Food & Beverage

Food & Beverage

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With over 20 years of food and beverage automation work, Malisko has completed hundreds of process automation projects for plants of all sizes in this industry. We know when your plant installs a state-of-the-art automation system for your production process, you expect to see a direct return on your investment through efficient, consistent production that ensures the safety and quality of every batch.

Applications

Batching
Blanching
Blending / Mixing
Boilers
Brewhouse Operations
Bulk Material Receiving
Bulk-Chemical Systems
Burner Controls
Centrifuge / Separators
CIP
Cooking
Evaporation
Extruders
Fermenting
Filling
Filtration
Grains Handling / Milling
High-Pressure Pumping
Homogenization
HTST and Legal Controls
Loadout
Pasteurization
Powder Conveying / Storage
Retorts
Reverse-Osmosis
Spray Drying
Ultra Filtration

Brewing Automation Simplified

Malisko Engineering, Inc. BatchBrew Logo
As a Rockwell Gold System Integrator, we’re experts at integrating BatchBrew™. The BatchBrew™ brewing control system suite is built to enhance operational productivity through intuitive user controls, streamlined recipe management, and detailed production reporting. Ideal for expanding breweries, BatchBrew is built to be flexible, scalable, and supportable. BatchBrew is powered by Rockwell Automation’s PlantPAx Distributed Control System architecture providing unparalleled performance. With Malisko Engineering BatchBrew, your equipment and your people are better utilized yielding higher quality and consistency in your artfully-crafted beers.
Built on the principles ANSI/ISA-88 Batch Control, BatchBrew breaks up the brewing process into modular, repeatable operations and procedures arranged into master control recipes. Dozens of control parameters, addition amounts, and procedural options are saved as formulation sets representing each of your brands.
Detailed, drilldown batch reports are the cornerstone of the BatchBrew reporting package. Batch Detail reports record the duration of each phase, operation, and procedure as well as any critical process parameters, deviations, or alarm conditions. Process trending via FactoryTalk Historian and VantagePoint provide a robust analysis platform for troubleshooting and process optimization.
Interaction with the system is no longer limited to plant floor HMIs. BatchBrew implements Rockwell Automation’s
FactoryTalk Batch View for a rich mobile experience. Current batch status and detailed views of the brewing recipe procedures may be securely viewed and controlled from a web browser or mobile device.
The BatchBrew enhanced brewing controls library complements the Rockwell Automation Library of Process Objects for a consistent user experience and user-friendly equipment control.
An extension of the BatchBrew enhanced brewing controls library, QA In-Process Sample Logging provides electronic record-keeping of common quality checks where inline instrumentation may not exist.

Brewing…On A College Campus?

In April 2018, Colorado State University (CSU), with support from both the university and industry companies like Malisko, opened a new hands-on brewing lab and industry showcase that will give students practical experience for careers in the brewing and fermentation industries. The lab is part of CSU’s state-of-the-art Fermentation Science and Technology (FST) program.

Automated brewing processes and precise control technologies to maintain product consistency and quality, while satisfying the discerning palates of the consumer base is nothing new to large multi-national and regional breweries. Today, smaller craft brewers are increasingly investing in these technologies for the same reason. Check out this video created by Colorado State University, featuring Malisko’s Dan Malyszko, that highlights the collaboration between industry and education to bring this state of the art brewery to campus.

This is the most sophisticated brewing system on any college campus, and is even rare in the industry for its size. It’s through partnerships like these that we can expose our students to industry standards and give them the best education possible.
Jeff Callaway

Associate Director, Fermentation Science & Technology Program, Department of Food Science and Human Nutrition, Colorado State University

I recalled my own senior design project at CSU and thought, ‘How cool would it be to involve some of these engineering students in such a unique application?’ I wish I’d had exposure to industrial manufacturing design in college, but now being part of providing the platform and coaching the students is very rewarding.
Dan Malyszko

CSU Alumnus, Malisko Director of Operations/Lead Engineer, Malisko Engineering, Inc.

A Major Donor to the Project

We have learned over the years that giving back to the community is a great source of inspiration and motivation for our team members. By combining our spirit of volunteerism, specialized skills, and economic resources, we knew we could be an asset to CSU students to set up the automation “brains” of the Lory Student Center and Gifford breweries. The students’ work is all part of a senior design project called “Brewery Design and Automation” sponsored by Malisko Engineering.

Heat Exchangers Offer Big Processing Paybacks

While it may not be as prominent as many other dairy processing technologies, the heat exchanger is far from lowly. The equipment, which is used to transfer heat between two or more fluids during the cooling and heating processes without mixing the fluids together, can have a major impact on processing efficiencies and operating expenses.

Controlling Temperature From Farm to Fork Protects Product Quality, Brand Name

There are rules for keeping fresh food under a certain temperature to keep it safe both in transit and storage, and—just as important—maintain its quality so you don’t have to throw it out prematurely.

Case Study: Dairy Producer Improves Separator Process Yield and Consistency with Controls Upgrade

A major provider and producer of dairy products wanted to reactivate an idle 20+ year old Separator at one of their plants.

Case Study: Dairy Producer Seeks Help to Assess then Execute Improvements to an Overly Manual Spray Dryer Operation to Increase Yield

A dairy products manufacturer had a vertical spray dryer utilizing predominantly manual controls causing wide variability in the methods applied by the various operators. The result was inconsistent dryer operation, unacceptable product consistency, throughput and yield.

Our Approach

No two plants are the same. No two production processes are either. We deliver an automated production process that works for you. And it will work as perfectly as physically possible. Whether you’ve already implemented some automation, just finished an OEE review, or are starting from the beginning, we’ll provide the service you need. We can provide a business justification for process automation, design your automated system, or implement a system that’s already been designed. We can do it all and jump in at any point during the process.

Our approach to process engineering and automation has delivered results for over 20 years. It has allowed us to provide our clients with consistent, efficient production, and measurable ROI. How do we do it?

Site Assessment
Before we can design your new system and implement automation solutions that save you money and improve efficiency, we have to understand your challenges. To achieve this, we can engage with you to perform a site assessment. We listen to your operators, maintenance staff, engineers and operations personnel to fully understand your process, how your business operates, the problems you want to solve, and what success means to you. Most important, we take the time to understand the best ways to collaborate with your in-house engineers throughout the automation process as we become familiar with your facility and systems that make it run.

Our site assessment follows a tried and true process and is the first step in implementing an automation solution. During each site assessment, we will :

Click the links above to learn more about each one.

Front-End Engineering Design (FEED)
Successful engineering has to align everyday production with the big picture. Each processing unit and work cell must come together with your automation system to form not only an efficient production process but also one that matches your business goals and realities. When we present an automation solution to you, we make sure it matches your budget, your timeline, your current production realities, and your goals all while minimizing risk.

Our Front End Engineering Design (FEED) sets the foundation for a successful project accomplished on time, on budget and in a way that fits your in-house team.

If the needs of your business, plant, and production line change over time, our systems come ready to change along with them. And if you need, we’ll even tweak the system design to fit the skill sets of your support team. We believe the best systems change for you. It shouldn’t be the other way around.

Once the FEED is completed, you will receive:

Click the links above to learn more about each one.

Detailed Engineering and Design
In our detailed engineering and design service, we transform the conceptual into the final design. We use all the knowledge we gain from the automation solutions site assessment and Front End Engineering Design (FEED) to minimize your risk, get you running quickly, and align our work with your business realities. Here we will also flush out project risks, planning for them by nailing down a realistic project budget, execution plan and timeline.

Malisko both designs your automation system and implements it. Our detailed engineering and design service picks up right after our FEED services leave off, and our system integration execution pick up right after our detailed engineering and design. We can handle the complete package: specification, design, procurement, development, on-site execution, troubleshooting and support of the control, network, security and MES layers.

During this phase we can provide you with:

Click the links above to learn more about each one.

Project Execution
After we’ve completed our thorough automation solutions site assessment, Front End Engineering Design and Detailed Engineering Design, we have the information we need to document, code and integrate your automated system. We keep in mind your business goals. We factor in the strengths and limitations of your team, and we prioritize your most important objectives.

We design your system on a foundation of understanding so that we can rapidly implement it with absolute precision. We program each function in your system and set up an intuitive Human Machine Interface (HMI) and reporting that allows your team to adopt your system efficiently. We outfit your system with the reporting you need to stay on top of your production. Prior to installation, we run your system through several rounds of intensive testing in a simulated environment to make sure it works. Once we have programmed your machines, set up your HMI, created a useful reporting program and tested the functionality and performance of your system, it is time to install your system in your facility. When on-site system installation is complete our Team again extensively tests the operation, performance and functionality of the new system holistically from the field devices through to reporting.

