Product realization is
the ISO 9001 term for product and /
or service provision. ISO 9001 section
7.1 states that: “The organization shall plan and develop the processes needed
for product realization.” A quality plan
involves the following:
- Quality objectives
- Product requirements
- Documented processes
- Resources needed to produce, monitor and test the product
- Required verification, inspection, monitoring and measurement procedures
- Records needed to show that the processes and the resulting product meet requirements
Quality objectives should be consistent with the
organization’s quality objectives.
Product requirements must be consistent with the outputs of the design
process.
Documented production processes are not required,
but it is a good idea to document how the processes that produce the product
interact. A flow chart is a good way to
show how the manufacturing of the product will occur and where the inspection points will be. Documented inspection procedures which
describe the product requirements, the inspection methods and tooling to be
used, and the frequency of inspection assure a consistent inspection process.
Once the production processes are determined, it should be
easy to determine the resources needed to create the product including:
- Manufacturing equipment
- Tooling
- Personnel needed to perform the work and do the inspection
- Inspection equipment and procedures
- Records needed
Inspection records are required. The organization must be able to show that
the product meets requirements, and the way to do this is to record inspection
results. Records should show the
features inspected, the specification for each feature, the values obtained, the
gauge / tool number used to perform the inspection, the inspector, and the date
/ time of inspection. Inspection records
can be a critical input to corrective actions, and analysis of data necessary
for continual improvement.
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