PROCEDURES
Why on earth have documented procedures that are not followed?Failure to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by 21 CFR 820 are correctly performed, as required by 21 CFR 820.25(a). For example: a. The job description for the Director of Quality Systems requires that the person have a Bachelor of Science/Technical/or Engineering discipline. The person holding the position does not have this type of degree, but rather a Business Administration degree. b. The person holding the Regulatory Affairs Manager position lacks the minimum of 5 years of regulatory experience required in the job description. c. The person holding the Quality Control Supervisor position lacks the required Bachelor degree in science or the alternative five to eight years experience in Quality Control. d. The person holding the Calibration Coordinator position lacks the required Bachelor degree and the four years of relevant experience. We have reviewed your response dated March 26, 2010, and have concluded that it is not adequate because the replacement Regulatory Affairs Manager does not have qualifications that meet the qualifications required in the job description. You stated that you are conducting a global review of personnel to compare qualifications and job descriptions of all individuals who have direct product impact to determine if their background and experience match the requirements of their current job description and are conducting a review of the Human Resources processes that support the development of job descriptions and the identification and selection of personnel. However, this process is ongoing and evidence of its completion and effectiveness was not provided. FDA Warning Letters June 2010 |
