When a global medical device company needed help setting up a reliability program, Marie Getsug was up for the task.
As a program manager of strategic consulting for asset management at Jacobs Engineering Group, she had the know-how—and the moxie—to be the firm’s change agent and develop a Design for Reliability (DfR) program from the ground up.
Simply described, DfR is a way to look at a project and the assets spanning all phases while honoring the perspectives of stakeholders across the entire lifecycle. Reducing the total cost of ownership (TCO) and avoiding strategic blunders are among its essential drivers.
One of the initial loopholes Getsug uncovered at the medical device company was that the product design group wasn’t consulting with the engineering group to ensure the products they designed were manufacturable. The disconnect created a gap that skewed knowledge about preconditions and limited the scope for lowering risks and increasing operational efficiency.
“The precision requirements for a needle in a syringe in an IV application specification are very precise,” said Getsug. “However, when those same precision requirements are applied to supporting components, they may not be necessary. And thus, it increased the expense by introducing that level of precision for a component that doesn’t require it.”
DfR is an approach that introduces “defect discovery” as a way to categorize previous lessons learned, best practices and industry experience to eliminate, reduce or mitigate failure modes so they don’t become future defects, Getsug explained.
From the standpoint of implementing a reliability program, the medical device company was unique in that it designed and produced every aspect of its medical devices and components, from IV systems to infusion pumps and accessories. In gauging what the company hoped its DfR program would bring, Getsug needed to ask a list of questions to assess the “manufacturability of a product” or efficiency of a process: Where’s your capital process right now? What do you currently do to manage capital projects that are going into the plant? Are the product tolerances based upon product requirements that provide optimum tolerance allowance in the transition to manufacturing?
This process of discovery unearthed a keystone requirement to have more stakeholders—including reliability and maintenance engineers—participate in capital project decisions, and influenced the overall criteria for the program she was to design in support of the corporate goal to double production capacity by 2020.
“Having run and maintained the equipment, their expertise, insights and standards ought to be included in the capital project and they should participate in the machine design aspects,” Getsug advised. She advocates that the alignment of all groups—from CapEx through OpEx phases—is fundamental to physical asset management. And, in the case of the medtech company, drawing attention to the impact of IV pump specifications on the next product and project was a springboard for further inquiry.
What is Design for Reliability?
The classic response: DfR is a methodology that blends aspects of statistics, probability, reliability theory, engineering analysis and subject matter expertise (SME) throughout a product or asset lifecycle to eliminate defects and evaluate, predict and verify the application of robust design.
“Reliability is certainly the goal; complex physical assets that are made up of systems and sub-systems depend on the reliability of their components,” explained Getsug. “Reliability is the probability that the asset will continue to perform its function over an interval of time, under specified operating conditions. It ensures functionality, performance, predictability and consistency. This all starts in the concept and design phase of an asset’s lifecycle.”
A successful DfR program depends as much on a practitioner's tactical experience as it does on the ability to integrate knowledge into decisions, said Getsug, a chemical engineer turned asset manager. While analytical work is at the centre of reliability engineering, the information and evidence come from the field, and this requires tapping into skillsets across the plant, as well as touchpoints in the supply chain.
Getsug’s penchant for predictive technologies, reliability-centered maintenance and DfR in particular are rooted in the mid-1990s when she worked at Unilever as a tallow business unit manufacturing manager and maintenance and reliability manager. Along with a team of predictive technicians, Getsug reinvented the way assets were used and fostered the multinational’s first team of predictive technicians in the U.S.
Since then, she has amassed certifications in reliability—she is the first woman, and among the first 10 globally, to earn her Certified Reliability Leader (CRL) Black Belt—and has formal training in ISO 55000 Asset Management Standards, as well as vibration analysis, ultrasound, lubrication, thermography and root cause analysis (RCA).
And if having the right credentials has allowed Getsug to do the job, her passion for helping people throughout her career is unfeigned. Back at Unilever, for example, Getsug was invited to be on the multinational’s Design Steering Committee for New Work Systems where she helped rewrite the union contract.
“Although the results of that experience produced a team that I was amazingly proud of, and who reinvented how we used the assets in our business unit to significantly increase the capacity of the company’s cash cow, I am most proud of the maintenance technicians who interviewed to be the first union predictive technicians for the plant,” Getsug recalled.
Design Out Failure Modes
The design and concept stages are the most significant triggers for DfR. Getsug characterizes it further as systematic, streamlined engineering that drives reliability into the asset lifecycle. She points out a few key considerations: Capital project decisions can affect facilities for decades, and it is why a DfR program introduces a set of tools that apply reliability concepts from the get-go.
In addition, up to 40% of defects realized after a capital project is turned over to operations stem from the design phase, Getsug noted. This is the best time to challenge the design to identify or “discover” defects before they are embedded in assets. Besides, “changes become more expensive and time-consuming once they advance to the Build, Assemble, Install and Operating Phases,” she said.
