"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 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

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

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

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”

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

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.

Solution Objectives (cont’d) Two main phases : 1.Provide a means to represent and visualize the way the process is today 2.Provide a means to identify opportunities (using scenarios) for process modifications and quantify their impact by changing : 1.The process itself 2.Shift schedules 3.Production schedules 4.Resource requirements 5.Task cycle times 6.Variability

Solution Objectives (cont’d) Main requirements : 1.Flexible input modules using MS Visio and Excel 2.Minimize changes to model required for scenario evaluation 3.Rapid what-if analysis capability 4.Gantt chart visualization of model output

Solution Components

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”

Solution Components (MS Visio)

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

Solution Components (Excel Input)

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

Solution Components (cont’d) Running Solution

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

Solution Components (cont’d) Orchestrate Schedule Visualization

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” ……

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

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?

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.

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 3 rd shift would increase the production capacity counter intuitively far beyond 50%

The First Answer (cont’d)

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. Confirmed adding the 3rd shift would increase the production capacity counter intuitively far beyond 50%

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.

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.

Questions???