Vision and Mission Statement
What We Do
ISO is Your Servant, Not Your Master
New Items and Updates
American Society for Quality
Automotive Industry Action Group
Elsmar Cove Discussion Forum
National Society of Professional
Patient Safety Quality Healthcare
Training for Health and Safety (PATHS) Free occupational health and
safety (OHS) webinars
Society of Manufacturing Engineers
Available presentation topics
6S (5S + Safety)
Productivity and Lean
Cycle Time; the Value-Adding Bang
Lose the Luddites
Theory of Constraints (TOC)
Learn to See the Waste
Shingo Process Maps
Culture: a Decisive Competitive Advantage
Failure Mode Effects Analysis*
Dynamic Control Plans*
* will be updated per AIAG VDA
Stakeholder-initiated rapid CAPA
Modified DD2977 as simple alternative to FMEA (in progress, ready early
SPC, Process Capability, Gage Capability
What to do when it's not a bell curve
Process capability analysis (including non-normal)
Measurement systems analysis (R&R)
Statistical Process Control (including non-normal)
Introduction to Design of Experiments
Short Run SPC (in progress, October 2018)
ANSI/ASQ Z1.4 and Sequential Sampling
Zero Acceptance Number (c-0) Plans
Narrow limit gauging (in progress, ready early 2019) but requires
ISO 9001:2015, Easier than you Think
Risk in ISO 9001:2015
ISO 14001 and 50001, and the Bottom Line
Risks of Omission
Make ISO 9001 the Servant, not the Master
Risks and Opportunities in ISO 9001:2015
Follow us on
Frederick Winslow Taylor told us this in 1911 (Principles of Scientific Management).
|Specializing in Quality
Management Systems, Advanced Industrial Statistics, and Lean
Vision and Mission Statement
Henry Ford believed and proved that industry holds the
solution to most of society's problems. Nothing has happened to change
this; manufacturing, and only manufacturing, can create almost
limitless wealth. Manufacturing is the foundation of the United States'
affluence and national security, and our nation must preserve and
expand its manufacturing base. Industrial methods can also reduce the
cost of services while improving their quality, and this has critical
implications for health care. It is the mission of Levinson
Productivity Systems to help clients achieve this vision through lean
manufacturing, statistical, and quality assurance methods.
What We Do
- Statistical Process Control, Lean
Manufacturing, Six Sigma, and Theory of Constraints deliverable
at your site
- Review courses for ASQ certification exams,
deliverable at your site
9001:2015 : ISO as "servant rather than
- Statistical process control and process capability
studies for non-normal
- Design of Experiments (DOE) and acceptance sampling
- ISO 9001:2015 readiness and implementation
- Lean manufacturing
"How Henry Ford
Saves Men and Money" By Louis Resnick. National Safety News, September 18,
1920. This is in the
public domain due to age (1922 or earlier but we have added numerous
that underscore valuable safety principles that are directly applicable
to ISO 45001.
Is Your Servant, Not Your Master
ISO Standards Users:
Is ISO 9001 something you "have to do" to make your customers and/or
marketing department happy, and just an added expense in terms of
registration costs? Do you regard audits as adversarial activities in
which you hope the auditor doesn't "catch" you doing something "wrong"
for which he or she can issue a nonconformance?
Original image: Edward Poynter (1867):
Israel in Egypt. Public domain due to age.
Source: The Arabian Nights Entertainments,
with Illustrations by Milo Winter. Rand McNally, New York, published in
1914 (public domain due to age)
* Does not imply endorsement of this Web site by
Tubecon, whose site we found through a Google search on the indicated
phrase. The takeaway is that this is how intelligent ISO standards
users approach the issue.
- ISO 9001
provides a framework for a quality management system that prevents the generation
of poor quality, and that can even
be used to address the other six Toyota production system wastes.
- These wastes, unlike poor quality, are asymptomatic; they do little or
nothing to announce their presence. They are often more costly than poor quality. They
can, however, be dealt with (once they have been identified) by the
same corrective and preventive action (CAPA) system you must have in
place under ISO 9001.
- ISO 9001 is best described as "invisible when
present, conspicuous when absent"--the perspective also taken by Tubecon.*
- ISO 14001,
when used properly, can add a lot of profit to your bottom line while
reducing costs for your customers and raising your worker's wages.
Henry Ford proved this more than 70 years before the standard was
developed, and when he could have legally thrown into the nearest river
whatever environmental waste wouldn't go up his smokestack.
- ISO 50001,
when used properly, applies Henry Ford's proven principles for reducing
- ISO 9004's
clauses on organizational identity, organizational culture, and
motivation, empowerment, and engagement of workers, offer an
overwhelming competitive advantage to any organization that can
- ISO 45001 is
synergistic with OSHA's
Voluntary Protection Program, and can reduce your experience
modification rating (EMR) for worker's compensation premiums along with
Days Away Restricted or Transferred (DART)**.
