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A PUBLICATION OF KAVON INTERNATIONAL, INC.

“Speaking Out”

April 2007

Francis Lamm

Francis Lamm holds an A.A.S. in Electronic Engineering Technology from the Central Technical Institute of Electronics and the American Society for Quality has certified him as a Quality Manager. Mr. Lamm brings over forty-five years of experience to the KAVON team. In that time, he has achieved countless benefits for his clients, including material review and scrap reduction programs for clients. This efficiency has helped them save over $250,000. Furthermore, he has lead countless clients to ISO 9001:2000 and ISO 13485 certification. He brings the expertise FDA current good manufacturing programs (CGMP) and Quality System Regulations, among many other things, to the KAVON team.

Internal Auditing

Why Should A Company Conduct Internal Audits?

By Francis Lamm

In order for any company's management system to be effective, it is absolutely necessary to conduct periodic audits of its procedures and processes to ensure that the goals and objectives established can be achieved and improved. Obviously, this is a mandatory requirement for any company that is required to meet Governmental Agency, Industry, and Domestic/International Quality Standards. Additionally, internal audits are required to:
  • assist a company in identifying opportunities for improvement (OFI), to prevent or correct real and potential problem areas before they escalate into disasters, and to insure that customer requirements are continually met and/or exceeded


  • provide inputs to mandated quality management system (QMS) review processes


  • identify quality and management system problems/deficiencies that could affect customer satisfaction


  • verify effectiveness and performance of the quality management system procedures and processes


  • provide meaningful and measurable performance analysis data so that appropriate continual improvements can be made to the quality management system


  • assure that all applicable statutory, government, industry, and regulatory agency requirements are achieved and adequately met in the immediate and long-term periods


  • support the company's efforts to register and maintain industry and regulatory requirements, such as FDA, FAA


  • maintain and improve customer satisfaction, and identify opportunities for continual improvement program activities


  • conform to ISO, AS, TS, and other required standards derived from ISO 9000, as required
An internal auditing program is the core of any company's quality management system. If a process management approach is being conducted to meet the requirements of an ISO or related quality standard, there is a need to conduct process audits. This adds an emphasis to the auditing process, which companies and related organizations need to understand when developing their audit plans. Some companies may already be conducting some forms of process audits and may not be aware of it. A point to consider is that the newer ISO, industry, and government regulatory standards are mostly process-based. When internal auditors verify and determine conformance to both procedures and processes, this allows for a more in-depth audit style that provides more information to determine if the processes are adequate and being religiously followed by all affected personnel. Experienced, trained auditors do not merely audit only individuals, they assess and evaluate the effectiveness of the total quality management system in place.

As a closing point, an ISO or government mandated quality management system is a formal, documented management control system, which promotes setting of quality and achievable (business) objectives and goals. Thus, an advantage of internal auditing is that a company can periodically generate opportunities to evaluate just how well a particular business objective or program is performing, or if changes in scope or program adjustments require consideration. Internal audits may be utilized to monitor and ensure that the activities are going as defined in the program plan and any issues found may be resolved early on in the process.


KAVON International, Inc. is a business consultancy that helps clients create Value in order to attain and sustain a Competitive Advantage in the markets they serve. If your company is seeking registration or compliance to any of the Quality Management System standards such as ISO 9001, ISO/TS 16949, AS9100, ISO 17025, ISO 14001, or ISO 13485, or wants to establish a continual improvement program using Lean Six Sigma methodologies, give us a call and let one of our Trusted Advisors help you with implementation and training.



© Copyright 2007 by KAVON International, Inc., All Rights Reserved

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