During this phase we can provide you with:

Click the links above to learn more about each one.

Validation
Computer System Validation (CSV) is a must in FDA regulated industries. We design and implement your system to deliver consistent, efficient production that also meets CSV for FDA. And we prove it too. If you operate in a regulated industry, we take care of the paperwork related to CSV and reduce your Regulatory risk. We can provide a Validation Master Plan (VMP) and use it to guide our work. We document requirement specs, design specs, functional specs, test plans, installation and operational protocols, trace matrices, and summary reports. We execute the protocols as well. We assist with keeping your records up-to-date via change control and help keep your system in compliance. Minimizing risk is ingrained in our company because we are committed to delivering you ROI.

During this phase we can provide you with:

Click the links above to learn more about each one.

Post Project Support
If any troubles emerge with your system, we have you covered; whether it is warranty or support under a formal service contract. When you work with Malisko Engineering, you don’t just get a system, you get a whole team to support it. If you have a full maintenance and system support staff on-hand, we will provide assistance to fill the cracks. As much as practical, we can help your team be properly equipped to maintain and troubleshoot your process and automation system. If you need full support services, we are available 24-7 to make sure your system works.

During this phase we can provide you with:

Click the links above to learn more about each one.

CIP Automation Practices: Mild to Wild

Manufacturers in the process industries can improve their Clean in Place (CIP) operations and efficiencies by effectively utilizing current technologies for CIP process automation. Simply provide your information below to download our White Paper on CIP Automation Practices.

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Corporate Office

500 N Broadway
Suite 1600
St. Louis, MO 63102
314.621.2921

Western Regional Office

4600 S Ulster Street
Suite 1020
Denver, CO 80237

Northern Regional Office

3610 Oakwood Hills Parkway
Suite 2
Eau Claire, WI 54701

Malisko Engineering, Inc. © Copyright 2021. All rights reserved

IDENTIFY EXISTING AUTOMATION CONTROLS

Here’s where our invaluable site assessment begins. We’ll come in and identify your existing process controls and gain a sense of how you use them. Our engineers know the ins and outs of process controls from all the major brands, and even some of the less common, and will use that knowledge to analyze the state of automation on your existing production line.

DISCOVERY

Assessing your current automation controls requires both a firm understanding of your existing processes and a clear understanding of your baseline goals. As your selected System Integrators, our work hinges upon learning the intricacies of your plant and your equipment. From reviewing operator’s manuals to direct interviews with your engineers and operators, the first step of this process requires we become almost a proxy member of your team. With over 20 years of experience working in automation, our team of professionals has developed a clear process to understand your business drivers and goals.

Not only does our support offer hands-on help, but it also requires we provide the best service coupled with the desire to maximize on your investment. This support is thorough and comprehensive, resulting in actionable steps which your team can utilize and are tailored for your existing system.


INTEGRATING OUT SKILLS INTO YOUR TEAM

We understand the complexities of every unique process system. Where there are standard variables found in a variety of systems, we also know one simple input or output, custom-tailored to your process can vastly alter flow and processes. With even one minor discrepancy having the power to generate less than one percent of output, we leave nothing to chance.

Building off our team of engineers' years of experience and dedication to our craft, we fully integrate into your team. Your Malisko staff support spends time learning everything from understanding current operator manuals to becoming a part of your team to ensure your automation fits your needs.


EXPERIENCE DEPLOYING THE LATEST TECHNOLOGY

Despite complex offerings and a wide variety of machines, software, and controls, our team is always updating our skill sets and understanding. We are capable of working within the constraints of a majority of major brands. No matter your current automation controls, we can find solutions.

Not sure where to start? As an automation industry expert, our team is ready to offer a suite of suggested solutions that manage current concerns while accounting for the complexities of implementation.


ANALYSIS OF YOUR PROCESS

Our analysis of your automation solutions is methodical to provide a clear path moving forward. We listen to your operators, maintenance staff, engineers, and operations personnel to fully understand your process, how your business operates, the problems you want to solve, and what you want to accomplish.

Once we have thoroughly analyzed your current process, we provide a customized plan accounting for your complexities and founded in your reality.

IDENTIFY POTENTIAL COST-SAVING SOLUTIONS

Process automation can change not only your production process but your entire business. Where we understand process automation is an investment, our work produces ROI in as quick a payback period as possible. Lowering costs is one of the most powerful ways that automation raises your bottom line.

REDUCING OFF-SPEC PRODUCTS

In traditional production, processes vary and these variances cause unknown events that can affect quality. When your process is inconsistent, you can get inconsistent batches and off-spec products that you can’t sell. An automated production system greatly enhances your ability to produce consistent results every time. A more consistent process means more consistent batches and less wasted product. That’s savings for you.


REDUCING DOWNTIME AND MAINTENANCE COSTS

Extended downtime can cost producers millions of dollars. That’s why we design our manufacturing automation systems to reduce the risk of downtime and operate at full production. Our automated technology provides you constant data and actionable intelligence, letting you know if production deviates.

If any issues arise, your maintenance team will most likely know long before a major disaster occurs. And if downtime does occur, our system creates digital reports telling you why, providing your operators with context. Automation allows you to invest wisely in your people, not recurring problems.


REDUCING PROCESS AUTOMATION COSTS

We understand that automating every manufacturing facility has different challenges and requires different solutions. Before we start automating any processes, we take the time to listen intently to you. We learn your business goals, your needs, and the specific skill sets of your team. Once we understand your needs, we only choose the solutions that provide you the highest ROI and solve your challenges.


INCREASING PRODUCTION BY APPLYING AUTOMATION

Better production means more sales. Malisko Engineering delivers automated solutions that can help deliver greater production from your existing machinery. We break down your existing process and find the most inefficient areas of your production. From there, we use automation to make your process more consistent, and in turn, make your products more consistent. We also eliminate inefficiencies in your system, allowing your equipment to process more input, meaning more output and allowing more to reach the market.


DECREASING COSTS BY DEPLOYING AUTOMATION

Malisko implements systems that not only lower the cost of producing each unit but also increase the amount of product you can bring to market. Ultimately, your profit margin for each product increases while we drop your costs in several ways.

Our manufacturing automation systems reduce your risk by promptly delivering actionable solutions to your team.

When you invest in automation, you invest in constant awareness of your system’s needs. Because your process is designed always to be consistent, automated reports will inform you if anything is deviating from the standard operation.


FUTURE-PROOFING

With all the different platforms, manufacturers, suppliers, and components available, there are countless variables to consider when automating your process. To sift through the many choices, we assist you in selecting the options that best align with your budget, team’s skill sets, and future needs.

We take the time to understand the competencies of your staff, selecting options they can use, and we thoroughly train your team in your selected system. We also use common components that are replaceable and fixable. And we partner with trusted local suppliers who service and support you day in and day out.

Best of all, we design your system to expand with your production needs and can easily be upgraded. That lowers your long-term automation costs and ensures you enjoy ROI for years to come.

IDENTIFY OPPORTUNITIES

A key to increasing your profit margin is using industrial automation to maximize your production. With this, every little thing adds up.

Every controller, process, and work cell in your plant must operate at peak performance if you’re to boost your bottom line.

When you work with us, you’ll have a team that’s experienced in efficiency supporting you throughout the project life-cycle and beyond. We take the time to listen to you and gain a thorough understanding of your business goals. And our determined engineers scour your plant to find opportunities to improve operational efficiency by applying intelligent automation. Our goal is to help you get more saleable products out of your facility through more efficient production.

IMPROVING OPERATIONAL CONSISTENCY

To increase your number of saleable products, we aim to make your production process as perfectly consistent as possible. Why? Because that reduces your risk.

Once we’ve thoroughly assessed your existing production, we identify solutions that will reduce variation in your process. Using programmed logic to automate functions in your process, we create repeatable procedures that are reliably consistent, time in and time out. And that means your batches will be on-spec and up to quality standards, reducing rework, reducing your costs.


AUTOMATION TRAINING TO EQUIP YOUR TEAM

At Malisko Engineering, we understand that efficiency isn’t just about equipment. It’s about the proper use of that equipment. It’s about personnel. That’s why we provide the best high-level and equipment-specific training possible.

When we come into your plant and automate your system, we align our work to the team you have on hand. We are there post-project support as you need to fully equip your team to operate, troubleshoot, and maintain your system. Even after our hands-on training and system hand-off, we are there for you. From simulated real-world runs to understandable guides, your team will have everything they need to fully master the proper use of your automation system.


