CMMS Software and 21 CFR 11 Compliance, Part 1: What You Need to Know
Today I got a phone call from an MPulse customer, Eric, who is a maintenance manager at a biotech company. He’s planning a maintenance software upgrade, and he had a good question: “Steve, I’ve got a coworker telling me our CMMS solution needs to be 21 CFR 11 compliant. Is MPulse Software certified for 21 CFR 11?” That’s a great question, but the answer isn’t simply “Yes” or “No.” What is Title 21 CFR, Part 11? If you work in the pharmaceutical, medical device, biotech, or related industry, Title 21 CFR Part 11 is a major part of your operations. The name refers to the part of Title 21 of the Code of Federal Regulations that establishes the U.S. Food and Drug Administration (FDA) regulations on electronic records and electronic signatures—defining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Naturally, 21 CFR 11 compliance is closely tied to software. And in the maintenance department, that software is—of course—CMMS software. Can CMMS Software Be 21 CFR 11 Certified? Eric’s question, however, relates to a common misconception about software and compliance. To be Title 21 CFR 11 compliant, Eric’s organization must show it has… Procedural controls Administrative controls Technical controls. Now a software vendor can provide the technical elements of a 21 CFR 11 compliant system, which MPulse Software factors—procedural and administrative controls—relate to the organization’s process, not the tool. So the answer to Eric’s question is MPulse Software provides the technical elements of a compliant system. However, we do not claim compliance as the bulk of compliance is related to the use of the tools, not the tools themselves. As such, there is no recognized certification process for software developers. Just like you cannot buy a 21 CFR 11 compliant socket wrench, you cannot buy 21 CFR 11 compliant software. It’s an important distinction that is sometimes not fully understood. However, CMMS software is the best tool for maintenance departments to achieve the technical controls for 21 CFR 11 compliance as well as other regulatory certifications like ISO or HIPAA or Sarbanes-Oxley. Learn more about the tools you need for CMMS and CFR 11 compliance. Or contact MPulse with questions. We have the answers you need.
Infographic: How to Calculate the Return on Your CMMS Investment
When our MPulse team talks with maintenance managers who are researching CMMS software, we get a lot of similar questions, such as… How can we use CMMS to reduce our company’s equipment downtime? How can CMMS help me control my costs of maintenance? How does CMMS save us money? How can we use CMMS to make our maintenance team more productive? How can CMMS software help us manage our parts and inventory? Although the questions are different, these maintenance managers are looking for the same thing—their return on investment (ROI) for purchasing CMMS software. CMMS Software is an Investment ROI measures the amount of return on an investment relative to the investment’s cost. And I believe CMMS software is an investment. Organizations want to see the return on their money. Also, like most successful investments, CMMS benefits compound over time. As your maintenance data becomes more comprehensive, your organization becomes more efficient and the return on investment climbs. Use Your Maintenance Data Effectively CMMS software helps your employees use maintenance data more effectively. Organizations can improve their maintenance processes and reduce costs through these five major areas: Labor costs through improved efficiencies Parts and inventory management Equipment downtime and emergency repairs Equipment life cycle and replacement forecasting Manufacturing scrap and rework It’s a great way to see the different components of CMMS ROI and how they can affect your maintenance operation. This quote from H. James Harrington on the infographic sums it up nicely: “Measurement is the first step that leads to control and eventually to improvement. If you can’t measure something, you can’t understand it. If you can’t understand it, you can’t control it. If you can’t control it, you can’t improve it.” That’s maintenance software in a nutshell. CMMS software helps you measure the productivity of your operations, which gives you a deeper understanding of your maintenance processes, and therefore the ability to improve them where necessary. Have questions? Want to talk about the ROI of MPulse Software, Inc? We’re here. Give us a call.
