Implementing Statistical Process Control

2003 by John G. Surak

Implementing Statistical Process Control linked with Continuous Improvement (SPC-CI)

in the food processing plant need not be a complex process. However, if the maximum
effect is to be achieved and sustained, SPC-CI must be implemented in a systematic
manner with the active involvement of all employees from line associates to executive
management.
The ultimate objectives of the SPC-CI process are the following:

Process and product data are reported as a mean and standard deviation.
Manufacturing process variation is stable or predictable.
The manufacturing process is capable of producing product that is in
specification. This is demonstrated using histograms and capability indices.
Control charts or graphical trend analysis are used to understand changes in the
process mean and process standard deviation.
Line associates at multiple locations on the plant floor use control charts. The
charts are used to determine when to adjust the process. This is done by
determining if the process mean or standard deviation is trending in a way that
may cause product deviation. In highly capable processes, it is possible to take
corrective actions prior to manufacturing a product that is out of specification. In
addition, both line associates and management use the control charts to identify
opportunities for process improvement. Management uses control charts to
ensure that the SPC-CI process is properly functioning.
Process variation is seen as the problem. It adds needless cost to the product
and is the reason why a product does not comply with specifications.
A systematic procedure that focuses on reducing variation is used to
continuously improve manufacturing processes.

The objective of SPC-CI differs significantly from the

traditional QC/QA process. In the traditional process,
the QC/QA tests are used to generate a datum point
and this datum point is compared to a standard. If the
point is out of specification, then action is taken on the
product and action may be taken on the process.
To move from the traditional QC/QA process to SPCCI, a plan should be developed, implemented, and
followed. This plan should address the following:

Leadership
Expert knowledge
Education and training

Poor quality and excess

costs are the result of
process variation.
Statistical Process
Control identifies both the
variability and the
capability of a process
and provides a guide to
process improvement.

Implementing Statistical Process Control

Northwest Analytical

Software and hardware

Implementation plan
Process control plan
Systematic process improvement
Financial aspects of poor quality

Leadership
Leadership is critical for the successful implementation of SPC-CI. One of the basic
objectives is to eliminate the idea that SPC-CI is a "flavor of the month" and "this too
shall pass." Leadership responsibilities include the following:

Walking the talk with regard to continuous improvement. Managers need to show
commitment to continuous improvement by taking actions to improve their
personal management processes.
Insisting on fact based reporting of data. Data should be reported as a mean and
standard deviation. Trends should be reported on control charts.
Allocating resources to SPC-CI and removing roadblocks that inhibit
implementation.
Setting priorities for continuous improvement. This can be done through a quality
council.
Conducting management reviews on the continuous improvement process. This
may be done through quality councils.
Establishing a measurement system to assess SPC-CI implementation.
Appointing continuous improvement teams, monitoring activities, and ensuring
celebrations for successful completion of projects.
Gaining experience in continuous improvement by serving as a member on a
continuous improvement team.
Ensuring inclusion of external suppliers (as appropriate) on continuous
improvement teams. Ensure that internal customers and suppliers are part of
continuous improvement teams.
Showing commitment to continuous improvement at the plant level by being
present at celebrations.
Developing and managing systems to ensure the communication of continuous
improvement success stories to other plants.
Ensuring alignment of the rewards and recognition systems to process control,
process capability and continuous improvement achievements.
Conducting an annual audit of the SPC-CI system.

Expert Knowledge
Companies implementing SPC should have access to expert knowledge in the areas of
process control and statistics. Utilizing either internal consultants or external consultants
can achieve this. SPC is based on statistical theory, process control theory and the
proper application of the theory to the manufacturing environment. The proper
application of these theories must be started at the beginning of the process so that bad
habits do not develop and derail later efforts.

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Northwest Analytical

The author has observed numerous examples of either poor knowledge of the theory or
poor application of the theory. These problems are not usually fatal at first, however
they can lead to serious issues as more complex problems are solved. When the fatal
incident occurs, a typical response is that "SPC does not work."
The SPC expert should also select and approve texts for the company since many SPC
texts have statistical errors.
Education and Training
Education and training in SPC-CI is a critical factor to the success of the implementation
of the process and to maintaining the SPC-CI system. The company should be willing to
make a long-term commitment to SPC-CI education. This is needed to deal with
turnover of personnel. In addition, the education requirements are dependent on the
responsibility of the employee. The following training objectives are for the basic skill set
needed by associates using SPC on the processing line and for SPC-CI leaders. The
SPC-CI leaders are team leaders, who will lead teams to improve the process.

Basic skill set

o Basic math
o Understanding central tendency (mean, median, mode) and variation
(range, standard deviation)
o Understanding trends
o Describing the process
o Describing sources of variation
o Interpreting a control chart
o Interpreting a histogram and capability indices
o Interpreting a Pareto diagram
o Functioning in a continuous improvement team
Skill set for SPC-CI leaders
o Basic
Basic math
Understanding central tendency (mean, median, mode) and
variation (range, standard deviation)
Understanding trends
Understand statistical thinking
Process mapping and understanding the process
Process analysis
Drawing a detailed flow diagram
Cause and effect diagrams
Understanding the sources of variation
Drawing a cause and effect diagram
Control charts
Understanding the types of control charts
Understanding of the proper selection of control charts
Understanding if a process is stable
Understanding how to interpret a control chart