SYSTEMS THAT KEEP IT SIMPLE

We not only train your team to fully use your automated production system, we design and implement it with them in mind from day one. We learn the skill sets that you have on hand and incorporate that knowledge into the solutions that we implement.

We specify Human Machine Interfaces (HMIs) that make it simple for your operators, engineers, quality, and maintenance staff to know your process. They will be able to efficiently operate, troubleshoot, and maintain your system. If your production needs change, your system will too. And our automated systems even monitor production variances and down-times, keeping your operators always aware of their environment. They not only know what’s going on, but they also have actionable information and a set process for keeping your system humming at full production.

To ensure simplicity, we choose common equipment that’s easy to replace. And we partner directly with top-quality manufacturers and distributors who can ensure that if you need a component, it will ship same-day or next day. We limit custom parts, and we build expansion potential directly into your system.


MAINTENANCE ENGINEERING

When it comes to maintenance engineering for your automated manufacturing process, collaboration is key. Every processing unit in your plant and every team member has a purpose. It takes a full staff, with a complete range of complementary skill sets, to operate, maintain, and manage your manufacturing facility. From operators to maintenance engineers and everyone in between, each person on your production line has to be on the same page.

Throughout our automation solutions site assessment, detail engineering design and system integration work, we align each component, code, and process with the skill sets on your team.

Since we design, develop, and install your systems integration code and components, we’re knowledgeable in your system and your production. And through our 24/7 post-project maintenance engineering support, we’re there with you – helping every member of your team execute their role effectively.


POST-COMMISSIONING MAINTENANCE ENGINEERING

If you require it, we can provide you a comprehensive, post-commissioning maintenance engineering service. Because we have complete automation expertise and a full automation support team, we can assist with keeping your system operating at maximum efficiency. When you invest in automation, you invest in the maximum production of your plant so if you need our maintenance engineering support to fully pay off your investment in automation, we’re there. Everything we do is about achieving a return on your process automation investment.


REMOTE SUPPORT

We encourage you to bring us into your maintenance and support process. We’ll set up a Virtual Private Network (VPN) that allows us to remotely connect to your process so we can address support needs as they arise and provide real-time support from anywhere in the world.

BUSINESS JUSTIFICATION

We understand process automation is an investment. We also know when your plant installs state-of-the-art operational technology, you see a direct return on your investment through efficient, consistent production.

Done right, process automation reduces your costs, maximizes your output, and boosts your profits.

The challenge with process automation is every project is unique. To manage this, our team first listens to you and defines your challenges. Then, we relentlessly attack those challenges from every angle to find the best solutions.

UNDERSTANDING YOUR SOLUTION

Before we get into the detailed designs of your system, we work with your team to gain a thorough understanding of your challenges, goals, and in-house expertise. Then, we proceed with a site assessment, where we learn the ins and outs of your existing operation. Here’s where we take stock of any existing automation components; or lack of; used in your manufacturing operation. Lastly, we use knowledge of your existing production to create a Gap Analysis and a Migration Plan for your review.

We present hardware, software, and information solutions that directed are directed towards lowering your operating costs and making your production more efficient.


EXCELLENT PROJECT EXECUTION

Our work is built on a foundation of understanding your system and needs. Before we automate anything, we always define clear, measurable goals. For over 20 years, we’ve been solving our client’s challenges, keeping in mind both minute details and the big picture. And we deliver our projects on time and budget.

Our efficient project management system ensures that every dollar you invest goes toward a lasting system that meets your needs. Our technical project lead serves as a singular point of contact for all parties, eliminating second-guessing and project stalls. With our multi-disciplines team of complementary skillsets, we use a highly collaborative approach. Everyone stays on the same page and we keep you in the loop throughout our work.


DELIVERING ROI

At Malisko, we don’t just design your automation system, and we don’t just implement it either. Through decades of experience, our team has developed a keen sense of understanding the business drivers behind every automation project. We strive to minimize cost impact while developing impactful solutions.

Our Team and its commitment to excellence is the reason for our ability to deliver success to you. We have the business expertise and experience to get the job done. We have a full team of engineers, designers, programmers, and specialists in automation, networks, security, and validation. When you work with us, you have all the knowledge, experience, and support you need to get the most from your investment in manufacturing automation.

PRESENTING AUTOMATION SOLUTIONS

The site assessment reveals a lot about the opportunities for improvements through automation within your facility. Most importantly, it gives our team the pertinent information needed to begin to shape an automation plan to meet your business goals.

Our recommended solutions have you in mind. When you receive the Assessment Report summarizing our findings and recommendations, we’re open for collaboration, as we are throughout every phase of a project.

SOLUTIONS TAILORED TO YOUR NEEDS

We understand there is no one-size-fits-all solution. Every project requires a thorough understanding of your business goals, bottom line standards, current processes, and future plans and objectives. We understand these facets first, then recommend the appropriate technologies best suited to accomplish your objectives. No two plants are the same, no two solutions are exactly the same.


IMPLEMENTATION PATH

Implementing the recommendations we make in our Assessment Report can usually take many different paths. Implementation hinges itself on your budget, intended goals, and timeline. To best implement our solutions, we allow for a variety of outcomes. If you seek to, our team offers options grounded in a phased approach. If you need to start on a small project basis, the solution and path to get there is clearly presented. If you want to move immediately into a comprehensive end-to-end solution, we are capable of a full implementation.

And if your team of stakeholders needs more information to make appropriate decisions, we stand ready to offer the support needed.


PROCEEDING WITH A DESIGN

After the site assessment and gaining full alignment with your team on the implementation path, we proceed to the next phase of the project, Front End Engineering Design (FEED).

OUTLINED BUSINESS OBJECTIVES

Efficiency and consistency: two attributes Malisko knows best. Every automation solution we implement on your plant floor is designed to improve one or both. And we have countless ways to do it, whether it’s a simple control scheme using a touchscreen panel or an upgrade from a legacy Distributed Control System (DCS) to a greenfield PlantPAx solution. All of our automation solutions aim to improve your plant’s process efficiency and batch consistency to save you time, money and labor.

SPECIFYING THE RIGHT TECHNOLOGIES

When we design your system, we use a variety of technologies and secure networking. Specifying which ones to use for various functions depends on several factors, including your business goals and justifications for investing in automation. We also consider whether we’re implementing a ‘greenfield’ system, replacing your system or expanding your existing system. Last, the choice of specific automation solutions and components depends on your team’s current expertise. We present hardware, software, and information solutions that directed are directed towards lowering your operating costs and making your production more efficient.

Depending on your needs, we can implement traditional automation schemes and platforms, or we can implement newer technologies that can minimize up-front installation cost and serve up loads of actionable information. The optimal choice depends on what solutions work best for you and your team.


SYSTEM MAINTENANCE AND SPARE PARTS

We reduce your costs by reducing your spare parts as well as choosing widely-supported COTS (commercial-off-the-shelf) components. Your plant needs to balance the need to reduce downtime with the need to reduce the cost of long-term maintainability. We use a straightforward, intelligently engineered process to accommodate both of these needs.

We strive to source hardware and software components from your local distribution channels. Working with parts suppliers you already work with streamlines the supportability of Malisko systems. Most importantly, though, the relationships we develop with your suppliers enhances the support structure that we build around your systems.


MINIMIZING MAINTENANCE

We believe predictive maintenance is better than corrective maintenance because it frees up your plant support and saves you money.

We design our systems to use components that require minimal maintenance and can provide predictive maintenance data for asset performance tracking and alarm management. Through intuitive HMI user interfaces, our systems enable your maintenance team to efficiently monitor equipment runtime and other critical cycle data that helps predict when maintenance is required so that it can be scheduled before a catastrophic event occurs. No catastrophic failures. No unnecessary preventative maintenance. No downtime due to equipment failures.


SAVING BY PLANNING FOR FUTURE EXPANSIONS

When we approach projects, we minimize your costs as much as possible. Not just in your initial investment, but also your TOC (Total Cost of Ownership). Our systems not only fit into your budget but they are also completely scalable for future expansions. This means less work for you and less hardware and software that you need to upgrade when it comes time to expand your plant and your system.


IMPROVING OPERATIONAL EFFICIENCIES

In many manufacturing lines, we find that process units and work cells can under-produce because of various inefficiencies. When we use automation to improve the output consistency of a particular operation, we attempt to help you reduce your o-spec products and your rework. When we implement automation to improve the capacity of your operation, we attempt to help you eliminate inefficiencies, allowing the equipment to run closer to its theoretical capacity.