Find Labor Cost Savings with CMMS Data
Maintenance managers know unexpected tasks pop up. These days, those unexpected tasks come not just from the plant floor or the field, but from the management team. A long-time MPulse customer, Glen, experienced this phenomenon when his managers asked him to analyze the labor costs for his maintenance team of ten people. His company’s accounting folks had noticed the maintenance team’s overtime costs were steadily increasing over time. “I was surprised when they showed me the numbers,” Glen told me. “Overtime pay was increasing so slowly, I didn’t notice how much extra time my team was putting in. It simply became part of our work week because it had to get done.” CMMS Software Has the Answers One of CMMS data’s most powerful benefits is maintenance managers can answer questions they never dreamed they’d need to ask when they starting using the software. That flexibility is invaluable in our ever-changing, modern maintenance world. CMMS software helps maintenance managers accurately estimate labor hours for both repair and preventive maintenance (PM) tasks, so they can balance staffing levels and the workload as well as reduce overtime costs. CMMS reports also can determine when it’s more efficient to add more staff members instead of paying current employees more overtime. Using his CMMS data, Glen charted out the time his maintenance techs spent on jobs. The data was clear—each team member was averaging 3‒4 overtime hours per week. With a little information from human resources, he calculated his company could save about 40% of their current overtime costs by hiring another full-time maintenance technician. Gold Mine of Maintenance Data Glen never imagined he would need this kind of data when he implemented his MPulse Software, Inc. But the steady collection of maintenance data over time meant it was available when he needed it. And his data’s value will keep growing with every work order or parts purchase. Interestingly, Glen didn’t stop with that first analysis. He also used his CMMS data to determine which employees were most efficient at which tasks, enabling him to balance the workload. By tracking repair times, he also created benchmarks for the team. Then he identified areas where his team needed more training or when it might be more efficient to outsource the repair. “I was sitting on a gold mine,” Glen told me. “All this fantastic information was in my maintenance software, and all I needed to do was ask the right questions.” Start mining your own CMMS gold. Contact us to get started.
Give Your Organization a Competitive Edge with Maintenance Management Software
Recently I had a meeting with Ted, a long-time MPulse user and maintenance manager for a medium-sized manufacturing company. Like so many others, Ted’s organization recently found itself fighting for market share as the competition lowered their prices—forcing his company to do the same. Ted’s bosses started looking at every expense to keep the company competitive. Maintenance teams get a lot of questions when company officials look at costs because they keep the organization’s major assets running—production equipment in Ted’s case—which is a big line item on a balance sheet. As they looked for ways to save money, Ted’s bosses wanted hard data on maintenance costs and asset productivity. Management Asks Tough Questions While Ted’s managers understood that cutting back on maintenance can be counterproductive, they also needed to see the dollars were spent wisely. Ted’s management team began looking closely at maintenance staffing levels and overtime costs. They wanted to know when it was more cost effective to repair an asset or replace it. They asked questions about the biggest repair parts expenditures and wanted ideas to improve inventory control management. This phenomenon is increasingly common in the maintenance world. It’s called data-driven management, which means decisions are made based on reliable data, instead of perceptions or assumptions. CMMS Provides Solid Answers CMMS software is the best tool for gathering, analyzing, and reporting on maintenance data. In just minutes, Ted created reports using his MPulse CMMS data to show how his department was functioning and where they might make changes to improve. Because Ted’s managers could see the numbers in front of them, the changes they made helped the maintenance team become more efficient—and the company more competitive. They invested in the areas where the savings were clear, and it paid off. Ted’s company is stronger than ever. Maintenance Contributes to the Bottom Line When Ted shared his experience with me, he mentioned something else that I found interesting. After reviewing Ted’s reports, his management team began to see the maintenance department in a different light. Company executives could clearly see the value his maintenance team brought to the organization, and respect for his department grew. That made it easier for Ted later when he needed to get approval or support for his projects and ideas. It’s likely your maintenance team is experiencing a similar situation, or it will be soon. With solid CMMS data and easy-to-read reports, your organization can make good decisions based on hard evidence, which will improve its ability to compete effectively and efficiently. And that’s something that works to everyone’s benefit. Contact us for more information.
