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Workflows, Part 2: Creation, Compliance, and Details
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Workflows in D365 Part 2: Creation, Compliance, and Details
Workflows in D365 Part 2: Creation, Compliance, and Details 700 500 Xcelpros Team

Custom Workflows in Dynamics 365

In the first part of our workflow series, we discussed workflows in Microsoft Dynamics 365 (D365), the stages involved in workflows, their benefits, and some use cases. This week, we will teach you how to create a workflow in D365. Finally, we will share how this technology’s workflows can help organizations comply with regulatory requirements to avoid quality assurance issues.

Dynamics 365 lets businesses tailor workflows to match unique requirements, ideally making processes faster and more efficient. With workflows in place, you can focus more on delivering exceptional customer experiences. A recent whitepaper by MSDynamicsWorld discusses how workflows give companies 100% control over orders, increasing gross margins significantly.

Creating Workflows in D365

If you are just starting with Dynamics and are unsure where to begin, you’ll want to consider partnering with a Microsoft CSP (Cloud Solution Provider) that can help. Your Microsoft Partner will be able to guide you through the decision-making process, helping you determine what parts of Dynamics 365 your company can utilize in terms of what software, and for what departments, etc.

Creating a workflow in Microsoft Dynamics 365 (D365) is very straightforward. You can easily set up simple workflows in D365 on your own in just a few simple steps. As this series is meant to be more of a summary about how simple workflows can be, not a comprehensive guide to setting them up, we’ll only look at a simple workflow. If you want to go deeper and learn about setting up complex workflows that span multiple departments, your Microsoft CSP will be able to help you get started setting up Workflows in D365.

If you already have Dynamics 365 or are in the implementation process, not to fear- you can set up workflows in D365 in a few simple steps. This is not meant to be a comprehensive guide to setting up workflows, but a summary of the steps involved so you understand how simple workflows can be.

Creating a Workflow in Dynamics 365

  1. 1.Defining the Process: Identify the process you want to automate via workflows and the steps involved.
  2. 2.Creating the Workflow: In Dynamics 365 for Finance and Operations (F&O), go to the “Workflow” module area and select “New Workflow.” Give your workflow a name and define the parameters.
  3. 3.Defining Stages: Identify the stages or steps involved in the process you are creating a workflow for. Then, define the actions that need to be taken at each one of those stages.
  4. 4.Assigning Roles: Assign roles to each workflow stage to ensure that the right people are notified and responsible for completing the tasks.
  5. 5.Testing and Refinements: Test the workflow to ensure it is working as expected, then refine the workflow based on feedback and performance.

Workflows and Compliance

A critical need often overlooked by organizations is ensuring continuous compliance with laws and regulations. Standard Operating Procedures (SOPs) provide a set of guidelines that employees can follow to ensure that every action taken within the business is consistent, reliable, and compliant with relevant laws and regulations. Thankfully, maintaining workflows and standard operating procedures (SOPs) directly in D365 is one of the best ways for businesses to track and maintain consistency, efficiency, and regulatory compliance.

Managing and enforcing paper-based SOPs has always been a complex and challenging task. Take advantage of Dynamics’ included workflow capabilities to manage SOPs digitally. This will simplify your business’s SOP (Standard Operating Procedure) compliance with streamlined processes and tasks.

Let us explore how workflows in Dynamics 365 effectively simplify SOP compliance.

Streamline SOP Management

With D365, you can centralize your standard operating procedures (SOPs), enabling easy creation, updates, and storage of SOPs in one place. Workflows are crucial in enforcing SOP usage by guiding employees through the necessary steps and ensuring adherence to established processes. This centralized approach promotes consistency and eliminates the risk of outdated or conflicting SOPs, ensuring your employees can access the most up-to-date procedures.

Simplify SOP Auditing and Reporting

Staying compliant with laws and regulatory standards often requires regular audits and reporting. D365 workflows help simplify collecting and organizing the data required to complete the audit process. By automating data capture and integrating it into the workflow process, your company can generate accurate and comprehensive reports on regulatory compliance and SOPs. These reports provide valuable insights into potential improvement areas, highlight non-compliance patterns, and ensure regulatory procedures are being followed throughout the organization. With workflows in place to simplify auditing and reporting, your organization can identify areas for optimization, strengthening your SOPs and other regulatory compliance processes.

Efficient SOP Approval and Review Processes

D365 workflows automate the SOP management process, reducing manual effort and potential bottlenecks. Whenever a new SOP is created or an existing SOP requires modification, workflows can be configured to automatically route the document to the appropriate department or team member for validation. This workflow-based automation streamlines the process, eliminates delays, and ensures that SOPs undergo thorough validation by the relevant individual(s) or department(s) before implementation. Businesses can maintain a smooth and efficient SOP management process by simplifying the approval and review processes with workflows.

SOP Task Assignment and Tracking Made Easy

SOP compliance involves assigning and tracking tasks related to specific procedures. D365 workflows can help your company automatically assign tasks based on defined roles and responsibilities. Each employee is assigned specific tasks according to their role and permissions within the workflow. This simplifies task management, ensures that individuals understand their responsibilities, and promotes compliance with SOPs. Additionally, workflows provide real-time tracking capabilities, allowing managers to monitor task progress, identify bottlenecks, and take corrective actions promptly.

Proactive SOP Notifications and Reminders

Another key benefit of workflows in D365 is sending automated notifications and reminders related to SOP compliance. For instance, when a task is due or a review is required, employees receive timely notifications. These proactive reminders within workflows help employees stay on top of their responsibilities, ensuring SOPs are followed and due dates are met. By reducing the risk of being out of compliance, workflows can reduce worry and improve overall compliance rates within your company.

Figure 1:Workflows, SOPs, and Compliance

Workflows, SOPs, and Compliance

Simplifying SOP compliance is a critical aspect of maintaining operational efficiency, regulatory adherence, quality control, and risk mitigation. Setting up workflows in D365 can empower your organization to achieve and maintain SOP compliance effortlessly. This helps foster a culture of adherence to regulatory and compliance issues and sets a foundation for long-term success in regulated business environments.

76%

of decision-makers reported that workflows have helped them reduce errors and improve consistency in their business processes, as highlighted in a recent article by SoftwareOne.

Source: SoftwareOne

More About Workflows in Microsoft Dynamics 365

As your business continues to grow and evolve, keeping up with the latest technology and software is essential. Microsoft Dynamics 365 is an excellent solution for efficient operations and improved productivity. Workflows are a critical software component to ensure operations run efficiently and tasks are completed accurately and on time.

As with any technology, there is always more to learn, so many resources are available to learn more about workflows in D365. From online video tutorials and articles to training courses and certification programs, you can use various resources to maximize your software investment (ROI). Learning about workflows will benefit you and your business, whether you are an experienced user or just getting started.

