Implementing Process Improvement

Robert Dream, HDR COMPANY LLC.

Driving manufacturing process improvement is one of the most effective ways to increase quality, operational efficiency, and ROI (Return On Investment). Improving the processes that contribute to the final product is an easy way to create scalable and sustainable changes. The right improvements can reduce defects, decrease production time, and boost client satisfaction, Figure 1.

For organizations experiencing rapid growth, finding new and innovative approaches will ensure that the enterprise operates at full capacity during busy periods. Those that simply want to improve their approach will benefit from adopting modern lean thinking methods. Every business could take advantage of new ideas, technologies, and best in practice/class examples in a way that fits with their existing model. Methodologies that can drive manufacturing process improvement, boosting the productivity of the operation, and insuring business outlooks are summarized below.

Steps to Excellence Journey

• Structure (5S Lean Workflow)
  • Work environment
  • Procedure and instructions
  • Abnormalities invisible

• Insight (Kaizen)
  • Visual management KPIs
  • WIP control
  • Continuous improvement culture

• Stability (Lean Manufacturing)
  • Stable processes
  • Eliminating waste
  • Flow and pull

• Capability (Six Sigma)
  • Reducing variation
  • In-process control
  • Statistical tools

• Robustness (DFSS)
  • Robust Processes
  • Design for Six Sigma
  • Quality function deployment

5S Workflow

The 5S methodology is all about getting the manufacturing floor organized. It is a structured approach to arranging everything in its optimal place to maximize productivity and output.¹ The beauty of this approach is that it is relatively simple to implement and doesn’t require specific training.

The 5S lean workplace steps process consists of the following elements: Sort, Set-in-Order, Shine, Standardize, Sustain, see Figure 2. The reason that this method is effective, is because it eliminates waste that is caused by disorganization. Every time a team member has to walk somewhere to find a tool or locate source material, it causes small delays to the production process. Over the course of the day, week, and year, these soon add up to significant amounts of time. What may seem like a small inconvenience is actually substantially multiplied over the production year. Eliminating these tiny blips in the system, will allow processes to flow more smoothly which leads to efficiency gains.

Standardization is also a crucial component of both quality control and productivity. It’s common for people to prefer their own way of doing things, but even slight differences can lead to delays that soon stack up. First rate manufacturers prioritize the final product above all else so there’s no room for individual quirks. A non-standard approach can cause defects, returns, and reputational loss. The simplest approach to setting standards is creating a checklist that people can follow. Displaying it prominently in the workspace acts as a visual cue and reminder to follow all of the steps. It’s a quick and easy way to drive manufacturing process improvement at a grassroots level.

Kaizen

The Kaizen approach is all about continuous improvement. It focuses on making incremental changes that can be consistently implemented to deliver scalable results. Instead of trying to initiate large-scale change, this continuous improvement model focuses on smaller tweaks. Over time, these seemingly small changes contribute to significant improvements in processes, efficiency, and outputs. The Kaizen six steps are: identify the problem, analyze current processes, create solutions, test the solutions, measure and analyze results, standardize the solution, see Figure 3.

Kaizen is based on the belief that everything can be improved, and nothing is the status quo. It also rests on a Respect for People principle. Kaizen involves identifying issues and opportunities, creating solutions and rolling them out -- and then cycling through the process again for inadequately addressed issues and problems. A cycle made up of seven steps can be implemented for continuous improvement and can provide a systematic method for executing this process.

Kaizen continuous improvement is both a philosophy and a practical tool. Embedding the philosophy of striving for continual improvement creates a culture of innovation over the long-term. Following the steps to achieve continuous improvement is what delivers impact in the short to medium term. Being proactive in waste reduction and process optimization can transform the dynamics of the business operations.

Lean Manufacturing Principles

Lean Manufacturing originates from the Japanese automotive industry and aims to minimize waste and remove activities that are not valuable to the production process. Removing waste from the system reduces the time required for production while improving the quality of products and reducing the overall costs.

There are many benefits that arise from using Lean Manufacturing techniques, these include:

• Waste Minimization: The main goal of lean manufacturing is to reduce the amount of waste throughout production. The elimination of wasteful processes will increase the efficiency and throughput of production. In addition, the elimination of defects and over-processing will bring you one step closer to building a more sustainable supply chain.

