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Product Safety in AS9100D Clause 8.1.3 - Hazards Analysis

DannyK

Trusted Information Resource
#1
AS9100D clause 8.1.3 states:
8.1.3 Product Safety
The organization shall plan, implement, and control the processes needed to assure product safety during the entire product life cycle, as appropriate to the organization and the product.

How does this clause apply to a machine shop or parts manufacturer, most of whom have no idea of the safety implications ?

Is the hazards analysis the way to implement this requirement?

Can this clause be non applicable for a build to print manufacturer?

Thanks for your input.

Danny
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
How does this clause apply to a machine shop or parts manufacturer, most of whom have no idea of the safety implications ?
As I see it, a build to print machine shop would support product safety by ensuring robust management of special requirements, critical items and key characteristics.
 
S

sunnycosta

#3
I am the QA of an AS9100C CNC Machine shop excluded from 7.3 (Design). We machine parts based on our Customers Drawings and CAD models.
Is Product Safety is a legitimate exclusion, for us? Our customers design the product and are responsible for how it works and what its safety condition is. Safety for us extends only to employee safety in the shop.
Please advice.
 

howste

Thaumaturge
Super Moderator
#4
I am the QA of an AS9100C CNC Machine shop excluded from 7.3 (Design). We machine parts based on our Customers Drawings and CAD models.
Is Product Safety is a legitimate exclusion, for us? Our customers design the product and are responsible for how it works and what its safety condition is. Safety for us extends only to employee safety in the shop.
Please advice.
Although product safety begins with design, producing the product to meet the design requirements can also have an impact on product safety. Obviously, as Sidney mentioned, any special requirements identified by the customer should be given special care. If you have knowledge of how the product is used, then you would have more insight about how to ensure product safety. If you have no knowledge of product use, then just making it to customer requirements is all you can do. IMO you couldn't say it's not applicable.
 
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Eredhel

Quality Manager
#5
We include the manufacturing process in our safety stuff. There is probably a lot of safety stuff you do and just don't realize it/document it. Buying a lockout/tag out kit for when a machine is being worked on is an easy example.
 

Eredhel

Quality Manager
#7
That's a great point, and very true. Sorry was throwing out something random. For product safety we do have things like corrosion prevention, deburr, packaging, shipping, et cetera, and the occasional critical feature callout. Very little of what we make will have product issues.
 

nacnack

Starting to get Involved
#8
Ok this clause has baffled me for some time and continues to do so with Machine shops that have no work performed for Flight Safety, Flight Critical, Mission Critical, Fracture Critical, No titanium products. Machine shops that do not bid on flight safety contracts therefore do not produce products that can potentially kill people if they fail in use.
I understand the need to control key characteristics, but in may cases those key characteristics are only to ensure the machined part meets the customers tight specifications. I'm in some need of clarity on this issues and how it applies. Not even the IAQG Product Safety Powerpoint on their SCMH is clear enough for me. I need practical application information, not some general statements. Please make me smarter on this subject gentleman.
What exactly would you look for during an audit if the company does not produce the list I mentioned above. In my opinion its not applicable to the scope of supply. Now if the company is an FAA Repair station, I get it, but a build to print machine shop, I need some help with this one.

:bonk:
 

Eredhel

Quality Manager
#9
Hehe, no doubt! Don't forget this language "...as appropriate to the organization and the product." You can look at your product and determine what is actually needed. Take a look at the parts you're running and just ask yourself what they need. For us that's usually handling issues like deburr, since we do a lot of assemblies, and corrosion prevention. A critical feature that's common for us is sealing surfaces where we need to be sure the surface finish is as required by the print. I don't honestly know if this is the original intent of the standard but it's as close as the majority of our parts get. There are some exceptions that have obvious safety concerns but that isn't what we have most.
 
S

SV Kishore

#10
The product must work in the assembly i.e aircraft or missile without causing mission failure , injuries to the operators at the time of assembly , to last/work till its designated life in hours or minutes , hence for precision machined components , operations like deburring , removing sharp corners ( as stipulated in drawings , maintenance of specified hardness or coating /plating thickness ( key characteristics ) maintenance of straight edges ( where functionally a snug/sliding fit is required -- rounding of edges not desirable ) , where a profile /contour is required the same to be maintained meticulously ( this may be critical feature ) , where explosive filled sub-assemblies like ejection seats are involved , the situation is again different.
 
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