Audit trail and data integrity
A log that can be edited is not documentation. Here is what an audit trail must be able to do, and what the ALCOA principles mean in practice.
What is an audit trail, and why is it a requirement?
An audit trail is an automatic log of what has happened in the system. Every measurement, every alarm, every acknowledgement and every user action is recorded with time stamp and user, and the entries cannot be changed or deleted afterwards.
The requirement exists because data without a trace cannot be verified. If a measurement can be corrected, nobody can know whether it has been. That is why it is not enough for the numbers to be right. It must also be possible to document that they have not been touched.
ALCOA is the mnemonic the authorities use. Data must be Attributable, meaning traceable to a person, Legible, meaning readable, Contemporaneous, meaning recorded at the same time as the action, Original, meaning not a transcript, and Accurate, meaning correct.
We supply the system with audit trail. Assessing whether your overall practice meets the requirements rests with you or your QA.
ALCOA in practice
Attributable
Every action is linked to a named user. Shared accounts make this impossible and break the principle.
Legible
Data must be readable and printable throughout the retention period, even if the system is replaced.
Contemporaneous
The record is made at the same time as the action. A form filled in afterwards does not meet this.
Original
The measurement is the one the sensor made, not a transcript or an entry copied from a display.
Accurate
The measurement has a known uncertainty, because the sensor is calibrated with a traceable certificate.
Unaltered
Entries cannot be edited or deleted. That is what turns the log into documentation.
Why a paper form rarely holds up
A handwritten form typically fails on three of the five principles. It is not contemporaneous, because the number is written down when someone gets round to it. It is not original, because it is copied from a display. And it is not unaltered, because a number can be corrected with a stroke of the pen. It is not a question of trust in the staff, it is a question of what can be verified.
Frequently asked questions
Can we correct an error in the audit trail?
No, and that is the point. You can add a note or an explanation, but the original entry remains.
What if a measurement is wrong?
It remains, and you document the cause. That is exactly what an audit trail is for.
Does everyone need their own user account?
Yes, as a rule everyone should have their own user. Shared accounts make it impossible to attribute an action to a person, and then the log does not hold up. There may, however, be exceptions where a shared account makes sense.
How long is data kept?
As long as your procedures require. Data can be exported as PDF and CSV, so it can be read independently of the system.
Does this also apply to alarm acknowledgements?
Yes. Who acknowledged and when is part of the log, and that is often what an inspection asks to see.
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