Case Study: Performance Monitoring of Databases in High-Volume Production Facilities
Manufacturing in all sectors is increasingly becoming data driven. Part of this shift to data is the use of databases for parts tracking on a production line, rather than the more traditional PLC shift register approach.
With a database managing the movement of data, individual machines on the line can operate independently, processing multiple lots simultaneously in a controlled manner.
Using this process, when a new part is loaded to a machine, the machine reads the part information from the database. This information includes previous process values alongside the part’s status. The machine can then determine whether to process the part or, if it was previously deemed a failure, not process it. If the machine does process the part, it will write back new part data and an updated status once its operations are complete.
This approach delivers substantial productivity gains as machines can produce lots independently of other machines on the line.
However, problems can arise when you look to scale a parts tracking database.
One of our customers faced this precise issue. The customer, a manufacturer in the life sciences sector, had developed their own part tracking database to move data between a large number of machines. This database operated effectively, but new plans for the line involved the acquisition of 50+ new machines.
How could the customer verify their database was fit for this new production capacity? Would the database be able to perform at the scaled-up level?
The customer engaged us at SL Controls to develop a solution that would give them the answers they needed to confidently move forward with enhancing their production capacity. The solution needed to fully scale and test interactions with the database at the enhanced level, ahead of the arrival of the new machines.
What We Did
The SL Controls team quickly dismissed one potential solution – the setting up of 50+ PLCs to run the required tests. This approach was too costly, it would take up too much space, and it would take too long.
So, we started to investigate existing database loader tools that enable the fast bulk uploading of data. There are a number of solutions available on the market, many with impressive features. However, they all lacked flexibility, only allowing you to insert either fixed data or randomised data at predefined levels.
This rigidity made the existing database loaders unsuitable because of the complexity of our customer’s part tracking database. Foreign key constraints when inserting data was also an issue.
Instead, we needed a solution that would allow us more flexibility when constructing interactions.
We decided the best approach was to develop a customised database loader tool that could facilitate all the requirements of the project and emulate all critical machines on the line.
Our new and fully customised SL DB Loader tool replicated seven different machine variations. It could also trigger four different database operations.
Each machine emulation had four key features:
- A dedicated session to an Oracle database server
- A configurable period for database interactions, both inserts and queries
- A configurable number of rows that could be inserted into the predetermined tables
- The ability to log database interaction times for analysis
The SL DB Loader tool allowed our customer to emulate the production environment with the additional machines before any of those machines arrived at the facility.
This enabled their database analysers to identify performance gaps. They were then able to use this knowledge to create solutions and countermeasures to ensure the database would be available to all machines at the enhanced level of production.
As a result, the customer had the verification data required to proceed with the acquisition and introduction of the new machines.
The solution went a stage further, too, as they were also able to use the SL DB Loader tool to understand how future machine performance improvements would impact the database.
Taking an Agile Approach to Talent Management to Meet Client Requirements
The needs of the high-volume manufacturing sector are rapidly changing, particularly in highly regulated industries. If you are in a leadership role in one of these industries, you need solution providers who can respond quickly to your requirements to ensure you remain competitive while also maintaining accuracy, quality, and compliance.
This requires a new approach to talent management, something which is especially important for service providers delivering Industry 4.0 solutions where the pace of change, scale of risk, and size of opportunity are all significant.
For us at SL Controls, we have adopted an agile approach to talent management to respond to the changing needs of clients, react to market conditions, manage the evolving requirements of regulators, and more.
The Agile Approach to Talent Management
We are a tech company, so we have extensive experience in the agile approach to developing software and technology solutions.
While you can’t export the entire tech agile approach to the talent management function of a business, you can adopt the same principles.
The goal is to strip away restrictive, bureaucratic, and rules-based processes, replacing them with simpler, faster, and more flexible models capable of responding to change.
This makes it possible to deal with rapidly evolving client needs, even at short notice.
Transforming Talent Management
The top-down, climbing-the-corporate-ladder approach has long been consigned to the history books, particularly in modern and rapidly growing companies. Only now, however, are we seeing a truly transformative approach to talent management in sectors like manufacturing where talent-related principles and processes are changing.
