Essential knowledge: The candidate must be able to demonstrate essential knowledge required to effectively do the task outlined in elements and performance criteria of this unit, manage the task and manage contingencies in the context of the identified work role This includes knowledge of: Awareness of manufacturing contaminants relevant to the manufacture of optical appliances including control methods to prevent occurrence possible consequences and the conditions under which they occur the types of contamination likely to occur Basic concepts of quality assurance including: control methods operating parameters quality specifications validation procedures understanding of related documentation including Standard Operating Procedures Basic understanding of the properties, handling and storage requirements of manufacturing aids, raw materials, measuring and calibration devices and manufacturing related components and final products Control methods and procedures used in the manufacture of optical appliances to maintain GMP which includes: an understanding of the purpose of control identifying variances to the manufacturing process the consequences if not controlled and the method of control if relevant It may also include: corrected use and supply of quality manufacturing aids purpose and requirements of validation procedures purpose of equipment calibration understanding of methods used to monitor process control, GMP responsibilities and requirements relating to work role GMP arrangements in the workplace including an awareness of relevant GMP codes of practice and related organisation policies and procedures Housekeeping requirements and responsibilities relating to own work (where relevant this may include use and storage of housekeeping/cleaning equipment) Organisation policies and procedures to investigate manufacturing contamination events and performance improvement processes continued ,,, |