- Audits are
Nonadversarial Activities. ISO standards users should want the auditor to find
nonconformances before they make trouble--just as most of us would
rather have the dentist find a cavity before it turns into a root canal
issue, and the gasteroenterologist find a polyp before it develops into
"The average VPP worksite has a Days Away Restricted or Transferred
(DART) case rate of 52% below the average for its industry."
on ISO as your servant and not your master
Detractors of ISO standards are quick to point to cases in
which an ISO 9001-certified organization has produced poor quality,
just as vaccine skeptics are eager to point out everybody who gets sick
after getting the vaccine as proof the vaccine "doesn't work." The flu
pandemic of 1918, which took place before flu vaccines were
available, killed 675,000 Americans (almost six times as many as were
lost during the First World War). Flu killed about 80,000
people, out of a population three times as large, in 2018.* Vaccine
detractors will be quick to point to the 80,000 who died (including
perhaps a handful among those vaccinated) while ignoring the invisible
millions who, because of the vaccine, never got sick in the first
place. The ISO standards detractors similarly fail to acknowledge the
poor quality that never gets produced because of the standard, the poor
quality that is produced but does not reach the customer because of the
clauses whose specific purpose is to prevent that, and the corrective
and preventive action that makes sure the poor quality is never
Standards are most conspicuous when they are absent (or not
followed). Lack of standards for the rivets
that held the Titanic
together--or failure to meet whatever standards existed--played a major
role in the loss of the ship and most of its passengers. We should
instead be able to take it for granted that the ship doesn't sink, the
airplane doesn't crash, and so on, and standards help make this happen.
We take it for granted that steam boilers do not explode in the 21st
century, and we have ASME
standards (which were developed after a series of such disasters in
the 19th and early 20th century) to thank for this.
We also take it
for granted that factory workers are rarely injured by machines in the
21st century, but how many people have ever heard of Robert A. Shaw, Henry
Ford's director of occupational health and safety? A Chinese folk
tale about three brothers, who were doctors, teaches the
same lesson. The youngest cured serious diseases, so he was famous
throughout the realm. The middle brother cured diseases in their early
stages, so his name never went beyond his village. The eldest prevented
the diseases, so nobody ever heard of him. We take it for granted that
we do not get smallpox or polio in the 21st century, but how many
people have ever heard of Edward Jenner or Jonas Salk? This is how ISO
work for you.
* Our position (not medical advice) is that most of these
deaths were preventable by an annual injection that costs less than $30
even without insurance. The Ford Motor Company's maxim regarding poor
quality applies to
publich health as well: "Don't take it, don't make it, don't pass it
along." If you get the vaccine, you won't take it (the disease) or, if
you do, you will probably get a much milder case, and you will be less
likely to pass the disease along
- January 4 2019 "ISO
9001:2015 Implementation: The Good, the Bad, and the Trending" by
Penny Ouellette (Orion Registrar) from Quality Magazine (November 2018)
cites the most frequent sources of
ISO 9001:2015 nonconformances. This is valuable information
because it enables organizations to focus on the most frequent trouble
sources. (Comments are ours.)
- Clause 4.4.1, Quality management system
and its processes. It is important to remember that ISO 9001 focuses on
a process approach as opposed to isolated standalone activities.
Processes have suppliers, inputs, outputs, and customers, and therefore
interactions with and handoffs between other processes. These handoffs
are frequent sources of trouble, just as handoffs from one shift to
another can cause trouble in factories and especially hospitals.
- Our thought; one of the two processes
involved, and probably the supplier, should include specific steps and
responsibilities for the handoff. Something that is Everybody's job
soon ends up as Nobody's job.
- Clause 7.2, Competence. How do you ensure
that employees and other relevant people (such as contractors and
suppliers) are competent for their jobs?
- Clause 8.4.1 Control of externally
provided processes, products, and services. Most organizations control
externally provided products through purchasing requirements, but is
there a process to cover services and externally provided processes?
- Clause 9.1.2 Customer satisfaction. Are
there processes to assess and monitor customer satisfaction? Remember
that many customers do not complain about poor quality, they just take
their business elsewhere.
- Clause 9.2.1 Internal audit. Internal
audit findings are inputs to the corrective and preventive action
(CAPA) process, and also to management review (9.3.2).
- Clause 9.3.2 Management review inputs. Do
these include audit findings, as well as key performance indicator
(KPI) metrics? Minutes of the management review meeting (quality
records) should reflect the inputs, and action (outputs of the
management review meeting) that was taken on them.
