Restoring Maintenance Compliance, Enhancing Capability
Our client required an approach to categorize critical utility system components, to allow for the adjustment of maintenance frequencies and verify the accuracy of information within SAP. Brevitas developed a standardized assessment method and successfully applied it to 30 critical utility systems across the site.
INDUSTRY
Pharmaceuticals
AREA OF EXPERTISE
Technical Services
DURATION
1.5 years
SERVICES PROVIDED
- Project Management
- Criticality Assessment
- Technical Documentation
IMPACT
A client’s production was temporarily shut down due to regulatory citations. Sciras services in project management, project engineering, and design support during the facility renovation were pivotal in addressing the compliance concerns and improving future manufacturing capacity.
Business Challenge
Our client required an approach to categorize critical utility system components, to allow for the adjustment of maintenance frequencies and verify the accuracy of information within SAP. The business drivers were to allow for the assessment and updating of maintenance frequencies to achieve cost savings and to help assess change control and validation requirements.
Our Approach
Sciras was recruited to develop and execute a procedure to categorize critical utility system components (i.e. valves, gauges, filters, pumps, etc.) according to GMP-criticality and business-essentiality criteria, based on existing engineering guidelines, site SOPs, alarming statuses, & system P&IDs. This procedure would allow for the identification of higher/lower priority components from a maintenance perspective. The procedure was executed for Compressed Air, Purified Water, Water for Injection, Clean Steam, and Medical Gas systems across 6 production buildings. After reviewing existing technical & quality documents, Sciras consultants suggested enhancements to procedures in place.
Results Achieved
- Ensured correlation between system P&IDs and SAP data
- Verified accuracy of data being transferred into upgraded SAP system
- Developed a clear categorization procedure, agreed upon by both Technical Services and Quality
- Categorized all components as found on P&IDs for 30 critical systems across the site, based on consistent and clearly defined criteria for GMP-criticality and business essentiality
- Presented data in a way that allowed for easy integration into SAP
- Facilitated identification of higher/lower priority systems, subsystems, and components to allow for adjustment of maintenance cycles, to achieve cost savings
