Successful projects don’t happen by accident. Instead, they need carefully developed and well-established structures. At SL Controls, we use the QUAD approach.

The QUAD approach for the successful delivery of projects is built on four pillars – Quality, Utilise, Accomplish, and Design. We are going to focus on the Design pillar in this blog.

The Design Pillar Explained

Robust design is a prerequisite to a successful project. It involves delivering functionality and features according to client expectations. It also involves engineering out problems in the most timely and cost-effective way possible and delivering the project within agreed timescales.

Crucially, design does not take place at a fixed point in the project. Instead, it is continuously part of the process with ongoing reviews and updates. It involves four main elements:

1. Scope
2. Research
3. Create
4. Review

A very structured and methodical approach to design is essential. At SL Controls, for example, we have a dedicated design team/group in the business. This team includes our most experienced people in solution design and architecture to ensure the project moves forward successfully.

What about the four main elements?

Scope

Without getting an accurate and agreed scope, the design team, developers, and others will have no firm or clear idea what the project is about. They can guess and make best estimates, but, without a scope, there will always be differences between what the client wants to achieve and what those delivering the project think the client wants to achieve.

So, agreeing the scope is an essential starting point.

The scope will then lead to a URS (User Requirements Specification) that must be agreed by all parties, so everyone understands what is involved.

Given the scope is such an important element, a lot of time goes into its preparation. That said, it is also necessary to make provision for when projects change during development. This requires a process of updating and getting new agreement on the amended scope and, when necessary, the amended URS.

Research

The research element involves researching different aspects of the scope to identify the best solution for the client. At SL Controls, our most experienced people lead on this part of a project and they use a range of techniques to conduct the research.

This includes using the in-house knowledge of our own people as well as our own internal design standards. It also involves referring to industry standards and best practices, plus we often use experiences, results, and lessons from past projects.

Feasibility studies can be part of the process too, depending on the project, plus it is sometimes necessary to bring in subject matter experts. This is beneficial when you have some knowledge and experience of an aspect of the project but believe the overall solution could be enhanced with the in-depth knowledge of a subject-matter expert.

Create

With the scope and all the research elements in place, it is now possible to create the design. The first step is to create a functional design specification. Functional risk assessments take place at this stage too, and actions are put in place to minimise identified risks.

The project then gets broken down further into an SDS (System Design Spec) which is essentially a blueprint of the project that developers can then work from.

Creating these documents is not enough, however, as it is easy to introduce problems at this stage. It is, therefore, beneficial to have a review system in place. At SL Controls, we use a peer review system where a peer in the design group reviews all documents.

In addition, system architects, managers, the quality department, and the client also review and approve the documents.

Review

Design is no good if it is static as this keeps problems in the project until the latter stages. In fact, without a robust and ongoing review system, you might not identify problems with the design until the install and commissioning stages of the project.

The problem with this is the financial and time costs involved in resolving a problem exponentially increases the longer the problem remains in the system.

Continuous review of the design and other aspects of the project helps prevent this. For example, when developers writing the code uncover issues, the design immediately goes back to the design team to resolve before moving on.

Benefits of the Design Pillar

Reducing the occurrence of errors in the latter stages of the project has several benefits:

• Lowers project costs
• Minimises delays
• Avoids reputational issues, including reputational risks the client faces by manufacturing sub-standard products as a result of errors in the project

In addition, by implementing all elements of the Design pillar in the QUAD approach, you will get a more robust design that delivers on client expectations.

There are machines, software solutions, processes, and equipment that can and will improve your production line output as well as the profitability of your business. There are also things that will cost money to implement but will deliver negligible improvements. Making a distinction between the two is the conundrum facing managers in today’s manufacturing facilities.

All productions lines can become more efficient and more profitable, but achieving these gains requires investment. How can you be sure the investments you make will help the business while avoiding wasting money on those that don’t?

Machine monitoring software is the solution.

What Is Machine Monitoring Software?

Machine monitoring software collects data from all the machines and processes on your production line. High-quality machine monitoring software, like TOTALdata, achieves this by being vendor neutral.

The data it collects includes both production and non-production events, allowing you to see what is happening on the line and why.

This greatly helps the day-to-day running of your production line, but machine monitoring software also offers additional benefits. Specifically, you can use machine monitoring software to run predictive models.

