Personnel controls ensure that personnel have a suitable education, experience and training.
This is controlled through a detailed job description which should correlate to the employees resume’ or CV.
Sample Job Descriptions
Part of the FDA’s audit process is to sample job descriptions and resume’s and verify that the personnel have the required education and experience, so it is imperative that these documents be aligned and good practice is to have signed and dated copies of the job descriptions as part of the training files.
Training Records
Additional personnel control is documented through training records which should provide evidence that the employee is trained on each process for which they are responsible for executing.
It is recommended that proficiency be further documented by providing a short quiz for each process and establishing minimum requirements.