There are many tools available to support quality and risk management in the IVF Lab. However, they are not specific to our field – they are all very well-established generic tools and techniques that have been used for many years in all areas of business.

Inspection and audit are observational tools that establish what is happening and whether defined practices are being followed. More in-depth investigations where a process must be analyzed and improved, or risks identified and managed, might need to be undertaken either proactively or retrospectively, for which the most commonly used tools are Failure Modes and Effects Analysis and Root Cause Analysis respectively.

Inspection

Inspection is simply the careful examination of what goes on in the IVF Lab:

• what the environmental conditions are in the lab;

• is the lab equipment working properly;

• what happens in the lab in terms of material and people movement;

• are the products used in the lab appropriate and suitable for use;

• how tasks are performed;

• how information is recorded; and

• how data are analyzed.

It involves the collection, collation and analysis of data, as well as the examination of processes, which is best accomplished using process mapping. The daily equipment logs maintained by IVF labs following GLP come under this heading, as does the filing of Certificates of Analysis for each batch of culture media and other reagents and routine QC checks on equipment. Unless such information is carefully recorded and/or filed it will not be available if required in a future troubleshooting exercise.