SL Controls is at the forefront of these changes in our industry and our field of equipment systems integration.
Our talent management function is comprehensive and detailed. Still, there are some significant differences we can highlight between the agile approach we have adopted and the more traditional way of managing a team.
Mix of Both Employees and Contractors
At SL Controls, we believe the right approach to delivering client expectations is to use both employees and contractors. This gives us stability and an in-house core of skilled and knowledgeable people while also enabling us to respond rapidly to client requests, even at short notice.
Focus on Teams Rather than Individuals for Project Delivery
A good analogy here is a scrum in rugby, where eight players interlink and move as one towards the same goal. Even if one drops out, the seven remaining can continue to drive forward, or a replacement can be slotted in.
Our approach to delivering projects follows a similar principle, where a tight-knit team of employees and contractors works together towards delivering on the client’s objectives. Rather than an approach where individuals perform individual tasks to make up the whole, the focus remains on the team.
Continuous Development of a Company-Wide Learning Culture
Industry experience can only deliver maximum benefits when the knowledge learned from those experiences is disseminated throughout the organisation. At SL Controls, we have well-established processes to ensure knowledge and information is available across teams and business units.
Enabling Multiple Career Path Opportunities
We embrace and nurture multiple career path opportunities based on the needs of the business instead of taking a linear approach to career progression. This ensures greater fulfilment for members of the team and helps everyone reach their full potential.
Furthermore, linking the process with the needs of the business ensures we constantly meet the needs of our clients, even as those needs evolve.
Continuous, Customised, and Multidirectional Feedback
Continuous, constructive feedback from supervisors, team leaders, peers, and managers at all levels enhances quality as well as the accuracy and speed of project delivery. It is a much more flexible and effective method of providing feedback than the traditional annual appraisal model.
Delivering for Clients
There are a number of benefits that an agile approach to talent management will bring to your business. They include:
- Availability of specialist engineers in multiple disciplines
- Those specialist engineers integrated with your team
- Vendor-neutral approach to project delivery
- Long/short term placement solutions available
- Structured management process
- In house technical support team
- Fast deployment of resourcing options
Industry 4.0 technologies and processes are transforming the manufacturing sector and will, in the near future, lead to disrupted business models. Our agile approach to talent management will help you navigate through these changes, providing you with the skills, resources, and project delivery expertise that you require.
Advantages and Benefits of Industry 4.0 Horizontal Integration for Pharmaceutical & Medical Device Manufacturers
Two concepts known as vertical integration and horizontal integration are key to moving your manufacturing facility closer to an optimised Industry 4.0 operation. We discussed the benefits of Industry 4.0 vertical integration in another blog. Here, we’ll look at the advantages and benefits of Industry 4.0 horizontal integration.
Let’s start with a recap – what is Industry 4.0 horizontal integration?
Horizontal integration is about integrating all aspects of your supply chain. This includes internal functions and processes on the factory floor, i.e. equipment systems integration across your entire manufacturing operation. This can be within a single facility or if you have a multi-site operation.
It also includes integrating with third parties in your supply chain:
- Upstream with raw material and part suppliers
- Downstream with your distribution chain all the way to the end-user, customer, or patient
As a pharmaceutical or medical device manufacturer, you may already have achieved an element of horizontal integration to meet your regulatory obligations. An example would be a serialisation or track and trace solution.
Full horizontal integration moves this strategy beyond compliance to deliver benefits for your business. It involves integrating equipment, systems, and processes to ensure real-time access to data, and to automate processes and decision-making.
The Benefits of Horizontal Integration
Streamlined Regulatory Compliance
One recent regulatory trend in both the pharmaceutical and medical device industries is the extension of compliance responsibilities across the supply chain. Track and trace, as mentioned above, is a good example, as are new requirements under the EU MDR.
Industry 4.0 horizontal integration streamlines compliance in relation to your operations and the operations of third parties in your supply chain.
