Ask the Experts: Standard vs. Specification and Guidance Documents


ISO documentation practices, requirements, records


What is the difference between a standard and a specification?


There is no single or simple answer to your question. The answer depends upon the context of the question. Relative to the ANSI/ISO/ASQ Q9000 Series: Quality management standards, I direct you to ANSI/ISO/ASQ Q9000:2005 Quality management systems – Fundamentals and vocabulary.

ISO 9000:2005 defines specification as a document that states requirements. A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

ISO 9000:2005 does not define “standard”. The first part of the ISO 9000:2005 introduction reads:

“The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.

ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.

ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.

ISO 19011 provides guidance on auditing quality and environmental management systems.

Together they form a coherent set of quality management system standards facilitating mutual understanding in national and international trade.”

In other words…

ISO 9000 is a standard that describes fundamentals and specifies the terminology.

ISO 9001 is a standard that specifies requirements.

ISO 9004 is a standard that provides guidelines.

ISO 19011 is a standard that provides guidance.

This implies that a standard is a formal document that establishes uniform criteria, methods, processes and practices — which may or may not be requirements.

ISO 9000:2005 also makes a distinction between quality management system requirements and requirements for products using the terms “specifications” and “standards.” It states:

“The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.”

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

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Amazon CEO Jeff Bezos Believes This Is the Best Way to Run Meetings

New York Observer

June 12, 2019

By Brittain Ladd

Jeff Bezos loves to write. A lot. In his annual letter to shareholders, Bezos does more than provide an overview of Amazons performance; he helps shareholders understand what makes Amazon different. Bezos always does one other thing: He attaches a copy of the first annual shareholder letter he wrote in 1997 to reinforce his commitment that Amazon will always operate with a mindset that it is still day one.

In a more recent shareholder letter, Bezos demonstrated his understanding of how to use language to advance his personal beliefs, educate others and command an audience. Whats unique about this letter, however, is that it expands on one of the techniques I have identified as being a major reason for the success of the companysix-page narratives and the internal press release.

Before moving deeper into this article, I want to make it clear that I am not suggesting that only six-page memos and press releases are the reason for Amazons success. Theyre not. Amazon succeeds because it attracts and hires the most capable individuals from all over the world.

Amazons secret sauce

One of the things I enjoyed most working at Amazon was attending meetings. Why? Because they were the most efficient and exciting meetings I had ever attended for any company. Unlike most companies where people come to meetings to review PowerPoint slides, Amazon doesnt use PowerPoint. Ever. Instead, Amazon requires everyone, regardless of their title, to begin meetings by reading every word in six-page memos. What makes the memos interesting is that they have writing on both sides of the paper so, in essence, 12 pages are being read. Most of the six-page memos I read also contained an internal press release at the beginning of the memo to provide a high-level understanding the of the product or service being proposed and discussed.

Although it may seem counterintuitive to believe something as simple as an internal press release and a six-page memo can be considered primary among the keys to Amazons success, its true. Note: The press release is for internal use only. Although written in the form of an actual press release, it is not distributed to the press for publication.

Amazon is focused like a laser on customers. Instead of starting with an idea for a product and trying to convince executives that customers will love the idea, Amazon works from the perspective of the customer to come up with ideas that will legitimately generate value. For example, Prime was created because it was understood within Amazon that customers wanted to buy quality products for less money, and customers wanted to receive products as fast as possible. Prime appeared to be a solution that would meet both customer needs. An internal press release was written centered around the existing problem (high costs, slow deliveries), why current solutions had failed to correct the problem, and how the new product (Prime) would blow away all existing solutions. I have read the original press release for Prime and Prime Now, and I can attest that the actual programs achieved the goals as outlined in each press release.

At a high-level, the press release follows this outline:

Heading: Name the product in a way the reader (i.e. your target customers) will understand.

Sub-Heading: Describe who the market for the product is and what benefit they get. One sentence only underneath the title.

