In Reply to Parent Post by dwend
Greeting to all:
We have just finished our stage 2 to 9100C and got a minor NCR for failing to establish Design and Development effectiveness metrics. We are a small company dealing mostly in legacy products but have one production line where we take in 2 or 3 development projects per year. One of the suggestions internally was to create a "self assessment survey" to be completed after each project or during key phases as associated with 7.3.4. I am concerned that there may be too much "opinion" given with this approach but we do not have much "data" to work with so this may have to do. I am wondering if someone else has had a PEAR completed on D and D and what was used as measures of effectiveness particularly with a small operation in mind. Thanks in advance.....
The size of the operation has little or nothing to do with the effectiveness of the process! It's often an excuse given, but I've never found a good example to justify it!
The effectiveness of any design and development process can be seen in process and down stream, once the design is released to production.
In process can be the successful exit from design reviews (V & V). When in development at one company I worked, if there was more than 2 iterations of a development product in the engineering model phase, program management lost their jobs! The closer to market they got, the higher the stakes! Those measures were linked to time and costs, of course.
Also, once released into production, the number of rejects flagged and engineering changes issued from manufacturing or suppliers is also a tel-tale sign. You can measure 'FTC' in the first 30 days of production. FTC - first time capability or FTT - first time through. If design and development have a robust process and did their job, this should be fairly high - 80% or better...