Vol. 11, Issue 4 (2022)

Author(s):
Dr. Sanjay Kumar Jain, Jitendra Kumar Jain, Jagdish Gohel and Bhavik Sanghavi

Abstract:
The purpose of this paper is to describe the approach adopted in upgrading the computer systems of manufacturing and packaging equipment, equipped with PLC / HMI / SCADA in a running manufacturing plant by adopting quality risk assessment (QRM) process. The Failure Mode Effect Analysis (FMEA) model was used for performing QRM to identify the overall risk, which were ranked as priority 1, 2 or 3. High Risk items (Priority 1) were immediately taken up for upgradation, while Medium risk items (Priority 2) were accepted to upgrade the systems within stipulated timeline. Low risk items (Priority 3) were accepted as such without any further action. This approach has helped in continuing the business with scientific documentation ensuring that adequate risks are identified and eliminated based on risk ranking. This upgrade has helped to comply with regulatory requirement focusing on critical equipment.