The impact of COVID-19 on businesses in all factions was felt swiftly and significantly, with the ripple effects still disturbing the waters of global markets. In the midst of turmoil and many hardships in the medical equipment space, there have also been stories of triumph. To reach the goal of optimal patient care, it is essential for OEMs to choose a partner that can offer significant experience in the engineering and manufacturing of battery assemblies, specifically designed for medical devices.
In the tradition of many great partnerships, this one started with a problem. How could we meet the increased demand of a pandemic climate? Pushing internal teams is one factor, but gaining the buy-in of external partners often presents a greater challenge. The challenge was to produce batteries at a rate several orders of magnitude higher than previous production rates required by the MOVES® SLC™ integrated, portable life support system. MOVES® SLC™ is a portable life support system that provides the highest level of patient care in extreme and rugged transport and emergency settings. Battery-powered, the MOVES® SLC™ integrates the functions of a ventilator, oxygen concentrator, physiological monitoring, and suction, making it an invaluable tool in the fight against COVID-19 in Canada and around the world. We worked together with Thornhill Medical to optimize the manufacturing process for high volume production and improve both throughput and data capture on battery final assembly testing.
At the outset, both Thornhill and Excell teams emphasized the importance of a clear, detailed, and consistent communication channel between engineering and production. Both teams quickly engaged in a daily cadence to meet deadlines. In rapid and efficient succession, we worked with Thornhill to source components, built and deployed fixtures and designed a new final-assembly testing system to accommodate the increased demand pressures. The data from the new testing system enabled rapid improvement to production throughout. We tapped into our extensive industry network to build a multi-channel automated cycling system in a matter of weeks, instead of months. Our combined expertise resulted in a testing plan that captured all product application needs within our timeframe.
After partnering with Excell, Thornhill Medical is successfully delivering MOVES® SLC™ life support systems to support the ongoing response to COVID-19. Our team understood not only the timelines but the vital importance of delivering a battery and testing system that supports a complex medical device. As the partnership continues, we look forward to future innovation with Thornhill, always striving to produce the highest quality devices for an ever-changing global medical landscape.
Over our 35 years, we have honed the ideal balance between innovative design and unyielding safety standards. Customers operating within hazardous locations (HAZLOC) face a host of safety-related complexities. All of the manufacturing – from the largest machinery, down to the smallest battery unit, must comply with the governing country’s safety requirements. The HAZLOC classification was the standard in North America. However, the US and Canada are moving towards the IECEx system, which closely resembles its EU counterpart, the ATEX system.
How do we do it? At Excell, the design process and regulatory requirements work in tandem with each other. All battery pack components are designed to operate seamlessly within their intended environments. Our engineers design with the larger safety picture in mind. Understanding that these certifications are stand-alone is a guiding factor in the engineering process. Despite their regulatory similarities, IECEx and ATEX-certified products cannot automatically be used together. Products must be rigorously re-tested in a certified lab before they are approved for use together in a specific hazardous environment. This process can be incredibly costly and frustrating for HAZLOC customers. With our world-class lab testing facilities, our Excell team helps customers navigate their unique safety requirements.
The ability to provide an integrated battery solution that satisfies the strictest safety standards is one of the cornerstones of our business. Customers operating under HAZLOC/IECEx/ATEX guidelines can rest assured that Excell products meet the most exacting standards.
This year, Excell Battery exhibited for the third time at ADIPEC (Abu Dhabi International Petroleum and Exhibition and Conference) from November 16th-18th. We had previously attended in both 2018 and 2019 and seen the opportunity to reach new customers, network with colleagues and learn about new products.
This year, the show was very informative and inspiring. It was also well-attended by several thousand visitors, all safely carrying vaccination cards and wearing masks in these exceptional times. We’ve seen dramatic growth in interest in Excell Battery’s products and capabilities since 2018, and we experienced this first-hand at the show.