• Cost Reduction: Lean manufacturing strategies allow you to reduce the amount of WIP items you need to store. Warehouses and inventory managing processes can incur very high costs so reducing the number of items that need to be stored will allow you to reduce or eliminate warehouse space.

• Meet Promised Dates: Streamlining the production process and removing wasteful activities allows you to reduce the manufacturing lead time for the object. This allows you to produce more items in a shorter time so that it can meet promised delivery dates.

• Improve Quality: Efforts to eliminate defects to reduce waste will often require an improvement of processes and lead to products of better quality. Lean manufacturing techniques also encourage the practice of continuous improvement.

The five principles of lean manufacturing include defining value, mapping the value stream, creating flow, using a pull system, and pursuing perfection. These five principles are outlined in more detail below in Figure 4.

• Define Value - Lean manufacturing principles aim to add value to the end customer. It is important to understand what the customers value in terms of their needs, what they really want, and what they are willing to pay for. It is possible that consumers are unable to properly articulate exactly what they want. This is especially common where new products are being developed or with technology. There are many techniques such as interviews, surveys, and demographic information that can help discover what exactly customers find valuable.

• Map Value Stream - The second principle within lean is identifying and mapping the value stream. In this step, the overall goal is to utilize the customer’s value as a reference point and locate areas that correlate with their values. Any activities and processes that do not add value to the end customer are considered wasteful. The waste can be broken into two categories: non-value added but necessary and non-value and unnecessary. The latter is pure waste and should be eliminated while the former should be reduced as much as possible.

• Create Flow - After removing the waste from the value stream, the following action is to ensure that the flow of the remaining steps will run smoothly without interruption or delays. Some strategies for ensuring that value-adding activities flow smoothly include methods such as re-configuring production steps, leveling out the workload, or creating cross-functional departments.

• Establish Pull System - Inventory is one of the biggest wastes within a production facility. The overall goal of a pull-based system is to limit inventory and Work In Process (WIP) items while ensuring that the requisite materials and information are available for a smooth workflow. A pull-based system allows for Just-In-Time delivery and manufacturing where products are created at the time they are needed and, in the quantities, needed (supply). Through following the value stream and working backward through the production system, it can ensure that the products produced will be able to satisfy the needs of customers (demand).

• Pursue Perfection - Waste is prevented through the achievement of the first four steps which include identifying value, mapping the value stream, creating flow, and adopting a pull system. The fifth step, pursuing perfection makes lean thinking and continuous process improvement a part of the organizational culture. All employees should attempt to strive toward perfection while delivering products based on the customer’s needs.

Six Sigma

Six Sigma is a disciplined, statistical-based, data-driven approach and continuous improvement methodology for eliminating defects in a product, process or service. It is based on quality management fundamentals.

Sigma (σ) represents the population standard deviation, which is a measure of the variation in a data set collected about the process. If a defect is defined by specification limits separating good from bad outcomes of a process, then a six-sigma process has a process mean (average) that is six standard deviations from the nearest specification limit. This provides enough buff er between the processes natural variation and the specification limits.

If a product must have a thickness between 10.32 and 10.38 inches to meet customer requirements, then the process mean should be around 10.35, with a standard deviation less than σ = 0.005, assuming a normal distribution.

Six Sigma can also be thought of as a measure of process performance, with Six Sigma being the goal, based on the defects per million. Once the current performance of the process is measured, the goal is to continually improve the sigma level striving towards six sigma. Even if the improvements do not reach six sigma, the improvements made from three sigma to four sigma to five sigma will still reduce costs and increase customer satisfaction, see Figure 5.

Using the standard deviation, equation 1, we could calculate the standard deviation value (Table 1).

                            σ = [Σ(X- x )2/(n-1)] ½                   (1)  

Six Sigma is a methodology that helps improve business processes by using statistical analysis. It is a data-driven and highly disciplined methodology and approach that ensures elimination of defects in any type of business or organizational process.

In order to achieve Six Sigma, organizational processes need to keep their defects to a maximum of 3.4 per million (99.99966%). A Six Sigma defect can be defined as anything that is outside of client specifications. Its objective is to minimize the variability in business and manufacturing processes. One of the salient highlights is the ability to create focus on achieving quantifiable and measurable financial returns from any six-sigma project.

Six Sigma DMAIC is a structured problem-solving methodology widely used in business. The letters are an acronym for the five phases of six sigma improvement: Define-Measure-Analyze-Improve-Control, see Figure 6. These phases lead a team logically from defining a problem through implementing solutions linked to underlying causes, and establishing best practices to make sure the solution stays in place.