Making Critical Investment Decisions

All too often, managers in manufacturing facilities must make investment decisions blindly. This happens when machine monitoring software is not in place.

Let’s look at an example of modifying a piece of equipment. The vendor has told you what it thinks the performance benefits will be, plus you will know the costs the vendor will charge.

You won’t, however, know the following with any degree of accuracy:

• Baseline performance data
• Predicted improvement data (rather than general figures from the vendor)
• Actual improvement data post-implementation

As a result, you must use assumed figures and estimations.

Making Informed and Transparent Decisions

Machine monitoring software gives you the data you need to make decisions based on facts. Firstly, the software will give you a performance baseline using real outputs from your production line.

Secondly, you can run simulations on the machine monitoring software. Crucially, you can do this before you make an investment or change anything on your production line, i.e. prior to engaging the vendor.

These simulations use data from your production line and enable your engineering teams to quantify and independently evaluate payback on process changes. They will do this by measuring the results from the simulation against your benchmarking data.

At this point, you will have an estimated return on investment figure based on real data. This enables you to make an informed decision on the investment.

There are also benefits of machine monitoring software post-implementation of the change in your production line. This is because you have the benchmark taken before any modifications. The software can then monitor the performance and profitability of your production line post-implementation, giving you an accurate and tangible return on investment figure.

In other words, you will have the following:

• Evidence the investment is worth pursuing before making a decision
• Proof the investment did pay off, enabling you to justify the decision post-implementation

The above applies to both small and large investment decisions, including decisions like buying a second production line.

Other Benefits of Machine Monitoring Software

Machine monitoring software is not static. Instead, it is flexible and dynamic, scaling and adapting to your business as you make continued improvements. In addition, the software is straightforward and cost-effective to implement when you use a product like TOTALdata.

To remain competitive, you must continually improve the efficiency and productivity of your production line and overall business processes. Machine monitoring software is an essential tool in achieving this.

The deadline for compliance with the new Falsified Medicines Directive (FMD) is fast approaching. If you haven’t already taken steps to upgrade the systems and processes in your manufacturing facility, you should do so now.

In most situations, this will involve an enterprise serialisation solution and an upgrade to your packaging lines.

Below we answer some common questions about the FMD to help you understand what you need to do.

What is the Objective of the FMD?

The EU wants to protect its citizens from falsified medicines. The FMD also gives added protection to the pharmaceutical industry, helping to protect supply chains, market position, intellectual property, and more.

Where Does It Apply?

The FMD applies to all existing members of the EU, including the UK as it is committed to keeping its regulations in line with the FMD after Brexit.

Other countries outside the EU are also coming into line with the FMD, including Iceland, Norway, Switzerland, and Liechtenstein.

If you sell pharmaceutical products in any of these countries, the FMD applies to you.

When Does the Falsified Medicines Directive Come into Effect?

The FMD goes live on 9 February 2019 so there is less than a year left to get ready.

What Does the FMD Mean for Pharmaceutical Manufacturers?

There are three main requirements you have under the FMD as a pharmaceutical manufacturer. They specifically apply to the individual products that consumers purchase/receive, i.e. serial numbers and other elements must be item-specific, not batch, carton, etc specific.

The three main requirements on manufacturers are:

1. Add an anti-tampering device to the packaging of medicines. The exact nature of this device is not specified by the FMD, so it is up to you to decide what to use. Most people interpret this as standard devices that are already widely used such as seals, tape, and glue.
2. Add a unique identifier (UI) to all packages. This must be a 2D barcode that contains the product code, a unique serial number, the batch number, and an expiry date.
3. Upload the UI code for each product to the European Medicines Verification System. You must also send other data to this system, including the countries the product will be sold in, details of the manufacturer adding the anti-tamper device, details of the wholesalers who will distribute the product, and more.

How Does the FMD Work?

Firstly, the European Medicines Verification System sends the data uploaded by pharmaceutical manufacturers to National Medicines Verification Systems in all participating countries.

There is then a responsibility at multiple points in the supply chain to verify products. Wholesalers, for example, must scan codes to make sure they come from the manufacturer as claimed. Pharmacists must do the same plus they must check the anti-tampering device, ensuring it remains intact.

What Else Do You Need to Know About the UI Code

The UI code that you add to each of your products must be a randomly generated 20-character alphanumeric code. The randomisation element of the code’s generation adds complexity and means you will need a specialised serialisation solution to ensure compliance with the FMD.