We’ve enjoyed the benefit of having our colleague and partner, Yahia Abdalrazzak, join us at the show. Yahia’s representation of Excell Battery in MENA has created inroads to new customers which have led to the success we’ve enjoyed in the region and we’re grateful for his support.
We’re looking ahead now to ADIPEC 2022. Please plan to join us again then!
Left brain versus right brain. Artistic versus scientific. We are all familiar with these classic dichotomies, but real-world experiences often land more in the grey than the black and white. A biochemist with a talent for watercolours might be unique but not impossible. Individuals who can look beyond their specialized field offer an invaluable perspective to the companies they work within. A marketing executive joining a sales rep on account visits will be able to see first-hand what impact a top-down marketing campaign has in the field. This approach holds true in the battery operating world as the best engineers share an ability to widen their lens from a single cell to the supply chain as a whole.
Choices made at the cell level have consequences on the entire manufacturing process. Our engineers design with the supply chain in mind. The ripple effects of each design choice are carefully weighed against their impact on the overall demand flow. We use our extensive North American resources to inform both our design and manufacturing decisions. Offering multiple cell and component alternatives allows production to move forward, unimpeded by material shortages. A quick internet search for cell vendors will pull up hundreds, if not thousands, of results. The quantity of results is not always accompanied by trustworthy rankings on the quality of these cells and vendors. A seasoned team of engineers provides the best oversight on supplier and product quality.
Curating a healthy catalogue of raw materials is often where some manufacturers stop. Smart engineering goes a step beyond by establishing quality control procedures to test all cell and component alternatives. Qualification of cells through rigorous in-house lab testing should be second-nature to battery suppliers. Even the most reputable cell vendors are not immune to quality issues. Before signing on with a supplier, OEM clients should ask tough questions regarding quality control and safety procedures. In addition to testing the quality and safety of individual cells, an established lab program also provides assurances that all manufacturing quality standards are followed. North American standards are particularly stringent so any manufacturers operating within the continent should be well-versed in protocols such as ISO 9001, ISO 13485, UN38.3, etc.
Strong supplier relationships are one of the most crucial differentials separating top-tier manufacturers from their competitors. When a demand spike forces a supplier to pick and choose which orders to fill, the tipping point is often the strength of the customer-supplier relationship. This scenario continues to play out frequently across industries weighed down with pandemic pressures. The trust and reliability forged with our suppliers over many pre-pandemic years became critical factors when the ultimate stress test of COVID-19 hit. Our supply chain is built to support our clients through the entire design and manufacturing process, regardless of external disruptions. We partner with suppliers who share that same methodology.
An infrastructure built on smart engineering principles provides the sturdiest foundation for OEM clients. Highly-specialized training does not have to translate to a hyper-narrow perspective. Engineers with a realistic approach to design and an awareness of the broader supply chain set clients up for the best chance of success.
There are many types of electrically operated devices, some of which are used in hazardous environments such as coal mines or petrochemical plants. The nature of these battery-operated devices may not be hazardous, but their environments may cause an explosive reaction due to potential hazardous combinations of materials.
To prevent unexpected combustion, equipment has evolved and is designed to be safe in these situations. Devices must undergo testing and certification before being distributed and used, which depends on the geographic location of the area of consideration.
In the US and Canada, these locations are termed hazardous locations or HAZLOC, and devices qualified to be used in these locations are known as HAZLOC-rated devices. However, Canada and the US are moving towards the IECEx system of classification, and all new devices must fit the IECEx code of standard. European countries use the ATEX system, which is similar to the IECEx system. It is required for devices to be evaluated based on the location in which they will be used.
Each system is based on different qualifications. The HAZLOC-based system is a class and division-based system:
I – gases may be present
II – dust may be present
III – fibres may be present
The division is based on how often the hazard is present, which is either the hazard is always present or the hazard may exist under abnormal conditions. The IECEx and ATEX systems differ from the HAZLOC system in that they are zone-based. The degree to which hazardous gases or dust are present is classified by numerical zones.
