ppt课件-internalaudits-healthcareconferenceadministrators.pptVIP

TrackA.Cekala-Reilly.3.29@10.30am MD Creating an Efficient Internal Audit Program Carol Cekala Susan Reilly TDC Medical Reilly Associates Presentation topics What is an audit? Making it work Who audits? Selling to management Communicating results What is a quality audit? What is a quality audit? Objective assessment, performed at defined intervals and at sufficient frequency, of a company’s quality system to operate against a given criteria Systematic Independent Documented What is a quality audit? Provide factual, unfiltered information to manage the quality system A tool for use by management Regulatory requirement (FDA, ISO, etc.) Help minimize risk “Close the loop” for other elements of the quality system What is a quality audit? Detect program defects and through isolation of unsatisfactory trends and correction of factors that cause defective products, prevent the production of unsafe or nonconforming devices. Assure the manufacturer is consistently in a state-of-control. What is a quality audit? Audits are not a quick look Audits are preventive, not detective Audits are planned, organized, and coordinated Audits are carried out for the benefit of the company, not the auditor A single audit will not find all noncompliant issues or potential problems Essential program elements Making it work Why do YOU audit? How many companies perform audits just because “you have to”? Best guess – at least 75% of medical device manufacturers Making it work Making it work Step 1 - Comply Conforming to requirements; to conform, submit, or adapt (as to a regulation or to anothers wishes) as required or requested Regulatory / standard compliance Do we have the systems and procedures we are supposed to have and do they meet the regulatory / standard requirements? Making it work Making it work Step 2 - Effective Producing or capable of producing an intended result Collection of and review of objective evidence Do we follow our procedures and maintain the required records