Bad Medicine

Recall is the latest hit for Tylenol maker

For almost 28 years, anyone talking about how best to handle a product recall inevitably mentioned Johnson & Johnson—the company behind a variety of over-the-counter medications, including Tylenol.

But the basis for that mention—the tampering crisis in 1982—is starting to look like a pebble compared with the mountain of problems that have emerged in the last few months.

Nearly 30 years ago, the drugmaker sprang to action when cyanide-laced capsules of Tylenol Extra Strength killed seven people in the Chicago area. The company recalled 31 million bottles of the drug and, two months later, relaunched the product with tamper-proof packaging and a media blitz touting its commitment to safety. The tab for the recall and relaunch topped $100 million. The payoff was a market share that went from 7% immediately after the recall to 30% a year later.1

But those heroic efforts are history, replaced most recently by a sweeping recall of a variety of children’s medications. And unlike the 1982 incident, when the bottles were tampered with post-production, this time the company has nobody but itself to blame.

The root of the problem was a plant in Fort Washington, PA, operated by McNeil Consumer Healthcare, a unit of Johnson & Johnson. The plant was already in the crosshairs of the U.S. Food and Drug Administration (FDA), which had it under a more rigorous inspection schedule since 2008.2

That proved to be a telling move, as the plant’s latest inspection in April revealed a list of issues that surfaced in an FDA report:

  • After receiving 46 consumer complaints between June 2009 and April 2010 about foreign materials in its drugs, McNeil failed to initiate "corrective and preventive action."
  • Quality control procedures were not followed, and lab facilities were inadequate for testing and approving products.
  • Plant employees were not trained in "current good manufacturing practices."
  • Pieces of equipment were layered with dust, and others were patched together with duct tape.
  • McNeil knowingly bought contaminated raw material from suppliers. The bacteria, later identified as Burkholderia cepacia, was discovered on drums the supplier used to transport raw materials, but McNeil said those drums never reached the plant in Fort Washington.3

"Remaining drums from that lot were sent to us, all of which tested negative for bacteria. Samples of finished product also tested negative," said Johnson & Johnson spokesman Marc Boston. The FDA inspection reported a different result, however, as the agency identified a handful of contaminated drums at the Fort Washington facility.4

The agency said—and testing confirmed—that no suspect material was used to manufacture any of the recalled products. But the potential for contamination led the FDA to recommend a recall—McNeil’s fourth since September 2009, when children’s Tylenol liquid products were pulled due to a substandard ingredient.

That had consumers running for generic brands and looking for answers that were tough to come by in the days following the most recent recall. Complaints rolled in about the company’s recall website, people struggled to reach customer service representatives on the recall hotline, and those who did get through were offered coupons rather than refunds.

The company quickly added more information to the website and staff members to man the phones, but that didn’t quell the frustrations of parents who were forced to toss their children’s Tylenol products for the second time in less than a year.

"It makes me question their quality control," said Mark Mandel, a microbiologist at Northwestern University’s Feinberg School of Medicine in Chicago and father of a 21-month-old daughter. "It makes me wonder if they have the parents’ best interest and the children’s best interest at heart."5

—Brett Krzykowski, assistant editor


  1. Judith Rehak, "Tylenol Made a Hero of Johnson & Johnson," New York Times, March 23, 2002.
  2. Alison Young, "Tylenol Recall Puts Drug Plant Inspection on Fast Track," USA Today, May 6, 2010.
  3. Parija Kavilanz, "Children’s Tylenol Recall: FDA Slams Factory Conditions," http://money.cnn.com/2010/05/04/news/companies/tylenol_recall_fda_inspection_report, May 6, 2010.
  4. Parija Kavilanz, "Bacteria Identified in Tylenol Recall," http://money.cnn.com/2010/05/05/news/companies/childrens_tylenol_recall_bacteria/index.htm, May 6, 2010.
  5. Natasha Singer, "Tylenol, Generics and Trust," New York Times, May 2, 2010.


