The human touch in analyst certification

Richard Prince

In recent years, the Food and Drug Administration (FDA), through enforcement actions, has required some pharmaceutical firms to certify their facilities, unit operations, products and processes. The concept of certification was extended by the FDA to include the competency of laboratory analysts engaged in release testing. Certification has meant that a firm must rely on the services of an outside expert to eventually document that the aspect of the operation of direct interest to the FDA is, in fact, certified. This column will describe a methodology for certifying QC laboratory analysts.

In certifying analysts or working with people in general, the human touch matters. Recently, several previously certified analysts were asked what characteristics of the trainer were most important in providing the proper environment for the analyst certification process to be performed. They stated that they appreciated working with a certifier who was knowledgeable in the given method and thus seen as credible. The analysts also preferred a certifier who was approachable and friendly, someone interested in their welfare and looking to perform the exercise in a fair and collegial manner. The analysts thus liked the certifier to be like a teacher, gently challenging but wishing to facilitate and maximize their inherent capacity to learn. Finally, the analysts said that they appreciated a customer-oriented approach because the analysts represented a collection of unique individuals possessing different backgrounds and personalities. An analyst who is somewhat timid needs to be handled differently than an equally talented analyst who is supremely self-confident.

A workable methodology that includes the human touch is needed to establish the basic competence of the QC laboratory analyst in performing a given test method. The methodology may incorporate the following basic elements:

a dossier containing documentation that demonstrates that the analyst possesses the necessary education and has been “qualified” on the basis of some internal standard such as side-by-side training;

an analyst interview that is conducted by a qualified or “expert” certifier; and

performance of the given method in real time by the analyst and which is monitored by the certifier.

Let`s take a look at these elements in greater detail.

The dossier should contain evidence that the analyst has been educated at an accredited university or college and has received ancillary training or product-specific training. Regarding product-specific training, the firm should have a procedure that describes the analyst training program. Side-by-side training using stability samples or actual samples represents one way to assess testing competence. Subsequently, a comparison of the results between the trainer and trainee would be performed. A requirement that the analytical results fall within a certain percentage of the expected (labeled) result would constitute an acceptance criterion. An analysis of precision, accuracy and bias is worthwhile at this point.

The interview phase of the analyst certification process is designed to demonstrate to the certifier whether the analyst is able to accurately recount how the procedure is performed. During the interview phase of the certification process, one becomes accustomed to periodically asking questions that would demonstrate that the analyst understands some basic underlying theory associated with the test. It is useful to assume that a firm wants QC analysts to be both testers and thinkers. The analyst should know why the test is performed and what the results signify. Thus, if discrepant results occur or if there is an equipment malfunction of some kind, a thinking analyst will be more alert to notify the supervisor of possible testing issues.

The final phase of the certification process entails the direct observation of the analyst performing the particular test. The analyst must be able to exhibit the necessary skill and demeanor throughout the laboratory testing process. If an analyst knows everything about the procedure but has two “left hands” when it comes to practicing aseptic technique when performing the sterility test, for example, it is not likely that the analyst will be deemed certifiable at that point. Of course, the certifier must always be mindful that, despite attempts to the contrary, many analysts will be extremely nervous that their performances are being scrutinized by an outside person. Any mistakes associated with nervousness must be separated from mistakes associated with a lack of competence in any given phase of the certification process. We all make mistakes. Few of us like to be monitored.

Richard Prince, Ph.D., is president of Richard Prince Associates Inc. (Short Hills, NJ), a compliance and technical based consultancy,and an officer of Microgen, a provider of quality disinfectant-cleaner products. He can be reached at (973) 564-8565, fax at (973) 564-8731 or by e-mail: [email protected].