Quiz: FDA ORA Laboratory Personnel Training and Competency Management
Test your understanding. Select the best answer for each question.
1. According to the technical training procedure, what is the correct sequence of steps for training an analyst on a new laboratory procedure?
Section 6.2 specifies a four-step sequence: the trainee first reads the procedure, then observes a trainer's demonstration, then performs the procedure under trainer observation, and finally performs the procedure independently.
2. A trainer wants to assess all phases of laboratory performance - including pre-analytical and post-analytical phases - in a realistic setting. Which assessment tool is most appropriate for this goal?
Section 6.3 states that blind QC samples - which employees are unaware of and which appear identical to routine samples - assess all phases of laboratory performance, making them the most comprehensive tool for realistic performance evaluation.
3. A laboratory analyst hired in 2019 has a doctoral degree and five years of prior FDA laboratory experience from another agency. Which statement correctly describes their Level I Analyst Certification requirement?
Section 6.8.3 explicitly states that all laboratory analysts hired after January 1, 2002, must complete the standard training curriculum and achieve Level I Analyst Certification regardless of education level or prior laboratory experience.
4. Under what two conditions is an employee required to undergo retraining?
Section 6.7.1 states that retraining is required whenever significant changes occur in policies, procedures, processes, methods, or instruments, and also when an employee's level of performance is assessed as unsatisfactory.
5. Which of the following must be included in a training record to meet the requirements outlined in this SOP?
Section 6.6 specifies that training records must include a description of the training, the trainee's legal name, the trainer's legal name, dates of received training, and an indication of whether successful completion was achieved by the named trainee.