Five Ways CMMS Can Make a Facility Manager’s Job Easier
I recently had coffee with my long-time friend and customer, Teresa, who’s a facility manager for a major university. Talking to Teresa reminded me how facility managers are constantly pulled in different directions, and prioritizing is complicated. “How do you keep on top of everything?” I asked her. “The biggest challenge is we’ve had to really tighten our security measures in the past 15 years,” she said. “That means a lot more paperwork. Honestly, I don’t know how we’d do it without our MPulse CMMS software. It makes all the difference.” I blushed a little here, but I asked her: “How does CMMS software make your job easier?” Teresa listed off these five ways… 1. Systems Integration: Teresa’s organization is a large, state-run institution, so she needs to share information all the time. Her MPulse CMMS software easily shares data with departments from purchasing to human resources to executive administration. Plus, it works both ways, so her CMMS software collects key data too. That means Teresa spends less time on paperwork and more time on her important tasks. 2. Flexibility: Teresa’s department has been an MPulse customer for years, so we’ve been there whenever they needed to upgrade, add licenses, or train new employees. Plus as the university has grown by adding buildings and assets, MPulse’s flexibility has enabled their CMMS software to grow with them—no matter how much the maintenance team’s workload has increased. 3. User Management: Teresa uses MPulse’s Role-Based Access Control (RBAC) extension module to manage her team and customers. That means her staff members or service requestors only see the records that are relevant for them. RBAC also helps Teresa with data security, making sure private information remains private. 4. Security: As Teresa mentioned, security has really ramped up in facility management. Teresa’s team uses MPulse Key and Lock Management to manage and track keys as well as authorized users, reducing the problem of lost or misplaced keys. At a glance, her team knows who has which keys out and when they are scheduled to be returned, so they spend less time searching for keys or following up with staff members. 5. Mobility: Maintenance doesn’t happen in the office. Teresa’s team uses MPulse’s adaptive interface and smart devices to report problems as they find them and capture data when they are working on the job. Best of all, her team members don’t need to come back to the office to get the next work order—they can see their work assignments wherever they are. I was pleased to hear how MPulse Software, Inc is making a difference for Teresa and her team. This business is about more than the bottom line. Helping people like Teresa do their jobs faster and more efficiently is a big part of what makes it satisfying to come to the MPulse offices every day. And the coffee’s not bad either.
KISS Principle: Achieving CMMS Success is as Easy as 1, 2, 3
Yesterday I asked a new MPulse customer: “Jim, what’s keeping you up at night?” It’s same question I’ve asked our clients for years. Yet I’m still surprised at how often I get the same answer. Most maintenance managers say almost exactly what Jim told me: “Steve, I need to figure out where I start with this new CMMS software.” Jim isn’t alone. Many new CMMS users feel exactly the same way. The answer I gave Jim hasn’t changed much over the years either. The best way to start with a new CMMS is to follow the KISS Principle—“keep it specific and simple” or, more colorfully, “keep it simple, stupid.” The KISS principle maintains that most systems work best if they are kept simple rather than made complicated. Now Jim is a smart guy, like most maintenance managers I’ve met. But he’s overwhelmed at the thought of what he needs to accomplish—which is also true for a lot of maintenance managers. So how do we boil down a CMMS implementation plan to the simplest steps? Here’s what I suggest. 1. Focus on Key Assets Take 10 minutes and write down your top 10 to 20 assets. Think about the ones your team spends the most time or money on, and those most critical to your business’s success. Then, for each asset, set up the PM schedule in your CMMS software. Tell your team that it’s now mandatory to log all PMs and repairs on those key assets in your CMMS. And tell them that you’ll be checking to ensure it’s been done. 2. Provide Regular, Consistent Feedback Create a report in your CMMS that tells you when and if the PMs and repairs on your key assets are being done. Check it weekly and follow up with your team members with “atta-boys” for completing them correctly, or with reminders and corrections when they’re not. Post the reports in a public area. It’s imperative that you do this regularly and that you let them know you’re checking. Once you’ve proven it’s important to you, it will become important to them. And the feedback conversations will give you opportunities to fine tune and improve how you’re using the CMMS. 3. Slowly Add More Assets Now simply repeat step 1 with 10‒20 more assets. Over a relatively short period of time, something that was new and scary will become routine for all the assets you want to track in your CMMS. By keeping things simple with these three steps, you’ll be surprised how a seemingly daunting project turns into a successful implementation. Managing maintenance with a CMMS is the fastest way to get visibility into your operation, see where there’s room for improvement, and find out where you’re spending your dollars. Before you know it, you’ll be on your way to achieving the bigger goals of CMMS software—reducing failures and emergencies and increasing the usable life of your assets.