End to End Visibility
Delays in production processes and workflows occur where there is a lack of information and collaboration. Industry 4.0 horizontal integration breaks down data silos to make information more accessible at each point in the supply chain. It also significantly improves collaboration.
From your perspective, you will have end-to-end visibility of your supply chain, so you know what is going on and can react to unpredicted situations quickly and effectively.
Improved Decision Making and Planning
With end-to-end visibility, you will have access to real-time intelligence that will give you more detailed and accurate information to make better decisions and improve planning.
With Industry 4.0 horizontal integration, your supply chain will be better equipped to deal with change and unpredictability. For example, if there is a problem with a production line, machine, or material, you will have the information you need to adjust the production workflow to minimise the impact overall.
You will also have flexibility with Industry 4.0 horizontal integration to react to external factors. Examples include changed regulatory requirements, as well as the impact of new technologies, competitor actions, and customer demand.
With end-to-end visibility, all parts of your supply chain can work together more productively and effectively. The result will be the identification of efficiency savings, such as reducing inventory levels, warehouse space, or distribution costs.
Digital simulations can then drive efficiency savings beyond what was previously possible. In other words, you can run predictive algorithms and digital simulations to find new and more efficient workflows, processes, and ways of working.
Meet Customer Demand
Several of the points above culminate in making your organisation better equipped to meet customer demand. Enhanced visibility and decision making, for example, means you can react to problems that previously would have resulted in issues with product availability.
Industry 4.0 horizontal integration also makes it possible for you to react more effectively to changing market conditions as well as changing consumer, patient, and end-user expectations.
Improved Quality Control
Your quality control processes will also improve with Industry 4.0 horizontal integration as you will have enhanced visibility across the entire supply chain. This makes it easier to monitor everything from raw materials to storage processes to transportation.
Better Understanding of Customers, Patients, and End Users
Industry 4.0 horizontal integration creates a closer link between your manufacturing operation and the end-user or patient, improving your understanding. You will also learn more about how your product is used in real-world conditions.
This information can be beneficial in various areas, including business planning, marketing, and product development.
All the points above contribute to improved levels of profitability in your business. This includes ensuring your operation remains competitive as Industry 4.0 technologies continue to disrupt manufacturing sectors.
Horizontal integration also helps you maintain value when the unexpected happens or when change occurs. Examples include adapting to deal with problems in the supply chain, being flexible enough to react to changing market demands, or better planning due to enhanced supply chain visibility.
You can also reduce costs through Industry 4.0 horizontal integration as you can run a leaner supply chain. Examples here include reduced warehouse costs and avoiding the costs involved with late shipments, overages, and shortages. You will also benefit from cost savings as a result of automating processes.
Adding Value Through Horizontal Integration
Further horizontal integration is the natural direction of travel for manufacturers in most industries, particularly in highly regulated sectors. Taking a strategic approach and staying ahead of the curve will improve your competitiveness, reduce macro-level risks, and ensure you are in a position to take advantage of new opportunities.
Benefits of Industry 4.0 Vertical Integration – Where OT and IT Converge
Vertical integration is about converging OT (operational technology) and IT (information technology) in your business, in addition to integrating processes and other systems across different departments and business units.
In its most advanced form, it involves all aspects of the business, from factory floor systems and processes to the ERP (enterprise resource planning) platform, CRM (customer relationship management) system, accounting system, and more.
In many manufacturing businesses, the first step involves ensuring full equipment systems integration at the production level before then integrating with other parts of the business.
While vertical integration is typically achieved in stages, in its totality, it is a significant undertaking. It also delivers significant benefits – benefits that will ensure your business remains competitive and profitable into a future where the regulatory landscape continues to evolve, and customer/patient demands and expectations continue to change.
Improving Data Collection & Replacing Data Silos with Integrated Systems
Vertical integration in your business involves collecting more data (from sensors on production equipment, parts, and products, for example), as well as replacing your existing data silos with integrated systems. Below are the main benefits of implementing this strategy.
With vertical integration, you will be able to move towards mass customisation and lot size of one business models and production strategies. This enhanced level of production flexibility will make it possible for your business to exploit new market opportunities, react quickly to trends, and deliver on the expectations of customers/patients.
