Auditing Tip of the Month
December 1997

Types of Auditing

Quality auditing is a skill that needs to be exercised at a variety of levels in order to be most effective. This month's tip will examine the three different types of auditing and how they should be used.

1. Personal Auditing
   Every person, regardless of the position or job title they have, is responsible for personal auditing. This requires that we look at the requirements of our job from time to time and examine our performance to see how we are measuring up, and what areas need improvement. When doing this, it is important not to forget to note the areas of job performance in which we excel as well as the areas in which we need improvement. Upon completion of this self-audit, it is good to make a plan for the future. This plan should involve concrete action plans to improve performance, and can be shared with a supervisor. It is often important to involve the supervisor, so that you get necessary support in carrying out the plan, and so that additional resources can be procured if necessary.
2. Internal Auditing 
   Internal auditing is executed at the company level. Companies must designate a person or team of people knowledgeable about company standards and governmental regulations to conduct internal audits. These people should not be directly responsible for the areas they will be auditing to encourage objectivity.  Internal auditors can then do routine checks of the manufacturing process, facility and equipment to ensure that all products are safe, pure, and effective, as well as having been manufactured in a state-of-control. Internal auditors should develop good relations at all levels of the company, as their function is to help all departments improve. Internal auditors who are seen as adversaries are much less effective than those who have developed trust and relationships.
3. External Auditing
   External auditing is performed by a governmental agency or other company to ensure that quality standards are being properly kept. FDA audits all regulated companies to ensure compliance with GMP and other regulations. It is important to be ready for an FDA inspection by always following SOPs and being devoted to continuous improvement. Companies, however, can also engage in external auditing of their suppliers. As companies are responsible for the quality of their final products, it is important that all raw materials and components are manufactured under a state of control. Therefore, it is often necessary to inspect the quality systems of suppliers.