Summary: Give a summary of the product and the benefit. Assume the reader will not read anything else, so this paragraph is critical. Note: If you struggle writing the summary, step back and reevaluate the idea.

Problem: Describe the problem your product solves. Be clear.

Solution: Describe how your product solves the problem. Be enthusiastic!

Quote From You: A quote from a spokesperson in your company. For example: Amazon customers want same-day deliveries. We created Prime and Prime Now to provide our customers with deliveries in as little as two hours, stated Amazon founder Jeff Bezos.

How to Get Started: Describe how easy it is for customers to get started using the service.

Customer Quote: Provide a quote from a hypothetical customer that describes how they experienced the benefit. For example: I was amazed that I could order protein bars and pre-workout supplements and receive them the same day, stated Brittain Ladd.

Closing and Call to Action: Reinforce to the customer why the product or service is a must-have and reinforce the value generated for the customer.

I wrote multiple press releases when I worked for Amazon, I read numerous press releases, and I taught others how to write press releases. I never witnessed a product or service become a reality if the press release didnt effectively identify the value of the product or service to the customer. The rule of thumb I used at Amazon was this: If it was hard to write a press release or understand why a product or service would add value to customers, the product or service wasnt worth the effort. Move on.

Six-page memo

I have been in many situations since I left Amazon in which I was able to identify that writing a press release and a six-page memo would have saved a consulting client millions of dollars and countless hours in wasted time and effort. How? The press release and six-page memo, early in the process, would have pinpointed that the scope of the project was focused on the product itself and not on the value to customers. For example, a CPG (consumer packaged goods) client that hired me had released a food product on the market, but sales were dismal. After meeting with the team responsible for creating the product and bringing the product to market, it was clear that not enough effort was placed on understanding what value (if any) the product would give to a customer. A high-protein food product was viewed as having too little protein, so customers ignored the product. Using a six-page memo and an internal press release, the scope of the project was changed, additional protein was added, and the product was released under a different name with packaging touting the higher protein content. Sales exceeded expectations.

Although I value the internal press release as an important tool, the technique I credit the most for giving Amazon an advantage is the disciplined and rigorous use of six-page memos referred to as a six pager inside Amazon. As with the press release, I wrote many six-pagers inside Amazon, and I taught others in the company how to better use six-pagers to advance an idea for a product or a service. According to Bezos:

The reason writing a good six-page memo is harder than creating a 20-slide PowerPoint deck is because the narrative structure of a good memo forces better thought and better understanding of scope and whats more important than that.

Six-pagers present and answer in excruciating detail the who, what, when, where and why of a product or service. Echo is an actual device, so a six-pager would include tremendous detail on the specifications of the product, value to customer, technology requirements within Amazon to bring the product to market, budget, etc.

A six-pager written about Prime would focus more on the requirements of the supply chain and logistics to meet demand, identify which products are Prime eligible, internal systems requirements, budget, value to the customer, etc.

Just like the press release, I never witnessed a product or service become a reality at Amazon unless the six-pager contained the required data and was able to clearly articulate the value to customers and to Amazon. Executives at Amazon believe in the use of six-pagers 100%.

The real value of the six-pager that I identified is this: It forces otherwise busy and distracted executives to give their utmost attention and opinion to decide on something. I cant stress this point enoughrequiring executives and associates to sit in a room, read every page (front and back) of a six-page memo, discuss and dissect the data and the idea presented, and then make a decision to move forward is a very powerful management and decision-making methodology.

Six-pagers prevent hiding. Six-pagers separate the vital few ideas and products from the trivial many. Six-pagers identify where a company should place its focus and why. Six-pagers enforce discipline and rigor in decision-making. Six-pagers are an excellent management tool.

Can the press release and six-page memo work for other companies?

It is no secret that most companies struggle to compete against Amazon.

Amazon perfected the use of the press release and six-page memo to give its executive team and associates a framework for identifying the optimal products and services to provide customers. Based on my experience and analysis, I can find no reason why other companies cant benefit from using the press release and six-page memo methodology.

