Toyota Kata: A Lean Strategy for Keeping Up With the Pace of Change

States News Service

June 14, 2019

By Brian Lagas


Why are our changeovers taking so long?


If youve asked this question on the shop floor, more than likely you were met with blank stares by your employees. Open-ended questions like this are overwhelming, so employees try to find quick answers that dont really address the problem. They dont have a starting point to form an answer.


But what if you asked a question with a specific, achievable goal?


What steps can we take to reduce changeover time by 15 minutes?


Youve then provided your employees with a measurable goal in the form of a question. Your workers may feel empowered to answer with some hands-on suggestions for incremental changes, such as reducing setup steps or combining workstations. This in turn could not only reduce changeover time, but significantly eliminate wait times and inventories.


This approach is often described as Kaizen, or continuous improvement, which serves as the backbone for lean manufacturing. Kaizen uses the Plan, Do, Check, Act (PDCA) problem-solving cycle to encourage manufacturers to use small ideas to solve big problems, such as costly, time-intensive changeovers.


These methodologies are the building blocks of Toyota Kata, an innovative, lean way of thinking described in the book by Mike Rother, Toyota Kata: Managing People for Improvement, Adaptiveness and Superior Results.


In essence, Toyota Kata goes beyond problem-solving to teach management, engineers, and operators a new mindset to develop their creative and scientific-thinking skills to make them more effective, lean manufacturers. This approach looks at lean manufacturing as a culture, rather than a single process.


With the world of manufacturing evolving at a breathtaking pace thanks to developments such as Artificial Intelligence (AI), labor skill gaps, and the Industrial Internet of Things (IIoT), Toyota Kata gives smaller manufacturers a lean strategy to help them grow with these developments. It empowers employees with the skills they can use to continuously improve, adapt, and generate ideas for a strategic, competitive advantage.


Small steps lead to big results for manufacturers


Toyota is known as the most successful early adopter of kaizen and the originator of the continuous improvement philosophy for manufacturers as part of its innovative Toyota Production System. This approach helped the company create vehicles famous for their reliability, while eliminating production waste, time, and energy resources. Toyotas plan slowly and act quickly philosophy helped create the Prius hybrid, which positioned the company as the leader in hybrid technology. More than 80 years after the companys founding, Toyota is the worlds largest automaker.


Toyota Kata builds on Toyotas continuous improvement success model, so other manufacturers can learn from its example. This approach has become increasingly popular with manufacturers who want to move beyond short-term production goals to empower their workforce to implement daily, sustainable process improvements.


In Arkansas, Almatis Premiun Alumina had previous experience working with lean tools and using those tools in the traditional point solutions approach that led to obvious improvements and positive results. The challenge was to sustain continuous improvement. The company was interested in revitalizing its lean efforts and pursuing sustainability. Almatis contacted the Arkansas Economic Development Commission Manufacturing Solutions (AEDC-MS), the MEP Center in Arkansas, for assistance.


AEDC-MS sought to create a program that would target bottom-line improvements through process cost reductions. A team of 18 people identified, managed and capitalized on opportunities within the manufacturing process. AEDC-MS led eight hours of Lean 101 training, including introductions to the Improvement Kata. Then, the team used leadership coaching to focus on individual responsibilities, human natures tendency to oppose change and exposure to the scientific process of continuous improvement. Sixteen hours of Value Stream Mapping was used to address the needs of a specific manufacturing line and office activities. Extra time was spent with the Almatis management team to assure they were ready for Kata delivery. A three-day Toyota Kata session led to a $12,000/month savings in the first two days of implementation, providing a full return on investment within the first 30 days of improvement.


Other results achieved included:

  • $2.5 million in increased or retained sales over one year.
  • 160 new or retained jobs.
  • $200,000 in cost savings.
  • $475,000 in new investment.


