Ever say, “What idiot designed this? Did they never consider…….”

Consider these:

A NASA orbiter was lost when no one picked up the fact that Lockheed Martin was using English units of measure while NASA used metric. Cost was $125,000,000.

The Washington State Department for Transportation had to may tens of millions of dollars to fix and change Highway 520 Bridge due to design errors

A $60,000,000 stadium in Allan, TX cannot open due to design flaws which caused inch wide cracks in the concrete concourse.

There is lot to consider when designing and we all have desire to “just do it”. But a rushed, haphazard design can bite, and bite hard.

A methodical approach pays off in the long run.

ISO 9001:2008 spends considerable time on Design and Development. If Design is one of your company’s offerings, so should you.

Today’s blog will take a look at 7.3.1 through 7.3.3 Planning, Input and Outputs.

Planning:

As with all aspects of your business, ISO 9001 requires you to plan and control the design and development of your product. Specifically, you are required to:

· Determine the design and development stages

· Ensure that the review, verification and validation (more on this in the next blog) are appropriate to each stage

· Define responsibility and authority

· Manage group interfaces and communication

Inputs:

Inputs go beyond that design on the napkin. They must be complete, unambiguous not in conflict with each other. They include:

· Functional and performance criteria.

o Pen3000 must be able to write for 1000 m in a temperature range of -15°F to 150°F.

o Pen3000 must write immediately after being “open” of 24 hours.

· Applicable statutory and regulatory requirements

o TSCA

o Meet ISO 12756 requirements

· Information derived from previous similar designs

o Design , manufacture and complaint history for Pen2500

Outputs:

The outputs must be able to be verified against the inputs. Really, how else would you be sure that your design is adequate?

Design is only a step along the way to customer satisfaction and profit. These outputs must be used by others. Therefore the standard requires that the outputs shall:

· Meet the input requirements

· Provide appropriate information for purchasing, productions and service provision

o Material specifications

o Final Product specifications

· Contain or reference product acceptance criteria

o Raw Materials

o In Process

o Final Product

· Specify characteristics that are essential for safe and proper use.

This may seem strict and a bit daunting. Don't be scared off. Your process does not have to be cumbersome, just methodical.

We’ll review the remainder of the Design and Development clause the next time.

As always, we’re here to help with any of your Quality System needs.

Be well,

DonnaLynn

ISO 7.3 Design and Development Part 1