Quality records kept "off site", is it ok or not?

M

Martijn

#1
Dear Covers, here's a question for you:

Is it ok to have a quality record (in this case a registration of calibration) that is not available on the location where the certificate is issued for (our sales HQ) but is only available at the place where it's being used (in this case our salespeoples home offices, from which they work).

My certifying auditor said the lack of these records in HQ was a non conformance because he couldn't audit it, but if he wants to audit our sales process shouldn't he have decided to audit the salesperson on site at a customer or in his home office? In other words, do we have to keep a double record, just for the certifying auditors ability to audit then.
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Martijn said:
Dear Covers, here's a question for you:

Is it ok to have a quality record (in this case a registration of calibration) that is not available on the location where the certificate is issued for (our sales HQ) but is only available at the place where it's being used (in this case our salespeoples home offices, from which they work).

My certifying auditor said the lack of these records in HQ was a non conformance because he couldn't audit it, but if he wants to audit our sales process shouldn't he have decided to audit the salesperson on site at a customer or in his home office? In other words, do we have to keep a double record, just for the certifying auditors ability to audit then.

Martijn,

As long as they are readily retrievable I don't see a problem, in my opinion. Would they be able to fax the copies when requested or deliver them within a reasonable amount of time?


Coury Ferguson
 

Miner

Forum Moderator
Staff member
Admin
#3
There is no requirement to maintain the records on-site. However, you do have to reasonably accommodate an auditor. All auditors that I have dealt with only require that the records be available for audit within a reasonable time.

This reasonable time has varied from "by the end of the day" to "before the auditors adjourn to prepare for the closing meeting". A faxed copy has always been acceptable.
 
#4
Martijn said:
...not available on the location where the certificate is issued for (our sales HQ) but is only available at the place where it's being used ...
Like the others, I would happily accept a faxed copy of the record. I also think it is reasonable that equipment and record can be found in close proximity to each other...

Martijn said:
My certifying auditor said the lack of these records in HQ was a non conformance because he couldn't audit it.
Did he really? If so, I wonder how he was planning on checking the equipment? Would he like a copy of that at HQ as well?

Martijn said:
...do we have to keep a double record, just for the certifying auditors ability to audit then.
Absolutley not. As always, the system should fit the users needs, and I can see no point in double records.

/Claes
 

RoxaneB

Super Moderator
Super Moderator
#5
Miner said:
There is no requirement to maintain the records on-site. However, you do have to reasonably accommodate an auditor. All auditors that I have dealt with only require that the records be available for audit within a reasonable time.

This reasonable time has varied from "by the end of the day" to "before the auditors adjourn to prepare for the closing meeting". A faxed copy has always been acceptable.
Bingo. The organization determines the process that works for them and if that means the records are maintained at the point-of-use, so be it. However, as Miner said, having the ability to provide the record to the auditor is the main issue...and this could mean either visiting Mr. Sales Person or having the record faxed in.

That being said...what does your procedure for record control state? Do you say that calibration records will be maintained on site? If so, then the finding sounds like it could be legit.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
When it's time for re-calibration how does that work? Does the item come back to HQ where it is either calibrated or sent for calibration? If so then you should have a record in order to maintain traceability.

If it was sent for recalibration to a 3rd party then purchasing should have a record of the PO, specifying the calibration standard(s), and an invoice even if the actual record travels with the device.

If it was calibrated in-house, then the calibration lab should have at least a copy of the calibration results.
 
M

Martijn

#7
Thank you all for your replies. I'm probably going for a digitally/faxible calibration record from home offices. Might even make some sort of lotus notes database out of it.

RCBeyette said:
That being said...what does your procedure for record control state? Do you say that calibration records will be maintained on site? If so, then the finding sounds like it could be legit.
You're right about this one, this is how it became a finding to begin with, but then i told him i was considering changing the record procedure stating calibration records can be kept at home offices as well, and then he said that won't do for him.

edit: and all the calibrations are done at home/in the car (not while driving)/at the customers lab

:thanx:
 
Last edited by a moderator:

RoxaneB

Super Moderator
Super Moderator
#8
Martijn said:
You're right about this one, this is how it became a finding to begin with, but then i told him i was considering changing the record procedure stating calibration records can be kept at home offices as well, and then he said that won't do for him.

edit: and all the calibrations are done at home/in the car (not while driving)/at the customers lab

:thanx:
It sounds as if there is a finding here but not quite the way the auditor phrased it. I would have identified the gap between the documented procedure and the acutal practice.

From there, as part of your action plan to address it, you could revise the document to reflect the actual proces...or re-instill the process to match the document.

As to where the records are maintained, as long as they are readily retrievable and safe from harm, there shouldn't be a problem. I think that your auditor's problem is not so much with their physical location, but how you will be able to guarantee that the records will be safe from damage if kept at the sales person's home/car.

Fire? Theft? Flooding? Accident?

Do these sales people have in-house safes or some other means by which to guarantee the safety of the records?
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#9
Martijn said:
Thank you all for your replies. I'm probably going for a digitally/faxible calibration record from home offices. Might even make some sort of lotus notes database out of it.



You're right about this one, this is how it became a finding to begin with, but then i told him i was considering changing the record procedure stating calibration records can be kept at home offices as well, and then he said that won't do for him.

edit: and all the calibrations are done at home/in the car (not while driving)/at the customers lab

:thanx:
just to play devil's advocate:

since the devices are calibrated by the user... what about the standards that they are calibrating to?

but I must also ask... are the devices actually being calibrated by the sales guys or are they just verifying calibration in the field?
 

Jim Wynne

Staff member
Admin
#10
Discordian said:
are the devices actually being calibrated by the sales guys or are they just verifying calibration in the field?
There's no difference between the two; calibration doesn't necessarily imply adjustment.
 
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