Get CMMS Buy-In from Your Toughest Stakeholders: Maintenance Technicians
Gaining buy-in from your maintenance technicians is essential for the successful implementation of CMMS, as their engagement directly influences the system’s effectiveness and long-term impact. After working hard to get purchase approval for his new maintenance software, Chuck called me up with a pretty typical problem. “Steve,” he said. “My maintenance techs are really making it difficult to get this CMMS project off the ground. All they do is complain about how much time data entry in the field is gonna take. This isn’t gonna work if my guys cut corners because they just don’t wanna take the time to use the system.” Oftentimes, maintenance managers focus so strongly on getting upper management to approve their purchase request, they forget all about other key stakeholders. One of the worst groups to leave out is the maintenance technicians who will use it every day. CMMS Buy-In from Stakeholders The people responsible for the bulk of the CMMS data entry are also the people who will benefit the most from it. But it’s your job to help them understand that. The key is showing them how to embrace the output. In other words, “What’s in it for me?” I call this the “WIIFM.” I believe maintenance techs get two huge benefits from CMMS software: More efficient workflows Less finger-pointing when things don’t go as planned. CMMS Makes Maintenance Work Easier CMMS software stores and organizes data gathered by your technicians, who in turn will use that data later on to do their jobs better and faster. Your maintenance techs will suddenly have access to key information that will become invaluable, including… Work history Condition monitoring Access to vendor information, guides, and manuals Inventory/parts availability. With CMMS data at their fingertips, your maintenance techs can answer questions quickly, access key information, see trends, and make faster decisions. They can do their jobs more efficiently and reap the rewards accordingly. CMMS Has Their Back Your techs know that when things go wrong, the maintenance department often gets the blame. Here’s how CMMS can support your maintenance techs when things aren’t going well: Validate the issue and provide the big picture Show who did what when Measure accomplishment Make the process visible Reduce stress level. With CMMS, it’s not their word against someone else’s. Now they have verifiable proof that they did what they needed to do when it needed to happen. Make Sure You Have Their Back Too If your maintenance technicians have concerns about your new CMMS software, make sure you hear them. Take the time to figure out what they are really worried about. Also, remember many concerns can be alleviated with good training, so make sure your implementation plan includes the funds to get them up and running. If you want your maintenance techs to support your project, make sure you have their back too. They may be your toughest stakeholders, but they’re also your most important allies. Have questions? We have answers. Contact us.
Is It Time to Schedule a PM for Your CMMS Software?
Your CMMS keeps your team on top of your preventive maintenance (PM) tasks for your assets and equipment. But when is it time to step back and perform a PM on your CMMS itself? Technology changes fast, and if your CMMS hasn’t had a good review in a few years, you’re probably missing out on updates that’ll make your team work faster and better. If there’s anything I’ve learned in this business, it’s that things change. When you’re caught up in your day-to-day work, it’s hard to step back and see the bigger picture. But that’s exactly what good maintenance managers do. It’s not enough to know what you’re doing now. Be proactive by making sure your maintenance team has the right tools to meet tomorrow’s demands too. Here are a few things to think about when crafting your “CMMS PM Checklist”: How Often Should You Schedule a PM for Your CMMS Software? I suggest checking in every six months. Schedule some quiet time away from your office to think about what’s going on and what you need to do. Make a list of the easy stuff first. If you’re on a software maintenance plan, have you downloaded any updates? Are there reports you need that you haven’t taken the time to set up? Are there reports you previously created that are really working for you anymore? Does your organization have plans to purchase new assets? Do you have enough user licenses for new employees? Ask Yourself the Tough Questions After you write down the easy stuff, don’t shy away from the questions with hard answers—or no clear answers at all. What’s making you nervous at work? What changes have you noticed and how will they impact your maintenance team? What resources might help you successfully navigate these changes? Get Feedback from Your Users Check in with your team to make sure they really are working as efficiently as possible. Do you have new employees who would benefit from some training? Could other team members use a refresher? Do you have new service requestors who need help on the best way to fill out work order requests? Does anyone have questions or ideas for doing things better? Ask for Help Pick up the phone and ask for help when you need it. Your CMMS vendor likely has some effective and affordable services to expedite your path to improvement. You don’t have to do everything yourself. Look for services like MPulse Reset, which helps our customers reconfigure workflows and benchmarks, and then determines where adjustments to your CMMS software can help. Good maintenance managers know that plans are fluid, and they need to adapt to changes in their organization. Scheduling PMs on your CMMS software has the same effect as it does on your other assets—protecting your investment and maximizing your maintenance savings for your organization.
