GMP Training Primer: Data Integrity and Human Error
In last week’s issue, we talked about how to develop a training program on CAPA. This week, we’ll take a look at the subject of data integrity.
Regulators are paying increasing attention to manufacturers’ handling of data, calling out those whose practices are incorrect, incomplete or downright fraudulent (QTA, Jan. 7). To bring the message home to trainees, use the following course model to clarify the difference between unintentional human error and a lapse in data integrity.
Part One: What is Human Error?
There are many reasons people make mistakes. Discuss them, their causes and consequences, and ways to prevent or manage mistakes. Some examples of common errors include:
- Annotating incorrect dates
- Signing/initialing in the wrong place
- Forgetting a signature
- Incorrect calculations
- Missing a process step
Part Two: How Can Human Error Become a Data Integrity Issue?
Most of the time, human error is unintentional. But when you add deliberate intention to human error, you cross the line into data integrity problems. Explain to trainees that intentional acts don’t necessarily have to have a negative motivation. Data integrity problems can result from employees trying to fix their mistakes.
Documentation errors, once found, must be corrected according to specific procedures. If these procedures aren’t followed, data integrity can be compromised. Discuss how improper corrections can damage the credibility of your data. Some examples include:
- Not using the right ink
- Recording data on sticky notes
- Erasing incorrect data and rewriting it without noting the change
- Back-dating corrections
Part Three: Consequences of Compromised Data Integrity
Trainees need to know why correct data procedures are important. Consequences can range from problems for the company – such as product loss, regulatory enforcement actions, recalls and damaged reputation – to discipline and possible termination of the employee at fault.
Next week, we’ll present a model for effective investigation training.
The complete Data Integrity Overview training package, including slides, leader’s script and knowledge assessment, is available as part of the FDAnews Customizable Training Series for drug manufacturers and devicemakers.