Laserfiche WebLink
<br />ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 <br />SOPAD018.08.07.12 Page 8 of 96 <br />2.3.3.2 Follow-up training is completed within 30 - 60 days and includes a more detailed <br /> <br />review and discussion of QA/QC policies and procedures. By this time, employees ' <br />are expected to be familiar with their responsibilities and have a general understanding <br />of ACZ's operations. The employee must read ACZ's QAP and any pertinent <br />supporting SOPS prior to attending the training, and should prepare questions in ' <br />advance, as material in each document will be reviewed and an opportunity to seek <br />clarification will be provided. The supervisor must schedule sufficient time for the <br />employee to read all pertinent documents prior to follow-up training. ' <br />2.3.3.3 A performance review will be conducted for a new employee after 90 days from the <br />hire date. The review is conducted by the supervisor and is based on general work <br />performance, supervisor observations, and feedback from the QA/QC department. <br />2.3.4 Sexual Harassment Training ' <br />Sexual Harassment training is required for each new employee and includes viewing a video <br />that demonstrates the identification, reporting, and remediation of harassment issues in the <br />work place. ' <br />2.3.5 Technical personnel must be thoroughly trained in the analytical techniques and operating <br />principles for all pertinent method procedures. Under no circumstances may any analyst <br /> <br />independently generate or review client data for a test procedure before completing the , <br />required training and receiving the explicit approval of the QA/QC department. Section 5 <br />provides details of ACZ's technical training program. <br />2.3.6 An employee performing only data AREV or SREV functions must be appropriately trained <br />regarding QC requirements, corrective action(s), and data qualification criteria stated in the <br />effective version of the test SOP. The trainee must first read the SOP, and then review all ' <br />pertinent information with the department supervisor. Items covered during training must be <br />documented using the appropriate form, and both the supervisor and the trainee must sign the <br />form. Thereafter, the effective version of the test SOP must always be used for data review. ' <br />2.3.7 Continuing training must be documented and at a minimum, the documentation must certify <br />that the employee has read, understands, and agrees to follow the effective version of a <br /> <br />revised SOP or other in-house document. The department manager is required to meet with ' <br />their staff to review the change(s) and to ensure each employee fully understands the <br />change(s). Training is documented using either FRMQA023 or FRMQA030, whichever is <br />most appropriate. <br />2.3.8 Training is required for all employees whose activities are affected by any procedural <br />change(s) to an SOP and is considered to be complete once the department supervisor has ' <br />reviewed the change(s) with all staff members and each employee has subsequently initialed <br />and dated the changed item(s) on the SOP Revision form (FRMQA030). Alternatively, if the <br />revisions have been incorporated into a new effective version of the SOP then training is , <br />documented using FRMQA023. <br />2.3.9 ACZ recognizes the benefit of continuing education and encourages employee participation in <br />advanced training courses, seminars, and professional organizations and meetings. ' <br />2773 Downhill Drive 970-879-6590 , <br />Steamboat Springs, CO 80487 www.acz.com <br />