Public Health, Food Standards Addressed at Recent USP Event

Editor’s note: The U.S. Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs to help ensure the quality, safety and benefit of medicines and foods. Don Singer, a quality scientist in the pharmaceutical and foods industries for more than 30 years, attended the USP’s recent membership meeting as an ASQ delegate and compiled this report. Singer has been a member of ASQ’s Food, Drug and Cosmetics Division for 29 years and is a certified pharmaceutical good manufacturing practice professional. He is also a former member of ASQ’s board of directors.

Patient care and key collaborations among USP and its partners to develop quality standards in medicine were the main topics discussed at the recent USP 2010 Membership Meeting.

Top officials from organizations that actively partner with USP offered keynote speeches and discussion to empower USP members to continue addressing public health issues related to health, medicines, drug and food ingredients, and standards for drugs, food ingredients and dietary supplements. About 500 people attended the event.

Margaret Hamburg, M.D., commissioner of the U.S. Food and Drug Administration (FDA), expressed confidence in the partnership the FDA and USP have in promoting a common public health mission and addressing public health issues relating to quality standards of drugs, foods and their ingredients, especially in recent years. The commissioner also praised USP’s global reach, which can become influential when "working with counterpart agencies and industries overseas to help establish science-based quality standards."

Michael Maves, M.D., CEO of the American Medical Association, addressed the importance of shared interests in drug standards, Medicare, drug naming, dietary supplement quality and patient safety.

Thomas Menighan, CEO of the American Pharmacists Association, stressed the need for collaboration to lead the way to healthcare reform. Menighan said the "medication use crisis in this country," referring to drug interactions, "is literally exploding" and presents a major opportunity for doctors, nurses, pharmacists and others to advance public health.

Jennie Chin Hansen, president of the Association of American Retired Persons and CEO of the American Geriatrics Society, echoed Menighan and pointed out that a growing population of older Americans is using more medications per person.

Of 3 billion yearly prescriptions, nearly 40% are not taken properly, leading to adverse drug events and higher healthcare costs, she said.

ASQ input and USP resolutions

Also at the meeting, USP members voted to approve nine key resolutions that will help determine USP strategy and benefit public health during the next five years.

One of the resolutions could make ASQ and its Food, Drug and Cosmetic Division a key contributor to USP by developing quality standards for food ingredients and strengthening the role of the Food Chemicals Codex as a global compendium of internationally recognized standards for the purity and identity of food ingredients.

The ASQ division’s contribution to the discussion resulted in a USP white paper and resolution No. 6, "Continue and Expand Commitment to Quality Standards for Food Ingredients." Other opportunities may exist for further ASQ collaboration relating to another resolution to promote quality standards for dietary supplements.

For more information about the USP resolutions, visit www.usp.org. To read the USP white paper, visit ASQ’s Food, Drug and Cosmetic Division website at www.asq.org/fdc.


ISO Releases New Toy Safety Standards

Two new standards related to reducing the risk of children being injured by unsafe toys, playground equipment or dangerous substances have been approved by the International Organization for Standardization (ISO).

The standards are additions to the ISO 8124 Safety of toys series of standards. Part 3: Migration of certain elements spells out the maximum acceptable levels of dangerous substances such as arsenic, cadmium, lead, mercury and other materials possibly found in toys.

Part 4: Swings, slides and similar activity toys for indoor and outdoor family domestic use details requirements and testing methods for the children’s equipment.

For more information about the new standards, visit www.iso.org/iso/pressrelease.htm?refid=Ref1319 (case sensitive).


Groups, Automakers Revise Guide

Two major automotive groups and automotive suppliers—along with the Big Three automakers and Toyota—have refined the warranty management process included in an industry manual that is expected to ultimately help improve customer satisfaction and the warranty process.

The second edition of the CQI-4 manual, also known as Consumer-Centric Warranty Management: A Guideline for Industry Best Practices, was rolled out last month and includes a self-assessment and toolkit. A training program to educate users of the CQI-14 warranty management process is expected to begin in July, said leaders of the Automotive Industry Action Group (AIAG) and the Original Equipment Suppliers Association.

The goal of CQI-4 is to reduce field warranty claims, which in turn improves consumer satisfaction "as measured by short-term initial quality and long-term vehicle durability and reliability," said J. Scot Sharland, AIAG’s executive director.

In addition to Chrysler, Ford Motor Co., General Motors Corp. and Toyota, 17 supplier member companies helped revise the guideline and develop the training.