I have also assessed the use of the press release and six-page memo by management consulting firms. Even though I have many tools in my consulting toolbox, if only given the chance to select two, I would choose the press release and the six-page memo over everything else. No joke.

In fact, I use a hybrid version of the six-pager for the articles that I write for multiple publications.

For example, the strategies and recommendations I identified for Campbell Soup were created writing a press release and a six-pager. Im convinced that if Campbell Soup required executives and associates to utilize press releases and six-pagers, the board would never have approved the acquisition of Bolthouse Farms, Snyders-Lance or any other of the acquisitions of former CEO Denise Morrison.

Working backwards from the customer, what customers want is a far cry from the carrots and other products offered by the soup company. (Note: Feedback from executives, consultants and financial advisers working at Campbells who read my article verified that the recommendations I made were accurate.)

I applied the same technique to identify and write about strategies I recommended for J.C. Penney. I also wrote multiple press releases and six-page memos when I worked as a consultant for Kroger.

The challenge for companies that want to use the press release and the six-pager is that it requires a significant amount of training to master the techniques. In my experience, too many individuals outside of Amazon who attempt to use either document tend to not invest the required time and effort in learning how to write and use both documents as designed.

Bottom line: The press release and the six-page memo work because they identify the products and services most relevant for generating value to customers, and they accelerate execution of the strategy by increasing the speed at which decisions are made.

Should companies introduce the internal press release and the six-page memo into its culture and way of doing business? Absolutely.

Amazon is Amazon because it has perfected the use of both techniques.

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Recall Alert: Tyson Foods Recalls 190,000 Pounds of Chicken Chunk Fritters

Dayton Daily News

June 12, 2019

By Natalie Dreier

Tyson Foods and the U.S. Department of Agricultures Food Safety and Inspection Service have announced a recall of more than 190,000 pounds of the companys Fully Cooked, Whole Grain Golden Crispy Chicken Chunk Fritters.

The fritters, which have case code 0599NHL02 and have establishment number P-1325, could have foreign material, specifically plastic, in the product.

The chicken fritters were sent to institutions, including some schools, but were not part of food provided by the USDA to schools for the National School Lunch Program.

The FSIS was told of three consumer complaints last week, but there were no reports of adverse reactions.

While the items were not sold to the general public, the items could still be in institutional freezers. The packages of fritters should be returned to the place of purchase or thrown away, according to the FSIS.

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Canada: Don’t Be Confused by Best Before and Packaging Dates

Mondaq Business Briefing

June 26, 2019

While much of the data on food labels is notoriously incomprehensible to the average consumer, at least “best before” and “packaging” dates are easy to understand and provide valuable information on food safety. Right? Wrong.

According to B.01.007 of the Food and Drug Regulations, when a pre-packaged product having a durable life of 90 days or less is packaged at a place other than the retail premises from which it is sold, the food’s label must show the durable life date and provide instructions for proper storage conditions if it requires storage conditions that differ from normal room temperature. The durable life date is to be expressed on food labels as “best before date” using standardized bilingual symbols. So, for example, this June 15 would appear as 19 JN 15.

But now it gets a little confusing. Durable life is defined as “the period commencing on the day on which a pre-packaged product is packaged for retail sale during which the product, when stored under conditions appropriate to that product, will retain, without any appreciable deterioration, its normal wholesomeness, palatability, nutritional value and any other qualities claimed for it by the manufacturer.” While it is true that “wholesomeness” is related to food safety, the durable life is more to do with food quality. There are no rules on how to establish durable life for products so this is a matter at the sole discretion of the manufacturer and the date is only valid for unopened products. Many foods could be unsafe within the best before date depending on how it has been stored and others perfectly safe for years after the best before date.

Even more confusing, if in the opinion of the manufacturer the shelf life exceeds 90 days, there is no requirement for any best before date. However, manufacturers now use them anyway for their own traceability purposes, so we have so-called best before dates on canned and other packaged products that can be safely on a shelf for years. Is it any wonder that a consumer is confused by a best before date on the bottom of a can that is five years away? This “information” says very little about quality and nothing about food safety.