Dynamics 365 F&O Workflows: Conclusion

In today’s digitally driven world, knowing how to use corporate technology tools is essential in maintaining a competitive edge. Workflows in Microsoft Dynamics 365 Finance and Supply Chain are an essential part of this process and are more accessible than ever. From speed to scalability, Microsoft’s flagship Enterprise Resource Planning (ERP) system helps increase efficiency and profitability, enabling users to customize the platform based on their unique business needs.

In the first installment, we explored the basics of workflows, their key benefits, and some use-case examples. This week, we discussed how to create a workflow, how workflows can help keep companies in line with SOPs and compliance, and provided some additional facts and resources about workflows in Dynamics 365.

Take your business’s quality operations into the future with workflows in Dynamics 365. Workflows help businesses improve efficiency and manage compliance standards without expensive hardware or IT support needs.

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Also Read: Quality Management and Control – Best Practices

Managing Chemical Compliance With an ERP
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Managing Chemical Compliance With an ERP System
Managing Chemical Compliance With an ERP System 700 500 Xcelpros Team

At a Glance

  • $700,000: A proposed increase to the maximum Occupational Health and Safety (OSHA) penalty for willful or repeat safety code violations.
  • $50,000: OSHA’s proposed hike in minimum penalties for these same willful acts.
  • $25,000: California’s additional safety violation penalties that are added to the federal fees.
  • $15,000: California’s maximum daily penalties for failing to fix these same issues.

Introduction

When used effectively, modern enterprise resource planning software (ERP) can help companies in several ways when it comes to chemical regulations:

  • Financial components of a chemical firm’s regulatory compliance solution.
  • Occupational Health and Safety Administration (OSHA) regulations.
  • Gathering, storing and managing material safety data sheets.
  • Gathering information from far-flung sources to create effective reports able to meet government criteria.

One study cited a multi-national corporation’s subsidiary using an ERP to comply with the Sarbanes-Oxley Act of 2002 (SOX).

“The findings demonstrate how managers can use an ERP to develop effective internal controls for the most common material weaknesses reported under SOX, thus providing insights into the crucial role of IT as a facilitator of control and reporting processes, and, more specifically, into the role, use and purpose of ERPs in relation to regulatory compliance,” according to the University of Greenwich.

Key points related to the chemical industry noted in this study include firms often failing to customize their ERPs for the specific requirements of the business, this applies specifically to chemical companies. Working with an ERP vendor experienced in the chemical industry helps ensure software works exactly as the company needs it rather than just installing an out of the box solution.

Unified systems like ERPs can help identify and evaluate hazardous substances. Manufacturers are then informed of the risk levels regarding the use and distribution of their chemical products. Identifying these hazardous substances early also allows manufacturers to act proactively, resulting in better safety.

Identifying Hazardous Materials With an ERP

Today, U.S. government regulations require the identification and labeling of hazardous materials. Modern ERP solutions can help create and manage safety data sheets (SDSs) along with any Globally Harmonized System (GHS) labels as required by the Occupational Health and Safety Administration (OSHA).

Each safety data sheet has 16 sections, 12 of which OSHA requires. These include:

  1. 1.Identification such as common names for the substance, recommended use of the chemical and restrictions on its use
  2. 2.Hazard(s) Identification such as signal words, pictograms and hazard statements
  3. 3.Composition and Information on Ingredients such as each substance’s Chemical Abstracts Service number
  4. 4.First-Aid Measures such as the most important symptoms
  5. 5.Fire-Fighting Measures such as the type of fire-fighting
  6. 6.Accidental Release Measures including emergency procedure and methods of containment
  7. 7.Handling and Storage including safe handling precautions
  8. 8.Exposure Controls/Personal Protection including OSHA Permissible Exposure Limits (PELs)
  9. 9.Physical and Chemical Properties such as the chemical’s odor, flash point and flammability
  10. 10.Stability and Reactivity including if the chemical is stable under normal temperatures
  11. 11.Toxicological Information including how the toxins are brought into a human body such as through inhalation or eye and skin contact
  12. 12.Other information including when the SDS was prepared or last updated

OSHA also suggests-but does not require-data on ecological impact, including:

  • The disposal of hazardous materials
  • The transporting of hazardous materials
  • Any other regulatory requirements, as needed

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An ERP manages regulatory compliance by comparing your existing SDSs to OSHA’s requirements. Once your safety sheets are updated to meet federal requirements, they are stored in a central repository for reuse. A single update ensures that all SDS are accurate when the same ingredient is used in several products.

That information can then be “chunked” and converted into the GHS labels. One method where ERPs excel is their ability to generate QR codes for labels automatically. Simply scanning the label with a cellphone can provide internet links to complete safety sheets.

When every second counts, such as in exposure to potentially hazardous chemical, workers don’t have hours to pour through filing cabinets looking for the right SDS. They might have a few seconds to scan a label, tap a link and then know what type of first aid to administer.

Other Safety Features in ERPs

Because ERPs access information from multiple sources, one way they help promote safety is by limiting access. When data access cards or passwords are linked to an ERP, they can help prevent unauthorized—and untrained—workers from accessing dangerous or harmful chemicals.

Your ERP can be used to restrict access to based on the individual’s role. This helps protect their help while also ensuring your data remains safe from prying eyes.

Using your ERP to monitor safety also lets you identify areas where more training is required. It can be tied to a learning management system (LMS). This in turn reduces the risk of workers with expired certifications or lack of skills.

Your SDS chemical management can help pinpoint at-risk employee groups, document recurring injuries, map frequent injury locations and then help you create a plan to correct them.

For example, many production employees are required to earn OSHA 10 certification. This ensures they have at least 10 hours of safety instruction.

OSHA 30 certification goes into greater depth when it comes to safety. Among its enhanced requirements are the following:

  • Hazard communication, which is useful in preparing and updating safety sheets
  • Materials handling, such as hazardous chemicals
  • Personal protective equipment (PPE)

Your ERP can identify which employees have active OSHA 30 certification, which have expired certificates and who lacks it. By denying access to unqualified workers, you reduce their risk of injury while also dropping your chances of being tagged for an OSHA violation.

Under a current proposal, OSHA provisions for willful and repeat violations could increase from a minimum of $5,000 to $50,000 per violation. The maximum fines would also go up ten fold to $700,000 per violation, Cal-OSHA states. These fines can change based on your location. For example, if a violation occurs in California, you can expect to pay as much as $25,000 for serious violations. These infractions can accrue daily penalties up to $15,000 for failing to solve the hazard issue.

ERPs and HazCom

OSHA’s Hazard Communication standard known as HazCom includes a checklist of 10 requirements.

