Product Safety - 4.2.3.4 - Safety considerations relative to the supplier's product?

[Douglas Purdy]

What is meant by "product safety" and "safety considerations relative to the supplier's product?"

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[Lassitude]

This requires you to consider these items. Due care means (1 meaning, I believe) you consider 'industry' standards, such as a margin for error (for example, if expected maximum stress in a lever will be 500 lbs, design the part with a 30% 'excess' factor [500 + {500*.3}].

As far as product safety, is is sharp? Is it an air bag (could explode in employees hand)? Are employees trained how to handle the air bag properly? Is process equipment properly guarded? Things like this, I believe.

Others?

 

[Marc]

--> [email protected] wrote:
-->
--> Lassitude,
-->
--> I did want to thank you for responding to my question on the Caymen
--> Forum. I also appreciated your prompt to get more feedback. It does
--> not look like I will get any more responses. I was fishing for how
--> people responded to that item in the 3rd Edition. Other than adding
--> a "NOTE" in their current 4.9 system procedure.
-->
--> Again - Thanks, Douglas E. Purdy...

You could address the issue to evidence consideration in a note, however the 'test' will be how you explain where and how you consider these issues. If your quality manual is rewritten to follow the latest QS, you could state there that you do it and be ready to explain where and how as opposed to a note in 4.9. To be honest, a note in 4.9 probably wouldn't cover the design aspect of the requirement (if you have design activity).

I wouldn't let this run over you. Have you been cited on this or are you now setting up your systems?

This is like Preventive Maintenance; Someone is expected to be able to explain how and where these issues are addressed. You could make a diagram as well or similar visual. If I was going to do this I would integrate it in the APQP map in the appropriate places.

And you want to look at your overall documentation. Does your design review or design procedure cover (mention/address) safety aspects? For example, during design is appropriate consideration given to employee safety at your company including during processing and storage? How about safety aspects of the person/company who buys your product and their employees? Be ready to explain this and to cite where / how, etc.

But remember there are limits of applicability. If you manufacture a small 0.5 kg gear for a transmission, how dangerous can it be? Then again, if you manufacture air bags there's a hell of a lot of potential danger all along the process and down the chain to installation. And, in fact, after installation through use and to eventual disposal.

Use 'common sense'.

Does this help?


[This message has been edited by Marc Smith (edited 28 June 1999).]