PROJECT TIMELINE & BUDGET

At the conclusion of our Front End Engineering Design, we put a proposal in your hands complete with a comprehensive plan for your project. This includes addressing the full costs of automation, calculating sensible timelines, and providing realistic schedules for implementation.

We assure you that our sights are set on achieving your business goals. We work around your production schedule. We finish projects on time and within the agreed-upon budget. And we make sure our work pays off for you.

REDUCING PRODUCTION RISK

We’re proud of our record, and we’re more than happy to put you in touch with a long list of references. They will tell you we complete projects on time and budget.

So how do we do it?

In addition to setting realistic expectations at the onset of a project, we reduce risks as we implement your system. By performing our FEED, we identify potential project risks and make plans to hedge against them.


ESTABLISHING AN INDUSTRIAL AUTOMATION BUDGET

You’re still asking one big question, “How much will this cost me?” In automation, every project is different. But trust us to throw it all out there. Our budgets include a worst-case estimate to eliminate surprises when we get into the detailed design phase. We show you what it costs to automate. And we’ll help calculate your ROI along with the cost so you can see exactly what automation will save you and the benefits you’ll gain in the long run.

If your budget allows you to fully invest in your facility, we’ll implement the full range of solutions that we present to you. If you have to pick and choose a few operations to automate, we’re there with you. And we work directly with your plant’s team, almost becoming part of your company, to identify the solutions that deliver the biggest and most immediate ROI.

DRAWING PACKAGES

Drawing development is the first step in the detailed engineering and design process. Here, we show you how your automation system will be powered, controlled, and networked. At the end of this stage, you’ll have several detailed drawings at your disposal, and all will serve as great resources for installation, commissioning of your system as well as for long-term maintenance and troubleshooting.

P&IDs: THE FOUNDATIONAL PROCESS AUTOMATION DRAWINGS

Since we tailor your automation solutions and system to your plant, we base all of our control system drawings on your process equipment, making use of the all-important Piping and Instrumentation Diagrams (or P&IDs). P&IDs depict process flow and specify your control system’s discrete and analog devices including such components as valves, pumps, motors, instruments, and control loops. These items are the foundation for a detailed device list that is used as the basis for sizing of the automation system including I/O count, processor type and memory size, automation server sizing, and even network capacity planning. P&IDs are also the basis for our HMI process graphics that your operators interact with. If you do not already have P&IDs, we can provide them for you. If your in-house process designers have P&ID generation capability, we can partner with them using our extensive knowledge and experience to ensure they capture the pertinent information related to the control system.


CONTROL PANEL DESIGN

We use the P&IDs as a reference to count the number of devices that your system will control or monitor. In the control panel design, we select the components that will power your control system and communicate with your field devices. Then, our skilled CAD designers lay out those components so we can safely work on them, optimize space and provide future-ready scalability. If you ever need to expand or update your system, our designs not only have spare I/O specified, but also have spare space for additional control equipment down the road.

Our panel design drawing package includes panel layout and elevations, I/O electrical schematics including field termination detail, and traditional loop drawings if required.

The control panel CAD drawing sets are then issued for construction and are built by one of our preferred UL508A panel builder partners.


POWER DISTRIBUTION DESIGN

Once we’ve designed the layout of your electrical cabinets, we’ll show you how we bring power to them in our power distribution design. Here’s where we provide your engineers with detailed drawings that show how we take the facility or area incoming power and step it down to usable voltages/phases for your area or facility, including wire and cable sizing, short-circuit analysis and branch circuit protection to meet current electrical code requirements. We can also include in the design metering of your power at both the incoming power and at the various usage points for effective power monitoring and power management.


MCC SPECIFICATIONS & LAYOUTS

With the cabinets and power distribution designed, we can also specify and lay out your Motor Control Centers (MCCs). These important devices power and control the motors that run in your process control system, and you’ll see them on equipment such as homogenizers, evaporators, separators, pumps, agitators, blowers, vacuum pumps and vibrators throughout your facility. In many cases, we specify intelligent motor controllers that use a variable frequency drives along with ethernet communications to control your motors while improving the efficiency and consistency of your production.


NETWORK DRAWINGS

Industrial Automation and Control System (IACS) networks include drawings for both the physical and logical layers. We provide constructible physical network drawings depicting space-planning, overhead pathways, cabinet elevations, and typical labeling and connectivity references. Our logical network topology drawings depict Cell/Area Zone network components as well as interconnections to the distribution and core layers of the Manufacturing Zone. In addition to topology drawings, we also provide detailed switchport connection and VLAN reference documentation.

DOCUMENTATION

In developing documentation for your system, we build directly on detailed system drawings. Whether you have us, your team, or a third party create the detailed drawings, we can use them to develop your documentation.
We handle the Functional Requirement Specification (FRS) and the detailed documentation you need to nail down specific project deliverables and show you how your automation system will operate at each step in its cycle. Finally, we provide system specifications and operator manuals so your team has written resources to reference how to run your process control system.

PROJECT SCOPE DEFINITION

Before we specify components we define the project scope, setting the boundaries by defining deliverables and objectives for everyone involved. That way, your in-house team members and our team know precisely what to do and what to expect from everyone else. We seek to eliminate miscommunication throughout the process and when your system is complete.


FUNCTIONAL REQUIREMENT SPECIFICATION (FRS)

With detailed drawings in hand and the project scope defined, we provide you with a functional specification. Here, we outline the required behavior of your automation system, defining what your system should do. The functional requirement specification (FRS) provides you a high-level overview of your system’s behavior. Through the FRS, we’ll provide the necessary process operation information to your plant operations team, project control engineers and, if you’re in a regulated industry, quality/validation personnel.


SYSTEM DESIGN DETAIL

While the functional requirement specification provides you the overview of your system, we use a separate document to provide your project and system stakeholders with the full technical details. In the system design detail, we cover system architecture design, data design, function design, equipment and network details, and system interface design. It will also detail other requirements of the control system, such as environmental requirements, electrical classification requirements or communications requirements with third party equipment or existing equipment and processes.


DESCRIPTION OF OPERATION & OPERATOR MANUALS

In the description of operation document, we show you an overview of how your operators will use your system. In the operator manuals, we supply your operators with easy-to-follow instructions they can reference while running your process control system. In many cases, we even digitize the operator manuals and make them accessible via the control system’s operator interface.

HARDWARE & SOFTWARE SPECIFICATION

Through our Detailed Engineering and Design service, we take your goals and the abstract vision of a working system and transform that information into the final automation design. To round out your system’s final design, we specify the hardware and software that will be critical components of your OT (operational technology) infrastructure. In today’s modern automation systems, hardware and software are closely coupled to provide agile integration as well as the ability to quickly harvest data, transforming it into actionable intelligence through advanced software platforms. Our systems use the most advanced hardware and software technologies available today, and we make it a goal to choose components that work together well as a cohesive system as well as provide a path for future growth and sustainability.

FIELD DEVICES

Automation hardware specification includes two primary types of field devices to consider when choosing industrial control equipment. The first type, inline process devices, includes valves, motors, and other equipment that provide process actions including moving product from one piece of equipment to another. The second device type, inline instrumentation, includes equipment that monitors aspects of your process, such as pressure, temperature, and flow. Each device’s control I/O will be specified to be hard-wired to control panels or handled directly through communications protocols such as EtherNet/IP. Whether hard-wired or handled via the network, field device integration is a key component of properly sizing the I/O and control platform that will run your process. At Malisko, we start at the field device level to ensure that the system is sized properly and delivers characterized, predictable performance.


CONTROL SYSTEM HARDWARE PLATFORM

Whether your process control system is a simple single controller, a standalone HMI interface, or a fully characterized PlantPAx distributed control system, your hardware infrastructure specification is a major component of ensuring real-time control and system determinism. The control hardware needs to be familiar and maintenance-friendly, so we work with your team to identify any plant control system standards that you may already have. We also keep our eyes peeled for any obsolescence issues or compatibility concerns before a hardware bill-of-material is finalized. We follow stringent system selection guidelines to ensure your systems are configured properly and adhere to best practices and industry standards.