How to integrate Toyota Kata within your facility


To help small and medium-sized manufacturers achieve lean success like Almatis and Toyota, the MEP National Network has developed a Toyota Kata overview: Toyota Kata: Developing the Skills to Thrive in Todays Constantly Changing Marketplace.


This overview highlights that, while smaller manufacturers may not have the level of strategic resources like the behemoth Toyota, they can apply the same methodologies of Toyota Kata, including:

  • Developing new habits and allowing people to think differently about problems and goals.
  • A way of working, and of working together.
  • Using scientific thinking as an ingredient to make teams and organizations more effective and successful.
  • Developing a culture of continuous learning and improvement at all levels through deliberate practice.


Implementation of Toyota Kata begins with the aptly-named Starter Kata. Starter Kata focuses on small protocols and processes that, when practiced early and often, help manufacturing employees learn faster and teaches them to work more collaboratively. The two main elements of Starter Kata are Improvement Kata and Coaching Kata, as noted in the above Almatis example.


The Improvement and Coaching Kata help employees:

  • Understand the direction or challenge.
  • Grasp the current condition.
  • Establish the next target condition.
  • Experiment toward the target condition.


By integrating Toyota Kata as part of your manufacturing best practices, your employees can successfully overcome obstacles and develop more confidence and scientific thinking to solve problems.


The MEP National Networks overview of Toyota Kata is a first step to empowering your workforce to become more agile, so they can find new ways to cut waste, develop new technologies, and adapt to these new changes in the ever-increasing competitive world of manufacturing.


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Medicines Recalled as Effectiveness May Have Been Compromised

Press Association Mediapoint

June 28, 2019

By Samar Maguire


People with Parkinsons disease, epilepsy and blood-clotting issues are being urged to return medication because its effectiveness may have been compromised.


Prescription-only medicines Neupro, Vimpat and Clexane with a B&S Healthcare label are being recalled by the Medicines and Healthcare products Regulatory Agency (MHRA).


The MHRA found the medicines, which were imported from Italy, were taken out of the regulated medicines supply chain during distribution and later re-introduced.


This meant they may not have had the correct transport and storage conditions during delivery.


The MHRA said it has been forced to recall them because the consequences to people who take them could be serious as they may not work effectively.


There was no evidence of the medicine being tampered with.


In a statement on its website, the MHRA said: As a precautionary measure, three medicines are being recalled to a patient level because in the very unlikely event that these medicines are not fully effective there is a potential risk to patient safety.


For these three particular medicines, whilst the likelihood of their effectiveness being compromised is low (because they are stable legitimate medicines), the consequences of a lack of effectiveness could be serious which is why we are treating them differently.


The three products that patients are being urged to return are Clexane 8000iu Injection 0.8ml, Neupro 4mg/24 hr. patches, and Vimpat 100mg tablets.


Pharmacists are also being urged to return Dovobet Gel, Incruse Inhaler, Provisacor (Crestor) 10mg Tablets, Seebri Breezhaler, and Spiriva Inhalation Powder.


People are being advised, however, if they have these medicines already, they do not need to return or arrange for a new prescription.


If patients have any questions, they should contact their GP or pharmacist.


The full list of medicines that need to be returned by patients is available at https://www.gov.uk/drug-device-alerts/fmd-alert-class-2-mdr-123-05-19.


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Ford Recalls Explorer, F-150 Over Crash Risk; Defects Found in Suspensions, Engines

USA Today

June 13, 2019

By Nathan Bomey


Ford Motor Co. issued several recalls Wednesday, including one covering more than 1.2 million Ford Explorer SUVs that could be at risk of losing steering control.


The automaker said that 2011-17 model-year Explorers built from May 17, 2010, through Jan. 26, 2017, will be recalled after the company discovered a defect that could cause a fractured rear suspension leading to the loss of steering control. That, in turn, raises the risk of a crash.


The Explorer recall will cost the automaker about $180 million, according to a regulatory filing.