Define

• Review project charter
• Validate problem statement and goals
• Validate voice of the customer and voice of the business
• Validate financial benefits
• Validate high-level value stream map and scope
• Create communication plan
• Select and launch team
• Complete define gate

Measure

• Value stream map for deeper understanding and focus
• Identify key input, process, and output metrics
• Develop operational definitions
• Develop data collection plan
• Validate data measurement system
• Collect baseline data
• Determine process capability
• Complete measure gate

Analyze

• Determine critical inputs
• Identify potential root causes
• Reduce list of potential root causes
• Confirm root cause effect on output
• Estimate impact of root causes on key outputs
• Prioritize root causes
• Complete analyze gate

Improve

• Develop potential solutions
• Evaluate, select, and optimize best solutions
• Develop “To-Be” value stream map(s)
• Develop and implement pilot solution
• Confirm attainment of project goals
• Develop full-scale implementation plan
• Complete improve gate

Control

• Implement mistake proofing
• Develop SOPs, training plan, and process controls
• Implement solution and ongoing process measurements
• Identify opportunities to apply project lessons
• Complete control gate
• Transition monitoring/control to process owner

Mapping or Flowcharting of Processes

Process mapping is utilized by Six Sigma, which can be defined as a process of flowcharting to enable documentation of a specific business process. Documentation includes various aspects of business processes like employee roles and decision points in overall work performance required for meeting specific client needs. These flowcharts are often used towards making improvement suggestion.

Elimination of Variation and Waste

After identification of improvement ideas, Six Sigma techniques can be used for elimination of waste and variation in business processes. Waste is defined as anything that doesn’t help in producing the service or product that is required to be delivered to a customer.

Reduced Defects

 One of the reasons why implementation of Six Sigma is important is that it helps in reducing defects. Using Six Sigma techniques, employees are able to identify problem areas as well as recurring issues that affect the overall quality expectation of a service or product from a customer’s viewpoint.

Room for Continuous Improvement

Employees trained in Six Sigma processes have the necessary tools and skills to identify problem or bottleneck areas that tamps down production or performance. This process helps employees to identify areas of improvement and work towards it continuously. At the end, it helps in improving existing services or products and assists with development of new high-quality products.

DFSS, Design for Six Sigma

Design for Six Sigma (DFSS) is a separate and an emerging business process management methodology related to traditional Six Sigma. Unlike Six Sigma, which is commonly driven via DMAIC (Define - Measure - Analyze - Improve - Control) projects, DFSS has DMADV (Define - Measure - Analyze - Design – Verify) and is sometimes synonymously referred to as DFSS.

The body of knowledge is focused on DFSS for Process Design and/or Product Design, see Figure 7.

• Define: Define the project

• Measure: Determine customer requirements and wishes

• Analyze: Identify functions, generate and select concepts

• Design: Develop designs, test/optimize design components and complete design

• Verify: Verify design performance, implement design

TRIZ: Teoriya Resheniya Izobreatatelskikh Zadatch (Russian for Theory of Inventive Problem Solving)

VoC: Voice of Customer

PUGH: The Pugh Matrix is one of the most widely used six sigma tools for finding out the best solution once a number of alternate solutions have been generated.

SIPOC: Suppliers, Inputs, Process, Outputs, and Customers

Industry 4.0 and Lean Six Sigma

Lean Six Sigma offers tools and techniques that can eliminate defects and errors in a process, reducing variation and allowing for more consistency in creating quality products. Tools and techniques found in both methods can help with Industry 4.0 processes.

Industry 4.0 creates what has been called a “smart factory”.² Within the modular structured smart factories, Physical-Digital-Cyber (PDC) systems2 monitor physical processes, create a virtual copy of the physical world and make decentralized decisions. Over the Internet of Things, PDC systems communicate and cooperate with each other and with humans in real time, and via the Internet of Services, both internal and cross-organizational services are offered and used by participants of the value chain.

Industry 4.0 Transformation

Traditional vs Holistic Model Based Solution

Conventional Model Based Approach: A typical traditional approach shows that there is interoperability and dependencies between several initiatives, but there is no mechanism to capture and align the impact between the several initiatives. This increases complexity, uncertainty, level of assumptions, misinterpretation and miscommunication, see Table 2.

