Service Form


When:

August 25-28, 2008

Where:

ORNL Metrology Laboratory Building 5510A

Who:

Calibrate, Inc. Technician

What:

Single- and Multi-channel Pipette Calibrations

A Calibrate, Incorporated technician will be available to calibrate single– and multi-channel pipettes on-site in the Metrology laboratory (in building 5510A) on August 25 - 28, 2008 for the ORNL community.  The Quality Systems and Services Division’s Metrology Laboratory is coordinating this service to improve the efficiency and effectiveness of the pipette calibration program at ORNL.  This is program event is the result of a successful pilot campaign that occurred in August.  

Calibrate, Incorporated offers four distinct levels of service for the repair and calibration of pipettes.  The table below summarizes the various levels of service and what each level includes:

Features

Level I

Level II

Level III

Level IV

New Seals, Clean, Grease Pipette

X

X

X

X

Functional Check

X

X

X

X

Documentation

Invoice Only Listing S/N's

X

 

 

 

Single Cal Certificate for Lot

 

X

 

 

Individual, Accredited Cal Report

 

 

X

X

"As-Left" Data

 

 

X

X

"As-Found" Data

 

 

 

X

cGMP and GLP Compliance

 

 

 

X

 

 

 

 

 

Price per Pipette

 

 

 

 

Single Channel

$19.00

$22.00

$29.00

$34.00

8-Channel

$29.00

$32.00

$39.00

$44.00

12-Channel

$34.00

$34.00

$44.00

$54.00

Not sure which level of service you need to ensure the integrity of your research work?  The Metrology Laboratory will be happy to assist you in making that critical decision.   

Level I service is basically a rebuild and functional check of your pipette, even though Calibrate, Incorporated calls it a “calibration”.  The “calibration” portion of the Level I service includes three tests at approximately maximum pipette capacity and three tests at a single dispensing point near the bottom end of the range.  This “calibration” does not meet the requirements for Calibrate’s accreditation scope as endorsed by the American Association of Laboratory Accreditations (A2LA).  Level I service does not include a calibration certificate nor does it provide you with a calibration sticker on the pipette (it does include a sticker which lists the “service” date.   There are no certified tolerances assigned to pipettes calibrated in Level I.   Level I service should only be utilized if you are independently calibrating your pipette elsewhere or performing a calibration yourself prior to use using an acceptable procedure.  Pipettes “calibrated” using the Level I service should be used only for  dispensing when the dispensed quantities are independently verified using another technique. 

Level II Service  provides all the services listed in level I plus a calibration certification for the entire lot of pipettes which states that the pipettes will, at the time of calibration, perform to a stated set of tolerances.    The entire lot of pipettes will be listed on the certificate by manufacturer, serial number and size.  No data will be reported.  The level II service is not accredited as a part of Calibrate, Incorporated’s A2LA accreditation scope. 

Level III Service provides all the services of Level I plus it provides an A2LA accredited calibration of each pipette after the pipette is serviced.  The calibration results are documented  in a calibration report meeting the requirements of ISO standard 17025 with the report bearing the A2LA logo.  The calibration includes tests at several volumes over the range of the pipette and consists of multiple tests at each volume to provide a statistically-derived uncertainty of each volume of the pipette.  The data is corrected for environmental conditions at the time of the calibration.    It should be noted that the calibration occurs after the pipette is serviced (“AS-LEFT” Data) and that no data is taken prior to the servicing of the pipette; therefore, there is no indication of the performance of the pipette prior to the servicing.  This provides no indication of the performance of the pipette during routine usage during the period immediately following the last calibration up to the most recent calibration. 

Level IV Service provides all the services of  Level III plus it provides an A2LA-accredited calibration of the pipette prior to its servicing.  This “AS-FOUND” calibration provides an indication of the performance of the pipette since its last calibration.  This indication can ensure that the measurements made during its previous calibration interval were within tolerances established for the pipette or, if the pipette performed out-of-tolerance, provides valuable tools for determining the impact of the measurement deviations on the experiments for which it was used. 

Important Definitions  

ISO Standard 17025—  A standard developed by the ISO (International Standards Organization) and by the IEC (International Electrotechnical Commission) to govern the operations of calibration and testing laboratories.  This standard’s purpose is to ensure the competency of a laboratory to perform calibration and testing services for the international community.  The standard includes a comprehensive set of requirements addressing the management (quality) systems and technical requirements for ensuring that a laboratory is competent to perform testing and calibration services within their scope of accreditation.  

A2LA-Accreditation—The American Association of  Laboratory Accreditation  (or A2LA) is a accreditation body which performs assessments of calibration laboratories to ensure compliance with International Standards Organization’s (ISO) standard 17025.  Additionally, laboratories compliant with the requirements of  ISO standard 17025 are also compliant with the requirements of  ISO standard 9001.  A2LA is an internationally-respected accrediting organization whose accreditations are recognized world wide.  Accreditation by A2LA requires a rigorous on-site assessment of the management (quality) systems, technical capabilities, technician training, laboratory environments, business systems and shipping and handling capabilities to ensure the integrity of the calibrations performed and results reported for those calibrations.  Equipment calibrated by an A2LA-accredited calibration laboratory is recognized internationally as having the capability, when used properly,  of producing data which is traceable, through a national laboratory, to the System International systems (Le Système international d'unités) of  units.  For additional information regarding A2LA, please visit their web site at http://www.a2la.org/

“AS-LEFT” Data—  Data taken immediately after a device has been repaired and/or calibration adjustments have been made.  This data is an indication of the performance of a device immediately following its calibration and can not be used to ensure that the device will remain within its performance specifications until the next calibration. 

