CR Bard Medical
*PREVENTIVE ACTION RESPONSIBILITIES:identified issues concerning the manufacturing process and took steps to ensure they would stop, or slow the production of a quality health care product; work with a health care system that or exceeded industry standard levels formedical devices
*ROOT CAUSE ANALYSIS RESPONSIBILITIES:in the instance were a good was found not to comply with Food & Drug Administration, International Organization for Standardization 13485, or Good Manufacturing Practices regulations; a reasonable and logical explanation was provided for product failure and/or corrective action.
*TIMELY: corrective action/preventive action and root cause analysis was given to the Director of Quality and Production within a time frame considerate of the production schedule and goals.
*TRENDS ANALYSIS: Reported all frequently occurring issues, pertaining to Federal Drug Administration, International Organization for Standardization 13485, and Good Manufacturing Practices regulations were charted, reviewed, and discussed on a weekly basis with the Quality Control Manager and the Production Supervisor.