Where Plant & Laboratory Asset Calibration & Maintenance Meet ISO & FDA Quality & Compliance, and Management Cost Objectives.
Case Study: Food & Beverage Client (Food Plant)
Problem before ProCalV5 :
Background:
-
One technician assigned to calibration management –also was a PLC technician, so calibration was not a full‐time focus.
-
Numerous “databases” (one access database, several excel spreadsheets, and some paper records) held calibration information.
-
Operators ran process by “feel” – i.e., ran too much steam to the process to make sure the product was properly sterilized. Operators didn’t trust the instrument readings.
-
Technicians frequently swapped instruments from one line to another to check readings. Two lines were down during this process.
-
Technician was out on medical leave the last time the FDA visited and no one else could deliver complete calibration records. FDA started to askmore pointed questions as a result.
Needs:
-
No “Hammer” with production to get calibrations done even though maintenance knew they needed to be done. Production people were a hindrance to any previous attempt at a calibration program.
-
No accountability to production or QA to make sure calibration records were accurate AND up to date.
-
Engineering Manager wanted plant personnel to know what needed to be calibrated ahead of time.
-
Wanted as found data and records on instrumentation and instrument
maintenance records in one place.
Results after ProCalV5:
-
Main goal was to get regulatory compliance with the FDA –this was achieved. • For the first time, EVERYONE trusts the instrumentation and the control loops. • Maintenance no longer takes two lines down at the same time swapping instruments. ($13k ‐ $15k/hr estimated downtime – 28,500 units produced per line per hour) – huge cost savings.
-
Troubleshooting time greatly reduced as maintenance trusts the instrument readings. • Lines rarely go to a “non‐sterile” condition anymore. Engineering Manager believes facility has saved $100k in not having this condition anymore.
-
Rework costs down. Finished product loss down – product loss was 4.64%. Engineering Manager believes at least 1% less product loss. (1% = $800k).
-
Steam usage down 15‐20% because operators trust the instrumentation and don’t run too much steam “just in case.” Engineering Manager believes it could be an 8‐10% reduction in overall energy bill. Feels that BTUs per can could go down 15‐20% as well. Time will tell.
-
Much greater product consistency by all accounts. • Engineering Manager and others feel the process can really be optimized now that it is trusted. There will be benefits paid for years to come.
FOOD & BEVERAGE MANUFACTURER