Maintenance Work Management for Pharmaceutical Companies
Almost every business today relies on machines of one type or another. You could argue the human brain is a sort of machine as well that requires maintenance.
Things like a resting period or a vacation all count as a form of maintenance. The stakes for our brain’s maintenance are the absolute highest, and we need to make sure we maintain it to the best of our abilities.
Similarly, maintenance in the pharmaceutical industry is incredibly important. The industry responsible for researching and developing medicines for the well-being of humans and animals should have the highest levels of maintenance standards.
In this post, we’ll go over the importance of Maintenance Work Management (MWM) in the pharma industry, common challenges faced, key elements of a successful MWM system, and best practices for implementation.
What is Maintenance Work Management?
Think about a car and all it takes to keep it running. The engine must run, the wheels must turn, the brakes must work, and the fuel must flow. A systematic approach is necessary to get things done the right way.
Maintenance work management is this systematic approach, making sure a facility or equipment keeps working with the highest possible level of reliability and operational efficiency.
For pharmaceutical companies, this involves taking intense care of highly sensitive machinery, such as tablet press machines, microscopes, dry heat sterilizers, and HVAC systems. It also includes routine inspections of cleanroom environments to ensure compliance with GMP standards. (Of course, legal standards must be met or ideally exceeded.)
Taking a structured approach like this helps operations run as expected, with efficiency and adherence to the strictest compliance regulations and moral standards.
Why Maintenance Work Management Matters in Pharma
The expectations of a high standard, safe product are applied to every industry, but more so to pharmaceutical companies than perhaps any other. It cannot risk not meeting the standards, and without proper maintenance work management, a pharma company will be unable to meet the high standards required for quality, safety, and compliance. Let’s break it down further to understand the gravity of the situation:
- Compliance and Regulation
Pharmaceutical companies are tightly regulated by bodies like the FDA, EMA, and WHO that keep them under a microscope, no pun intended. These bodies enforce the guidelines provided by, for example, Good Manufacturing Practices (GMP) and rules by the FDA.
A singular piece of equipment relevant to the end product’s safety standards, for example, being unfit, could result in legal action, fines and, on the far end of the spectrum, risk getting shut down. So, maintenance in the pharmaceutical industry matters because it ensures all equipment operates within these strict standards, and companies can keep a detailed record of repairs and inspections to pass audits.
- Product Quality and Safety
Every company needs to make sure their product is not hazardous, and that is the Voldemort word for a pharmaceutical company. A product must not be deemed unsafe when its sole purpose is to improve health. The quality of pharmaceutical products directly impacts patient safety. Contaminated or improperly manufactured drugs can have serious health consequences.
- Unplanned Downtime Costs a Lot
The pharmaceutical industry globally was valued at $1.6 trillion in 2023. [1] While not strictly a study about pharmaceutical companies, large plants from various manufacturers were reported to be losing a staggering $129m per year (in certain sectors) due to unplanned downtime and the number was only predicted to increase, as it had already been doing so. [2]
Equipment breakdown, after all, brings a halt to the entire cycle and results in idle time for both machinery and employees. Deadlines are missed, which is detrimental to both the market and the individual, especially considering this industry is essential to the well-being of society on a very fundamental level.
- Equipment Longevity and Managing Costs
Machinery is expensive. Regular upkeep is manageable, provided it is done on a consistent schedule and fixing a machine that has broken down is, again, expensive.
Reactive maintenance, which is fixing equipment only when it breaks, is quite an investment, especially if it happens regularly. Going back to our car metaphor, oil changes are always cheaper than engine repairs. Moreover, with regular maintenance, the lifespan of a machine drastically increases, fetching you a much better ROI.
- Environmental Duties
Every industry must owe something to the planet upon which it goes about its day. When machines run efficiently, due to proactive maintenance, they use less energy and create less waste. This aligns with global efforts made by every business around the world to minimize their environmental impact. Every step counts, and being such a giant, the pharma industry must set a good example.
Common Challenges in Pharmaceutical Maintenance
Meeting the rigorous requirements for regulatory compliance is essential. To address these challenges effectively, it’s important to understand the common challenges companies face in managing their maintenance processes. Here are some of them:
- Regulatory Compliance: Since pharmaceutical companies are held to incredibly high standards by regulators, maintenance activities must meet these requirements and have thorough documentation to prove them. Oversights can lead to costly fines and damage a company’s reputation.
- Reporting: Any adverse event that occurs within a pharmaceutical facility, especially if it involves the product, must be reported immediately. Failing to do so leads to compliance issues due to delayed reporting and an inability to identify the core issue.
- High Stakes of Equipment Failure: Equipment failures can have serious consequences. The entire production line may be derailed, and pharmaceutical products are often time-sensitive. A breakdown can compromise raw materials and call product sterility and effectiveness into question.
