MANUFACTURING

Formula Management Scales Up Process Manufacturing

Formula Management Scales Up Process Manufacturing

Formula Management Scales Up Process Manufacturing 2400 900 Xcelpros Team

Introduction

Formulas are at the core of process manufacturing and managing them is a critical function in the product development cycle. However, we see manufacturers show little effort in how they store and access their formulas, often keeping them siloed. However, today’s connected world makes sharing information across business units critical.

Seldom are formulas managed with any regularity. We find them in manual logs or at best, Microsoft Excel files. Companies spend years perfecting a single formula, ensuring it is scalable and able to maintain consistent quality across all batches and then restrict access to it.

At Xcelpros, we help our clients modernize their formula management. Keeping these formulas updated and secure from prying competitors results in higher productivity. That translates into a stronger bottom line.

Enterprise Resource Planning (ERP) software such as Microsoft System Dynamics has the ability to manage formulas. An ERP brings consistency, product scalability and improved efficiency to formulas while achieving better compliance scores.

Formula management (FM) includes the ability to optimize formulas. It also creates and manages workflows, creates formula variants, manages labeling content, plans inventory for scaling up production and validates the formulas to meet regulatory requirements.

An essential part of electronic batch processing, FM helps modernize the product development process. The resulting efficiency increase results in shorter times to market.

Automating formulas ensures consistent products. It removes manual calculations of ingredients, their properties and costs, thereby removing a source of error.

This process also causes better regulatory compliance. It reduces the chances of recalls, rejections and fines. Each of these actions costs your firm money while negatively impacting brand value.

The Downstream Impact of Formula Management

As discussed above, formula management is at the core of process manufacturing. Using the chemical industry as an example, formulas are at the center of each company’s assets. The research and development (R&D) section likely has an “n number” of formulas and variations. When each formula is processed, it delivers a unique product. Having related formulas scattered across multiple locations increases the compliance hazard, reducing efficiency.

An integrated FM system gives top executives control of:

  • Transparency in terms of cost – An integrated business application such as an ERP includes ways to control formulas. The software also shows costs associated with the manufacturing process. ERPs give you a holistic picture. They provide the downstream impact of a formula from raw materials procurement to setting end product pricing.
  • Visibility of formula properties – ERPs let you analyze the change in physical properties of key ingredients in real-time. For example, you can vary the quantity or substitute one raw material for another. Making these changes in the ERP lets you see the impact on areas such as the nutritional value of products.
  • Authentication and formula protection – This security feature helps an organization define access rights to each formula. It allows you to limit modification rights to a select few while giving master control to the administrator. The administrator can reverse any changes to the formula.

Your business deserves the power of a unified system for formula management.

ERPs are the Way Ahead

ERPs provide an effective solution with the ability to unify production processes with research and development formulation in a common, secure platform. ERP systems can transform the way formulas are managed by players in industries such as chemical, pharmaceutical, food & beverages, etc.

Keeping formulas confidential is critical for every manufacturer in every industry. Managing formulas efficiently can be a competitive advantage, especially when a company is growing.

Instead of making FM a daunting task, using an ERP ensures your manufacturing processes are standardized across your production units regardless of their location.

ERPs are Transformational

Modern businesses generate gigabytes of data every single day. That number continues to increase as handheld devices and connected systems add to it. ERP software is designed to handle massive volumes of data. It generates insights letting top executives gain deeper understanding of core business functions. Using an ERP, top leaders can see the data behind critical decisions.

Looking at batch processing, which includes FM, leaders have a centralized information source covering all products that being processed, manufactured or stored. Having access to this data in one spot lets leaders generate important business insights.

Batch size, quality, quantity and components are essential items captured by ERPs. The system allows organizations to set security controls ensuring only authorized personnel can access the firm’s trade secrets and formulas. The ERP also maintains a version history of all changes made to the formula, letting authorized people go back to a previous version in case of unauthorized access.

Connecting Silos

In many businesses, data is captured and stored in stand-alone “silos.” A problem with this approach is its inability to share data. This is especially true when data from multiple business functions is captured in different systems.

Siloed data is not easily accessible from systems outside that area. It doesn’t give key executives enough variables to make informed decisions. The silo approach causes inefficiencies and lower returns on investments from technology assets.

