Science & Research
Volume I - 5.2 Personnel
ORA Laboratory Manual of Quality Policies
5.2.1 Personnel Competence
Laboratory management ensures that laboratory personnel have the knowledge, skills, and abilities to perform their duties. Competence is based on education, experience, demonstrated skills, and training. Staff records contain the documentation of personnel education, experience, skills, and training for the position held.
Trainees undergo a training program in accordance with the laboratory’s training procedure and FDA Office of Resource Management/Division of Human Resource Development (DHRD) standards. For in-house training, a senior analyst serves as the trainer. Trainees perform procedures when training is completed and competency has been demonstrated. The documented demonstration of competence is an exercise that the trainee performs independent of supervision. The trainee is considered competent after the specified criteria have been successfully met.
18.104.22.168 Goals for Education, Training and Skills
The individual and management are jointly responsible for the setting, the pursuit, and achievement of educational goals for professional advancement. The annual performance evaluation process can be used by the individual to discuss career advancement and training possibilities. By using this process, individuals have the opportunity to identify areas of study and request training oriented towards the attainment of their goals. Procedures for employee career development are described in SMG 3120.1, Staff Development and Training, and FDA Supervisor’s Desk Reference, Chapter 8, Training and Development.
Training needs are identified in accordance with the analyst’s discipline (e.g. Chemist, Microbiologist) and FDA ORM/DHRD standards. In-house training is conducted according to laboratory’s training procedure. Present and anticipated tasks of the laboratory are addressed in the planning of special training modules.
Skills of personnel are based upon demonstration of competence. This demonstration is to be completed successfully before analysts generate data independently. The effectiveness of personnel training is documented in, but not limited to management reviews, internal audits, external assessments, proficiency testing, and performance evaluations.
5.2.3 Employees and Contracted Personnel
The laboratory utilizes the skills and talent of both full-time employees and contract personnel. The requirements of the management system are administered equally to both categories. No differentiation is made between the two categories of workers. Supervision, training, and competence are documented for all technical and key support personnel.
5.2.4 Job Descriptions
The laboratory maintains active job descriptions for managerial, technical, and key support personnel involved in tests. Job descriptions are established based on current duties and technologies utilized.
5.2.5 Management Authorization
The Laboratory Management authorizes identified personnel to:
- perform testing and calibration,
- issue test reports,
- give opinions and interpretations, and
- operate particular types of equipment.
Records of authorizations, demonstration of competence, education, training, and experience are maintained by the laboratory and dated. Training files are maintained and include these records.
- Volume II, Section 2, ORA-LAB.5.2 Personnel: Training Procedure.
- Each ORA laboratory maintains employee training files and authorizations.