The document discusses the importance of training for quality management systems and certification audits. It makes three key points: 1) Inadequate training can negatively impact an organization's certification status, as standards boards will no longer accept excuses of "employee error" for nonconformances. Comprehensive training is needed to avoid issues during audits. 2) Training needs to be tailored to different employee levels and roles. While extensive training is not required for temporary employees, more permanent employees need to thoroughly understand processes. Senior managers also require training on their quality roles. 3) Organizations should develop detailed training plans and budgets to ensure employees are properly prepared for audits. Neglecting training can lead to

1. By Jean
White,
Qualidoc
Training is
everything. The
peach was once a
bitter almond; the cauliflower nothing
but cabbage with a college education.”
–Mark Twain in Pudd’nhead Wilson’s
Calendar, 1894
Organizations entering the
quality system arena through
standards such as ISO 9000 and
AS9100 might find that, although
training is not everything, they
will need to increase their training
resources. While senior executives
acknowledge the need for train-
ing, they might not regard it in
the same critical light as business
processes such as marketing or
production.
Inadequate or neglected train-
ing, however, can have a serious
effect on the certification status
of the organization. Standards
boards such as the American
National Accreditation Board
and the Standards Coordinating
Committee have warned that
“incomplete reports will no lon-
ger be tolerated”—“incomplete”
meaning, among other things,
nonconformance reports closed
out without sufficient root cause
analyses. The boards suggest that
unsatisfactory training could be a
root cause along with ambiguous
procedures and working instruc-
tions. They are adamant that they
will not accept root causes based
on “employee error, human error,
operator error or anyone else who
made an error.”
Given these constraints, it can
be difficult and time consuming
to decide what sort of training is
required. Above all, a quality sys-
tem should be a healthy discipline,
not a straitjacket. Some training
needs might be obvious, such as
recognizing counterfeit or suspect
parts, different reporting require-
ments, new documentation or pro-
cesses, or the difference between
containment, and corrective and
preventive action. Others are more
subtle, such as introducing unfa-
miliar concepts and obligations to
employees who often believe the
quality system is management’s
business.
Employees must be confident
about their responsibility and
authority, and be committed to
the success of the quality system.
Clearly, the certification bodies and
standards boards expect the certifi-
cation audits to reflect this commit-
ment. Employees at all levels should
be able to answer qualified ques-
tions about their work, especially if
they are questioned in unfamiliar
circumstances such as the assess-
ment for certification. Consider
an example from the draft ISO
9001:2015 (ISO underlined words
for emphasis):
Clause 5.1—Leadership and com-
mitment: “involving, directing and
supporting persons to contribute
to the effectiveness of the quality
management system.”1
Lack of training can show up
during the audit when the asses-
sor might ask anyone questions
such as: “Can you show me your
working instructions?” A relaxed,
well-trained employee will refer
the assessor to the master docu-
ment list (also known as the quality
system document index) and the
relevant documents without floun-
dering.
Training becomes less onerous
when trainees discover they con-
tribute to the quality system, but
getting this kind of cooperation
is not always easy. One long-term
employee (I will call him Louis) fol-
lowed me around the shop floor
on each of my site visits, muttering
about trade union intervention.
He even produced a tape recorder
at one of my training sessions. As
work progressed on the quality sys-
tem, however, Louis became a fan.
He made some useful comments
on the draft procedure, which our
organization was able to incorpo-
rate into a working instruction. In
his interview with the assessor, he
conducted himself well and empha-
sized the importance of the weld-
ing procedure. I was impressed.
Unfortunately, Louis forgot
advice not to talk too much dur-
ing the audit. Before preparing his
report, the assessor decided to wan-
der around the shop floor again.
As a result of another encounter
with Louis, he asked to see the pur-
chase order for the welding rods.
The organization had a purchase
order with a standing order for
welding rods, but it was 15 years old
and had never been reviewed or
revised. It had no specification on
it or quality assurance requirement.
The assessor regretfully issued a
minor nonconformance, and I was
left with a very red face.