Today is the age of connected business ecosystems, not stand-alone silos. Collaboration is the key to efficiency, transparency and easier operations. Sharing data means quicker and informed decision making, all of which eventually leads to success. Only an ERP can break the silo walls, connecting your data to provide a complete 360-degree view of your production process.

A connected system helps you calculate formulas and break down the costs of each product, percolating down to provide improved competitive and operational advantages.

ERP Software Systems and Formula Management

Some areas where ERPs are instrumental in formula management include:

  • Versioning formulas
  • Scaling formulas to create larger batches
  • Determining and establishing coproducts or byproducts
  • Categorizing active ingredient formulas by
    • Weight
    • Percentage
    • Operations related to ingredient consumption
    • Approvers
    • Batch sizes

Figure: 1ERP Software For Process Manufacturing

ERP Software For Process Manufacturing

Versioning Formulas for Compliance

Process manufacturers are continually updating and improving their formulas. Updates are driven by changing industry trends, customer demand and most importantly, ever-changing regulations.

Keeping up with rule changes is a constant task, especially for companies with multinational manufacturing and distribution operations. They must be compliant with the laws in each country where they operate.

Compliance impacts formulas directly, making keeping different versions a “must have” feature. For example, formaldehyde is a chemical agent dangerous to humans at levels of 100 parts per million. It is banned for use in cosmetics across the European Union but is found in hair-straightening products and nail polish in the US. Atrazine is used as an herbicide in the US, but was banned in the EU since 2003 over concerns of it polluting water bodies.

Differing regulations requiring different formulas—even with minor alterations—can be intimidating. Formulas must be managed properly to meet the regulations in each country or region.

Scaling Formulas for Consistency

Another formula function ERPs automate is scaling. When a customer changes its order size, the quantity of raw materials varies. Formulas do not.

To the uniformed, the impression of an ERP at a manufacturing location is like taking a widget, adding some gadgets plus a few man hours and presto, you have a finished product. This is at best oversimplification and at worst a mathematically challenging extrapolation.

Why is scalability a challenge? Consider a scenario where you are preparing soup for a family of four. Something happens. Now you need to make soup for your neighborhood, maybe your city or even your county. Most people realize your raw materials will increase as you add people, but what about making your soup look and taste the same or ensuring your serving quantity is right?

To accomplish all of this requires software that can scale production while maintaining consistency in product composition. An ERP solution such as Microsoft Dynamics 365 for Finance and Operation can help categorize all your formulas based on parameters such as: weight, percentage, ingredients, production size, approvers, etc. Top executives have complete control of their manufacturing operations regardless of how many customers one product serves.

Creating New Efficiencies

In addition to providing consistent products regardless of batch size or manufacturing location, ERPs can help manage your formulas to create new levels of efficiency by:

  • Ensuring changes made to a formula have real-time implications to raw material procurement, production, inventory management and planning.
  • Scaling formulas regardless of production size.
  • Adjusting user fields to suit current requirements and configurations.
  • Keeping tabs on production costs such as raw materials, labor and other variables based on changes to your formula.

Conclusion

Most chemical manufacturers have a legal pre-defined volume to weight ratio for using certain ingredients. The process becomes more complex when using multiple measurement units of such as dry and wet volumes. Adding to the complexity are when different measuring systems are used, such as imperial in the US compared to metric elsewhere. The complexity increases when adding storage temperature or acidity of the ingredients into the mix. How will a particular chemical or ingredient react when it comes in proximity or contact with another agent? Will it lose effectiveness at a specific temperature?

An ERP’s formula management function allows companies to automate the production process. The integration process also means firms can publish relevant labels. These labels are pasted on the products providing required information.

Using FM in an ERP lets companies concentrate on the business of selling products. They can avoid the costs and headaches caused by an inefficient formula management process. Powered by a self-sustained connected ecosystem hosting a universe of business applications, Microsoft Dynamics 365 offers a secure and holistic formula management suite. Dynamics 365 ensures your formulas are secure, scalable, compliant and most importantly, strategically placed to elevate your organization to the next level of efficiency.

