Did any of you catch that recent WSJ report on the negative impact of mass layoffs? OK, I know that M&A layoffs are different, but today brought the sad news that Pfizer/Wyeth will lay off 6,000 employees and close eight of its manufacturing plants in Ireland, Puerto Rico and the U.S.

From the Wharton business school, an interesting piece on an easy way to motivate employees...connect them to those who benefit from their work. Professor Adam Grant has tested this theory and found it works....I'm betting that plant accidents or quality problems wouldn't happen  as frequently if employees had regular contact, of some sort, with the end users of the products they make.  For more, read on.

AMS

I've always found one of the most evocative terms in the Toyota lexicon to be “gemba” ----the real place, or as it has more poetically been translated, “the place where truth will be found.”  The word already implies that you may have preconceived notions of what the truth is and need a reality check. What better way to define the workplace, whether that's a laboratory or a factory?

Every so often, one gets a major reminder of the strategic importance of manufacturing and the largely invisible "CGMP set" to the drug industry and, yes, its bottom line. Former FDA chief Mark McClellan gave pharma a good one years ago with his famous "potato chips and soap flakes"  comment, immortalized in a Wall Street Journal piece. Typically, manufacturing continues to be thought of something that will get done....quietly, invisibly, wherever and by whomever.

Has anyone missed the bold "Jaws" cover of Pharmaceutical Executive? In this feeding frenzy of M&A, Pfizer has been at the center of much discussion. So, many who might not otherwise have attended SOCMA’s luncheon yesterday flocked to hear a presentation by John LaMattina, former head of R&D at Pfizer and author of a new book. This is a very quick summary of points he made in his speech.

After watching the three presidential and one VP debates, I am struck with the "Aw Shucks" tone of one of the particpants, in particular. No names, but this one loves the "Joe Sixpack" epitaph. It got me to thinking; how do we choose professions in this country?

Before you can achieve a high level of operational excellence, you've got to nail down predictability, says Dr. Patrick Yang, Genentech's Executive VP for Products Operations. Too many companies aim high at the start of operational excellence initiatives, Yang says, at the expense of planned, predictable operations. Predictability is fundamental to operational excellence, Yang says, a prerequisite to all endeavors.

Looking for a book to take to the beach this summer?  How about a novel about ISO 9001?

Well, if it's not a riveting page-turner, at least it could be a safer alternative to Ambien or other pharmaceutical sleep aids.  Instead of sleep-walking, binging on candy or driving in your sleep, you'd intone Toyota precepts and chapter and verse from ISO to your sleeping family members or friends, so no one would get hurt.

But, all kidding aside, its authors deserve praise simply for attempting to maintain "fast pace and humorous dialogue" in a book addressing ISO....I suspect that the hard core Lean afficionados will rush to get their hands on this book.  We promise to get an advance copy and let you know how the authors succeeded with their seemingly impossible challenge.

The Society of Manufacturing Engineers announces the release of a new novel, LEAN 9001: Battle for the Arctic Rose, a compelling science fiction story that contrasts differing approaches to implementing Lean and ISO 9001.

Set in the year 7278, readers will identify with the book's vying characters,Mark Alexander, general manager of the Arctic Rose Company and his fierce cut-throat competitor, Damar Iratus, vice president of operations, Krote Corporation. Through an intertwined plot, readers will be the judge as the two apply divergent approaches to achieving quality and customer satisfaction.

Spies, security forces, consultants, suppliers, and pirates are also among the cast of characters who are in search of the most valuable plant in the universe – the Arctic Rose tree.

Anyone involved with integrating quality management systems and lean will enjoy this story as told by authors John Guderian and Timothy Renaud. Its fast pace and often humorous dialogue will captivate and engage readers asthey uncover how ISO 9001 and Lean techniques can actually complement one another. Thought provoking, the novel also begs the questions: How do you see your company? Which path will you take? How can bureaucracy and non-value added activities be removed from your daily work?

The foreword written by Peter E. Teti, technical fellow, quality engineering at Hamilton Sundstrand, United Technologies Corporation says, "Quality is the Lean enabler. . . Lean is all about creating value for the customer. One key learning you'll discover as you read this story is that procedures alone, although important, do not necessarily represent what the customer values . . . A strong upfront design for quality process will 'vaccinate' the value stream against long-term diseases and reduce the risk of warrantyclaims, customer returns, and field failures . . . To truly achieve the customer's perspective on what value is, a company must first have a rock-solid quality system in place. Only then can the full benefits of Lean be realized."

Lean 9001 is being released just in time for summer reading and has already received positive reviews from manufacturers and lean practitioners.As ATS Automation Tooling Systems Senior Machine Tool Builder andIntegrator Peter Schnurr explains, "Lean 9001: Battle for the Arctic Rose is an exciting story that kept me wanting to read on. It was helpful to actually follow an ISO 9001/Lean implementation and see a parallel example of an improper implementation. I recommend this book for anyone wanting to learn about the synergies of applying ISO 9001 and Lean."

NCR Canada, Ltd. quality auditor and ISO coordinator David B. Wilson adds, "Reading this novel will provide a fantastic kick-start for auditors or anyone leading or participating in process improvement activities. Well-written, it uses a futuristic setting to illustrate how ISO 9001 and Lean principles complement one another. It's a good, fun read…"

And as NovAtel, Inc. Director of Quality, Dan McGonigal best sums up LEAN 9001, "I thoroughly enjoyed the story. It is an interesting and effective way to learn the basics of ISO 9001 and Lean methodology."