Holistic Model Based Approach: The holistic model-based approach, where several initiatives are supported and guided by respective Industry 4.0 models to incorporate and manage interoperability and dependencies. The model-based repository handles the complexity in the background while updating the models with all changes, see Table 2.

Industry 4.0 Transformation

Industry 4.0 definitions refer to the combination of multiple major technology innovations. However, it is necessary to realize that enterprises need to undergo a major transformation, which is usually performed using a pragmatic agile approach. Creation of an IT-OT (Information Technology – Operational Technology) architecture according to Reference Architecture Model Industry 4.0 (RAMI 4.0), Figure 8.^3,4

• RAMI 4.0 is a three-dimensional map showing how to approach the issue of Industry 4.0 in a structured manner.

• RAMI 4.0 ensures that all participants involved in Industry 4.0 discussions understand each other.

IEC: International Electrochemical Commission

DF: Digital Factory Framework

IEC 61512: Defines reference models for batch control as used in the process industries and terminology that helps explain the relationships between models

IEC 62264: Is an international standard for enterprise-control system integration

IEC 62890: Life-cycle management for systems and products used in industrial-process measurement, control and automation

Traditional approaches focus on a single system at a time; however, in Industry 4.0 everything is much more connected and integrated and therefore the dependencies are a multifold higher than in current environments. These interdependencies require projects to use a holistic approach and manage these dependencies. To be able to achieve this, a digitized model-based approach is proposed that can be used to drive the full life cycle of such transformation.

Holistic Model-Based Transformation

Besides several major technology innovations, Industry 4.0 is also characterized by new ways of collaboration, product development, the need for integrated horizontal and vertical value chains and new business models. All these need to be fully transparent and give the right insights to the user, anytime, anywhere. The fundamentals of the proposed solution are based on dynamic system thinking and modeling. In the holistic model-based approach six constituents are defined for Industry 4.0 transformation that can be described as dimensions.

The six integrated dimensions are defined as:

• Users: this can be internal, external and or a combination of both aligned with the defined collaborative eco landscape

• Enterprises: includes internal as well as external parts of enterprises that collaborate to reach Industry 4.0 business benefits

• Processes: includes internal processes as well as the integrated processes of the value chain needed to deliver the defined benefits or products

• Applications: all applications to support the system of processes and product lifecycle

• Physical Assets: all machines involved in the eco landscape

• Infrastructures: to support and facilitate the above; support for communication and integration

Such a solution approach, makes it possible to structure, organize and execute in an agile format, with full flexibility executing the strategy and roadmap. A typical Industry 4.0 transformation challenge remains. This is where the holistic model-based solution and the need for digitized dynamic models kicks in.

The following possible model types are defined:

• Dimensions
• Subsystem
• Building blocks and artifacts.

Dimensions are incrementally created and extended following a bottom-up approach. A dimension is first instantiated with small building blocks that at least as a whole or partly can be reused in subsystems, which at the end will contribute in defining the dimension. Artifacts can be created by combining dimensions, subsystems and/or building blocks. Artifacts can fulfill the dynamics of the Industry 4.0 using transformation cases. A project usually produces an artifact containing multiple building blocks that belong to different dimensions.

A key artifact is the IT-OT architecture that merges the Information Technology and the Operational Technology worlds and contains the integrated constituents of the above. A holistic model-based approach makes it possible for enterprises to design, build and implement their IT-OT architecture with optimal flexibility.

As Industry 4.0 includes mission critical, high performance, quality and rapid market demand behavior, the models should be formalized, sustainable and at the same time be accessible and interactive in the different system dimensions through the subsystems and building blocks.

In general, a holistic model-based solution for Industry 4.0 should exist of at least the following components:

1. Model creator, designing the models
2. Management and governance on how to work with the different model types
3. Data contextualization of the artifacts to enable fact-based decisions and analytics.

Value of Holistic Models

To directly receive value out of holistic models, a seven-step approach is described that creates a path towards Industry 4.0 transformation. The main difference to a typical traditional approach is that the steps are supported by dynamic digitized models.

• Perform Digital Maturity Assessment: Here an As-Is and To-Be digital maturity analysis is done, to understand the gap and the ambition. The difference with traditional approaches is that now the As-Is and the To-Be are modeled, which makes the activities sustainable and visible. This dramatically helps to understand benefits, challenges, use cases and maximize leadership as well as secure shop floor commitment.