The company also recalled about 123,000 Ford F-150 pickups equipped with 5-liter and 6.2-liter gas engines that were insufficiently repaired in a previous recall. The pickups may be subject to a sudden transmission downshift that could cause them to lose control, causing a crash.


The F-150s had previously gotten a powertrain control module software fix, but it turned out to be incomplete, Ford said in a statement.


It did not have the updates necessary to prevent a potential unintended downshift into first gear or the updates necessary to ensure illumination of the malfunction indicator light in the event of an intermittent transmission output speed sensor signal, Ford said.


The F-150 pickups affected by the recall were built between May 7, 2012, and Oct. 27, 2013, at the companys Dearborn, Michigan, plant and between April 18, 2012, and Nov. 18, 2013, at the companys Kansas City, Missouri, area plant. The company also recalled about 4,300 2009-16 Ford Econoline vehicles to fix faulty welding.


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Canada: Health Canada Responds to Medical Device Regulation Gaps

Mondaq Business Briefing

June 13, 2019

By Josh Hanet, Erin Farrell and Emily Hayes


In late 2018, a series of news articles took aim at Canadas regulation of medical devices, alleging that Health Canadas medical device approval and adverse event monitoring systems were severely lacking. This article will provide an update regarding steps Health Canada has now taken to tighten up regulation of medical devices.


Reports of regulation gaps


As part of a larger international investigation, the Toronto Star and CBC reported in late November 2018 that there were significant gaps in medical device regulation in Canada. These gaps included the following:

  • Medical devices implanted into patients may only have been tested on animals or cadavers.
  • Once a device was available on the market, legislation permitted regulators to rely on manufacturers and importers alone to provide updates, alerts, and recalls (compared to the United States, where reporting by hospitals and health clinics is mandatory).
  • Some medical devices withdrawn from the market in other countries continued to be implanted into uninformed Canadians.


The investigation highlighted the limited access Canadians have to information about devices. Most notably, the articles alleged that the lack of a patient registry in Canada resulted in medical device patients having less recall information than purchasers of other products such as vehicles. The system for medical device recalls has long been contrasted with that of automobiles, appreciating that health information is much more sensitive.


As explained in the series of articles, applications by manufacturers for new medical devices sometimes relied heavily on data from old versions of devices. Additional information about new versions only became available after the device was on the market and used under real life conditions.


Health Canada vows to respond


Four days after the articles were published, Canadas Health Minister responded by announcing three new goals:

  • To strengthen processes for the pre-market approvals of medical devices: This will include a review of the policies and scientific requirements governing the approval of higher-risk medical devices, including requirements for clinical data. The Minister also directed Health Canada to enable more medical device research by health professionals. Specifically, the Minister suggested expanding the use of outside medical and scientific experts to advise the Department on medical device issues.
  • To enhance post-market surveillance of medical devices: Health Canada will take steps to improve the reporting of medical device incidents by industry, health professionals and Canadians and make these reports publicly available. Specifically, Health Canada will propose new rules requiring companies to inform Health Canada promptly when foreign regulators issue warnings about a device.
  • To make the system for medical device approvals and surveillance more transparent: The Department will provide summaries of regulatory decisions when it approves more complex medical devices (known as Class III and Class IV devices). Health Canada will also work to improve access to the clinical data.


The Medical Devices Regulations separate medical devices into the following 4 risk categories:

  • Class I: Low risk devices such as wound care and non-surgically invasive devices.
  • Class II: Low-to-medium risk devices including contact lenses and the majority of surgically invasive devices (e.g., surgical gloves, needles, magnetic resonance imaging equipment).
  • Class III: Medium-to-high risk devices such as hip implants, glucose monitors, ultrasound diagnostic imaging equipment, and surgically invasive devices that are intended to be absorbed into the body or that are intended to remain in the body for at least 30 consecutive days.
  • Class IV: High-risk devices such as pacemakers and surgically invasive devices that diagnose, control, or correct a defect in the central cardiovascular system. The device manufacturer, importer, or distributor is responsible for classifying the device.


