Unlocking Efficiency and Compliance – The Advantages of a CMMS in the Pharmaceutical Industry
In the highly regulated Pharmaceutical Industry, maintaining stringent standards for safety, quality, and efficiency is crucial. At Hanley, we understand the importance of these standards better than anyone. With decades of experience, we have honed our expertise in managing and administering Computerised Maintenance Management Systems (CMMS), ensuring our clients achieve and maintain compliance with industry regulations.
Our team’s extensive experience spans creating Standard Operating Procedures (SOPs), managing data transformation, and developing processes for the daily management of data entry and modification. We’ve provided sustaining services for multiple customers across various CMMS platforms, giving us a unique insight into the workings of an effective CMMS.
At Hanley Calibration, we pride ourselves on our deep understanding of CMMS functionality. We know that a CMMS is only as good as the processes and people who manage its use. Our tailored approach ensures that your CMMS is not just a tool but an integral part of your operational excellence. Here are some of the advantages offered by an effective CMMS, as demonstrated through our extensive experience.
Enhanced Regulatory Compliance
The pharmaceutical industry is governed by rigorous regulations such as Good Manufacturing Practices (GMP) and guidelines from the FDA, HPRA, CHP and other regulatory bodies. A CMMS helps in:
Documentation and Reporting: Automating the generation of maintenance records and providing a clear audit trail on equipment maintenance and repair.
Compliance Tracking: Monitors adherence to scheduled maintenance, ensuring equipment meets regulatory standards.
Approvals and Ownership: A robust CMMS ensures that all critical activities are viewed and assessed by those who need to make critical decisions.
Improved Equipment Reliability and Uptime
Equipment reliability is crucial in pharmaceutical manufacturing to avoid costly downtimes and ensure continuous production. A CMMS enhances equipment reliability by:
Preventive Maintenance: Schedules regular inspections and maintenance tasks to prevent equipment failures.
Predictive Maintenance: Utilizes data analytics to predict and pre-empt potential equipment issues.
Corrective Maintenance: Defined robust processes for managing repairs and issues discovered on equipment ensures issues are escalated quickly and efficiently.
Asset Management: Tracks the lifecycle and performance of equipment, helping to plan replacements and upgrades proactively.
Cost Efficiency
Effective maintenance management directly impacts the bottom line. A CMMS contributes to cost efficiency through:
Reduced Downtime: Minimizes unexpected breakdowns by ensuring timely maintenance.
Inventory Management: Manages spare parts inventory, reducing excess stock and preventing stockouts.
Resource Optimization: Schedules and assigns maintenance tasks efficiently, ensuring optimal use of maintenance staff and resources.
Enhanced Safety and Quality Control
Safety and quality are non-negotiable in pharmaceuticals. A CMMS supports these functions by:
Safety workflows and classifications: Ensures Safety related maintenance tasks are performed according to safety standards, reducing the risk of accidents. With a robust escalation process ensures that EHS/Engineering departments are engaged in the safety of all staff.
Quality Assurance: Maintains equipment in optimal condition, ensuring consistent product quality. Well defined workflows for Abnormal condition assessment ensures that compliance is engineered into the system.
Risk Management: Identifies and mitigates potential risks associated with equipment and maintenance activities. Ensuring that due date extensions, past due conditions or backlog works are appropriately assessed and documented.
Streamlined Workflows and Communication
Efficient workflows and clear communication are vital for smooth operations. A CMMS supports this by:
Work Order Management: Automates the creation, assignment, and tracking of work orders.
Collaboration Tools: Facilitates communication between maintenance teams, production staff, and management.
Administrative processes: Ensuing that data is managed correctly by having a single point of data entry modification ensures consistent data management and a robust system.
Hanley’s experience in working with multiple CMMS over the years from the user position of the Calibration or Maintenance technician to the Planning stages and acting as the data governance/transformation team places us in an unrivalled position to support our customers in ensuring that they are getting the very best from any CMMS.
Hanley have years of experience in supporting our customers in the following key areas with responsibilities in CMMS :
Work Order Administrator – dedicated team acting as the gatekeepers to the CMMS, essential in ensuring that the CMMS is maintained as it was designed and functions effectively.
> New data entry
> Data modification/changes
> Work request processing.
> Data integrity management
> Reporting and metrics
Maintenance Planners – Operating as the bridge between the maintenance team, vendors, inventory, EHS, and production. Planners ensure that works are effectively managed and prepared ahead of execution.
> Work order planning.
> Permitting
> Purchase orders.
> EHS qualification
> Scheduling
> Verification of materials and tools
> Craft capacity analysis.
> Management and escalation of Safety and Corrective works
> Updates and improves the Job plans and task lists based on feedback from craft teams.
> Supporting shutdown planning