Scale up your manufacturing process with formula management, book a free consultation with our expert to learn more.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Mobile Devices, WMS Work Together to boost manufacturing efficiency

How Mobile Devices & WMS Work Together to Boost Manufacturing Efficiency

How Mobile Devices & WMS Work Together to Boost Manufacturing Efficiency 2400 900 Xcelpros Team

Introduction

Using cellphones, tablet computers and other mobile devices in warehouses and on the factory floor gives executives another tool to improve manufacturing efficiency, especially in terms of inventory control. Mobile devices can:

  • Adapt to changing requirements
  • Track raw materials through the entire supply chain
  • Update data streams on a near real-time basis

Mobile devices like cell phones, tablets and other specialized devices, are becoming as common in the pharmaceutical industry as they are in our daily lives. Under the supervision of today’s chief financial officers (CFOs) and chief technical officers (CTOs), employees can use these devices to improve manufacturing supply chain efficiency, especially when it comes to inventory control.

Current handheld devices, ‘can provide full functionality and access to a company’s business systems without any sort of limitations’– Redwood Logistics

How do mobile devices help? By providing:

  • Increased productivity and responsiveness to customer requests by adapting on the fly to changing needs.
  • Regular Real-time data exchanges between workers and managers.
  • Geographic flexibility allows raw materials like active pharmaceutical ingredients and finished products to be stored closer to areas experiencing increased demand while moving materials from areas with decreased requirements.
  • Accurate location tracking on the road and inside a warehouse using smart devices’ built-in global positioning system (GPS) functions.
  • Reduced overhead through accurate, real-time, inventory tracking using barcode scanners to track everything from individual batches to large containers.
  • Reduced employee downtime.
  • Simplified training through consistent use of similar handheld devices and software that work regardless of the location. Employees working in Sudan and Southern California share the same devices and software.

Connected Mobile Devices vs. IIoT in Manufacturing

Mobile devices allow workers and managers to gather massive quantities of data but they lack one major function the industrial internet of things (IIoT) has: the ability to physically react to the information the sensors gather.

While mobile apps gather data, they can’t physically react to it. An employee needs to interpret that data and then react with the new information in mind. However, the IoT creates a proactive supply chain rather than a reactive one’ | Triskele Logistics

If, for example, a warehouse worker notices a critical active pharmaceutical ingredient (API) is at critical stocking levels, the worker must let a manager know, who then places an order for the product. An IIoT-equipped mixer, for example, may track the API storage level and place a reorder before the quantity drops to a critical level. Unlike with a mobile phone, human intervention is not required.

Mobile devices working with IIoT enabled machines permit the best of both situations: workers can remotely monitor machines and respond quickly when a problem occurs.

Using WMS with Mobile Devices

Some warehouse management software (WMS) works on mobile devices like phones and tablets, not just desktop and laptop computers. These systems help pharmaceutical manufacturers logically and effectively keep track of everything from raw materials to finished products, including the state of a given production run (e.g., finished).

When using the mobile app version of a WMS, warehouse workers can:

  • Print new barcodes and text labels and reprinting existing labels.
  • Start production orders and issue reports when a production process is finished.
  • Look up information on products stored elsewhere.
  • Perform one task that triggers a second. One example from Microsoft Dynamics 365 Warehouse Management System is receiving a purchase order that automatically generates a put-away order.
  • Perform a task triggered by a previous task, such as putting away the received materials listed on the purchase order.
  • Change batch disposition codes.
  • Transfer products from one location to another using the license plates.
  • View work available to specific users (requires a tablet).
  • Split work between two license plates when one is full.
  • Pick and pack items from a sales order into a single shipment.
  • Pick the oldest batches using configurable app software that can be set to Warn workers listing the oldest expiration dates or Force telling them there is an older batch to pick.

Using a Cell Phone or Tablet Camera

Warehouse workers need to input information into their mobile devices. Workers can painstakingly input product numbers into a keypad, risking problems when an error occurs, or they can scan barcode and QR codes.

Some firms prefer using dedicated handheld scanners. However, these devices may be restricted to proprietary WMS software that may offer limited functionality.

Cameras built into cellphones and tablets can be enabled for use as scanners. Users simply position the barcode within brackets on the screen and take a picture, automatically and accurately inputting the information into the portable device.

Improving Worker Efficiency With Barcodes and Scanners

A common scenario where mobile devices improve manufacturing efficiency is when a worker has a purchase order and receives several items with different quantities and warehouse locations. The worker scans the barcode. The mobile device, either cell phone or a tablet, tells them the quantity of each item and location where it goes, such as a warehouse section and bin number.