A common factor of these systems, and international systems, is that they are end-product standards. The products are evaluated based on the explosive environment’s regulations alone. This means that two HAZLOC/IECEx/ATEX certified products cannot be plugged into each other and used. Their certifications stand-alone, and if they are to be used together they must repeat the testing and certification process to ensure they can be used together in that specific location.
Testing is an expensive and time-consuming process and requires a specialized lab that has the knowledge to evaluate these types of products. Consulting a lab should be one of the first steps in the process of designing such a device. Once a product is evaluated and approved, it will bear certification marks from a well-known certification company. Depending on the certification, it will also have markings depicting explosive atmospheres in which the product can be used.
The “buy local” movement has gained steady support over the past decade. From the food we eat to the clothes we wear, consumers are increasingly aware of the origin of their products. Electronic products are more challenging to apply the “local” buying lens to, but there are still ways to incorporate this mindset into both manufacturer and consumer behaviours. As a North American-based company, we prioritize the talents and resources of our Canadian and American employees and facilities to bring products closer to home.
In any industry, the greater the distance required to move components through a supply chain, the greater the risk for delays. Perishable food suppliers are keenly aware of this risk as the window of freshness for items like dairy or produce starts to close rapidly once those items leave the farm. The major ports of Los Angeles and Long Beach in Southern California are in the midst of a huge congestion problem, with shipping containers often waiting weeks simply to be unloaded. Batteries have longer shelf lives than fresh fruit, but delays in the supply chain can still have dire consequences for tech suppliers. Production lines can sit idle as key component pieces remain boxed up on ocean freighters circling an overcrowded port. This situation is increasingly common for manufacturers with a heavy reliance on overseas suppliers. By partnering with primarily North American suppliers, we are less susceptible to the problems attached to long-distance transit. Taking our cues from our clients, we have focused our manufacturing production on North American hubs. With Canadian facilities in Vancouver, Calgary, and Toronto and our American production centered in Houston, Texas, we have strategically built our plants to best serve North American entities.
On top of the shipping nightmares, tech companies are facing an extreme talent shortage for engineers. A shortage that began building pre-pandemic has only intensified as demand for tech output skyrocketed alongside COVID-19. The pool of experienced engineers is simply not big enough to sustain the overwhelming consumer demand. This situation again forces many companies to look overseas for solutions. Too often, the result of this approach is an engineering team scattered globally with members contracted by a fee but not committed to a company’s mission. With a close-knit North American engineering team, we are able to oversee the entire design process with a speed and efficiency unaffected by offshore complications. Even small hurdles like managing workflow amongst different time zones are eased or eliminated when a core team is centralized.
Apart from a team’s geography, the most successful engineering departments often employ individuals with strong investments in the company culture. High skill level, combined with the emotional investment in their clients’ successes, make for teams highly motivated to design superior products and provide exceptional client service. The unique alliance between engineering expertise and a sincere attachment to our company goals has allowed Excell Battery to maintain successful stability for clients throughout the pandemic.
With a holistic approach to the electronic supply chain, manufacturers are better able to focus their energy on the geographic and experiential needs of their end customers. From the engineers employed to the location of warehouses, every juncture of the supply chain is thoughtfully mapped with our client in mind.
Avid gardener or not, most of us can relate to the adage, “get to the root” when looking for the source of a problem. The proverbial “root” in the manufacturing supply chain is the sourcing relationship. The sourcing of product components is a manufacturing make-or-break step for successful assembly of the finished item. The most talented engineers and innovative product designs will be all for naught if a manufacturer cannot secure a reliable group of sourcing suppliers. The root of your supply chain is hidden from consumers, but the fruits of a solid supply chain will be felt when a new client adopts your product line.