Mobile CMMS Technology is Now a Must-Have
The future CMMS mobile technology is here. After more than two decades in the maintenance software industry, I’ve seen lots of technology changes. But I’ve never seen anything that’s been as readily and widely adopted as modern mobile technology. The smartphone I carry in my pocket today is far more powerful than my first desktop computer. It’s transformed the way I do business, from how I communicate with employees and customers, to how I track sales numbers and learn about what my competitors are up to. Mobile devices are clearly changing the way maintenance operations work, too. The recent Mobile CMMS Software UserView survey from Software Advice sought to understand how maintenance organizations were using mobile. It demonstrates why mobile CMMS functionality is now a “must-have.” Among its top findings, it showed that… Tablet users reported the greatest efficiency increases, Real-time data access and easy-to-use interfaces topped requirements lists, and Older users demonstrated the least improvement in efficiency from mobile tech. It’s clear that many organizations have discovered mobile technology is a natural fit with maintenance workflows—and mobile CMMS, specifically. It allows maintainers to access information and record data on the spot—where maintenance happens, instead of in a plant or campus office. I’m convinced every MPulse customer can benefit from mobile technology, and I think it’s on the cusp of transforming the way CMMS fits into maintenance workflows. Software Advice’s findings helped me better understand the ways mobile technology is being used in the maintenance world—and what maintainers should be thinking about as this technology becomes ever more commonplace. Here are a few of my key takeaways. Old Dogs and New Tricks Organizations using mobile devices in maintenance operations are reporting some impressive efficiency gains. 43 percent of respondents reported a significant increase in efficiency, with another 28 percent reporting a moderate increase. That’s encouraging, because increased efficiency is what CMMS users want most of all, and mobile devices are helping them get there. Dig a little deeper into the data, though, and you’ll quickly realize one of the key challenges in mobile adoption. It’s still hard to teach an old dog new tricks. As you might expect, younger employees account for the bulk of efficiency increases, because they’re more comfortable with the future mobile technology. Efficiency Increase by Age Group Part of the solution to this problem involves companies like MPulse continuing to make future mobile technology easier to use. And we’re working hard to do so. But you can get ahead of the game by ensuring your older employees get good, hands-on training on mobile tech. Don’t just assume they know how to use the latest apps—or that they’ll figure them out, like “digital natives” tend to do. Tablets Rock All mobile devices are not created equal, and maintenance technicians are already leaning toward tablets over smartphones. 44 percent of those surveyed report using a tablet, versus 34 percent who use a smartphone. Based on personal experience, I wasn’t surprised at this finding. A tablet’s larger screen size (when compared to smartphones) is easier on the eyes, and allows big, hard-working, indelicate hands to more easily work buttons and drop-downs menus. As smartphone screens (like Apple’s iPhone 6 Plus) continue to grow, though, we may see some changes to these numbers. Consider providing your employees with large-screen devices like tablets or big smartphones. It will go a long way to encouraging adoption of the technology and will eliminate some frustration along the way. Real-Time Data is King When it comes to what CMMS customers expect from mobile CMMS, real-time data tops the list. 40 percent of respondents said it was their number-one priority. Ease of use came in a close second. These top two requirements make perfect sense, when you remember CMMS customers strive for improved efficiency. Access to real-time data is the best way to save time and help your maintenance staff boost productivity. And an easy-to-use interface means better acceptance from your workforce and a better way for maintainers to quickly enter data on the job. Be sure to highlight these two key requirements to your CMMS vendor as “deal breakers” if they can’t provide them. You don’t want to get stuck with mobile technology that’s hard to use and doesn’t give you immediate access to the data you need. If they can’t fulfill these requirements, you should look elsewhere. Mobile CMMS is Here to Stay If these findings haven’t convinced you that mobile tech is here to stay, consider this sobering fact from a recent Boston Consulting Group study, titled The Mobile Revolution: How Mobile Technologies Drive a Trillion-Dollar Impact: Small-to-medium enterprises (SMEs) “that are mobile leaders are winning. Typically, the 25 percent of SMEs that use mobile services more intensively see their revenues growing up to two times faster and add jobs up to eight times faster than their peers.” The organizations that aren’t? They’re falling behind. Truly capable mobile devices are still relatively new to the maintenance management world, but they have huge potential to change the way maintainers track data. Mobile CMMS can help your team spend less time on the computer and more time doing what you hired them for—maintenance.