These include the need to perform the following:

  • Train employees on the hazardous chemicals in the workplace
  • Instruct workers on how to recognize exposure to hazardous chemicals
  • Provide training on container label elements
  • Offer instruction on Safety Data Sheet (SDS) format and content
  • Explain to employees how to access SDSs
  • Update SDSs when new versions become available
  • Update the written HazCom program as needed
  • Explain to employees how to obtain a copy of the written HazCom program
  • Train employees on any in-house labeling system used
  • Make sure all container labels in the workplace are compliant

An ERP can ensure that data on any single chemical or hazardous material is thoroughly covered in your documentation. For example, each SDS can be linked to related labels and training materials. An update to the SDS ensures everything that flows from it is also current. That means your employees are safer as is anyone else who handles your products.

The Bottom Line

While some executives think of ERP’s, they consider ways to improve efficiency. The reality, however, is that ERPs can also be used to make workplaces safer for everyone. This is primarily achieved with constantly updated processes and carefully labelling and managing any goods and raw materials.

Creating and updating an SDS in your ERP, for example, allows you to link all critical information about a product including labels, handling guidelines, storage requirements, training materials, and more. Increasing the safety and handling for everything you store and work with not only reduces the costs of injuries and by ensuring OSHA compliance, but you also minimize the potential for fines and infractions, which further helps to increase profits.

Also read: 3 Ways to Manage Disruption in the Chemical Industry

The importance of pharmacovigilance during a pandemic banner
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The Importance of Pharmacovigilance During a Pandemic
The Importance of Pharmacovigilance During a Pandemic 700 500 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) emphasizes providing the most effective drugs that do not cause severe adverse effects.
  • Understand adverse effects and how to prevent them by assessing the right chemicals, quantities and processes in medical vaccine manufacturing.
  • Digital solutions and services are designed to help scientists and pharmaceutical company decision-makers detect, assess, understand and prevent adverse effects from their medicines.
  • Starting now, pharmaceutical companies are placing a greater emphasis on drug quality checks to avoid mistakes caused by rushing the production process.

Introduction

Today, most people are familiar with terms like “clinical trials,” “safety assessment tests for vaccines” and “FDA approvals” because of COVID-19 media coverage over the last few years. While these terms have always been a part of any pharma and biotech manufacturing companies’ quality assurance program, the ongoing pandemic has made them part of everyday conversation.

People often wonder why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer however, lies in the principles of pharmacovigilance, also known as drug quality control.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Source: The World Health Organization

The Primary Goals of Pharmacovigilance Guidelines

The goals of a typical pharmaceutical quality control program include:

  • Assessing a drug’s short-term and long-term adverse effects and any harm the drug might cause a patient.
  • Continuously collating and monitoring a particular drug’s safety data.
  • Assessing the risks and rewards of the drug to make a guided decision on the administration of the drug.
  • Communicating adverse drug reactions (ADRs) data between health professionals and clinical researchers while maintaining transparency at all levels.
  • Preventing the distribution and administration of unsafe drugs by medical bodies and drug companies.

All pharmaceutical companies require a team of professionals to carry on this constant quality check of their drugs. This team can include scientists, clinicians, biochemists, physicians and medical writers. The team’s job is to collect, collate, analyze and assess the safety profile of every drug.

This task requires constant alertness and unprecedented agility for an accurate and quick response. In today’s market, manual data reviews are no longer adequate. Combining finely tuned digital tools and well-trained employees is the best way to protect patients from severe injury or death.

A drug maker’s automated quality control program should be smart enough to help collect, analyze and check data. The software equipped with artificial intelligence can check a drug’s composition, verify safety profile mapping and perform other crucial steps required for necessary quality checks.

Pharmaceutical companies need to follow a wide range of procedures to ensure their pharmacovigilance is up to government and industry standards in order to remain compliant.

“The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.” Elizabeth Ndichu, MD, and Kevin Schulman, MD

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To comply with new quality standards and still meet today’s demands for fast-track drug development and clinical trials, pharmaceutical and biotechnology firms need to strictly adhere to the process of end-to-end pharmacovigilance.

  • Carrying out detailed patient surveys for different age groups, countries and health conditions
  • Using consultants and experts to manage its quality control program
  • Using software such as Microsoft Dynamics 365 for the pharmaceutical industry to help ensure error-free data maintenance, analysis and report generation
  • Keeping all stakeholders in loop at all times to avoid any errors
  • Maintaining records of their quality control policies and procedures. These records are required for medicines plus other products such as cosmetics, nutritional supplements and dietary products
  • Formulating a plan for intervention, mitigation, assessment and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies need to take an agile approach toward pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is no longer a matter of convenience but a necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply Chain Management provide Quality Control functionality. Each of these computer programs has methods to collect, track and report quality test results. This software is a comprehensive solution that makes it easy to leverage technology to streamline quality check operations.

These solutions can pave the way towards regulatory compliance, stringent component mapping and monitoring of a drug’s safety profile. It reduces manual intervention by employees, allowing individual case safety reports (ICSRs) to be performed easily.

Microsoft Dynamics modules can be used by different departments by the likes of clinical researchers, scientists, medical writers, physicians, medical representatives and government drug governing bodies. These solutions for monitoring drug safety are considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for today’s pharmaceutical companies.
  • The pharmaceutical sector continues to evolve on a large scale. This change requires gathering medicinal data at a global level to map drug safety.
  • Forming a blueprint to follow the pharmacological journey is a critical step for any pharma and biotech company.

References: Pharmacovigilance: Regulation and Prequalification

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How a Pharma CDMO can manage the Serialization Challenge
How a Pharma CDMO can manage the Serialization Challenge 700 500 Xcelpros Team

At a Glance

  • Today, serialization has moved from being a luxury option to a necessity.
  • Pharmaceutical companies are hiring contract development and manufacturing organizations (CDMOs) to develop solutions that maintain drug quality while avoiding supply chain problems.
  • Pharmaceutical serialization lets manufacturers keep accurate track of their inventory wherever it may be.

As more pharmaceutical and chemical companies move to digitize their operations, they’re looking for ways to track raw materials and finished products through the manufacturing cycle. One way to track these products is through serialization.

“Serialization is the assigning of a predetermined coding type to each product item, assigning it a distinct identity” for tracking and tracing its location in the supply chain,” RFXcel.com states. A simple definition calls serialization, “the process of assigning a unique identity to each saleable product item,” according to Neurotags.com.

Pharmaceutical companies that have gone digital are starting to use serialization to track and trace their products throughout the supply chain. The industry is constantly looking to improve its tracking systems to combat counterfeiting, theft, packaging and storage errors. Companies are also worried about their products being altered after leaving their plants.

Pharmaceutical companies often hire contract development and manufacturing organizations (CDMOs). Using digital labeling methods such as barcodes and QR codes (a type of barcode) helps serialize the supply chain, making tracking raw materials and finished goods easier.

