How long should audits be?

Описание: Frequently I'm asked how short we can make an audit, but that depends upon what the scope of the audit is and what the audit criteria are. It also depends upon how many records your company has to sample.

Typically a supplier audit will be one day in duration if it is on-site because if you are taking the time to travel to the supplier you will want to get as much out of the audit as possible. You will typically only focus on the process that you are outsourcing to the supplier. Therefore, you will not be doing a full quality system audit. Instead, you can focus on just the manufacturing, packaging, or sterilization process that the supplier performs. If you were doing the audit remotely, you could even have a shorter supplier audit, because you only need the time to cover the processes that you outsource and the cost of travel is no longer a consideration for remote audits.

For internal audits it is very difficult to complete a full quality system audit in a single day. The FDA requires procedures for 25 processes and ISO 13485 requires procedures for 28 processes. If you are planning on completing a full quality system audit of each of those processes in one day, you would need to complete each audit in about 20 minutes. That is not nearly enough time for a thorough audit. Therefore, most full quality system audits are at least three days in duration.

An even better strategy is to schedule some of the more critical process that have changed for individual process audits that might be several hours in duration. Then when you conduct a larger full-quality system audit, you could skip those processes or spend less time sampling those processes because they were audited previously in the audit schedule.

If you are an audit program manager and scheduling audits, you also need to make sure you account for the time that is required to prepare for an audit and to create the audit report. We typically plan on at least 30 minutes for audit preparation for each day of auditing, and approximately 2 hours of time is needed to write a report for a day of auditing.

If you would like a quote for an internal audit, supplier audit, or mock-FDA inspection, please visit our audit quote webpage:

https://medicaldeviceacademy.com/audi...