One of the problems with relying heavily on the quantity of audits an auditor has performed is that it goes against the concept of quality over quantity. Qualifying the
Quality Professional Experience

I have been in my fair share of interviews in my life within the quality arena, on both sides of the table.  Every time I am intrigued by the questions used to determine how qualified one is to be in a quality role.  In my current role, I evaluate consultant skills and assist clients through interviewing consultants to assess their fitness for use.   While many approaches are taken, and many questions asked; I would like to discuss the question I find most fascinating.

So, how many audits have you done?

An interesting concept, using the number of audits one has performed to determine the fitness of an auditor. On paper, this makes incredible sense.  It’s even a value one can make into a great spreadsheet for upper management to compare across candidates.  It can quantify qualified from unqualified simply by choosing a number, and then rejecting all applicants without the specified number of audits.  In a world of science, simple analytical answers are ideal.  Unfortunately, science has rarely given us simple analytical outputs without incredibly complex inputs.

I haven’t decided if I’m impressed by individuals who know this number by heart, or alarmed.  I’m also not completely sure if I believe them.  Not they are being deceitful; rounding carries its own flaws.  But assuming an individual can actually answer this question on the spot with complete accuracy, what does it really tell you?

For example, assume two (2) GCP Auditor candidates have five (5) years of experience in GCP’s.  Jane Doe has performed 57 audits in her career.  John Doe has performed 100.  Clearly, John is more qualified than Jane.  Or is he?  Would answers to any of the following questions have an impact on your decision?

  • What was the length of these audits?
  • What types of audits were they?
  • Were they on-site or remote?
  • Were they co-auditing situations?
  • What types of trials were these related to and what was their complexity?

One (1) of the problems with relying heavily on the quantity of audits an auditor has performed is that it goes against the concept of quality over quantity.  The quality of the audits should outweigh the quantity of audits. The experience one gains from a five (5)-day, intense, for-cause onsite audit is going to be vastly different from a one (1) day remote vendor audit.  And a two (2)-week Trial Master File audit is going to be different from a two (2)-day Investigator Site Audit.  All of these can contribute to the qualifications of an Auditor in different ways. Then of course there is the more obvious concern that having done a large number of audits does not in any way mean they were done well.

Moreover, as the Manager, should one really want their new hire to be concerned with the number of audits they are doing?  When they are approached in the hallway and asked if they can switch to the two (2) two (2)-day audits on the schedule in place of the four (4)-day audit, will they be considered a go-getter?

Of course, the amount of auditing experience is important. But if in the hiring process, the hiring manager shows that the quantity of audits performed is one (1) of the key hiring factors, then a candidate can only assume it will also be one (1) of their key performance indicators.

What do you think are important factors to consider when assessing the quality of your auditor?

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