As noted in the World Health Innovation Network whitepaper entitled, Transforming Canada into a Global Centre for Medical Device Innovation and Adoption, Class I devices are exempt from licensing and do not need to obtain Health Canada approval to market. Class II devices require that applicants assert the safety and efficacy of their device without having to submit evidence to support this conclusion. Class III and IV devices require more documentation and provision of evidence proving the safety and effectiveness of their device.


Health Canada publishes its action plan on medical devices


On December 20, 2018, Health Canada published the Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness, and Quality, in which it acknowledged that more can be done to improve the safety and effectiveness of medical devices under Canadas regulatory regime. The Action Plan outlines a three-part strategy to optimizing health outcomes for Canadian patients:


Part I: Improve how devices get on the market: Health Canada will increase research by allowing health professionals and other researchers to file an application for authorization to conduct investigational tests. Currently, only manufacturers (not independent researchers or healthcare professionals) can apply to undertake investigational testing for medical devices. Health Canada will form a new expert advisory committee on womens health issues for drugs and medical devices in collaboration with the Canadian Institute of Health Research. Health Canada will also review its evidence requirements for higher-risk medical devices with a view to strengthening the evidence required for new devices based on previously authorized versions.


Part II: Strengthen monitoring and follow-up: The proposed Protecting Canadians from Unsafe Drugs Act (Vanessas Law) intends to amend the Food and Drugs Act to include new rules that strengthen the regulation of therapeutic products and improve the reporting of adverse reactions by healthcare institutions. These measures are intended to improve Health Canadas ability to collect post-market safety information and take appropriate action when a serious health risk is identified. Pursuant to Vanessas Law, in January 2018, Health Canada published proposed regulations in the Canada Gazette, Part I to amend the Food and Drug Regulations and Medical Devices Regulations to require hospitals to report serious adverse drug reactions and medical device incidents. The proposed regulations have not yet been published.


In tandem with new regulations being developed under the proposed Vanessas Law, Health Canada will implement new regulations requiring mandatory reporting from Canadian hospitals on medical device incidents. Health Canada will also work to improve reporting from healthcare facilities other than hospitals (such as long-term care facilities, clinics, etc.). Proposed regulations under Vanessas Law will seek to compel manufacturers to conduct further assessments, tests and studies on medical devices. Manufacturers will be required to inform Health Canada within 72 hours if selected foreign regulatory agencies issue warnings about serious risks related to their medical device. Manufacturers will also be required to submit information regarding label changes or license suspensions Health Canada has also committed to further supporting investigation and enforcement efforts in the Department by expanding the role of inspectors in promoting the compliance of manufacturers, importers, distributers and healthcare professionals. This will include mandatory requirements to report issues with medical devices to investigators.


Part III: Provide more information to Canadians: Health Canada will implement new regulations to release clinical trial data provided in medical device submissions Health Canada will also publish summaries of decisions made by the Department when it approves license applications for Class III and Class IV medical devices. Previously, only Class IV license applications were published by Health Canada. The proposed change will increase published summaries from fewer than 100 per year to well over 1,000.


Proposed changes will take time


Although the Action Plan commits to major changes in the regulation of medical devices, Health Canada has yet to implement the majority of the suggested modifications.


The Action Plan outlines specific 2019 Milestones for each element of the three-part strategy. Thus far, Health Canada has successfully delivered on the following Milestones:


Health Canadas Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and QualityInforming Canadians about medical device treatment options: Further to Part III of the Action Plan, Health Canada started publishing Regulatory Decision Summaries for Class III medical device licenses on January 31, 2019. Scientific Advisory Committee on Medical Devices Used in the Cardiovascular Systemannouncement of meeting, 1 March 2019: Pursuant to Part II of the Action Plan, on February 1, 2019, Health Canada announced an upcoming meeting of Health Canadas Scientific Advisory Committee on Medical Devices used in the Cardiovascular System. The advice received from this meeting will be used to facilitate and enhance the review process for medical devices used in the cardiovascular system. Scientific Advisory Committee on Health Products for Women (SAC-HPW): nomination call for members: In accordance with Part II of the Action Plan, on January 30, 2019, Health Canada published a nomination call for members for the proposed SAC-HPW. The SAC-HPW will provide Health Canada with advice on current and emerging issues regarding womens health and the regulation of medical devices and drugs. Consultation on Draft Guidance Document for Software as a Medical Device: Pursuant to Part II of the Action Plan, Health Canada has developed the Draft Guidance DocumentSoftware as a Medical Device to better define regulatory compliance requirements for emerging technologies. Consultation on the draft guidance document will be open until March 29, 2019.


Implications for medical device manufacturers


Canada is not alone in its response to this international investigation. Germany, Italy and Denmark have also taken steps to review how their countries regulate implantable devices. Despite the findings of the investigation, Health Canada maintains that Canadas medical device regulatory regime is one of the most stringent in the world.


The Action Plans proposed changes will alter the medical device approval process in Canada. They will also require manufacturers to notify Canadian regulators about foreign recalls and warnings. New disclosure and transparency measures may change how options and risks are explained to device recipients if clinical data is more accessible. However, Health Canada has yet to implement the majority of its proposed modifications.


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Ford to Cut 12,000 Jobs in Europe

New York Times

June 27, 2019

By Amie Tsang


Ford Motor Company said on Thursday it would cut about a fifth of its European work force and shut down five plants as the company deals with weak demand for its cars.


The automaker, which has struggled to turn a profit in Europe, said that about 12,000 of its 65,000 workers across Europe would lose their jobs, with most being offered voluntary separation programs.


The job reductions were announced along with plans to build more electrical vehicles in the region, as part of a new business model to streamline the companys European operations.


Ford started to shrink its European presence in 2013, but said at the start of 2019 that it would cut thousands of jobs. Like many global automakers, it has been buffeted by changes in the industry that have made it increasingly difficult to justify maintaining production facilities in the region.


Ford is closing three plants in Russia, one in France and another in Britain, leaving it with 18 facilities in the area by 2020. It will also consolidate two headquarters in Britain and move them to one location.


Employees at its assembly plants in Saarlouis, Germany, and Valencia, Spain, will also have shifts reduced.


Separating employees and closing plants are the hardest decisions we make, and in recognition of the effect on families and communities, we are providing support to ease the impact, Stuart Rowley, president of Ford of Europe, said in a news release.


The job reductions were announced along with plans to introduce new vehicles, including ones with the option of running on electricity.


Ford will be a more targeted business in Europe, consistent with the companys global redesign, generating higher returns through our focus on customer needs and a lean structure, Mr. Rowley said.


In recent months, companies including Nissan, Honda and Jaguar Land Rover have all announced plans to withdraw from parts of Europe, where tighter regulations over fossil fuels, sluggish sales and Brexit have made markets harder for carmakers.


At the same time, traditional auto companies are facing more competition from technology companies and have turned their focus to China, the worlds largest maker and seller of electric cars.


Since announcing in January that it would be cutting employees and facilities, Ford has teamed up with Volkswagen in an alliance intended to spur the development of electric and self-driving cars, as well as to cut costs.


The company said on Thursday that all its new models would have options for electrification and it would be building electric vehicles in Europe.


Our future is rooted in electrification, Mr. Rowley said.


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Sale of Used Cars Under Recall Would Be Banned by Proposal in Congress

Chicago Sun-Times

June 27, 2019

By Stephanie Zimmermann


It would be illegal to sell or lease used cars that are the subject of current safety recalls under legislation introduced this week in the U.S. Senate.


The measure aims to address the widespread availability of used cars that have been recalled, sometimes for serious issues like defective airbags or ignition switches.


