This
section summarizes ISO 9004-3. It highlights the main points. It
does not present
detail. If you need a detailed and complete interpretation of the
ISO 9004-3 standard, please consider purchasing our hardcopy version.
ISO
prepared ISO 9004-3 in order to explain how quality assurance
concepts can be applied to organizations that process materials.
- Processed
materials
are tangible products that result from transformations.
Processed materials can be solids, liquids, or gases, or
a combination of these materials. They are usually
transported in bulk using pipelines, drums, bags, tanks,
cans, or rolls.
- Develop
a quality policy. Develop a
policy that describes your attitude towards quality and
ensure that it is understood and applied throughout your
organization.
- Develop
quality objectives. Develop objectives that
support your policy.
- Develop
a quality system. Develop and implement a
quality system in order to apply your quality policy and
achieve your quality objectives.
- Develop
a quality organizational structure.
- Define,
document, delegate, and distribute the
responsibility
for carrying out all quality oriented activities.
- Give
your people the authority they need to carry out
all
quality system responsibilities.
- Define
the patterns of interaction and communication
that will integrate and regulate your quality
system.
- Define
the patterns of reporting and accountability that
will integrate and regulate your quality system.
- Provide
the resources that will be needed to implement,
maintain, and improve your quality system.
- Develop
quality system procedures. Develop
procedures to govern and control all quality oriented
activities.
- Document
every aspect of your quality system. Document
your quality policies, procedures, programs, and plans.
Documents will include manuals, records, and reports.
- Develop
a quality manual. Develop a manual which
describes your quality system and serves as your main
coordinating document.
- Develop
a quality plan. Develop a quality plan
whenever you intend to launch a project to develop a new
product, service, or process.
- Develop
an internal audit plan. Develop
an audit plan that describes how every element and aspect
of your quality system will be evaluated.
- Perform
internal audits. Your audits
should evaluate your:
- Organizational
and interactional structures.
- Policies,
procedures, and programs.
- Tools,
technologies, equipment, and supplies.
- Work
patterns and personnel behavior.
- Processes,
products, and services.
- Documents,
reports, and records.
- Prepare
audit reports. These internal audit
reports should:
- Itemize
nonconformities, deficiencies, and causes.
- Recommend
corrective and preventive actions.
- Evaluate
actions that were taken in response to previous
audits.
- Develop
a management review procedure. It should
describe and explain how senior managers will evaluate
your quality system.
- Measure
quality costs. Measure the cost of your
quality system and routinely report this to management.
Track and distinguish between:
- Internal
quality operating costs.
There are two kinds:
- Investments,
which are divided into:
- Prevention
costs. This is money spent trying
to prevent failures and
nonconformities.
- Appraisal
costs. This is
money spent on testing,
inspections, reviews, audits,
etc.
- Losses, which
are divided into:
- Internal
failures. This is money spent
handling nonconforming products
before they are sold.
- External
failures. This is money spent
dealing with nonconforming
products after they are sold.
- External
quality assurance costs. These
are costs incurred trying to prove to customers
that your quality system meets requirements.
- Perform
market research. Ask your marketing people
to:
- Determine
if there is a demand for the product you wish to
develop.
- Define
the market demand and clarify who needs the
product.
- Specify
exactly what customers need and expect from the
product.
- Explain
customer needs and expectations to your
organization.
- Prepare
a product brief. Ask your marketing people
to prepare a product brief. This document is a
preliminary specification. It should describe the product
and list customer needs and requirements.
- Develop
a customer feed back system. Ask your
marketing people to develop and maintain a customer
feedback system. Such a system should monitor customer
comments, experiences, expectations, and problems, and
provide a basis for improving your products and services.
- Select
a design team. Select a product design
team, define their responsibility and authority, and give
them the resources they need.
- Define
a product development plan. Ask your
design team to define the product development project.
Ask them to define a project plan that lists the steps
that should be taken and the resources that will be
needed.
- Design
your product. Ask your product design
team to:
- Encourage
your customers to help translate qualitative
expectations into quantitative specifications.
- Translate
the product brief into a set of technical
specifications. Define specifications for
materials, products, and processes.
- Ensure
that your product will meet all regulatory
requirements.
- Identify
the characteristics that will define the quality
of the product.
- Define
all of the characteristics that will be used to
control the quality of the process and to plan
process maintenance tasks.