30-40% of all medicines circulated in the developing countries are counterfeit.
5-7% of all medicines circulated in the developed countries are fake. Source: WHO Report

Counterfeit drugs pose a serious threat to the public’s health. They also damage the reputations of legitimate companies and the pharmaceutical industry globally.

CDMOs worldwide face challenges when implementing a robust pharma serialization solution. Streamlining manufacturing and distribution processes while understanding their client’s unique requirements is challenging.

Serialization Challenges Faced by CDMO

Some of the challenges a CDMO faces while implementing pharmaceutical serialization for track and trace functionality include:

Seamless Serialization for Multiple Clients

CDMOs typically prefer to operate globally, providing comprehensive drug manufacturing and supply services to many pharmaceutical companies. Catering to a diverse client base has its unique set of challenges, especially when it comes to the serialization of individual drugs.

CDMOs need to equip themselves with the right technology to be able to modify their production or manufacturing lines and seamlessly label multiple drugs for different clients.

Regional Compliance

Every country around the world can have different regulations for exporting drugs. Labeling—or serialization—is part of that compliance. CDMOs are expected to take responsibility in terms of drug quality of drugs and compliance with various government rules. Being in compliance is challenging for CDMOs, especially considering the volume of information required to achieve it.

Figure: 1Key Serialization Challenges Faced by CDMOs

Key Serialization Challenges Faced by CDMOs

Picking the Right Labelling Solution

When it comes to drug serialization, a “one size fits all” approach to labeling solutions doesn’t always work. Assuming a CDMO has a preferred labeling software, there’s still the important decision of choosing:

  • Printer types such as thermal inkjet, thermal transfer, lasers
  • Printing materials such as paper, film or holograms
  • Special formulas to make counterfeiting harder

In terms of label design, everything must meet government codes and regulations. This applies to label layout, orientation, barcode configuration and other design elements. Every label must be printed in time to avoid delaying shipments. CDMOs are pressured to make the right choices for coding and labeling products.

Understanding Market Requirements

While larger pharmaceutical manufacturing companies use an in-house team of analysts and marketing specialists, smaller firms often rely on CDMOs for market intelligence.

When it comes to labelling client drugs, CDMOs need to understand the different markets and their requirements. Using market analysis, CDMOs must decide how many drugs need to be labelled for a particular market, including whether they’re choosing to label randomly or with a centralized approach.

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Overcoming Serialization Challenges

No two CDMO clients are the same and neither are the challenges each CDMO faces. In terms of how each company deals with its serialization issues, they should consider:

  • Equipping their workforce with the technical knowledge and details of serialization hardware and software
  • Making use of advanced technological applications like Big Data, cloud computing, the Internet of Things (IoT and advanced analytics)
  • Understanding how enterprise resource planning (ERP) software, like the Microsoft Dynamics 365 line of modular product, can help them maintain and monitor client data

With the right software and people skilled in its use, a CDMO can manage multiple production lines while meeting drug production requirements for different clients.

Investing in the right partner with experts that understand global pharmaceutical regulations will help CDMOs label and locate their products no matter where they are in the world.

Since CDMOs are not only vendors but also producers, they need to be in constant contact with their clients and suppliers. This includes dealers, wholesalers, packagers and transporters. Using the right ERP will help them maintain transparency at every level while avoiding recalls or stock-outs.

CDMOs benefit by developing flexible templates for their serialization solutions. These templates serve as a blueprint for any pharmaceutical client. Making them flexible lets a CDMO adjust a process to meet the client’s requirements, saving time, effort and money.

Final Thoughts

Drug serialization and labelling pose several challenges for CDMOs around the world. However, managing these challenges is an excellent opportunity for an organization to show its technological skills. When a CDMO has the right team and solution, it can overcome any challenge.

Taking advantage of products like Microsoft’s Dynamics 365 suite of solutions gives pharmaceutical companies access to powerful tools. Included is a way to track serialization, such as customer onboarding and lot traceability to toll manufacturing, from start to finish.

Using a powerful and effective ERP to enhance serialization will help a CDMO combat counterfeiting and theft while ensuring government compliance. At the same time, good software can also help a CDMO establish a more efficient supply chain.

Meeting serialization requirements for pharmaceuticals pose many technical and skill-based challenges. CDMOs worldwide are constantly looking for more efficient ways to handle these challenges. Investing in the right partner can make a big difference.

With the help of cutting-edge applications, a skilled team and a systematic approach toward serialization, CDMOs can establish themselves as leading end-to-end manufacturing and distribution partners.

References: What Is a CDMO (and Why Do You Need One)

Challenges in Pharmaceutical Supply Chain due to Covid-19
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Pharmaceutical Supply Chain Challenges due to Covid-19
Pharmaceutical Supply Chain Challenges due to Covid-19 700 500 Xcelpros Team

Introduction

Even while the United States and much of the world continues to vaccinate and protect its citizens from COVID-19, new variants of the disease continue to pop up around the world. Since its arrival, not only have millions of lives been lost and affected, problems caused by the disease continue to wreak havoc on the pharmaceutical supply chain.

As of May 2021, Google states nearly 3.4 million dead in 220 countries and territories worldwide, including over 587,000 in the US alone

Some of the more prominent short-term effects cited in a July, 2020 article on Springer include

  • Demand changes leading to shortages caused by panic-buying oral home-care medications
  • Supply shortages of active pharmaceutical ingredients (APIs) and finished products, especially those coming from China and India
  • Shifting communications and promotions to telecommunication and tele-health, resulting in a 70 – 80 percent drop in visits to physician offices and clinics
  • Change in the focus of research and development programs to dealing with COVID-19

More Long-lasting effects include:

  • Delayed approvals for non COVID-related pharmaceutical products, partially caused by the closure or semi-closure of regulatory agencies
  • Self-sufficiency and lower demand for APIs and finished products made in China and India caused by delays in manufacturing and disruption to shipping and logistics
  • Organization growth impacted by economic slow-downs around the globe
  • Ethical issues from poorly researched clinical therapies and products
  • Drastic change in consumer use of cleaning and health products

By the Numbers

  • 2x increase in investigational treatments in the U.S.
  • 100% – 700% increase in the use of medicines to treat COVID-19 in U.S. hospitals (January-July 2020)
  • Upwards of 24 million excess prescriptions have been written in the U.S. alone, for things like hypertension, mental health issues, respiratory problems, diabetes, and anxiety.
  • 156 clinical trials for COVID-19 in the Middle East and 140 in the EU
  • 70%-80% reduction in patient visits to doctors’ offices in the EU
  • 23% of patient interactions in the EU are now being done online

Source: Springer.com

Supply Chain Effects

A recent report by Deloitte about the impact of COVID on the pharmaceutical industry includes a look at Supply Chain Management. The report cites a number of key risks to be aware of in different functional areas, including the following

Procurement

  • Quality checks of received materials. Mitigation measures include increasing warehouse space for quarantining shipments from China.
  • Shortages of raw materials, APIs and solvents due to dependency, inadequate materials to complete BOMS/batch size processing. Prevented by boosting stocks of critical inventory, evaluating alternate sourcing of impacted materials and using government support policies when looking at investments in production plants.
  • Shutdowns of vendor plants. Solved only by identifying shutdowns from remote (i.e., Asian) sources and pressure testing supply chains for various scenarios.

