Quality management system audit checklist

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I. Contents of quality management system audit checklist

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In looking at current auditing standards, ISO 19011 makes reference to Preparing work
documents in Clause 6.4.3. The following is an extract from this clause:
The audit team members should review information relevant to their audit assignment and
prepare work documents as necessary for reference and for recording audit proceedings. Such
documents may include

Checklists and audit sampling plans, and

Forms for recording information, such as supporting evidence, audit findings and records
of meetings.
The use of checklists and forms should not restrict the extent of audit activities, which can
change as a result of information collected during the audit
The use of audit checklists:
Whilst not always required in management system standards, audit checklists are just one tool
available from the auditors toolbox. Many organizations will use them to ensure that the audit
at a minimum will address the requirements as defined by the scope of the audit.
There can be different approaches audit for ISO 9001:2000. For example:

Audit from the organizations Quality Management System to the ISO 9001:2000
requirements.
Use of checklist to audit from the requirements to the organizations management system.

However, it is beneficial to audit from the organizations quality management system up to the
requirements. A checklist may be used to ensure that all relevant ISO 9001 requirements
addressed.
Advantages of using audit checklists:
1. Checklists if developed for a specific audit and used correctly:

Promote planning for the audit

Ensure a consistent audit approach.
Act as a sampling plan and time manager.
Serve as a memory aid. Provide a repository for notes collected during the audit process
(audit field notes).
2. Audit checklists need to be developed to provide assistance to the audit process.
3. Auditors need to be trained in the use of a particular checklist and be shown how to use it to
obtain maximum information by using good questioning techniques.
4. Checklists should assist an auditor to perform better during the audit process.
5. Checklists help to ensure that an audit is conducted in a systematic and comprehensive manner
and that adequate evidence is obtained.
6. Checklists can provide structure and continuity to an audit and can ensure that the audit scope
is being followed.
7. Checklists can provide a means of communication and a place to record data for use for future
reference.
8. A completed checklist provides objective evidence that the audit was performed.
9. A checklist can provide a record that the QMS was examined.
10. Checklists can be used as an information base for planning future audits.
11. Checklists can be provided to the auditee ahead of the on-site audit.
Disadvantages of using audit checklists:

1.
2.
3.
4.
5.
6.
7.
8.

The checklist can be seen as intimidating to the auditee.

The focus of the checklist may be too narrow in scope to identify specific problem areas.
Checklists are a tool to aid the auditor, but will be restrictive if used as the auditors only
support mechanism.
Checklists should not be a substitute for audit planning.
An inexperienced auditor may not be able to clearly communicate what he/she is looking
for, if they depend too heavily on a checklist to guide their questions.
Poorly prepared checklists can slow down an audit due to duplication and repetition.
Generic checklists, which do not reflect the specific organizational management system,
may not add any value and may interfere with the audit.
Narrow focused checklists minimize unique assessment questions / approach.
Conclusion: There are advantages and disadvantages in using audit checklists. It depends on
many factors, including customer needs, time and cost restraints, auditor experience and sector

scheme requirements. Auditors should assess the value of the checklist as an aid in audit process
and consider its use as a functional tool.
==================

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:

2. Control chart

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

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 audit

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