I hasten to point out that
attempts to train employees to
respond in parrot-fashion to an
auditor’s questions are doomed. As
long as they are trained thoroughly
in the day-to-day processes and they
know how to answer questions
about their work (questions that
might not be phrased in familiar
terms), the audit should not reveal
ambiguities in the quality system or
extend into assessment overtime.
While comprehensive training is
YOUR
OPINION
Tackle Training Before the Audit
S I X S I G M A F O R U M M A G A Z I N E I A U G U S T 2 0 1 4 I 29
“

2. By Daniel
Zrymiak,
Accenture
The U.S. Food
and Drug
Administration’s
(FDA) 2004 final ruling titled
“Bar Code Label Requirements
for Human Drug Products and
Biological Products” was projected
to result in more than 500,000
fewer adverse events during the
next 20 years. Thus, the FDA esti-
mated a 50% reduction in medica-
tion errors. The FDA elaborates on
this subject in its 2010 Guidance for
Industry: Bar Code Label Requirements
Questions and Answers document.1
According to 69 FR 9120, the
FDA published a final rule requir-
ing certain drug and biological
products to include linear bar
codes and machine-readable
information on drugs, biological
products, and labels for blood and
blood components. The intent is to
help reduce the number of medica-
tion errors that occur in hospitals
and healthcare settings, including
nursing homes. The scope of this
ruling includes manufacturers,
repackers, relabelers and private
label distributors. Noncompliance
will represent a “misbranding”
regulatory violation.
The FDA final rule requires the
use of a linear bar code and does
not restrict organizations from add-
ing other technologies (such as two-
dimensional symbology and radio
frequency identification chips),
unless an exemption is formally
requested and approved. This essen-
tially locks down linear bar codes as
the acceptable standard technology
to represent product data. Specific
approved machine-readable bar
code symbology standards include
Codabar and ISBT 128 protocols. As
an automated data capture method,
bar codes provide organizations with
a rapid and inexpensive improve-
necessary for full-time employees,
it is neither necessary nor required
for temporary employees. They
might be hired for eight hours at a
time. It is not reasonable to expect
supervisors to spend four of the
eight hours explaining a quality
system. Instructions are usually con-
fined to “This goes here, that goes
there, check with Joe Smith, the
foreman, if you have any questions.”
These conditions can be found in
any industry or service. Just ensure
that the certification body is aware
that temporary employees could be
on site at the time of audit.
Training at more senior levels
has its own pitfalls. My clients some-
times assume that training the qual-
ity assurance manager (QAM) to be
a manager is part of my job as a con-
sultant. I expect to train the QAM
incumbent or candidate in quality
system requirements, but I can’t
make managers out of them if they
haven’t the potential. I’m reminded
of one purchasing manager who, on
returning from sick leave, was told
he had been appointed QAM. He
had neither the strength nor the
inclination to take on those respon-
sibilities so had to be replaced. This
was not good for morale.
QAMs must be able to balance
the requirements of the quality
system and the practicalities of the
business, and have a mature out-
look when handling employees.
QAMs often have other responsi-
bilities that have to be given priority
at times. The strain can be eased
by delegating tasks, such as main-
taining the master document list,
as long as the delegated authority
is shown on the organization chart.
Training can take many forms.
I encourage my clients to avoid
slogans and mission statements.
I asked one QAM to prepare a
notice for the large nonconforming
product segregation (quarantine)
area of a warehouse. I discovered
that his idea of a notice was an 8
x 8-inch piece of paper with a vis-
ibility of about two feet. It pays to
think about: Who needs to know?
What do they need to know? When
do they need to know and where?
Training is an important part
of quality standards implementa-
tion. It requires alert participation
from all employees. We don’t want
them to discover their involvement
for the first time at assessment.
Assessors do not take kindly to train-
ing plans that have been hastily con-
trived or postponed through lack of
time or funds. If the training plan
is given the attention it deserves,
it won’t become an immediate
casualty if resources are strained
temporarily. As a bonus, auditors
will appreciate being spared the
embarrassment of reports returned
by the certification body because
of “insufficient root cause analysis.”
REFERENCE
1. International Organization for Standardiza-
tion, ISO 9001:2015 Draft International Standard,
Clause 5.1—Leadership and commitment.