"A cultural change focusing on reducing incident rate is needed," said Dave Sakata, vice president of technology at Freudenberg-NOK and a leader of the Consumer-Centric Warranty Management workgroup.

"It is necessary to develop continuous improvement processes that keep track of warranty parts information and other data for further investigation, and to conduct root cause analysis so that solutions and lessons learned can be determined and implemented in current and future programs," he said.

You can find out more about the guideline and training program at www.consumercentricwarranty.com.


Quality Report: Airlines Improve Performance in 2009

As airlines fly fewer flights and passengers book fewer trips in the air, the nation’s leading carriers are improving performance in many areas, including on-time performance and reduced customer complaints.

In fact, this is the second consecutive year that leading carriers have improved their scores in the annual U.S. Airline Quality Rating (AQR) study—a joint research project funded as part of faculty research activities at Purdue University in Indiana and Wichita State University in Kansas. Last year, airlines had the third-best overall score in the 19 years researchers have tracked airline performance. In total,  18 airlines were examined in the study’s 20th year.

The AQR was developed as an objective method for assessing airline quality based on several performance criteria. The 2009 AQR scores were based on 15 elements in four major areas focused on airline performance most important to air travelers.

In 2009, airlines improved in three areas:

  • On-time performance.
  • Baggage handling.
  • Customer complaints.

The only area in which performance dropped was related to denied boardings, or passengers being "bumped."

Comparing numbers

The overall leading carrier rankings changed little from 2008 to 2009, and the top four airlines remained the same. The top 10 carriers were:

  1. Hawaiian.
  2. AirTran.
  3. JetBlue.
  4. Northwest.
  5. Southwest.
  6. Continental.
  7. Frontier.
  8. U.S. Airways.
  9. American.
  10. ExpressJet.

The report also found:

  • Hawaiian Airlines had the best on-time performance (92.1%), while Atlantic Southeast—ranked 17 out of the 18 airlines—had the worst (71.2%).
  • Fourteen airlines improved their on-time arrival performance, and only six of the airlines had an on-time arrival percentage more than 80%.
  • JetBlue had the lowest involuntary denied boardings rate at zero per 10,000 passengers. American Eagle, ranked 18th in the overall list, had the highest rate at 3.76 per 10,000 passengers.
  • Overall, nine airlines improved their denied boarding rates last year.
  • AirTran had the best baggage handling rate with 1.67 mishandled bags per 1, 000 passengers,  while Atlantic Southeast had the worst with 7.87 mishandled bags per 1, 000 passengers.
  • Customer complaints per 100,000 passengers dropped from 1.15 in 2008 to 0.97 in 2009.

While the majority of the report indicated good news for airlines and their passengers, the study’s authors said there is still room for improvement.

"Seeing a continuing upturn in quality is good news for all air travel consumers, but it does not mean we have fixed the system," said Brent Bowen, professor and head of the department of aviation technology at Purdue. "Industry will never be successful in terms of quality until it can be successful financially. The financial crisis in the industry is a significant factor in the decline of quality."

The biggest challenge for airlines will be to improve performance quality as more people choose to fly.

"Every time there are more planes in the sky and more people flying, airline performance suffers," said Dean Headley, associate professor of marketing at Wichita State University. "Airlines are focused on generating revenues, not necessarily on customer service."


  • Bowen, Brent D., and Dean E. Headley, "Airline Quality Rating 2010," April 12, 2010, http://aqr.aero.

—Nicole Adrian, contributing editor


More Customers Ready to Switch Their Banks

Bank customers continue to be less loyal to their banks, in large part because of perceived poor service and high fees, according to a J.D. Power and Associates study released last month.

For the fourth straight year, however, retail banking customers’ overall satisfaction averaged 748 on a 1,000 point scale—slightly better than 749 last year.

The percentage of customers who said they "definitely will not" switch banks during the next year decreased significantly during the past three years to 34%, compared with 46% in 2007. Poor customer service was cited by 37% of the customers who changed their primary bank this year. High fees were cited by 29% of those who switched banks.

For more details about the 2010 U.S. Retail Banking Satisfaction Study, visit http://businesscenter.jdpower.com/news/pressrelease.aspx?id=2010068.