There appears to be no standard or scientific basis for the determination of what is a durable date or shelf life for products. Foods prepared by a commissary and sold in automatic vending machines or mobile canteens and prepackaged salads and fresh fruit trays are exempt from the regulations, even though they have all been a recent source of foodborne illness.

Retail-packed products require a “packaging date” and there are definitional problems here as well. “Packaging date” means “the date on which food is packed for the first time in a package in which it will be offered for sale to a consumer.” A roast, for example, can be packaged by a butcher with a packaging date and there is no labelling law that prevents the retailer from cutting up the roast later with a new date as stewing beef and then again later with a new date as ground beef. Your chicken shish kabob packaged yesterday may have been chicken breasts packaged last week, and no labelling law has been broken.

The issue has taken on new complexity with the growing concern about food waste. A recent report by the National Zero Waste Council says that confusing best before dates are a “major source of food waste in Canada” with the result that “Canadians are among the biggest food-wasters in the world.” The Council is against removing products from shelves after the best before date. There is even now a thriving store chain in the U.K. called Affordable Foods that sells super- cheap food on or near its best before date. Whether consumers will be less confused by this or this movement has implications for food safety remains to be seen.

Follow storage and cooking instructions carefully and remember that best before and packaging dates do not provide reliable information on food safety.

This article originally appeared in Food in Canada and is republished with the permission of the publisher.

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6M Secret Medical Device Problems

Star Tribune (Minneapolis)

June 26, 2019

The U.S. Food and Drug Administration last week published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.

The roughly 6 million reports released Friday cover a wide array of devices in reports that were secretly filed with the FDA from 1999 to April of this year. From Allergan to Zimmer, dozens of medical device makers have filed reports on everything from breast implants and heart monitors to pediatric breathing machines. Device makers with Minnesota ties in the data include Boston Scientific, Coloplast, Medtronic and the former St. Jude Medical.

Advocates for public transparency cheered Friday’s announcement. The industry’s biggest trade group, AdvaMed, said it supported the move.

Medical device companies are required by law to file such reports within 30 days of learning that a device may have caused a patient injury or death, though the law contained a loophole that allowed millions of files to remain hidden as “summaries.” The FDA said many of these summary reporting arrangements were allowed because new files were duplicative and wouldn’t add to the body of knowledge about existing problems in Manufacturer and User Facility Device Experience (MAUDE), the FDA’s public database of adverse event reports.

The Alternative Summary Reporting (ASR) program “allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks,” the FDA statement said.

The Star Tribune first wrote about the program in 2016 after Medtronic, which is run from offices in Fridley, disclosed that it had filed more than 1,000 reports of patient harm associated with the use of its Infuse bone-growth product as summaries instead of individual reports.

The ASR program was formally ended this month, as the result of a decision by the agency in 2017 to “gradually sunset” the program, according to an FDA statement published Friday.

Madris Tomes, a former FDA device reviewer who left the agency and started an independent company to analyze the agency’s public-facing files, said Friday that the decision to revoke the ASR program apparently includes the revocation of an even more obscure program called “retrospective summary reporting,” which was so secret that a spokesperson for Johnson & Johnson once claimed the program did not exist – until presented with a J&J subsidiary’s own filings in the program.

“Consumers can now see what the FDA has seen over the years (i.e. the true numbers of adverse events), and physicians can make better informed decisions about which device(s) to recommend to their patients,” Tomes, CEO of Device Events, said in an e-mail.

Medtronic, the world’s largest medical device company, said Friday that although the company works hard to reduce or eliminate product malfunctions and events, its employees also make every effort to tell regulators, clinicians and the public about malfunctions when they do occur.

“Medtronic has utilized these various reporting programs and our reports and submissions are included in the reports released today by the FDA,” company spokesman Jeffrey Trauring said in an e-mail. “We applaud the FDA for their ongoing efforts to drive transparency and openness around medical device performance, and we will continue to work with FDA on future, modern programs of reporting.”

