Design and Development Changes

CONTROL OF DESIGN AND DEVELOPMENT CHANGES Clause — 4.4.9 Revision 0 ISO 9001 1994 ... 

Design and development changes are identified, and records are maintained. The changes are reviewed, verified, and validated as appropriate and are approved before implementation. The review of design and development changes includes evaluation of the effect of the changes on constituent parts and the delivered product. 

Q9001-2000, Section 13.1, is titled Control of Design and Development Changes. It reads as follows ... 

You should prepare a design and development plan for each new design and also for any modification of an existing design that radically changes the performance of the... 

Design and Development (Design Plans, Inputs, Outputs, Reviews, Verification, Validation and Change)... 

The design and development of kinematic mounts is a rich and complex field, but we only introduce the subject and its basic ideas here. When dealing with optics, stress-free mounts are often essential in order to avoid distorting the optic. Possible disturbances that must be considered include changes in gravity vector and changes in the thermal environment. 

A HAZOP is performed on all new chemicals following process review, preliminary equipment review, and development of preliminary standard operating procedures (SOP). What-if and checklists are typically used to review a process without process design and chemistry changes. 

The design and development processes are systematically reviewed to ascertain that the progress goes as planned. Any problems and opportunities for improvement are identified and necessary action is taken and any changes are controlled. 

Records of both verification and validation and review of changes of the design and development and any necessaiy action shall be maintained. 

As far as possible, systems existing in a production mode prior to the effective date of the GALP standards, as well as purchased systems, should be docmnented in the same way as systems developed in accordance with the EPA System Design and Development Guidance and Section 7.9.2 of the GALPs. Documentation relevant to certain phases of the system fife cycle, such as validation, change control, acceptance testing, and maintenance, should be similar for all systems. 

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