Depending on the WMS software configuration, the worker inputs the quantity and selects the measurement unit. They have the option of clicking ‘OK’ when everything matches up or clicking ‘Cancel’ when spotting a deviation.

Managers can also have the software configured to have workers confirm the required quantity is in the correct location. They have the option of confirming the purchase order or updating it to reflect a different quantity.

By the Numbers

Figure: 1Advantages of an Inventory Management System

 Advantages of inventory management system

The connected logistics market – an interdependent set of communication devices and the internet of things (IoT) permitting the sharing of data, information and facts with supply chain partners – was expected to grow by a factor of four from 2016 to 2021.

$10.04 billion – the connected logistics market in 2016.

$41.33 billion – the forecast connected logistics market in 2021.

32.7% the connected logistics market Compound Annual Growth Rate from 2016 – 2021.

Source: Markets and Markets Connected Logistics Market Report

Challenges to Using Mobile Devices

Off-the-shelf mobile devices used for supply chain management offer a host of potential benefits. They also come with some challenges. The main risks associated with them are:

  • Different designs: Cellphones are not designed with supply chain management (SCM) uses in mind.
  • Data Security: Data sent over the air using a wi-fi or Bluetooth connection is not as secure as when the data flow is done through a wired connection.
  • Durability: The majority of modern cell phones and tablets are not designed for the rugged, dangerous conditions of many factory floors.
  • Interoperability: Some smart devices may not be compatible with the company’s preferred WMS.
  • Obsolescence: Computer technology is constantly evolving. Today’s fastest device is tomorrow’s paperweight.
  • Cost: CFOs must budget for new devices and replacements for those damaged or destroyed in the course of business.

Summary

Cellphones and tablets are becoming increasingly popular tools alongside WMS on factory floors and in warehouses, offering businesses numerous benefits as the technology continues to mature. When combined with mobile versions of warehouse management software, these products:

  • Let workers stay on task and on target in terms of inventory control.
  • Provide workers guidance on picking the oldest items first.
  • Give managers an additional tool to improve manufacturing efficiency.

Take a step forward into digitizing your manufacturing inventory. Start your free trial.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

The Role of ERP in Improving Manufacturing Performance and ROI

How an ERP system can help improve Manufacturing performance?

How an ERP system can help improve Manufacturing performance? 1920 1080 Xcelpros Team

At a Glance

  • Installation and modernization of ERP software comes at a high cost for manufacturing companies, and they are rightfully looking for ways to maximize their manufacturing performance from these software investments.
  • Manufacturers must embrace the comprehensive ERP model and let their production line and their vendors work in tandem with the software to streamline processes.
  • ERP systems are no longer a part of the business backend- newer tools and applications like Cloud, Internet of Things (IoT), and Machine Learning are changing ERP systems’ face, affecting the overall ROI of technology spend.

The implications and benefits of using a comprehensive tool like ERP are well measured in advance by large and small/ medium scale manufacturing organizations. However, there are still ways with which ERP systems can be used to better the overall operational efficiency in manufacturing, streamline existing processes, and improve the production line. These ways with which a solution like ERP can become the catalyst in generating ROI are usually the difference-makers for the manufacturing sector.

Mid-size businesses’ adoption of ERP software will grow at a CAGR of 7.9% from 2014 to 2020.– alliedmarketresearch.com

As the investments in ERP keep pouring in, manufacturers find themselves looking to adapt and manipulate their current practices to reap the maximum benefits from these investments above. Let us look at these practices that will improve ROI with ERP in the manufacturing industry. But first, let us learn how the ROI is calculated when it comes to manufacturing ERP.

Figure 1:Factors that Decide the ROI of Manufacturing ERP

 

Calculating the ROI for ERP Manufacturing- A Comprehensive Look at the Benefits of Installing the ERP System

Every organization has specific short and long term goals in mind while installing an ERP system. So, while the ROI might be a relative concept for every manufacturer, certain common areas can help you decide as to exactly how beneficial can your ERP system be for your company:

  • Does the ERP system help you in streamlining the processes and improving overall production line efficiency?
  • Does it minimize human intervention and the cost spent on intensive labor for data management and analytics?
  • Does it help you in managing your purchases, procurements, and inventory better?
  • Does it help you get real-time visibility across the production line for improved communication and faster response time?
  • What other tangible benefits mainly in terms of cost savings and profit gains can you see after installing the ERP system?

