How to Develop and Implement the Successful Internal Audit Program

Internal auditing is the key activity to ensure that your FDA or ISO compliant quality system continues to be suitable and effective.The internal audit system must be efficient, effective and most importantly, user-friendly. However, more often than not, internal audit programs can have their own inbred set of problems that may cause delays, inefficiencies and outright failure. These problems can include:

• Perceptions of the work force
• Workload of the audit staff
• System design inefficiencies
• Lack of management support
• Poor corrective action tracking and timely closure

Without an effective, efficient and supported internal audit system, the culture of compliance will deteriorate and the loss of registration or a warning letter becomes more of a possibility. Each of these issues have been experienced and managed to closure by the presenters.

• How will we select the audit staff?
• How many auditors and lead auditors should we train?
• To what criteria will we train our audit staff?
• How will we schedule our audits and auditors?
• How many audits are appropriate for a department or a requirement?
• How will we measure corrective and preventive action effectiveness?
• How can internal audits be measured and integrated into business metrics?

• Quality Directors & Managers
• Quality Engineers & Auditors

Instructor Profile:
Daniel S. Whelan, Mr. Whelan has more than 30 years experience in manufacturing and quality assurance, working for leaders in their respective fields such as Polaroid, Orion Research and Pfizer Hospital Products Group.

Since 1993, Dan has consulted in the medical device industry and elsewhere as Principal Consultant at Quality Assessment Services, a quality management consulting firm based in Plymouth, Massachusetts. Global assignments include work in Central & South America, and in Europe. He has been a featured speaker and presenter at local society meetings, regional and national conferences, and New England area colleges. He has also conducted public seminars and client training in a number of subjects, including: Quality Auditing, international quality management standards ISO 13485 and ISO 9000, and the US DHHS FDA’s Good Manufacturing Practices for Medical Devices. The QA Services client list includes prominent medical device manufacturers such as SynCardia Systems, Inc; Arrow International; Boston Scientific Corp.; Ethicon Inc. and Ethicon Endosurgery; Smiths Medical; GE Sensing and Accellent Inc., among others.

Mr. Whelan was an elected officer of the American Society for Quality.

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