Paul Mason, Ph.D., Senior Director, Lachman Consultants05.18.23
Most companies will recognize and state that their most important assets are the people who work for them, which is naturally also the case for the pharmaceutical industry. It goes without saying that the number of staff and their competency can have a consequential impact on product quality/patient safety, and this is recognized by health agency investigators. For example, CPM 7356.02 states, under the inspection of a firm’s Quality System:
“Training/qualification of employees in CGMP: Includes coverage of quality functions, risk management, and specific CGMP operations assigned to individual employees.”
And for inspection of Laboratory Control System there is reference to:
“Adequacy of staffing for laboratory operations”
This can lead a department or area manager to ask, “How do I know whether my staff are suitably trained and whether I am adequately staffed?” Companies will commonly use quality metrics where one would trend for events/deviations/audit findings, assessing for any causal linkage to staffing level and/or staff performance. However, there should always be awareness, when evaluating a quality incident, that the direct cause may be assigned to human error but, upon trending, there may be indication of an underlying cause, such as inadequate staffing and/or adequacy of a training program.
When evaluating a training program, there should be a focus on the robustness of the criteria by which one determines a newly trained employee is considered qualified for a task/activity and the mechanism for periodic assessment to determine whether they continue to be qualified. For example, is “read and understand” always an appropriate approach for training? It should be clear within a firm’s training program when “hands‑on” demonstration is required, along with a quantitative criterion, such as the testing of blind samples for the basis of being qualified on an analytical technique. Similarly, there should be a process by which management assigns tasks/activities to minimize the risk of overloading anyone, which can result in “rushing,” with a detrimental impact on quality. Considering this risk, it is critical that every firm foster a culture where employees can “speak up” and notify management when they feel that what they have been assigned is too much in terms of either the number of tasks or timeline, whereby minimizing the risk of rushing or cutting corners.
A lot of firms fail to give staff training/oversight the focus required, considering that it is the foundation for a majority of the activities at the firm. It is recommended that firms risk‑assess their detection measures to identify instances of operator error, recognizing that not all instances may result in incidents. Could your firm’s quality system detect cases of human error resulting from training issues or "rushing”? For example, in a Quality Control Chemistry laboratory, a firm may design its Reference Standard to have a unique profile such that if it were inadvertently used in place of the sample, this would be readily detected during data review—understanding that not every human error results in a specification being exceeded as there is a risk of a human error resulting in a false positive.
If you have any questions relating to staffing and associated systems/processes, Lachman Consultants can help you!
Please contact Paul Mason at p.mason@lachmanconsultants.com for support with this critical undertaking.
Paul Mason, Ph.D., is a Senior Director at Lachman Consultants who has 20+ years of experience in the pharmaceutical industry. He is a Quality Control chemist experienced in sterile parenteral, API, and solid oral dosage forms. His experience spans finished dosage form, CMOs, and API (intermediates) manufacture support in both a Quality Control and Analytical Development setting. Dr. Mason possesses a deep understanding of business strategy relating to drug research, development, quality assurance, quality control, CMC submissions, laboratory design, clinical and pre-clinical quality/analytical development support. In addition, he has provided expert scientific support for the timely resolution of complicated scientific issues raised by FDA application reviewers.
“Training/qualification of employees in CGMP: Includes coverage of quality functions, risk management, and specific CGMP operations assigned to individual employees.”
And for inspection of Laboratory Control System there is reference to:
“Adequacy of staffing for laboratory operations”
This can lead a department or area manager to ask, “How do I know whether my staff are suitably trained and whether I am adequately staffed?” Companies will commonly use quality metrics where one would trend for events/deviations/audit findings, assessing for any causal linkage to staffing level and/or staff performance. However, there should always be awareness, when evaluating a quality incident, that the direct cause may be assigned to human error but, upon trending, there may be indication of an underlying cause, such as inadequate staffing and/or adequacy of a training program.
When evaluating a training program, there should be a focus on the robustness of the criteria by which one determines a newly trained employee is considered qualified for a task/activity and the mechanism for periodic assessment to determine whether they continue to be qualified. For example, is “read and understand” always an appropriate approach for training? It should be clear within a firm’s training program when “hands‑on” demonstration is required, along with a quantitative criterion, such as the testing of blind samples for the basis of being qualified on an analytical technique. Similarly, there should be a process by which management assigns tasks/activities to minimize the risk of overloading anyone, which can result in “rushing,” with a detrimental impact on quality. Considering this risk, it is critical that every firm foster a culture where employees can “speak up” and notify management when they feel that what they have been assigned is too much in terms of either the number of tasks or timeline, whereby minimizing the risk of rushing or cutting corners.
A lot of firms fail to give staff training/oversight the focus required, considering that it is the foundation for a majority of the activities at the firm. It is recommended that firms risk‑assess their detection measures to identify instances of operator error, recognizing that not all instances may result in incidents. Could your firm’s quality system detect cases of human error resulting from training issues or "rushing”? For example, in a Quality Control Chemistry laboratory, a firm may design its Reference Standard to have a unique profile such that if it were inadvertently used in place of the sample, this would be readily detected during data review—understanding that not every human error results in a specification being exceeded as there is a risk of a human error resulting in a false positive.
If you have any questions relating to staffing and associated systems/processes, Lachman Consultants can help you!
Please contact Paul Mason at p.mason@lachmanconsultants.com for support with this critical undertaking.
