Announcement: Meeting the Instrument Validation and Certification needs of HunterLab’s End-Users during the COVID19 crisis and beyond Follow
From: Tod Kerr - VP of products and Technology
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.
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.
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.
- End-user requests Instrument Calibration Verification
- HunterLab identifies instrument type and appropriate verification measures for that instrument type.
- HunterLab arranges with end-user a testing window of time and schedules the delivery to certified test artifacts to the end-user lab
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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