The filing of an adverse event report is not itself an admission that the device in the report caused the problem. Sometimes the reports include such admissions, but more commonly they simply disclose a medical problem following the use of a medical device, plus a manufacturer’s conclusion that no direct link could be definitively established. Also, the same event may be reported more than once in MAUDE, and the files released Friday may also contain duplicative reports.

AdvaMed, a Washington-based trade group for the med-tech industry, said it was important for physicians and the public to have access to information about medical device performance, and the group supports the FDA’s efforts to make old ASR filings public.

“It is important to note, however, that while the ASR information was not accessible in FDA’s MAUDE database, the agency had access to all this information and used that data in its analysis to determine the risk profile of the devices subject to ASR,” AdvaMed spokesman Jim Jeffries said Friday.

Dr. Michael Carome, director of Public Citizen’s health research group, said the FDA should never have created the program. He said allowing summaries gave the appearance that the FDA was serving the device industry, not the public.

“It was easier for the industry to file these reports” rather than individual adverse event reports, Carome said. “But [summaries] hid information. Important safety information was not available to the public. What we need now is for the hidden information to be available and easily searchable.”

The newly released files are not easy to read. The summaries include numerical codes that represent specific problems, because that’s how the device companies were reporting the problems under the ASR program.

There are several different types of summary reporting, and at least one form is still allowed, known as the Voluntary Malfunction Summary Reporting Program.

Med-tech regulatory attorney Mark DuVal said Friday that the move to publish the old summary data was an appropriate way to build public confidence in the reporting system, even though the system wasn’t heavily used in the past.

“Whether the information will be useful to the public, I doubt it,” said DuVal, CEO of DuVal & Associates in Minneapolis. “But the agency is increasingly criticized for stuff like this, and they are avoiding perceptions.”

ASR reports have come under close scrutiny in recent months as the International Consortium of Investigative Journalists and Kaiser Health News have published critical stories about the program’s hidden reports regarding breast implants and surgical staplers. The Star Tribune published a story in December about long-lost reports of problems following the use of Medtronic’s Infuse in upper-spine fusion surgery.

The Washington-based not-for-profit National Center for Health Research welcomed the end of the summary reporting program.

“While we’re very pleased that the FDA has done the right thing by releasing the information as promised, this summary reporting program allowed thousands of serious adverse events involving medical devices to remain hidden from public view,” government affairs director Jack Mitchell said.

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Revisiting Strategies for Buying a New Car

Telegram & Gazette (MA)

June 25, 2019

With the cost to own a new vehicle rising, it’s more important than ever to consider what you’ll pay for a car loan and to shop for the best interest rate.

The average new car loan interest rate reached 5.5% in 2018, up about one percentage point from the previous year, according to Ben Bartosch, J.D. Power’s manager of forecast analytics. Meanwhile, a new car purchase price is $33,000, on average, he says. That means a buyer will pay thousands of dollars in interest on a 60-month loan.

Indeed, many car owners report feeling stressed by their debt. A recent Harris Poll survey of 2,000 Americans for Fair, which provides cars each month for a flat fee, found that 47% of people who’ve had auto loan debt say it’s taken away some of their peace of mind.

With the shift in the loan market, anyone looking to buy a car or refinance a loan needs smart strategies. Here are five things financial and automotive experts say will help you lock in financing that fits your budget.

1. Check your credit

If you don’t know your credit score, you don’t know what interest rate you could qualify for. Additionally, if you find a problem on your credit report, you can fix it before entering the car-buying process. And, if you already have a loan, you may be able to refinance into a lower rate and payment if your credit is stronger than when you started the loan.

Your credit score is available for free from many personal finance websites, banks and credit card issuers. And you can use to request the free credit reports you’re entitled to every 12 months from the three major credit bureaus.

2. Shop around for the best rate

The loan-shopping process should start long before the car-buying process, Bartosch says. Calling around, or submitting online applications, could save you hundreds of dollars.

