This week, Dr. Simon highlighted the importance of quality audits and especially internal audits. The FDA expects each organization to conduct at least one internal audit per calendar year. Internal audits are usually conducted in parts by independant employees to the part/process being audited. This can be a huge burden on small organization that has only one quality engineer. This quality engineer cannot audit his own work, and the company may not have the resources to hire another quality engineer just for audits.

What is your take on this? have any of you had experience in dealing with such issues?