API

API focuses on a "3 + 1 Steps Approach" to Technical Compliance Auditing by evaluating: Firstly: Our Quality Management Systemassesses whether your supplier's top management has committed to continuous quality improvement process and whether the framework necessary to achieve adequate quality levels is in place. The quality managment system specifically evaluates the responsibilities and authorities; the Quality Manuals & Operational Procedures; company policy, objectives, targets and indicators as well as commitment to continuous improvement; documentation and records control and finally the customer satisfaction and complaints management. Secondly: API Product Qualification assesses whether your supplier has the relevant product knowledge and is able to manufacture products that comply with international regulations and the customer's requirements. PI audits specifically evaluate internal quality control standards; the design and engineering of new products; the knowledge of international regulations; the capacity to ensure products conformity and effectively manage technical construction files management,and finally,internal laboratory evaluation as well as relationships with and control of 3rd party laboratories. Thirdly: API Mass Production Control assesses your supplier's organization and implementation of quality procedures at each step of production which allow supplier mass production to achieve the necessary quality level. PI Audits specifically evaluate the selection of suppliers of incoming materials, the handling of incoming materials, the quality inspection procedures upon receipt of materials (IQC); workplace organization (planning, performance follow-up, layout); factory capacity, production tools and workers training; thehandling of semi-finished products, quality inspection during production (IPQC) and finally the handling of finished products and final quality inspection (FQC) up to shipment procedures. In order to evaluate the capacity of your supplier to deliver goods in a disorganized work environment, we have developed a final step: the "Production Flow Control" process. This step is designed to help you to evaluate whether or not your supplier has taken into account threats for product quality arising from badly organized and unclean work environment.