As noted earlier, issues can arise in areas other than just the product. Here are a few examples of systemic issues related to processes.

Example 1

An internal audit determined that the Quality System did not address an aspect of CAPA requirements, namely the means to assess effectiveness of corrective actions. Since the process documents had already been reviewed, approved, and implemented, the issue was considered systemic.

Example 2

During an FDA inspection, the company was issued a 483 for not always recording customer complaints. Customers were calling in with problems and the individuals receiving the calls were walking the customers through the resolution process. The individuals taking the calls did not understand that all complaints had to be recorded. Note that because of this, a latent design flaw was not being addressed! During a registration audit, the auditor found that the company was not conducting internal audits. The procedures were in place but there was nothing that triggering the internal audit and so they were just forgotten.