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interested party requirements. The common structure of the two standards is demonstrated
in Figure 1.
Understanding the approach
The process approach is one of the eight quality management principles upon which the entire
ISO 9000 series of standards is based. This principle says a desired result is achieved more
efficiently when activities and related resources are managed as a process.
The word "process" is defined in ISO 9000:2000 clause 3.4.1 as "a set of interrelated or
interacting activities that transforms inputs into outputs." Inputs to a process are generally
outputs of other processes. Processes in an organization are generally planned and carried out
under controlled conditions to add value.
From the principle and process definition you can see the process approach is a powerful way of
organizing and managing how work activities create value. While a more traditional structure
organizes and manages work activities vertically by function, with quality problems frequently
occurring at the boundaries of the functional departments, the process approach organizes and
manages work horizontally the way work activities create customer value.
The process approach directly links process inputs that come from suppliers to the outputs of the
process that go to customers. This horizontal linkage between suppliers and customers is an
excellent way to manage and continually improve both the effectiveness (the amount of value
created for the customers) and the efficiency of the process (the amount of resources
consumed). Figure 2 (p. 72) shows these relationships.
Methodology
Once the processes needed for the QMS and their sequences and interactions have been
identified (see Figure 1), it is necessary to establish management responsibilities and
accountabilities for the performance of these processes. Many methodologies are available for
managing and improving processes, but all share some simple basic elements. A simple process
management and improvement methodology organized in a series of steps is described in the
following:
Step one: Establish the responsibilities for managing the process. It is critical to have an
overall process manager or process owner with end to end responsibility and accountability for
all aspects of process performance. The process manager needs to understand the entire process
and have the authority to effect changes in any part of it.
The process manager is responsible for the following:
Forming the process management team, which includes representatives from each major
part of the process.
Ensuring the process operates in a controlled state of predictable performance.
Establishing process performance measures that adequately characterize the efficiency
and effectiveness of the process in meeting the needs of all customers and other interested
parties.
Ensuring all aspects of process management and improvement are performed. This
includes creating documentation, tracking performance, and securing and allocating
resources.
Step two: Define the process. The process manager and process management team need to
carefully define the process so everyone working within the process has a shared understanding
of how it operates. How much documentation is required depends on such attributes as the
stability and education of the workforce and the complexity and criticality of the process.
All process inputs and outputs are identified, along with the suppliers and customers, who may
be internal or external. The team also identifies process steps and flows. Many quality tools, such
as block diagrams and flowcharts, are available to support these activities.
Step three: Identify customer requirements. Carefully gather, analyze and document customer
needs, including how customers use the outputs of the process. Communicate frequently with
customers to understand needs from their viewpoint.
To the extent possible, define measurable customer needs and rank them in order of importance.
Directly validate needs and requirements with customers.
Step four: Establish measures of process performance. Translate customer needs and
requirements into measures of process performance. This is one of the most important and
difficult steps in process management.
Include customer satisfaction, in-process measures and measures of supplier performance in
process measures. Relate all important customer needs, such as on time performance, defect or
error rates, tolerance intervals, product reusability, and worker health and safety, to performance
measures.
The process approach is therefore one of the strongest approaches for integrating management
system standards because each process must be managed and improved simultaneously for all
process performance measures. Directly linking process performance measures with customer
needs is one of the most powerful aspects of process management.
Step five: Compare process performance with customer requirements. Use the process
performance measures to ensure your process is operating in a stable and predictable manner.
Compare the process performance measures with the needs and requirements of the customers.
Use a variety of statistical tools for analyzing process measurement data to help quantify process
performance. Identify critical process improvement opportunities through gaps in process
performance.
These first five steps provide a basic methodology for process management. But the
responsibilities of the process manager and process management team do not end there. A
significant benefit of process management is its natural fit with process improvement. Once
process performance has been compared with customer requirements, process improvement is
the natural next step.
Step six: Identify process improvement opportunities. Use gaps in process performance vs.
customer needs to determine critical process improvement opportunities. Analyze process
performance measures for improvement opportunities related to sources of such attributes as
errors and defects, process simplification opportunities, process bottlenecks and lack of adequate
process controls.
Both process effectiveness and efficiency can improve as a result of process improvement
activities. Many tools exist to identify process improvement opportunities.
Once process improvement opportunities are identified, any of the many quality improvement
methods can be used to improve process performance. These quality improvement methods fit
naturally into step seven of the process management and improvement methodology.
One quality improvement method that can be used at this step is the plan, do, check, act (PDCA)
cycle.
Step seven: Improve process performance. Select the process improvement opportunity to
pursue. This selection should take into account such attributes as the criticality of certain
improvement needs, difficulty of improvement opportunities, and resources and expertise
available.
Establish quality improvement teams to pursue specific improvement opportunities. These teams
are established by the process manager and process management team. The quality improvement
teams report to the process manager or the process management team and are typically disbanded
once their improvement project is completed.
The quality improvement teams complete the following activities:
Management responsibility.
Resource management.
Product realization.
Each process can be managed and improved using process management and improvement
methodology, but managing the interrelated processes as a system introduces additional
improvement opportunities.
First, processes can be analyzed and improved together as mega-processes, increasing the
opportunities for improvement. But you can also directly pursue improvement of the entire QMS
using audit and self-assessment (using 9004:2000 or quality award criteria) results and the PDCA
cycle.
The multiple levels at which continual improvement occurs make QMSs based on the process
approach a powerful way to manage organizations toward achieving performance excellence.
==================
1. Check sheet
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.
3. Pareto chart
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