1. Quality process management
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I. Contents of quality process management
==================
It is rarely too early to start thinking about quality and process management since the choices
made early in the biodesign innovation process can affect a company’s speed to
commercialization and large-scale manufacturing. The steps below have been excerpted from
Chapter 5.5 and are presented with active web links to assist innovators in getting started.
Identify Quality Needs and Decide on an Approach
1. What to Cover – Begin by understanding in what geographic locations the company
intends to distribute its products in the next five to seven years. Then, determine which
quality system(s) apply (QSR and/or ISO). If the company is at all uncertain about where it
will distribute its products, consider building a quality system that is compliant with both.
Some elements can always be “turned off” if the alternative system is not required at the
time. Understand the requirements of the chosen standard carefully so that an appropriate
approach can be decided upon. There are a wide range of quality publications and software
tools designed to help a company understand, implement, and become registered to a

2. quality management system. A range of workshops, seminars, and training courses are also
available.
2. Where to Look –
 The FDA’s Quality System Regulation – Provides an overview of good manufacturing
practices for manufacturers of medical devices doing business in the U.S. [link updated
10/5/09]
 The FDA’s Quality System Manual – Provides the final rule on 21 CFR Parts 808,
812, and 820 effective 08/17/2009. [link updated 10/5/09]
 International Organization for Standardization – Provides access to the ISO 13485
standards which set forth quality management requirements for manufacturers of
medical devices doing business elsewhere in the world (the standard is for sales on the
site). Quality manuals for understanding ISO requirements can also be purchased from
many third-party consultants and ISO-accredited certification bodies on the web.
 American Society for Quality – Provides general information about quality, including
overview of other quality systems not discussed in this document (e.g., SixSigma). The
ASQ store also sells many helpful tools and references.
Hire a Quality Professional
1. What to Cover – Because so many potential pitfalls exist in implementing a quality
system, and because the consequences of noncompliance can be so devastating to a
company, it is often a good idea for a company to hire or contract with an experienced
quality professional (or team of professionals, depending on the scope of the need) to lead
the implementation and ongoing management of a quality system. Companies often work
with external quality consultants because they have deep experience and the most current
information about effectively navigating quality standards. All management, however,
should be trained in quality systems and motivated to lead quality compliance efforts within
their areas. Look for a consultant facile in the systems the company desires (ISO, QSR,
both) and familiar with the company’s stage of development (start-up, emerging,
established). Ask about the consultant’s approach to quality system design. For example,

3. does the person have a “recipe” approach (i.e. one size fits all) or does s/he consider the
unique circumstances of the company and the team?
2. Where to Look – In addition to working with recruiters, reviewing the choices of
competitors, and seeking referrals from investors, board members, and other advisors, try
making connections through the local chapters of quality associations, such as the ASQ.
Engage Executive and Cross-Functional Management and Define Quality Policies
1. What to Cover – Responsibility for a quality system begins with executive management.
Therefore, it is vital that executive management is involved from the beginning of the
process. Meet with executives to ensure their understanding of the management
responsibility sections of QSR and/or ISO. Then, initiate the quality system design and
implementation process by developing an organizational strategy with top management to
engage key players across the organization. Assemble a cross-functional team to define the
company’s overarching quality policy. The quality policy should set forth the overall
intentions and direction of an organization with respect to quality, as established by
management with executive responsibility. Validate and reinforce the policy with
appropriate employees at all levels within the organization.
2. Where to Look – Refer to the documentation for the standard being implemented to
understand executive management responsibilities. Network with individuals in the field
and visit other companies to observe their operations and ask about their approach to
quality. Leverage the experience of the company’s quality professional(s).
Build a “Shell” of the Quality System and DevelopElements as the Product Progresses
1. What to Cover – Map out the high level requirements and processes of the quality system
from “end to end” (i.e., from design through manufacturing, distribution, postmarketing
surveillance). Then, depending on the stage of the company and its product(s), determine
which processes and procedures need to be developed further, at a greater level of detail.
Design control is usually one of the first elements to be developed at the tactical level.
Change/document control often comes next, followed by corrective/preventive action
processes (to guide continuous improvement), and then production/process controls. These
elements should be built-out (following the guidelines provided in the quality policy and

