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