Contact Support

Medical Device Audit Preparation

Quality system audit schedules are typically published at the beginning of each year; however, internal auditing personnel may find themselves unprepared when actual audit dates approach. In such instances, companies undertake last minute preparations of checklists and audit questions that generally take months to develop. This can lead to a rushed audit process where corrective actions and improvements may be missed.

Proper preparation for internal system audits is crucial for positive outcomes for all audit processes; time management makes up a large part of this preparation. Proper scheduling and formal allotment of time for the audit effort and for the resources involved are critical for audit preparation and success.

What does appropriate audit preparation look like?

Auditing staff can generate checklists and questions relevant to procedures they’re examining, and familiarize themselves with procedures under their auditing scope ahead of time. The first time auditing a process or procedure is usually the most difficult for staff because prior checklists may not exist, so proper preparation time makes a big difference in these cases.

Solution: Proper Planning and Preparation:

Examples of steps and strategies organizations can take to ensure better audit preparation include:

  • Utilize calendar programs to schedule preparation time
  • Formally allot work time for audit preparation activities
  • Establish checklists and questions, and require adherence to them.
  • Familiarize yourself with processes and procedures to be audited before auditing them.
  • Assemble a team with competency in the necessary fields that are to be audited
  • Schedule Meetings on a regular basis for status updates