Meager Internal Auditing Program

This week, I will address the ninth of nine common CGMP Quality System shortcomings; Meager Internal Auditing Program.

Many of the internal auditing programs that I have witnessed are less than stellar. A collection of loose audit plans conducted by semi-qualified personnel is not a recipe for success.

Although auditing can be less than a glamorous job, a comprehensive auditing program is critical to implementing a successful Quality System. A robust auditing program can greatly increase the effectiveness of a Quality System by; ensuring raw materials are suitable for use, catching issues early enough to preventing them from becoming a crisis, facilitating methods for improvement, and eliminating the tragedy of significant regulatory deficiencies being discovered by the Authorities.

Many companies only expect auditors to have a minimal amount of experience and then rely on the auditor’s experience to do the job right. These companies treat auditing more as an art form instead of a regulatory science. This approach may work if the auditors are extremely experienced and had developed their own set of auditing tools, but the reality is that most experienced auditors are pursuing higher paying and more powerful positions.

To overcome this shortcoming, the Quality Units should establish a systematic audit program that relies less on auditor experience and more on robust auditing tools. Once established, retention of trained and qualified auditors should become a high priority. I have developed such a system that will transform a meager auditing program and train less seasoned auditors. See my website: www.gmpace.com.