Incident Resolution During Protocol Execution

The key to the successful execution of Qualification and Validation tests, begins with the timely identification of incidents. This will then ensure that each unique incident is addressed, documented, and resolved appropriately.

Successful execution of protocols is an essential part of Qualification and Validation testing. In addition to understanding roles and responsibilities, test procedures, acceptance criteria, and expected results, the tester must be able to record the actual results in an acceptable manner and according to Good Documentation Practices. It is, however, possible for one or more incidents to take place while executing protocols. Incidents that occur can take several forms, including a failure to meet acceptance criteria, failure to meet expected results, or changes to the approved protocol. We may also come across incidents that would be classified as discrepancies due to minor spelling errors or incorrect step numbering in the test script. (These will not affect the meaning or intent of the protocol.) Regardless of the type, measures need to be taken to ensure that every incident is addressed, documented, and resolved appropriately accounting to procedures and cGMP.

An incident resolution process is likely to be outlined in the protocol. Although the resolution process is expected to be specific to the type of incident, a few general guidelines can be followed if it is suspected that an incident has occurred. Firstly, the actual results should be recorded, and all additional testing should be discontinued. Following this, the results should be reviewed, and the project team should be requested to start an investigation. In the case that an incident could lead to a system change, the quality unit would need to be immediately contacted. However, if the incident itself is due to a test case or system issue that may occur again when execution resumes, the problem would need to be resolved before testing can proceed. In this case, execution should be ceased until a protocol deviation report is completed.

Significant incidents require a protocol deviation report, which would document details of the testing incident, its root cause, any corrective or preventative action taken, and details regarding the resolution of the incident. Once completed, protocol deviation reports must be approved by the project team, which consists of the Business Owner, Validation Unit, Quality Unit, and Technical Owner. A protocol deviation report would be required if the tester failed to follow the test procedure, document the actual results, capture support documentation, or in the case that the tester alters the actual result after test step completion. The use of poor documentation practices, which could lead to questioning the validity of the testing, can also warrant a protocol deviation report. Protocol deviation reports will also be required for each of the following: system changes that have occurred post-testing initiation, test steps that were performed out-of-sequence, system failures unassociated with the test occurred, and/or actual results that fail to meet the intent of the expected result.

Certain incidents that have the potential to affect the quality, efficacy, purity, or safety of a product are termed Quality Management System (QMS) deviations. These are formally tracked and managed by the Quality Unit and require a formal investigation to be conducted to determine any corrective or preventative actions that need to be taken. Although the chances of one occurring are low, QMS deviations typically occur when facilities, equipment, systems, or utilities are undergoing requalification. It is important to determine when an incident, protocol deviation, or QMS deviation has occurred to avoid the likelihood of future issues in testing that could affect the quality of the product.