“AS-FOUND” Data—  Data taken from a device in its “as-received” condition at the calibration laboratory.  This data is taken prior to any repair or adjustments to the device beyond what would be normally performed in its actual usage (eg, some devices in actual usage may require adjustment of the zero prior to making a measurement, etc.).  “AS-FOUND” data is useful to demonstrate that a device performed within specified limits during the period immediately following its last calibration up until the time the “AS-FOUND” data was taken.  The data can also be used to determine the impact of any measurements made using the device should it be determined to be performing out-of-tolerance during the  “AS-FOUND” test. 

Frequently Asked Questions 

Question:  For my specific application, which service level should I obtain for the calibration of my pipettes?

Answer: Level I and II services should only be used where you have a program in place to independently verify the performance of the pipette prior to each use or for those applications where convenience  dispensing of  liquid materials is being performed with no requirement for accurately measuring the quantity dispensed.  Level III services should only be used when a pipette requires repair and you wish to ensure that it is performing properly following its repair.  Level III services cannot provide any assurance that the measurements made using the pipette remain within specification limits during its calibration interval.  Level IV services should be used when you require traceable measurements which will be accepted both nationally and internationally and for which you require assurance that the measurement made with the pipette are within specification limits during the entire calibration interval. 

Question:  How much will the servicing and calibration of my pipettes cost me in this campaign?

Answer:  The cost for servicing and calibrating your pipette will be as shown in the above table.  There will be no additional charge levied against your account for any services provided by the ORNL Metrology Laboratory.  

Question:  How do I get my pipettes calibrated in this campaign?

Answer:  First of all, you need to determine which level of service you need for your pipettes.  Then, you can bring your pipettes, along with a valid charge number, to the Metrology Laboratory in building 5510A between the hours of  7am and 3:30pm any time the week of  August 21st (or before).  They will be calibrated to your requirements and made available for pickup later in that week.  You will be notified when your pipettes are calibrated and ready for pickup via e-mail.  When you bring your pipettes to the Metrology Laboratory, Metrology Laboratory personnel will be available to answer any questions you have and provide a brief tour of the Metrology Laboratory and discuss its capabilities and services it provides to the ORNL community.   

Should you be unable to bring your pipettes to the Metrology Laboratory, Laboratory personnel will be available to pick up your pipettes and safely transport them to the laboratory for servicing and calibration.  Following the calibration, Laboratory personnel will transport them back to you along with documentation per the service level you have selected.  For questions concerning pickup/delivery please call Katherine Sellers (241-4406) or e-mail Katherine at sellerska@ORNL.gov. 

Question:  Do I need to do anything special to my pipettes prior to bringing/sending them to the Metrology Laboratory for calibration?

Answer:  Prior to bringing/sending your pipettes to the Metrology Laboratory, you should ensure that they are free from any hazardous materials.  This includes hazardous/reactive materials, radioactive materials, bio-hazardous materials, etc.  Pipettes located in rad areas should be surveyed by Health Physics prior to being brought/sent to the Metrology Laboratory.  Of course, prior to bringing/sending the pipettes to the Metrology Laboratory you should look around their storage location to ensure that all parts of the pipette are brought/sent. 

Question:  My pipette needs repairs beyond what is mentioned in the standard service levels.  Are the additional repairs going to be available during the campaign?

Answer:  The Calibrate technician will have parts available to perform additional repairs on your pipette.  Those repairs will be charged at Calibrate’s standard repair rates and will be billed to the account number provided with the pipette.  If desired, you can be notified of  and approve the estimated repair cost prior to their performing any actual repair. 

Question:  How will I know when its time to service and calibrate my pipettes again?

Answer:  Metrology Laboratory personnel will contact you to discuss the recommended time between servicing and calibration of your pipettes.  With your approval and at no cost to your organization, the Metrology Laboratory will enter your pipettes into its calibration tracking database.  This database will monitor the calibration status of your pipettes and advise you via e-mail when they are due for servicing/calibration based on the calibration interval determined during the above discussions.  This will ensure that the pipettes continue to perform within specifications and relieve you of the responsibility of remembering to have your pipettes serviced/calibrated so that you can focus your attention on your research/analytical experiments.  

Questions:  Will this service be offered again in the future?

Answer:  Plans are for this service to be offered periodically as necessary to maintain ORNL’s pipette performance to meet the needs of the research community, provided there is sufficient participation.  The actual interval between campaigns will be determined after discussions with users to determine the acceptable calibration intervals based on the pipette usage, accuracy requirements, etc. 

For questions concerning the pipette calibration campaign, please contact any of the following Metrology Laboratory staff members: 

Mike Duncan, Manager ORNL Metrology Laboratory 574-7349,
e-mail: duncanml@ornl.gov

Bill Wright, Metrology Laboratory Technical Manager, 574-7249,
e-mail: wrightwe@ornl/gov

Greg Strickland, Metrology Laboratory Operations Manager, 241-4403,
e-mail: stricklandga@ornl.gov 

“Ensuring Scientific Integrity through excellence in measurements”

 

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