Once you get answers to these questions, you can calculate the ROI for your ERP.

The Road to Better Manufacturing ROI: Improving Manufacturing Performance with ERP

01.Efficient Machine-to-Machine and Machine-to-Human Interaction

In the times of Cloud dominated software practices, everything is virtually connected. Manufacturers have a chance of enhancing their ecosystem where real-time connectivity between the workforce and machines is established efficiently. This will add transparency to the entire production line from the top floor to the shop floor; it will also help the skill base use smart manufacturing techniques to save both time and effort. Application of ERP software to adopt smart manufacturing techniques will help manufacturers avoid production delays, track material and equipment with better efficiency, and move faster. All of this will result in more significant revenue generation.

Figure 2:ERP in the Manufacturing Industry

 

02.Better Management of Inventory

Large-scale manufacturers can afford to hire a larger workforce to manage their inventories. Small and mid-scale businesses often suffer a loss due to glitches in inventory management and its usage. Even larger companies are looking for a centralized network that can keep track of all the raw material, incomings, outgoings, and maintenance schedules for their inventories. This is where a modernized, sturdy ERP system succeeds where older, legacy platforms fail. It allows companies to get real-time data on their personnel and material in the inventory, allowing them to better plan their management well ahead in time. Any manufacturing company- large or small- will vouch that a well-managed inventory is a must to avoid stock-outs and other related production delays. So a robust ERP system will help in improving ROI by assisting manufacturers to improve their inventory management.

03.Forming a Competent Skill Base

No advanced software or tool could provide a manufacturer with better ROI if their workforce is not fully acquainted and expert in using the said software or tool. Well, the ERP system is no exception to this rule. Especially with the modernization of many of the ERP systems and its integration with cutting-edge applications like Internet of Things (IoT), Machine Learning, Advanced Analytics, and Artificial Intelligence, it has become highly imperative for manufacturing companies to train their skill base in expertly using the ERP system to its fullest capability. This will not only ensure lesser glitches but also prove to be beneficial in long term profit gains.

These positive changes in your manufacturing ecosystem will not only help you gain maximum benefit from your ERP system, but it will also solidify your work standards and technical competencies in the long run.

Key Takeaways:

  • Modernization of ERP systems need not necessarily mean a costly affair for manufacturers if they utilize smart manufacturing techniques to improve their ERP ROI.
  • Large and small and medium-scale manufacturers need to look at ERP software as an integral part of their production line and get their workforce well-acquainted with all the details for a better profit model.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

PHARMACEUTICAL QUALITY CONTROL

Pharmaceutical Quality Control – Improving Methods & Systems

Pharmaceutical Quality Control – Improving Methods & Systems 1920 1080 Xcelpros Team

At a Glance

  • The definition of quality has evolved with changing business dynamics, particularly in regulated industries such as pharmaceutical, chemical, and food & beverage.
  • The Pharmaceutical & Drug industry witnessed a 168% increase in drug approval by the FDA in 2018 compared to 2016, testifying the growing quality adherence among manufacturers.
  • Compliance to quality guidelines is only getting more stringent with time. Pharmaceutical & Drug industry also saw high rejection (73) through 2018 including Recalls, Market Withdrawals, & Safety Alerts, highlighting the importance of quality standards set by the industry watchdog.
  • While quality is increasingly becoming an integral part of modern-manufacturing practices, our research revealed that some organizations continue to devalue the importance of quality to a mere afterthought.

Introduction

Quality plays a pivotal role in the success of a business and is no longer considered an impediment to a successful business. It’s often that the release of a product for shipment is delayed due to standards not being met, causing stress on the customer service reps working closely with Customers.

Saying yes to sub-standard ‘products to the market’, however, are catastrophic, with damages that could at times be irreparable. Companies that are embracing modern-day Quality Management are supporting technology initiatives. Successful businesses ensure that the right systems are in place to allow a product to pass all quality checks.

This article highlights a small section of Quality Management related to processes and systems. The intent is to help businesses understand how technology has evolved with the changing business landscape and how manufacturers (in any highly regulated industry) can leverage technology such as the One-Microsoft ecosystem to stay relevant, and ahead of competition. In this article we will discuss Quality Management holistically, and follow it up with the finer aspects of Quality Management in subsequent posts.

