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ISO 9000 Quality Standard

By Charlie
Bennett

Clause 8 Measurement, Analysis and Improvement

In the last several articles weve talked about measurement, analysis, and non-conforming product. These
requirements are relatively simple. In this article were going to discuss the analysis of data, improvement and
corrective/preventive action.
Even though the requirements for analysis of data are simple, the amount of effort expended by an organization to
select, collect and analyze data can be difficult. However, the rewards can be tremendous. The reason that
analyzing performance data is important is because it helps identify successes, opportunities, and improvements
for your business operations and processes. Everything should be about improving business processes,
practices, and adding value to the organization.
8.4 Analysis of data.
This clause simply says that a company must determine what data to collect and then collect it. However,
collecting data is not enough; you must analyze the data for it to become useful information. Think about when
you purchase a book. The book doesnt add value if it sits on the shelf and is not used or referenced. It must be
taken off the shelf and read it to obtain the knowledge and get the benefit. The ISO standard does not designate
exact data to collect and analyze but it does require that the data must provide information on customer
satisfaction, conformity to product requirements, process/product characteristics, and supplier performance. To
maximize the analysis effort, the data collection plan should be well designed, thought out, and collected in order
to yield accurate and meaningful information.
One of the important outcomes of collecting and analyzing data is the indication that it provides for the
effectiveness of the quality management system. Probably the most important outcome, however; is that it
identifies where improvements can be made to processes. But, a company must act on the improvements that are
practical, feasible, and economical. When analysis of data and process improvement are combined with planning
and process implementation, you have followed a process approach, or scientific method called Plan, Do,
Check and Act. Plan is to establish the objectives and processes necessary to deliver results in accordance
with customer requirements and company policies. Do is to implement these processes. Check is to monitor
and measure processes and products against policies, objectives and requirements for the product and report the
results of this monitoring and measuring. Act is to take actions to continually improve process performance.1
This is a great segue into continual improvement.
8.5 Improvement
8.5.1 Continual improvement
The definition of continual improvement is recurring activity to increase the ability to fulfill requirements.2 The
ISO standard intended continual improvement to relate to processes, not product. It is important to have the best
possible product and to improve that product when needed. But, that could mean change and generally customers
want consistency with the products they buy. The product theyre purchasing from you could be only one
component of many. If the characteristics of such an input product are altered, then the customer might have to
change their recipe or formula for producing their output product. These changes may increase costs and that
can affect the customer base. Process improvement is the key and should be reflected in an increased
effectiveness and efficiency for work processes. When processes are not effective or efficient, there is real
possibly for a problem or nonconformity. Thats where corrective and preventive action(s) become important.
8.5.2 Corrective Action
8.5.3 Preventive action
The definition of corrective action is action to eliminate the cause of a detected nonconformity or other

undesirable situation.3 The definition of preventive action is action to eliminate the cause of a potential
nonconformity or other undesirable situation.4 Note that there is a distinct difference between corrective action
and preventive action. Corrective actions are used for a problem or nonconformity that has already occurred.
Preventive actions are used to avoid a potential problem or nonconformity. Corrective action is reactive and
preventive action is proactive.
The ISO standard requires a documented procedure(s) that defines how nonconformities and potential
nonconformities are identified, resolved, and recorded.
In manufacturing, nonconformities can be identified through monitoring, measuring and observing
processes/products. A customer can also identify nonconforming product if it leaves the production premises
undetected. Customer complaints can also be handled through the corrective action system. This would also be
true if your organizations work product is a service. Services tend to be more intangible but the
corrective/preventive action process would be the same. Possibilities include monitoring, measuring, and
observing service parameters such as on-time delivery, proper paper work, or accuracy of orders. Internal audit
findings are another source to identify nonconformities that must be addressed in the corrective action system.
After the nonconformity has been identified, a resolution must be determined to eliminate or mitigate the problem.
This means some type of root cause analysis must be done. There are a variety of methods and tools available to
determine the root cause, no matter how simple or how complex the problem. Once the root cause has been
determined, an effective solution must be developed. After allowing sufficient time once a solution is implemented,
objective evidence should be collected to verify that the implemented solution was effective and has eliminated or,
at least, mitigated the problem.
Records must be kept to provide evidence of conformity to this requirement. Generally that means forms will have
to be completed to capture all of the important information; such as, description and basis of nonconformance, root
cause, solution, implementation period, acceptances and approvals, and verification of effectiveness. Also, a log
sheet should be maintained to collect data, which will help in identifying trends, and reference the status of the
corrective or preventive action.
In closing, the main theme of the ISO 9001 standard is continual improvement. Improving on a process or
eliminating problems may be an admission of making a mistake, which is sometimes difficult. James Joyce, an
Irish author (1882 1941), said that Mistakes are the portals of discovery. Problems and mistakes will occur, but
can be successfully managed to become portals of discovery. Continual improvement is the focus.
This is the last article of the ISO 9001:2008 requirements. I hope that the information weve presented has put
these requirements in simple terms. Also, I hope that these articles have helped you to understand the standard
and to apply some of its principles.
1 ISO 9000:2008 Quality Management Systems Requirements,
Introduction 0.2 Process approach.
2 ISO 9000:2000 Quality Management Systems Fundamentals and
Vocabulary, 3.2.13.
3 ISO 9000:2000 Quality Management Systems Fundamentals and
Vocabulary, 3.6.5.
4 ISO 9000:2000 Quality Management Systems Fundamentals and
Vocabulary, 3.6.4.
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