Tracking Preventive Maintenance Effectively

M

mguilbert

#1
First a little background.
Our upper level docs state records can be either electronic or hard copy.
They maint. Employees are both around 65 with very little or no computer skills.
Facility management prints PMs for them to do. Once signed management enters them to a file. I as an auditor am worried that management may just update the file even if the Pms are not performed as they do not store the hard copy.

Should a non conformance be issued?

Thanks
 
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S

ssz102

#2
no records either electronic or hard copy, so the traceability are still non-conformance

i think that's a major non-conformance
 

harry

Super Moderator
#3
............... Once signed management enters them to a file. I as an auditor am worried that management may just update the file even if the Pms are not performed as they do not store the hard copy. .....................
Am I right to conclude that this is just a suspicion? A suspicion is not 'objective' evidence.

I think the auditor should probe further for cases of breakdowns, trends, etc before making any conclusion but to me, a major is out of the question if it is a third party audit.
 
M

mguilbert

#4
Am I right to conclude that this is just a suspicion? A suspicion is not 'objective' evidence.

I think the auditor should probe further for cases of breakdowns, trends, etc before making any conclusion but to me, a major is out of the question if it is a third party audit.
This is an internal audit. And at this time this is just a suspicion. We asked the maintenance personnel if they performed these duties and they answered in the affirmative. We have been granted access to the location where this is stored and we plan to track changes from outside the facility.

I guess the suspicion could be the same with paper but there are several factors you can check. Same pen, writing style, etc. For the electronic version we will track changes, and dates of changes.


Thanks,
 
M

mguilbert

#5
no records either electronic or hard copy, so the traceability are still non-conformance

i think that's a major non-conformance
The hard copy record is transfered to an electronic copy. And the hard copy is not retained but the electronic copy is retained as a record. Sorry about the confusion.
 
#6
In order for it to be a nonconformance, there has to be a requirement. Where is the requirement to maintain records? Where is the requirement to even perform preventive maintenance?

Putting those questions aside for a moment, let's assume we agree that PM is important. If the PM were not performed (and the files updated anyways), what kind of events would you expect to see? I would think that you would see an increase in unplanned downtime, and more extensive repairs. Is there any evidence of such? I do know that in some cases, it might take a great deal of time before the lack of PM shows up and then it is usually catastrophic.

I would think, based on what you posted that the weak area is management updating the files without the signed PMs. That could be a symptom of a rather significant issue (what else might they be validating as complete without knowledge it was done). One more thing, rock solid employees are rock solid, shaky employees are shaky. That is the weakness of records. Just because maintenance signs the PM does not necessarily mean the PM was accomplished. We need to determine what level of control is required.
 
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