AS9100 Clause 7.3.3 - Design and Developement Requirements d and e

[bigbirdy]

All,
We are preparing for our AS9100C transition audit and I wonder if you can help me with the intent of section 7.3.3 Design and development output requirements d) specify the characteristics of the product that are essential for its safe and proper use , and e.) specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items.

Does this section implies the requirements d and e be included in print (drawing)? Or in other output of design and development like Specification, Work order task information and test plan.?How can we satisfy these two requirements?​

Our company designs and manufacture products. ​

Thanks

 

[Big Jim]

How do you handle the rest of 7.3.3? Don't forget that this is an element that requires maintaining records.

As you are gathering requirements (inputs), you need to allow for both of these topics. In both cases you may find them with customer documents (prints for example), or they may be things that you have determined are necessary. Look for what the customer says first.

 

[bigbirdy]

Big Jim, Thank you for the reply!

We keep all the records of all the Designs and changes. We have a CM system in place. For purchasing we have a set of QR requirements that we flowdown to the suppliers and to the 2nd tiers. We also have Work Orders that spells out the task to be done on each operations and Workmanship standards for pass-fail criteria.

I am confused where we should specify the critical items in our process? Is it in the print since it is in section 7.3.3. (Usual output of design and development besides the specification and acceptance criteria).

Any advise how to satisfy these requirements? What is the best approached to comply with these requiremetns. Thanks

 

[Big Jim]

First of all, let me correct myself. 7.3.3 does not have a requirement to maintain records. Of the seven topics in design, five require keeping records. The two that don't, 7.3.1 and 7.3.3, are topics for which you are likely to keep records anyway.

The main output for design (7.3.3) is usually drawings. You may have recognized the need for critical items / key characteristics (and things that are necessary for safe and proper use) from the inputs, which often come directly from your customer. No matter how they are recognized, either flowed from customers or identified internally, once recognized, they need to be accommodated. The accommodation would be at the point of use or interface. Usually on the work order / traveler / router.

In some cases, some of the stuff about safe and proper use, may need to be flowed down to users in the form of operator instructions.

Anyone else should feel free to add their comments.