Structured Process Analysis

Structured Process Analysis (Carlos Paco)

Structured processes are formally defined, standardized processes that involve day-to-day operations: accepting a return, placing an order, purchasing raw materials, and so forth. The structured business process we are focusing on is the batching process in the Buffer Preparation (BP) area. The main purpose of the Buffer Preparation Process is to batch various solution buffers to supply the Purification (PUR) batching process. 

Buffer Preparation Batching Process Steps (Carlos Paco)

• BP and PUR production coordinators will meet, discuss, and plan for upcoming buffer solutions required for PUR’s batching process. 
• BP batch data (material code, description, batch size) are placed on a shared Excel Integrated scheduling spreadsheet by the BP coordinator several weeks prior to executing the batch.   
• After adding the BP solution batch data to the Integrated Schedule and using an assigned group chat via Teams the BP production coordinator will advise the scheduling coordination team that BP data was added in order to generate process orders in MES. 
• Scheduling coordination will generate an electronic batch production record (eBPR) and a process order (PO) numbers are created in the MES.
• Scheduling coordination adds the PO numbers to the corresponding BP data that was previously inputted by the BP production coordinator on the shared spreadsheet.
• Scheduling coordination will advise the dispensary department via the group chat and email that PO’s were generated in order for the dispensary department to Kit and stage the material and components required for each process order. 
• Dispensary operators initiate the PO, complete the dispensary portion activities on the eBPR, and send out a daily report of all production batches kitted and staged to all required personnel via a group email. 
• BP supervisors conduct a 2-week batch production look ahead, instruct BP operators to pick up the completed kitted material and components from the staging area, and store the kit in the BP suite in order to be ready for use.
• Prior to batch production activities, supervisors conduct daily meetings with BP operators to discuss batching activities for the day, safety concerns, training compliance for batching activities to be performed, quality issues, and other important company topics.
• BP operators log on to MES and locate the active process orders that are planned to be batched for the day. 
• BP operators follow the eBPR step by step to complete the batching process and transfer the BP solution into a Buffer Hold Solution tank in a different location. 
• BP operators confirm on MES that all steps have been completed and eBPR automatically closes and is at a completed status.   

    Providing that production coordination, scheduling coordination, and dispensary operation were completed accurately there should be no barriers, interruptions, errors, etc. present and the process should proceed effectively and efficiently. That said there are always unplanned events and problems.
    Some problems that arise are systems not being online due to weather or system updates, loss of time due miscommunications between systems (especially legacy systems), and incorrect data input due to human error.

Information system (IS) (Carlos Paco)

Information Silos (Carlos Paco)
Information silo is the condition that exists when data is isolated in separated information systems. At Lilly, all MISs need to be formally requested and approved from either a supervisor, manager, or director from another MIS software. Depending on the system being requested in order for access to be granted prior justification must be met. In addition, some MISs require both computer and class training and proof of completed training is required prior to granting access. That said, for the BP production process there are no silos as long as all criteria have been satisfied. Though according to the manager, a common occurrence regarding data or information being separated, many times some of the “right” people are not invited to sit in meetings and emails regarding upcoming projects.

The MISs at Eli Lilly eliminates many of the silo problems. The process for granting access can be somewhat restrictive at first but this process ensures security, confidentiality, and compliance. Somes issues with having multiple IS are data can be duplicated and inconsistent causing data integrity issues.  though at Eli Lilly some IS making it impossible for data to be duplicated. Additionally, when changes are made within these systems there's tracking capabilities that log every transaction, for example, adding, deleting, or modifying data. Many of these systems have data query options for a higher degree of visibility.  

CRM, ERP and EAI (Carlos Paco)

• Customer Relationship Management (CRM) system is a suite of applications, a database, and a set of inherent processes for managing all the interactions with the customer, from lead generation to customer service. 

• Enterprise resource planning (ERP) is a suite of applications called modules, a database, and a set of inherent processes for consolidating business operations into a single, consistent, computing platform. An ERP system is an information system based on ERP technology. 

• Enterprise Application Integration (EAI) to solve those problems. EAI is a suite of software applications that integrates existing systems by providing layers of software that connect applications together.

ERP vendors (Carlos Paco)

• Microsoft

• SAP

• Oracle

• Sage

• Epicor

• Infor

Eli Lilly's ERP (Carlos Paco)

The company has various SAP software applications, which are utilized to integrate core functions and to automate the performance of various business controls through continuous control monitoring across MFG, SC, HR, IT, Finance, QA, and Security.  

Inter-enterprise IS (Carlos Paco)

Processes are used at three levels of organizational scope: workgroup, enterprise, and inter enterprise. The wider the scope of the process, the more challenging the process is to manage. Inter-enterprise information systems support one or more Inter-enterprise processes, such as 1000+ users and systems procedures. It can provide problem solutions that affect multiple organizations. One example is resolving problems of duplicated enterprise data.

Eli Lilly's Inter-enterprise IS (Carlos Paco)

To avoid information silos and allow for data integration the company does have inter-enterprise IS. Having a robust inter-enterprise IS allows the company to collaborate with both internal and external business organizations. Eli Lilly being a large global firm needs to respond and adapt to the changing business environment, industry and global trends. Some of these trends include automation tools and digital advancement in the pharmaceutical industry. For example, Eli Lilly has taken advantage of Blockchain technology to increase supply chain management (SCM). Short- and long-term solutions can respond effectively when facing unforeseeable factors and issues in production and supply chain operations. Another example includes collaborating with other companies. In 2019 Eli Lilly established an alliance with the company Atomwise to provide artificial intelligence solutions to support preclinical drug discovery efforts. This year the company partnered with Elektrofi Inc and entered a research collaboration and license agreement to produce next-generation medications to be delivered subcutaneously.