About the Authors:

John Guderian received his bachelor's of applied science in mechanical engineering from the University of Waterloo (Ontario, Canada) in 1986. He is a Certified Quality Engineer (American Society for Quality) and a licensed Professional Engineer. He has worked for Raytheon Canada as a six sigma expert. In 2003, he joined Delta Elevator Company Ltd. (Kitchener, Ontario, Canada) as its vice president of manufacturing. There he and his colleagues have successfully integrated Lean manufacturing and ISO 9001 concepts to produce a highly efficient company with an outstanding product. Additionally, he has taught college courses on quality assurance and assisted many organizations in their efforts to implement Lean strategies and achieve ISO 9001 registration.

Timothy Renaud received his bachelor's of applied science in engineering degree from the University of Waterloo (Ontario, Canada) in 1981. He is also a licensed Professional Engineer. Renaud's business experience spans over 20 years consulting and working for both small and large organizations. As a principal partner with the ISO Support Group (Guelph, Ontario, Canada) and a primary auditor, trainer, and consultant, he has served such diverse clients as John Deere, Huntsman and Georgia-Pacific by helping them to streamline their processes and maintain their ISO registrations. He has also authored and self-published the e-book, The Three Biggest Mistakes People Make with ISO 9001 as well as published hundreds of articles on a diverse range of business topics.

To purchase, call 800-733-4763. Outside the U.S., please call 313-425-3000, ext. 4500.

At a meeting at DIA in Boston yesterday, Mike Svinte, President of Global Life Sciences at IBM provided a sneak peek and insights into a new report probing CEO challenges and concerns and their implications. The report, which is due to be released next month, will distill interviews with more than 1,100 CEOs from around the world, 40 of them heading life sciences companies, including mid-sized companies, in North America, Europe and Asia. Not that their individual names can or will be disclosed, but the CEO’s appeared very willing to engage in open dialogue and creative discussion of issues. "The interviews were a bit like therapy for some,” Svinte said.

Nearly a quarter of the life sciences CEOs interviewed admit that they have had no, or only minimal success at managing change within their organizations.  At the same time, IBM analysts found, they are hungry for change.  The study suggests that CEOs need to “seed” their organizations with challenges and to gain inspiration by examples from other industries that have already undergone transformation. They will then need to convince their companies that change is necessary, and cultivate enthusiasm for it

IBM’s research shows that life sciences companies’ financial performance tends to be better when CEOs encourage change and invest in new areas, Svinte said. The questions are where to invest and why, and how will pharma’s industry model and business model need to change for the future. Will pharma companies be the "dinosaurs" predicted years ago---holding companies that outsource all key functions?

Not enough CEO’s have actively wrestled with these questions, the survey suggests.

Talent shortages top the list of their concerns---63% of pharma CEOs named this the major problem (compared with 48% in other industries. Regulatory issues, as one might expect, came in second (53% vs. 45% for other industries).

One factor driving change, CEO respondents say, is a better informed consumer, who demands more as he or she pays more."We’re experiencing increased pressure related to environmental initiatives,” wrote one anonymous CEO from
North America.“Transparency is being driven by the government as well as by consumers. There is great risk in not focusing on rising consumer expectations."

As pharma moves from the old multinational model to a globally integrated one, Svinte said, issues of global regulation, intellectual property protection and talent shortages in India, China and other regions of the world may pose risk but more CEO's say they are investing there.

Three quarters of pharma CEOs are pursuing innovations in business models. More than half are focused on enterprise model innovation or reconfiguring the breakdown between what work is done inhouse and what is outsourced. Only 17% were focused on new industry model innovations, including those that will involve diagnostics and targeted or personalized medicine, and will require new revenue and enterprise models.  Among blue sky possibilities discussed was the concept of consumers paying for a therapy only if it worked.  (Ha! Don’t hold your breath waiting for this to happen – brief editorial interjection)

62% of the life sciences CEOs surveyed also see rising expectations of corporate social responsibility as a positive, rather than a negative one. But nearly a quarter of respondents don’t expect such work to have any impact on their corporate bottom lines. IBM analysts suspect that new dimensions of corporate responsibility may not yet have reached pharma CEOs’ radar screens.Pharma CEO’s may recognize the drug industry’s duty to “do no harm,” but they may not be able to measure the footprint that pharma has on society, analysts suggest, pointing to the issue of drug residues in the world’s municipal water supplies.

Knowledge management and the drive to turn data into information are becoming more important to a growing number of CEOs, the study found, since these establish a framework for more collaboration and cross-functional product development.

Manufacturing and supply chain management are becoming a priority for more CEO’s, Svinte said, although they were not probed in depth, by themselves, in this survey.

Among other subjects that came up at this discussion was IBM’s patient-centered healthcare project,

Also talked about was the MidEast Consortium on Infectious Diseases, a program underway in the
Middle East that is using supercomputers to predict future pandemics and the potential impact of changes within patient population.

Look for more detailed reporting on the research and trends in future issues of our magazine and online.

And now for something completely different (for any opera fans or Italophiles out there).

AMS

Spoke briefly with one, Michael Kowolenko, SVP of biopharmaceutical manufacturing at Wyeth, who talked about the industry’s fear of change, why it exists and offered some suggestions on what to do about it. Below are some (raw) audio snippets of the interview.

An Interview with Michael Kowolenko of Wyeth Biopharma, Part One

An Interview with Michael Kowolenko of Wyeth Biopharma, Part Two

AMS