Test Deviations during Validation

Document the deviation
The deviation should be documented according to the applicable procedure or protocol.
This should include assignment of a reference number to the deviation, the test section
(and run number, where applicable), the test step (where applicable), a description of the
deviation and the signature and date of the person recording the deviation.
Although errors may be grouped by type, repetitive protocol errors are the most
practically grouped in this way. When deviations are grouped, care should be taken to
ensure that the link between each individual issue identified, its investigation, and
corrective actions is clear. In addition, all issues will need to be resolved (or transferred
to a tracking system) to allow closure of the deviation.
Investigation
An investigation should be conducted to determine the root cause of the deviation. In
many cases, this will not require any in-depth analysis. However, for system or process
failures, a formal investigation including appropriate technical representatives may be
required. Such a detailed investigation should be conducted according to applicable
procedures.
The investigation may be used to identify the type of deviation; this can be documented
descriptively on the form or by using check boxes. Examples of types of deviations could
include:
- System/Process Error -An actual problem with the functionality of the system
or a technical problem with the process, whereby the system or process does
not meet the acceptance criteria when the test step is executed.
- Protocol Error -The test step instructions require addition, deletion,
modification and/or clarification due to missing/incorrect/ambiguous test
instructions. Or the acceptance criteria require addition, deletion, modification
and/or clarification due to missing/incorrect/ambiguous acceptance criteria.
- Other -A deviation occurs that is not related to the test method, acceptance
criteria or system, for example, operator error.
Protocol errors that require correction in order to allow the test to be executed as intended
may include missing test instructions or incorrect acceptance criteria.