- Complexity of Machinery: Modern medicine is a marvel, but it’s made possible by the dedication of everyone in the industry. The machinery used to produce pharmaceutical products is highly sophisticated and requires skilled personnel and specialized tools. Acquiring both can take valuable time, especially when every second counts.
- Working Under Deadlines: Given the critical role of the pharmaceutical industry, the demand and supply for products are consistently high. Constant production can place overwhelming loads on equipment. Without proper scheduling, machinery can break down, causing missed deadlines.
- Dependence on Predictive and Preventive Maintenance: To prevent unexpected breakdowns, both predictive and preventive maintenance are necessary. However, these methods are resource-intensive. Thankfully, CMMS (Computerized Maintenance Management Systems) software can assist in managing these processes. More on this later.
- Documentation Overload: The administrative burden of maintaining accurate and detailed records is immense. This task is almost impossible without digital tools to manage and organize documentation.
- Spare Parts Availability: Maintaining supercars is difficult because they are rare machines with scarce spare parts. The same logic applies here. The challenge is further intensified by the need for a highly skilled and experienced workforce to manage such sophisticated systems.
- Corruption, Supply Chain, and Fraud: Bad actors exist in every industry. However, within the pharma industry, they can be an absolute menace. Slack, bribery, improper handling or storage, and unauthorized distribution of products can result in patients receiving potentially harmful products. This puts both the company and the consumer at risk.
Key Elements of a Maintenance Work Management System
An efficient maintenance work management system is important for equipment reliability, minimizing downtime, and optimizing costs. Below are the four core elements that make these systems effective:
- Preventive Maintenance (PM)
The focus of preventive maintenance in the pharmaceutical industry is to stay ahead of potential issues by scheduling regular inspections and upkeep. Tasks like lubrication, filter changes, and other routine maintenance activities are planned to address wear and tear before they become significant problems.
By addressing these early, you greatly reduce the risk of equipment failures, save money, and extend the lifespan of your assets. Preventive maintenance schedules are based on time intervals or usage metrics.
- Predictive Maintenance (PdM)
Predictive maintenance brings modern technology into the equation. By analyzing real-time data, your company can predict when equipment issues are likely to arise. Unlike preventive maintenance, which follows a set schedule, predictive maintenance continuously monitors machinery and relies on a historical database of its performance.
For example, tracking vibration levels or temperature changes in a machine can signal a major issue. This allows employees to address problems beforehand, preventing breakdowns and saving valuable time and money. You can easily enhance pharmaceutical operations with predictive maintenance tools.
- Work Order Management
Effective work order management is needed for smooth operations. Without a system in place, tracking tasks becomes a manual and error-prone process. As the number of factors to manage grows, this approach becomes impractical.
A well-organized work order system makes sure no task is overlooked and that resources are allocated based on priority. A centralized work order system allows teams to track progress, document completed tasks, and generate reports for continuous improvement.
- Inventory and Spare Parts Management
Maintenance depends heavily on the availability of the right parts at the right time. For pharmaceutical companies, delays caused by waiting for parts to be shipped and installed can result in huge losses. An inventory and spare parts management system identifies the most-used and critical parts. With this data, your company can maintain optimal stock levels, avoid overstocking, reduce storage costs, and minimize downtime caused by waiting for replacement parts.
Best Practices for Maintenance Work Management in Pharma
If you want to reduce equipment failures, minimize costs, maintain product quality, and meet regulatory requirements, you must improve efficiency in work order management with proven strategies like these:
- Training Staff on Compliance Standards
Staff members are often too focused on their daily responsibilities, so staying updated on the latest regulations and standards from organizations like the FDA or GMP gets sidelined. Proper and thorough training is essential for the maintenance team to understand how their work impacts compliance. This knowledge empowers staff to be more proactive, reducing the risk of non-compliance or lapses in quality during maintenance processes.
- Using CMMS Software
A Computerized Maintenance Management System (CMMS) is an invaluable tool for effective maintenance management. It centralizes tasks like tracking maintenance history, monitoring pharmaceutical equipment maintenance process, and managing documentation. It automates preventive and predictive maintenance tasks, identifies recurring issues, and optimizes maintenance schedules.
For example, our CMMS+ solution, LLumin, can send notifications to technicians about upcoming maintenance tasks, flagging when required spare parts are unavailable. This allows for timely procurement and ensures maintenance activities proceed as scheduled.
- Integrating Maintenance with Production
To minimize disruptions, maintenance and production teams must collaborate. Scheduling maintenance during production downtimes or planned shutdowns reduces conflicts and makes sure maintenance activities are carried out effectively.
Moreover, establishing real-time communication channels between these teams helps in prioritizing critical equipment repairs and maintaining production quality.