4. working within the construct of the quality system “shell”) as they are needed, based on the
progress of the company.
2. Where to Look – Leverage the experience of the company’s quality professional(s).
Involve the people who will perform the functions where the quality system is being built
(e.g., ask R&D engineers to help design the design control procedures, work with the
production manager to design production process and controls). Compliance will be
increased if the systems are built by those using them in a way that makes sense in the
context of their workflow and a participative process will yield a better quality system. In
addition, a company can leverage a variety of other resources and publications to provide
them with relevant information:
 ASQ Biomedical Division Publications
 The FDA and Worldwide Quality System Requirements Guidebook for Medical
Devices (purchase site) – A helpful reference complied by Kimberly A. Trautman, a
GMP/quality systems expert.
 Textbooks on Quality Systems
 Marie Teixera and Richard Bradley, Design Controls for the Medical Devices
Industry (CRC Press, 2002).
 Michael E. Wiklund, Medical Device and Equipment Design: Usability
Engineering and Ergonomics (CRC Press, 1995).
 Basem El-Haik and Khalid S. Mekki, Medical Device Design for Six Sigma: A
Road Map for Safety and Effectiveness (John Wiley & Sons, 2008).
 Richard Fries, Reliable Design of Medical Devices (CRC Press, 2006).
Assign Functional Champions to Monitor and Maintain Quality System
1. What to Cover – While it can be tempting to implement a quality system and then let it run
on “auto pilot,” a company must proactively monitor and maintain its quality system to
ensure ongoing compliance. Quality systems are meant to be dynamic, changing and
improving with the organization as new information, issues, and opportunities are
identified. By naming functional champions to oversee the entire quality system, as well as
the specific sections most relevant to their individual expertise, the company is more likely

5. to anticipate and prevent challenges and improvements. For this reason, a team approach is
typically preferable to assigning a single quality executive to maintain end-to-end oversight
of the quality system.
2. Where to Look – Work with executive managers to identify and empower the appropriate
quality champions. The company’s quality professional(s) can help structure these roles,
responsibilities, and oversight processes.
Prepare for Audits
1. What to Cover – Train employees and executives on good audit techniques (discussed in
Quality Enforcement section). This training should be ongoing, not simply performed in
advance of a scheduled audit. Provide representative of the company with the opportunity to
practice their audit processes by performing internal audits on a periodic basis.
2. Where to Look – Many external training courses are provided that can be useful to helping
employees and professionals prepare for audits (e.g., offered through ASQ). The company’s
quality professional(s) can also develop and lead such trainings internally. For more
information about the FDA’s audit process, refer to the FDA’s Quality Systems Manual.
ISO training is available through the many ISO-accredited third-party organizations
authorized to award ISO certification.
Apply Process Management Approach to Other Areas of the Business
1. What to Cover – Once the company’s quality system is under development, look for other
work streams where the company will potentially benefit from increased rigor, discipline,
and accountability. Apply the same general principles to articulate goals, define processes,
developing metrics, and establish monitoring and correction mechanisms.
2. Where to Look – Based on its learnings from implementing a quality system, the team may
be able to tackle this step itself (ideally, through cross-functional collaboration). Process
consultants can also be engaged to assist.
==================
III. Quality management tools

6. 1. Check sheet
The check sheet is a form (document) used to collect data
in real time at the location where the data is generated.
The data it captures can be quantitative or qualitative.
When the information is quantitative, the check sheet is
sometimes called a tally sheet.
The defining characteristic of a check sheet is that data
are recorded by making marks ("checks") on it. A typical
check sheet is divided into regions, and marks made in
different regions have different significance. Data are
read by observing the location and number of marks on
the sheet.
Check sheets typically employ a heading that answers the
Five Ws:
 Who filled out the check sheet
 What was collected (what each check represents,
an identifying batch or lot number)
 Where the collection took place (facility, room,
apparatus)
 When the collection took place (hour, shift, day
of the week)
 Why the data were collected
2. Control chart
Control charts, also known as Shewhart charts
(after Walter A. Shewhart) or process-behavior
charts, in statistical process control are tools used
to determine if a manufacturing or business
process is in a state of statistical control.
If analysis of the control chart indicates that the
process is currently under control (i.e., is stable,
with variation only coming from sources common
to the process), then no corrections or changes to
process control parameters are needed or desired.
In addition, data from the process can be used to
predict the future performance of the process. If
the chart indicates that the monitored process is

7. not in control, analysis of the chart can help
determine the sources of variation, as this will
result in degraded process performance.[1] A
process that is stable but operating outside of
desired (specification) limits (e.g., scrap rates
may be in statistical control but above desired
limits) needs to be improved through a deliberate
effort to understand the causes of current
performance and fundamentally improve the
process.
The control chart is one of the seven basic tools of
quality control.[3] Typically control charts are
used for time-series data, though they can be used
for data that have logical comparability (i.e. you
want to compare samples that were taken all at
the same time, or the performance of different
individuals), however the type of chart used to do
this requires consideration.
3. Pareto chart
A Pareto chart, named after Vilfredo Pareto, is a type
of chart that contains both bars and a line graph, where
individual values are represented in descending order
by bars, and the cumulative total is represented by the
line.
The left vertical axis is the frequency of occurrence,
but it can alternatively represent cost or another
important unit of measure. The right vertical axis is
the cumulative percentage of the total number of
occurrences, total cost, or total of the particular unit of
measure. Because the reasons are in decreasing order,
the cumulative function is a concave function. To take
the example above, in order to lower the amount of
late arrivals by 78%, it is sufficient to solve the first
three issues.
The purpose of the Pareto chart is to highlight the
most important among a (typically large) set of
factors. In quality control, it often represents the most
common sources of defects, the highest occurring type

