Personnel

It is our policy to hire only qualified personnel and to assure that they are trained in all aspects of their jobs. Copies of job descriptions, job applications, resumes and annual performance reviews are kept on file in the Human Resources Department.

The Company has a Personnel  Training Program (including the applicable regulations), conducted by Quality Assurance, which all employees are required to complete. Upon satisfactory completion of this training by an employee. Quality Assurance maintains a master log of
all training attended record of completion issued. Ongoing training, as necessary, assures personnel are familiar with applicable requirements.

The Company has provided the risk analysis training to Managers and Directors responsible for the manufacture and testing of our products. It is the responsibility of these trained employees to assure that all of their employees are familiar with the pertinent

aspects of these regulations.

Regulatory Affairs maintains a file of all pertinent Standards and assures that the latest revisions are available. When revisions are available, this is communicated to Quality Assurance and other pertinent personnel so that we can keep up-to-date on the latest regulations and standards.

Each department maintains job-specific training records for its employees. Supervisors are responsible for job-specific training, for training on new or revised documents, for assuring that training is effective and for maintaining training records. Notification of document changes are issued as a trigger for training.

Related procedures:

• Personnel Training Procedure 
• Procedure for Generating Training Reports 
• Required Standards Listing, Maintenance and Review