Planning of product realization EN 9100 Clause 7.1 e

[Angelika]

I need your help regarding the following requirement of EN/AS 9100, Sect. 7.1 e)

Identification of resources to support operation and maintenance of the product

Which action is required? Does it mean that companies have to issue operating and maintenance manuals? Does it have to do with after-sales-service? Somehow I am at a complete loss.

Any help is appreciated.

 

[Justin]

AS9100 7.1(e) The identification of resources to support operation and maintenance of the product.

We have a flow diagram that identifies all the operations/processes.

For each process there is an operations manual to support the process.

There is also a maintenance manual for each process.

This is how we do it, and has satisfied our registrar thus far.

Hope it helps

 

[Angelika]

Thanks a lot Justin, your reply was a great help to me!

 

[Justin]

Any time Angelika

I have been through several AS/EN 9100 registration audits and implementations. I am happy to share my experiences, good and bad.

Keep smiling

 

[RCW]

Re: 7.1 Planning of product realization EN 9100

AS9100 7.1(e) The identification of resources to support operation and maintenance of the product.

We have a flow diagram that identifies all the operations/processes.

For each process there is an operations manual to support the process.

There is also a maintenance manual for each process.

This is how we do it, and has satisfied our registrar thus far.

Hope it helps

I have read and re-read this reply several times in an attempt to figure out what 7.1(e) is asking for. (Maybe I just can't make the analogy between Justin's answer and the manfacturing processes within my own company.)

From one of the many books I am using to try to make sense of AS9100:
"A requirement is added as section (e) to places (sp?) emphasis on the long term and lifecycle of a product including support and maintenance. Aerospace parts usually have a long lifecycle, and require traceability from specification to disposal. Design has to consider the user."

If I am performing build-to-print/contract manufacturing of the customer's designs, is 7.1(e) even applicable to me? To me, it looks like the development/control/distribution of operation and maintenance manuals for products are required.

Can somebody attempt to clear this up?

 

[Jeff Frost]

Re: 7.1 Planning of product realization EN 9100

Ok let me try this one for you.

ISO 9001:2000 is not specific regarding maintenance of the product, whereas EN9100 (known as AS9100 in North America) does. The “resources” would include personnel, equipment, repair parts, and/or machine repair, tooling for performing the maintenance.

Examples would be aircraft engines, avionics, hydraulic systems or product that can be rebuilt on the aircraft. It should be noted that not all product fall within this requirement such as machine to order parts or expendable parts such as o-ring seals.

In reality for most companies that are only machining parts to order or are supplying expendable parts they only have to maintain the ability to make more of them when needed by the customer.

 

[Angelika]

Re: 7.1 Planning of product realization EN 9100

In the meantime, I have had a lot to do with Design Organisations that mainly design changes to approved type design of Aircraft.

My today's thoughts when reading this paragraph again are the following:

1. What means do I need to achieve initial airworthiness and how can it be achieved?
2. What means do I need to achieve continued airworthiness and how can it be achieved?

Following this I would start in the design phase because the Design Organisation is the one that determines how a product must be produced, operated and maintained to ensure correct and safe operation.

1. How to achieve initial airworthiness:
As a result of prototyping the Design Organisation must clearly specify
a) the manufacturing programs including any relevant drawings/diagrams etc.
b) the operating manuals
c) the maintenance manuals
d) the installation manuals etc.

2. How to achieve continued airworthiness:
If there is a need to change the Design (improvements, airworthiness matters etc.) there must be a system that makes sure that
a) the manufacturer
b) the operator/user of the product
c) those maintaining the product
(if airworthiness is touched, of course the aviation authority, too)
are informed of the relevant changes in due time.


Depending on the type of product, any means required to support production, operation and maintenance of the product must be specified during the design yet. This also includes a systematic reporting system between the parties.

Looking forward to your comments.

 

[kiwisfly]

Re: 7.1 Planning of product realization EN 9100

Hi All
I think the thread explains the requirement of 7.1.e very well. If I could add that the requirement I believe follows the Rule Part 21 requirement that the designer and/or manufacturer of an aircraft, system or component is responsible for the component's continued airworthiness as approved through the Part 21 process. For example, if you are the OEM for an aircraft type and hold the type certificate, then under Part 21 you are bound to support that aircraft whilst it is being operated. Hence the AS9100 requirement to consider support activities to support the ongoing operation and maintenance of the aircraft. The process similarly flows down to system and component approval holders. Note, this may or may not be the designer, just as manufacturing can be contracted out, so too can design.

If a build-to-print manufacturer excludes 7.1.e then I believe this would be acceptable under the requirements of AS9100.

I hope this helps.

Cheers

 

[RCW]

Re: 7.1 Planning of product realization EN 9100

If a build-to-print manufacturer excludes 7.1.e then I believe this would be acceptable under the requirements of AS9100.

I guess from my original question this is where I was probably going. From what I have read above regarding 7.1.e there is a requirement to "oversee" the life of the product. This is done through service manual development and its upkeep, verifying that components are still available for maintenance, verifying that all documentation is kept current to support the products manufacture, and additional items which I have most likely left out.

From the point of a build-to-print manufacturer, I don't own the rights to the product to perform the above functions, with the exception of maintaining documentation supplied by my customer. Therefore I will most likely take an exception to 7.1.e and wait for the registration auditor to tell me otherwise.

Maybe because I'm a build-to-print manfacturer (aerospace ground support equipment), I still can't fully grasp what the 7.1.e requirement is.


What is "Rule Part 21"??

 

[kiwisfly]

Hi RCW
I'm a bit surprised you are required to comply with AS9100 as a Ground Support Equipment manufacturer as the standards are more applicable to airborne equipment that are subject to airworthiness requirements such as Rule Part 21.

Part 21 is the common number used by nearly all (there is a project on the standardise numbers) national authorities for the Certification of Products and Parts. The rule describes the process for gaining initial or supplementary certification for aircraft, assemblies and/or components. Once certified, the owner becomes the Type Certificate holder for the life of the aircraft or part.

There are some differences between different airworthiness authorities about how much is in Part 21 (eg FAA include manufacturing) but the general certification area is much the same. Most rules are accompanied by Advisory Circulars so if you're interested in reading up on the certification process I recommend you have a browse of the AC's at faa.gov

Cheers