Is ESD (Electro-Static Discharge) a Special Process under ISO 9001:2000?

[David Hartman]

For us dummies who can't stand acronyms- ESD is what???

ElectroStatic Discharge - The result of electronic potential differences between dissimilar materials (a static spark - although in many cases unseen by the human eye that travels between a human hand, shirt sleeve, plastic bag, etc. and a sensitive electronic device such as a Integrated Circuit).

 

[Icy Mountain]

Ed,
We cover this several ways:
6.2.2 Training: We reference a training procedure that makes sure that everyone knows what ESD is, what it does to our products, how to use the supplied infrastructure to control it, and what the customer will get if we don't control it.
6.3 Infrastructure: We reference a procedure for testing all of the mats, painted surfaces, etc. that specific individuals do not have the resources, competency or equipment to verify/validate on their own.
7.5.5 Preservation of Product: We reference our daily ESD procedure here along with other procedures for stock rotation, etc. The daily proc. requires wrist strap, heel strap, cord checks, and signoff. So we are validating the specific individual equipment.
7.6 Control of M&M devices: Our mat and strap checkers are controlled equipment.

I agree with your management. ESD control is a training, infrastructure and handling issue. Think of it like climate control. Maintaining a constant temperature so you don't spoil your temp. sensitive product is not a special process. And you don't have to prove again and again that your product didn't spoil, just prove that the temperature is maintained.
-John

 

[energy]

On the money, IMHO!

Ed,
I agree with your management. ESD control is a training, infrastructure and handling issue. Think of it like climate control. Maintaining a constant temperature so you don't spoil your temp. sensitive product is not a special process. And you don't have to prove again and again that your product didn't spoil, just prove that the temperature is maintained.
-John

Proof of component failure due to static electricity is virtually impossible. The whole idea behing ESD Protection is to prevent "possible" failures down the road. If a capacitor, diode, resistor, etc. fails, nobody can say with absolute certainty that is was ESD related. By not calling it a special process, you avoid having to measure it. JMHO

 

[db]

By not calling it a special process, you avoid having to measure it.

Could you explain please?

 

[energy]

Leave me alone

Could you explain please?

Thanks for the reply,

The real issue is that 9001:2000 has a requirement in 7.5.2 that processes where "subsequent monitoring and measurement cannot verify the resulting output" be validated. Based on the wording I assume this is what used to be called "Special Processes."

We have an effective, well audited ESD program. The problem is how do we validate our ESD procedures? Do we need to take first articles apart and verify with electron microscopy that there is no latent ESD damage? We actually can do that, but we sure don't want to!

So if we did treat ESD as a "Special Pprocess" (or a process under 7.5.2) how would we validate our ESD control processes without great expense and disruption?

Thanks,

Ed Gibbs

I was referring to any monitoring and measuring for the reasons explained in the other quote above. Stop picking on me!

 

[Cathy]

I worked in Electronics for a few years. The only thing we did where ESD was concerned was test wrist and foot straps before going on the floor and tested the floors and benches every 6 months. Ed is already probably much more thorough! What valuve would you gain from monitoring ESD levels? like Energy said, don't call it a special process and you don't have to monitor it. I reckon doing any investigation like Electron Microscropy is more expensive than its worth. Does the Civil Aviation Authority have any guidelines on process control?

 

[howste]

Although I know ESD protection is very important, I agree that it's NOT a special process. The comment ddhartma said about value-added processes is exactly what I thought when I read this. If ESD protection is a special process, then material handling would also be a special process, because you might drop something and cause undetectable internal damage. It's way too easy to take this too extremes.

 

[Randy Stewart]

FWIW, here's my thoughts:
1) It is not a special process,
2) Monitoring and Measuring can be - Verification (resistance checks, etc.) of equipment.
3) Validation - from the number of failures attributed to ESD.

 

[Mike Smith]

Preventive Action

I work for a electronics company and ESD is a part of out everyday process. We do not consider it a special process. We do consider it as more of a preventive action. If we dont wear our wriststraps, special clothing, ESD safe painted floors, ESD mats, ETC. it could cause damage to sensitive electronic components. There is no way to tell when damage is caused by ESD and this is why we take all the precautions. Just my two cents worth.

 

[Icy Mountain]

Perfect example!

Mike Smith,
Excellent preventive action example. I'm going to use that one on my CEO the next time he says, "All actions are corrective or we wouldn't know we need to make them".