Design and development controls, outputs, and changes (ISO 9001:2015 clause 8.3)
- Design and development control.
To ensure that design and development process will deliver
intended results, certain controls must be implemented at some phases of design
and development process. These controls include regular reviews to evaluate the
results of design and development and determine whether they need inputs
requirements.
For example, at end of each phase of design project, the
manager, or some other member of design development team that responsible for
the phase, can do a review to determine whether the result of the phase meets
the requirements.
Beside review, validation and verification activities must
be conducted at some phases of design and development to determine whether the
outputs meet inputs requirements. If there is a problem during the design and
development, activities should be taken to resolve those problems and the
records of the activities should be retained.
- Design and development outputs.
The 2nd section from clause 8.3 from ISO
9001:2015 required the following criteria that design, and development outputs
must meet:
- The outputs must be adequate for the subsequent process for the provision of product and services.
For example, the design team may send to production
department the drawings in file format is not supported by software used in
production department.
- The outputs must specify the key characteristics of the products and services regarding their intended purpose and safe and proper provision.
All key characteristics must be stated in product or service
specification. Also, all necessary information for the customer should be
defined. Such as the content of instruction Manu.
The design and development outputs must be documented in
design review minutes or some similar form.
- Design and development changes.
Very often there is need for changes during the design and
development. Those changes should be identified, reviewed, and controlled in
order to prevent their adverse effect on conformity to input requirements.
For example, the customer may require change in material to
be used for production to reduce the cost, but the cheaper material may not be
suitable for the intended use of the product.
The design and development changes must be identified and
documented. So, the design team can clearly know what is expected from them.
Also, able to review the changes to determine is it possible to apply them.
Record for this review must be kept because there are necessary for the next
step authorization of changes.
Depending on the results of changes review, the responsible
person will allow changes to be applied or not and the record of authorization
of changes must be kept.