Trying to get my head around 7.3 Design and development. What is the criteria for design and therefore a design review? At my company we generally have two types of projects that go through our engineering department. First, customer has an idea and we design something from scratch based on customer's desires/needs etc. I have no doubt that this will require design review. The second type of work is the customer has already designed the product, and our engineering team reviews the customer drawing to determine whether it gives enough information for the shop to build. If it is, the customer's drawing (controlled) goes to the floor. If not, we would create shop drawings from the customer's supplied drawings to convey information the shop needs. Question - is the second type actual design? If not, does it need to go through design reviews etc as indicated in ISO9001:2000 7.3

Thanks

Boubacar

From what you describe, the second scenario is not design - the customer's already done it! What you are doing is described very well in 7.2 of the ISO 9001 requirements, you are "determining the requirements relating to the product", to ensure you have a good shot at making it correctly!
:2cents:

What you describe sounds like a design review to me! You have a business process that takes an input (customer design), you review it to determine manufacturability, and if so, it goes to the floor. If you document this review, I believe you've met the "review spirit" for your process. I think the key is that you describe (allow) this model in your process documents.

What happens in the case that you have to do a transformation (create shop drawings)? Do you review these with the customer? Do you conduct an internal review? These, too, would meet the review spirit, I believe.

From what you describe, the second scenario is not design - the customer's already done it! What you are doing is described very well in 7.2 of the ISO 9001 requirements, you are "determining the requirements relating to the product", to ensure you have a good shot at making it correctly!
:2cents:

Yes. It's more a matter of contract review than design review.

What you describe sounds like a design review to me! You have a business process that takes an input (customer design), you review it to determine manufacturability, and if so, it goes to the floor. If you document this review, I believe you've met the "review spirit" for your process. I think the key is that you describe (allow) this model in your process documents.

What happens in the case that you have to do a transformation (create shop drawings)? Do you review these with the customer? Do you conduct an internal review? These, too, would meet the review spirit, I believe.

What you say is correct, IMHO, however two vital points need to be brought out - one, who 'owns' the design (sanctions changes etc.)? Two, is since the customer does, this is more a feasibility review or 'process design' review.

Neither are, however, product design reviews per the intent of ISO 9001:2000 7.3.........

Trying to get my head around 7.3 Design and development. What is the criteria for design and therefore a design review? At my company we generally have two types of projects that go through our engineering department. First, customer has an idea and we design something from scratch based on customer's desires/needs etc. I have no doubt that this will require design review. The second type of work is the customer has already designed the product, and our engineering team reviews the customer drawing to determine whether it gives enough information for the shop to build. If it is, the customer's drawing (controlled) goes to the floor. If not, we would create shop drawings from the customer's supplied drawings to convey information the shop needs. Question - is the second type actual design? If not, does it need to go through design reviews etc as indicated in ISO9001:2000 7.3

Thanks

Boubacar


Hello Boubacar,

My Fellow Covers provided excellent information regarding 7.3.

Here is some information (http://isotc.iso.org/livelink/livelink/5308362/APG-Design_Development.doc?func=doc.Fetch&nodeid=5308362) about Design and Development from an auditing perspective.

Your post was not about audits, but this information may be of help to clarify.

Stijloor.

I may be "off-forum" here, but 21 CFR Part 820.30 does not prescribe the actual frequency or timing of design reviews. In my experience, FDA, as a minimum, would expect a design review prior to the design transfer stage. Practically speaking, they will likely opccur at several phases in the design process but no, FDA does not indicate when/where they need to occur. This should be established in the design plan.

Typically, product designs are reviewed and the timing is (most effectively) associated with some other key development milestone(s), like the results of testing, 1st production run off, customer initial feedback, etc.

These are often also linked with project reviews (which can be confused with design reviews) but are more about time/money etc. that a critical review of the design's ability to meet requirements.