New Webinar Details ISO 9001:2008

A new ASQ webinar describes the ins and outs of the ISO 9001:2008 standard. ISO 9001 experts Charles Cianfrani and Jack West—who co-authored ISO 9001:2008 Explained, third edition—along with Joseph J. Tsiakals, provide an overview of the new standard, address its key changes and answer commonly asked questions.

The 90-minute webinar is available to ASQ members.

For more information and to access the webinar, visit www.asq.org/knowledge-center/iso-9001/index.html.


THE AMERICAN NATIONAL Standards Institute (ANSI) has announced this year’s World Standards Week will be celebrated Sept. 21-24, and that Sept. 23 will be World Standards Day. Visit www.ansi.org/meetings_events/wsw10/wsw.aspx?menuid=8 for a preliminary schedule and other information about activities related to the standards celebrations.

CUSTOMER SATISFACTION SCORES remained relatively unchanged in the fourth quarter of 2009, according to the most recent American Customer Satisfaction Index (ACSI). Analysts saw the scores as a good sign in a troubled economy. For more information about the quarterly scores and commentary, visit www.theacsi.org/index.php?option=com_content&task=view&id=13&itemid=31.

THE FEDERAL COMMUNICATIONS Commission (FCC) has approved the ANSI-ASQ National Accreditation Board/ACLASS to accredit laboratories that test telecommunication equipment subject to FCC rules. For more information about this development, visit www.aclasscorp.com/news/archives/2010/03/fcc-recognition-for-aclass.aspx.

THE BALDRIGE NATIONAL Quality Program is one of the top 10 leadership development programs among U.S. government and military organizations, according to Leadership Excellence magazine. The publication chooses its top leadership development programs from more than 1,000 candidate organizations based on seven criteria: vision and mission; involvement and participation; measurement and accountability; curriculum; presenters, presentations and delivery; take-home value; and outreach. This is the third straight year the Baldrige program has been included in the magazine’s rankings. For more information about the rankings, visit www.leaderexcel.com/best_ranking.html.

THE JURAN INSTITUTE has relaunched its website in an effort to make it more interactive and user-friendly. Visit www.juran.com to look over the changes and new features.

A NEW RADIO frequency identification (RFID) standard has been released by the International Organization for Standardization (ISO). The standard, ISO 17367:2009, Supply chain applications of RFID—Product tagging, defines the basic features of RFID for use in the supply chain when applied to product tagging. For more information about the standard, visit www.iso.org/iso/pressrelease.htm?refid=Ref1293 (case sensitive).

THE SIXTH EDITION of Juran’s Quality Handbook, the classic compendium for many quality professionals that was first published in the 1950s, has been released. New topics have been added by co-author and editor-in-chief Joseph A. De Feo of the Juran Institute, including sections on benchmarking best practices, continuous innovation, eco-quality, lean, root cause analysis, Six Sigma, and agile software and systems development. The book, published by McGraw Hill, retains material originally written by Joseph M. Juran.


TAG 176 Honors Five Members

Technical advisory group (TAG) 176 presented awards at ASQ’s spring standards meetings in San Diego. Those honored included:

  • Scott Bickley, TAG 176 secretary/treasurer—Unsung Hero Award.
  • Charles Cianfrani, TAG member—Outstanding Professional Achievement.
  • Denise Robitaille, TAG 176 vice chair—Outstanding Professional Achievement.
  • Dan Harper, TAG member—Honorary Lifetime Achievement.
  • Harrison Wadsworth, TAG member—Honorary Lifetime Achievement.

TAG 176 develops the U.S. positions on international standardization activities of ISO technical committee 176 on quality management and quality assurance.

ASQ News

QUALITY IN DUBAI The Dubai Quality Group (DQG) held an event for DQG members, ASQ members and other quality professionals in February in Dubai, United Arab Emirates. About 100 people attended the gathering, which was sponsored by Middlesex University in Dubai. Robert Chalker, ASQ Global managing director, and Tommy Tam, ASQ Global new business development director, represented ASQ. They discussed ASQ’s "Future of Quality" report and presented an overview of ASQ.

