The planning of product realization process defines the following controls, as appropriate to the product:
This output of this process is often called a product quality plan.
The plan should be generated collectively by the Design, Engineering and Quality Functions. The resulting plan may be a one-off, project-specific plan or more general documentation.
The plans may be defined in associated production/service documents such as process flowcharts, control plans, operator/installation instructions or process validation reports.
Planning also leads into the following areas of product realization (doing the job):
Some exclusions from the standard are permitted but they are limited to Section 7 Product Realization.
Exclusions are only permitted where an element of Section 7 is genuinely not relevant to the company but, to be honest, most of Section 7 will probably apply to your organisation, since it’s likely that:
In the event that an excludable requirement is present, the quality manual should clearly define which requirements have been excluded with detailed justification for their omission.
Excluded requirements must not:
It is not a mandatory requirement to document your planning of product realisation process. However, you should always look to adequately define and control any operational processes that directly impact upon product quality. Therefore, the implementation of a planning of product realization procedure will be appropriate to many businesses.
Develop and implement a procedure that defines:
The approach that service organisations take to planning of product realization activities might be different to the approach taken by manufacturing organisations.
We provide a template for the operational procedure '7.1 Product Realization and Planning' to help you document this process in many of our ISO Templates.
The effectiveness of the planning of product realization process might be determined by reviewing the subsequent process outputs to ensure they correspond with the initial product requirement inputs.