Sens. Richard Blumenthal, D-Connecticut, and Edward J. Markey, D-Massachusetts, on Tuesday reintroduced the Used Car Safety Recall Repair Act, which would require car dealers to fix all safety recalls before selling, leasing or loaning vehicles to consumers.


They and U.S. Rep. Jan Schakowsky, D-Illinois, tried to pass similar legislation in 2017.


Its easy to find vehicles offered for sale despite having open safety recalls, a Chicago Sun-Times investigation in February found.


Dealers cant legally sell new cars with open recalls, and car-rental companies cant legally rent vehicles with open recalls, but theres nothing in the law to stop used-car dealers from putting them on the road.


Blumenthal called it a no-brainer measure to protect American consumers and our roads from unsafe cars.


Markey pointed out that not only are drivers of the recalled cars at risk, but so are pedestrians and people in other vehicles.


All carswhether they are brand-new or usedneed to be safe before they leave the lot, Markey said.


Consumer advocates hailed the move. The bill is supported by Consumers for Auto Reliability and Safety, the Center for Auto Safety, Consumer Federation of America and Advocates for Highway and Auto Safety.


But whether the consumer-protection legislation can pass the Republican-controlled Senate is anyones guess.


Rosemary Shahan, president of Consumers for Auto Reliability and Safety, said a national law would be better than the patchwork of state laws.


Illinois has a broad consumer fraud act but not a law addressing recalled used cars.


Some consumers have successfully sued car dealers after realizing they were sold a car with an open recall.


But a national law would keep those cars from being sold in the first place, Shahan said.


Consumers often trust that a dealers inspection includes checking for safety recalls, consumer advocates say.


Most people dont even realize that dealers are even doing this, Shahan said. Theyre not going to some person on the streettheyre going to a licensed dealer, and theyre paying extra for that.


Its easy to find vehicles offered for sale despite having open safety recalls, a Chicago Sun-Times investigation in February found. The National Independent Automobile Dealers Association, an industry group for used-car sellers, opposes any rules that would require dealers to fix recalls before selling a used vehicle. It argues that parts shortages can make it impossible to get a quick fix for certain recalls but advises dealers to check for recalls and disclose that information to would-be buyers.


Since the recall system was created in 1966, the National Highway Traffic Safety Administration has issued safety recalls for more than 390 million vehicles.


Carfax, the vehicle-history tracking service, estimates that more than 57 million vehicles are on the road with open, unaddressed recalls.


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ASQ: Handbook of Investigation and Effective CAPA Systems, Second Edition

Handbook of Investigation and Effective CAPA Systems, Second Edition

José Rodríguez-Pérez


Hardcover,

234 pages, Published 2016

Dimensions: 6 x 9

ISBN: 978-0-87389-926-0

Item Number: H1504

Member Price: $37.00


List Price: $61.00

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Keywords

  • CAPA
  • quality system
  • FDA
  • medical devices

Description

Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries.
Features include:

  • Information about the importance of the CAPA system within the quality system for the medical products regulated industry.
  • Fully updated with current versions of regulations (U.S. FDA,
    EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations.
  • Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard.
  • New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA.
  • A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system.
  • Discussion of a dozen of the most common pitfalls commonly
    encountered in the investigation and CAPA world of regulated companies.
  • An example of an investigation and CAPA expert certification program being used for many companies.
  • Forms and examples of the different elements (investigation report, root causes checklist, human error investigation,
    CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format.

While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.

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Benchmarking – ASQ™ TV

Today, we’ll learn the basics of benchmarking, review the recommended six phases of a successful benchmarking process, and finally, we’ll get reacquainted with one vital ingredient in benchmarking: metrics.

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Is the Workplace a Zombie Breeding Ground? – ASQ

In this Journal for Quality and Participation article (open access), learn how creating an environment that fosters the development of spiritual intelligence can be a key leadership strategy for encouraging individuals to not choose to become zombies.

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