FIGURE 1 Classification of Quality Management

The Evolution of Quality Management

Quality management has evolved from being an afterthought to becoming a rigorous self-discipline that most modern-day manufacturing companies have taken onto themselves. What used to be quality control in the 1960s has evolved to become “total quality control” in its present form. The US FDA is tightening its norms to ensure higher quality standards, and companies are responding to such challenges by increasing their quality standards. The below timeline depicts how the definition of quality has evolved over time since the 70s.

FIGURE 2 The Evolving Definition of Quality Management

Process Improvements in Quality Control

Improvements always start by first understanding the issues that reside in a department. Following are some typical activities in the Quality control department of a Pharmaceutical company:

  • Manage Quality control tests
  • Manage Quality control specialists and their workload
  • Allocate and calibrate test instruments
  • Establish appropriate test methods
  • Document test specifications
  • Perform tests in the order of priority and
  • Accurately record test results.

Trending and analysis, as well as stability studies, would be a follow up of quality data that is captured for understanding the reliability of manufactured batches. This is just a quick and simplified view; in reality, all of the activities listed above have many details involved. Ensuring that all processes and procedures are handled with precision ultimately reflects on how well you are able to maintain the quality standards.

Processes in the Quality Department

A typical day in the life of a Quality control department could start with lab analysis and paper requests to perform quality tests on a sample batch size. At times it could be multiple batches for different products that are either produced in-house or received from 3rd party manufacturers. The Quality lab prepares test instruments for each test and accurately records the test results along with any digitally signs-off for each work order. If we were to take a quick view of what is involved in ‘getting it right’, our understanding of all essential requirements for an optimal quality process could change.

Use cases with digitization and automation have demonstrated a more than 65% reduction in deviations and over 90% faster closure times.” The Future of Quality Control, Pharma Manufacturing

It involves having all the SOPs opened up in front of you to perform a test with precision and not allowing any deviation in process unless the ‘method to deviate’ is clearly spelled out. It is challenging to hold the people in your department compliant to a process unless there is a stringent system in place. If the system is paper-based, you are adding laborious tasks with corrections and piled up paperwork. Every time an audit occurs, it would require digging through so many stacks of paper to bring out the right answers.

FIGURE 3: A Central Filing System to Manage Documents and Information

Quality Control Systems

Pharmaceutical companies that are implementing an electronic system need to decide how tightly the system has to be built. The process could add discomfort to users due to various systemic restrictions, or an uneasiness around user errors.

People could start feeling anxious about making mistakes, as every change would have a digital stamp tied back to the person modifying the data. It could also get a bit cumbersome to fix errors in retrospect while using a controlled and validated system that is 21 CFR part 11 compliant.

The idea is not to add discomfort but to build the right kind of habits in users. Ideally business users need to be given enough information about how the overall system works. A well-planned training plan can help the users move from discomfort to being champions – promoting the process in the organization.

Anyone with a basic understanding of compliance would prefer an electronic system instead of a paper-based process, for the strength and ability to capture data as is. It then requires a change in mindset of ‘ continuously fix errors’ to ‘proactively do it right in the first place’. At the end of the day you want to foster efficiency in your whole organization. This can be achieved by evaluating a reliable process that could be quickly adapted by your department.

Elimination of up to 80% of manual documentation work will improve productivity. The Future of Quality Control, Pharma Manufacturing

Quality Management Challenges – What Does a Plant Manager Look for?

A Plant Manager would have a specific view of the business as their purview is not restricted to one department but to the overall operations of the plant. Some key concerns that typically need to be addressed by a Plant Manager or a General Manager of Plant are:

  • Quality Management
  • Compliance with evolving regulatory standards
    • Take control of your Documentation such as COA
  • Safety
    • Corrective and Preventative Actions management (CAPA)
    • Location directives
    • Raise flags when two reactive chemicals are placed in proximity
  • User Adaptability and training to conform to the new Quality standards

These concerns are typically addressed by:

  • Efficient Document Management – allows you to centralize documents into a secure repository that is seamlessly accessible. This ensures quicker decision making and effective change management. It also helps in ensuring visibility of your documents, enhances traceability by tracking amendments, and document safety with revision control features.
  • Addressing Non conformance – can be done through a unified platform to log non conformance, quality of incoming raw materials, complaints, delay, etc. This helps in addressing compliance at an early stage, paving the way for course correction and registering the same in the system.
  • Corrective & Preventive Action – a method with advanced analytical features built in to help you learn and unlearn from records of the past. As discussed, registering a non-conformance incident into the system initiates a workflow for corrective measures. This system learns from past incidents and recommends preventive action to control similar incidents from recurrence.
  • Implementing the right kind of tools and technology can help with Process automation and reduce data entry errors along with tracking process efficiency.