What Do You Need to Do Now?

If you haven’t already engaged a vendor to provide the systems and processes you need in your manufacturing facility, you should start looking now.

The solutions provider should have the abilities and resources to provide support at your location, plus the solution should be scalable and future-proof. The latter is important given the evolving nature of regulations relating to the Falsified Medicines Directive as well as pharmaceutical product serialisation in general, product traceability, and more.

SL Controls has experience of the FMD and making manufacturing facilities compliant, so please contact us today.

With support and help from the right solutions provider, implementing systems to comply with the FMD can be a smooth and benefit-producing process.

At SL Controls, we have developed an approach called QUAD for the successful delivery of projects. Each of the letters in QUAD stands for an essential pillar – Quality, Utilise, Accomplish, and Design.

We use the QUAD approach in the delivery of all our projects. This includes automation, controls, serialisation, and validation projects. QUAD has much wider uses than this, however, particularly in the fields of engineering and software development.

In previous blogs, we looked at the Quality and Utilise pillars. This blog will focus on the Accomplish pillar.

The Accomplish Pillar Explained

The Accomplish pillar is concerned with executing a successful project. In other words, it is the doing pillar so includes the practical steps required to deliver the project on the ground.

There are four main elements to this:

• Safety
• Execute
• Validate
• Communicate

Let’s look at each in more detail.

Safety

Safety is the single most important part of any project. It involves taking steps to ensure the safety of employees as well as ensuring their actions are safe.

This all begins at head office and at other regional offices. Specifically, it involves providing a safe working environment for all members of the team. This helps establish the right health and safety culture.

This health and safety culture is then carried through to the client side of the project during, for example, the installation and commissioning stages.

Firstly, all employees should be safety inducted onto every job and every site.

In addition, many companies have their own health and safety group or health and safety officer. It is important on-site teams and project managers ensure there is good communication with these people.

At SL Controls, we specifically focus on ensuring we are on the same wavelength as the client-side health and safety team, as well as ensuring we comply with all safety standards of the client.

Other health and safety best practices include:

• Carrying out risk assessments on all project tasks
• Producing safe plans of action and method statements
• Conducting safety toolbox talks
• Reporting all accidents and near misses both internally and with the client

Execute

The execute element involves project management tasks including scheduling, the creation and management of Gantt charts, and the implementation of agile software development techniques. The objective is to effectively manage the project to ensure it stays within budget and finishes on-time.

The practical steps involve the design group working upfront on the design aspects of the project. This then goes to the developers to complete their work. At SL Controls, we operate a closed loop feedback system between the developers and designers to ensure efficient delivery of the code. In other words, the process of giving feedback is structured and effective, with changes risk assessed and implemented as we go.

In addition to the above, SL Controls also operates a peer review system which we have found to be an effective tool for accomplishing the successful delivery of projects. The peer review system involves one developer creating and checking the code before giving this to another developer to conduct a double-check. This second check ensures nothing in the project requirements is missed as well as ensuring nothing is outside the standard.

In our experience, this peer review system reduces the occurrence of human error.

As well as the in-house phase, you should also plan and implement the installation and commissioning phase. The best approach is to assign a dedicated team, depending on the customer’s requirements. Those requirements might, for example, include evening or weekend work. This needs properly planned and executed.

Validate

The validation element ensures the project is validated against the acceptance criteria. Crucially, you should not only do this during the end stages of the project. Instead, validation should be part of the project from the beginning – at the user requirement stage. It should then continue through to completion.

At SL Controls, we follow the GAMP 5 V-model for validation. These are guidelines for project delivery in a regulated environment and are based on industry best practice.

To ensure we meet requirements for the project, we break it down into essential stages and elements. We then track this breakdown through traceability matrices. The objective is to ensure delivery meets requirements from the beginning through to completion when the customer signs off. At each stage, we get client approval.

Communicate

The way you manage communication in a project is critical to ensuring its successful delivery. The following communication tips will help:

• Only have meetings when they are needed.
• Only include people in meetings when they must be there.
• Use a RACI analysis to determine who should be a meeting. This first involves identifying the key stakeholders on your team, on the client side, and any other third party. With the RACI analysis, you then decide if that stakeholder is Responsible, Accountable, should be Consulted with, or should be Informed. This will help you decide who should be at what meeting.
• Once you have determined who you need to communicate with, you should put in place a stakeholder management plan. This should include, for example, who gets daily updates, who gets weekly updates, and who gets monthly updates. Make sure you deliver these updates according to client expectations.
• Collaborative working platforms, such as Trello, can help with project communication.

