posted 03 August 1998 09:28 AM               

Marc Smith
07-29-98
09:47 AM
Design Control
bbs@Elsmar.com
That's one way of doing it. You might want to take a look at a simple example of a 'plan' in Excel - Well, I posted it as a pdf file). It is a general plan which lists responsibilities across the top, but you could replace the responsibilities with dates and - Voila!

A Simple Sample APQP Matrix

I've seen it done in project programs like MSProject.

The topics you listed are typically encompassed in your plan. For example, you put in Design Review - of which there are typically several.

Don Winton
07-29-98
08:19 PM
Design Control
*** Dead Link Removed ***
Monica,

That is a good way of doing it, which is very well planned out. I would suggest, however that you refer to 21 CFR 820.30(b) which states, in part, "Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for the implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated and approved as design and development evolves. Also refer to the "Small Business Compliance Guide" and the preamble to the final rule.

The key here is phrase is "plans shall identify and describe the interfaces with different groups." Which, by the way, is excluded from your list. Be sure that your matrix (very good, again, by the way) includes these, either in the plan or otherwise by objective evidence. Remember, to be in compliance with ISO 9001 is not the same as being in compliance with 21 CFR 820 or vise versa. By e-mail, I am forwarding some documents that may be of some use. Use as you see fit, and you may want to try www.fda.gov/cdrh for additional info.