QUALITY FORUM IN CHINA More than 300 people attended a quality forum organized by ASQ China and the Shenzhen Association for Quality earlier this year. ASQ China members and other quality professionals discussed the evolution of quality and what’s expected of quality professionals today. Presenters included Kevin Wu, ASQ China’s general manager; Lestie Carey, an organizational change specialist; and Peter Shi, an ASQ member.

HUNTER AWARD DEADLINE Applications for the 2010 William G. Hunter Award are now available through ASQ’s Statistics Division. The award, named for the division’s first chairman, recognizes leaders in applied statistics. Nominees do not need to be members of the division but must demonstrate significant contributions to the field and "inspirational leadership and application." Nominations are due July 15. Visit www.asqstatdiv.org/awards.htm for award criteria, nomination forms and other details. You can also contact Robert H. Mitchell, one of the award’s organizers, at 651-736-8684 or rhmitchell@mmm.com with questions.

NEW BOOK ON LEAN AND HEALTHCARE Two efficiency experts recently wrote an ASQ Quality Press Book about lean principles in hospital settings after they took their daughter to an emergency room and saw first-hand how lean could improve healthcare practices. Lean Doctors: A Bold and Practical Guide to Using Lean Principles to Transform Healthcare Systems, One Doctor at a Time, describes Aneesh and Carolyn Suneja’s journey through Children’s Hospital of Wisconsin and illustrates six steps they say will help implement an effective lean system in healthcare. The book is available at www.asq.org/quality-press/display-item/index.html?item=H1387 (case sensitive). There, you can also find a link to a free webinar on the book and the benefits of lean in healthcare.

LEAN CERTIFICATION  ASQ is now offering lean certification through a new alliance with the Society of Manufacturing Engineers, the Association for Manufacturing Excellence and the Shingo Prize for Operational Excellence. To learn more about this certification and ASQ’s 16 other certifications, visit www.asq.org/certification/index.html.


Australian Quality Group Awards Honorary Title to Past ASQ President

The Australian Organisation of Quality (AOQ) has awarded former ASQ President H. James Harrington the title of "Global Leader in Performance Improvement Initiatives," the first time the recognition has been given to someone outside Australia.

"He is an inexhaustible creative author of over 36 books that have added value to countless businesses around the world," Shan Ruprai, the president of AOQ, said in a prepared statement. "Harrington writes the books that other consultants use."

In addition to this recognition, Harrington was appointed to an advisory board to contribute to a task force formed by former House Speaker Newt Gingrich earlier this year that will address jobs and the economy.

The task force, organized by Gingrich’s political advocacy group, "will discuss ways of turning American economic problems around," according to a statement prepared by the group.

Harrington served as president of ASQ from 1985-1986.


Quick Poll Results

Each month at www.qualityprogress.com, visitors can take an informal survey, and we post the results.

Here are the numbers from a recent Quick Poll:

"What aspect of the healthcare reform bill will have the biggest impact on quality?

  • Medicare reimbursing for quality of care 44.7%
  • Quality-based reporting requirements 34.2%
  • Comparative effectiveness research 10.5%
  • Grants rewarding best practices 10.5%

Visit www.qualityprogress.com for the most recent poll question:

"How does your organization support innovation now vs. when the economy was better?"

  • Less supportive
  • More supportive
  • No change


QP regularly tallies the web traffic to www.qualityprogress.com. The top five most accessed articles this month are:

  1. James J. Rooney, Lee N. Vanden Heuvel, Donald K. Lorenzo and Laura O. Jackson, "Cause and Effect," February 2009, www.asq.org/quality-progress/2009/02/basic-quality/cause-and-effect.html.
  2. Michael S. Perry, "A Fish (bone) Tale," November 2006, www.asq.org/quality-progress/2006/11/problem-solving/a-fish(bone)-tale.html.
  3. James J. Rooney and Lee N. Vanden Heuvel, "Root Cause Analysis for Beginners," July 2004, www.asq.org/pub/qualityprogress/past/0704/qp0704rooney.html.
  4. Simha Pilot, "What is a Fault-Tree Analysis?" March 2002, www.asq.org/quality-progress/2002/03/problem-solving/what-is-a-fault-tree-analysis.html.
  5. QP’s Annual Salary Survey, "Holding Steady," December 2009, www.asq.org/quality-progress/2009/12/salary-survey/holding-steady.html.