• Execute Proof of Concepts and Pilot Projects: How and which proof of concepts, pilots and projects to start could be quite a challenge, but you need to start. Combining an agile execution approach with the first created models gives the possibility to understand fact-based impact as well as complexities, costs, benefits and quick wins. This gives a first insight to showcase and understand the started transformation in an early stage.

• Identify Enablers and Accelerators: As all knowledge, lessons learned and gaps are captured, this is linked to the models. Holistic sustainable insight will continuously evolve within the enterprise and gives feasibility of enablers and accelerators. Execution and roadmap can be adjusted accordingly, whilst showing impact and benefits from an operational perspective.

• Design and Create IT - OT Architecture: Deployment and transformation are directly tied to the enterprise architecture capabilities. Industry 4.0 demands that the business information technology architecture should be integrated with the engineering and manufacturing IT (Operational Technology) architecture. As this is more than just integration or data communication, this could be seen as a fusion of architecture (models). This is where the ‘mother of Industry 4.0 models’ of your enterprise should be defined, created and managed and thus will be the enterprise’s gold assets.

• Build Analytics Capabilities: Analytics should not be limited to data, but should extend to processes, applications, infrastructure and assets. Contextualization and dynamic behavior capabilities are characteristic analytics requirements for Industry 4.0.

• Drive Digital Transformation: Culture and user experience are essential for successful transformation. Changes should be visualized before and during such transformation, giving users interactive access and involvement. As digital transformation has direct and constant impact on a global reach into every square meter of the enterprise, knowledge sharing, capturing and interactive feedback should be part of any global deployment.

• Sustain Eco Landscape: Integration of horizontal and vertical value chains requires tight collaboration and knowledge sharing on multiple levels, such as product development, manufacturing and associated business processes. The whole eco landscape should benefit of the value creation.

Within each of these step’s sprints can be defined, using the models to:

1. Analyze, Test and Validate: understand the current situation either before starting the project or as an evaluation of the implemented to-be situation; the focus here is on validating that the model is (still) consistent with reality
2. Plan and Decide: define the to-be state of your project; identify dependencies, understand design alternatives and their consequences, etc.
3. Execute and Implement: the plan based on the planned activities

In this article, in an abbreviated format, we discussed the “Steps to Excellence Journey” to improve the process. Then introduced industry 4.0, in reality today we find ourselves at the beginning of a paradigm shift. The beginning of the fourth industrial revolution, looking forward and more important, possessing the ability to influence its path.

Knowing what is required to thrive is one thing, acting upon is another. Where is all this leading and how can we best prepare?

Combine the power of data and digital, reimagine the products you make and how you make them. Greater resilience, productivity and sustainability using cloud, AI, 5G, and digital twins, scalable solutions.

The 4th Industrial revolution is the 21st-century convergence of digital, physical and biotechnologies driving an unrelenting acceleration of human progress. According to the report, Global Poll: Impact of the 4th Industrial Revolution, rapid changes are coming to IT, businesses, globalization, and interaction among the users and providers. Learn the six keys to success that can help an organization adapt and innovate faster.

The six keys to success in the 4th industrial revolution based on a new global poll of 1200+ IT leaders conducted by Quadrant Strategies finds these are the top forces shaping the 4th Industrial Revolution—and driving its winners.

• Market agility
• Operational efficiency
• Accelerated innovation
• Stronger security
• Enhanced growth
• Differentiated experiences

Resources

1. Robert Dream, ‘Using Cycle Time Analysis to Enhance Operations and Improve Yield’, September/October 2006, Vol. 26 No. 5, pp. 50-55, Pharmaceutical Engineering; Case Study: This article analyzes the necessity of a pharmaceutical expansion project or new plant by attempting to understand the business and the production capability of the firm. https://ispe.org/pharmaceutical-engineering/september-october-2006
2. Robert Dream, ‘The factory of the future’, volume 25 Issue 2, March 2022. https://www.americanpharmaceuticalreview.com/Featured-Articles/584572-The-Factor y-of-the-Future/?catid=25701
3. Robert Dream, ‘Industry 4.0: What’s Next?’, The Bioprocessing Summit, Philadelphia, PA;11/07/2018.
4. Karsten Schweichart, ‘Reference Architecture Model Industrie 4.0 (RAMI 4.0)’, 2016, https://ec.europa.eu/futurium/en/system/files/ged/a2-schweichhartreference_architectural_model_industrie_4.0_rami_4.0.pd

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