CMMS Setup: Get it Right the First Time
Many MPulse customers get so excited about their new CMMS software they want to jump in with both feet and start entering data right away. I get it. I feel the same way when I start a new project. But the old adage “garbage in, garbage out” says it all when it comes to setting up CMMS software for the first time. It’s important not to get carried away importing outdated, incorrect, or insufficient information. To get the most out of your CMMS investment, you need to proceed carefully so you have a solid foundation of good data that will build in value over time. If your CMMS software gets bogged down with bad data, you’ll never get truly meaningful information about your assets—which is why you bought the software in the first place. So how do you setup your CMMS software right the first time? Here are a few tips I’ve picked up through years of experience. Step 1: Identify Your Key Assets Start by making a list of 10-20 of your important assets. You can always add more assets later, but first pick the ones that play the largest part in your operations. They’re likely to be the ones your maintenance team works on most, so a quick review of your past year’s work orders should show you where to focus. Step 2: Determine Each Asset’s Maintenance Policy Next determine the best maintenance policy for each asset. Plant Services contributing editor David Berger, in his 2013 article, “How to determine the best maintenance policy,” outlines three ways maintenance can be triggered: use-based maintenance, fail-based maintenance, or condition-based maintenance. Use-based maintenance (UBM) is triggered by time, meter, or event. This type of maintenance is pretty common in maintenance departments, as preventive maintenance programs are based on a certain time, meter, or event triggers—such as changing the oil every 3,000 miles or every 3 months. Fail-based maintenance (FBM) is running an asset to failure. A simple example would be replacing a burned out lightbulb. While the point of CMMS is to reduce fail-based maintenance in favor of a more proactive maintenance plan, there are some exceptions. Plus, if your assets have been maintained based on failure in the past, you have important data that can help you predict future failures. Condition-based maintenance (CBM) is triggered based on meters and gauges on assets. When an asset’s condition changes outside of a specified range, maintenance events are triggered. CBM data can be gathered manually or automatically. Step 3: Build a Work Plan Once you have determined each asset’s maintenance policy, you can use your CMMS to build work plans. For assets on a UBM policy, you’ll build a work plan and schedule maintenance tasks based on the factors you’ve chosen. For CBM, you’ll create a range of conditions that will form the basis of a work plan and schedule as well as forecast when CBM will likely occur. Last, but not least, while it’s hard to plan for FBM, you can forecast when failure is likely to happen and ensure you’re ready to react, with the right parts in stock and repair procedures in place. Step 4: Support the Maintenance Plan with the Right Data Next you’ll decide what data you need to capture to support your plans. Some may be available in your archives, but much of it will need to be collected from this point forward. And that’s okay, because over time, it will grow in quantity and in value. If you choose the right data, it won’t be long before you realize its value—and you’ll be glad you took the time to get it right. Creating a solid foundation with good CMMS data will make everything run more smoothly and successfully. Don’t create more work for yourself by taking shortcuts on the front side just because you’re in a hurry. Take the extra time to get it right the first time, and your CMMS investment will pay dividends for years.