8. of defect, or the most frequent reasons for customer
complaints, and so on. Wilkinson (2006) devised an
algorithm for producing statistically based acceptance
limits (similar to confidence intervals) for each bar in
the Pareto chart.
4. Scatter plot Method
A scatter plot, scatterplot, or scattergraph is a type of
mathematical diagram using Cartesian coordinates to
display values for two variables for a set of data.
The data is displayed as a collection of points, each
having the value of one variable determining the position
on the horizontal axis and the value of the other variable
determining the position on the vertical axis.[2] This kind
of plot is also called a scatter chart, scattergram, scatter
diagram,[3] or scatter graph.
A scatter plot is used when a variable exists that is under
the control of the experimenter. If a parameter exists that
is systematically incremented and/or decremented by the
other, it is called the control parameter or independent
variable and is customarily plotted along the horizontal
axis. The measured or dependent variable is customarily
plotted along the vertical axis. If no dependent variable
exists, either type of variable can be plotted on either axis
and a scatter plot will illustrate only the degree of
correlation (not causation) between two variables.
A scatter plot can suggest various kinds of correlations
between variables with a certain confidence interval. For
example, weight and height, weight would be on x axis
and height would be on the y axis. Correlations may be
positive (rising), negative (falling), or null (uncorrelated).
If the pattern of dots slopes from lower left to upper right,
it suggests a positive correlation between the variables
being studied. If the pattern of dots slopes from upper left
to lower right, it suggests a negative correlation. A line of
best fit (alternatively called 'trendline') can be drawn in
order to study the correlation between the variables. An
equation for the correlation between the variables can be

9. determined by established best-fit procedures. For a linear
correlation, the best-fit procedure is known as linear
regression and is guaranteed to generate a correct solution
in a finite time. No universal best-fit procedure is
guaranteed to generate a correct solution for arbitrary
relationships. A scatter plot is also very useful when we
wish to see how two comparable data sets agree with each
other. In this case, an identity line, i.e., a y=x line, or an
1:1 line, is often drawn as a reference. The more the two
data sets agree, the more the scatters tend to concentrate in
the vicinity of the identity line; if the two data sets are
numerically identical, the scatters fall on the identity line
exactly.
5.Ishikawa diagram
Ishikawa diagrams (also called fishbone diagrams,
herringbone diagrams, cause-and-effect diagrams, or
Fishikawa) are causal diagrams created by Kaoru
Ishikawa (1968) that show the causes of a specific
event.[1][2] Common uses of the Ishikawa diagram are
product design and quality defect prevention, to identify
potential factors causing an overall effect. Each cause or
reason for imperfection is a source of variation. Causes
are usually grouped into major categories to identify these
sources of variation. The categories typically include
 People: Anyone involved with the process
 Methods: How the process is performed and the
specific requirements for doing it, such as policies,
procedures, rules, regulations and laws
 Machines: Any equipment, computers, tools, etc.
required to accomplish the job
 Materials: Raw materials, parts, pens, paper, etc.
used to produce the final product
 Measurements: Data generated from the process
that are used to evaluate its quality
 Environment: The conditions, such as location,
time, temperature, and culture in which the process
operates

10. 6. Histogram method
A histogram is a graphical representation of the
distribution of data. It is an estimate of the probability
distribution of a continuous variable (quantitative
variable) and was first introduced by Karl Pearson.[1] To
construct a histogram, the first step is to "bin" the range of
values -- that is, divide the entire range of values into a
series of small intervals -- and then count how many
values fall into each interval. A rectangle is drawn with
height proportional to the count and width equal to the bin
size, so that rectangles abut each other. A histogram may
also be normalized displaying relative frequencies. It then
shows the proportion of cases that fall into each of several
categories, with the sum of the heights equaling 1. The
bins are usually specified as consecutive, non-overlapping
intervals of a variable. The bins (intervals) must be
adjacent, and usually equal size.[2] The rectangles of a
histogram are drawn so that they touch each other to
indicate that the original variable is continuous.[3]
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