Design and Development Review 7.3.4 - Planned intervals for outputs and validation

H

Hoosierken

#1
Our Auditor recently gave us a corrective action regarding 7.3.4 because he said we could not show that design reviews occurred at planned intervals for outputs and test validation.

We manufacture large electric motors. The design plan is well written, drawings and specifications are asigned to each department. Each department has "checkoff" forms to validate their manufacturing duties with tolerances.

The forms end up back in the design/Engineering department where our engineers compile, review and finalize the design review form. They validate all outputs.

The auditor is telling us that our system needs a "Formal" system of review at planned intervals. We thought we were in a continuous system of review and that it would suffice. I'm not thoroughly clear on this.

What would adequately satisfy this auditor while not completely creating an entire new monster to take care of?

thanks
Ken
 
Elsmar Forum Sponsor
#2
Hoosierken said:
The design plan is well written,
When you say "design plan" does that include the project schedule?

We just denote our design review activities on the project schedule and conducted them accordingly. They are planned in relation to other pertinent project milestones. If the review is "planned forward" for some reason, we revise the schedule.

The only issues we have had (from an audit standpoint)are due to reviews not being conducted according to schedule and the proper records not being generated/maintained.
 
#3
Hoosierken said:
The auditor is telling us that our system needs a "Formal" system of review at planned intervals.
The question is a matter of definition. Are the words "formal" and "systematic" the same? I would argue they are not. There are four parts to the requirements.

1) Are the reviews occuring at suitable stages?
2) Are they performed in according to planned arrangements? (Depending on your "planned arrangements", you might have an issue here)
3) Do they meet the requirements of a) and b)?
4) Do they involves the appropriate folks?

Based on the information you provided, I can see questions with questions 2 and 3 above. However, a "formal" review might still not answer the questions. In the old days, a formal review was required. It almost sounds like the auditor might be stuck in the previous century.
 
M

mitsu11

#4
Other Departments' Interaction?

It sounds to me as though the other departments are simply verifying that they can or cannot meet the design requirements; nothing more (i.e. "specifications are assigned"). As DB mentioned, 7.3.4(a) and (b) are important here. How do the other departments help you:
"(a) to evaluate the ability of the results of design and development to meet requirements, and
(b) to identify any problems and propose necessary actions"?

You do not indicate a meeting where engineering discusses the plan with manufacturing, purchasing, quality, etc., and asks what they think of the plan. "Do these tolerances seem reasonable? Is this the best tool to use? Could you outsource this, or must we build it in-house? What kind of problems will we run into? Can you think of a better way?"

I think that "formal" is a misnomer, though. Formal, to me, simply means that the meeting is recorded. If you can discuss the whole thing during lunch with your production manager, that might be a formal review, so long as you write it down afterward, and he is "THE GUY" to talk to.
 
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