Understanding the Differences Between Deviation and Nonconformance

Create clear definitions within your workplace and keep up with standard practices

The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation and nonconformance. Often, this leads to confusion about how events should be classified and managed.

This article explains the difference between a deviation and a nonconformance, and why your own organization’s definition is ultimately the most important. We also discuss the role of an enterprise quality management system (EQMS) in managing events and incidents.

Deviation vs. nonconformance in pharma and biotech

In the pharmaceutical industry, a deviation refers to any departure from an approved instruction, procedure, established standard, or specification. A nonconformance, on the other hand, is defined as an output that doesn’t meet specifications or requirements.

For example, a documented SOP states that lab personnel must shower and change clothes every time they move from Lab A to Lab B. Anytime someone doesn’t follow the procedure, that’s considered a deviation.

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Comments

Useful insight

Great article. It is potentially very useful to use a deviation over a nonconformance to lessen, as you say, the "penalty to the plant" and "negative cost". But since both processes include corrective actions, is there a benefit to calling procedural errors that do not result in product nonconformities as deviations, as opposed to minor nonconformities?

Nonconformance

The distinction between deviation and nonconformance isn’t clear, particularly in processes. The example of employees not following shower accordance to SOPs is a not conforming to process requirements, risking contamination that is difficult to detect. If this was a hospital, sterility suffers and won’t be detected until an infection occurs. FMEAs recognize the need for early detection, potential severity and likely occurrence. Lately this as a deviation is a detriment to safety and quality.