4.4. Design Control

4.4.1. General

This section requires you to maintain documented process for the design of your product that produces the performance characteristics you promise your customers.

  • You must have documented procedures to ensure the designs of your products meet your customer's requirements.

4.4.2. Design and development planning

This design plan must define how the design process will be carried out. It encompasses all levels of staff evolved, their communications, and process paths. The design process must undergo regular and documented management reviews by approved personnel. Those in charge of design control must staff the function with appropriately trained people and equipment.

To accomplish this:

  • You must have a documented plan for every design.
  • This plan must define who is qualified to perform the designs and the qualified resources needed.
  • The plan must be updated at your defined milestones as you evolve the design.

4.4.3. Organizational and technical interfaces

All interfaces between the design and other organizations required to design a product need to be identified, communicated, and reviewed regularly. For example, marketing, sales, manufacturing, legal, and product safety. The information required for the design process from other organizations (input requirements) must also be defined.

Therefore:

  • Your plan should define from whom you must receive information and guidance, as well as the information to be received.

4.4.4. Design input

You must have a defined system to ensure all appropriate design requirements are received by the design group. This includes all customer regulatory requirements. A listing of specifications and unique characteristics of the product must be maintained. The design group must actively communicate, detail, and resolve inconsistencies in the product requirements.

This effort is designed to:

  • Ensure your designs meet all applicable regulatory agency requirements and provide supporting documentation.
  • Resolve design ambiguities with the input source.
  • Ensure your design input plans and reviews document the customer contract requirements where appropriate.

4.4.5. Design review

You will need to perform design reviews at defined stages of product development. You need to define what is involved at each stage, and who needs to be involved at the particular stage. This means that at some point during, the design, you must invite all those you have identified to approve of the design (4.4.3). Their acceptance must be recorded and maintained.

Therefore:

  • At your defined design review stages, you must have records that show participation by those operations required for the review.
  • The design review must include documented input as well as outputs.

4.4.6. Design output

The output of the design process will include documented drawings, test requirements and tolerance requirements, materials specifications, appropriate assembly instructions, and test methodologies. Design output is to be documented and expressed in terms of requirements, calculations, and analyses. This output will also specifically reference all the appropriate regulatory or association standards and any critical requirements to the design that relate to the safe assembly and operation of the product.

This clause seeks to ensure that:

  • The design characteristics are documented in such a form as they can be verified.
  • The design characteristics meet the design inputs as well as contain acceptance criteria.
  • The design review ensures that unique requirements such as handling, storage, and safe operation are included as part of the output.

4.4.7. Design verification

You will conduct a formal and documented verification of the product design to ensure that all defined criteria are satisfied. This design verification should include qualification testing, comparison with a similar design, or any other calculation that will enable you to ensure that you meet the design requirements. These verification measures will be recorded and retained along with the design verification acceptance.

Design verification specifies that:

  • As your designs evolve, the design must be verified to ensure the inputs are being met prior to release.
  • Designs are verified via tests, calculations, demonstrations, comparisons with previously proven designs, and all methods used have the appropriate supportive documentation.

4.4.8. Design validation

You need to ensure the final product meets the design input, which should be the same as the customer's requirements. This validation should occur in the same environment for which the product is intended. If you have multiple environments and intended uses, it should be tested for all of them. The product must meet the full requirements.

To achieve design validation:

  • The product shall be tested in its expected operating environment following design verification to ensure it meet customer's requirements.

4.4.9. Design changes

The process for making changes to your design should be documented. The routine should essentially meet the same criteria as those for a new design with all the authorized signatures.

When you make a design change:

  • You must have a documented system that accommodates identification of the change, a review by those involved and affected by the change, and show approval by the authorized individuals.