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

Is ESD a special process under 9001:2000

  • Yes

    Votes: 1 14.3%
  • No

    Votes: 6 85.7%

  • Total voters
    7
E

edward.gibbs

#1
I'm having a "discussion" with my management.

I have always considered ESD to be a special process, as ESD damage is not readily apparent and cannot esaily be verified by subsequent testing.

My management feels that ESD should not be a special process as it is not a "process' per se, but part of our overall handling process. They argue (convincingly) that lots of other handling requirements such as not dropping an item on the floor would then need to be treated as special processes as well.

In searching the web I have come across at least one other company that explicitly defines ESD as a special process. I have also come across many postings and articles that describe welding, heat treating, etc. as special processes but make no mention of ESD controls.

Is there any "official" guiidance as to whether or not ESD control is a special process? If not, how are other peope treating it?

My industry is aerospace electronics, BTW. We are an ISO-9001:2000 registered company, but are not AS-9100.

Thanks in advance,

Ed Gibbs
 
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C

Cathy

#2
hi Ed,

I am inclined to agree with where you say that damage can be latent. ISO9001;2000 does not have specific requirements for 'Special Process' but it does have specification for process control and preventative action.

I personally, would treat it as procees control, in that you have your controlls in place and checks in place as would happen with welding. You can periodically test the work areas and presonnel for compliance of their footstraps, overalls, wrist bands, etc, and ensure feedback from your customer. Some ESD damage will show in system tests.

ESD protection is much more that just a handling risk. Personnel are invloved in preventing this. and a certain level of training for everyone on the shopfloor will be required. The right equipment for storage needs to be spec'ed, ensure your floor carries away static, machines are set up right etc,

What are you going to do differently if you set it up as a special process?

Cathy
 
E

edward.gibbs

#3
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
 
T

tschones

#4
Ed-

Our external auditor made the same point about ESD being a special process when he was here for the 9000:2000 certification audit. I countered his argument by saying that ESD is not a process, it's an outcome or output. But, if one looks at it another way, it's the handling "process" of the boards that causes ESD. In this case you would validate your process through training, certification, and re-certification of your operator who handle the boards. Your certification and recertification (validation and revalidation) would show that your operators know how to protect the boards from potential damage and know why this is important. I don't think anyone would expect that you go beyond this to validate your process.

All the Best-
Tom
 
C

Cathy

#5
Ed,
I agree with you Tom

The most reasonable thing to do here is prove your operators competance and ensure the ESD/EDC testers are validated (can be done by company who supplied you) You ESD control system should have that already.

One thing I would say is don't get bogged down in ISO9001;2000. You changed the words from 'Validate' to 'special process'.

The advice I give my work mates is do what's best for the business and what works for us and when we have the system in place, check it against the std.

By the sounds of it your ESD system is under very good control. one other thing I would do to validate this is going back over the complaints for say 5 years and see how many have been due to latent failures. If you have quite a lot of repeat complaints for this reason, you have a problem. If not, you must be doing something right!!!

Cathy
 
D

David Hartman

#6
edward.gibbs said:
I'm having a "discussion" with my management.

I have always considered ESD to be a special process, as ESD damage is not readily apparent and cannot esaily be verified by subsequent testing.

My management feels that ESD should not be a special process as it is not a "process' per se, but part of our overall handling process. They argue (convincingly) that lots of other handling requirements such as not dropping an item on the floor would then need to be treated as special processes as well.

Is there any "official" guiidance as to whether or not ESD control is a special process? If not, how are other peope treating it?

Ed,

To address your question: No I don't believe that there is any "official" guidance as to whether ESD control is a special process or not.

Now to MHO as to it being a special process: Let me first state that my opinion is based on my interpretation that a "special process" is a "value added" process within your production operation (where some beneficial action/process is intentionally performed on the product - something is added, removed, changed, verified, etc.); but the result of that action/process is not easily/readily verifiable (may require some form of destructive testing for verification).

Which means that processes to control "unwanted" modifications, damage, loss, etc. from occurring would NOT fall into this category. This could include such processes as: Shelf-life control, ESD control, maintaining separation between dissimilar metals, controls to prevent corrosion, etc.

Once again let me reiterate the above is JMHO. :bigwave:
 
#7
edward.gibbs said:
I'm having a "discussion" with my management.

I have always considered ESD to be a special process, as ESD damage is not readily apparent and cannot esaily be verified by subsequent testing.

My management feels that ESD should not be a special process as it is not a "process' per se, but part of our overall handling process. They argue (convincingly) that lots of other handling requirements such as not dropping an item on the floor would then need to be treated as special processes as well.

In searching the web I have come across at least one other company that explicitly defines ESD as a special process. I have also come across many postings and articles that describe welding, heat treating, etc. as special processes but make no mention of ESD controls.

Is there any "official" guiidance as to whether or not ESD control is a special process? If not, how are other peope treating it?

My industry is aerospace electronics, BTW. We are an ISO-9001:2000 registered company, but are not AS-9100.

Thanks in advance,

Ed Gibbs
First of all, Welcome to the Cove Ed! :bigwave:

I'm not sure we are asking the right questions. Whether ESD is a "special process" or not is not the issue. The issue is whether the process you use (that is susceptible) to ESD is a special process. I’m not even sure that question is relevant. What is the important issue? I would imagine it is preventing damage to the devices from ESD. Whether you call the processes you use “special” or not is quite meaningless. The important thing is to put in place the required safeguards.
 
#10
Bill Ryan said:
For us dummies who can't stand acronyms- ESD is what???
Electo-Static Discharge (like walking across a carpet and zapping someone)

added-------------

Okay now we know who has the faster typing ;)
 
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