Vertical integration will improve the resilience of your manufacturing operation. In other words, making it possible for you to adapt to changing circumstances (such as unplanned downtime) more quickly while also minimising the impact of changed circumstances on customers/patients.
Increased Market Agility
Both the above points give senior executives the options they need to react more effectively to market and business conditions. This could be anything from reducing risk to remaining competitive to taking advantage of a new opportunity.
Improved Security and Privacy
One of the technologies that make Industry 4.0 vertical integration possible is cloud computing. With cloud computing, systems run on the cloud and data is stored in the cloud rather than on-site at your facility.
These cloud solutions are typically built on enterprise-standard platforms like Microsoft Azure. As you might expect, enterprise-standard platforms like Azure come with enterprise levels security.
Therefore, you will enhance security and privacy in your business by implementing cloud technologies (alongside also implementing relevant security processes and procedures) as part of a vertical integration strategy.
Improved Management Oversight and Visibility
Vertical integration provides engineers, managers, and executives with access to greater levels of accurate, well-presented, and highly relevant data. Not only that, but the data is available in real-time.
Enhanced Levels of Automation
Vertical integration increases the processes in your operations that you will be able to automate. Machine maintenance, production planning, and raw material ordering are just some examples.
Productivity levels in your business will improve in a number of areas, not least because all departments and systems will work together more effectively towards the same goal. Even ensuring each person on your team has ready access to information improves productivity as time is saved compared to the previous process of requesting information and then waiting on a response.
More Efficient Operation
You will benefit from efficiency savings too, through productivity gains and enhanced automation, as well as by reducing unplanned downtime, improving access to information, faster decision-making, and more.
Enhanced Customer Service
Responding faster to market conditions, trends, and consumer demands improves standards of customer service.
The integration of customer-facing departments with the production line will also improve customer service. An example of this is customer-facing staff being able to provide information, assurances, and updates to customers based on real-time production information.
Reduced Requirement for Physical Equipment
Converging OT and IT in your business, as well as implementing cloud technologies, should result in a reduced need for physical equipment on-site. This delivers a range of additional benefits including:
- Lower costs for IT and OT infrastructure
- Reduced requirement for physical space for IT and OT infrastructure
- Reduced energy consumption which also lowers costs while helping you achieve your environmental and CSR goals
- Improved performance, particularly in relation to systems and processes moved to the cloud
- Reduced maintenance requirement
The above benefits combined will deliver higher levels of profitability for your business in addition to ensuring you achieve your ROI objectives.
Moving Your Business Forward
It is likely that you will already have achieved a level of vertical integration in your business, particularly if you have implemented automation and/or equipment systems integration solutions.
Going further using a staged approach is the way forward with vertical integration, where you measure improvements and realise the benefits at each step.
Horizontal and Vertical Integration in Industry 4.0 for Pharmaceutical and Medical Device Manufacturers
In an Industry 4.0 context, horizontal and vertical integration offers substantial benefits to pharmaceutical and medical device manufacturers. These benefits include everything from improved agility and flexibility to enhanced productivity, decision-making, and competitiveness.
Horizontal and vertical integration delivers these benefits by achieving unprecedented levels of alignment across entire organisational ecosystems, from the factory floor to enterprise-level systems, across the supply chain, and in all processes, business units, and third-party partners.
Defining Industry 4.0 Horizontal and Vertical Integration
Horizontal integration and vertical integration are terms used in various contexts, including in relation to business growth strategies. Specifically, it refers to acquisition strategies where companies use horizontal integration to acquire companies with similar products and customers or vertical integration to add new capabilities and bring outsourced services in-house.
However, within the field of Industry 4.0 and the pursuit of the Smart Factory goal, horizontal and vertical integration have a different meaning.
The two concepts centre on technologies, processes, and systems that enable the collection, collation, communication, and use of data.
Industry 4.0 Vertical Integration Explained
Industry 4.0 vertical integration involves connecting all business units and processes within your organisation. In other words, converging operational technology (OT) at the production level with information technology (IT) at the enterprise level.
