During our internal audit with Quality and our ESD team, a question came up around section 7.3 and the following statement:
“Independent of the organization’s qualification method, qualification records shall include the test method used, the test results obtained from that method, and the test limits. Also, the qualification data shall include the environmental conditioning used during the testing as defined within the test method.”
We currently rely on our vendor data sheet as proof of compliancy as it states the item, a smock in this case. “Meets or exceeds S20.20-2021 requirements” which in the past has been sufficient for audit purposes. However with the addition of the statement in S20.20, does this mean this is not sufficient as it does not contain the environmental conditioning and other requirements?
ESD control items that have been qualified under a previous standard do not have to be requalified by the new standard. The current documentation should be sufficient. If there are new ESD control items (new supplier, new worksurface not bought before) they need to be qualified. Ask the suppliers for a copy of their test data or qualify them based on the lowest RH level at your site.
For new items, if you want to do site qualification, develop a plan to test until the lowest RH is reached at your site.
Additionally, if a vendor claims “Meets or exceeds S20.20-2021 requirements” they should be able to provide a test report to back that claim up.
You state the vendor “should” be able to provide a test report. So “must” we have this data on file to be compliant? Or only that the vendor could supply it if asked?
If the vendor states the item was qualified to S20.20-2014. But the item is new to us… which qualification requirement must we meet? Is what the vendor already completed good, or must we repeat qualification to S20.20-2021?
Once you adopt ANSI/ESD S20.20 - 2021 all new ESD control items must have the test report. They need to supply the data, just saying it is compliant will not be enough. Of course you can do the qualification based on your lowest RH at your facility. That is new in the 2021 version.
For ESD control items qualified before the adoption of the 2021 version, those items DO NOT have to be requalified.
I am in an almost similar situation, but in this case the ESD control elements have technical sheets or certificates for years, and no other new product or element has been purchased.
my question is
Regardless of this, do I have to make my ratings with the lowest HRs and keep those records?
If ESD control items have been qualified before the adoption of ANSI/ESD S20.20 - 2021 by previous requirements, requalification is NOT required. The current ESD control items are still considered qualified without any additional testing or reporting.