The Cove Business Standards Discussion Forums
Handling Calibration Postponement - just a note/deviation report/others?
Please read this thread...
Software update
Handling Calibration Postponement - just a note/deviation report/others?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Handling Calibration Postponement - just a note/deviation report/others?

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 22nd April 2008, 10:33 AM
Quality Priest's Avatar
Quality Priest

 
 
Total Posts: 48
Let Me Help You Handling Calibration Postponement - just a note/deviation report/others?

I'm looking for some feedback on how you guys would/ have handled Calibration Postponement.

We have a sampling machine for thermal conductivity, which was due to be calibrated in week 5 (Very expensive involving the a company representative coming over from Europe to the UK), but as we were purchasing a second model it was decided to postponement, the calibration until the new model arrived when we would have both done at the same time.

The calibration had therefore been booked in for week 16, however due to delays with the manufacturing of the new model the calibration will not be conducted until week 25.

We have an external surveillance audit coming up in the next couple of week. I don’t think this will prove to be a problem for us as we have a planned calibration date and the machine is checked on a weekly basis against reference samples prior to use.
What i am looking for is how you would handle this;
Just a note in the calibration file or
Formal document (Deviation) signed off by the Quality Manager or
Some other way?

in advance

Sponsored Links
  Post Number #2  
Old 22nd April 2008, 10:48 AM
Dale D. Barnes's Avatar
Dale D. Barnes

 
 
Total Posts: 40
Re: Calibration Postponement

I have a folder that is labeled "Calibration Extensions". When the need arises for a calibration to be extended I send the Quality Manager an E-mail describing the situation and asking for approval. He/She then replies with the approval and I save that in the file. I had this same issue when trying to get all the CMM's onto one schedule. I showed that it was checked with a certified sphere and all the masters were still within calibration. The auditor was fine with the situation. I also re-label the item with a yellow sticker that states calibration extension. No need to hide anything the luck of the auditor is to choose the one item out of a thousand that isn't done correctly.

Dale
Thanks to Dale D. Barnes for your informative Post and/or Attachment!
  Post Number #3  
Old 22nd April 2008, 10:59 AM
Jeff Frost

 
 
Total Posts: 646
Re: Handling Calibration Postponement - just a note/deviation report/others?

Extension of calibration due date is something that can be done if your calibration data suggests that it will not be detrimental to product quality. Analyze your data to determine if you can justify a temporary extension of calibration due date as you proposed and be ready to explain the extension to your surveillance auditor.

My recommendation would be to create a written extension memo for the devices stating the justification for the temporary extension of the interval with the data analysis attached to it. Have Calibration Engineer (if you have one), Quality Manager and Production Manager sign off on the extension. This documentation package can serve as objective evidence that Top Management is aware of this extension and are in agreement.

If your review of data suggests that it will affect product quality then you cannot extended the due date then have the calibration as scheduled. Also be mindful of customer, regulatory or statutory requirements which may govern calibration activities within you facility. You may be required to obtain a waver from customer or the government on extending the calibration due date.
Thanks to Jeff Frost for your informative Post and/or Attachment!
  Post Number #4  
Old 22nd April 2008, 11:00 AM
Boscoeee's Avatar
Boscoeee

 
 
Total Posts: 210
Re: Handling Calibration Postponement - just a note/deviation report/others?

Quote:
In Reply to Parent Post by Quality Priest View Post

I'm looking for some feedback on how you guys would/ have handled Calibration Postponement.

We have a sampling machine for thermal conductivity, which was due to be calibrated in week 5 (Very expensive involving the a company representative coming over from Europe to the UK), but as we were purchasing a second model it was decided to postponement, the calibration until the new model arrived when we would have both done at the same time.

The calibration had therefore been booked in for week 16, however due to delays with the manufacturing of the new model the calibration will not be conducted until week 25.

We have an external surveillance audit coming up in the next couple of week. I don’t think this will prove to be a problem for us as we have a planned calibration date and the machine is checked on a weekly basis against reference samples prior to use.
What i am looking for is how you would handle this;
Just a note in the calibration file or
Formal document (Deviation) signed off by the Quality Manager or
Some other way?

in advance
My first question is what is the normal calibration interval? Second is what are the risk with extending the calibration cycle?

