Quality management system

Quality management system
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• qualitymanagement123.com/86-quality-management-interview-questions-and-answers
I. Contents of quality management system
==================
ISO stands for the International Organisation for Standardisation which currently comprises the
national standards bodies of 91 nations. Its function is to develop global standards in an effort to
improve the exchange of goods and services internationally. The ISO 9001 standard is a quality
management standard.
Benefits of Certification
Improved corporate image
Competitive advantage-market positioning
Reduced warranty/liability claims through defect reduction
Improved records in case of litigation
Reduction of need for multiple second part assessment.
Improves traceability to 'root causes' of quality problems
Independent, impartial and professional verification
Required by an increasing number of buyers
Results in errors rectified, at the earliest stage-not repeated
Clearly defines responsibilities and authorities.
How is compliance to ISO 9000 demonstrated?
Compliance to ISO 9001 standard is demonstrated by registering a supplier's quality system to
the ISO 9001:2000 standard. The process involves a review of the supplier's documentation and

on-site audits performed by a certification body. Upon approval of corrective actions
implemented to correct any deficiencies found, a certificate is given granting registration.
Surveillance visits assure the maintenance of the supplier's quality system.
Is 'STQC Certification Services' an Accredited body?
Yes, STQC Certification Services are internationally recognized and accredited by NABCB,
IndiaNABCB, India for QMS certification scheme with the scope covering majority of areas.
Why to Choose STQC?
Established in 1992, STQC is First certification body of Indian origin
Reputation for excellence in the electronics sector
Recognized by major buyers, Domestic and International
Hardware and software experience and expertise
All auditors are professionally qualified and certified
Credibility built through experts in quality
Extensive auditor capability and availability
Leader in the development of quality standards
Transparent operations
Certification Process
Pre-certification requirements
Client interested in obtaining certificate of registration under QMS scheme, shall have
established a documented quality system complying with the requirements of current version of
the ISO 9001 standard and the applicable product standards.
Application: STQC Certification Services provide an application along with an offer based on
defined criteria to its clients for initial information. The duly filled application along with
applicable fee, quality system documentation and certification agreement needs to be submitted
to STQC Certification Services.
Evaluation of Documentation: STQC Certification Services reviews the submitted
documentation against the requirements of ISO 9001 standard and prepares a report detailing its
finding. The deficiencies, if any, will have to be corrected prior to assessment, since this
documentation will form a part of assessment criteria during assessment.
Stage I - Assessment visit:Following documentation review, Stage 1 assessment is carried out at
the client’s premises to gain first hand information about the applicant’s processes, size,
complexity, applicability of regulatory requirements and applicant’s readiness for Stage II
assessment. The weaknesses and / or issues identified and reported during Stage I assessment

must be corrected before proceeding further.
The duration of Stage I assessment is normally one or two days. The finding of Stage I
assessment are documented in a Stage I assessment report and used for planning detailed
assessment known as Stage II assessment.
Stage II - Assessment visit: The Stage II - Assessmentvisit is a detailed on-site assessment that
takes place at the applicant's locations(s) and determines conformance to the ISO 9001 standard
and the effectiveness of the quality system.The Stage II assessment also specifically pursue in
detail the weaknesses and issues identified during Stage I assessment. Non-conformances, if any,
found during the Stage II assessment process, are reported to client objectively. At the end of the
assessment, a report of Stage II assessment is prepared and handed over to applicant in original
for taking corrective actions.
Corrective action :The applicant will be required to take corrective action for any non-
conformances reported during the Stage II assessment before initiating the process of granting
certification. The evidences of corrective actions shall be submitted to assessment team leader,
for review and acceptance, within the committed time frame.
Certification:STQC Certification Services will issue a certificate of registration to the applicant
once the corrective action has been accepted. The certificate carries a validity of three years from
the date of issue subject to satisfactory findings during surveillances.
The certified client’s are committed through signing of certification agreement to comply with
the certification body’s requirements.
Surveillance:During the certificate validity period, three surveillance assessments are carried out
at an interval of 6th, 16th and 26th months from the date of certification in the period of the
certificate validity. The Certification Body also reserve the right to order unplanned and / or
additional surveillances in case of compliants. In case of failure to accept surveillance, major non
conformities, failure to take timely corrective actions or failure to fulfill financial obligations
may lead to suspension of the certificate.
Failure to take effective timely actions for revoking suspension may lead to withdrawal of
certificate.
==================
III. Quality management tools

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
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
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
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

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]
III. Other topics related to Quality management system (pdf download)
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