SYSTEM DESIGN DETAIL

The Industrial Internet of Things (IIoT) is enabled by intelligent integration of hardware and software. Gone are the days of only having to consider a visualization platform and maybe a data archiver. To quickly act on information, the automation software platforms need to seamlessly integrate with today’s smart devices, and Malisko works with many of the industry’s leading software suites. Rockwell Automation’s FactoryTalk software platform, for instance, hosts common control system services like Security, Alarming, and Diagnostics. Other FactoryTalk software products use the common platform features across the entire suite of software to provide a consistent and cohesive user experience. Visualization software and manufacturing information software products are integrated together now more than ever. But it doesn’t stop there. Malisko can also help your team select the right software to handle integration with Enterprise systems. As today’s data requirements become more intensive, the convergence of IT and OT systems is becoming a requirement for manufacturers. We help our clients navigate the sometimes cumbersome integration scenarios for disparate software systems by following industry standards such as ANSI/ISA-95 to develop automated software interfaces between enterprise and control systems. We also hold industry certifications for some of the leading software platforms used within automated production environments. Whether simple or complex, we have a proven track record of delivering comprehensive, robust software solutions that align with your goals, budget, timeline, and the expertise of your team.

INDUSTRIAL IT INFRASTRUCTURE DESIGN

Sound network and security infrastructure is a prerequisite to today’s advanced manufacturing automation systems. Industry’s thirst for actionable information and intelligence has pushed the limits of legacy automation systems and the proprietary networks of days past. Modern IACS (Industrial Automation and Control Systems) are built on future-ready network and security infrastructures that are based on information technology (IT) best-practices. These infrastructures enable the “Connected Enterprise” and the Industrial Internet of Things (IIoT) while also providing real-time control of your critical production equipment. At Malisko, we consider industrial networking and security as one of our top priorities in building a solid automation foundation for your manufacturing facility. Infrastructure in this sense is the basis for everything we do. When it comes to infrastructure, we subscribe to the motto, “You’re either going to do it right, or you’re going to do it over.” We get it right the first time to enable your processes to run reliably, safely, consistently, and efficiently while satisfying the data requirements of today and the future.

FROM THE TOP FLOOR TO THE SHOP FLOOR

Industrial networking and security have evolved. Today, information flows in both directions — from the enterprise level all the way down to the process and machine control level. Proprietary controls networks have given way to converged Ethernet networks integrating more tightly with enterprise systems. The convergence of IT and OT (information and operations technology respectively), has brought a whole host of new challenges for manufacturers and systems integrators alike. Convergence of these technology platforms opens up many more vulnerabilities if the infrastructure is not properly designed. Poorly designed network infrastructure has sub-performance implications; but equally as important is how a design reflects overall consideration of security. Industrial networking and security go hand-in-hand, and should be designed in parallel. Malisko Engineering Network, Security, and Information Specialists bring a wealth of knowledge and experience to your team in applying IT concepts to the OT world. When you partner with Malisko, we are your ally in keeping your OT systems robust, safe, secure, and reliable.


DEFENSE-IN-DEPTH: THE PHILOSOPHY BEHIND INDUSTRIAL SECURITY

No single appliance or software package can serve as a comprehensive security safeguard in a manufacturing environment. That is why we employ a defense-in-depth strategy. Our experienced team has a detailed understanding of industrial networking and security. From proper network segmentation, policy enforcement, access control lists, to using the appropriate industrially-hardened IT equipment, we’re attentive to minute details of how network and security infrastructure affect the IACS. Our best-practice, multi-layered defense strategy consists of physical hardware layers, procedural layers and electronic layers of defense that complement, and even integrate directly with, your enterprise security. Every layer works together. Every layer is individually secure. And that adds up to form a wholly secure system. That’s defense-in-depth.


COLLABORATION BUILDS THE BEST PROCEDURES, AWARENESS, AND TRAINING

Convergence of IT and OT goes beyond the integration of hardware and software. We work with your IT and operations teams to balance functional and application requirements. You need sound, robust, and always-available network and security infrastructure that is transparent to your operation. Like building infrastructure, IT and OT infrastructure is simply expected to do its job in providing a platform that enables other activities and processes. The team who supports these systems needs to be comfortable with the physical and logical frameworks. Malisko-designed Network and Security infrastructure incorporates industry-best practices; but the overall deployment is unique to you and your operation. We take the extra time and care to get your team on-board with IT/OT convergence initiatives to get the most out of your future-ready system.


SECURING SERVERS, WORKSTATIONS, APPLICATIONS, AND DEVICES

When it comes to Industrial IT systems, we focus first on plantwide network and security infrastructure to pave the way for the rest of your system deployment. But even the best infrastructure deployments don’t provide end-point security for your peripheral devices. That’s why we take security down to individual components within your system. Your servers, workstations, applications, and devices all require security measures to fully and properly secure your system.

We set up a protection mechanism for your servers and workstations through thorough hardening methods including group policies, software patch management, anti-virus detection software, uninstalls of unused Windows components, and protection of computer interface ports, such as USB, parallel or serial interfaces.

We secure your applications by hardening out-of-the-box access. Many automation platforms have fully open security and administrator privileges granted for all users on fresh installations of the software suites. We go through the extra steps required to properly grant access. Our systems can track user access and user changes through authentication, authorization, change management and accounting.

We deploy industrial service routers to protect Cell/Area Zones within a manufacturing network restricting access to entire functional areas of a plant.

We use device hardening to restrict physical access to authorized personnel only, disable remote programming capabilities where appropriate, encrypt communications, restrict network connectivity to authenticated users and restrict access to internal resources. We practice controller hardening. This allows us to use authentication and authorization to restrict logical access to PLCs from restricted engineering workstations. We track both access and changes using change management. We restrict physical access to your system using cable lock-in and port block-out devices. Unauthorized personnel will simply not have “walk up, plug in” access to your system and your network.

We implement switch hardening using firewalls, network infrastructure access protection, domains of trust, secure remote access policies and encrypted switch operation systems.

PROGRAMMING & LOGIC DEVELOPMENT

We begin our project execution by developing a logical framework along with the PLC code that will run your automated process. Depending on the challenges we’re solving and the inefficiencies we’re addressing, we can use a combination of several programming languages to control your system. No matter which programming platform selected, we use widely-supported programming methods that lead to the best possible system configuration for your application. And it’s ultimately your system, so it is written so your team can support and help operators troubleshoot production issues.

LIBRARY DEVELOPMENT

Modern control systems can have intricate output requirements including actionable intelligence. As data requirements have become more intensive, so has the underlying control logic in the industrial controllers. To optimize code management while balancing maintainability, Malisko leverages reusable global code and add-on instructions wherever possible. We have developed our own robust libraries across various system platforms, and also leverage the use of standardized libraries such as Rockwell Automation’s Library of Process Objects. Whether a commercial-off-the-shelf library is right for you, or you require advanced library customization, we have you covered.

Our skilled engineers and programmers have a wide breadth of knowledge and experience on the most common industrial programming languages and techniques. At times, however, manufacturing facilities have a mixed-bag of technologies where we have to reverse-engineer and interface to proprietary, legacy, and ‘black-box’ programming styles, languages and methods. Most often, we help customers move away from these non-standard approaches and replace with widely-supported, modern methods and platforms.


LANGUAGE OPTIONS

Sequential Function Charts
For many plants, we develop process control logic in Sequential Function Charts (SFCs). This graphical programming language divides code into compartmentalized procedural steps. The flowchart-style configuration of SFCs is a versatile and powerful tool to develop logic that visually complements sequential processes while not sacrificing process control performance.

Function Block Programming
Function Block Programming is a graphical language that links the function of input variables with output variables and consists of various interconnected blocks. Each block performs a specific function that requires inputs and produces actions on outputs.

Structured Text
Structured Text and scripting languages are not widely used within industrial controllers in the process industries. However, text-based programming might be used to execute a complex mathematical or logic function in a few lines of simple text instructions that may otherwise take dozens of rungs to accomplish in a ladder logic program. We support and implement structured text and other scripting languages as required and where it makes sense.

Ladder Logic
Ladder Logic is the most prevalent process and machine control programming language we deploy. This graphical language is based on the functionality of circuit diagrams of relay logic hardware and wiring. Ladder Logic is used in sequential process control and machine control. It can be deployed in most industrial control scenarios. Many of today’s advanced application code libraries are written in ladder logic, and can ultimately interface to other languages such as SFC, Function Block, and Structured Text. Ladder Logic is widely supported and understood by the vast majority of the industrial control community.

HUMAN MACHINE INTERFACE (HMI) DEVELOPMENT

The Human Machine Interface (HMI) for your operators allows your team to control your system and monitor production. It provides them with real-time information about your system and shows them how their interactions with your system affect your production. And your operators won’t just have data; they’ll have data they can use — real and actionable.

We understand how important it is for your operators to have effective situational awareness so we develop HMIs to be clear, thorough, and user-friendly.