Additionally, your calibration procedure or work instructions should dictate the process for handling calibration extensions and who approves the extension. If you have the process in place for this analysis and make a business decision to extend the calibration cycle you are good to go.
Thank You to Boscoeee for your informative Post and/or Attachment!
  Post Number #5  
Old 22nd April 2008, 11:28 AM
Jerry Eldred's Avatar
Jerry Eldred

 
 
Total Posts: 530
Re: Handling Calibration Postponement - just a note/deviation report/others?

Before getting into my reply -- REGARDING THE PREVIOUS REPLY FROM BOSCOEEE - Although I am now in New Hampshire, I lived in Leander TX for 7 years (worked for Motorola/Freescale) and love Lago Vista. Feel free to send me a private message about the area (love Lake Travis, and hope to get back some day - maybe for retirement). Anyway, back on topic....

You have all covered it so well that my response is more of the same.

Since the Cal Interval is a defined length of time between which statistically a unit can be expected to perform within its specs, a cal interval extension should be based on the same. My present method for extensions:

For my customer- no extensions (a prudent method). I have no argument with it.

For my instruments- There is a defined limit as a portion of the normal interval, and must be supported with in-tolerance history.

My Opinion- Minimum practice for anything that involves product quality must be some legitimate level of statistical evidence that during the period of the extension the instrument can be expected to perform within its tolerance to an acceptable confidence. If you have some history, you could plot drift per time over multiple intervals and develop a prediction curve as to max interval (vastly oversimplified).

You also mentioned a check standard. If your check standard is well characterized and has enough stable history, it may well provide the data you need to justify the extension.
Thanks to Jerry Eldred for your informative Post and/or Attachment!
  Post Number #6  
Old 22nd April 2008, 04:38 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 9,029
Thumbs up Re: Handling Calibration Postponement - just a note/deviation report/others?

Quote:
In Reply to Parent Post by Boscoeee View Post

My first question is what is the normal calibration interval? Second is what are the risk with extending the calibration cycle?

Additionally, your calibration procedure or work instructions should dictate the process for handling calibration extensions and who approves the extension. If you have the process in place for this analysis and make a business decision to extend the calibration cycle you are good to go.
Nice answer, thanks.

To emphasize the point - you've gotta have something in your calibration management system which helps you to identify how to handle and authorize an extension to the recall date.

Many folks never write this kind of 'wiggle room' into their cal. systems. It's perfectly legit. to do so and you should exercise it when applicable to buy some time etc.

Some proprietary cal. databases have it, if not write a small part of your procedure to say how it's done, create a form and file it! Get it out when you get audited, in cases where you need to show you're in control!
Thank You to AndyN for your informative Post and/or Attachment!
  Post Number #7  
Old 24th April 2008, 07:31 AM
Quality Priest's Avatar
Quality Priest

 
 
Total Posts: 48
Re: Handling Calibration Postponement - just a note/deviation report/others?

Well thanks all round guys it been helpful
Calibration Procedure now updated to handle extensions to calibration periods.
Request and justification for calibration extension document now created.
Just working out maximum period of extension for various items
  Post Number #8  
Old 24th April 2008, 08:23 AM
curryassassin

 
 
Total Posts: 143
Re: Handling Calibration Postponement - just a note/deviation report/others?

Maybe, one last point. What does your deviations procedure say? Ours says if anything is contrary to procedure, then it is a deviation. We also write tolerances into our calibration schedules, e.g. calibrate monthly +/- 1 week. So if the calibration is performed late, then it is a deviation. Finally, how do you track the issue if it is not recorded as a deviation? You may find that calibration throughout the organisation is frequently performed late, so then you have an opportunity for preventive action.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Can anyone share an Note to File for justifying postponement of Internal Audits ? kellascat Quality Manager and Management Related Issues 5 13th January 2014 04:06 PM
Manufacturing Process Deviation linked to DMR (Discrepant Material Report)? todayssunny 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 31st August 2012 12:16 PM
AAR (Appearance Approval Report) with general note for Grain vardar3 APQP and PPAP 1 12th March 2012 06:00 PM
Instrument Handling & Calibration Training Material P.Natarajan General Measurement Device and Calibration Topics 3 25th August 2009 07:59 AM
Bug Report Thread 070418 --> NOTE: Testing new advertisement layouts Marc Old Forum News and Issues Threads Archive 17 18th April 2007 04:18 PM



The time now is 07:22 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"