Identifying the right system to help make the most impact will be the first essential step to move in the right direction. Once that hurdle is crossed, it is important to build a ‘to be’ mindset instead of worrying why the system doesn’t do what your workforce is used to doing. Evaluate how stringent you want your process to be, based on your company’s needs and accommodate a well-defined method that is native to the application.

Key Takeaways

  • Quality management is no longer an afterthought and has evolved to become a discipline in most prosperous manufacturing organizations. Quality management which was once considered as a business function that hindered speed to market and product launch, is now embracing modern technologies to fuel innovation, bring in efficiency, eliminate the scope of incidents within a plant, and offer better predictions for the future.
  • Pharmaceutical companies that have evolved to modern, automated quality control systems are able to empower their workforce to rapidly adopt process improvements and optimize all the functions in the department.
  • The adoption of better tools in one department typically sets the standard for the entire ecosystem, including functions such as regulatory compliance, procurement, demand management, research & development, inventory and warehouse management, etc.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

how manufacturing companies are pivoting operations

The new world reality post Covid 19 – How manufacturing companies are pivoting operations?

The new world reality post Covid 19 – How manufacturing companies are pivoting operations? 1920 1080 Xcelpros Team

Introduction

Process Manufacturing companies are adapting to the sudden changes in the economic landscape due to COVID-19. Dependency on China for raw material and supplies has hindered the local US market forcing manufacturing companies to pivot operations and meet consumer needs. Starting late January, China’s industrial production came to a standstill as companies suspended their operations completely amid the lockdown. Though China is getting back on its feet now, the whole world had to take its heat as the event disrupted the global supply chain massively. In 2020, China contributes nearly 20% to the global GDP. You can now imagine the losses businesses will suffer all over the world and how long it will take to recover and ramp up operations fully.

A survey by the German company Kloepfel Consulting states that every third company has Chinese customers in a higher number, and on top of it nearly 81% of them are dependent on Chinese suppliers to run their operations.

From the above facts it can be anticipated that a major supply chain restructuring is coming on your way. Now, more than ever, integrated technology is imperative to streamline and automate the lines of business, people and processes.

FIGURE 1 Industry-wise Projected Covid-19 Impact from Minor to Severe

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1=Minor impact

2=Moderate

3=Significant

4=Major

5=Severe

Source : Statista

What is the new world reality in manufacturing?

The World Health Organization (WHO) has declared COVID-19 a public health emergency which led to a seismic shift in the life of manufacturing and distribution companies. The industry is now experiencing a new reality in running operations while they continue to produce finished goods to meet customer demand. Of course, remote tools and collaboration softwares are helping certain departments within these companies to manage work remotely. However, full quarantine is not a viable alternative for certain sections of the industry that require an actively engaged workforce in manufacturing and supply chain operations.

Honeywell now plans to start making over 20 million face masks a month to help healthcare workers battle the coronavirus.

Honeywell’s move of ‘coming to aid’ at this time is commendable and is paving the path to other enterprises from the same industry. Current day consumers’ needs have shifted to safety and hygiene which in turn has become one of their business objectives.

Companies that have always been historically change-averse are now forced into a new way of working.

Conventional manufacturing and distribution organizations have always been apprehensive in making any process or technology advancements. With the sudden change in market dynamics, these businesses are realizing the need for an enhanced technology they wished they had adapted earlier. This thought process has created a forced awareness which is now their ‘new reality’ and there is no going back after that.

So, how are companies pivoting operations?

Manufacturing facilities that are already suitable to create products requiring batch processing, are taking a leap into newer areas of production in an agile mode. These companies have the facilities to accommodate materials and processes. They are familiar with proper quality testing standards and potency detection methods for batches. Quite a few companies have already pivoted to help out in every way possible. But only companies that are well automated, are the ones that can move quickly in such emergencies.

Corona Virus Pandemic is hurting the bottom line of Manufacturing Industry globally. You need to find an effective alternative sourcing strategy to survive through this massive supply-chain disruption.

