Planning a Thorough and Effective Quality Audit

• Define Objectives:

  • Clearly outline the objectives of the audit. What are the organizational goals and desired outcome.

• Identify applicable regulations and/or standards

  • Establish audit criteria based on applicable industry regulations and standards, and internal best practices.

• Determine purpose and scope

  • Determine the scope of the audit, including specific departments, processes, or systems to be reviewed.

• Gather relevant information

  • Collect and review relevant documentation, such as SOPs, batch records, training records, previous audit reports, and regulatory guidelines. This helps auditors understand the processes and systems to be evaluated.

• Review audit history

  • Understand historical audit findings and how successfully remediations were implemented into the organization.

• Prepare a detailed audit agenda

  • Prepare checklists or questionnaires to guide the audit process. These should cover key areas of compliance and performance. Notify relevant departments and personnel about the upcoming audit. Provide them with information on the audit scope, objectives, and schedule.