Pharmaceutical manufacturers continually strive to improve the quality of their products along with improving their production operations. Over the years, many manufacturers empowered their workforce to follow the management techniques of Six Sigma — the statistical-based, data-driven method to reduce costs and increase profits, and Kaizen — the gradual and methodical process to boost productivity by improving the work environment. These initiatives can bring improvements to an operation as long as the manufacturer has a structured means of measuring the results by hour, shift, day, week and so on. One such key performance indicator, or KPI, is Overall Equipment Effectiveness (OEE).
OEE is a measure of how effectively a manufacturing operation is being utilized. The term OEE has been around for over 50 years, created by Seiichi Nakajima, a Japanese citizen and pioneer of the Total Productive Maintenance system. OEE is most effectively applied in production where “units” are produced or created, such as capsules, vials, bottles, syringes, intravenous (IV) bags and packaging (blister packs, cartons, cases, kiting and pallets). A production operation’s OEE value is measured in percentages and is based on three factors:
Availability [A], Performance [P] and Quality [Q].
OEE = A x P x Q
Availability = Run Time/Planned Production Time; Run time is negatively affected by occurrences of downtime.
Performance = (Ideal Cycle Time x Total Count)/Run Time; Also referred to as “throughput,” a measure of how close production is running to the maximum possible speed.
Quality = Good Count/Total Count; Good count is defined as units that meet quality standards on a first pass basis; aka, no rework or total rejects.
A well-run pharmaceutical manufacturing facility concentrates on maximizing both productivity (the measurement of output over time) and efficiency. OEE addresses both in the same calculation. The many components of OEE can become very useful KPIs for several of the operational groups of a manufacturing facility including production, engineering, maintenance and management.
Some pharmaceutical manufacturers have been utilizing OEE for many years; others not yet. This split between embracing/not embracing OEE in pharma is no different than other manufacturing industries. Costs to implement OEE and the corresponding ROI become key factors in the decision of whether or not to implement OEE.
Implementing OEE in a manufacturing facility typically requires a capital investment. The magnitude of the investment is heavily dependent on the number of components of the production line, their age and the type of machine controllers used in the manufacturing operation. OEE starts at the work cell level, which can include a process unit such as a batch tank or fermenter, but more commonly includes filling and packaging equipment such as fillers, cappers, checkweighers, labelers, cartoners, casepackers or bundlers. Key to the success of implementing OEE in manufacturing is the crucial step of verifying the data being extracted from each work cell, including root cause for downtime and stoppages.
A properly designed, configured and verified OEE system can deliver timely and meaningful information geared towards improvements in pharmaceutical manufacturing.
OEE Q&A WITH INDUSTRY LEADERS
How can OEE help pharma companies?
Tim Gellner, Senior Consultant, MAVERICK Technologies: Implementing an OEE program is an essential part of the overall continuous improvement process. If done properly, OEE provides the framework of standardized methods for the acquisition, analysis and reporting of a broad range of production data, which is key to understanding the true performance (both good and bad) of the manufacturing equipment.
The OEE number that results from the calculation model is a good indicator of performance; however, the real power of the OEE calculation model is the constituent data that goes into it. Through the analysis of the components of availability, performance and quality, the root causes of production losses can be quickly identified and acted on. With the near universal implementation of automated production equipment, and using automated analysis and reporting tools, the root causes of losses can be identified in near real-time.
Steve Malyszko, President, CEO, Malisko Engineering: Implementing an OEE system can help pharma manufacturers improve operational efficiency and increase productivity when they are experiencing any one, or all, of the following situations:
When the manufacturer is having difficulty filling orders on time due to limitations, restrictions, or problems on the manufacturing line and doesn’t have a way to capture and analyze downtime and quality data.
When the manufacturer has a “gut feel” that they can improve production efficiency but they don’t have a system to capture the root cause(s) of downtime and poor quality.
A real-world example we saw was a pharma manufacturing client who had difficulty meeting their scheduled speeds on a multi-dose line. Very shortly after we activated the OEE system, the manufacturer quickly found the major pinch-point was the filler. Additionally, the client found that the operators were pressing the emergency stop button anytime the operators wanted to or needed to pause filling. E-Stop completely shuts down the filler and removes all electrical power; pause merely pauses the filling operation, keeping the system powered. Rebooting or restarting the filler after E-Stop took several minutes, thus causing excessive and unnecessary downtime. The OEE system captured this incorrect procedure and caused production to re-train the operators to press pause instead of E-Stop, thus significantly increasing filler run time.