ISO 9001:2008 Design Control Summary
Design control is a hot button for many product designers that are self-appointed kings of their own domain. ISO is like an invader trying to make engineers document things that were always kept in the engineer’s head. I have worked with many great engineers that produced excellent products but they usually felt that the job was completed when they got the first fully functioning product in the lab. There was never any time to pass on important information about how to build and test the product. Well this is no longer acceptable at an ISO certified company.
The ISO 9001 requirements for design control were create to solve many of the problems that companies have with unsuccessful design project. The standard helps guild companies by making the following requirements:
Define or specify the requirement for the product before starting the project
- Perform design review to confirm that the product will meet the specification
- Use revision control on the specification to
- Perform validation and approval of the product to ensure that it meets the requirements.
- Document the design process
The optimum lean design control procedure is basically a checklist of the documents that are required to meet the “document the design process” portion of the requirement. This checklist should include items to ensure compliance with the other requirement (1 to 4 above). Prior to the 2000 revision of ISO 9001, Design control was a separate standard (9002) that could be ignored by organization with uncontrolled design projects. Now it is an integral part of the standard. The procedure will require the creation of a quality plan. This "quality plan" should be kept in a notebook that is transferred to document control at the end of the project and is maintained in a defined area during the project. The notebook should be taken to every design review and should be used as the basis for driving the project. Since the specification is the heart of the quality plan, all design, review, and testing discussions should revolve around the controlled version of the specification.
The quality plan should include:
- A project authorization with signatures showing that the project is approved and resources are available (capitol and personnel).
- A timeline for the project including proposed design reviews
- A summary of team members with their responsibilities (cross function assignments)
- A revision controlled specification
The design notebook for each project should include the Quality Plan and:
- Records of design review meetings with feedback. Usually I recommend a minimum of 3 design reviews. The preliminary design review
- Verification of the design to the specification
- Validation of the design by appropriate personnel. This can be a version on the specification placed in a spreadsheet with a column for result and signature. Each testable specification should be validated
- Once the product is validated, it can be approved. The approval is documented by having the appropriate signatures for the various team members or management.
Usually I recommend a minimum of 3 official design reviews. There may be more design discussions, they may happen on a weekly basis. Unofficial design reviews or discussions should be logged in the project notes but they do not require roll calls or signatures as part of the process. By separating everyday design discussion (that do not change the specification) from the major design reviews, you will simplify your record keeping. Usually I recommend a minimum of 3 design reviews. The official design reviews include the:
- Preliminary design review for approval of the controlled specification. I call this phase the lock down of the specification to make it clear to marketing that change to the specification will be very difficult after this point.
- Critical design review(s) at key point in the project schedule. Key points are completion of the first design iteration, just before prototypes are made, and just before production staging begins.
- Final design review to confirm that the final product meet the specifications.
When you are done, put these documents in notebook, transfer them to document control and have a party to celebrate the completion of the project.