Reliability-Centered Maintenance for a Pharmaceutical Manufacturer
A global manufacturer of pharmaceuticals was issued a warning letter by the FDA after foreign materials were discovered in the product during the packaging process at a plant in Puerto Rico. DPA was brought in to help the manufacturer meet its commitment to the FDA to implement a reliability-centered maintenance program to improve equipment reliability and to specifically address the packaging area issue.
The client promised the FDA it would conduct reliability risk analyses, conduct a root cause investigation, and develop a corrective action plan for the foreign material issue.
To address the goal, DPA developed a Reliability-Centered Maintenance program to incorporate reliability risk analysis into the existing maintenance environment as part of the corrective action plan. This program included tasks to accomplish the following objectives in collaboration with the pharmaceutical’s engineering, maintenance, and production groups:
- Modify job plans to reflect risk analyses outcomes as they are completed
- Update CMMS with approved tasks and frequencies based on completed risk analyses
- Update staffing requirements to reflect new job plans
- Establish equipment baseline performance metrics and track performance for each piece of equipment
- Assure adequate planning and scheduling (maintenance as well as production) to support reliability in terms of access to the equipment and timely execution of maintenance job plans
- Make sure parts Inventory can support the reliability effort
- Make sure the work order process enables correct data gathering for repair history and PM findings (condition as found during inspection)
- Make sure proper maintenance management practices are in place to support reliability
With regard to the specific product packaging issues, DPA worked with the client to review all practices and procedures specifically relating to packaging equipment. This review included:
- Prioritized preventive maintenance job plan review
- Spare parts review
- Manufacturer walk-downs
- Mechanic and operator training
- Line clearance checklists
- Line cleaning procedures
- Overhaul recommendations
- After a critical line’s annual shutdown extended from the planned 1 month to 3, the client was able to recover the 2-month’s lost production and get ahead of plan by the 12th month through the application of the Risk Analysis findings. They determined that they had only added approximately 15% additional maintenance activity on this line and realized a 25-30% reduction in corrective maintenance (i.e., unplanned downtime).
- As a result of DPA’s project, the client was able to meet its commitment to the FDA and correct the foreign materials problem.