Benefits of the Accomplish Pillar

• Everyone goes home safe because of the emphasis on safety.
• The project will deliver on customer expectations.
• You will see a reduction in human error which helps you complete the project on-time and on budget. It also helps reduce double work.
• Members of the project management and delivery team, as well as others, don’t waste time in meetings they don’t need to be involved in.
• Generally, helps you bring projects to completion on time and on budget

Successful projects don’t happen by accident. You need all the pillars in the QUAD approach, including the Accomplish pillar.

Turning factories into smart factories is a key consideration for everyone in manufacturing. After all, Industry 4.0 promises significant benefits in terms of efficiency savings, productivity improvements, and enhanced business intelligence. What next step can you take, however, that will help turn your manufacturing facility into a smart factory? TOTALsolution is the answer.

TOTALsolution is part of the TOTALline suite of products. Those products are:

• TOTALbatch – automates batch changeover and traceability processes
• TOTALdata – improves production line data collection and reporting

TOTALsolution features several modules enabling you to choose exactly what you need for your business. We then customise each module to your production line giving you the cost savings of an off-the-shelf product while still getting a solution tailored to your needs.

Watch our short video on TOTALsolution to get an overview of how this unique product works.

To find out more about TOTALsolution, the modules that are included, and how your business can benefit, please contact us today by emailing [email protected]

How long do batch changeovers take on your production lines? These processes should not take longer than a minute or two.

What about ensuring batch traceability? Are your current batch traceability systems inefficient, open to errors, and time-consuming? You should have an automated process that provides instant and full traceability on every product and batch.

All this is possible with TOTALbatch from SL Controls. TOTALbatch automates both the batch changeover process and your system for batch control, record-keeping and traceability.

This short video explains how TOTALbatch works and how your business can benefit.

Speak to a member of our team today about improving batch control in your business. Email [email protected] and we will get back to you.

Data is central to almost all significant improvements your production line and overall operation will experience over the coming years. Industry 4.0, enhancing OEE, automating additional processes, integrating machines and platforms – all this and more relies on data.

In simple terms, this means a machine putting out data and another machine or system acting on that data to populate a report, track products, send a notification, trigger another stage in the production process, trigger a business process such as system optimisation or ordering new materials, and more.

The Challenge

There is a major barrier that is and will prevent you from achieving the improvements and benefits that new technologies and processes present: there is no consistency in data standards.

Various control vendors, OEMs, and automation technologies all produce data of some sort, but they do so according to their own standards. This means, in the vast majority of cases, solutions from different vendors do not talk to each other out of the box.

In many respects, this silo mentality of vendors is understandable. They believe they have the best solution for your production line and they want you to purchase all available products from them. Even if they don’t provide a particular machine or technology you need, they are still reluctant to work to a standardised data format because of the engineering hours involved and because it may mean compromising on the functionality, performance, and uniqueness of their products.

Busting this down to the reality of your plant, however, means you can have two machines, both from different vendors, both dependent on the other, and both producing data. Neither machine, however, recognises the data of the other.

The results for your business in this scenario are all negative: inefficiencies, increased risk, production delays, compliance issues, increased production costs, and more.

The Process

The solution to this challenge is obvious – develop a standard that works regardless of the platform. In other words, using a standard that makes it possible for your system to understand and, crucially, interpret and use data, regardless of how the machine creating the data was programmed.

Of course, this is easier said than done. The biggest consideration is developing a standard that performs equally and consistently across all vendors and platforms. There are three elements to this:

• Requires exposure to – and experience of – a wide range of different control systems, platforms, and technologies.
• You also need a deep understanding of the programming of the machine or platform. In other words, how the machine analyses itself, how it processes performance data, and how the data it produces is summarised, published, data-logged, and reported.
• Finally, you need a process that enables ongoing development of the standard to keep it up-to-date as vendors launch new platforms and technologies.

The Solution

Taking a vendor-neutral approach to developing a standard for data is the only workable option. This is exactly what we did at SL Controls, following the process detailed above.

