This procedure makes compliance easy by give a list of exactly what should be generated and maintain as a quality record for each and every design project. Once you have created a few notebooks, it will become natural to create and maintain design notebooks for every project.

1. PURPOSE

The purpose of this procedure is to define the requirement for design control.

2. SCOPE

This procedure applies to all company personnel who are responsible for planning, development, use, and maintenance of the quality management system (QMS) at ACME, Inc.

3. DEFINITIONS

None

4. REFERENCES

4.1 Quality Manual.

4.2 Inventory Control Procedure

5. ASSOCIATED DOCUMENTS

Design Control Notebooks (kept in document control after project completion)

6. PROCEDURE

The engineering department manages all design projects. The initiation of each project requires a:

  • Authorization
  • Project plan
  • Definition of resources and all organizational and technical interfaces.
  • Specification
  • Test or acceptance plan The result of the project shall be a:
  • Product design that meets the specification
  • Product documentation set (BOMs, drawings and procedures)
  • Record set of the development (maintained in a design notebook)

If new manufacturers are required for the new product, then the QA department must certify the new vendor before they can be used for production. This is done in compliance with the inventory control procedure.

6.1 Project Notebooks

As part of each project, a design notebook shall be created and maintained. For all intrinsically safe products, this notebook shall included the following minimum requirements:

  • Evidence of project authorization
  • Project plan with timeline showing key events
  • Definition of organizational and technical interfaces including the responsibility and authority for all critical tasks.
  • Design input (product specifications)
  • Design output (document and part specifications or reference to location where files are kept)
  • Evidence of design reviews and approvals The minimum requirement is a:
    •  Preliminary design review approving the specification
    • Critical design reviews before prototypes are made
    • Critical design review to confirm that the product meet the specifications.
  • Evidence of Design verification and validation. This should include test results showing performance testing, as the customer will use the product.
  • History of changes to the design and specification In addition the design notebook may contain:
  • Critical communications
  • Details about critical design elements
  • Design backup documentation

After the project is completed, the design notebook shall be kept in document control for future reference.