Planning

  • Expiration of materials and monitoring for reassessments and quality certificates where the solution is submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns from contract manufacturers, requiring sufficient communication regarding their ability to deliver products.
  • Additional quality control checks for contamination issues. This can be mitigated by having quality control personnel on-site and thorough sanitizing of all in-bound products, employees and equipment.
  • Contamination after final packaging. Requiring the disinfecting of shipments before delivery, possibly with photographic proof.

Transportation and logistics

  • Non-availability of local transportation to move raw materials and finished goods. Can be solved by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues related to transportation or vehicles. Requires the disinfecting of all vehicles, plans for properly storing temperature-sensitive products in assigned warehouse space.

Export

  • Contractual compliance. This can be mitigated by ensuring the person collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Preventing this requires seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain or personnel issues occur.

Figure: 1Pharmaceutical Supply Chain Areas Affected by Covid-19

Supply Chain Effects

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Lasting Effects

The effects from COVID have caused businesses to do whatever necessary to stay competitive, such as the repurposing of disposable components from single use systems to use in COVID-specific programs at the expense of other critical efforts. This is just one of the continuing effects on the supply chain cited by Contract Pharma in a recent COVID-19 Impact Report, as well as the following pointed out by other executives in the industry.

  • Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for their services. The increased demand, “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones”. This boost to business requires additional planning and communication to ensure resource allocation for multiple programs.
  • James Rogers of Sterling said, “The impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.” He predicts that supply chain resilience and reliability will be given the same importance as price when developing future supply strategies.
  • Danita Broyles of U.S. Pharmacopeia is quoted by Contract Pharma as saying, “the decrease in on-site inspections has the potential to increase quality risks to the global supply chain,” adding pressure to manufacturers and suppliers to ensure the quality of their products.
  • Ben Wylie of ChargePoint Technology said that, “many governments are now pushing the industry to rethink its model to safeguard drug production.” He cited a program in India to reduce reliance on China for critical drugs and APIs.

Final Thoughts: The Impact of COVID-19 on Regulatory Practices

COVID-19 will continue to have an ongoing impact on regulations in the areas of clinical study trial design, clinical trial study development and post-clinical trial regulatory submissions, Dr. Ronan Brown of IQVIA wrote in an article on European Pharmaceutical Review.

Among the changes forced on drug manufacturers includes a more decentralized approach to collecting patient information and rapid access to regulators, Dr. Brown said. This includes pre-investigational new drug meetings with the FDA now granted in less than 30 days. The FDA has also taken steps to accelerate the review and start of new studies.

Flagging potential obstacles and safety concerns during these early meetings lets pharmaceutical companies move faster into human trials, he explained.

Decentralized clinical trials, which he expects will ultimately cost about the same as the traditional versions, will offer greater diversity in terms of patient cohorts along with increased mobility and convenience.

Key Solutions to Chemical Company Operational Challenges
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Operational Challenges in a Chemical Company: Key Solutions
Operational Challenges in a Chemical Company: Key Solutions 700 500 Xcelpros Team

At a Glance

Recovery by end-use markets and export consumers are expected to boost the U.S. Chemical industry in 2021 and 2022. The American Chemistry Council (ACC) predictions include:

  • A global gross domestic product (GDP) increase of 6.1% in 2021 and 4.4% in 2022
  • A rise in the U.S. GDP of 6.4% in 2021 and 4.3% in 2022 after a 3.5% fall in 2020
  • U.S chemical volumes will increase by 1.4% in 2021 and 3.2% in 2022
  • Chemical shipments will increase 8.1% in 2021 and 8.2% in 2022 after a 13.5% decrease in 2020
  • Capital spending will increase 11.9% to $30.6 billion in 2021 and 3.1% in 2022 after falling 17.6% in 2020
  • Basic chemical production will rise 0.5% in 2021 and 3.4% in 2022
  • Specialty chemicals will expand by 3.8% in 2021 and 4.1% in 2022 after falling 10.8% in 2020
  • Chemical exports will rise 5.8% in 2021 and 13.2% in 2022 after falling 7.6% in 2020
  • U.S. Chemical imports will rise 1.7% in 2021 and 13.7% in 2022 after falling 5.1% in 2020

Also affecting U.S. chemical companies are tariffs and regulations.

  • U.S. tariffs on Chinese goods were averaging 19.3% on a trade-weighted basis in early 2021, up dramatically from the 3.8% rate before the U.S. China trade war, CNBC states
  • China currently has a 20.7% tariff on U.S. goods
  • Failure to meet global harmonized system (GHS) labelling requirements can generate fines of $12,600 per violation and up to $127,000 per violation for the most serious issues

Making Sense of the Numbers

Higher production translates to higher capacity requiring production managers to equip themselves with the technology needed to adapt to the changing market.

A sophisticated enterprise resource planning (ERP) business application helps plant production managers keep up with rapidly changing challenges. ERP software also lets them track key metrics such as inventory turnover and manufacturing throughput to optimize cost of production.

Production in modern-day chemical companies involves unforeseen challenges. These range from obtaining raw materials to ensuring proper quality, fluctuating demand, tariffs, dwindling margins, capacity and resource planning. It also requires keeping formulas secure from data thieves.

Regulatory compliance plus international tariffs add additional stress to profit margins and the supply chain.

Tariffs require leveraging resources more efficiently to achieve better margins while promoting trade. One effect is forcing companies to explore near-shore vendors that can supply essential materials at a reasonable price.

One way to become more efficient is by using modern technology. ERP solutions such as Microsoft Dynamics 365 (D365) Business Central have tools that let production managers take more control of their production floor.

For example, production scheduling is complex, requiring an understanding and balancing of specific elements such as:

  • Resources Planning
  • Continuous production
  • Optimal asset planning
  • Fluctuating demand
  • Tighter lead time
  • Procurement delays
  • Outages
  • Quality check
  • Recalls and regulation requirement

Five Key Concerns

Five key concerns for chemical production plant managers are:

  1. 1.Fluctuating product demands
  2. 2.Volatility in raw materials supplies
  3. 3.Complying with government regulations
  4. 4.Ensuring consistent quality
  5. 5.Resource and production throughput

Fluctuating Customer Demands

Capital spending will increase 11.9% to $30.6 billion in 2021 and rise another 3.1% in 2022 after falling 17.6% in 2020, American Chemistry Council states.

