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How to Comply with ISO 9001 Clause 7.3.1 Design and Development planning

R

Rosana

#1
We have a design / development checklist (please see the attachment). My question is how to comply with 7.3.1 “the organization shall plan and control the design and development of product.” “Planning output shall be updated, as appropriate, as the design and development progresses”
Our Engineering Department says that their checklist is enough because they are planning what they are going to do. For them that is a plan. I am not sure if we need to add a date to the plan when we are going to do that. The checklist I attached doesn’t have a place for who is going to do the tasks and when they are going to be completed. Any help would be appreciated!

Rosana :)
 

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#2
Hows that working for you

Rosana said:
We have a design / development checklist (please see the attachment). My question is how to comply with 7.3.1 “the organization shall plan and control the design and development of product.” “Planning output shall be updated, as appropriate, as the design and development progresses”
Our Engineering Department says that their checklist is enough because they are planning what they are going to do. For them that is a plan. I am not sure if we need to add a date to the plan when we are going to do that. The checklist I attached doesn’t have a place for who is going to do the tasks and when they are going to be completed. Any help would be appreciated!

Rosana :)
Hi Rosana

As Dr. Phil would say "Hows that working for you?"

If your programs launch on time, with no issues, and make tons of money, I might just walk away.

If there are significant issues, it might be worth digging into. It sounds to me like Engineering may be "trying you on." If you made airplanes, I'm pretty sure I wouldn't fly in one if that checklist is your total procedure.

It seems almost impossible to me that any reasonable sized project would not include some kind of timeline and status tracking. But I could be wrong.

My advice is forget ISO, talk about what the business needs. Then when you all agree on what you want to do, check to see if you met all ISO requirements, I bet you will have.
 
O

Oriondad

#3
How we did it

We are a design and build house with several (20) new design projects per month. We don't have the time nor the resources to track progress via a gantt chart or the like. We have a list similiar to what you have shown, but much more extensive. Also, we include sales in the process as they are as have some influence in the final design. We get signed approvals, prior to engineering release. Final design verfication comes via final assembly runoff, in our shop.

Here is our procedure:

Order for Contract Review is accepted. Engineering Manager or an appointed representative receives Engineering Jacket from sales department. Engineering Manager reviews job, determines scope of project and schedules job accordingly.

Engineering Manager or an appointed representative assigns job/project to the appropriate Engineer.

Engineer produces a layout based on Customer Requirements.

Engineering Manager or an appointed representative assigns a team to review the Layout. The team performs a design review to verify that the Layout agrees with the Customer Requirements. If it does not agree, then an investigation is done and the team returns to step 3.

If the Layout agrees with the Customer Requirements, then the Layout is sent to the customer for approval.

If not approved by customer, the Layout returns to step 3. If Layout changes are made, the team updates the documents and communicates the changes to all resources. Requested changes are maintained in job folder .

If approved by customer, Engineering Manager or an appointed representative assigns detailing of design to appropriate Engineer.

After detailing, Engineering Manager or an appointed representative assigns final check of design to appropriate Engineer.

• Design, Detail and Check can be performed by one individual as appropriate. Authorization to be given by Engineering Manager based on scope of project and engineers skill level.

The design is released to Manufacturing.

Final Design Validation will be performed per Qualification Runoff Procedure.

Changes to design that occur during or after design verification are logged onto the detail or assembly drawings as revisions.

• Design revision wording to be recorded by engineer. Revisions should be considered a summary of the change being recorded. Resultant updated drawing may reflect inclusive changes (i.e. revision of tightened tolerance may include addition of grind marks or updated GD&T)

Revision logs are located on detail and assembly drawings only. No central log is maintained.
 
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