ASI’s has implemented Statistical Process Control in conjunction with Six Sigma methodology to track the performance of internal processes and customer complaints. SPC and Six Sigma provide a common internal language for the management of Advanced Scientifics manufacturing environment, assurance of Quality and control of operations.
Environmental monitoring is conducted and statically trended to assure compliancy to ISO Class 7 & ISO Class 8 clean room requirements and to assure ASI Single Use Systems are manufactured under controlled conditions. All processes are centrally controlled by a highly customized ERP software system. This system allows the traceability, document control, quality control, and price control of customer part numbers.
Internal/External audits are performed regularly to strengthen the internal Quality Management System and to comply with ISO 13485:2003 and FDA 21 CFR 820 regulatory requirements.