Basic chemical production will rise 0.5% in 2021 and 3.4% in 2022. Specialty chemicals will expand by 3.8% in 2021 and 4.1% in 2022 after falling 10.8% in 2020.

“Following the worst downturn since the 1930s, the world economy is on the rebound,” Kevin Swift, chief economist at ACC is quoted as saying. “We expect recovery to proceed apace despite multiple risks and uncertainties. These include supply chain constraints and increased demand as economies reopen; trade tensions; weather events, cybersecurity and similar shocks; inflation; financial volatility and public and private sector debt.”

While these developments position chemical companies in a bright spot compared to 2020, not all is bullish. As demand for chemical products increases, so does competition and the demand for innovative products. Production Managers now handle unprecedented customer demands causing tight deadlines and highly-stressed resources.

Production Managers need an air-tight strategy to meet sporadic demands and ensure business continuity. Products such as D365 Business Central are equipped to handle such strategies, ensure complete visibility, provide control over the entire supply chain and support informed decision-making.

Some of the critical elements in production planning and control include Master Planning, Production Scheduling and Production Control as shown below.

Production management

Today we live in an on-demand economy. Production managers face rapid changes and increased sales order quantities from customers, adding pressure on Production.

Example #1: A Chemical Plant

Using a chemical plant as an example, say Customer A doubles their order quantity from 5,000 to 10,000 pounds.

To meet this demand, the production manager must respond quickly by evaluating available resources and scale batch sizes in the reactor.

Companies using a modern, well-designed order management system can update the sales order quantity and set the order priority to high.

Order priority can be designed to consider critical demand, customer categories and customer relationships. Changing the order priority signals the materials requirement planning (MRP) system. It issues an updated production order to reflect the larger batch size.

After seeing the revised production order, the production supervisor can review the production schedule and adjust resources to meet the customer’s new demand.

Similar situations are common at chemical companies. Plant managers recognize the need for an integrated ERP system that seamlessly manages communication between different business areas.

Using Gantt Charts

The production control module within Microsoft Dynamics 365 Supply Chain Management creates powerful Gantt Charts. These charts visually represent production flows, map resources, check on material availability and inventories plus see which machines are available. This information helps managers control and optimize the production plan and make informed decisions.

Gantt charts within Dynamics 365 Finance provide a uniform view of schedule activities within a defined time interval. Managers can use these charts to:

  1. 1.Schedule jobs from production orders. Managers and schedulers can modify production plans by dragging and dropping or using an online menu.
  2. 2.Schedule jobs from planned production orders. Scheduling starts after the production plan converts to an actual order.
  3. 3.See hourly schedules of all jobs. A calendar that has active working times is a prerequisite for all production activities. Seeing the real-time status of every job lets managers know the status of “jobs that have started” and “jobs that have ended.”
  4. 4.View production orders organized by order and resources. Production managers get a real-time view of a production schedule displaying scheduled production orders, material availability and resource capacity. Managers can change schedules when required.

Order view

View of the resources available or engaged.–

Resource view

Volatility in raw materials supplies

Chemical manufacturers use crude oil and natural gas byproducts as the base for their products, accounting for about 50% of the production cost. Oil and gas are extremely volatile commodities with pricing subject to many macroeconomic factors beyond the chemical companies’ control. Volatility causes include geopolitical unrest, OPEC member nation policies, sanctions, currency fluctuation, etc.

Keeping track of raw material cost and availability—especially with the continuing pandemic—is another important production manager function. In the “old days,” managers used a series of Microsoft Excel spreadsheets to manually keep track of key metrics such as inventory turnover and manufacturing throughput. Modern ERPs track data real-time offering benefits to help minimize the effect of raw material price fluctuations:

  • Transparently tracking actual costs while accounting for cost of goods sold, revenue, margins, cash flow, etc.
  • Adjusting for currency fluctuations when dealing internationally. Managers can obtain materials from the lowest cost supplier.
  • Analyzing order volumes and budgeting for cost. Managers can get better pricing and plan production more efficiently.

Complying with government regulations

Any company working with hazardous chemicals is regulated at the federal and state levels. Many also face scrutiny from local officials.

Common requirements are labels meeting GHS standards. Software able to generate the right labels for each product coupled to label printers on the production floor are essential in meeting regulatory requirements.

In the US, companies dealing with hazardous chemicals including manufacturers, distributors, transporters and end-users must adhere to the Globally Harmonized System (GHS) label compliance requirements. Noncompliance can cost $12,600 per violation, while the more serious ones could range up to $127,000, not counting damage to a company’s reputation.

A labeling solution that includes chemical properties, characteristics, batch and lot number, test specifications and other required information is crucial.

Hazardous chemicals need to be distinctly identified to avoid disasters such as when reactive chemicals come in close contact. Labeling applications, such as Integrated Chemical Management (iCM) in D365, can address these issues in Production and elsewhere.

iCM not only provides labels meeting GHS standards, it also includes Safety Data Sheet authoring and management. It reduces human error when printing labels during a production run by knowing which product labels to print during the process.

Production order

Ensuring Consistent Quality

The effects of quality checks and recalls can have a long-lasting impact on a company’s reputation. Creating the required documentation for processes such as production, use of raw materials, packaging and others helps track each product from its source to its final destination. Accurate documentation improves visibility in the supply chain and enhances traceability in the event of an inquiry, recall or audit.

Chemicals are used as a base in multiple industries such as automotive, paints, food and beverage, appliance, electronics, packaging, textiles, cosmetics, toys, etc. The graph below shows recalls across major industries in 2016.

Production recall by Number of insurance claims 2016

A closer look reveals the reasons for such recalls. Top reasons for medical device recalls in the U.S. as of the second quarter, 2019 according to Statista were:

  • Software issues (49)
  • Mislabeling (32)
  • Quality Issues (31)
  • Sterility (18)

Common reasons for drug recalls according to WebMD are:

  • Health hazards
  • Mislabeling or poor packaging
  • Poor manufacturing quality
  • Packaging and product misalignment

Microsoft Dynamics 365 has the ability to track and trace products at a batch or lot level from the source to the end user. This function helps:

  • Ensure regulatory compliance
  • Track and trace batches and lots to identify damaged or contaminated products
  • Visualize the journey of the product from the manufacturing site to its end-users
  • Trace the root cause of an issue and treat it accordingly

Resource and Production Throughput

Managing the production shop floor requires diligent planning of human capital and other interdependent machine resources such as blenders, reactors, mixers, hot ovens, separators, packaging, tanks, etc.

Production planning and scheduling can get overwhelming depending on the number of resources and shifts. Production managers are constantly under pressure to increase production volume using less resources. Recurrent variation in batches to meet higher volume demand and continuous production often results in inconsistent batch quality.

