B
Bob_M
OK I've posted, read, and searched about design process/procedure before on the cove.
I'm trying to create a simple process / procedure / form that will cover the ISO requirements without creating to much paper work (like current system) and I'm getting stuck...
While working on THIS area I've been reading and re-reading the standard, samples, posts, and our own 1994 style forms, and I'm getting more lost and confused by the minute. (Manual is due 7/28/03 and Design procedure is past due in boss's eyes).
To start: Small company - metal stamping and spot welding, I'm Quality and Engineering, most designs are customer owned and controlled, we typically DON'T design anything from scratch, we may provide input to customers to assist them in updating THEIR design. We occasionally will modify some internal sub-component and have typically MANAGED that via an ECN (Engineering Change Control), Registar recommened that we NOT exclude design.
I'm just going to post MY understanding of the standard and please point my in the correct direction if I'm wrong...
7.3.1 Planning
If we have a "design" project, we should PLAN on how we will Manage the project (responsibilities, timing, reviews, etc). Rather straightfoward. I suppose this is simple enough if you do it on a regular basis. The form I'm working on has a Team Member Section and "Planning" section.
7.3.2 Inputs
We have to identify and record our inputs. OK we document and record/retain our ideas/drawings/suggestions/etc that are the driving force behind the design. No Big deal, we DOCUMENT our input whatever form it may be...
7.3.3 Outputs
We have to make sure out outputs meets our input requirements...
A simple example I understand is: The drawing created (output) must match the designs inputs and requirements. What if the input is a drawing?
7.3.4 Review
Now someone has to REVIEW the output, and document that they believe it matches the input. Seems simple but this is the start of my confusion... What if the person providing the input is also creating the output, reviewing, verifying, validating, changing etc... (seems like a waste of time/paperwork).
7.3.5 Verification
Now someone has to VERIFY the output and Document that they have VERIFIED it... Didn't we just do that during review? Is this typically verfication of a physical sample? If not it just seems like a repeat of review.
7.3.6 Validation
Now someone has to VALIDATE what has been reviewed and Document it... How many times do you need to recheck input vs. output (on a simple design)?????
I guess I'm confused about Review vs. Verification vs. Validation, and past posts reading has not clarified it enough for me...
7.3.7 Change
Ok I get this one, if they design changes, we need to redo all the reviewing, verifing and validating...
We have a seperate Engineering Change PROCEDURE that technically incorporates "designs" that are already in production.
Any guidance or additional tips/examples/suggestions are welcome.
Like I stated the harder I work on this the more confused I get. This is partly due to not having a "functional" design process even though we were certified to 1994:9001, also we haven't "designed" anything our self since BEFORE our certifcation to 1994.
I'm not as "freaked" out about handing NEW PRODUCT introduction and minor internal changes. I suppose those should/do fall under the "design" umbrella, but we've never really treated them like it...
Well thanks for any help.
If my rambling is totally confusing, we its the stress and deadlines fogging my mind.
Thanks Bob M
I'm trying to create a simple process / procedure / form that will cover the ISO requirements without creating to much paper work (like current system) and I'm getting stuck...
While working on THIS area I've been reading and re-reading the standard, samples, posts, and our own 1994 style forms, and I'm getting more lost and confused by the minute. (Manual is due 7/28/03 and Design procedure is past due in boss's eyes).
To start: Small company - metal stamping and spot welding, I'm Quality and Engineering, most designs are customer owned and controlled, we typically DON'T design anything from scratch, we may provide input to customers to assist them in updating THEIR design. We occasionally will modify some internal sub-component and have typically MANAGED that via an ECN (Engineering Change Control), Registar recommened that we NOT exclude design.
I'm just going to post MY understanding of the standard and please point my in the correct direction if I'm wrong...
7.3.1 Planning
If we have a "design" project, we should PLAN on how we will Manage the project (responsibilities, timing, reviews, etc). Rather straightfoward. I suppose this is simple enough if you do it on a regular basis. The form I'm working on has a Team Member Section and "Planning" section.
7.3.2 Inputs
We have to identify and record our inputs. OK we document and record/retain our ideas/drawings/suggestions/etc that are the driving force behind the design. No Big deal, we DOCUMENT our input whatever form it may be...
7.3.3 Outputs
We have to make sure out outputs meets our input requirements...
A simple example I understand is: The drawing created (output) must match the designs inputs and requirements. What if the input is a drawing?
7.3.4 Review
Now someone has to REVIEW the output, and document that they believe it matches the input. Seems simple but this is the start of my confusion... What if the person providing the input is also creating the output, reviewing, verifying, validating, changing etc... (seems like a waste of time/paperwork).
7.3.5 Verification
Now someone has to VERIFY the output and Document that they have VERIFIED it... Didn't we just do that during review? Is this typically verfication of a physical sample? If not it just seems like a repeat of review.
7.3.6 Validation
Now someone has to VALIDATE what has been reviewed and Document it... How many times do you need to recheck input vs. output (on a simple design)?????
I guess I'm confused about Review vs. Verification vs. Validation, and past posts reading has not clarified it enough for me...
7.3.7 Change
Ok I get this one, if they design changes, we need to redo all the reviewing, verifing and validating...
We have a seperate Engineering Change PROCEDURE that technically incorporates "designs" that are already in production.
Any guidance or additional tips/examples/suggestions are welcome.
Like I stated the harder I work on this the more confused I get. This is partly due to not having a "functional" design process even though we were certified to 1994:9001, also we haven't "designed" anything our self since BEFORE our certifcation to 1994.
I'm not as "freaked" out about handing NEW PRODUCT introduction and minor internal changes. I suppose those should/do fall under the "design" umbrella, but we've never really treated them like it...
Well thanks for any help.
If my rambling is totally confusing, we its the stress and deadlines fogging my mind.
Thanks Bob M