As we rapidly move into the 2nd quarter of 2019, Supplier Compliance continues to be a hot button for Quality Assurance, Procurement and Engineering.
Governmental audits of contractors and suppliers have identified a fairly long list of Supplier Non-Compliance in failure to qualify materials, manufacturing practices, assembly and distribution of EEE devices.
As a device decreases in size, the available real estate on a PCB is sacrificed due to densification and higher speed. As a result, the protective packaging (on the outside), becomes even more critical for the protection of Class 0Z (<+/-50 volts) electronic (EEE) parts.
The author has recently published two articles relevant to the rise of EEE device failures from medical device to space & defense for material qualification.
Today, one cannot separate a material from a component in the design of a product from smart batteries to CubeSats to aircraft components. The use of lighter materials and more advanced engineered composites will intensify, often circumventing formalized qualification testing that will sacrifice product performance.
Proper packaging and handling of EEE Parts (ESDS devices) is often ignored or overlooked although central to potential damage of a component. In the first quarter of 2019, it was learned that two similar complaints from Avionics professionals of component failure when pulled out of long term storage. The EEE parts passed the ESD hardware testing, but, after removed from storage, said parts failed upon repair or replacement.
Just as a EEE device is required to undergo incoming inspection and periodic testing, static control materials (ESD gloves, wriststraps, field service kits, garments, etc.) must also be verified after initial qualification and on a periodic basis.
Due to suspect counterfeit/non-compliant materials and packaging in the supply chain combined with offshore buys and substitution of original products, one must practice due diligence in the qualification and purchase of EEE parts packaging for continuous improvement to safeguard consumers goods and the WarFighter.
The original 2017 article (to the left) details qualification of ESD gloves critical to the handling of EEE devices from the Medical Device sector to aerospace. There are numerous companies that manufacture and distribute ESD gloves, but few adhere to ANSI/ESD S20.20-2014 by providing 3rd party test results less than 2 years old. Typically, a glove company will provide a technical data sheet that is meaningless without data.
Others have been observed to provide test data that is over 10 years old or most often conducted to an old or incorrect standard test method by both US and offshore suppliers.
The 2nd article (2019) focuses on the Medical Device and Pharmaceutical sector in the use of ESD gloves that have been qualified by an approved 3rd party laboratory not tied to product sales. Click on R&D to the right and below.
Reliance upon product suppliers or distribution houses for static control compliance will almost certainly increase your purchasing dollars. More than likely, the integrity of the product will be in question if there is no qualification or validation of the material before manufacture, assembly, kitting or long term storage.
All three articles outline and define the need for Industry awareness today that requires the engineer or technician to look beyond the build of a product to what is required to house, store and transport that same product from the raw material to final shipment and/or return for repair.
Because static shielding bags are used throughout Industry in the millions, one must be aware that this product in particular is commonly "knocked off" or "downgraded" due to large buys by procurement, R&D and subcontractors.
The reader can download the pdf version of this article by clicking on the image to the left.
See pages 32-37 for details on the qualification testing of static shielding bags.
Any questions, please contact the Author direct by emailing email@example.com or call 650-964-4792.
For upcoming training that ranges from Material Handling to Incoming Inspection to ESD Awareness and iNARTE Certified ESD Aerospace & Defense Engineer or Technician programs by the RMV leadership team, please call or email Renee at 650-964-4792 of current requirements or firstname.lastname@example.org