Real-time data monitoring using measured and inferred values can increase production by as much as 4%. D365 uses measured and inferred values to track batch completion in real-time, reducing batch cycle time. It also is also used to achieve batch consistency. Using data collected over time to predict events that can disrupt the production cycle, production managers can reduce those delays, decreasing operating costs.

Being able to track and analyze real-time data also improves asset and resource effectiveness by up to 4%. Unscheduled downtime due to maintenance or breakdown isn’t new to manufacturing plants. Using predictive analytics, past asset performance can model scenarios that detect equipment health and prevent failures.

Key Takeaways

The US Chemical industry is still a volatile market, one that seems to be rebounding from the vagaries of Covid-19 one minute and then being hammered by political crises the next. Individual companies face growing competition to produce unique products, increase production, gain customer loyalty and comply with stringent regulations.

The life of a Production Manager in a chemical industry is stressful. Embracing modern technology will help them achieve company goals while also staying compliant with changing regulations.

Microsoft D365 offers easy-to-use visualization of data across all organizational departments including production, sales, compliance, marketing and others. It’s ability to seamlessly share data across multiple sites and locations enhances transparency and improves product and material tracking and tracing. The combined functions of each D365 application boost productivity and increase efficiency.

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mistakes that slow the growth of a chemical manufacturing company
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Mistakes that slow the growth of a chemical company
Mistakes that slow the growth of a chemical company 700 500 Xcelpros Team

7 Quotes

Companies need to grow if they wish to flourish and prosper. There are many quotes already related to business growth you might have heard before, including:

  • “Conformity is the jailer of freedom and the enemy of growth,” President John F. Kennedy
  • When you stop growing, you start dying,” author William S. Burroughs
  • “Every problem is a gift —without problems we would not grow,” motivational speaker and author Anthony Robbins
  • “Out of your vulnerabilities will come your strength,” neurologist Sigmund Freud
  • “Strength and growth come only through continuous effort and struggle,” author Napoleon Hill
  • “The only way you are going to have success is to have lots of failures first,” Google co-founder Sergey Brin
  • “The journey of a thousand miles begins with a single step,” Chinese philosopher Lao Tzu

Introduction

What do you consider growth for your business? How this is measured is up to each individual organization. Data points that highlight company growth includes:

  • Sales
  • Revenue
  • Profits
  • Company Value
  • Number of customers
  • Number of Employees

The next question to ask is, “Are you growing in a way that is sustainable and lets you achieve all of your company’s goals?” As they grow, companies can make several mistakes that doom their opportunities for growth.

According to Growthink, the most common growth-related mistakes are:

  1. 1.Ignoring the Ansoff Matrix—also known as the Product/Market Expansion Grid—that details ways to increase sales.

Figure: 1Ansoff Matrix: Product-Market Expansion Grid

Ansoff Matrix: Product-Market Expansion Grid

  1. 2.Failing to conduct market research, such as a SWAT (strengths, weaknesses, opportunities and threats) assessment.
  2. 3.Developing weak financial models showing the impact of each growth opportunity.
  3. 4.Forgetting what worked in the past for your company.
  4. 5.Starting at the wrong place and lacking a clear vision of where you want to go.
  5. 6.Lacking focus, which can occur when a company lacks a clear growth plan.
  6. 7.Ignoring the human factor by not having the right people.

Chemical Industry Mistakes

The previous items apply to all companies wanting to grow, regardless of industry. The heavily regulated pharmaceutical and chemical industries face additional challenges when they want to grow.

According to Global Safety Management, these unique challenges include:

  1. 8.Ignoring jurisdictional regulations.
  2. 9.Costly errors from operations.
  3. 10.Failing to evolve into an intelligent enterprise.
  4. 11.Delivering products, not business outcomes.

Ignored regulations often result in hefty fines. For example, if your pharmaceutical company sells its products in Europe, and then decides to expand into the U.S., not following FDA labeling regulations is a major no-no. Violating Section 21 of the Federal Food Drug and Cosmetic Act (aka, title 21, section 331) mislabeling a prescription drug for interstate commerce is expensive. Penalties include prison sentences up to 10 years, fines of up to $250,000 and civil penalties up to $10 million, the law firm of Wallin & Klarich states.

Problems often result from manufacturing errors and omissions. Many of these can be traced to the supply chain. For example, inaccurate inventory counts lead to starting a production run only to discover a key ingredient is missing, stopping production.

Evolving by using available technology as a way of moving forward can be done when company leaders are looking toward the future. Tools exist today—such as the Industrial Internet of Things (IIoT) coupled with modern enterprise resource planning (ERP) software—to let small and medium-sized businesses grow. They also let larger companies get even bigger.

Having total control over your inventory and an ever-changing grasp of your supply chain lets you reduce raw materials and shipping costs while still delivering products on time.

Translation Errors Can Prove Fatal

The final error in our “devils’ dozen” is:

  1. 12.Translation Mistakes.

Let’s face it: many American chemical manufacturers purchase materials from suppliers outside the U.S. and ship finished products overseas. That means labels must not only be in the languages used by your customers and others in the supply chain, they must also meet safety regulations at their destination.

If, for example, a formula using imperial measurements (i.e., pounds and ounces) is incorrectly translated into its metric equivalent or instructions are unclear, the resulting product may fail safety and purity tests. Poorly translated labels could cause regulators to deny a shipment until the products are relabeled correctly. Translation errors could even result in a large batch failing its tests, wasting the materials, time and equipment.

“If the mistakes are severe enough, the resulting chemical combinations could be dangerous or deadly for staff members who follow mistranslated instructions to the letter,” GLTaC states.

Under terms of the European Chemicals Agency’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) act of 2006, dossiers are required on each substance produced or imported weighing more than one metric ton.

“Inaccurate information due to translation mistakes could result in regulatory action by the European Chemicals Agency that could prove financially crippling,” GLTaC, a translation services provider, warns.

Technology Helps Reduce Mistakes

ERP software like Microsoft Dynamics 365, especially when paired with something like Xcelpros’ Integrated Chemical Management (iCM), helps companies better manage their growth.

Figure: 2Integrated Chemical Management with Microsoft Dynamics 365 Supply Chain Management

Integrated Chemical Management with Microsoft Dynamics 365 Supply Chain Management

ERPs can work with IIoT sensors, gathering large quantities of data. Dynamics 365 Finance helps turn the raw numbers into actionable data. Using this data, and the charts and graphs created from it, executives can spot areas operating inefficiently. For example, machines are down and staff is doing make-work while waiting for earlier cycles to complete.

Having access to real-time numbers lets these leaders know where changes can occur, boosting overall production.

iCM helps chemical companies hit their growth targets. It integrates seamlessly into D365’s Finance module, providing impeccable security. Among iCM’s value propositions are:

  • Built-in labeling and safety data sheets (SDS)
  • Fully integrated SDS management
  • Real-time SDS data sheets are consistent and compliant with Global Harmonization System requirements

These SDS features reduce the total cost of ownership (TCO) by removing the need to maintain product safety documentation and data in-house.

iCM becomes the repository of record for all regulatory data while making it accessible to authorized D365 users. It also integrates SDS authoring at the formula/item level, embedding workflows for authoring and approvals.

