The purpose of an inspection is to show that the facility’s employees are properly trained and competent and to determine whether the procedures are effectively implemented and maintained.

What Will The Inspector Look For?

Inspectors look for system conformity and regulatory compliance through interviews, observations and the review of documents and records.

Documented or verifiable evidence that:

• Activities are understood;
• Activities are conducted consistently;
• Activities are completed;
• Records are maintained as required.

Review of documents and records

• Check for sequence of data and incomplete forms;
• Check for use of correct version of documents and forms;
• Compare data that is transcribed or copied;
• Verify latest information is available for use by individuals.

How To Prepare For An Inspection?

1. Review your quality manual and procedures to ensure they are up to date;
2. Review documents and records to ensure they are complete and up to date;
3. Verify that all employees have been trained on all aspects of the HT Program.