Dear frined


for company manufacturing of Molding and spare parts


they get the order from customer in two way :

1- design of spare parts needed from customer

0r


2- requirements of customer and then make the design and implement it


i think clause 7.3 is must be apply ( right or wron ?)




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please give example for

1- design input ?


2- design output ? and what meaning of design output



please i hope to get clear answer


thanks

Where do you get the prints you manufacture the parts to? Do you make the prints in-house or does your customer supply them?

no we do the design and sketch as

sample provided from customer

Then you are responsible for design so ISO 9001 Clause 7.3 Design and Development applies.

please can any one advice me as example

for

1- Design input

2- design output

because i can't understand

Here's a start:

Design Inputs (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=design+input)

Design Outputs (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=design+output)

Extended:

Design Inputs (http://www.google.com/custom?domains=Elsmar.com&q=design+inputs&sa=Search&sitesearch=Elsmar.com&client=pub-1385417534940691&forid=1&channel=6124086287&ie=ISO-8859-1&oe=ISO-8859-1&cof=GALT%3A%23008000%3BGL%3A1%3BDIV%3A%23336699%3BVLC%3A663399%3BAH%3Acenter%3BBGC%3AFFFFFF%3BLBGC%3A000099%3BALC%3A000000%3BLC%3A000000%3BT%3A0000FF%3BGFNT%3A0000FF%3BGIMP%3A0000FF%3BLH%3A50%3BLW%3A350%3BL%3Ahttp%3A%2F%2Felsmar.com%2Fpng%2Fheader-G-search.png%3BS%3Ahttp%3A%2F%2FElsmar.com%2FForums%2F%3BFORID%3A1%3B&hl=en)

Design Outputs (http://www.google.com/custom?hl=en&client=pub-1385417534940691&channel=6124086287&cof=FORID%3A1%3BGL%3A1%3BS%3Ahttp%3A%2F%2FElsmar.com%2FForums%2F%3BL%3Ahttp%3A%2F%2Felsmar.com%2Fpng%2Fheader-G-search.png%3BLH%3A50%3BLW%3A350%3BLBGC%3A000099%3BT%3A%230000ff%3BLC%3A%23000000%3BVLC%3A%23663399%3BDIV%3A%23336699%3B&domains=Elsmar.com&ie=ISO-8859-1&oe=ISO-8859-1&q=design+outputs&btnG=Search&sitesearch=Elsmar.com)

Then you are responsible for design so ISO 9001 Clause 7.3 Design and Development applies.
There are hundreds of companies which supply as per sample given by customers and claim exemtion from cl.7.3.
No auditor has NCed them.
V.J.Brahmaiah

we get the sample from the customer and as this sample we make the drawing and the customer approve it and then we start to make it

If they give the company a part and say reproduce this, and that is how the company operates, yes - They can probably get an exclusion.

hi marc

are u mean we apply design in case new product , we didn't have a refrence sample for it

1- design of spare parts needed from customer

2- requirements of customer and then make the design and implement it

IF they give you a part and say "Make this", you can get an exclusion.

we get the sample from the customer and as this sample we make the drawing and the customer approve it and then we start to make it
A sample is the design given by the customer. Donot worry about cl.7.3.
Some consultants may freighten you unnecessarily.
V.J.Brahmaiah

are u mean we apply design in case new product , we didn't have a refrence sample for it You start getting into gray areas here. A new product has to be designed. The question is who is *responsible* for (owns) the design process.

If a customer gives you a part and says "Make This" and you measure it, make prints from it, the customer tells you aspects such as tolerances, you can probably claim that the customer is providing the design (or, at least, is design responsible).

If they come in and say "I want something that does this", but there is no part or print, you would be hard pressed to convince me you were not design responsible.

I guess you could argue that the customer ultimately is design responsible, but in any case you are going to be a design input and a design output (the prints, at the very least) to their design process.

A sample is the design given by the customer. Donot worry about cl.7.3.
Some consultants may freighten you unnecessarily. This really has nothing to do with 'frightening' a company. It has to do entirely with understanding and agreeing who, as in which company, is responsible for ('owns' and controls) the design process, and what role each plays. At the very least, the company that makes the print from the part is a design input and/or output (depending upon how you look at it), even if they are not 'design responsible'.