From the rudimentary to the highly specialized, supply chain sourcing has been crucial since the beginning of the industrial world. Over that long history, there have been many hurdles along the way, but few events have rocked the manufacturing world as dramatically as the COVID-19 pandemic. The pandemic climate introduced unique challenges felt on a global scale. Manufacturers with pre-pandemic supply chain issues saw those problems amplify, forcing many companies to shutter their doors. Manufacturers with strong supplier partners were far better suited to weather the pandemic-sized supply chain storm. In the era of “social distancing,” there is intense pressure on the electronics industry in particular to provide products that connect people in remote work and social situations.
While there will always be some level of risk in even the steadiest supply chain, finding suppliers with a healthy approach to managing risk offers the greatest security to manufacturers. At Excell, this is the approach we use whether we’re referring to engineering or manufacturing or smart recycling. With multiple facilities operating strategically throughout North America, we have a network with fail-safes for the fail-safes. Company-wide cross-training throughout all of our factories allows the flexibility to shift production capacity between different facilities. A wide footprint of production facilities should be a top consideration for manufacturers when assessing potential suppliers as it presents less of a risk for a bottle-neck situation with production pushed out from only one warehouse.
Production capacity and warehouse spacing are only half the battle. Without a robust supply of product components and suitable alternatives, production lines will quickly grind to a halt. As one exec observed, “the industry’s motto has shifted from ‘Cash is King’ to ‘Stock is King’”. Smart inventory management involves not just the abundance of stock, but the ability to shift production based on material availability. We achieve this flexibility by identifying multiple component alternatives within our North American supplier network. Consequently, we can adjust production as needed without disruption to our end customer. Product components move easily between facilities with significantly reduced transportation costs in a North American-based circuit.
Predictions for future supply chain disruptions might be murky at best, but aligning with predictable suppliers is the best success strategy for manufacturers. Leaning on the core principles of realistic risk management, adaptability and transparent operations, the search for a dedicated supplier will surely lead to the best partner for your business.
The Part Production Approval Process (PPAP) was generated by the automotive industry, in an effort to ensure that parts approved for automotive applications were of uniform quality and dimension. The automotive supply chain is large and complex, and part uniformity is essential for a quality vehicle. Therefore, the automotive industry created the PPAP standard. The PPAP standard is published by the Automotive Industry Action Group (AIAG), and it provides guidance on how the process works. In practice, no two PPAPs are alike, as a certain amount of negotiation between the supplier and the customer occurs as to what will constitute an acceptable process for a part. Common to all PPAP systems is extensive documentation and measurement of the product, especially at the prototype and initial production run stage including verification and validation. This can include gauge R&R, MSA, MTE evaluations as well as software and process validation. Run at rate testing can also be performed during the PPAP to determine if a manufacturer can produce the required number of pieces per day, with the required uniformity. It is typically used when the number of parts produced will be on a continuous basis, with lot sizes of at least 500 pieces, but has been used for smaller production runs using special sampling plans. PPAP sampling plans are statistical in nature, so tend to work better for larger production lots.
Critical Parameters and Components
As part of the PPAP, several critical factors will be determined for the product – for the product itself or for the components of the product. These are typically called out as critical parameters or critical components. For the product, critical parameters will be called out that will need to be measured and checked prior to shipment to the customer, while for critical components various verification parameters will be called out to be checked before use in the product. As the number of pieces associated with these items is typically very large (think in terms of thousands or millions of units), rather than perform arduous, time-consuming 100% inspection of these items, a smaller sample of these items would be evaluated. This would be referred to as a sampling plan, usually conducted under the guidance of a standard like ISO-2859, MIL-STD105E or ANSI Z1.4 / Z1.9. At a decided-upon lot size, the specified number of pieces is inspected, the result of which is evaluated against the plans pass/fail criteria to determine if the lot is acceptable or rejectable (re-work required), prior to use or shipment. If the part and product measurements indicating the specification requirement are met, then you proceed to the next step in the process. If the parts or products do not meet sampling plan requirements, the parts will be disposed of, as was determined at the PPAP stage. Outright rejection and scrap may be the outcome. More typically, the customer or supplier would be informed, then a more aggressive sampling plan to cull out or re-work the defective items would be instituted. QMS systems functioning under this kind of approval process assume all parts, pieces and processes are tagged as rejected units until such time as the inspection result shows that they are acceptable. Lacking documentation of a product’s measurement results would be a rejected condition.
