Preparing For An Audit

Conducting internal audits are a wonderful opportunity for an organization to learn about itself and improve. To receive the maximum benefit from an internal audit, it must be carefully planned and well organized. Here are a few hints to make your next audit run more efficiently. If you're a manager or supervisor of a department and not involved in actually conducting the audit, our goal is to give you a better understanding of the audit process.

The initial phase of the audit process is preparation. In his book Quality Audits for Improved Performance, Dennis Arter lists nine steps for successful preparation.  According to Arter the first step is defining the purpose of the audit. In essence this is your mission statement, the reason why you are conducting the audit. The second step is defining the scope of the audit or the specific focus and direction the audit will take. To help the process run smoothly, it is advisable to share this information with the auditee prior to the audit.

The third step is determining your resources. Resources need to be examined from the perspective of both tools and people. Who are the members of your audit team?  Do you have a representative from the training area? Trainers make excellent members of the team since they are frequently called upon to support corrective action in the form of retraining. Participating in audits also helps them assess the effectiveness of their training efforts. Other people to include are technical experts and management representatives.

Identifying the authority for the audit is the fourth step. The need to conduct "planned and periodic audits" is explicitly stated in the Medical Device Quality System Regulation. By clearly establishing the authority of the audit team, you increase cooperation from the auditee. The fifth step, identifying the performance standards that form the criteria for the audit, should be driven from a review of all appropriate policies, procedures, technical drawings and any other documents used in the operation. Informing the auditee is the sixth step in Arter's process. We advise you share all the information generated from the first five steps with the auditee.