What Should My Product Qualification Plan Include?
Section 7.3 in ANSI/ESD S20.20–2014 includes a requirement for a product qualification plan. This requirement is completed before the selection of ESD control items that will be used for the ESD control program. The product qualification requirements for each ESD control item can be found in Table 2 for personnel grounding, Table 3 for ESD control items used in the ESD protected area (EPA), and in ANSI/ESD S541 for packaging of ESD sensitive items.
There are no humidity control requirements in ANSI/ESD S20.20. However, the testing requirements for product qualification may include low humidity environments to conduct the tests. For example, one ESD control item, worksurfaces, is required in Table 3 to be tested according to ANSI/ESD STM4.1. The limits in ANSI/ESD S20.20 are a point to point resistance of less than 1.0 x 109 ohms and a point to groundable point resistance of less than 1.0 x 109 ohms. The test method in ANSI/ESD STM4.1 requires testing at 23oC at 12% RH and 50% RH. The testing at these two humidity levels is to ensure that the ESD control item works regardless of the humidity level where the ESD control item is installed.
Table 3 in ANSI/ESD S20.20 is the list of optional ESD control items that can be found inside an EPA. However, not all materials that may be used in an ESD control program are included in the table. For an ESD control item to be included in Table 3, there needs to be a standard test method and a defined limit. In some cases (for example gloves) the current test method is not a standard test method and a limit has not been established. For these items, the user must present the rationale for qualification if used in an ESD control program.
Objective evidence of qualification can come from various sources. If the capability exists, in house testing is a source. An independent third-party lab could also be a source of information. The manufacturer’s product data sheet is another alternative. These reports must contain at a minimum, the values measured, the standard test method used, and exceptions, if any, to the test method.
Exceptions would have to be documented with a tailoring statement (more information below). An additional method of qualification can be used if the ESD control items have been in place for a while. The compliance verification data can be used for qualification but it should contain more than one data set and at least one of the data points coming from a low humidity time of the year. Keep in mind that the compliance verification data needs to exist before using this as objective evidence. For example, if a footwear/flooring system is used for personnel grounding and has been in place for years, the compliance verification data for the floor and footwear system could be used for the floor and shoes, but data that shows body voltage generation would still be required as per ANSI/ESD STM97.2.
Exceptions to a product qualification requirement can be done using tailoring in ANSI/ESD S20.20. Technical justification and rationale will need to be documented for the exception to be accepted during an audit. An example of a tailoring situation would be a facility that does have humidity controls. While not required in ANSI/ESD S20.20, if the facility had a minimum humidity level of 30%, then qualification could be done at that minimum level provided the objective evidence exists that the EPA does not drop below that level. This tailoring statement only applies to ESD control items that remain inside the defined EPA. Items such as packaging, which may travel to uncontrolled environments, must be tested at the prescribed humidity levels as per ANSI/ESD S541.
Product qualification is an essential part of any ESD control plan and is necessary to become certified to ANSI/ESD S20.20. Objective evidence through various alternative options can be used for demonstrating qualification of an ESD control item. With the proper qualification testing, humidity may not be required to control static within an EPA. As discussed above, a reduction in the humidity range necessary for qualification may be allowed if objective evidence of a controlled humidity range in the EPA can be provided. This is just one example in which tailoring can be used to modify a product qualification to meet specific user needs.