In other words, we work with a broad range of clients so have extensive experience of a variety of vendor technologies, and we understand the programming of those technologies. In addition, we regard keeping the standard up-to-date with new developments in the industry as being a core business focus.

The benefits of a data standard like this to your operation are substantial. These include:

• You will gain a deeper understanding of your production line which will enable you to take performance improving decisions.
• Overall OEE will improve.
• Your production line will become more efficient.
• Opens the door to further integration, automation, and implementation of other Smart Factory technologies.

To say all this is possible with data is far too simplistic for a modern production facility. The benefits above are only possible when data is usable. This can only happen when you have a workable data standard, such as we offer at SL Controls.

Data has never been more important than it is today. It is how you use that data, however, that will determine the success of your production lines in the future.

It is crucial to have integrated systems so that data from one machine or process can be read and used by other machines. This should happen within a production line, across multiple production lines, and across multiple production facilities, regardless of geographical area.

This is a complex challenge to address, particularly if you have machines and systems from different vendors.

TOTALdata is the solution. Check out the video for an introduction to how TOTALdata works:

Speak to a member of our team today about improving how your production line uses data. Email [email protected] and we will get back to you.

You can improve OEE in your production line by up to 20 percent by introducing a new product from SL Controls, TOTALline. You can do this at a cost that is up to 50 percent cheaper than comparable solutions with similar features.

In addition, TOTALline improves decision making as well as delivering business efficiency savings. If you want to find out more about the product and its features, you can read the TOTALline pages of our website. This blog focuses on why and how we developed TOTALline, so you can get a better understanding of how it can benefit your business.

The Challenge

Every business is different, and every production line is different – different products, processes, machines, servers, software applications, and more. The goals of most businesses are similar, however. This includes operating more efficiently, improving OEE, reducing the resources required to operate the line, improving access to data, generating actionable reports from that data, and more.

Businesses face challenges in achieving these goals, however, not least of which is cost. There are also integration issues to consider particularly when you have machines, platforms, and software applications from different vendors. There are customisation issues too, i.e. there are products available that:

• Have some features you need;
• Lack other features you also need; but, instead,
• Have features you don’t need.

This leads to inefficiencies in implementation, confusion, and waste as you are paying for features you’ll not use. There’s also frustration as features you need are lacking.

This was the starting point for the development of our TOTALline suite of products – lines and plants have varied starting points, but everyone wants to achieve similar goals at minimal cost.

Of course, we could come into your business like other automation and controls solution providers to develop a system that works specifically for your business. This solves the customisation and integration challenges, but it’s an expensive option. We knew there was a better way.

So, the modularised TOTALline range of products was born – a multi-functional product that is easily tailored to specific needs.

It’s Not What TOTALline Does – It’s How It Does It

We have implemented individual and fully customised solutions for many customers that deliver the same results that TOTALline can achieve. In other words, it’s not what TOTALline does that makes it so innovative in the industry – it’s how it does it.

In addition, it’s the “how” that will deliver substantial benefits for your business.

SL Controls was able to achieve this because of our broad experience in implementing automation and controls solutions. We are unlike other vendors in this respect who may understand part of your line or a specific machine very well. We have the benefit, however, of having a complete overview of the process, enabling us to deliver integration, control, data logging, and data visualisation solutions covering your entire production line.

What TOTALline Does

By way of a very brief summary, TOTALline consists of a range of modules that:

• Automates and improves batch control changeover processes
• Enhances batch data integrity and improves traceability
• Enables machines to self-report
• Collects and logs machine, device, and line data centrally to provide actionable and meaningful reports

Benefits of TOTALline

The modular nature of the product brings a range of benefits to your business:

• You can customise the solution using the modules you need, leaving the ones you don’t
• Considerably less expensive than developing a solution from scratch
• As the core architecture of the modules is already in place, the system can be rapidly customised and deployed
• Easy to scale when you need additional features or if the needs of your business change
• Vendor-neutral so it will work whatever machines, systems, servers, platforms, or software you currently use
• Highly flexible so suits production lines in a range of industries including pharmaceutical and medical device manufacturing

The OEE improvements you make by implementing a customised TOTALline solution will depend on your business, but we regularly see improvements in the 10-20 percent range.

In terms of cost, if you compare the product with a full-scale line batch and data solution, TOTALline is up to 50 percent cheaper. In other words, it’s a product that can make a significant impact on your business for the better while delivering impressive ROI.