional and self-motivated especially during the conduct of the audit, can remain impartial and thus be unbiased when it comes to truly evaluating a vendor’s capabilities? Are there key questions that help determine if an individual has the ability to assimilate and analyze information rapidly, is confident in working alone or in a team?
- Ask thought provoking interview questions – Have you ever asked someone if they were to pick one word, liked or respected, what would they pick and why? Although you may automatically think the correct answer is ‘liked’ it’s not about one correct answer, but about hearing the candidate’s thought processes and explanation to a question that catches them off guard. Another effective query is to ask a candidate to rate their knowledge level (scale of 1-5) of for example, GCP or GCLP principles. What assumptions can be made if a person indicates that they rate their knowledge at the highest level? Are they being truthful? Are they over confident? Challenging them with a follow on question or a scenario can help differentiate true knowledge from superficial familiarity.
Selecting the right QA auditor who can ultimately foresee any potential concerns and provide you with the insight to proactively address those concerns is a process that takes forethought and planning. Giving yourself sufficient time to put remediation steps in place will help to ensure the success of your auditing program and ultimately your clinical trial.
Halloran Consulting Group
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.