CREATING USER-FRIENDLY HMI DESIGN

We design your HMI as a graphical representation of your automated system to meet your needs. Like many technologies, newer HMI methods can deliver measurable efficiency improvements and cost savings. We believe the best HMIs use technology to organize data around your goals and cater to the way your operators process information and make decisions.

Because your team needs data they can quickly process and do something with, we design our HMIs to provide them an understanding of both process details and bigger picture production trends. This efficient combination provides your operators the greatest possible situational awareness of your system.

When your team can easily see everything they need to know about your system, they can keep a beat on individual processes, ensure the smooth operation of your entire production operation and identify potential future needs.

With all kinds of production data available, we work with you to bring only the most important information into focus. We highlight the critical information, using contrast to differentiate various types of information, use repetition to highlight important operations, use consistent alignment to create visual connections between information and use proximity to group elements together. The result is a simple and understandable HMI that your team can maximize.


OUR HMI DEVELOPMENT PROCESS

To properly highlight the data that your team needs, we identify the relevant information your operators need.

First, we collaborate directly with you and them to understand precisely what information your operators require. We then pick the best software platform and features for your HMI platform; then work side-by-side with you to develop standards and guidelines. If we’re building on an existing platform, we can handle migrations of graphics to new systems to minimize operator re-training.


HMI SOFTWARE OPTIONS

We can use several HMI packages, depending on your needs. We routinely use FactoryTalk View, Wonderware InTouch, Wonderware Archestra or GE Fanuc’s Intellution. We are a Rockwell Automation Solution Partner and use FactoryTalk View as part of a PlantPAx solution. But we’re a fully independent integrator, and we’re not tied to any one platform.

REPORTING

Our reporting information is comprehensive and focused, providing you with data you can use. With our system in place, you and your team will be able to measure your system’s efficiency, consistency and performance over time. And if you’re in a regulated industry, our system uses certifiable electronic signatures, audit trails and batch records to help you meet FDA computer system validation requirements.

DATA TRACKING AND OEE REVIEW

Pick up any manufacturing business journal today, and you’ll see mentions of Overall Equipment Effectiveness; OEE. It’s constantly on the minds of plant managers. But what does it mean? OEE is a key performance indicator and there’s a good chance it can help your bottom line.

The OEE measure is based on four important metrics: loading, availability, performance and quality. OEE can help gauge the efficiency, productivity, and potential of your entire operation. If you have a mix of old and new equipment, equipment variety, documentation inconsistency, employee turnover and other factors odds are you have room for improvement.

At Malisko Engineering, we’re experienced in efficiency. We have a tenacious, multi-disciplined team of engineers, designers, programmers, automation and validation specialists with the know-how to help identify exactly how productive your equipment is and how productive it can become.


BATCH DATA TRACKING

Once your automation system has been designed, selected and coded, we can set up batch reports, where your system provides you a full summary of the key variables you need to measure each lot of product that you produce. Batch reports typically include process measurements at specific time intervals, batch start time, batch stop time, operator comments, recipe data, such as target and actual material additions to the batch, and other useful key performance indicators. You can use this important record to assess whether or not your process is staying within spec and if your system produces batches of product within spec.


TRENDING DATA TRACKING

While our batch reports deliver you actionable information from individual batches, it’s useful to have a measuring stick for those reports. That’s why the systems we implement can provide you trending reports that show your system performance over time. It collects process data over time at defined intervals and stores that data in a database. With this historical data in hand, your team can perform statistical process analysis to determine whether or not your process is in control.

We design and implement your system with the absolute highest quality, and we can provide 24/7 technical support for your system. If and when process irregularities arise, you’ll know why, and you’ll know early enough to correct them before they become major problems.


ALARMING & ALARM MANAGEMENT

To further protect your system and production, we set up top-quality alarm reporting that increases operator response effectiveness. And we drastically reduce nuisance alarms that sap operator time, by setting alarm limits and priorities so your operators can react to alarm deviations before they lead to more substantial and potentially devastating process issues.

In addition to standard, real-time alarming, we develop alarming reports that show just about everything your team needs to know about your alarms. From alarm types and alarm frequencies to alarm timestamps, allotted alarm response time and everything in between — we can provide it all.


DOWNTIME DATA TRACKING

Without an automated system or even with an outdated automated system, you’re left with either paper records or no records. If you use paper records, your operator has to actively and accurately record each downtime, the length of that downtime and the reasons for it. Implementing our reporting system, you can automatically capture when your process or machine is not functioning. And your system will either automatically record a reason for the downtime or prompt your operator to do so.

After the downtime event, you’ll be able to access that information from a database so if your process or machine isn’t working, you’ll know and if it’s not running at optimal capacity, you’ll know why.


MEETING FDA COMPLIANCE

We ensure that our systems comply with FDA Title 21 CFR Part 11 regulations and can provide you with the computer system validation (CSV) documentation to meet regulatory compliance.


PRE-DEPLOYMENT TESTING ASSURES DATA ACCURACY

Reporting data provides you with what you need to better understand your operation, both in the short-term and over time. And it can catch issues that arise before they cause process or machine problems. Furthermore, before we implement your system, we conduct thorough system integration testing in a controlled environment.

SYSTEM INTEGRATION TESTING & SIMULATION

At Malisko Engineering, we solve problems. And we solve them efficiently. But we believe in the age-old adage: measure twice, cut once. That’s why we test every detail of your system in an on-site controlled environment before we ever run any batches allowing us to minimize on-site changes and save you start-up time and resources.

SIMULATION DEVELOPMENT

To perform system integration testing, we develop a low or medium-fidelity process simulation. The simulation is a model-based representation of the various units within your process, and at a minimum, it includes basic mass and energy balances. We then use the simulation for code testing. We typically use MiMiC® to develop the simulation environments.


INTERNAL TESTING

Before you see the final system, we thoroughly test each software component to verify that the control works correctly in your system.


FACTORY ACCEPTANCE TEST (FAT)

Once we’ve performed simulation testing and internal testing, we begin the Factory Acceptance Testing process. Here’s where we collaborate directly with you and your stakeholders to test your system and ensure that it works seamlessly for you. The FAT flushes out any system changes so your system will be ready for efficient on-site startup and process commissioning. Once we’ve completed this rigorous testing, we consider the system “Accepted,” and ready for installation.

ON-SITE PROCESS COMMISSIONING

Once we begin process automation commissioning, we will have already performed an automation solutions site assessment, gained an understanding of your plant, team, and goals, designed your system, chosen solutions and performed all programming configuration. Now, it’s time to take your automated production system and integrate it on-site at your facility.

FIELD DEVICE CHECKOUT AND TROUBLESHOOTING

Up to this point, all code and HMI screens have been checked in a simulated environment. The first step we do on-site after power-up is check your field devices and verify that the inputs and outputs to and from your devices work as they should. Our checkout methodology runs end-to-end; meaning we physically and visually verify device operation in the field and at the HMI screen. When a device doesn’t work or shows a discrepancy between HMI and field, we work with your electrical, maintenance, and instrumentation technicians to find root cause. We’ve designed and built your system meticulously, and we commission it on-site with the same care.Up to this point, all code and HMI screens have been checked in a simulated environment. The first step we do on-site after power-up is check your field devices and verify that the inputs and outputs to and from your devices work as they should. Our checkout methodology runs end-to-end; meaning we physically and visually verify device operation in the field and at the HMI screen. When a device doesn’t work or shows a discrepancy between HMI and field, we work with your electrical, maintenance, and instrumentation technicians to find root cause. We’ve designed and built your system meticulously, and we commission it on-site with the same care.


24/7 ON-SITE SUPPORT

When you work with us at Malisko Engineering, you don’t just get an automation system. You get a team of committed experts who become an extension of your team. After system commissioning, we can provide 24/7, on-site support for your system. We work side-by-side with your operators, and technical support team to ensure the system does what we said it would do. We also understand how important it is to get your manufacturing line producing as quickly as possible. That’s why we finish the jobs on time.


ON-THE-JOB OPERATOR AND ENGINEER TRAINING

During the commissioning process, we’re there with your team as they begin to operate your system. Whether or not you request formal training from our team, we work with your team, right in the control room or out on the floor whenever possible.

When your process first starts up on a new Malisko system, we guide your operators until they get comfortable running it without our support. We let them ‘drive’ while we supervise and are there in case any issues come up. Our goal is to empower your in-house staff to be confident in the control of your operation.


