ISO 9001:2008 requirement for Design Organization Approval prior to "Repair"

[QLearning]

Hello All,

I posed the following situation under the AS9100 category and am reposting here, hopefully for further detailed response.

We are a contract manufacturer for electronics assembly, with AS9100C/ISO9001:2008 certification. Recently, we received a corrective action request from a non-aerospace customer that wanted to know why we performed a "repair" on a board without first obtaining their approval.

I could not find any specific terms or requirements from the customer that requires notification before performing the repair. My management felt that because they are not an aerospace customer, AS9100C clause 8.3 Control of Nonconforming Product - "disposition of use-as-is or repair shall only be used after approval by an authorized representative of the organization responsible for design" does not apply to them.

My long-winded question is, does ISO 9001:2008 specifically require obtaining approval from design organization prior to repair?

Thanks in advance for any help.

 

[Mikishots]

Re: ISO 9001:2008 requirement for "repair"

They don't have to be an aerospace customer.

The standard also says "Parties requiring notification of nonconforming product can include suppliers, internal organizations, customers, distributors and regulatory authorities". What does your process state? It's fairly obvious that the customer was expecting to be informed.

I wouldn't be taking the stance asking "show me where it says this". The customer has spoken. Will you say "we don't have to tell you because you're not an aerospace customer"?

 

[Marc]

Re: ISO 9001:2008 requirement for "repair"

To keep this from happening in the future, you would have to explicitly omit the specific requirement for non-aerospace customers. I would think that would also be a contract addendum which you would put in during the initial contract review stage.

I do know companies that separate, for example, TS 16949 customers from ISO 9001 customers. Their documentation reflects this and it is noted on all contracts. In some companies, if a customer wants a "TS 16949" part, and they sell the same part to non-TS 16949 customers, the TS part costs more.

The "problem" with that approach is you end up with multiple systems in your company which can be confusing if not properly documented, not to mention if you have a part that you sell to TS 19696 customers and ISO 9001 customers, how do you keep them separated?

As to your question, no - ISO 9001 does not have the "extra" that AS9100 has.

 

[QLearning]

Re: ISO 9001:2008 requirement for "repair"

Dear Mikishots, thanks very much for your input. Our planned response to our customer would be along the lines of, "sorry, as prior notification/approval was not a contract and/or purchase order requirement, we did not take that step, BUT we are happy to do it from here on out. Thanks again.

 

[QLearning]

Re: ISO 9001:2008 requirement for "repair"

Dear Marc,
Thank you so much for your response, especially your final sentence "As to your question, no - ISO 9001 does not have the "extra" that AS9100 has." That was the question I really wanted answered.

That being said, we will definitely include this requirement in the future for this particular client. I agree with you. Splitting the process into two paths for aerospace and non-aerospace seems more cumbersome. Thanks again!

 

[Sidney Vianna]

My long-winded question is, does ISO 9001:2008 specifically require obtaining approval from design organization prior to repair?

If one understands that any repair is a departure from an approved design you would be, in effect, changing a design without approval, concession, etc.

Pay close attention to the bold font from 8.3:

A documented procedure shall be established to define the
controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;

Any supplier that would perform unauthorized repair on a product is not managing it's product safety/liability risks adequately.

 

[Marc]

Good point, Sidney, yet I think one has to look at contact requirements and the company's internal documents (procedures, etc.) to determine specifically what they have to do.

 

[Big Jim]

What could be clearer in all these responses is the basic definition of repair as compared to rework.

Rework is performed to bring something fully into specification. For example on a machined part if there is still too much metal, additional machining to bring it fully into specification is rework.

Repair is performed to bring something into functionality, usually back into functionality. This does not include bringing it back fully into specification. In fact, that is what differentiates repair from rework.

Element 8.3, in either ISO 9001 or AS9100, prohibits you from shipping anything that doesn't meet specification without obtaining a waver.

You are clearly out of place making repairs without permission.

 

[Marc]

Yes, but it comes back to the company's internal procedures and their contract with the customer.

Let's remember the original question:

<snip> My long-winded question is, does ISO 9001:2008 specifically require obtaining approval from design organization prior to repair?

The question doesn't address shipping repaired parts per se, which is what most of the responses here are about.

Let us all remember, as well, that we have to take into account what is being made. For example, if a company is injection molding rubber ducks for kids to play with it is going to be different than, for example, a part for an airbag for a car.

Nowhere in ISO 9001 does it explicitly state that a company specifically require obtaining approval (aka Waiver) from their design organization prior to repair, although it isn't the wisest thing to do.

I agree that it is not normal for a repair to be shipped without a specific customer approval prior to shipping.

What could be clearer in all these responses is the basic definition of repair as compared to rework. </snip>

I was thinking about this and one of the old discussions here as "food for thought":

Rework vs. Repair - What's the practical difference? - http://Elsmar.com/Forums/showthread.php?t=27010

 

[Paul Simpson]

Hello All,

Hi, QLearning and welcome to the Cove. Unlike some I'll ask for a bit more information before judging your company!

I posed the following situation under the AS9100 category and am reposting here, hopefully for further detailed response.

We are a contract manufacturer for electronics assembly, with AS9100C/ISO9001:2008 certification. Recently, we received a corrective action request from a non-aerospace customer that wanted to know why we performed a "repair" on a board without first obtaining their approval.

This leads to the $64,000 question(s).

1. What did the contract require and what did it preclude? If they gave you a scope to work in you have to look at it to see if you were working outside it.
2. What did your customer ask you to do? If you were being asked to make / populate boards from new there are different rules from if you were being asked to repair / check pre-existing boards.
3. Were you operating 'normal' manufacturing processes or were you dealing with non-conforming product from your own processes?

Without answers to these it is not easy to give advice.

I could not find any specific terms or requirements from the customer that requires notification before performing the repair. My management felt that because they are not an aerospace customer, AS9100C clause 8.3 Control of Nonconforming Product - "disposition of use-as-is or repair shall only be used after approval by an authorized representative of the organization responsible for design" does not apply to them.

Again there is a commonly accepted way of working that you don't change a design without checking with the design authority but the question is whether the repair you carried out is a repair or even affects the original design intent.

In either case you need to have the competence in house to be able to assess the effect of any process you apply to the design - whether the product is supplied by the customer or you manufacture it to their design.

My long-winded question is, does ISO 9001:2008 specifically require obtaining approval from design organization prior to repair?

Thanks in advance for any help.

In all of this the contract terms are key.

Hope this helps.