ESD wrist strap test - Record always required? If not, why not?

normzone

Trusted Information Resource
Hello fellow Covers ...

I am tasked with reviving an ESD controls system that fell in disarray about 8 years ago, as near as I can determine by examining the evidence.

The persons owning the process jumped ship and the process continued on with varying levels of compliance based on the areas involved.

In addition to building something that is going to outlast me, I'm looking at the practice of testing a wrist strap and logging that test.

I have one area that works with PCBAs and is supposed to do that every day -
There is another area that only logs a test when they perform operations on ESD sensitive material -
And then there are engineering areas where they don't log ever -

So, before I go further down this rabbit hole, in the absence of specific requirements are there valid rationalizations for not logging a test?

As always, I'm indebted to the lot of you.
 

Bev D

Heretical Statistician
Leader
Super Moderator
If you don't log a test, what evidence do you have that it took place?
Well you can falsify the log…fairly rampant in my experience. The emphasis on “if it isn’t documented it didn’t happen” was better than nothing in the old days I guess.

You can ‘prove’ that little or no ESD damage was done thru performance & defect data…but that’s too complicated for auditors.

(1) The only real ‘a priori’ way to enforce compliance and establish a reliable record is to have an automated system that logs the test and a n ERP system that relies on the logged passed test to enable use of the system. But again this can be fooled if there are no serial numbers in bar code form tied to individuals, etc.

ESD these days is not the widespread big bugaboo it was when I started in industry (good designers use on-board ESD protection) and so many people simply don’t bother with all of the rules. Other passive preotections are quite protective as well.

(2) In my experience knowing when ESD straps are required and establishing an overseeing culture that self enforces compliance is all that really works. Education/training, Peer and supervisor pressure with real consequences to non-compliance are needed. But this level of regulation is often abhorrent in today’s culture.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
If your product has components sensitive to ESD or it is possible to damage the product with ESD I would make ESD a strict requirement so the company doesn't have a future complaint requiring an investigation that concludes with ESD during handling as a possible finding. It takes time but it reflects your commitment to quality. Log it in my opinion.
 

Tidge

Trusted Information Resource
I worked at a manufacturer that had a relatively robust set of ESD controls (albeit at a 'middling' level of device sensitivity). We required training to ESD protocols to be up-to-date; the use of wrist straps (and turning on ionizers, etc.) was addressed during training.

We did not require any specific records relating to ESD controls(*1) beyond:
  • employee training records
  • PMs for ESD-related equipment
  • (I suppose, but I never saw them) purchasing records for straps, bags, totes, hand lotion, etc.
(*1) for day-to-day operations. We maintained whatever records we had for assessments and validations.

Specific to wrist straps: part of the training was to have each user verify that their wrist strap (and attached alarm system) was working in both the fault and no-fault conditions.
 

Mike S.

Happy to be Alive
Trusted Information Resource
If you don't log a test, what evidence do you have that it took place?
I'm gonna be a contrarian I guess.

If you do log a test, what evidence do you have that it took place? Just an easily fudged piece of paper, as Bev alluded to, unless your tester does automatic logging.

In my experience, a much bigger problem is getting the employees to wear the darn wrist strap every time they sit down to work - a much bigger compliance deal than the initial daily test, with no log to verify anything. So what evidence do you have that they wore it? Logging the initial test is, IMO, 5% of the key to preventing ESD damage.

And if your managers don't set the tone by setting a good example and constant monitoring of their employees as they (hopefully) regularly walk the floor, you're in trouble. (Culture as Bev said.)
 
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