Course Code: ELM-302-02

Audit Terminology You Need To Understand [Video]

Audit terminology is not always consistent and for that reason the organization’s SOP’s need to define the terms used, but for our purposes we’ll use the terms as follows.

Observations

Observations are just that, observations of note during an audit. They may be based on actual observation of activity, or observations of procedures and documentation.

They are notes which may be either positive or negative in nature. Observations are reviewed by the lead auditor and determined if they are findings or not.

Findings

A finding is a departure from an expected process. Findings are often divided into further categories.

These typically include:

  • Major Non-conformances
  • Minor Non-conformances
  • Recommendations

Although some organizations will use additional categories or alter the naming.

All categories need to be defined in the company’s procedure, but the following is how we will describe them in this course:

Major Non-conformances

Major Non-conformances are missing systems or systemic issues where a process is not being followed consistently or is not adequately meeting the expected criteria,

Minor Non-conformances

Minor Non-conformances are single or sporadic instances of non-compliance

Recommendations

Recommendations are not non-conformances, but recognized opportunities for improvements or recommendations of best practices.

Each finding should be referenced back to the specific observation.

Author

Don Rackham

Associate Director QA Asterias Biosciences