Announcement: Meeting the Instrument Validation and Certification needs of HunterLab’s End-Users during the COVID19 crisis and beyond

From: Tod Kerr - VP of products and Technology

Date: 04/02/2020

HunterLab is exploring possibilities with our end-users to provide continuity of instrument certification services in light of restricted access to end-user facilities and restrictions on service personnel travel.

 

Current Model

HunterLab’s primary existing model for delivering instrument calibration verification services entails performing a combination of specific instrument diagnostics routines and data collection, with the measurement of a variety of specific artifacts and traceable standards. 

 

The results of each test are compared to known target values and mathematical differences are compared to the allowable tolerances for each artifact to determine whether the specific instrument remains with allowable performance tolerances.  Allowable tolerances are typically based on general instrument performance criteria as well as industry-specific acceptance ranges.

 

The resultant data from the tests are compiled in a report that certifies the performance of the tested instrument and provides suitable evidence of performance validation for audit purposes.  Reports indicating an instrument’s acceptable performance (PASS) are provided for end-user documentation and are stored at HunterLab as well.  The instrument’s that Pass performance testing a labeled with a Performance sticker that displays the pertinent data.

 

Instruments that do not Pass (Fail) the performance testing require remedial actions to resolve the source of performance testing failure.  Depending on the degree of performance variance, the underlying problem can most often be resolved through instrument cleaning or adjustments that can typically perform at the end user's site.  More severe issues most often require the instrument to be returned to a HunterLab service center which is equipped with additional diagnostic and calibration equipment.

 

Modified Models

The existing calibration verification model has been proven effective in many industries with thousands of verifications conducted annually.  However, the tests traditionally require HunterLab personnel to be onsite to perform the testing.

 

With the current COVID19 constraints now pervasive across the globe, HunterLab is seeking to modify or enhance the existing calibration verification services to meet the needs of the end-user community while avoiding service personnel travel and navigating the issues of on-site visits.

 

Two obvious options exist, 1) return end-user equipment to HunterLab for calibration verification and related services, and 2) provide end-user with the capability to securely collect, unbiased instrument performance data that can be reported to HunterLab for evaluation and subsequent instrument qualification can be determined with appropriate certification documents provided.

 

While many end-users have selected the “return instrument to HunterLab” for service and verification model, as we well know, many would prefer to avoid this option as instrument requalification is often required when an instrument is removed from a lab for any reason.

 

In order to address the need for users to continue to receive on-site instrument performance certification services, HunterLab is offering the following model for consideration.

  1. End-user requests Instrument Calibration Verification
  2. HunterLab identifies instrument type and appropriate verification measures for that instrument type.
  3. HunterLab arranges with end-user a testing window of time and schedules the delivery to certified test artifacts to the end-user lab
  4. On receipt of test artifacts, at the direction of HunterLab, end-user first performs a series of pre-programmed system diagnostics tests that are independently stored in the instrument
  5. If Diagnostic tests yield passing results, end-user can proceed to the collection of test artifact data.  If Diagnostics tests fail, end-user will be directed by HunterLab on remedial actions.
  6. End-user will sequentially measure each test artifact and allow the system software to collect and store test results.  ER (electronic records) software systems will automatically log measurements and prevent data tampering.
  7. At the conclusion of artifact testing, the end-user will be instructed by HunterLab to either securely send the data file stored in the ER software or print and sign the results of the testing to HunterLab.
  8. On receipt of the test data, HunterLab will compare test results with test artifact target values and compile a report of comparative test results culminating with an assessment of calibration verification Passing or Failing test criteria.  In the event of Passing results, the end-user will be provided with an electronic and hard copy record of the results as well as an instrument performance validation sticker, to be applied to the tested instruments front cover. 
  9. Instruments that do not pass test criteria will require remedial action.  HunterLab will provide a list of possible corrective measures to be taken onsite by end-user, or request that instrument be returned to HunterLab service center for more comprehensive diagnostics and repair.

 

HunterLab has presented these modified models to end-users in a number of industries and has received either immediate acceptance or feedback necessary to meet the end user’s specific industry needs.  We offer this framework as an outline of the service model or a basis for further refinement when needed.

 

Hunter Associates Laboratory, Inc.

Remote Calver FAQs
  • I have a calibration verification maintenance that needs to be done on my instrument, but we are not allowing on-site visits, does HunterLab provide an alternative solution?

HunterLab created a program - Remote Calver - that provides a remote, end-user assisted measurement and data collection process that replicates the process used by HunterLab technicians when performing the verification calibration on site.