“Most people just think of going to the dealer to get a loan,” says Sonia Steinway, president of auto loan company Outside Financial. But, “There’s a whole world of options available to them.” She says credit unions offer some of the lowest rates and the best customer service.

To compare loan offers, keep these terms the same:

  • Loan amount. In addition to the negotiated purchase price of the car, sales tax and fees will increase the amount you’ll need to borrow.
  • Down payment. The more you put down, the less you have to borrow, saving you money on interest and it might help qualify you for a better rate.
  • Loan term. Experts recommend 60-month loans for new cars and 36 months for used vehicles.

3. Design a loan you can afford

Once you know the interest rate you qualify for, use a car loan calculator to estimate your monthly payment. Aim to spend no more than 10% of your take-home pay on your loan payment and less than 20% for total car expenses, which also includes gas, insurance, repairs and maintenance.

If you’re refinancing, extending your loan term can lower your monthly payment, but you may pay more in interest overall. Use an auto loan refinance calculator to see if you’ll save money by refinancing.

4. Get pre-approved for a car loan

Pre-approval can help you get the most competitive rate. Michael Bradley, internet sales manager at Selman Chevrolet in Orange, California, encourages buyers to apply for financing before they get to the dealership, then to ask the dealer to beat their rate.

Recently, Bradley has seen more shoppers coming in with pre-approved loans from credit unions, but others, he says, are waiting for 0% financing from car manufacturers’ lending companies. These loans aren’t offered as frequently as in the past, he says, “so when they come out, people jump on them.” Search a carmaker’s website for information on low-interest financing deals and other incentives.

5. Carefully review the contract

While the loan contract is long and the verbiage is dense, it’s important to review it carefully before signing. Double-check the numbers using a loan calculator. Mistakes sometimes intentional do happen, says Oren Weintraub, president of car-buying concierge service Authority Auto in Tarzana, California, who reviews contracts for clients.

If the numbers don’t add up, make sure the lender hasn’t slipped in extra items you don’t want, like an extended warranty or gap insurance. And question any extra fees you weren’t told about initially or that other lenders don’t charge.

This article was provided to The Associated Press by the personal finance website NerdWallet.

The original headline for this article was With the Cost to Own a New Vehicle Rising, Its More …

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The Car Industry Is Under Siege

The New York Times

June 10, 2019

Jack Ewing

Its a scary time to be in the car business.

The internal combustion engine is under attack from electric challengers. Car ownership is becoming optional in the age of Uber. Regulators around the world are fining companies that dont do enough to cut carbon dioxide emissions, even as buyers demand gas-guzzling SUVs. Global auto sales are slipping for the first time in a decade, disrupted by President Trumps escalating trade war.

With so much bearing down on them simultaneously, its little wonder that companies like Fiat Chrysler and Renault were considering joining forces to survive. Fiat Chryslers decision Wednesday night to withdraw its offer to merge with Renault, citing government demands in France, was another reminder that change is complicated for traditional carmakers.

The aborted proposal to create the worlds third-largest automaker was a response to the disruption threatening an industry that accounts for many of the worlds factory jobs and is crucial to the economic fortunes of the United States, Japan and Europe.

New technology has unraveled industries like entertainment, media, telecommunications and retailing, weakening the job security of millions of workers and helping to fuel populism. Carmakers, clearly, are next.

Its going to be the biggest change weve seen in the last 100 years, and its going to be really expensive even for the biggest companies, said Erik Gordon, a professor at the University of Michigan Ross School of Business.

The major auto companies will spend well over $400 billion during the next five years developing electric cars equipped with technology that automates much of the task of driving, according to AlixPartners, a consulting firm. They must retool factories, retrain workers, reorganize their supplier networks and rethink the whole idea of car ownership.

For the auto manufacturers, this upfront investment is a matter of survival. If they dont adapt, they could become obsolete. Yet no one is even sure whether customers are really willing to pay for the technology and whether it will ever earn a profit.