- Clause 10.2.1 Nonconformity and
corrective action. Remember that there is a difference between containment, i.e. protecting the
customer from poor quality, and corrective
action, which removes the root cause of the nonconformity.
General Curtis Lemay phrased this as, "Stop swatting flies and go after
the manure pile."
- The article also cited difficulty with
clauses 4.1 and 4.2, context of the organization and needs and
expectations of interested parties respectively. These are two of the
most important new clauses of ISO 9001:2015, and are inputs to clause
6.1, Actions to address risks and opportunities (which the article also
cites as an area of difficulty).
- Also cited is 5.1.1(d) which relates
(again) to the process approach
and risk-based thinking. Remember that deficient processes, as opposed
to people, are responsible for 80 to 85 percent of all trouble such as
poor quality. This carries over into health care where roughly five out
of six "malpractice" cases are due not to doctor negligence but rather
deficincies in the systems--and ISO 9001:1987 stressed the importance
of systems more than 30 years ago--in which the doctors must do their
- November 21 2018 New words to support quality and lean
manufacturing: "Poka hatto" and "Muda hatto"
hatto ("Experience of almost accident situation" or "sudden
awareness of unsafe condition"), an employee-initiated near miss report
that supports OSHA VPP
and ISO 45001:2018 requirements for worker participation. This is not a
new word, it has been around for some time in this context, but it can
also be applied to quality and lean manufacturing as follows.
hatto = "Awareness of error situation" in which a worker
realizes he or she could have produced poor quality because the process
allows the production of poor quality. Poka yoke, or error proofing, is
the obvious remedy.
hatto = "Awareness of waste" in which a worker or other
stakeholder notices muda or waste that has hidden in plain view for a
long time--thousands of years in the case of brick laying.
- July 20 2018 "Three
Apple workers hurt walking into glass walls in first month at $5bn HQ."
Unmarked glass doors and
walls in workplaces can be dangerous; people can walk into them the
same way birds can fly into them. Treat as a hiyari hatto
("experience of almost accident situation") to avoid hazardous
workplace conditions. See "Glass manifestations" as required by the UK,
but not in most of the United States.
- March 23 2018 ISO
45001 (successor to OHSAS 18001) became available on March 13.
- Dec. 22 2017 Excellent
video by BSI on the transition to ISO 14001:2015. BSI is a highly
regarded organization with a lot of valuable knowledge to offer.
- 3.1 trillion British pounds is a lot of waste (muda) just
waiting to be eliminated and turned into higher profits, higher wages,
and lower prices simultaneously as done by Henry Ford. We recommend,
however, a focus on all material waste as opposed to environmental
aspects. Anything that doet not come out of the process as saleable
product is waste.
by SGS, another highly regarded certification body, on ISO
- Dec. 22 2017 iLearningU
video (first of three, the video links to the others) on how to
respond to ISO 9001 audit findings.
- Audits are NOT adversarial activities! Their purpose is
to find potential problems with your quality management system (an
inanimate object) before they can manifest themselves in ways you and
your relevant interested parties will not like, such as scrap and
customer returns. If you go to the dentist, for example, you want him or her to
find little cavities before they grow up to become big cavities or even
problems that will require crowns or root canals.
- Dec 22 2017 "The
Role of Specification Limits." Excellent explanation of rational
subgroups. If your control charts don't work, incorrect selection of
the rational subgroup might be the issue.
- Dec 22 2017 "Calibration
and Measurement Systems: The Unsung Hero in Quality Efforts"
Excellent article at Quality Magazine
- Dec 22 2017 "Counterfeit
Parts and the 1,000 Risk Priority Number." Our article at Quality Digest.
- Counterfeit parts can have severity ratings of up to 10
(especially in military, automotive, and aerospace), occurrence ratings
of up to 10 because they are introduced deliberately, and detection
ratings of up to 10 because malicious efforts are made to conceal them.
- Dec 22 2017 Process
Capability Analysis book by Dr. Neil Polhemus (StatGraphics),
review at Quality Digest.
- August 2016 EpiPen alternatives
for as little as $10 (a doctor's prescription is required)
- February 2, 2010. We have read several articles
that suggest that long periods of sedentary work (e.g. at a computer)
increase the risk of cardiovascular disease. We therefore offer a free
downloadable recurring alarm that the user can set as a reminder to
stand, stretch, and/or walk around at user defined intervals. Freeware,
no warranties are implied or expressed, but we use it every day. Update
March 6 2017. We are now using a variable-height
desk that provides the option of standing while working. This has
delivered tangible health and productivity benefits.
Levinson Productivity Systems P.C.
6 Lexington Court
Wilkes-Barre PA 18702
TheBoss "at" ct-yankee.com
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