JEAN WHITE is a quality management
consultant at Qualidoc in Cheltenham,
Gloucestershire, U.K. White has a bach-
elor’s degree in English language and lit-
erature and is a member of ASQ.
Beyond Bar Codes
30 I A U G U S T 2 0 1 4 I W W W . A S Q . O R G
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OPINION

3. ment over manual methods.
To realize the desired improve-
ments in patient safety and error
reduction, bar codes must comple-
ment lean Six Sigma initiatives
emphasizing risk management, safe-
ty analysis and process engineering.
Understanding bar codes
The correct preparation and suc-
cessful deployment of bar codes
require their own level of require-
ments analysis and subsequent vali-
dation. Only after these needs are
identified and fulfilled can bar cod-
ing support improvement initiatives.
To appreciate this position, it is
important to first understand the
composition and functionality of
bar codes. Bar codes use symbols to
represent information which, due
to international inconsistencies,
may generate misleading or incor-
rect data. The information must be
readable and protected from dam-
age or deterioration. An unread-
able bar code potentially causes
delays as the healthcare practitio-
ners must repeat bar code scans
or revert to manual data capture
methods. Business rules are neces-
sary to make the data meaningful.
For example, different regions
use different formats for how
dates are indicated (such as dd-
mm-yyyy or mm-dd-yyyy). Other
issues include names with special
characters (such as accents and
apostrophes), truncation or partial
matches. For the consistent and
correct capture of data, business
rules must be established and con-
sistently applied.
The FDA guidance document
suggests that linear bar coding will
be sufficient to generate the desired
improvement in patient safety and
risk mitigation. Consistent processes
that continually assess the biological,
chemical and physical risks of the
substance or specimens, along with
appropriate controls, are needed to
mitigate those risks with timely alerts
and warnings. Bar coding supports
improvement by ensuring consistent
data capture at appropriate control
points in the process.
Using lean and Six Sigma
To have a stable process that
ensures patient safety, lean and
Six Sigma techniques are required.
Value stream mapping is a lean
technique in which the processes
are analyzed to determine the
value points, constraints and areas
of waste. After the redundant or
nonessential steps are removed, the
process can be suitably prepared
for further application to improve
patient safety. Product and process
hazard analysis is conducted to
determine the items of greatest risk.
Techniques such as a failure mode
and effects analysis can highlight
and quantify hazards and determine
the anticipated effect on the patient
or specimen involved. Following
process and hazard analysis, suit-
able mitigations can be determined
and prioritized. Bar coding—along
with the other mitigations—can be
incorporated into a revised and re-
engineered process.
Process improvements must be
validated and controlled, ensuring
that the core purpose of the pro-
cess is fulfilled and no new issues
have been introduced. Process con-
trols can be demonstrated by the
audit trail of records necessary to
prove correct process completion.
Automated data capture using bar
coding or any other format depends
on correctly uploading data to the
intended database fields for valid
analysis and archiving. Long-term
benefits only can be realized
through a deliberate improvement
initiative such as lean or Six Sigma.
After defining and measuring
performance (incidents or near-
misses, in the case of patient safety),
a Six Sigma team can analyze, set
targets and make improvements.
The improvement steps will most
likely require more than just imple-
menting linear bar coding data
capture, such as revising processes,
conducting training, deploying
additional resources, and adopting
more visual indicators.
By engaging a process expert to
work alongside the healthcare prac-
titioners, the ideal processes will be
defined and supported, fulfilling
the necessary transactions and pre-
serving patient safety. Technology
solutions can be formed by col-
laborating with the biomedical
engineering and information tech-
nology groups. Process expertise
can be readily obtained.
For example, the ideal blood
transfusion process was defined
in 2003 in the Serious Hazards of
Transfusion (SHOT) program by
Mike Murphy and colleagues at
John Radcliffe Hospital at Oxford
University. This process defines the
critical points where neutral data
capture technology can be intro-
duced to offset the process and
product risks associated with blood
transfusion.
A professor of blood transfusion
medicine at the university, Murphy
said, “We’ve looked very carefully at
the hospital’s transfusion process,
which is very complex and involves
many staff. We’ve broken this down
into a series of simpler steps and
designed the software around
them. The new system now means
that one nurse is prompted to carry
out 14 checks, where it previously
required two nurses following 27
stages making paper records. It’s
safer, it’s less time consuming and
we know that staff prefers it.”
