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7.1 Planning of Product
Realization
We are to
determine the process steps ahead of time. Determine the important
steps, checks, records and objectives. This can be done in any
manner the company chooses. Some companies use flowcharts, process
maps, and/or process descriptions. Most people like the flowcharting
or mapping methods because they can see the process interactions and
linkages.
7.2 Customer-related Processes
7.2.1 Determination of requirements related to product
This clause is one of the most
important in providing customer satisfaction. It requires you to
have a complete understanding of the customer’s requirements.
Including something the customer may have overlooked but you know is
needed based on the customer’s use of the product.
7.2.2 Review of requirements
related to product
Before we provide a quote
or accept an order we must make certain we can do what the customer
wants. This includes anything from a written description of the
product or service to how soon they want to pay you for the product.
Don’t forget shipping schedules, packaging and labeling!
If any of the
requirements change we must make sure everyone involved is told of
the change.
7.2.3
Customer Communication
Figure out
the best way to communicate with the customer from the order to the
delivery of the product. It could be by phone, fax, email, personal
visit or any combination. We must keep the customer up-to-date.
Listen to them about changes and their expectations.
7.3 Design and Development
There are seven sub-clauses in
this section.
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control
of design and development changes
7.4
Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3
Verification of purchased product
It is customary to buy some of the things you
need for your product from other suppliers. This could be anything
from completed assemblies to raw materials. It might be
sub-contracting some of your work to a specialist, (i.e.); painting
or plating or welding.
Let’s say we make
computers and you buy the monitor from another company with your
name on it. When the monitor breaks and your customer calls, do they
call you or the maker of the monitor. You, of course. You can try
and tell the customer it was the monitor maker, but they won’t care.
They bought the computer from you. You are responsible in the
customer’s eyes.
It is the responsibility
of the company selling the product to make sure it meets the
customer’s requirements, regardless of where the materials or parts
came. Your company must evaluate the quality of their suppliers and
approve the supplier for use. This means there has to be some
criteria for that evaluation and suppliers are held to meeting those
needs. If they don’t they will need to take action to fix the
situation so it won’t happen again.
But, regardless of the
fact the supplier is approved, your company is charged with making
certain the goods you get meet all the requirements. The
requirements need to be spelled out in the purchase documents sent
to the supplier.
Also, if
anyone from your company or your customer wants to inspect the goods
at the supplier’s location, this is to be written in the purchase
documents as well.
7.5 Production and Service
Provisions
7.5.1
Control of production and service provisions
This may be
the most important clause in the ISO 9001:2000 standard. The
standard is based on this concept: If you control the input to
your process and make sure it is good, the output has to be good.
Why? Because the process consists of the input, that’s all there is.
If it is good going in it will be good coming out. Therefore, this
clause tells the company the things they need to do make sure the
input is okay.
7.5.2 Validation of processes
for production and service
This
requirement is for processes where the output can’t or isn’t
inspected or tested to see if it is okay. You have to make sure that
everything in the process is controlled. Like how to do the work,
what equipment and material must be use. It could even require the
operator(s) be certified to run the operation. Once that’s all
settled, it has to be checked on from time to time or what the
standard calls ‘revalidation’.
7.5.3 Identification and
traceability
The standard defines
quality as conformance to requirements. Earlier we discussed the
importance of clearly defining the customer’s requirements that are
measurable. This clause reminds us it is necessary to always keep
these requirements in mind.
As items move
through the steps of processing, we need to know if they are ready
for the next step. As obvious as this seems, at one time companies
didn’t know what was what and where it was because it wasn’t always
clearly identified.
The other
condition in this clause is about traceability. This means we can
look back and find where the materials came from, when it was made
and who bought it.
7.5.4 Customer-owned property
The first thing you need
to ask is “Do I have any customer owned property?” This can be
anything the customer retains title to. It can be parts, materials,
tooling, packaging and labels. Also include is intellectual property
like blueprints, methods, formulas and recipes.
You are responsible for
the care, custody and control of customer property and that means
keeping it safe from damage and loss. It can also mean keeping it
clean, properly identified and in useable condition.
If anything
happens to it you must tell the customer and keep a record of the
problem.
7.5.5
Preservation of product
You have to
be careful in handling the materials and goods while being
processed. You must use the appropriate containers and fillers so
items won’t be chipped, broken or bent. Reducing the distance
between operations inside the plant and fixing cracks and holes in
the floor so the towmotors aren’t bouncing your stuff around like an
eight-year old on a trampoline may be needed.
The final stage is seeing
the goods are packaged correctly for the method of shipping; truck,
air or sea. Sometimes a supplier doesn’t get to choose the shipping
method or the carrier because the customer is paying the freight.
Unfortunately, you are still responsible for seeing the goods arrive
at your customer’s in good shape. We need to always keep in mind the
customer pays for the product quality at their dock, not yours.
7.6
Control of monitoring and measuring devices
A lot
people think this clause is about inspection gages and instruments.
It’s not. It’s about data, good useable data. If we are to make a
decision regarding the quality of something we must be able to rely
on the data we use to make the decision. In order to feel
comfortable about the data we have to be comfortable about the
methods used to gather the data. This does include making sure the
gages and instruments used in the data gathering method are stable
and reliable.
More information on these pages
Clause 4
Clause 5
Clause 6
Clause 8
Online
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What is ISO 9004?
What is ISO 19011?
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