Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials
Addressing quality requirements of an investigational medicinal product for a given clinical trial without sharing…
“The following is an edited excerpt taken from The Windshire Group’s webcast Quality in the Laboratory: It’s in the Details Live Free Webcast Expert Panel Discussion
Deborah Miller: From our first introductions into a laboratory, we are inculcated with quality concepts and these concepts become part of our vocabulary, and are embedded in our procedures and processes. I have seen many cases where laboratorians, who considered themselves well-versed in quality management concepts and who can cite regulations and standards, and yet they are involved with assignable cause deviations, non-conformances and worse, release of erroneous results. So what goes wrong?
It appears that the concept of quality is so much a part of our day-to-day routine, we have blinders to the details needed to achieve quality outcomes. We think we are following quality principles, but we end up complacent about the execution.
I’ve seen instances where supervisors have been standing in a laboratory watching someone train another individual with no labels on any of the beakers, and when asked why aren’t there labels on the beakers? How do you know what’s in them? The person says, “Oh, this is just training,” and the supervisor allows that to continue. Or given a common laboratory requirement like wearing Personal Protective Equipment (PPE) and when it is worn incorrectly and it is ignored both by supervisors and coworkers working side-by-side, and no one says a word. So what is this? Why do we not “see” these digressions from what we know is right? And what causes this blind spot to carry into our policies, procedures and processes. We think we know what our procedures say and we think we’re executing them, but when there is a deviation investigation and the procedure is reviewed, we find that the procedure didn’t say what we thought it said.
During a recent review of a client’s deviation, the root cause was listed, as the technologist did not follow the SOP for the rest time before the next step, but when I reviewed the SOP, I found that the specific timing requirement that was assumed to be in there was not in there. So again, it’s in the actual details.
The training program is one precursor to this heedlessness at the bench. Is training comprehensive? Or do we just say read and understand the procedure, watch somebody else perform the analysis, demonstrate the analysis once and then the trainee is signed off as qualified on the procedure? I was the quality manager in an organization that hired analysts with no laboratory experience other than their college science courses, went through the read and understand training and the demonstration of the procedures and then gave the trainee an unknown sample to test. If they passed i.e., got the acceptable result for the sample, then they let her loose on the bench (signed the analyst off as qualified to perform the assay). There was no additional training on how to get samples, how to manage workload, troubleshooting or problem-solving or how to manage documentation. The ensuing waste of resources needed to follow-up on the resulting multiple deviations and the effect on the turn around time were all predictable outcomes from a deficient training/qualification process with the appropriate emphasis on learning and following the procedures and processes as defined.
So again, it’s in the particulars. Are we content to just document the training so we have a training record that is compliant with requirements? Or do we ensure that training is effective? Do we think “re-training” is the answer to every deviation? Or do we spend the time to ensure that employees really understand their task? Do our procedures have the detail necessary to ensure that the tasks are performed they same way, every time?
We need to recognize that being exceptionally conversant with quality concepts can cause us to be over confident in our ability to balance on the edge of the compliance cliff and can trigger quality sightlessness.
Need help with your quality operations or have any consulting needs? Please feel free to contact us. We have a broad range of expertise in all major therapeutic classes at all stages of the production life-cycle from clinical to commercialization – firstname.lastname@example.org; (+1) 844.686.5750
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Read the entire transcript – click here
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