This is a successful example of
S I X S I G M A F O R U M M A G A Z I N E I A U G U S T 2 0 1 4 I 31

4. first determining the hazards of
a medical procedure, defining a
process, and applying bar cod-
ing technology to fit the process.
Because the process was defined
first, bar coding was successfully
applied. Alternatively, if the pro-
cess steps or business rules were
compromised or neglected, bar
coding alone would not ensure
patient safety. Bar coding requires
suitable and compatible tech-
nology, symbology, interfaces
and business rules for correct
operation. Bar coding is worth-
while and applicable only when
incorporated after hazards have
been analyzed and mitigated,
and sound processes have been
defined with critical control
points for the timely application
of data capture.
Ultimately, patient safety is best
guaranteed by removing risks and
hazards at their root cause. This is
the essence of Six Sigma and the
only way to achieve the target of
500,000 fewer adverse events dur-
ing the next 20 years and a 50%
reduction in medication errors.
There is no “silver bullet” tech-
nical solution to achieve these
goals. Only through a carefully
considered, continually updated
sequence of analysis and regular
improvements of medical pro-
cesses is the best hope for better
patient safety.
32 I A U G U S T 2 0 1 4 I W W W . A S Q . O R G
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OPINION
NEWSSIX
SIGMA
FORUM
Plans Underway for 2015
Lean and Six Sigma Event
The 15th annual ASQ Lean and Six Sigma Conference
will be held March 2-3 in Phoenix.
Organizers are planning various activities around
the conference theme, “Leading the Quality Journey
Through Lean and Six Sigma.” Focus areas at the con-
ference include:
• Lean and Six Sigma fundamentals.
• Implementing lean and Six Sigma.
• Nontraditional applications of lean and Six
Sigma.
• Sustaining results.
• Establishing and sustaining a culture of quality.
Before the two-day event’s formal programming
begins, the Six Sigma Forum plans to host a recep-
tion on Sunday, March 1, to give conference-goers a
chance to meet keynote speakers, fellow attendees,
as well as sponsors and exhibitors.
A speed-networking session also is in the works
to occur sometime during the conference. At this
activity, participants will rotate through a series of
stations with prescribed questions, aimed to help
people make new connections and share experiences
related to the conference theme and focus areas.
Keep tabs on all conference updates, including
details on keynote speakers, presentations and
workshop sessions, by visiting http://asq.org/
conferences/six-sigma/index.html.
Case Study Focuses on
Six Sigma, Army Project
ASQ’s Knowledge Center has released a new case
study related to lean Six Sigma.
The study describes a define, measure, analyze,
improve and control project involving a U.S. Army
contractor working to improve vehicle inspection
standards.
You can read the entire case study at http://
asq.org/2014/06/six-sigma/uniform-inspection-
standards.pdf.
Earlier this year, the Knowledge Center released
another case study describing how Max Life Insurance
Co., headquartered in New Delhi, India, used Six
Sigma and quality tools to improve customer retention.
You can find that case study at http://asq.
org/2014/05/six-sigma/life-insurer-improves-
customer-retention.pdf.
REFERENCE
1. U.S. Food and Drug Administration, Guidance for
Industry: Bar Code Label Requirements Questions and
Answers, 2010, http://bit.ly/guidanceforindustry.
DANIEL ZRYMIAK is a mobilization lead at
Accenture in Vancouver, British Columbia.
He holds a bachelor’s degree in commerce
with honors in marketing from the University
of Saskatchewan in Saskatoon. Zrymiak is
an ASQ fellow and an ASQ-certified quality
auditor, hazard analysis and critical control
points auditor, biomedical auditor, engineer,
manager, Six Sigma Black Belt and software
quality engineer. He is also a QMI Canada-
certified environmental management systems
lead auditor and quality systems lead auditor.
Zrymiak is an ASQ Quality Press author and
reviewer, regional director for ASQ Region
4 (Canada) for the 2015-2016 term, and
active with the Quality Management Division’s
finance and governance technical committee.