- Prioritizing Predictive Maintenance (PdM)
Maintenance processes generally fall into three categories: predictive, preventive, and reactive. Their effectiveness aligns with this order. Predictive maintenance in the pharmaceutical industry uses technology, such as sensors and IoT devices connected to CMMS systems, to monitor equipment health and predict failures. To start, focus on equipment that has the greatest impact on production and build on that.
- Conducting Regular Risk Assessments
Proactive risk assessments identify potential issues that could disrupt production or compliance. The key steps include:
- Identify Critical Assets: Identify equipment that poses the highest risk if it fails.
- Evaluate Failure Modes: Analyze potential causes and mechanisms of failure.
- Develop Mitigation Plans: Create actionable strategies, such as adding redundancies or increasing maintenance frequency, to address identified risks.
Think of this as a contingency plan, like Batman’s strategies for the Justice League – tailored for machinery instead of superheroes.
- Focusing on Documentation and Traceability
Every maintenance activity in the pharma industry, from inspections to repairs, must be recorded with timestamps and the names of the personnel involved. CMMS tools can help store and organize these records, making sure they meet regulatory requirements. Periodic reviews of documentation will also help with compliance and highlight areas for improvement.
How LLumin Can Help with Maintenance Work Management
LLumin’s Computerized Maintenance Management System (CMMS+) is designed to address the critical needs of industries like pharma. By reminding yourself of the key elements and best practices of maintenance work management, LLumin helps you actually apply them.
It becomes the centralized location for documentation, such as maintenance logs and records. Besides helping you streamline your processes with a CMMS work order system, it simplifies the recording process and makes retrieving this information easy, which is incredibly important during regulatory audits and making sure operations comply with the regulations. Other features include:
- Track asset life cycles
- Control operational costs
- Maintain optimal stock levels
- Reduce unplanned downtime by ensuring proper inventory levels, leading to better maintenance planning and smoother operations
- Intuitive design with easy-to-access information
- Customizable dashboards for quick reference
- Reliable troubleshooting assistance
- Expert guidance for seamless implementation and usage
Our CMMS+ solution, which has AI capabilities, is able to put predictive maintenance into action by using real-time data to anticipate equipment issues.
LLumin is available on iPhone, iPad, and Android devices, allowing technicians to not only be notified of upcoming maintenance but also access work orders, record diagnostics, and perform tasks directly from the field.
Indeed, while all of the above tasks can be performed manually, it’s much more efficient to use a CMMS+. There’s no need to carry boulders on your shoulders when the wheel has already been invented. Make use of LLumin and align with the industry’s commitment to quality, safety, and efficiency.
Closing Thoughts
Maintenance work management, at face value, might appear as merely fixing things when they break, but it is so much more than that. It’s about keeping everything running while meeting regulations and industry standards and upholding the moral responsibility an industry like pharma has.
The key is to place major emphasis on preventative and predictive maintenance, and using LLumin’s CMMS+ solution makes doing so much easier. Doing so will allow your company to avoid the chaos of unplanned downtime.
FAQs
How do pharmaceutical companies benefit from work order systems?
Similar to every other industry, work order systems help pharma companies stay organized and on top of their maintenance tasks. They make it easier to track work requests, prioritize tasks, and assign them to the right team members. The result? Fewer missed tasks, faster response times, and an overall better workflow. In fact, we could argue work order systems are more important in pharma than in other industries because equipment downtime or missed maintenance can affect product quality and safety, something that simply cannot be allowed to happen.
What compliance challenges do pharma companies face in maintenance?
Pharma companies face several compliance challenges, including, but not limited to, Regulatory Compliance, Intellectual Property Protection and Data Management, Usage of Legacy Systems, Integration with Existing Systems (Many pharmaceutical plants operate with legacy systems), Access to Skilled Personnel and Supply Chain Compliance. However, with the right systems in place, these challenges are manageable.
Can automation improve work order management efficiency?
Absolutely! Automation makes life much easier by taking the manual labor out of work order systems. You can schedule preventive maintenance, track progress, and even get alerts for potential issues before they happen without having to manually track each step. This saves time, reduces human error, and helps keep everything running smoothly. In the pharma world, where no compromises can be made, automation makes sure everything is completed on time and in line with compliance standards.
References
- https://www.statista.com/statistics/263102/pharmaceutical-market-worldwide-revenue-since-2001/
- https://assets.new.siemens.com/siemens/assets/api/uuid:3d606495-dbe0-43e4-80b1-d04e27ada920/dics-b10153-00-7600truecostofdowntime2022-144.pdf
Karen Rossi is a seasoned operations leader with over 30 years of experience empowering software development teams and managing corporate operations. With a track record of developing and maintaining comprehensive products and services, Karen runs company-wide operations and leads large-scale projects as COO of LLumin.