With this integration in place, data flows between and is made available to all business units. This includes the factory floor, marketing, sales, customer service, purchasing, accounting, HR, quality control, R&D, and more.
Vertical integration isn’t just about integrating enterprise-level systems with the factory floor, however, as it also creates opportunities for integration across the entire field layer of your organisation.
A good example of this is in the batch-size-of-one business model where a customer requests a product customisation. Instead of the sales department retrieving information from production on whether the request can be delivered, the information will be readily available in the ERP system.
Another example is the alignment of raw material procurement with market demand to maximise the efficiency of batch production.
Industry 4.0 Horizontal Integration Explained
While vertical integration involves alignment within your organisation, Industry 4.0 horizontal integration involves connecting all parts of your supply chain. This deeper alignment improves visibility, flexibility, and productivity while also enhancing levels of automation.
Horizontal integration applies within your production facility, across multi-site operations, and to third-party partners in your supply chain, both upstream and downstream.
Within your production facility, horizontal integration is about achieving the Smart Factory, where all systems, processes, and machines are connected, enabling constant communication.
Horizontal integration delivers the same level of connectivity across multi-site operations, ensuring maximum visibility, production adaptability, and collaboration.
The real-game changer is achieving similar levels of decentralisation and connectivity across your entire supply chain, from suppliers and manufacturing through to logistics and distribution, all the way to the customer/patient.
Industry 4.0 technologies make the above integration goal possible in all manufacturing industries, but there are additional considerations in regulated sectors like pharmaceuticals and medical devices. This particularly applies to traceability requirements where serialisation and track & trace solutions are essential components.
Continuing the Journey
Following on from the point above, by implementing a serialisation or track & trace solution, something which is necessary for regulatory compliance, you have already started on the road to Industry 4.0 horizontal integration.
You may also have achieved a level of Industry 4.0 vertical integration.
As with all aspects of Industry 4.0 and the implementation of new technologies, processes, and systems in your business, it is a journey. There is a direction of travel, though, particularly for manufacturers in the pharmaceutical and medical device industries. That direction of travel is towards the achievement of Industry 4.0 horizontal and vertical integration.
The Human-Centred Approach: A Key Component to Industry 4.0 Success
Industry 4.0 is transformative. Among other things, it enables you to move from being a product-centric organisation to being customer-centric. This presents massive and potentially game-changing opportunities for your business.
Implementing Industry 4.0 and Smart Factory solutions is, of course, a marathon rather than a sprint. That said, even in the early stages of the transformation, all areas of your business are likely to see an impact. This includes manufacturing, product design, supply chain management, customer service, corporate strategy development, and more.
This covers a lot of people on your team. In fact, your whole team is likely to be impacted at some point by Industry 4.0 transformation.
Industry 4.0 is About More Than Technology
A lot of the discussions that take place in relation to Industry 4.0 focus almost entirely on technologies. In other words, how the development of new technologies has ushered in the era of Industry 4.0, making it possible to develop Smart Factories and truly digitalised organisations.
Processes often come up in these discussions too, whether that is equipment maintenance processes, validation processes, regulatory compliance processes, quality management processes, etc.
However, the people element of implementing Industry 4.0 initiatives and solutions is too often forgotten about completely. When the human factor is mentioned, it is usually relegated to points regarding efficiency savings, i.e. the potential for headcount reductions or resource redeployments.
From our experience at SL Controls implementing Industry 4.0 solutions for pharmaceutical and medical device industry clients, people are core to achieving success.
We believe people are as important, if not more important, than the technologies that we are all rightly excited about using, developing, and creating.
Not only are people directly impacted by the operational and business transformations that Industry 4.0 makes possible, but they are crucial to every stage of solution and technology implementation.
Managing change, implementing new technologies and processes, and making the most of the opportunities that Industry 4.0 presents, requires a people-centric leadership approach.
This means ensuring your team, particularly those at the coalface, have the knowledge and skills they need. You also need to engage them in both the overall strategy of the business and in individual projects, and they need to be empowered.
The worst case is when those on the frontlines feel disconnected, afraid, and frustrated with the changes you are implementing.
