From: ISO Standards Discussion [email protected]
Date: Wed, 5 Jan 2000 09:32:53 -0600
Subject: Re: Doc and Aud of the 'R & D' Effort /Guinan/Kozenko
From: [email protected]
> At present, we have little documentation on the objectives, budgets, plans,
> processes, etc. of this 'Research and Development' effort. What will be the
> impact of this on our proposed ISO 9001 compliance registration? What should
> be done about the documentation and internal auditing of this effort?
> Alternatively, is it possible to continue with this effort in this manner?
Roger:
Read your Articles of Incorporation, which state in very broad terms what your business can do legally and "by plan." They probably say something equivalent to this: "... anything that shows it makes the firm money."
Apply that "learned perspective" to your quality planning right now, and leave the door open to authorized individuals who can make "seat of the pants" decisions on what to do in the day to day grind, to make money for the firm. I'd also recommend stating in your quality planning docs. that your firm will review the quality plans twice a year (pick a number) as the firm grows, so that such plans can be revised to fit the future unknown circumstances with appropriate business acumen.
The education, experience and training of authorized person(s) should demonstrate that they are indeed capable of "steering the ship."
I'd also recommend placing Return on Investment into the individual R & D projects, so that over time you know what works best, what doesn't work at all, and to some degree, what makes it fall somewhere in between. The "acceptance criteria" and the procedure for auditing the R & D efforts should be documented, and changed as often as necessary so that practice and procedure continually match. That way, you'll pass any audit (Certification or Surveillance).
I'd predict that as you nailed down the R & D metrics, everyone in the company would fall in line with expectations, become results oriented, and probably even know when to throw in the towel and ditch a non performing R & D before it drains the firm's coffers, all attributable to the firm-wide "in the boat" perspective you should achieve in your continued implementation of ISO9000 to the business operations.
Sounds to me like you're off to a great start. Good luck.
David Kozenko
Date: Wed, 5 Jan 2000 09:32:53 -0600
Subject: Re: Doc and Aud of the 'R & D' Effort /Guinan/Kozenko
From: [email protected]
> At present, we have little documentation on the objectives, budgets, plans,
> processes, etc. of this 'Research and Development' effort. What will be the
> impact of this on our proposed ISO 9001 compliance registration? What should
> be done about the documentation and internal auditing of this effort?
> Alternatively, is it possible to continue with this effort in this manner?
Roger:
Read your Articles of Incorporation, which state in very broad terms what your business can do legally and "by plan." They probably say something equivalent to this: "... anything that shows it makes the firm money."
Apply that "learned perspective" to your quality planning right now, and leave the door open to authorized individuals who can make "seat of the pants" decisions on what to do in the day to day grind, to make money for the firm. I'd also recommend stating in your quality planning docs. that your firm will review the quality plans twice a year (pick a number) as the firm grows, so that such plans can be revised to fit the future unknown circumstances with appropriate business acumen.
The education, experience and training of authorized person(s) should demonstrate that they are indeed capable of "steering the ship."
I'd also recommend placing Return on Investment into the individual R & D projects, so that over time you know what works best, what doesn't work at all, and to some degree, what makes it fall somewhere in between. The "acceptance criteria" and the procedure for auditing the R & D efforts should be documented, and changed as often as necessary so that practice and procedure continually match. That way, you'll pass any audit (Certification or Surveillance).
I'd predict that as you nailed down the R & D metrics, everyone in the company would fall in line with expectations, become results oriented, and probably even know when to throw in the towel and ditch a non performing R & D before it drains the firm's coffers, all attributable to the firm-wide "in the boat" perspective you should achieve in your continued implementation of ISO9000 to the business operations.
Sounds to me like you're off to a great start. Good luck.
David Kozenko