Investors have already signaled who they think will come out ahead of this transformation. The electric carmaker Tesla, despite all its problems, is still worth more on the stock market than either Fiat Chrysler or Renault. Uber is worth much more than the two combined, even after reporting a $1 billion quarterly loss.

The stakes for society from this industrial realignment are high. Car companies like Volkswagen, General Motors or Toyota are among the last employers that operate vast factories where thousands of workers pour in and out of the gates at shift changes.

Worldwide, eight million people work directly for auto manufacturers, and many times more work for companies that supply brakes, tires, sensors and other components.

Those jobs are threatened. Last year global car sales declined for the first time since 2009. Though small, the decrease may signal the onset of a global recession because the auto industry is such an important economic catalyst, analysts at Fitch Ratings said in a recent report.

The immediate cause of the dip in sales was Mr. Trumps tariffs on Chinese goods last year, which hurt the Chinese economy and brought sales growth there, the worlds largest car market, to a standstill. American carmakers suffered, too. Fords sales in China plunged 36% in the first three months of 2019, to 136,000 vehicles, because of the tariffs, the company said. But there are also ominous long-term trends at work.

China increasingly rules the global auto market and determines its course. In recent years, Chinas voracious appetite for vehicles has accounted for almost all of the growth in global sales. Chinese consumers bought 24 million cars last year, far more than any other nation. Americans were a distant second with 17 million cars. General Motors sells far more cars in Asia947,000 in the first three months of this yearthan it does in the United States.

Auto sales in America and Europe are stagnant, and the growth in potential drivers is not encouraging. The number of young Americans acquiring drivers licenses has been falling since the 1980s, according to research by Michael Sivak, a former professor at the University of Michigan.

Increasingly, car ownership is a luxury rather than a necessity. In urban areas, where more and more of the population lives, people can avoid parking costs and the expense of insurance by relying on ride services like Uber or Lyft or hourly rentals with services like Zipcar.

The wavering relationship between consumers and cars has been hastened by the emergence of climate change as a potent political issue, as well as worsening air quality in major cities. Transportation accounts for about one-fifth of carbon dioxide emissions worldwide, according to the World Bank. Policymakers, responding to public opinion, have been forcing auto companies to improve fuel efficiency and reduce emissions. Carmakers ability to push back has been weakened since emissions cheating scandals were uncovered at Volkswagen and other carmakers, including Fiat Chrysler.

In the European Union, carmakers must achieve average fuel economy equivalent to about 57 miles per gallon by 2021 or pay substantial fines. But European carmakers are behind on achieving the goals, in part because European consumers, like people in the United States and Asia, have developed a taste for thirsty sport utility vehicles. As a result, the car companies face penalties of 34 billion euros, or about $37 billion, the research firm JATO Dynamics estimates.

The potential fines were one of the reasons that Fiat Chrysler sought a merger with Renault, which already has a longtime (if lately troubled) alliance with the Japanese carmaker Nissan. The French company offers battery-powered cars, like the subcompact Zoe, that would have made it easier for Fiat to hit the emissions targets.

The Trump administration has been rolling back air quality regulations, but even in the United States, carmakers are under pressure because California and other states are requiring manufacturers to meet quotas for zero-emission car sales. On Thursday, in a letter to Mr. Trump signed by 17 companies, the automakers said a divided market in the United States, where some states apply the rolled-back federal rules and others have a stricter standard, would be untenable.

Regulators and a growing segment of environmentally conscious car buyers are pushing the internal combustion engine toward obsolescence. China, Britain and France lead a list of countries aiming to phase out cars that burn gasoline or diesel by 2040. Norway is trying to convert entirely to electric vehicles by 2025.

Auto executives in Detroit, Stuttgart, Yokohama and other carmaking capitals foresaw these seismic shifts years ago and have been preparing.

BMW has been selling an electric car, the i3, since 2013. Nissan introduced the battery-powered Leaf in 2010. Traditional carmakers like G.M., Daimler, BMW and Volkswagen responded to the decline in car ownership with their own ride-sharing services, albeit with mixed success.

