Where Plant & Laboratory Asset Calibration & Maintenance Meet ISO & FDA Quality & Compliance, and Management Cost Objectives.

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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

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