Validation Deviations

Validation deviations are just a part of life when you are working through validation protocols and test scripts; it’s highly unlikely that you will ever complete a full validation project without raising the odd validation deviation here and there.

So what is a Deviation or Exception?

It’s quite simple it’s an error or a failure which occurs during Verification of Validation.
Types of Deviations

There are three main types of deviations that can occur during a validation project they are:

    Critical
    Non-critical
    Simple

Simple Deviations

Simple deviations are usually classified as documentation or protocol errors, these errors are usually found prior to execution or are “obvious” errors or typos. These deviations have no impact on the validation and offer to real risk to the validation process.

Examples of simple deviations include:

    Wrong test selected for product
    Incorrect specification for product
    Loss of power to the equipment being tested

Non Critical Deviations

Non-critical deviations are errors in the protocol or execution of the validation which have no impact on the validation, there errors are normally found during or after the execution. It is good practice to carry out an assessment to determine if the deviation has any impact. There is no real need to document the risk or lack thereof.

Examples of non-critical exceptions include:

    Operator not trained to perform the operation
    An interruption in the computer system or the equipment’s performance

Critical Deviations

Critical deviations are errors which have an impact on the validation, these errors are found during or after execution. It is good practice in this scenario to carry out an assessment to determine the impact if any.

Examples of critical exceptions include:

    Acceptance criterion failure
    An interruption in the computer system or the equipment’s performance

Deviation Process Flow

SME involvement throughout the deviation process is critical. You cannot document enough, even if all of it does not make it into the final event write up. A CAPA may not be needed for simple events, but consider a CAPA if there are many of them or the same ones repeatedly.

General Process Considerations

It is advisable to commence with the resolution process as soon as the event is observed. Involve the SME’s/QA throughout the process as appropriate and get agreement on next steps and/or results prior to execution, or after the completion. Immediately notify the relevant SME/QA if there is any potential Product/Material impact. Conduct a risk assessment to determine the impact and actions to be taken.
Types of Deviations

Typographical errors
These errors are found prior to execution or are “obvious” errors or typos.

External Issues
Failures caused by factors external to the process or system under test.

Execution Errors
Failures to follow instructions within the Test Document or referenced procedures.

Document Generation Errors
Incorrect detail in procedures, acceptance criteria or referenced documentation.

Acceptance Criteria Failures
Pre-defined acceptance criteria have not been achieved.