Instead, they should feel part of the Industry 4.0 development process, fully engaged with the principle of continuous improvement and the pursuit of excellence.
The approach of Industry 4.0 solution providers is important too. The best results are achieved collaboratively through human-centred design.
In other words, the traditional ways of developing and implementing technology solutions are not effective in the Industry 4.0 world. These conventional approaches are top-down, where executives and managers decide on a solution that they believe will benefit the company before overseeing the development and implementation in partnership with a solution provider.
From a technical point of view, the technology works, so the executives and managers move to the phase of overseeing frontline worker training before telling those frontline workers to get on with it.
Unsurprisingly, the new solution rarely sticks the way the leadership originally planned, and the results rarely live up to expectations.
Instead of focusing on developing technology and then figuring out how to make it stick, the better approach is to focus first on the perspectives of users: how they work, their pain points, the challenges they face, how and why they use information, where their data comes from, how they think things could be done better.
You need strong executive and management level support too, of course.
Support from the other side – bottom-up support – is also essential. This means not only getting buy-in but proactive engagement from operators, technicians, and engineers on the factory floor as well as team members in other business units and departments.
Focusing on Business Objectives
Recent history is littered with stories of technologically fantastic solutions that are only used to a fraction of their capabilities because of a failure to take a human-centred approach in their design and implementation.
Industry 4.0 technologies offer opportunities to members of your team at all levels to develop their skills and become an integral part of this ongoing industrial revolution. We need to facilitate and nurture the potential of all people in our industries. This will help achieve Industry 4.0 success as well as your medium and long-term business objectives.
The Relevance of OEE in the Industry 4.0 and Smart Factory Era
OEE is a well-established method of measuring productivity in manufacturing operations. Its origins can be traced back to the 1950s, however, so does it still have relevance today in the Industry 4.0 era?
Not only is OEE still relevant, but its importance has been amplified with the opportunities and challenges created by Industry 4.0 technologies and processes, as well as the ongoing push to develop the Smart Factory of tomorrow.
In-Brief OEE Definition Recap
OEE is a calculation that measures machine availability, performance, and quality. So, a score of 100 percent means you are manufacturing with no downtime and as fast as possible while only producing good products with zero defects.
Getting as close as possible to this 100 percent ideal means you are maximising your facility’s productivity.
The Modern Realities of Manufacturing Facilities
Today, there is an ever-increasing requirement on manufacturing facilities to produce high-quality products while meeting often challenging production timescales.
These requirements are being driven by things like increasing consumer expectations, greater industry competitiveness, and, in relation to sectors like pharmaceuticals and medical devices, the demands of regulators.
With Industry 4.0 technologies, we are also moving closer to mass customisation and batch size of one production capabilities, increasing the need to monitor, improve, and maintain productivity even further.
How OEE Fits into These New Manufacturing Realities
While OEE has been a productivity performance metric for decades, it has never been more important than it is now.
Even with new technologies, systems, platforms, and processes, it remains the best way of benchmarking the productivity of your operation. It can help you identify areas for improvement before giving you a tool to objectively monitor your progress towards an enhanced level of productivity.
OEE in the Industry 4.0 Era
So, OEE as a productivity performance metric is more important today than ever before. We can take this a stage further, though.
This is because Industry 4.0 and Smart Factory technologies enhance OEE effectiveness as a manufacturing productivity measurement. It does this by improving the accuracy of OEE calculations. There are several reasons for this:
- Enhanced levels of equipment integration – equipment systems integration is often the starting point for implementing Industry 4.0 solutions into your production facility. In relation to OEE, integrated systems and equipment improve the value of the data you collect for OEE calculations.
- More data points collected – sensor technologies are another crucial component of solutions that fall under the Industry 4.0 umbrella. These sensor technologies make it possible to collect multiple data points within a machine, section, production line, and overall facility.
- Higher data sampling rates – sensors, networking infrastructures, and cloud computing means you can collect data with sampling rates as high as you need them.
- Improved data quality – sensor technologies and modern data collection and processing systems improve the quality and accuracy of data used in OEE calculations.