As I said, if a part is provided (make us copies of this) the company can probably claim exclusion.

thanks marc

but this lead us to another question

when customer give me a sample and ask me to make this

then i make this part how i can validate it ?

i make verification by analysis of certificate or measuring dimension and tollrance


but i didn't know how to make the validate ?

when customer give me a sample and ask me to make this

then i make this part how i can validate it ?

i make verification by analysis of certificate or measuring dimension and tollrance


but i didn't know how to make the validate ? You should be talking to your customer about aspects such as this. Let us say the customer gives you a part to copy and manufacture. And let's say the customer assumes responsibility for the design of the part they are asking you to make prints for and to manufacture. Since they 'own' the design process, I would ask them how they want it validated. I would also make sure they do not have an expectation that you will be responsible for verification of the design.

Remember, design validation is where you test the part to ensure it will work correctly in service. Also remember, there are designs which can only be validated once they are actually in service (elevator cars are an example of where validation is typically done 'in actual use').

*Assuming* the customer is giving you the part to copy and make prints for and then to manufacture, I would be asking them for their verification requirements (if any) and their validation requirements (if any). Again, in this case we are *assuming* the customer is design responsible because they gave you a part to copy and make.

What makes this unique is that if they gave you a part, there should already be prints and other documents related to the design. Why are they wanting you to make prints for the part they give you? Who is making decisions such as tolerancing decisions for the prints? After all, assuming they didn't steal it they got the part somewhere/somehow.

If the sample is 'copied' and only the customer can authorize changes to the specification (material, dimensions etc.) then they (only) are design responsible.

i am so sorry marc i know i ask more question i will list my question in one reply but please answer all of them to didn't disturb you again


1- is it possible that the customer give me a sample and told me to make this ?
but the factory will responsible about the design not the customer ?

and responsibilty to review and verification of design process ?

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2- in the above case where i am responsible for the design i will make the validation ? and how to make this validation ? can validation and verification consuct as one step ( analsis and measuring of specification ?

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3- if we consider the customer is responsible for design and we exclude the clause 7.3 how we treat the matter of getting the sample and make drawings and sketches ?

can we consuct at as product realization as planning and provision of product

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i have a question about design output i will ask about it later

1- is it possible that the customer give me a sample and told me to make this ?
but the factory will responsible about the design not the customer ?

and responsibilty to review and verification of design process ? This depends upon what you and the customer have agreed to. At the very least this should be part of your contract review where terms, conditions and responsibilities (in cases like this) should be agreed upon and stated. It is possible either way.

I would be somewhat suspicious of a company which brought me a part and asked me to make prints for it and to produce it unless they could explain how they got the part to begin with. Again, where did the part they give you come from? Is it an old part that the original prints were lost? How will you know exactly what the material specifications are, and again, as I have said, how do you know what tolerances to use on the print?

2- in the above case where i am responsible for the design i will make the validation ? and how to make this validation ? can validation and verification consuct as one step ( analsis and measuring of specification ? First off, verification and validation are completely different things.

Definition of Verification and Validation (http://elsmar.com/Forums/showthread.php?t=5829)

Again, you will have to ask your customer their expectations. You may not be able to validate the design. Do you know it's function? I this a single piece part, or is it an assembly?

If YOU are design responsible, it is up to you to have a procedure to follow and part of the design process is to determine if, and if so how, validation will be performed.

In my past life, many years ago, I wrote Environmental Design Criteria Test Plans. They are essentially design validation plans. My company was design responsible. For each different product I had to determine what the assembly would be exposed to and from that and other information I would write up a validation plan. But - There are things you have to know, such as where and how it will be used. For example, I was involved in aerospace electronics, so to validate the product I had to write in the test plan many things such as altitude tests, vibration and shock tests (with justifications for the profiles used {e.g.: broadband on sine vibration}), explosive atmosphere, temperature and humidity, MIL-S-901 torpedo shock, etc. I did this by profiling the life cycle of the assembly, mixing in reliability information/data, etc.

So - In short you and the customer have to decide what validation is appropriate for the part but you need information about its use and such. And as I pointed out earlier, there are things which can only be validated 'in use'. The example I gave was an elevator cab. You can give a supplier the design (prints, etc.) and all that, but until it is actually installed in the elevator shaft with all the components working the cab cannot be fully validated. In a case like this a company like Otis sends out prints to several suppliers. Otis is responsible for design (and therefore validation requirements) but the companies which make the cabs just make and ship them.

3- if we consider the customer is responsible for design and we exclude the clause 7.3 how we treat the matter of getting the sample and make drawings and sketches ?

can we consuct at as product realization as planning and provision of product The customer should have a design procedure. They should be telling you what they want and how they want it. If the customer is design responsible it is their responsibility to tell you what is expected from you in the way of design inputs and outputs, including time line, prints and things like that.

As to how to 'getting the sample', are you referring to getting a part, doing the prints, etc., and then making a sample part to give (or sell) to the customer?