 

  • What is the difference between Remote Calver and the onsite calibration verification?

 

The calibration verification service is provided on-site at a customer’s location and is performed by HunterLab Technicians. The service may also be provided in Reston; particularly as a follow-up to instruments that did not pass the verification in the field and that are returned for repair.

The Remote Calver program is conducted by HunterLab customers, mainly the users of the instrument, with the remote assistance of HunterLab Technicians. To perform the Remote Calver program, HunterLab Technician provides instructions, steps, and tools required for the end-user collection of color data using reference standards supplied by HunterLab for the purpose of certification of instrument color performance via remote collection, analysis, and reporting methods.

 

  • Which instrument is eligible for Remote CalVer?

CalVer is limited to the following instrument: LSXE, AGERA, USPRO, and USVIS. 

If you would like your instrument to be calibrated and verified using the Remote Calver option please conduct HunterLab Tech support at support@hunterlab.com 

 

  • What are the steps needed to obtain Remote Calver?

 

To conduct a Remote Calver HunterLab Technician and the customer will follow these steps:

Step 1: Customer call or e-mail the service department to request Remote CalVer.

Step 2: HunterLab supplies traceable standards to the end-user for evaluation on the subject instrument.

Step 3: Customer collect color measurement data on a set of traceable standards provided by HunterLab from the target instrument.

Step 4: The customer sends the collected data to HuntrerLab through a method in accordance with proper Electronics Records requirements.

Step 5: HunterLab compares measurement results with the assigned values for each measurement artifact, calculate the color difference, compare to acceptance tolerances for the color difference, and determine PASS/FAIL for each of the artifacts.

Step 6: HunterLab issues a report to the customer detailing the results and the overall PASS/FAIL assessment.

Step 7: In the event of instrument FAIL results, HunterLab will recommend remedial steps to correct cause for failure and allow for instrument retest

For details about each step check this article: https://support.hunterlab.com/hc/en-us/articles/360045760692-Remote-Calver-Procedure-

 

  • Is there a software that I need to use to conduct Remote Calver?

Remote Calver uses EZMQC or EZMQC-ER to collect data. For a step by step instructions on how to use EZMQC or EZMQC-ER to collect data, please visit these articles.

For USPRO and USVIS customers:

https://support.hunterlab.com/hc/en-us/articles/360046181571-USVIS-USPRO-Remote-Calver-Procedure

For LSXE and Agera customers:

https://support.hunterlab.com/hc/en-us/articles/360045762632-Agera-LSXE-Remote-Calver-Pocedure

 

If you have any questions, please contact HunterLab Tech Support: support@hunterlab.com 

Remote Calver Procedure

The Remote Calibration and Performance Verification (Remote CalVer) procedure provides a remote, end-user assisted measurement and data collection process that replicates the process used by Hunterlab technicians when performing the process onsite. 

To order Remote Calver, HunterLab customers will need to follow these steps:

1- End-user contact HunterLab Service department to request Instrument Calibration Verification. Part number# “Calver-Remote”

2- HunterLab service department identifies instrument type and appropriate verification measures for that instrument type.

3- HunterLab service department arranges with end-user a testing window of time and schedules the delivery to certified test artifacts to the end-user lab.

4- On receipt of test artifacts, at the direction of HunterLab Technician, end-user first performs a series of pre-programmed system diagnostics tests that are independently stored in the instrument

5- If Diagnostic tests yield passing results, end-user can proceed to the collection of test artifact data.  If Diagnostics tests fail, end-user will be directed by HunterLab on remedial actions.

6- End-user will sequentially measure each test artifact and allow the system software to collect and store test results.  ER (electronic records) software systems will automatically log measurements and prevent data tampering.

7- At the conclusion of artifact testing, the end-user will be instructed by HunterLab to either securely send the data file stored in the ER software or print and sign the results of the testing to HunterLab.

8- On receipt of the test data, HunterLab will compare test results with test artifact target values and compile a report of comparative test results culminating with an assessment of calibration verification Passing or Failing test criteria.  In the event of Passing results, the end-user will be provided with an electronic and hard copy record of the results as well as an instrument performance validation sticker, to be applied to the tested instruments front cover. 

9- Instruments that do not pass test criteria will require remedial action.  HunterLab will provide a list of possible corrective measures to be taken onsite by end-user, or request that instrument be returned to HunterLab service center for more comprehensive diagnostics and repair.

For more questions, please contact HunterLab Service at service@hunterlab.com