SITUATION
A Four Hundred (400) person R&D Facility, part of a 2 billion dollar per year Medical Device Company, required a solution for the following problems:
- Maintenance requirements for equipment where causing unacceptable impact on facility operations
- Lab techs lack sufficient regulatory knowledge leading to QA violations
- Maintenance plans and work execution did not meet SOP requirements
- Unacceptable levels of potential rework on critical equipment
- Inefficient methods of executing cost control or work history retention for maintenance program components
APPROACH
Our proprietary approach incorporated equipment validation, equipment criticality reviews and several risk-based programs to achieve the results required by our client. We implemented a centrally managed work control process, enabled by our proprietary data management system. A team of Subject Matter Experts and Technical Staff in the area of regulatory compliance and maintenance work control with support from client leadership and staff implemented an integrated maintenance best practices and validation information into a robust fully compliant maintenance program designed for maximum reliability at reasonable cost.
SCOPE OF WORK
We initiated our process which combines regulatory and maintenance process experts to aid understanding work management and control needs of the client. The process began with the development of a maintenance plan and master equipment list (MEL) with assigned criticality. Critical compliance and work practice information was loaded into a project data management system for each component in the plan. Each subsequent piece of equipment was entered in this manner. The next step is to conduct life-cycle analysis for each record in the MEL by first developing maintainability reviews from equipment specifications and procurement documents and subsequent criticality categories for cGDP components and other process/utility equipment. Based on the criticality review, specific maintenance plans were developed and converted to PM tasks from existing IQ and OQ protocols, manufacturers recommendations and/or warranty requirements. Based on criticality reviews conducted we were able to ensure calibration and PM task frequencies were optimized for cost and regulatory impact. The next phase was to develop an approved network of service providers and vendor support for equipment groupings. The final element was to complete knowledge transfer to client staff to ensure sustainability.
MAINTENANCE PROGRAM PLAN
The initial step was to establish Maintenance Plan for the maintenance and configuration control process. The plan included a complete inventory of all required equipment and all recurring maintenance tasks. The Maintenance Plan assisted in integrating the prioritization of project elements and manpower resources. Our Implementation Manager supported by validation and maintenance program experts provided the configuration control function for this plan.
PROJECT DATA MANAGEMENT SYSTEM (PDMS)
The entire maintenance process was enabled at start up by our proprietary data management system. The system supports basic accounting and reporting functions, plans, schedules work, approved service provider records provide critical data to all stakeholders, collect metrics for continuous improvement, and functions as the going forward the compliant work control process.
Client staff gained on-line access to maintenance support information like work status, cost and regulatory information. Our methods, processes, and technology became part of the business environment and culture through the data management system.
KNOWLEDGE TRANSFER
We partnered with the client to implement our maintenance program approach with a focus on knowledge transfer. The integrated package of risk-based technology and support services that includes 400 benchmarked best practices was instrumental in establishing process control.
The approach to managing day-to-day work and interfacing with the site team included planning, execution, and continuous improvement. We utilized the underlying PDMS system to enable the entire process and provide demand-driven information. Prior to systems turnover all maintenance and operations critical information was thoroughly reviewed by the client staff through effective on-the-job training. Our implementation methods drove new behaviors in a learn-by-doing environment.
METRICS
The third part of our approach was to support the new process by a suite of metrics to ensure effective decision-making and compliance is maintained. We worked with senior management to establish new performance measures and identified the metrics that were used. The effectiveness of the model will be driven by the accuracy of measured performance and the effectiveness of data based maintenance and compliance based decisions.
OUTCOMES
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Fully implemented maintenance system for work control with full online access to critical information needed to assure compliance and cost control.
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Established a fully compliant and sustainable system.
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Implemented an effective Preventative Maintenance program.
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Knowledgeable and informed staff/knowledge transfer
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Ability to schedule maintenance around operations schedules
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Identification of process equipment criticality
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Control of service providers and vendor support
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Increased lab tech availability to technical related jobs
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Merged two traditional manager roles to one