ON-GOING SUPPORT

Once we’ve finished commissioning your system, it’s up and running. At this stage, we’ve performed a site assessment, provided you with a Front End Engineering Design, Detailed Engineering and Design, and integrated your system. But even when your system is fully operational, we don’t just leave you hanging. We can provide you the post-project technical support you need to confidently operate and maintain your system.

COMPUTER SYSTEM VALIDATION DOCUMENTATION

Our documentation services are a crucial step in validating your manufacturing automation systems and reducing those risks. Through validation documentation, we meticulously document how your system works under normal, upset and recovery conditions, list functional requirements, provide detailed design documentation, help you generate relevant standard operating procedures and create execution protocols. This highly detailed process mitigates risks and greatly enhances your compliance with regulatory requirements.

VALIDATION MASTER PLAN

We start our documentation process by creating a Validation Master Plan (VMP) that guides every aspect of the validation process. The VMP defines your facility’s areas and systems that will be validated and provides a written roadmap for your facility to achieve and maintain validation. The VMP will include computer system validation, facility and utility qualification and validation, stakeholders and participants, equipment identification and summary of documents. This document shows auditors and inspectors a well-planned validation strategy with logical reasoning based on a risk assessment.


FUNCTIONAL REQUIREMENTS SPECIFICATION (FRS) DEFINITION

When you work with us at Malisko Engineering, you don’t just get an automation system. You get a team of committed experts who become an extension of your team. After system commissioning, we can provide 24/7, on-site support for your system. We work side-by-side with your operators, and technical support team to ensure the system does what we said it would do. We also understand how important it is to get your manufacturing line producing as quickly as possible. That’s why we finish the jobs on time.


ON-THE-JOB OPERATOR AND ENGINEER TRAINING

When we define the functional requirements of your system, we document what your process control system should do and specify its required behavior. We provide you, your team and auditors with a comprehensive written description of your system’s operation and planned performance. The FRS becomes one of the foundational pieces we use to create an operational protocol necessary to validate your process operation.

Detailed Design Specification The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies the how each system component is to be configured as well as how each component factors into making a completed automation system.


DETAILED DESIGN SPECIFICATION

The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies how each system component is to be configured as well as how each component factors into making a completed automation system.


TEST PLAN

The Test Plan specifies precisely how we perform off-site system integration testing and on-site validation testing on your hardware, software and networking components after completing code development and then after completing on-site process commissioning and system installation. Before your system handles any live runs, we test it in both a simulated environment and on-site at your facility. Through rigorous testing, we reduce your operational risks, and make validation protocol execution much smoother and more efficient.


TRACEABILITY MATRIX

In the Traceability Matrix, we define the relationship between the Requirements Specification Documents, Design and Functional Documents, and Validation Protocol Test Scripts. We use the Traceability Matrix to ensure that system validation addresses all requirements, specifications, and functions that were noted in the system specifications. The Traceability Matrix provides you evidence and a documented cross-reference to show that your automation system meets the stated requirements and specifications.


GENERATE STANDARD OPERATING PROCEDURES (SOPs)

SOPs relating to a validated manufacturing automation system are essential for the proper sustainability of the system throughout its life cycle. Topics covered by SOPs include document storage, change control, disaster recovery, training, audit trail, system updates, periodic reviews and system retirement.

With proper SOPs, you have repeatable, unchanged processes, procedures, and documentation that allow you to identify the causes and effects of any system issues through ongoing system performance tracking. We don’t just meet regulations. We help you use SOPs to stay compliant with regulatory regulations while keeping your production at maximum efficiency and achieve uniformity throughout your production process.


GENERATE INSTALLATION QUALIFICATION PROTOCOLS

The Installation Qualification (IQ) verifies the proper installation and configuration of your system. Your IQ ensures that necessary software modules have been loaded, equipment has been installed, configured and calibrated, the necessary procedures have been approved, and the appropriate personnel have received the appropriate training. The IQ follows the installation requirements that we define in the Detail Design Specification. IQ must be performed before completing the Operational Qualification or Performance Qualification. Through the IQ, we validate the installation and configuration of your system and keep you in compliance.


GENERATE OPERATIONAL QUALIFICATION PROTOCOLS

The Operational Qualification (OQ) is a collection of test scripts we use to verify that your system functions properly under normal, stress, upset, recovery and abort conditions. Through the OQ, we validate that your system will work and make it straightforward for auditors and inspectors to verify your system’s repeatable operation as designed through documented evidence. We perform the OQ before the system is released for production use.

EXECUTED VALIDATION PROTOCOLS

Through CSV documentation, we set you on the right course to ensure your system complies with FDA regulations. When we integrate your system, we also document every step of our work consistent with CSV. If you prefer to have your in-house team document and execute validation protocols, we can be right there with you, supporting your team to ensure a thorough and accurate validation. When your system is in place, we can help you place your automation system in full compliance with FDA regulations.

PERFORM PROTOCOL EXECUTION

To validate your automation system, you are required to execute protocols for Installation Qualification (IQ), Operational Qualification (OQ) and, potentially, Performance Qualification (PQ). When we execute the IQ, OQ, and PQ, we go through every document and execute the test scripts while following the test plan to validate every portion of your automation system. We ensure that your system is completely tested, that you have documented evidence of the tests and that the CSV meets regulatory standards.


PERFORM VALIDATION SUPPORT

In some instances, we find that our customers employ a validation staff who are responsible for CSV within their facilities. We know how to support that sta. If your compliance team creates and executes the validation documents, we’re there to help assist them in any manner they need. Whether it’s our team or your team executing the protocols, we assist to assure that your system is thoroughly and accurately validated.


RETROSPECTIVE VALIDATION

We can perform a gap analysis followed by a retrospective validation for existing manufacturing automation systems that are already in operation but might not meet current FDA regulations for CSV. We might be able to use existing system documentation as a starting point for creating the other needed CSV documents. When we perform a retrospective validation we are very conscience of being fiscally responsible while helping you bring your automation system up to current regulatory compliance.


21 CFR PART 11 COMPLIANCE AND VALIDATION

Manufacturing automation systems that store data used to assess product quality and/or product integrity decisions within a facility under FDA compliance must meet Title 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures. To comply with CFR Part 11, you need CSV documentation that clearly defines system operations and maintenance for unadulterated data integrity, data access and storage, physical and system security as well as audit trails and traceability.

At Malisko Engineering, we have the experience to help you create and execute a CSV plan that produces a comprehensive set of documented evidence demonstrating that your system meets 21 CFR Part 11.


GENERATE SUMMARY REPORTS

Validation Summary Reports provide an overview of your entire validation process. These reports include a description of your validation approach, a test definition, a record of tests, test results, test deviations and resolutions of those deviations, and a summary statement declaring that your system meets the defined requirements.

Once the system owner and other stakeholders identified in the Validation Master Plan review and sign the summary report, your validation project is complete. The finished package of validation documents is a CSV portfolio where we align every document to fit together so that the methods, details, execution steps and results flow in a logical fashion. Once our validation project is complete, you’ll have all validation packages stored according to your site document control procedures.

ELECTRONIC RECORDS

For manufacturers operating in FDA-regulated industries, such as life sciences and pharmaceutical, Title 21 CFR Part 11 mandates the requirements of automation systems for electronic records and electronic signatures. We have implemented numerous automated production systems over the years meeting Part 11 and can help you with completing your journey to Part 11 compliance of your manufacturing automation systems.

WHAT PART 11 REQUIRES

Title 21 CFR Part 11 places data integrity, security and audit trail requirements on open and closed systems. A closed system is an environment where system access is controlled by the persons responsible for the content of electronic records on the system. An open system is an environment where it’s not. Most computer-based Control, Data Acquisition and Reporting Systems used in manufacturing are closed systems.

Unsure about CFR Part 11 Requirements and Guidance? Download them now.

HOW WE SUCCESSFULLY ENSURE FULL COMPLIANCE

We leverage our extensive experience and automation expertise to ensure that your system meets Part 11 requirements for:

 
We provide related SCV documentation. When we complete our work, you have a system that complies with.

HOW WE MEET SECURITY REQUIREMENTS

REQUIREMENT: Employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records.
   
SOLUTION: We develop Standard Operating Procedures (SOPs) to support the use of electronic records in the regulated environment. We validate the procedures and system. The validation follows an established System Life Cycle (SLC) methodology; such as GAMP V (ISPE).

REQUIREMENT: Limit system access to authorized individuals only.
   
SOLUTION: We specify limited physical access to the servers and data storage devices. We also specify robust Windows Security. We ensure user account policies implement password aging, minimum password length, password uniqueness, and account lockout after a reasonable number (typically 5) of unsuccessful login attempts. And we configure each Operator Node to use ‘User Login’ Timeout.

