An equipment log is the written documentation repository of activity history for a piece of equipment. This log should detail maintenance work being done, outages, setting changes and other details that may affect the chamber’s operation. A logbook should not be confused with a laboratory notebook. The equipment logbook is dedicated exclusively to the piece of equipment and its associated components. A laboratory notebook can be used for multiple processes and if audited allows the auditor to view other processes that may not be in the scope of an audit.
The SOP that covers the operation of chambers should discuss the use of the logbooks and should identify what items need to be entered. Major items that should be documented are: Maintenance work whether scheduled or unscheduled, temperature/RH outages, cleanings, daily checks and set point changes. Some minor items that may be an option to document are entries by personnel and the addition/removal of samples.
A logbook should be a hard backed, bound book with numbered pages. This requirement ensures that there are no missing pages and gaps in data during an audit. The inside cover of the book should have the following information: assignable book number, information on the date assigned and completed, Area for a signature log for multiple personnel. Each page should be individually numbered with the book number on the top, clearly defined sections for the date, work done and signature.
Entries in the log book should always include the date of the entry, the asset number for any equipment that is attached to the main unit such as recorder numbers. A detailed entry of the issue needs to be entered; I.E. In the case of a temperature outage, the start and end times, a calculation of duration, high and/or low temperatures observed, Work Order number, resolution to the outage and an impact assessment statement and the signature of the person entering the info.
Entries in the logbook need to be entered in real time, not after-the-fact. All issue entries, should follow rules for cGMP if they need multiple entries to complete the documentation. These entries start with the calibration of probes before validation. Include the validation process and an entry to document the approval date of the validation package. When a chamber is decommissioned an entry of that date, needs to added to close the logbook requirement for the chamber.
Logbooks should be reviewed on a set schedule by a third person in a supervisory or management role, to check for Completeness, Correctness and Compliance. This review should be documented in the log to answer an auditor’s question of process control.
The logbooks should have a dedicated place to reside while in use that protects them from loss and damage. Logbooks should be kept with the assigned piece of equipment in a visible location close to the controller or entry door of the unit. Storing all logbooks in a central area in the room has the potential for wrong, missing and incomplete entries and being in violation of the governing SOP. Logbooks should not be removed from the chamber area until it is completed.
When a logbook is completed it should be stored per the Records Retention Policy set by your company. These records are primary support documentation for the operation of the chamber and are reviewable by the auditor.
If you have any questions, feel free to contact us firstname.lastname@example.org