7.3.2 Design and Development Inputs clause - What is the record needed?

J

Jeff Frost

#11
Rooch

ISO 9001 2K Clause 7.3.2 Requires that product requirements are to be determined and records are maintained. As an auditor I look for documented evidence that there are defined design inputs for current and completed projects and that the record contains evidence that these inputs have been reviewed and approved.

Record associated with this clause would be design project files. The files should contain input documents including customer, industry, regulatory and statutory requirements that are applicable. Most organizations then clearly state in a recorded form (letter, form or memo) the concise input requirements related to the product the organization intends to supply. These records must clearly indicate that a review was performed and that the output (inputs into 7.3.3) were approved by the organization.

I good document to use as a reference to the requirements of ISO 9001 is ISO 9004 2K. 9004 is a guideline for process improvement but in many cases it is very useful in clarifying the intent of ISO 9001 clause.

Hope this helps
 
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R

Rooch

#12
Thanks JSW05, my arguement is with the auditor, who was expecting a signoff, that the inputs have been reviewed.
Thanks Jeff, we have a project file with all the things you said you would look for, except I do not sign a form or letter stating the concise input requirments we intend to supply. The input reqirements come from the customer in the forms we have talked about, (bid specs, contracts, industry standards, conveyor specific requirements etc.) what we intend to supply will evolve throughout the design process.
I stand by my interpretation, there is no need for records that the review of the inputs took place, only objective evidence that the review took place.
Perhaps I am wrong :(

Have a great day!
 
T

Tanahy

#13
Hey Rooch,
I see the best useful answer was Jeff's one, I am still in these discussions with my consultants trying to figure out how will we handle this issue, well, I know one good thing, as they all say, you pay the auditor to come audit you, so you should ask the auditor himself, (what do you suggest?) and compare this to Jeff's answer and see if it works with you, one more thing I wanna add, we all learn and will always be learning, but also ... AUDITORS ARE NOT GODS.... so smile and it will go fine. I wish you best of luck....
and by the way, JSW05, for god sake, I got scared from your answer, were you trying to be useful? I think we post here to help, it frustrates me when I see someone answering saying " I AM AFRAID I CANT HELP YOU" or someone does like what you did " start throwing words like you are playing games and makes the man feel like he is mistaking asking "
THERE IS NO STUPID QUESTION, THERE IS ONLY STUPID ANSWERS. I see your Karma is high... I hope i am not very rude saying that, but I really hope that we all try to be useful for each others..
thanks everyone, and Rooch, please let me know how did it go.
Laters
 

RoxaneB

Super Moderator
Super Moderator
#14
Rooch, this may sound naive of me, but what do you have against signing the review? You asked for our opinion and the majority of us appear to feel that the auditor's finding is valid.

Rooch said:
evidence? That is a lot different than a record!
How so? What else is a record other than the means to demonstrate (i.e., provide evidence) that the formalized process is adhered to?

Rooch said:
How else would I be able to supply the customer what he wants if there is no review of inputs. How would I determine verification points to check like, speed, lift height, paint color,etc (design output has met design input), or validation results.
The evidence abounds that inputs have been reviewed for adequecy, but the finding I received states that I have no record of the review of these inputs.
Okay, you reviewed them. I'll agree with that. However your review does not guarantee that the Customer will get what s/he ordered (i.e., a review for adequacy was not done). A list of inputs is compiled. These specifications go to Manufacturing. Who verifies that the specifications are correct? How does Manufacturing know that this is the proper list of specifications?

Regarding interpretation, if you wish to receive an official response to your question, I believe TC 176 has a website where you can post a yes/no question regarding interpretations of ISO 9001:2000. Perhaps if one of the other Cove members knows this site, they would be kind enough to insert a link.
 
Last edited:

Jim Wynne

Staff member
Admin
#15
Tanahy said:
JSW05, for god sake, I got scared from your answer, were you trying to be useful? I think we post here to help, it frustrates me when I see someone answering saying " I AM AFRAID I CANT HELP YOU" or someone does like what you did " start throwing words like you are playing games and makes the man feel like he is mistaking asking "THERE IS NO STUPID QUESTION, THERE IS ONLY STUPID ANSWERS. I see your Karma is high... I hope i am not very rude saying that, but I really hope that we all try to be useful for each others..
Had you read through the posts you would have noticed that I offered my apologies and they were apparently accepted. If my response scared you, you must live in constant fear, so I'm afraid I can't help you in that regard.
 
J

Jeff Frost

#16
Rooch

Do your records contains evidence that these inputs have been reviewed before moving on to 7.3.3 in the Design and Development process. If there is not a formal approval by your organization then you are up the audit creek without a paddle and nonconformity finding is valid even if you are using the customer documents.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#17
Very interesting discussion. I want to add my 2 cents. For those who want to disregard the INTENT of 7.3.2 and stick to the cold text of the paragraph, the standard allows for the records to be comprised of the specs, blueprints, etc… without evidence of review and approval, as I read it.
So, I definitely see Rooch’s side. Further, for those who insist that a signature/approval page is required, let’s not forget that, like Rooch already mentioned, numerous times, during the actual design development phase, AFTER the initial review required in 7.3.2 the product specification changes continuously. Sometimes, due to customer re-defining the requirements; other times because requirements that were not considering conflicting early on, are found to be so, later.
And for those of us, who have audited project folders, trying to figure out if the communication between supplier and customer clearly shows what has been agreed to, at the end, can be a daunting task.

I personally side with Rooch’s perspective on this issue. My impression is that he sees no added value in creating an artificial “check sheet, duly signed” that would be deemed as the record of the input review, for his organization. And I can see 7.3.2 allowing for this. Once again, I know that there are many covers that do not like the idea of auditing to the intent of the standard, but imo that is the ONLY way to audit a system.
 

Al Rosen

Staff member
Super Moderator
#18
Ask and ye shall receive. TC 176 Interpretations

BTW, sometimes it's easier to go with the flow. There's no need for a separate check sheet. Describe the review process in your SOP, including provisions for the reviewer to initial the document and maintain it in the file. Initialing the document doesn't take much effort or time. Besides, it's more important to get what you want than to be right.
 
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