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8.1
General
This clause asks you to do 3 things:
1) Identify the important measuring processes,
2)
Use the data to make sure things are okay and to make them better,
3) Determine where you need to use statistics
You need to determine the information you need
to collect and how to use it. Ask if the right information is being
collected and if it is useful. Many companies collect and keep data
that has no value. Others fail to analyze data that can provide
insights for valuable improvements.
Get a picture
of your data and information plan by identifying the sources of the
data, how the data are collected and where the data goes. Data may
come from measuring product characteristics, process performance,
audit results, complaint reports, customer surveys, etc. It can be
useful to flowchart the collection, use and analysis of data.
8.2 Monitoring and Measurement
8.2.1 Customer
Satisfaction
This clause reinforces what the standard is all
about. Remember from earlier in the discussion that the customer
defines quality? Companies have two types of assets, tangible and
intangible.
Tangible
assets are the physical things they own like buildings, machinery,
automobiles and everything else that is real. Intangible assets
aren’t physical things. That can’t be touched or seen. Things such
as goodwill, brand recognition, market position, customer loyalty.
8.2.2 Internal
Audit
Auditing is one of the four primary controls
specified in the standard:
1) Planning your processes
2) Controlling your processes
3) Examine your processes (auditing)
4) Correct or improve the process.
These four controls are the basis of the Plan –
Do – Check- Act cycle. Therefore, auditing is a critical function in
your QMS.
The first
thing you need is an audit schedule. The schedule shows what
processes are to be audited, when they are to be audited and who
will be the auditor(s). The audit schedule should be developed and
published by the lead auditor or audit program manager. It should
cover a year’s worth of audits. Although this isn’t required by ISO
9001 it has become an industry guideline. At the very least the
schedule should cover 6 months, but 1 year is preferred.
8.2.3 Monitoring
and measurement of processes
8.2.4 Monitoring and measurement of product
One of the primary rules of quality is “Do it
right the first time.” The processes for providing product must be
monitored and measured against an acceptance criteria. A company
should know when processes are operating effectively. If the
production and delivery processes are performing okay, it is likely
to result in acceptable product and customer satisfaction.
Product quality is defined as conformance to
requirements. These are measurable features and need to be verified
through inspection and test procedures. The three most common
product inspections are:
1) Receiving inspection,
2) In-process inspection, and
3) Final inspection.
These are the
classic quality control concepts used for years by companies. They
provide us with the data to show the customer that you are making
product to the requirements. The amount of inspection will decrease
as your processes become more capable through continually
improvement activities. However, some inspection will always be
necessary.
8.3 Control of Nonconforming
Product
What is meant by nonconforming product? If we
go back to the definition of quality being conformance to
requirements therefore, nonconforming is not meeting the
requirement. This is a go/no go issue. It’s determined through
testing and inspection. There are five possible choices in dealing
with nonconforming product:
1) Reject
2) Rework
3) Repair
4) Regrade
5) Release
Which one of
the five that is used depends on the product itself, the customer,
the industry and of course the cost?
8.4
Analysis of Data
Here is where you decide what data will be analyzed to
effectively measure performance and identify areas for improvement.
The information from this clause will provide empirical (factual)
data that can be used to determine progress and make management
decisions.
You should collect and analyze all the data
that will let you determine process and system effectiveness. And,
then figure out where improvement is needed. At the very least you
will need to provide and analyze data for these four issues:
1) Customer satisfaction,
2) Product quality,
3) Product and process trends, and
4)
Supplier performance.
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
Although you have planned, implemented,
controlled and measured your processes sometimes things go bad.
Usually we give it a quick fix and life goes on. However, once in
awhile the mistake is serious. Customers are angry and dissatisfied.
Internal costs are getting out-of-hand. The most serious mistake
causes injury to people. Something needs to be changed. The QMS
needs to be corrected or improved.
Before you can change the QMS, you need to know
which problems need the most attention. You need to focus on the BIG
problems. The small stuff will probably take care of itself during
the course of normal activities. The important thing here is to
figure out the difference between the small and big problems. Many
times the only criteria a company uses is which wheel squeaks the
loudest. Everyone runs around in frantic action constantly putting
out fires. You need to develop a method to evaluate which problem
comes first. .Perhaps cost, risk to customer satisfaction or
compliance with regulations, or current events (those things your
company or group are currently focused on). If the kick-in threshold
is too low you see every problem as an immediate crisis. If the
threshold is too high it will let serious problems continue and
eventually close you down.
There has been an ongoing debate over the
difference between corrective action and preventive action. The
generally accepted explanation is if a problem has occurred,
corrective action is needed. If the problem has not happened, but
could, preventive action is needed. The potential severity of the
problem needs to be determined so a decision can be made. Since no
company has enough resources to address everything all at once, a
priority must be set.
Whether you need corrective action or
preventive action, the method for taking the action needs to formal
and disciplined. Flowcharting, data analysis, and root cause
analysis are some of the methods that can be used.
What if there
haven’t been any serious problems in the process? Is action needed?
The answer is a definite maybe. Those processes that are critical to
producing an output for your customer should be analyzed for
continual improvement. Raise the bar a little. Figure out how you
could reduce cycle time, increase throughput and maybe improve
yield. Continual improvement doesn’t need to be a home run or grand
slam every time. Small changes on a continuous basis can have a
tremendous impact.
More information on these pages
Clause 4
Clause 5
Clause 6
Clause 7
Online
ISO 9000 Introduction Course
Auditor Training:
Classroom
Online
Auditor Training
Courseware
What
is a Quality Management System?
What is ISO 9000?
What is ISO 9004?
What is ISO 19011?
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