Very stressful, high pressure, volume-based business. More than a dozen people in leadership positions were fired this year alone and this has created a culture a fear, distrust and uncertainty. The managers who remain must be almost tyrannical to their employees to survive. Quality Assurance is presently not given enough authority to achieve the necessary assurance of patient safety and effectiveness. (This is now changing however) Production often makes significant changes overnight with no advance notice and no involvement by Quality Assurance. (Again, there is hope of turning this around though).
Process Changes are poorly thought out, often without procedural change controls and execution of those changes results in painful errors and deviations which take hundreds of man hours to resolve and crush the morale of the employees. New product introduction is rushed to validation without first performing engineering batches. Quality Assurance often doesn’t know that a validation batch is running on the floor until they have to clean up the aftermath of non-conformances and documentation nightmares resulting from the lack of communication, training, and preparation for these new batches.
Newly hired sterile compounders are rushed through what should be 6 weeks of intensive aseptic technique training in a matter of days. They are pushed into doing their media fill qualifications and then immediately put to work to achieve production quotas while the product itself remains on Quality Hold until the results of their qualifications are ready. The Quality Hold system, which was only designed to handle exceptions, is now being forced into an almost daily routine of scores of batches on hold. This is straining that QA Hold system to the breaking point and putting product and patient at risk. No incidents have happened so far, but the Lot Disposition team has discovered several instances where product that was compounded by a new employee awaiting qualification results had NOT been put on hold and was nearly released. This is obviously a serious concern.
I believe the root cause of all of the above is fear. After witnessing a dozen colleagues receive the Ban Hammer around them, management is terrified to tell it like it is to the CEO and executive management and honestly inform them of the true cost of rushing things without proper preparation, training and communication.
Meanwhile, exceptionally talented employees are not recognized or promoted fast enough to retain them. They are quickly snapped up by companies that do. The result is a talent drain which leaves behind demoralized and unmotivated staff.
I am sad to say now, that my perception is that our CEO and venture capitalists who have invested in QuVa appear to care more about growing the business quickly so that they can sell it at the highest possible profit one day than they care about the welfare of the patients that our products serve.
I was once proud to work for QuVa. I still am in some ways, but that pride which once shined like a new penny, has now dulled like one left at the bottom of a cup holder soaking in the sticky mire of spilled coffee in a 10-year old car.