- Improved contextualisation and processing of data – this is delivered through big data solutions, machine learning, data dashboards, and more. For example, data can be used by a machine-learning algorithm to move to a predictive maintenance model for machines rather than a scheduled maintenance model, with the driver for this change being an improved OEE calculation.
Proactive OEE Improvements
Industry 4.0-related technologies and solutions also make it possible to improve OEE proactively rather than always being reactionary. This takes OEE calculations beyond real-time monitoring of data into predictive modelling of different scenarios.
The specific technologies that make this possible include digital twin and virtual simulation technologies. With these technologies, you can model different scenarios to analyse their impact on OEE without interrupting the live production line. The results of these models can then be used to make changes that will improve OEE.
Staying Focused on Return on Investment
With all the above, the most important factor is return on investment, whether that is through enhanced profitability by improving productivity, greater competitiveness in the market, or the capability to explore new business and product development opportunities.
This, whenever everything else is said and done, is what OEE is about, i.e. giving you an objective tool to measure return on investment from your Industry 4.0 and Smart Factory initiatives.
Industry 4.0 and the Importance of Technology, Executive Support, and Skills Alignment
Often when discussions take place around Industry 4.0, they revolve around technologies. In other words, how technologies like cloud computing, robotics, AI, digital simulations, autonomous vehicles, data analytics, etc are creating opportunities for manufacturers to move into the Industry 4.0 era.
Industry 4.0 is about much more than technologies, however. Instead, it is about digitally transforming your business and developing deeper integrations and more efficient workflows between all components in your organisation. This includes manufacturing, supply chain, product development, marketing, sales, customer support, HR, and finance.
Therefore, to maximise the benefits of Industry 4.0 and remain competitive in the digitally transformed world of tomorrow, you need to develop an alignment of technology, executive support, and workforce skills.
Transforming Your Entire Business
Industry 4.0 is a journey, but the endpoint is likely to be a very transformed business model. Examples of how this might look include batch size of one manufacturing capabilities or mass customisation.
This demonstrates that Industry 4.0 doesn’t just impact the factory floor and closely connected business functions, such as the supply chain. Instead, opportunities and transformation potential exist across the entire business.
As a result of the above, Industry 4.0 requires executive-level buy-in at an early stage.
This doesn’t just mean buy-in for the next project you plan to complete as part of your Industry 4.0 journey, but buy-in for the overall concept and potential of Industry 4.0.
Here is an example of why this is important: Industry 4.0 processes, technologies, and solutions that can be implemented today can give you substantially greater insight into your customers and a better understanding of emerging market trends. This is achieved by integrating the marketing and sales functions of the business with the manufacturing and product development functions.
Solutions like this give senior executives access to data that enables them to pivot and adapt the company as required to meet customer demand and expectations.
However, the technology that makes it possible for executives to access and analyse this information is only an enabler. Executives still need to make decisions in the best interests of the company.
This requires a collaborative approach across all parts of the organisation as well as fast decision-making processes to ensure opportunities can be seized upon quickly.
For this to happen, you need executive-level buy-in.
Furthermore, with executive-level buy-in, it will be much easier to get buy-in across the wider organisation. This is another important element of successful Industry 4.0 implementation, particularly as the solutions you implement become more advanced.
Upskilling Your Team
The fact that technology is an enabler of Industry 4.0 applies right through your workforce in addition to at the executive level.
Also, almost all Industry 4.0 technology solutions have a human element. This includes operators and engineers as well as data analysts, product designers, and other roles across the company, i.e. not just in production.
Therefore, upskilling your team is a crucial part of Industry 4.0 success.
With the introduction of Industry 4.0 solutions, advanced capabilities will be available to your organisation in a range of areas. Your team needs the necessary skills to ensure you can capitalise on them.
People and Processes
The benefits of Industry 4.0, and the opportunities it offers your business, are substantial. In fact, there are likely to be opportunities and benefits that we can’t yet quantify or fully understand.
However, looking at Industry 4.0 as a technology issue, or even a manufacturing issue, will limit your potential.