HOW WE MEET COMPLIANCE FOR ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

REQUIREMENT: Generate accurate and complete copies of records in both human-readable and electronic format. Protect records to enable their accurate and are ready-retrieval throughout the records retention period.
   
SOLUTION: We help develop SOPs to ensure that records are securely retained for an appropriate duration of time.

REQUIREMENT: Implement secure, computer-generated, time-stamped audit trails.
   
SOLUTION: We specify Microsoft Windows Clock Synchronization among all computers and servers in the application.

REQUIREMENT: Ensure that signed Electronic Records (ER) contain the following:

  • Printed name of the signer
  • Date and time when the signature was executed
  • Meaning of signature – i.e. review, approval, responsibility, authorship. Ensure these requirements also apply to ANY human-readable form of the ER – both the hard-copy printout and electronic display.
   
SOLUTION: We make sure the audit trails includes:

  • Date and time stamp
  • Node of origination
  • Operator's User Name
  • Action Taken
  • What Parameter (Tag Name) Acted Upon
  • Message Type

REQUIREMENT: Ensure Electronic Signatures (ES) and Hand-Written Signatures executed to ERs are linked to their respective ERs in such a way as to ensure that signatures cannot be excised, copied, or otherwise transferred to falsify an ER by ordinary means
   
SOLUTION: We help develop SOPs to prevent unauthorized access to the Relational Database containing the Audit Trail File. We also validate the procedures and system.

HOW WE MEET COMPLIANCE FOR STANDARD OPERATING PROCEDURES (SOPs)

REQUIREMENT: Establish and adhere to written policies that hold individuals accountable and responsible for actions initiated under their ESs to deter record and signature falsification.
   
SOLUTION: We help develop SOPs to support the use of ERs and ESs in your Regulated Environment. And we validate the policies and system.

REQUIREMENT: Establish and adhere to written policies that:

  • Maintain the uniqueness of each combined identification code and password
  • Periodically check, recall, or revise ID code and password issuances
  • Follow loss management procedures to electronically deauthorize stolen, missing, or compromised tokens, cards, or other devices
  • Use transaction safeguards to prevent unauthorized use of IDs and PWs Conduct initial and periodic device testing
   
SOLUTION: We employ one of two possible scenarios. Use current, robust SOPs already in place via our clients’ IT/IM departments; or develop new SOPs to control and properly maintain the identification names and passwords of individuals. And we validate the policies and systems with Qualification protocols.

HOW WE MEET COMPLIANCE FOR SYSTEM INTEGRITY AND TRACEABILITY

REQUIREMENT: Use operational system checks to enforce permitted sequencing of steps and events.
   
SOLUTION: We typically recommend logging all Parameter (Recipe) downloads, sequence events, and operator actions in a secure SQL database.

REQUIREMENT: Use device checks to determine the validity and integrity of the source of data input or operation instructions.
   
SOLUTION: We verify sources of data input, such as operator stations (thin clients) as part of the validation process, restrict access to program code only by authorized technical support personnel, and deploy recipe/formula/operational procedures to a secure server computer environment.

REQUIREMENT: Ensure revision and change control procedures to maintain an audit trail that documents time-sequenced developments and modifications of system documentation.
   
SOLUTION: We typically cover this requirement with the IQ and OQ Validation Protocols, Change Control procedures and existing IT/IM and Compliance SOPs.

HOW WE MEET VALIDATION & DOCUMENTATION COMPLIANCE

REQUIREMENT: Validate the system to ensure the accuracy, reliability, and consistency of intended performance while providing the ability to discern invalid or altered records.
   
SOLUTION: We develop and execute IQ and OQ Validation Protocols creating documented evidence of compliance with Title 21 CFR Part 11.

REQUIREMENT: Ensure adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
   
SOLUTION: We help align SOPs to cover this requirement.

MORE ABOUT OUR COMPLIANCE METHODS

Our Validation efforts help ensure you establish and adhere to qualification criteria for persons who develop, maintain or use the ER/ES system and ensure teams have education, training, and experience to perform their assigned tasks.

We help ensure that your closed computer systems have a collection of technological and procedural controls to protect data within your system. We help make sure that safeguards are in place so your electronic records are authentic, incorruptible, and confidential.

We provide accurate record generation so that records entered into the system are completely retrievable without unexpected alteration or unrecorded changes. We test this during validation by verifying that records entered into your system are accurately displayed and accurately exported from your system with no adulteration.

And we provide the related validation documentation that you need as evidence that your manufacturing automation system meets Part 11 compliance.

POST-COMMISSIONING TECHNICAL SUPPORT

If you require it, we can provide you a comprehensive, post-commissioning support service. Because we have comprehensive automation expertise and a large automation support team, we can help ensure that your system operates at a high and achievable efficiency. And that’s why we’re here. When you invest in automation, you invest in the goal of maximum production output from your plant. And if you need our technical support to help with your investment in automation, we’re there.

SPARES, DRAWING UPDATES, PATCH MANAGEMENT, AND MORE

When necessary, our team of automation specialists stand ready to walk you through a comprehensive, post-commissioning support service. Through these processes, we check to see if your system is operating at full efficiency. Our post-commissioning process includes spare parts management, ongoing document updates, system monitoring and critical software patch deployment. We understand that your technical support staff has to keep the plant running 24×7; and we can be available to augment that team when their attention is diverted elsewhere and timely response is critical. A post-commissioning support plan can be crucial to the long-term sustainability of your automation system.

Our post-commissioning support service can include numerous areas of focus, such as:

  • Spare Parts Management
  • Equipment life-cycle refresh planning
  • Controller firmware update management
  • Software and operating system patch management
  • Remote server system health monitoring
  • Remote network communications health monitoring
  • Virtual machine backup management and disaster recovery planning
  • End-point health checks
  • Database backups and maintenance
  • Ongoing CAD drawing services for system updates
  • Ongoing SOP document maintenance and updates
  • Network and Security documentation management
  • Periodic Computer System Validation (CSV) reviews to maintain FDA regulatory compliance

 
Whether done by us or your staff, we can be there to assist and facilitate.


24/7 ON-SITE SUPPORT

When you work with us at Malisko Engineering, you don’t just get an automation system. You get a team of committed experts who become an extension of your team. After system commissioning, we can provide 24/7, on-site support for your system. We work side-by-side with your operators, and technical support team to ensure the system does what we said it would do. We also understand how important it is to get your manufacturing line producing as quickly as possible. That’s why we finish the jobs on time.


SYSTEM MAINTENANCE AND SPARE PARTS

After working with us, you will find that our team delivers methods based on best practices, industry standards and vendor recommendations to ensure “right first time” system deployments. Our post-commissioning support structure also allows us to help you as your needs adapt, change and increase. 90% of our business is repeat, which we believe is a testament to long-term customer satisfaction and our commitment to helping clients with their long-term success.

When you have thousands of systems integrators to choose from, we know it can be daunting to find a partner who is like-minded and someone you can trust. Time and time again, we have delivered results to address our customers’ problems, challenges and opportunities. We become that trusted partner. We take pride in that. We are your Allies in Intelligent Automation.

REMOTE SUPPORT

We can provide a post-project support program to supplement your automation support team. Our programs are cost efficient and effective. We’ll set up secure remote access following Cisco- Validated Security guidelines. We utilize Virtual Private Network (VPN) technology using encrypted communications allowing us to remotely connect to your system when needs arise. There is always someone at Malisko Engineering available to provide support. With our skilled use of today’s technology, we can securely access your system and provide real-time support when you request it.

SETTING UP REMOTE ACCESS

Just as we take care in providing robust security and access between your enterprise and manufacturing networks, the same principles apply when connecting from outside the plant. We use next generation firewalls with VPN technology to provide authentication, authorization, and accounting. We utilize Cisco’s intrusion prevention system (IPS) threat detection, advanced malware protection (AMP), and URL filtering. We streamline remote access user management through integration with the plant’s Microsoft Active Directory. Through this advanced remote access integration, it is almost as if our staff is sitting right by your side.


REMOTE SUPPORT LENDING TO IMPROVED EFFICIENCY

In automation, efficiency and timeliness are critical. Having worked with the design and implementation of numerous systems, our team of qualified automation specialists know that automation is only worth its weight when backed by effective support mechanisms. Delays in getting timely support can quickly snowball into a sizeable lost opportunity for production at your company. Let us continue to focus on your behalf on your automation systems so your team can focus on making good product and achieving good KPI’s (Key Performance Indicators).