In a recent example, a biotech client collaborated with ITT Inc., a critical component manufacturer, to redesign a traditional diaphragm valve by eliminating the failure modes. In so doing, they would “design out” the defects with which they had historically struggled, explained Getsug. The resulting design, called the “EnviZion” diaphragm valve, appears to completely change the performance, reliability and quality impact of this component and boasts the following claim:
Estimated Total Cost of Ownership (TCO) savings over one decade by investing in 1,000 ITT EnviZion “EZ” Valves vs. the traditional Diaphragm Valve: $1,600,000
There are other factors that must be considered when making these decisions, including the supply chain, delivery capability, integration capability of the skid manufacturers, standardization, history and confidence of this new design, said Getsug. The fact that new designs inherently offer failure modes (“we don’t know what we don’t know”) must also be considered.
“The purpose of designing out failure modes or modifying failure modes is to be able to avoid errors,” said Getsug. And if operational readiness is a priority, design aspects related to the lifecycle cost, as well as the overall maintenance and reliability of an asset, system or project, must be taken into consideration at the design phase of an asset’s lifecycle.
Reliability Enabler
The DfR value proposition, according to Getsug, is comprised of the following factors:
- Total Cost of Ownership (TCO): Delivers up to 40% reduction in the TCO with a focus on TCO versus Initial Investment.
- Vertical Startup: Provides a more rapid and less variable project start up by reducing typical start-up time and the number of problems encountered when transitioning from the CapEx to the OpEx Phase of an asset’s lifecycle.
- Performance and Reliability: Improved performance by proactive and timely identification and elimination of defects related to lost performance and reliability. This is also accomplished by applying reliability centered maintenance (RCM) principles and concepts to apply on condition monitoring maintenance mitigation strategies versus time-based or frequency-based maintenance.
- Stakeholders: Stakeholders are invited to participate and encouraged to share their expertise to realize value throughout the asset lifecycle and CapEx phases as the project matures.
- Defect Discovery and Prevention Process (DD&PP): The DD&PP is applied to address defects as the assets and project matures.
Continuous Improvement
In practice, nothing happens without executive buy-in. Only when leadership commits and has a vision to have a comprehensive asset management program (and, by extension, a DfR program) can there be a structure for success, advised Getsug.
Stakeholder analysis is another core element, as it provides a mechanism to identify and engage subject matter experts and stakeholders early in the concept and design phase of a capital project.
“Stakeholders and SMEs, including original equipment manufacturers (OEMs) bring their expertise to identify and eliminate or mitigate defects in the design, procurement, storage, installation, operations and maintenance, and finally retirement phases of the asset lifecycle,” explained Getsug, adding that defects are present throughout the asset lifecycle and appear as the asset matures.
Even when good data is not available, an insightful facilitator should be able to extract knowledge from stakeholders and SMEs and find creative ways to apply this data. “Sharing expertise, evaluating or providing perspective on design reviews and mechanical completions can be fundamental to realizing added benefits and results,” said Getsug.
“One of the biggest barriers is getting clients to embrace the total cost of ownership concept—that a TCO analysis will differentiate one asset from another—even when they grasp it conceptually,” said Getsug. Her most recent client tripled its capital portfolio to $15 billion and decided DfR was going to be a major driver. “They needed to make sure their projects would come up and run when they were done with them. But it’s still a struggle sometimes to get them to make decisions based on the total cost of ownership.”
Paradigm Shift
Getsug’s breadth of experience with asset management implementations stretches across industries, from metals and mining, military, chemical manufacturing and water & wastewater treatment, to paper, consumer products, biotechnology and medical device manufacturing. It is from this vantage that she delineates three paradigm shifts:
- Transitioning from a frequency-based maintenance to reliability centered maintenance (RCM) strategy has cultivated support for next and best practices, including predictive maintenance technologies, on-condition maintenance and process analytic technology to reduce intrusive maintenance while improving asset performance and reliability;
- Standardization and the introduction of process and procedure became ubiquitous with the application of maintenance planning and scheduling in a computer maintenance management system (CMMS) or enterprise asset management (EAM) system with a continuous improvement loop; and
- Establishing alignment between the strategic and tactical asset management, along with an Industrial Internet of Things (IIoT) digitization platform, provides an integrated solution with layers of data, perspectives, disciplines and subject matter expertise to inform decisions with balanced, science-based and risk-based solutions.
For Getsug, getting the best results invariably means influencing the culture of a facility by using socio-technical design principles, problem solving and technical skills to break down silos and build collaboration among all stakeholders. In turn, a DfR program with buy-in can bring a reliable product to market when it’s focused on designing out or mitigating potential failure modes prior to production.
“Proactively getting stakeholders and SMEs involved early provides a means to identify and eliminate defects at every phase of the asset’s lifecycle,” said Getsug. “Fundamentally, by removing the defects, the total cost of ownership will be reduced.”
Sample Manufacturability Criteria
- Are the product tolerances based upon product requirements that provide optimum tolerance allowance in the transition to manufacturing? Have “stackable tolerances” been avoided in specifying the product dimensions? This especially applies when tolerances add up from one component to the next.
- Was a manufacturing engineer included in the product development team? What suggestions were incorporated already in the product design to support the manufacturability of the new or revised product?
- Is the new or revised product fragile? If so, what can be done to make it more robust?
- What suggestions, if any, were made by vendors? Were these suggestions incorporated into the design? If so, what specifically was done and can further progress be made?