To support assessment of client’s product qualification compliance per ANSI/ESD S20.20-2021 Section 7.3, the ESD Association has compiled a summary of requirements that you may use.
The document is split by category (Personnel Grounding, EPA, and Packaging) and then by each control item – each entry contains the following information:
• Test Method
• Required Limits
• Quantity of Samples
• Type or Method & Quantity of Results
• Environmental Conditioning
Environmental Conditioning:
Many of the existing standard test methods require both Low and Moderate Humidity conditioning, most of these methods (except static shielding bags (STM11.31) which requires Moderate RH) will be moving towards requiring only Low Humidity conditioning. As mentioned in ANSI/ESD S20.20-2021, organizations may use their facility’s lowest annual humidity for qualification if the control item remains within the facility and they have objective evidence that qualification was done at the low point.
Prior Adoption:
ESD control items that were previously qualified before the adoption of ANSI/ESD S20.20–2021 do not need to be requalified. For example, if an organization has used and verified a worksurface prior to adopting ANSI/ESD S20.20-2021, their verification records may be used in place of qualification.
We hope this document is a benefit to you and your organization, please provide us with any feedback on this document as you use it in future audits.
As the mention that : “Prior Adoption:
ESD control items that were previously qualified before the adoption of ANSI/ESD S20.20–2021 do not need to be requalified. For example, if an organization has used and verified a worksurface prior to adopting ANSI/ESD S20.20-2021, their verification records may be used in place of qualification”
It means that we can use the option of compliance verification records older than 1 years to demonstrated product qualification. However, is it a major criticality that the compliance verification records did not specify the Humidity and temperature at the time of testing?
Because in the ANSI/ESD S20.20-2021 Section 7.4 does not mention about this data so we don’t have Environmental conditioning data on our compliance verification records.
I hope to receive a reply from you.
Hi ESDA:
Can you please confirm if the following sentence still applies?
"Prior Adoption:
ESD control items that were previously qualified before the adoption of ANSI/ESD S20.20–2021 do not need to be requalified. "
No need to update the documents. If the qualification data was done, then the report or objective evidence that you have should be fine. If would help if the report was dated and to which version of ANSI/ESD S20.20 it was qualifed to.
good day experts,
with regards to the number of samples, say for example for packaging in particular, STM11.11, STM11.12, STM11.13 stated that minimum of 6 samples is required, if we only used 3samples each, do we need to provide a tailoring for this requirement?
please advise.
Yes, you would need a tailoring statement because the sample size does not meet the requirements in the ANSI/ESD STM 11.11, 11.12, or 11.13. Currently the packaging working group is considering lowering the minimum sample size but I am not sure what the outcome will be.
A couple ideas on how you could justify your tailoring statement:
-If the 3 samples test results all are well below the limits in ANSI/ESD S20.20, this may be sufficient
-If you have sufficient compliance verification data on the packaging in question, for instance showing the last years worth of compliance verification testing was all within specification.
Hi Andy,
actually the minimum number of samples is very difficult to obtain considering that it is coming from the supplier and some were expensive. though we maintain that the samples were only 3, we have statement in the report that we are still checking the additional 3 samples after first delivery to suffice the 6min samples. would that be acceptable? we only stated in the program that we require only 3samples for product qualification though.
I don’t think it is important to check exactly 3 more samples in house to achieve the 6 samples because the 6 samples from ANSI/ESD STM11.11, 11.12 and 11.13 would all be done at 12% humidity which is a worst case. If you are checking them when they are delivered to your factory, unless you have a humidity chamber to do the testing, you are likely checking them at a higher humidity.
I still think your best way to justify the 3 samples is as I stated above. If the 3 samples test results all are well below the limits in ANSI/ESD S20.20, this may be sufficient. If this doesn’t work then you could test the first delivery samples and they all are well below the ANSI/ESD S20.20 limits, that should be sufficient. Thanks