- Specify
product and process testing and measurement
methods, and define the technical criteria that
should be used to accept or reject product and
process results.
- Appoint
a design review team. Appoint a
product and process design review team, define their
responsibility and authority, and ask them to develop a
design review procedure.
- Develop
a design review procedure. This
procedure should be carried out at the end of each phase
of the product development process.
- Perform
a market-readiness review. Before you begin full-scale
production, make sure everyone is ready to bring the
product to market.
- Control
design changes. Develop and document procedures to
control changes in product and process design.
- Re-evaluate
products and processes. Develop procedures to periodically
re-evaluate your products and processes.
- Authorize
commercial production. Ask your senior management to
review all documents that discuss the proposed product
and its manufacturing process and give formal approval to
proceed with commercial production.
- Control
purchasing.
Develop
a quality purchasing program to plan and manage
procurement activities and to control purchasing
documents.
- Control
subcontractors. Control their selection and
supervision.
- Control
selection of subcontractors. Develop procedures
to
evaluate and select your suppliers and
subcontractors.
- Control
communication with subcontractors. Develop a
subcontractor feedback system.
- Develop
quality assurance agreements. Develop formal quality
assurance agreements with your subcontractors and
suppliers. ISO 9004-1 has already
discussed quality assurance agreements. So if you wish to
see more detail, please click ISO 9004-1.
- Control
incoming materials and supplies. Develop procedures to
receive, inspect, and control incoming products.
- Control
production process. Your production process must
operate under controlled conditions. You must control
your raw materials, supplies, tools, equipment, and
instruments. And you must control your process and
environmental variables.
- Develop
process control procedures. Develop procedures to
control every aspect of your production process.
- Control
processed materials. Develop methods and procedures to
control the quality of processed materials during the
process of production.
- Verify
final products. Develop methods and procedures to
verify the quality of final products. Inspect and test
final products.
- Control
measurement process. Develop procedures to control
measurement methods, standards, equipment, and records.
- Develop
a record keeping system. Develop a quality record keeping
system. This system should identify, collect, index,
file, store, and maintain quality system information.
- Control
nonconforming products. Develop methods and procedures to
manage and control nonconforming products.
- Correct
or prevent product nonconformities. Develop procedures to
correct or prevent nonconformities.
- Develop
product handling, storage, and transportation procedures.
Develop
and document procedures to handle, store, identify,
package, and transport processed materials.
- Develop
customer support programs.
- Develop an
after-sales service program to advise customers
on how to handle and use your products.
- Develop a
customer feedback system in order to collect
customer complaints, track product failures,
initiate corrective actions, and encourage design
re-evaluations.
- Control
documents and data. Develop procedures to control the:
- Revision of
quality system documents.
- Use of
quality system documents and data.
- Removal and
disposition of old documents and data.
- Develop
training and awareness programs. Develop:
- An executive
training and awareness program to teach all
senior executives about the quality system,
including how it should be managed, monitored,
and evaluated.
- A personnel
training program that covers all aspects of your
quality system. Ensure that all workers know how
to do their jobs, and ensure that all workers
understand how they contribute to quality.
- A quality
awareness program to motivate all personnel to do
their best and to make everyone aware of why
quality is important.
- Develop
a quality recognition program. Develop a quality job
recognition program to identify, recognize, and reward
individual and collective quality achievements and
improvements.
- Develop
a risk control program. Develop a program that will maximize
product safety and minimize product liability.
- Monitor
quality system effectiveness. Develop a statistical
methods program whose purpose is to measure, monitor, and
analyze the effectiveness of your quality system.
Related Publications |
If you would like to purchase a complete
and detailed
version of
ISO 9004-3 Guidelines Translated
into Plain English, please consider
the following options. Notice that ISO 9004-3 is part of
Titles 5, 7, and 9. |
Title 7: ISO 9000
Translated into Plain English |
Title 7
covers ISO 9000(1-2-3-4), ISO 9001, ISO 9002, ISO 9003,
ISO 9004(1-2-3-4), ISO 10011(1-2-3), and ISO
10013 |
I want to order Title 7 |
I want to see ISO 9001, ISO 9002,
ISO 9003 before I order
I want to
see ISO 9000, ISO 9004, ISO 10011, and ISO 10013 before I
order |
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