See Figure 1 of an overview of the PPAP process.
The accepted conditions for parts, processes and product are specifically documented, at the Part Submission Warrant stage of the process. It is at this stage, the specification, design, FMEAs (either design or process), prototyping and production sample phase, that all of the associated parameters and specifications are decided, documented and approved. These typically emerge as control documents and process plans. Note that the warrant is for the processes and the parts. Reject conditions on the production process aspect of the production item can also exist. Flow charts are typically used to document process plans. Specifications and documentation are typically associated with the parts. Process charts are usually associated with process quality. Various parameters can be charted, like run charts for critical component measurements, CP and CPk charts as measures of process capability and stability. CP is a measure of process parameter stability, where CPk is a measure of how well the process is centered on its specified range. The difference can be visualized as throwing darts at a dartboard. If the centre of the dartboard is seen as the target, then if the darts thrown all land on the triple 20, the dart-throwing process will have a good CP; you are hitting the target consistently (the triple 20), but not a good CPk, as the darts are not landing in and around the desired target consistently (the darts are not centered around or hitting the bullseye). Run charts, Cp and CPk charts can be used as measures of process quality and stability.
The Feedback Process
There is a feedback process associated with PPAP. During the part warrant stage of the PPAP a typical stipulation is put in place that changes to the part or process will not occur without express written consent of both parties to the PPAP warrant. If such changes become necessary or desired due to ordinary conditions (desire to increase profits by using alternate vendors) or extraordinary conditions (pre-approved parts become unavailable), change notifications are issued. The results of a change notification can be varied, both parties may accept the change unconditionally, one party may refuse any changes at all, or it may be decided to re-run the part warranty process completely. Regardless of the outcome, it is necessary for both parties to be informed of any proposed changes to the product, and to agree to the changes, with formal documentation.
Partnership of PPAP and Medical
The tie-in to medical devices with PPAP occurred several years ago. Major automobile manufacturers developed this process to ensure that automotive parts suppliers could produce highly-uniform, high-quality parts in desired quantities. Several parts suppliers to this sector participated in the procedure. As a result, these parts suppliers became familiar with these techniques in making high-quality parts with the documentation trail associated with the PPAP process. Another manufacturing field that also requires highly-uniform, high-quality parts with a stable supply chain is the medical device field. As a result, the AIAG offered ISO 13485 (Medical Device Quality System Standard) classes to auto parts suppliers that wanted to diversify into the medical device field. A key part of the ISO 13485 standard is the medical device file. A PPAP product warrant will typically satisfy the requirements for a medical device file. Hence companies familiar with making products under a PPAP warrant, find that meeting the requirements of a medical device file to be familiar territory, accommodated by their already existing systems.
Tools and Documents
There are many associated PPAP tools and documents. Some typical ones are:
The phrases “vendor” and “partner” are often used interchangeably to describe members of your supply chain. However, when evaluated closely, they are two very different identities.
When one considers the definition of a “vendor”, it refers to a one-touch type of activity or a specific task purchase. For example, a butcher might argue that they provide quality, service, and price advantages. A customer may switch or change vendors without much disruption to their lives or businesses simply because there are multiple options that often change frequently.
A “partner”, however, is integral to the success of their customers. Working together and seeking to understand each other’s business, they develop a synergistic approach to providing the best possible Total Procurement Cost. Partners in your business bring critical expertise and high-value resources. They are aligned, integrated, and committed to your success. In many cases, true Partners in your business will often place the interests of their clients ahead of their own, because ensuring the success of their clients translates to long-term stable success for both organizations.
