Greg Millinger and Alicia Bowers, GE Intelligent Platforms, review the move away from manual operations and paper recording towards electronic methods that ease compliance and reduce costs
Imagine an operator on the plant floor is performing manual weigh and dispense of the materials needed for use in a pharmaceutical production process. The operator must ensure exact quantities as well as proper record keeping. This same scene could have been from the 1950s. Many manual processes taking place half a century ago in production plants still occur today. The manual decision-making during production steps, the clipboard and paper forms, dusty Standard Operating
Procedure (SOP) binders, and a long paper trail of production records still exist within many companies.
However, manufacturers are expected to deliver better yields, with tighter margins and stricter compliance every day - and having deep knowledge about what is happening on the plant floor is more important than ever. Manufacturers need this knowledge and assurance to avoid quality issues that can result in disastrous product recalls and harm brand equity.
There are many variables that affect the availability and reliability of data on the plant floor and throughout the supply chain. Most manufacturing environments contain a mix of automated and manual interactions between equipment and personnel. These production processes may not be fully documented and can include extra steps and resources. As such, they are difficult to track and trace - and difficult to adapt to changing business needs.
In addition, when detailed compliance procedures and SOPs are in place, it can be difficult to monitor compliance with them. New operators may not follow SOPs properly - or systems may not be in place that record both automated and manual data. For example, a procedure may require an operator to verify a minimum weight or, in another case, check that lot codes are printed clearly and correctly, but the records of the actions may be incomplete.
Electronic work process management offers a way to improve production by digitising and documenting both manual and automated processes, ensuring compliance with SOPs. Electronic work process management captures the manual data entry necessary on the plant floor and connects it with equipment, people and systems. Manufacturers can track both manual and automated processes in real time, capturing data and creating a critical infrastructure for taking immediate corrective action.
In the event of a recall, work process management ensures that historic production data on batches/lots, equipment set-up, validated calibration and operators are readily available. Furthermore, companies can cut the potential for recalls by improving production processes.
By definition, a workflow is "the automation of a process during which information or tasks move from one participant to another for action, according to a set of rules." As an enabling tool, industrial workflow software provides a system for improving and optimising industrial and production practices - combining automated and manual processes through authoring, execution and analysis capabilities.
This software takes a production "flowchart" and digitises it, connecting people, equipment and systems. Unlike Business Process Management (BPM) in the enterprise, which operates in hours and days, industrial work process management operates in seconds and subseconds. Industrial work-flow, when based on an industrial Service Oriented Architecture (SOA), can also make existing systems more flexible and adaptable to change.
Just as production has a broad range of work processes, industrial workflow software can solve a broad spectrum of challenges. Workflows can involve basic tasks such as asking an operator to check tank levels every hour, to managing an entire production process and orchestrating data transformations between ERP and MES.
The workflow system - and its reporting - can touch almost all production personnel, including quality managers and quality technicians, maintenance, operations supervisors, production engineers and more.
Additionally, digitisation of a process can involve one or many steps. It can take place in one station with one user or spread across the plant and move from person to person, following a set of rules. The workflows follow the execution path logic developed by the power user through easy-to-use graphical authoring tools. Each step could include linked documents such as work instructions - or any information that pertains to how the user should complete the process.
production challenges
Unlike traditional systems, industrial work process management allows production teams to mix automated and manual tasks. The use of the system can vary among companies. However, many organisations face common production challenges. Common uses for industrial work process management include:
Electronic work instructions and digitised SOPs: Instead of using a static piece of paper or a binder at their station, operators follow SOPs and work instructions through industrial workflow. They accomplish their work with fewer errors, and the system records the information. Industrial workflow guides operators through step-by-step instructions. Companies can ensure production complies with defined processes - with validated entry - capturing data for analysis and historical records.
The system can analyse in real-time and document the operator, shift, batch, equipment settings and validated calibrations, equipment serial numbers, product conditions, and more. This process decreases costs by reducing errors and waste, and increases compliance by enforcing SOPs.
Quality hold: non-conformance, rework and quarantine: The system can automatically trigger non-conformance workflows to manage better and take steps to prevent and minimise quarantines and recalls. It guides operators through assignments, inventories, supplemental testing, inspecting, rework and re-dispositioning.
Manufacturers can bracket product batches/lots suspected of sharing a quality problem - and manage and track the process of testing and assessing bracketed product for conformance, and then releasing, splitting, rejecting or reworking. This use closes the loop on non-conformance, reducing costs of product waste and decreasing shipping delays by driving non-conformance to fastest resolution.
Compliance monitoring procedures: Companies can electronically monitor and record production work processes and compliance, taking immediate corrective action when compliance issues occur. Teams can ensure that operators are diligent about procedures and respond faster to compliance problems.
Alarm management, corrective action and exception management: The system allows companies automatically and dynamically to respond to production problems and events, monitoring alarms and out-of-spec conditions from multiple systems. Users can send tasks to people or systems to correct problems in real time and can minimise nuisance alarms and ensure proper action on critical alarms.
Additionally, users can track QA data in real- time and automatically adjust work processes to conform to specs. Corrective action can be taken on an event-triggered basis, adjusting processes as needed. Furthermore, they can record exceptions and corrective actions for compliance audits and continuous improvement of processes. A system such as GE's Proficy Workflow can make every operator an expert - and decrease costs by reducing waste and labour, downtime through faster response, and risk through automatic remediation or escalation.
QA plan and sampling: Manufacturers can automate and manage the QA plan and sampling, enabling more sophisticated, situation-driven sampling, testing and inspection routines. The industrial workflow system can automatically trigger QA sampling based on production events or elapsed time, and connect operator work instructions with production actions and real-time quality data. This use can increase quality through improved product consistency and decrease costs of waste.
Troubleshooting: In addition to extensive production task management, industrial workflow also offers a basis for "decision wizards" or "troubleshooting trees". At a major global manufacturer, teams have now documented troubleshooting trees for the first time. These trees capture the knowledge of workers due to retire before employee attrition affects production.
Industrial workflow digitises the trees into "decision wizards" that walk newer employees through processes - related to both equipment repair or in-process product remediation. The digitised decision trees help guide the newer workers on what corrective actions to take in certain circumstances.
Production set-up: To speed production and improve quality, industrial workflow can guide operators through the steps to set up a machine or recipe properly. The system walks users through set-up, provides documentation and records the time it takes for operators to move through each step. Additionally, teams achieve historical records that verify proper machine or recipe set-up, including calibrations and serial numbers connected to specific batches, prior to raw materials usage.
In reviewing the uses, industrial workflow spans production challenges from set-up to managing entire production processes and communicating among many different systems. As the complexity of the workflows increases, industry standards become more important to ensure successful execution.
To create common ground between systems, companies need a common definition of data. Even at the simple end of the spectrum - such as a workflow that performs basic tasks - companies must exchange and store data. The ISA-95 standards provide a common framework and data model in which different systems can communicate and give context to data found in static and real-time systems. Once standard data models are in place, workflows can use the data within the models to carry out their execution and have a place to store results of execution.
Workflows are a key element to connecting and managing flexible work processes that can be very dynamic. By leveraging a common reference model and workflow engine to improve production operations, companies can enable workflows to execute across many systems - and know that they have achieved a foundation for sustainable advantage. mc