Quality now has a full instrument master, calibration records with readings, out-of-calibration impact assessments, issue and return, MSA studies and daily checks.
Calibration records with readings and as-found verdict
Calibrations record readings per test point (as-found, as-left, error and tolerance), and the result is the as-found verdict. External calibration needs a lab accreditation that is valid on the date plus the certificate file. Internal tape verification needs a reference standard.
Fuller instrument master with derived due status
Each instrument now holds its plant, range, least count, accuracy, calibration method, lab, criticality, MSA settings, daily check, custodian and department. Due and Overdue are worked out from the next due date and the plant's due window instead of being typed. Under repair, Lost and Obsolete are new statuses, and status changes only through actions such as send to lab, out of service or return to service.
MSA studies: gauge R&R, bias and linearity
You can run gauge R&R (average and range), bias and linearity studies, judged against acceptance limits per instrument category that are frozen on the study. The Head of Quality decides a Conditional GR&R result. A Not acceptable result proposes taking the instrument out of service.
Daily instrument checks
Each instrument gets one daily check per working day. The check is marked Missing after the plant's cut-off time (11:00). A failed check on a process machine proposes raising an NCR.
Calibration reports, prints and notifications
There are five new calibration reports and an instrument history card. You can print a QR instrument label, a DO NOT USE label, the history card and an MSA report. Scheduled jobs send notifications for due calibrations, overdue returns, missing daily checks and expiring lab accreditations. Impact assessments and MSA studies get their own document numbers.
Record the instrument used on inspection results
Lot results and measurement-check values can now store the instrument used. A picker lists usable instruments for the plan's category, with the custodian's first. An instrument that is out of service, overdue or the wrong category is refused by name. Making the instrument mandatory is a per-plant setting that is off by default.
Out-of-calibration impact assessment
A failed as-found calibration, a lost instrument or a damaged return opens an assessment. It lists every lot measured with the instrument since its last passed calibration and shows where each batch is now. For each lot you choose No impact, Re-inspect or NCR, and a remark is required. Return to service needs the assessment complete and a passing calibration after the trigger.
Instrument issue and return
Instruments can be issued with a condition and returned, and overdue returns and calibration recalls are flagged.