Trusted “partners” will seek out solutions that can help you position your organization above the crowd of competitors in your marketplace. Your reputation in your chosen marketplace will be as important to them as their own reputation.
“Excell has been part of Lotek’s extended supply chain for a number of years. They work in concert with us so that they can manage their supply chain and production in alignment with our varying demand. This has been particularly important during the added challenges of the recent pandemic. Although quality, delivery and price are paramount, it’s the overarching value of the relationship “the partnership” in an ever-changing supply chain world that allows uninterrupted flow of product and continuous long-term business for both companies” – Michael Wroblewski, Lotek Wireless
At Excell, our focus is on becoming a Partner in your supply chain. We place the highest possible value on producing quality products, driven by our years of experience, our engineering and design team knowledge, our internal quality programs such as ISO9001/ISO 13485, and our commitment to value-added solutions. Many competitors will make similar claims, backing those claims up with facts is often the difficulty. Excell has developed and retained many long-term customers over our 35+ years in the industrial battery pack solutions markets. When we use the term “Partner” in your supply chain, it’s not just another claim.
Manufacturers should be aware that products containing dangerous goods like lithium batteries must be shipped within the guidelines of multiple regulations. Individual countries’ transportation regulations such as the USDOT, Transport Canada, the International Air Transport Association (IATA), and the International Maritime Dangerous Goods Code (IMDG) all regulate the transport of lithium batteries.
Transporting lithium batteries can be dangerous if not packaged and handled safely because they present both chemical and electrical hazards. The UN Manual of Tests and Criteria, Sixth Revised Edition, SubSection 38.3 was created to ensure safe transportation of batteries. Frequently known as UN 38.3, these recommendations are enforced by all regulatory bodies and must be followed when shipping lithium batteries.
The Hazards of Lithium Batteries
Lithium batteries may pose significant hazards if mishandled or abused. Consequently, safety practices must be followed when packaging and handling lithium batteries for transport. Abusive conditions can cause lithium batteries to catch fire, leak corrosive liquids, or explode in certain situations.
To help explain the various hazards that may occur if batteries are mishandled, Excell Battery has made our Safety Training Course available online for free.
The Steps to Follow
As outlined in the above regulations, several things must be in place before a business is allowed to ship lithium batteries. These include:
All persons involved in preparing, packaging, and completing paperwork must be formally trained in these procedures before offering batteries for transport. Specific training requirements are outlined in the UN 38.3, but they generally include the following:
General awareness/familiarization training of regulations
Function-specific training on shipping lithium batteries
Lithium battery safety
Security awareness training
Many training organizations and companies offer this type of training either online or in person.
Lithium batteries must be tested safe for transport in accordance with UN 38.3. A variety of tests is performed, from altitude to forced discharge, to ensure the batteries can be transported safely. For more information, review theUS DOT/IATA lithium battery testing requirements.
Performance tested shipping containers must be tested in accordance with the above regulations. These boxes must contain the proper UN marking in order to be used for shipping lithium batteries. In addition, labeling of boxes (Class 9, Cargo Aircraft Only if applicable) must be properly applied to the packaging.
HAZMAT Bill of Ladings, Airway Bills, and other Dangerous Goods paperwork, such as a Shipper’s Declaration of Dangerous Goods, must be completed before lithium batteries are offered for transport. Failure to comply can result in costly delays, the shipment being rejected by carriers, or even fines for failure to follow the proper paperwork requirement.
About Excell Battery
Excell Battery has a proven track record of manufacturing safe, reliable battery solutions for over 35 years. When it comes to shipping safety and regulations, it’s important to have a professional team partnering with you to ensure the safety of your product. Contact us today and let us help you bring your product to the world!
An exceptional record of quality and service for 35+ years.