FIGURE 2 Supply chain within manufacturing with the ability to pivot operations

In this ‘new normal’, companies that can pivot quickly to accommodate consumer needs will become the front runners and market leaders of the future.

Business users adapt quickly ‘only’ if they are ahead in process automation and optimization. The benefit is leveraged by using the right kind of technology that can effectively handle various processes and procedures. New-age technology is instrumental in simplifying work and transforming business users into advanced users, especially to streamline HR processes that enable users to be ready for any changes. With newer skills, users can easily adapt to sudden changes and disruptions caused due to a pandemic like COVID-19.

What do operators need to adjust to the change?

54%

of respondents believe that coronavirus could have a significant impact on their business operations.

-A PWC Survey of CFOs

A well-streamlined workflow can help the workforce fall into the rhythm. Especially workforce with native knowledge of their regular operations, need to rapidly adapt to the change in functioning. It is not always easy to handle the new set of production lines that are abruptly put in place. Operators would require a detailed understanding of the new product batch records in order to adapt to the change.

Workflow for warehouse operators should be streamlined to –

  • Guide them while using mobile devices
  • Help them progress through each step
  • Hand hold them during unknown situations
  • Allow them to record inline deviations

If companies are unprepared, they may go through a chaos during manufacturing execution. Production managers and supervisors who have also been used to familiar batch records with specific yield expectations, are now adapting to the ‘new thing’ that they need to produce. Alerts on each operation would immensely help them be aware of how the overall production job is progressing.

FIGURE 3 Supply chain within manufacturing with the ability to pivot operations

When it comes to the regular production operations, Production supervisors or Plant managers are used to seeing both the norms and deviations in the process. Without an internal view of the new product history, they will need to be extra aware of test results and yield quantities of each production job to quickly analyze and extrapolate how to adjust batch formulas, and rapidly incorporate the learnings of each production run. A rule-based algorithm that can look at the last ‘n’ batch runs and automatically suggest changes for ‘approval and instant adoption’ will be crucial to keep the process optimized in an agile manufacturing environment.

Companies that are taking up these initiatives are also required to understand how the end consumer is reacting to the new products released in the market. An easy way would be to label their products with proper QR codes that can be scanned to quickly send an end-user survey back to the manufacturer about their new product. These quick surveys help the manufacturers understand consumer feedback about the product. The feedback can be incorporated into their testing methods to make on-the-fly decisions and corrections of their manufacturing execution.

What are the few technological elements companies wished they had within operations during the Covid19 pandemic?

A question that every manufacturing company is asking to understand is how they can simplify and streamline their processes further to keep the momentum in the operations going. A few technical elements are depicted in the picture below.

Companies have asked me how all of this is different from what was recommended in the past year? It isn’t, but the need is more real now and is no more a nice-to-have. These technological advancements have become an ‘essential-to-must-have’ if businesses want to survive the current condition.

How do we get the required automation?

Unless we see what the business is at its core, it may not be possible to provide a specific view of what all changes would be needed. However, going by some assumptions there are a few business solutions that can be drawn out to help businesses to become more agile in their operations.

FIGURE 4 Batch Manufacturing Facility Agile And Optimized

All of the different ways to speed up, simplify and automate overall operations can propel companies to function a lot more efficiently and be agile to changes that are thrown at them while they are still dealing with a limited workforce.

Key Takeaways

  • There is never an individual contribution that can move a huge ship forward during difficult times. It is always the collaboration and synchrony of an entire workforce that really pushes the throttle. The trick is in how well you are able to keep your people aligned with all the technologies you invest in.
  • Technology centric Manufacturing organizations are already ahead of the market curve and when sudden changes occur, a well defined HR department of a company that has agile training plans in place helps with the changes that are thrown at them.
  • Finally, it is important to understand that even though temporarily it may feel as though companies need to bear the cost of advancement and changes, in a bigger schema a good technology stack like Microsoft is essential for the overall success of any organization.

Recommendation to the reader: Evaluate Microsoft suite of tools to help your business and stay agile in this volatile market.

Xcelpros is a direct Microsoft Cloud Solutions Provider and can help you with your business continuity and make you nimble during these times. We are currently offering various discounts on multiple Microsoft products and Transformation packages. Contact us right away!

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

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