Documente Academic
Documente Profesional
Documente Cultură
QUALITY CULTURE
October 2015
Reprinted from
PHARMACEUTICAL ENGINEERING
THE OFFICIAL TECHNICAL MAGAZINE OF ISPE
www.PharmaceuticalEngineering.org
QUALITY BY DESIGN
James Hale and Scott Fotheringham, PhD
Editors note: Unless indicated otherwise, all quotations are
the result of personal interviews or correspondence
By turning to Jurana Romanian-born engineerJobs embraced one of the gurus of modern quality management. During
a stint with Western Electric, Juran had developed a theory that
everyone involved in the manufacture of a product played a critical
role in its success. Expressed in his 1951 book, Quality Control
Handbook, his theory is credited with adding the human factor
to the focus on quality in manufacturing, which had its roots in
Pharmaceutical Engineering
October 2015
Along with Iowa native William Edwards Deming (see Qualitys Midwife), a Shewhart acolyte who had
also passed through Western Electric,
Juran played a major role in rebuilding
and reshaping Japans industrial system in the 1950s, moving the
devastated country into a new era of manufacturing excellence.
Jobs
Babbitt
69
October 2015
Pharmaceutical Engineering
Growing a Culture
Success breeds imitation, and today, the adoption and nurturing
of a quality culture is viewed as a business necessity. Seventyfive percent of senior executives surveyed by Forbes Insights and
ASQ in April 2014 said their organizations had a culture of quality,
and 20 percent said their quality programs were world class or
state of the art. Among the key findings, according to Quality
Progress, ASQs official publication:
} Knowing your marketand, most importantly, your customersare key to fuelling an organizations commitment to
quality;
} Incentive programs tied to quality metrics and focusing on
innovation and risk-taking allow organizations to nurture a
culture of quality;
} Leadership is critical in setting the tone for an organizations
culture of quality; and
} Leaders must provide examples and ensure that the principles
of quality are understood and communicated throughout the
organization.
Many organizations today embrace quality at the top levels,
says Jordan Freed, director of performance excellence at Curtiss-Wright Controls Defense Solutions, whose products are
found throughout the U.S. military. More often than not, he says,
the senior executives get it, and place a high level of importance
on it. The further up you go in an organization, the more connected they are to their customers. Reliable performance is essential
to customers; it comes from quality systems.
Where you encounter problems, he says, is when middle managementoften more concerned on a short-term basis with profit and lossdoes not buy in or the quality staff is undersized.
Quality is a long-term process, he says, and keeping an eye on
overall goals is critical.
He says that in regulated industries like pharmaceuticals the head
of quality is often also responsible for regulatory compliance.
Regulatory bodies are one of the stakeholders that pharma companies have to please. If you dont have a quality system that is
responsible to compliance, you wont succeed in business.
Joseph FitzGibbon, president of Orion Canada, which consults
on issues of quality with organizations throughout North America,
says that support and involvement throughout the management
chain is essential for quality principles to be effective.
The present ISO 9001:2008 standard calls for a management
representative to champion a QMS (quality management system)
within the organization, FitzGibbon says. This person does not
have to be a member of top management, butfor purposes of
ISO 9001does have to have a direct line to top management.
Pharmaceutical Engineering
October 2015
Qualitys Midwife
W. Edwards Demings influence is everywhere, says Babbitt.
His work is everywhere, or we see organizations moving naturally
toward his philosophy.
Born in Sioux City, Iowa in 1900, Deming trained as an electrical
engineer, but gravitated toward mathematical physics. His most
significant early work was the development of scientific sampling,
which continues to be used to extrapolate census and labor statistics in the U.S.
At 27, Deming encountered Walter Shewhart, a physicist, engineer and statistician who worked at Bell Telephone Laboratories
and was developing a theory of statistical measures that would
be published in his 1931 book, Economic Control of Quality of
Manufactured Product. Shewharts work pointed out the importance of reducing variation in a manufacturing process and the
understanding that continual process adjustment in reaction to
non-conformance actually increased variation and degraded quality. Consistency
was key.