The reality is that Industry 4.0 is about people and processes as much as it is about technology. Having all the right elements aligned will ensure you maximise success.
Digital Validation and Why It’s Important to Pharmaceutical and MedTech Manufacturers
Modern technologies make it possible to create digital simulations, digital twins, and virtual 3D models of products, parts, manufacturing processes, machine processes, systems, and more.
Engineers can then use these simulations and models to facilitate the design process, improve quality, identify errors, and improve performance. They can do this by testing multiple design variations in multiple environments under multiple conditions.
For many industries, including pharmaceutical and medical device manufacturing, this is a game-changer.
However, what happens if the digital simulation is incorrect or inaccurate? Of course, the answer is the results produced by the simulation or model will also be incorrect or inaccurate.
Enter digital validation.
Digital validation is a process that, in simple terms, ensures the accuracy and correctness of digital simulations and models.
This gives everyone, from engineers to decision-makers to end-users, confidence. Confidence not only in the simulation or model but also in the real-world outputs that result, i.e. outputs such as product design changes, changes to processes, etc.
The Importance of Digital Models and Simulations
The digital modelling tools that are currently available make it possible to create powerful thermal, mechanical stress, injection moulding, computational fluid dynamics, and circuit simulations in a virtual environment.
This can help determine things like the best materials to use in a product, for example, or the design and shape of various parts. It’s also possible to use simulations to identify failures that occur over time, i.e. failures that are hard to identify with a physical prototype.
Furthermore, digital models of products, parts, processes, or systems can be simulated in various environments and under a range of different conditions.
This provides engineers with accurate data to make decisions so eliminates common issues that can cause problems, such as making educated guesses or over-engineering products.
Benefits of Digital Models and Simulations
The potential benefits of digital models and simulations to manufacturers in the pharmaceutical and medical device industries are substantial. They include:
- Reduced time to market for new products because design changes can be implemented and tested in a virtual environment speeding up the iterative process
- Reduced costs at all stages of a product’s lifecycle but particularly in the product design stage as digital simulations and models are highly effective at avoiding downstream design changes
- Improved quality of existing products
- Improved OEE and manufacturing productivity
- Helps ensure regulatory compliance and streamlines compliance processes, particularly when getting approval for a new medical device
The Need for Digital Validation
Creating a digital simulation of a product or part is not enough, however, particularly in highly regulated industries like pharmaceutical and medical device manufacturing. This is because each stakeholder in the process, from company decision-makers to regulators to end-users and patients, needs to know the simulation, and the results it produces, are correct.
Also, while the technology that exists today is extremely powerful and can now produce virtual models that are very close to being exact replications of real-world products, parts, and processes, close to exact is not the same as exact.
The existing paper-based process for validation of existing products, parts, manufacturing processes, machine processes, and systems is extremely time-consuming, labour intensive, and inefficient, and will potentially negate the benefits of digital models and simulations.
As a result, a new approach for the validation of digital models for their intended purpose is essential.
How Digital Validation Works
Digital validation is an iterative process that happens during the development of the simulation. Since the digital simulation of a product or part is available during the design stage of the project, digital validation can begin at this stage. Test simulation models can be built to test the user requirements and verify that these requirements are being met. These test simulation models are automatically updated with any changes to the model and can be re-executed at any time to verify that the model still meets the original user requirements. The digital validation process ensures, confirms, and quantifies the accuracy of the simulated model.
This could be accuracy compared to the real-world product, part, process, or system. It could also be accuracy compared to the conceptual description of the model or accuracy compared to experimental data.
The digital validation process significantly reduces the level of effort involved to qualify products, parts, manufacturing processes, machine processes, and systems, which, in turn, significantly reduces the associated validation costs.
Typically, the validation process ensures the simulated model is accurate within an acceptable range for the intended purpose of the model. Therefore, it’s important to create simulated models for a specific purpose.
So, in summary, digital models and simulations provide significant opportunities for pharmaceutical and medical device companies while digital validation ensures the validity of those simulations, giving them measurable and fully documented credibility while also making validation more efficient and affordable.