Design Control Necessary - Specification development company

I work for a specification development company that is in the process of adapting an existing reusable device to single-use-only. Our QSR and ISO consultant insists that we can delete the design control portion from our quality system without fear of being dinged by the FDA or auditors, because the "design" is already done. I maintain that although the application and operating principle of the device is unchanged, the changes in materials, construction, and dimensions are design processes, and they have to be considered within the framework of design control.
The product development team is ecstatic to have done with formal design control as this reduces demands on them, but as the designee, I don't want to have to tell them and upper management "I told you so" when we bomb an audit.

[Don Winton]

<FONT COLOR="BLUE"><BLOCKQUOTE>Our QSR and ISO consultant insists that we can delete the design control portion from our quality system without fear of being dinged by the FDA or auditors, because the "design" is already done.</BLOCKQUOTE></FONT>

Your consultant is more ISO than QSR, methinks.

From the QSR:

<FONT COLOR="BLUE"><BLOCKQUOTE>Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.</BLOCKQUOTE></FONT>

This specifically states that procedures are required. Even if you do not design a device, you <FONT COLOR="RED">shall establish and maintain procedures...</FONT>. Even if the procedures state "we do not do this" you must have them.

Also from the QSR [820.30(i)]:

<FONT COLOR="BLUE"><BLOCKQUOTE>Design changes: Each manufacturer shall establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation.</BLOCKQUOTE></FONT>

So, how does the consultant propose to comply with this without the <FONT COLOR="RED">design control portion from our quality system</FONT>.

My suggestion:

Even if you are not designing a device, you should have procedures to dictate what would happen if a device were to be designed (look towards the future). You must have procedures to dictate what would happen if a (your) design were to be changed.

<FONT COLOR="BLUE"><BLOCKQUOTE>I maintain that although the application and operating principle of the device is unchanged, the changes in materials, construction, and dimensions are design processes, and they have to be considered within the framework of design control.</BLOCKQUOTE></FONT>

I agree.

Your consultant may want to consider this when dealing with any compliance issues, especially Government bodies:

<CENTER>"Better to have it and not need it than to need it and not have it."
dWizard</CENTER>

<FONT COLOR="BLUE"><BLOCKQUOTE>The product development team is ecstatic to have done with formal design control...</BLOCKQUOTE></FONT>

They really should cool their jets and read the QSR.

Regards,

Don

[Don Winton]

From the FDA's Small Entity's Compliance Guide:

Section 3, Page 1

<FONT COLOR="RED">...all non-exempt manufacturers including very small manufacturers and manufacturers that design less complex devices or processes are expected (Translated to FDA speak:</FONT> required<FONT COLOR="RED">) to define, document and implement design control procedures and other quality system procedures as called for in the regulation.</FONT>

Regards,

Don