Word To The Wise

To educate newcomers and refresh practitioners and professionals, QP features a quality term and definition each month.

Quality loss function

A parabolic approximation of the quality loss that occurs when a quality characteristic deviates from its target value. The quality loss function is expressed in monetary units: the cost of deviating from the target increases quadratically the farther the quality characteristic moves from the target. The formula used to compute the quality loss function depends on the type of quality characteristic being used. The quality loss function was first introduced in this form by Genichi Taguchi.



QP looks back on a person or event that made a difference in the history of quality.

June 18, 1887

E.H. Waloddi Weibull, a Swedish engineer, scientist and manufacturer and the namesake of Weibull distribution, was born on this date.

He began his career in the Royal Swedish Coast Guard in 1904 and eventually achieved the rank of major in 1940. During that time, he also took courses at the Royal Institute of Technology in Stockholm, Sweden, becoming a full professor in 1924.

Weibull obtained his doctorate from the University of Uppsala in Uppsala, Sweden, in 1932. Later, he worked in Swedish and German industries as an inventor and as a consulting engineer.

In 1939, he published his paper on Weibull distribution in probability theory and statistics. It can be applied in several areas, including survival analysis, reliability engineering, industrial engineering, extreme value theory and weather forecasting.

In 1941, Bofors, a Swedish arms factory, gave him a research professorship in technical physics at the Royal Institute of Technology in Stockholm. There, he continued to publish papers related to the strength of materials, fatigue, rupture in solids, bearings and the Weibull distribution.


Who’s Who in Q

NAME: Lori A. Terpstra.

RESIDENCE: Conn, Ontario.

EDUCATION: Terpstra received a bachelor’s of science degree from the University of Guelph in Guelph, Ontario, followed by an MBA from Wilfrid Laurier University in Waterloo, Ontario and college diploma in quality from Conestoga College in Kitchener, Ontario.  She is an ASQ certified manager of quality/organizational excellence, quality engineer, reliability engineer, quality auditor, quality technician, mechanical instructor and quality improvement associate. She is also an International Register of Certified Auditors and Registrar Accreditation Board-trained auditor and has received a Six Sigma Black Belt from Six Sigma Academy Florida.

CURRENT JOB: Service operations manager at Shred-Tech in Cambridge, Ontario. Shred-Tech designs and manufactures reduction systems and shredding machinery.

INTRODUCTION TO QUALITY: Terpstra said she fell into the quality field almost by accident. While going to the University of Guelph, she worked part time in a research lab and became part of a test method development team working on DNA fingerprinting. Her involvement in quality kept growing and evolving from there.

ASQ ACTIVITIES: A member since 1995, Terpstra is the 2009-2010 chair-elect for ASQ Section 405 and has been a preliminary round judge for the International Team Excellence Awards for the last two years. She has spoken twice at the World Conference on Quality and Improvement and presented at her local and Chicago sections. Terpstra recently served as vice chair for the ASQ section in Raleigh, NC, and has volunteered at ASQ headquarters, developing exams for several certifications.

PUBLISHED: She has had two papers published that were associated with ASQ world conferences in 2001 and 2002, as well as an After 5 Session presentation for the 2009 world conference.

RECENT HONORS: Terpstra was named an ASQ fellow earlier this year. Three times while she worked at Moen, she was a member of teams that received Team Excellence Awards. She also received a Corporate Ring of Quality Award while working at ITT Corp.

PERSONAL: Married for five years. Four-year-old son and expecting her second child in October.

FAVORITE WAYS TO RELAX: Reading with her son, helping on her farm (Terpstra’s husband is a full-time farmer) or working with her horses, especially those she rescues, rehabilitates and finds new homes for.

QUALITY QUOTE: A lot of people understand the concept of quality. Many understand the methods and techniques required to implement quality processes, procedures and products. Only a few can turn those methods and techniques into actions and commit themselves to the dedicated time and effort needed to overcome the hurdles and resistance to make quality happen as an infrastructure component (way of life) at their companies and services. To reach excellence, you have to be one of those few.

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