Overview

Audits are a critical tool for all safety critical industries - including medical devices, nuclear power, and transportation. Audits are a planned, independent and documented assessment that can be used to determine compliance with applicable regulations and standards as well as whether procedures are followed and are effective.

Each audit I perform begins with a detailed Audit Plan that identifies what, when, where, and who. The Audit Plan is reviewed and approved by the client prior to the audit.

The Audit Plan contains an agenda for each day of the audit. An Opening Meeting is held with the client’s Management Team to ensure everyone understands what will be happening. During the audit, documents and records are reviewed and people are interviewed. Copious notes are taken to help prepare the Audit Report. At the end of each day, a de-briefing is held to review the results of the day’s work. At the end of the last day of the audit, a Closing Meeting is held with the client’s Management Team to present the initial set of findings and observations and to ensure that everyone understands them.

A detailed Audit Report is prepared documenting what was found during the audit including both positive and negative findings. If requested, a "gap analysis" can also be provided along with recommendations for improvement.

Auditing Credentials

I hold ASQ Certifications as a Quality Auditor (CQA) and Software Quality Engineer (CSQE). I have completed the following additional auditor training courses:

• ISO 9000 Lead Assessor Training
• SEI CMM℠ Assessor Training

I have been the Lead Auditor on dozens of audits covering both software development and manufacturing functions in regulated industries.

My experience in software engineering, training, facilitating and auditing can help plan for and conduct a cost-effective audit. I have developed an audit process that minimizes disruptions while providing the meaningful results. This approach provides the best return on investment.