Introduction
Workflow is defined as a structured hierarchy of configured, reusable, and tested objects for routings, operations, phases, and actions
Operators are guided through the execution of all product manufacturing activities in a sequential way, with the completion of a workflow providing high traceability of all activities within an Electronic Batch Record report.
Standard routing vs Workflow
A standard routing provides the definition of all operations to be performed and their "overall" sequence. Operations are at a high level and do not provide:
- High granularity in the traceability of every action carried out by the operator
- Dynamic sequencing (Via looping / branching) of operations
Workflows provide a much more precise description of all activities to be performed and in which sequence said activities must take place. The workflow model comprises of the following hierarchy:
- Operations: Macro steps to reach to a finished or semi-finished good.
- Phases: Operations are divided into phases. When completing all phases, the operation is finished.
- Actions: All activities and transactions to be performed. This is the lowest
level of execution. When all actions are complete, the phase is finished.
- Operator based: Scan a pack to consume, perform an inspection.
- Machine based: Read/write a PLC value, read a weight value.
- Computer based: Perform a background calculation, set a value in transition parameters.
- Transitions: Links between operations, phases or actions, and transitions define the flow of activities based on the progress and results from actions. This enables looping between actions and branching on exception.
When you need Workflow
Workflow is intended to provide MES with the capability to better track and steer a manufacturing process with a focus on strong action by action traceability. With MES able to run in this mode and with more conventional routings, it is key to understand which suits your manufacturing process better.
The Workflow module is highly configurable, so it is important that sufficient training time is allocated for key users to ensure proper and sustainable set up of the master data..
Here are some requirements typically associated with workflow solutions:
- Electronic Batch Record (eBR), Device History Report (eDHR)
- Review by Exception
- Batch/Lot/Product release process
- Operator Guidance, Batch Control, step-by-step production execution
- Dynamic product routing, loops, exception handling
- Heavily regulated industries, for example, life sciences, food and beverage, or aerospace and defense
A combination of these requirements might lead you to consider using Workflow in MES solutions.
Typical Use Cases
It is possible to use mixed solutions, where traditional and Workflow routings can be run in the same production environment for these scenarios:
- Use of Workflow for strict, operator guided process control on some manufacturing operations
- Use of non-workflow routings for manufacturing operations that do not require operator guided process control.
Because workflow is highly configurable through master data, its usage can scale in complexity from simple process guided weigh and dispense to a full pharmaceutical production line with complete eBR.
These are some use cases where a workflow solution has been implemented:
- Recipe management
- Getting to a recipe is typically a strict process with defined operations and activities to perform in a detailed sequence
- Weigh and Dispense is a typical pharmaceutical process where Workflow can bring a structured approach and high traceability
- Assembly
- Complex assembly with a sequence of production, testing, signature, and validation activities
- Provide dynamic work instructions for each activity or phase
- Device History report
- FDA / GAMP5 regulated environment
- Pharmaceutical or food and beverage processes
- eBR / eDHR
- Tracking sheet
- Workflow is designed to replace the tracking sheet which circulates with the product to all machines
- eBR / eDHR
- Full detailed traceability
- Batch release process