How to Remove Variation From GMP Auditing

Those of us with a manufacturing quality background can easily explain the evils of variation in manufacturing. Variation in manufacturing leads to nonconforming product (defects). We readily recognize the two types of variation.

Common Cause variation is variation that is inherent in the process. The source of this type of variation might be difficult to identify and control. Special (Assignable) Cause variation can be pinpointed to a specific cause. Because the source can be identified, control of assignable cause variation tends to be easier. Special Cause variation must first be removed, prior to attempting to control Common Cause variation.

GMP Auditing is no different. Variation in GMP Auditing can have the same impact as variation in manufacturing. Instead of creating nonconforming product, GMP Auditing variation results in an ineffective GMP Auditing system. In a worse case, GMP Auditing variation could result in the collapse of the Pharmaceutical Quality System.

It is important to note that when we discuss variation in GMP Auditing we are not talking about making all GMP Auditors audit exactly the same way and do the exact same things. Removing variation does not mean that we need to remove any flexibility GMP Auditor’s need to properly perform their tasks.