71
October 2015
Pharmaceutical Engineering
Gulbinski
Pharmaceutical Engineering
October 2015
Zayas
The company has also embraced the tenets of lean manufacturing, continuous improvement and the emphasis on the elimination of waste, theories that were developed at the Toyota Motor
Company in the decades following World War II. Gulbinski says
BMS has developed a deep understanding of lean quality and
the relationship between eliminating waste and improving quality.
Good business is good quality, she says. The lean quality motto
of right first time is key for us.
The company started implementing the tenets of lean manufacturing at just a couple of its sites, including one in Ireland, where
the company was able to more closely understand and learn how
to maximize its efforts.
Pharmaceutical Engineering
October 2015
75
Espejo
October 2015
Pharmaceutical Engineering
77
we do. Its hard not to stress the human element because thats
who we are. We have the processes in place, but people run the
processes.
One of the things that stays with him from his time in Mount
Vernon is a line adapted from the Rascal Flatts song Every Day.
Says Espejo: We coined the phrase, every day you help save
a life. When we did our site strategy engagement sessions
we would close the sessions with videos of our people talking
about what they do and what it means to their life If you dont
focus on people, on the patients we work for, quality gets lost
in the compliance mire. When people make the connection to
themselves, their loved ones, to patients it brings it home: Im
not just making widgets. People are relying on the quality of the
products I make help treat serious diseases.
Franois Sallans
Vice President, Quality & Compliance and
Chief Quality Officer, Johnson & Johnson
Regardless of industry,
every organization has
a culture. The degree to
which quality is embedded
in an organizations culture
can mean the diff erence
between success and
failure. In some industries,
such as healthcare, quality
is more than a competitive
advantage, it is a social
responsibility.
October 2015
Pharmaceutical Engineering
Patients and
caregivers expect,
moreover, deserve
safe and efficacious
products that are
available on demand.
Pharmaceutical Engineering
October 2015
Foster &
Develop
Improve
& Learn
Monitor &
Measure
Figure 1: The ISPE Six Dimensions of Cultural Excellence Framework
79
October 2015
Pharmaceutical Engineering
Underpinning a quality culture is regulatory compliance. Our independent, internal audits are conducted on a regular cycle. Results,
current status, and progress are all reported to business leaders
and to the management of each Johnson & Johnson Company
to help them support their sites efforts to achieve compliance in
a timely manner. Compliance is a companion to quality; it should
not be mistaken as a measure for quality.
A Management Review Process allows management of the individual companies to seek continuous quality improvement by
regularly reviewing the suitability, adequacy, and effectiveness of
their respective quality systems. We also recognize that systems
are run by people. Internalization of quality ingrains quality into the
culture. Employees are challenged to demonstrate how they own
quality in meaningful, measurable, and sustainable ways.
lives. Our Credo unites the people of Johnson & Johnson in this
mission.
Cascading from Our Credo and Our Aspiration are strategic principles and growth drivers. The pursuit of growth drivers is guided
by the Leadership Imperatives, a tool by which every employees
performance is evaluated. The Leadership Imperatives are proof
that we recognize that how we achieve results is as important as
the results themselves.
In furtherance of Our Credo, the Johnson & Johnson Quality &
Compliance organization, led by the Johnson & Johnson Chief
Quality Officer, developed our Quality Policy, Quality Policy Framework, and Quality Policy Standards. These tools define the requirements that our operating companies must achieve in how
we design, make and deliver our products. These tools cascade
down to more detailed technical documents and procedures that
require each company to have processes that include monitoring,
escalation, correction, and accountability, resulting in a system of
continuous improvement.
As part of our quality system, we organized our structure to implement these quality requirements across the Johnson & Johnson
Family of Companies. Johnson & Johnson operates in different
segments: consumer, consumer medical devices, pharmaceuticals, and medical devices. Segment level Chief Quality Officers
are responsible for developing strategies, providing oversight and
delivering quality results end-to-end for the segments.
Pharmaceutical Engineering
October 2015
81
Landertinger
Mike McGrath
October 2015
Pharmaceutical Engineering
Pharmaceutical Engineering
October 2015