Xcelpros’ product adds to one of D365’s many strengths: its labeling prowess. The Supply Chain Management module lets companies track products from the moment raw materials arrive in their warehouse to the instant a customer receives them. iCM builds on the existing technology, further focusing on the chemical industry.

For example, iCM becomes the system of record for all labels, integrating them into operational workflows like production and shipping. To learn more, download the iCM brochure.

Figure: 3Translation Service Process in Dynamics 365

Translation Service Process in Dynamics 365

Customers using D365 also have access to the Dynamics 365 Translation Service (DTS). Hosted in Microsoft Dynamics Lifecycle Services (LCS), it uses a machine translation system to maximize translation output quality. It also recycles linguistic assets from D365 and partners, such as Xcelpros. DTS is compatible with D365 Finance, Commerce and CRM modules among others.

Summary

Chemical companies face potential mistakes common to all growing businesses. In addition, they also face certain hurdles that other industries do not. Regulation is a major issue for chemical companies, especially those who rely on raw materials and finished products made outside the U.S. or shipped overseas.

Taking advantage of technology like Microsoft Dynamics 365 and Xcelpros’ unique Integrated Chemical Management software can help prevent these mistakes and let executives continuously grow their companies.

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References: Distribution Of Mislabeled Products In Interstate Commerce

Overcoming Chemical OSHA Compliance Challenges using Technology
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Overcoming OSHA Compliance Challenges in the Chemical Companies using Technology
Overcoming OSHA Compliance Challenges in the Chemical Companies using Technology 700 500 Xcelpros Team

At a Glance

  • Differing definitions of what’s considered hazardous makes it tough for chemical companies to comply with rules that could vary from region to region.
  • Chemical companies face daunting regulatory and operational challenges when complying with workplace safety rules.
  • Finding ways to make compliance smoother is crucial to chemical companies.
  • Using modern technological tools such as Integrated Chemical Management for Microsoft Dynamics 365 (iCM) can help chemical companies comply with complex, confusing rules and regulations.

Introduction

The chemical industry is constantly under increased scrutiny due to potential health and safety risks inherent to its workforce. These companies continuously face challenges following current regulations, applying updates, ensuring accurate documentation and following labeling guidelines. Chemical companies need to be able to carry out hazard determinations, have a full understanding of applicable regulations and stay up to date on OSHA guidelines. Those that don’t, risk exposing themselves to additional inspections and the possibility of serious fines. Thankfully, more companies are finding that compliance ratings can be improved using cutting-edge tools and technologies.

Occupational exposures, exposure to lead and acute poisonings resulting from unsound management are estimated to account globally for 1.3 million deaths.Source: The World Health Organization

Regulatory Compliance Challenges

Some of the regulatory compliance challenges facing chemical companies include:

  1. 1.Data Management: Regulatory changes can require wholesale updates to a chemical company’s data management system. “The Final Rule to Improve Tracking of Workplace Injuries and Illnesses does not add to or change an employer’s obligation to complete, retain and certify injury and illness records. It only requires certain employers electronically submit some of the information from these records to OSHA,” the department states. Complying with this rule may require costly updates.
  2. 2.Geographic Barriers: Chemicals are used, supplied and manufactured worldwide. The definitions of hazardous chemicals can change with every region. Having to include environmental and workplace safety laws that can vary from state to state, not just country to country, makes it tough for companies to stay on top of the laws.
  3. 3.Language Barriers: Moving chemicals from one part of the planet to another means manufacturers and shippers are also likely to run into different languages, which can add problems.
  4. 4.GHS Labeling: OSHA states the Globally Harmonized System (GHS) of Classification and Labeling “provides a common, coherent approach to classifying chemicals and communicating hazardous information stored on labels and data safety sheets,”. GHS also helps reduce trade barriers and increase productivity for American businesses that handle, store and use hazardous chemicals. Complying with GHS standards, which OSHA has enforced in the United States since 2012, requires chemical containers to have a harmonized signal word, GHS pictogram, a hazard statement for each hazard class and category plus a precautionary statement. Chemical companies need to be agile enough to monitor and adapt to these updates.

Role of Technology in Meeting the Dynamic OSHA Compliance Needs

More and more, chief experience officers (CXOs) and chief executive officers (CEOs) of chemical companies around the world are realizing the benefits of applying cutting-edge technology to chemical regulatory compliance. Using newer products such as Integrated Chemical Management for Microsoft Dynamics 365 (iCM) is the best way for chemical companies to keep pace with dynamic OSHA guidelines. Tools like iCM can integrate with a company’s existing data to make it more agile and effective.

ICM is the chemical industry’s first overarching tool designed to help automate Safety Data Sheet (SDS) authoring and maintenance, GHS-compliant label management and safety management compliance. Aside from ensuring compliance with changing OSHA guidelines, ICM helps organizations with the following:

  • Centralizing data, making it easier to access. Any changes in data enjoy increased visibility and can be tracked across different functions and regions.
  • Removing the need to pay for outside labeling and SDS authoring.
  • Reducing manual data inputs and related errors.
  • Providing real-time maintenance and updates to SDS and label management while remaining in compliance with existing GHS guidelines.
  • Reducing time-to-market through greater efficiency.
  • Promoting better OSHA compliance through integrated Safety Data Sheets (SDS) management and by removing the need to maintain paper product safety documentation.

Figure: 1Key Functionalities of Microsoft Dynamics iCM

Integrated Chemical Management Key Functionalities

This is a critical aspect for staying power in the industry. Chemical companies need to audit and update their IT infrastructure to ensure processes and procedures stay current with any changes to OSHA and GHS guidelines. GHS guidelines for example, have been updated five times since 2012, and most recently in 2019.

Updating data collection technology not only promotes better legal compliance, it also improves safety in the workplace, better protecting employees, and the environment, from the misuse of hazardous chemicals.

Today’s customers are more aware of potential chemical hazards than ever before. They are more likely to use a company that takes safety guidelines seriously. Adapting and leveraging advanced technologies is an integral way chemical companies can improve their OSHA compliance and boost their brand presence.

For those companies finding the ever-changing landscape of OSHA guidelines intimidating, updating to iCM can make managing regulatory compliance a much smoother process.

Key Takeaways

  • Managing regulations across the supply chain from raw material suppliers to end customers is easier with the help of a comprehensive system like Microsoft Dynamics 365 with iCM.
  • Chemical companies can use technology experts to smoothly implement the latest tools and ensure compliance to health and safety rules.
  • Obeying safety and environmental regulations improves the public’s perception of a company’s brand.

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