But despite their size, automakers like Fiat Chrysler, Ford or Volkswagen are at a disadvantage to newcomers like Uber or Dyson, the vacuum cleaner maker, which is developing an electric car. The old-line carmakers still get almost all of their revenue from cars with internal combustion engines, and must maintain factory networks that quickly become a financial drain when not running at capacity.

China is emerging as a new competitorand it is battling saturation even in its domestic market. China is absorbing only half the cars that Chinese plants churn out each year. Big producers like Guangzhou Auto had been preparing to enter the United States until Mr. Trump imposed 25% tariffs on Chinese cars.

So far, Chinese automakers have made some inroads to European markets. Zhejiang Geely Holding Group has a foothold after buying the Swedish carmaker Volvo from Ford in 2010. Geely also owns the British sports car maker Lotus and the company that makes London taxicabs, while its chairman, Li Shufu, owns about 10% of Daimler, the maker of Mercedes-Benz cars.

The shifting balance of power in the auto industry is already squeezing the lives of thousands of workers. General Motors, girding for a possible downturn, shut down its plant in Lordstown, Ohio, in March, one of four factories in the United States that it plans to mothball by the end of this year, eliminating more than 10,000 factory and white-collar jobs. Volkswagen said Wednesday that it would create 2,000 new jobs in digital technologies while gradually cutting 4,000 jobs that would no longer be necessary because of automation.

By some estimates, half of all auto industry jobs in Germany are at risk. Battery-powered cars have far fewer parts than cars reliant on gasoline or diesel, endangering suppliers of valves, pistons and other parts in conventional engines. The most important part of an electric car, the battery cells, usually comes from Asia.

Mergers as big as Fiat Chrysler and Renault may prove too difficult to pull off, but carmakers are already forming dozens of smaller alliances. This year, Ford and Volkswagen agreed to develop new commercial vans and pickups together to go to market by 2022 and cooperate on technologies like electric cars and autonomous driving. BMW and Jaguar said Wednesday that they would cooperate to develop drive systems for electric cars.

These partnerships can be difficult to manage, as Renaults recent experience with Nissan shows. The alliance of those carmakers survived for nearly two decades but is wobbly after the arrest in November of Carlos Ghosn, its chairman, on charges of financial wrongdoing. Mr. Ghosn denies the accusations.

Mr. Ghosn was keenly aware of the need for automakers to combine forces, and, in part, his fervor undid his relationship with Nissan. In many ways, John Elkann, the Fiat Chrysler chairman, and Jean-Dominique Senard, the chairman of Renault, were trying to take his vision a big step further.

Large-scale alliances are essential to have a path for success in this transformative era, said Jim Press, former deputy chief executive of Chrysler.

The companies arent going to do it alone.

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Kroger Recalls Some Frozen Berries for Possible Hepatitis A Contamination

Dayton Daily News

June 10, 2019

The Kroger Co. is recalling some frozen berries under the Private Selection label for a possible hepatitis A contamination, according to an FDA alert released Friday.

The berries were manufactured by Townsend Farms under the store brand and were distributed to the family of Kroger stores across the country. The following items are under recall:

  • Private Selection Frozen Triple Berry Medley, 48-ounce best by 070720; UPC: 0001111079120.
  • Private Selection Frozen Triple Berry Medley, 16-ounce best by 061920; UPC: 0001111087808.
  • Private Selection Frozen Blackberries, 16-ounce best by 061920 and 070220; UPC: 0001111087809.

Customers who have purchased the above products should not consume them and should return them to a store for a full refund or replacement.

No customer illnesses have been reported.

Customers who have questions may contact Kroger at 1-800-KROGERS.

Hepatitis A is a contagious liver disease. It can range from a mild illness lasting a few weeks to a serious illness lasting several months. Illness generally occurs within 15 to 50 days of exposure and includes fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool, according to the FDA.

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