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"Using Simulation with Scheduling Visualization to evaluate Change Initiatives in a Bio-Pharma Environment”. Topics. The issues Solution objectives Solution components The first test The first answer Tangible benefits Intangible benefits. The Issues.

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  1. "Using Simulation with Scheduling Visualization to evaluate Change Initiatives in a Bio-Pharma Environment”

  2. Topics • The issues • Solution objectives • Solution components • The first test • The first answer • Tangible benefits • Intangible benefits

  3. The Issues • Pharmaceutical manufacturing processes are complex and subject to a unique set of challenges • “Delicate” product that is subject to • Expiry constraints • Contamination • Strict environmental condition requirements • High production costs • High revenue loss for rejects

  4. The Issues (cont’d) • Equipment use and management is also subject to constraints • Clean and Dirty hold times • Re-use in multiple steps • Highly specialized • High cost • Limited maintenance/cleanliness facilities

  5. The Issues (cont’d) • Personnel issues include • Specialization and certification for tasks • Gowning De-Gowning • Critical scheduling • Burnout

  6. The Issues (cont’d) • The process • Relatively long cycle time • Multiple testing and reject points • “Re-work” usually not an option • Complex timing of steps • Not conducive to automation • Inherent inefficiencies • Many steps require task executor and observer • Change requires “act of congress”

  7. The Issues (cont’d) • The consequences • Communication of process via “village folklore” • ISO - TTWWHADI • Process change impact in real world expensive • Vulnerable to personnel turnover • Stagnant process – “if it ain’t broke don’t fix it” stance limiting • Difficult to identify relationships between issues

  8. Solution Objectives …. to provide an organizational capability to more accurately predict the production throughput of a production process while considering the many variables that can effect the system.

  9. Solution Objectives (cont’d) • Two main phases : • Provide a means to represent and visualize the way the process is today • Provide a means to identify opportunities (using scenarios) for process modifications and quantify their impact by changing : • The process itself • Shift schedules • Production schedules • Resource requirements • Task cycle times • Variability

  10. Solution Objectives (cont’d) • Main requirements : • Flexible input modules using MS Visio and Excel • Minimize changes to model required for scenario evaluation • Rapid what-if analysis capability • Gantt chart visualization of model output

  11. Solution Components

  12. Solution Components (cont’d) • MS Visio Diagram : • Represented the process flow using a nomenclature standard and simple relationship mechanisms • Included Visual Basic “export” function to export task information to MS Excel worksheet • Identified “trigger tasks”

  13. Solution Components (MS Visio)

  14. Solution Components (cont’d) • MS Excel Worksheet : • Multiple “hidden” sheets acted as link between Visio Diagram and ProModel model • Provided means to enter : • Task cycle times • Resource/task assignment and utilization • Resource information (shifts, qty available, type) • Production schedule (identical format to client report) • Trigger task information • Orchestrate infrastructure

  15. Solution Components (Excel Input)

  16. Solution Components (cont’d) • ProModel Model : • Visio diagram used as background • Makes exclusive use of excel worksheet data for routing, cycle time and resource information • Linked to Orchestrate project file • Standard output statistics keeping track of : • System throughput • Overall Cycle Time • Work In Process • Utility Consumption (WFI) • Resource Utilization

  17. Solution Components (cont’d)Running Solution

  18. Solution Components (cont’d) • Orchestrate Project File : • Linked to model to provide Gantt visualization of model events and measurements • Infrastructure information maintained in MS Excel input workbook • Updated in real time with model progress • Tracked : • Batch production progress • Task events • Resource states • Key metrics

  19. Solution Components (cont’d)Orchestrate Schedule Visualization

  20. The First Test • During technology transfer training, a senior production manager asked if the model could examine the possibility of going from a two to a three shift operation with batches being initiated back to back as opposed to the normal “one start a week” ……

  21. The First Test (cont’d) …. Oh, and by the way, can you give me the answer by tomorrow?

  22. The First Test (cont’d) More specifically : • Could the solution handle the complexity of scheduling the complicated, highly variable prep steps to take advantage of the third shift ? • Could a batch be completed in less than a 5 day week in the new scenario ? • Would this increase the production capacity linearly or by least 50% ? • Would the increased production be worth they investment?

  23. The First Answer • Together with a client SME, and a ProModel consultant, the answer was obtained in the matter of a few hours. • Normally, this question would have taken weeks to answer.

  24. The First Answer (cont’d) More specifically : • Confirmed the model & user could schedule the complicated highly variable prep steps • Confirmed a batch be completed in less than 5 days, in fact the average time to complete was 4 days and 10 hours. • Confirmed adding the 3rd shift would increase the production capacity counter intuitively far beyond 50%

  25. The First Answer (cont’d)

  26. The First Answer (cont’d) Confirmed adding the 3rd shift would increase the production capacity counter intuitively far beyond 50% • The additional counter intuitive capacity (over 100%) came from providing the client with the ability to schedule and manage the highly variable “Prep Steps” in a much more dependable fashion such as • Reduced batch loss due to expiry • Optimization of feeding constraining resources.

  27. Tangible Benefits • Going from a two shift to a three shift operation would theoretically enable the facility to produce 1 batch per week versus .5 batches per week resulting in an increase in revenue in the tens of millions …. annually. • The client team now has the ability to analyze their process on a virtual test bed before submitting proposed changes.

  28. Intangible Benefits • The architecture used on this project is widely “reusable”. • The client was now familiar with process modeling and could leverage this knowledge to study other production processes (which they are doing). • “Proof of concept” aspect created visibility opportunities for the client team.

  29. Questions???

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