The Company
Nationwide Pharmaceutical Packaging Company
The Situation
A national pharmaceutical packaging company did not have a formalized maintenance process or a Computerized Maintenance Management System (CMMS) where information and maintenance work could be tracked and used to plan, schedule or manage parts. Downtime factors and root cause analysis were not, at the time, being used to pinpoint repetitive problems. Equipment breakdowns were so frequent that crews were sent home on a regular basis.
The Scope
The Focus OCG team was engaged to incorporate FDA requirements and Current Good Manufacturing Practices (cGMP). Equipment identification, part serialization and choosing and implementing a new first time CMMS was required as well. Training was needed across all maintenance, operations, and engineering and quality/compliance departments.
Focus OCG Action
Utilizing Focus OCG’s participative management approach to develop the Asset Reliability Model, the consultant crafted a reliability process for the Company that was fully FDA, cGMP and ISO compliant. The process incorporated all documentation requirements for maintenance and was extended into operations utilizing the CMMS system. Equipment strategies, PM’s and work order documentation was implemented, and a technical library was designed and outfitted with current equipment manuals. An operator-to-mechanic communications methodology was developed to exchange sufficient information and expedite the repair using the correct maintenance skill set. A fully functional storeroom was developed, bar coded and entered into the CMMS.
Results
The Asset Reliability Process created a fully functional maintenance environment where reactive work was minimized, and proactive work became a focus. PM’s were completed with extensive information and feedback, and mechanics were more fully utilized throughout the work day. Downtime was also reduced significantly through the use of root cause analysis, and Continuous Improvement initiatives were enabled through the improved performance.