Implementing Statistical Process Control

Northwest Analytical

Understanding how to calculate and interpret a color

(rainbow chart) at locations that use the chart
Histograms and capability analysis (Cp and Cpk)
Understanding how to interpret a histogram
Understanding how to interpret capability indices
Understanding if a process is capable of meeting
specifications
Collecting of data
Analysis of data utilizing the following techniques:
Pareto diagram
Scatter diagrams
Check sheets
Systematic problem solving
Planning a continuous improvement project
Selecting a cross functional team
Using project management techniques
Running efficient meetings
Utilizing the PDCA Cycle
Conducting problem analysis
Conducting gap analysis
Identifying root cause(s)
Formulating several potential solutions
Selecting best solution
Testing
Standardizing results
Understanding how to mine data
Developing a process control plan
o Intermediate
Understanding the use of SPC to control manufacturing processes
Understanding advanced control chart theory
Recalculation of control chart limits
Rational subsample
Understanding measurement systems
Understanding sampling systems
Utilizing quality function deployment
Utilizing failure mode and effect analysis
o Advanced
Using design of experiments
Processes must be stable before DOE can be effectively
done in production

Implementing Statistical Process Control

Northwest Analytical

Software and Hardware

Companies usually face a dilemma in implementing SPC-CI. A decision must be made
as to whether to plot the data on control charts by hand using graph paper, or plot the
data using SPC software.
Some companies elect to delay installing SPC software to "save" money. A SPC
software and hardware system can cost around $1200 to $1400 per site, while a piece
of SPC graph paper costs around $1.00.
However, when the decision is made to use a paper charting process, the company
does not account for a large number of hidden costs that include:

The time it takes to plot the data.

The time it takes to interpret the
chart (SPC software automatically
interprets the data.)
The time it takes to determine a
root cause of a problem when the
data are not plotted correctly.
The time it takes to enter the data
manually into a computer to
generate a histogram and calculate
process capability indices.
The time it takes to generate
additional data analysis graphs for
the continuous improvement process.

SPC Software, such as NWA Quality Analyst, will

handle the mechanics of charting and analysis, and
allow you to focus on problem solving and process
improvement.

Thus, the initial short-term savings that were achieved by delaying the purchase of
software and hardware may cause medium term losses.
There is another reason for the immediate implementation of SPC software and
hardware. An old saying is that the easy things get done first. Plotting control charts by
hand is not an easy task. It takes time and concentration. Thus, if a company makes
this process more difficult by hand charting, this may be one more reason for line
associates not to comply with the process of SPC implementation.
There are a number of factors in selecting SPC software. Several critical factors include
software support, flexibility of integrating data collection systems including automatic
data collection systems, and ease of learning the software. If the software is not easy to
learn, this will cause needless increase in the training costs.
Implementation Plan
Time must be allocated to properly implement SPC-CI. It takes time to learn the new
skills, and time to apply those skills properly. The author has observed that repeated
training classes might be necessary to ensure that the employees properly learn to
apply SPC-CI techniques. Old habits must be replaced with new habits.

Implementing Statistical Process Control

Northwest Analytical

In implementing SPC-CI in a multiple plant scenario, it is recommended not to try and

implement SPC at all plants at once. This recommendation is made for several reasons.
Managers must learn new skills in managing facilities using SPC. This must be done at
both the plant level and the corporate level. Learning and applying these new skills must
be done in addition to the current work responsibilities. Having too large of an
implementation process will result in over extending the managers, thus potentially
leading to failure.
Using a phased-in implementation system allows a systematic and sustained
implementation plan. The initial plants selected for implementation allow the company to
identify the lessons learned, the lessons failed, and to improve the SPC-CI
implementation process. In addition, it allows the company to build success stories,
which can be used to further motivate the additional plants to implement SPC-CI.
As part of the implementation process, the resources that are needed to properly
implement SPC-CI include:

Selecting hardware and software

Educating and training of line associates
Educating and training of management
Developing a process control plan
Utilizing control charts to make adjustments on the process
Utilizing control charts, histograms and capability indices to identify areas for
improvement
Selecting continuous improvement projects
Gathering the success stories of several cycles of continuous improvement
Improving the implementation process
Communicating the success to other facilities in the company - It is
recommended that companies utilize the line associates involved in the
continuous improvement projects to communicate the success stories

Process Control Plan

The process control plan is the heart of the SPC process. It defines the process
measurements used to assess the process or the product, and actions taken if the
measurement signals that a change has taken place in the process.
Systematic Process Improvement
A systematic process should be used to drive the continuous improvement process.
This should be done from the very start of the implementation process. Early projects
can be defined as picking the low hanging fruit, or
Develop good SPC and
projects where it is easy to have success. Associates
process improvement
may question why they have to follow the "continuous
improvement drill." The reason why they need to follow
skills by solving the easy
the drill is to develop the skill set and discipline to solve
problems first.
problems that are more complex. The following is an

Implementing Statistical Process Control

Northwest Analytical

eight-step continuous improvement drill:

Define the problem in context of the process and the system

Select a process improvement team
Document the process
Measure product and process performance
Understand why the problem exists
Develop hypotheses and test the best hypothesis
Evaluate test results; implement and standardize the best solution
Celebrate the success and start all over again

Financial Aspects of Poor Quality

Typically, implementing a "cost of poor quality program" is not needed at first. It is easy
to develop a rough estimate of the cost of poor quality for most of the initial problems
that must be solved. Usually these rough estimates will actually underestimate the
actual cost of poor quality. As the quality improvement process matures, it is
recommended that the company start to systematically estimate the cost of poor quality.
These estimates can be used as financial drivers to achieve larger gains.