The word “audit,” in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.
In these examples, there’s a systematic attempt to take a closer look at something — whether financial statements or a factory process or customer service — for the purpose of evaluation and, ultimately, decision making.
The fact that the audit process casts auditors on one side and the people being audited on the opposite side has created a general impression that auditing is adversarial. While there may, indeed, exist a point-and-blame atmosphere in some cases, more and more organizations recognize that an audit does not have to be a negative experience or a dreaded event. When implemented properly, it can be one of the most effective means for improvement. From financial institutions to manufacturers to hospitals, audit is being utilized as an important management, compliance, and quality tool.
In the FDA and ISO environments, audit — both compliance and performance — is critical. Considering the type of products that the FDA regulates and the diversity of the industries where ISO quality standards are applicable, auditing for the purpose of maintaining high quality standards directly impacts public health and safety. In these environments, the audit process is closely associated with quality and directly related to regulatory compliance.