Hi, I've been posed the challenge of weighing up a standard procedure for documenting all repairs carried out during regular service and maintenance.
Purpose being to identify if all remedial work at point of service on a device, should be recorded in the Medical Device Database (MDD) on the Planned Preventative Maintenance (PPM) or record as a separate/additional repair record if faults are found during inspection or servicing.
What is the general consensus for the two options below, when considering the following;
Faults/failed calibration found during routine maintenance should...
1. all be documented within the PPM job already created in the MDD.
or
2. create a separate repair record to detail specifics of fault found and remedial work carried out, including parts not covered under a regular service. This would then be followed by the completion of the upcoming PPM once repairs are successful.
I have created a Poll to collect views of where either are standard practice.
I welcome any reference materials, links or citations where either are strongly advocated.
Many thanks in advance for your input.
