Auditor driving us nuts - ESD requirements

Bev D

Heretical Statistician
Staff member
Super Moderator
#11
Ed - I feel your pain. A non—expert. Simply disagrees with the science because he can’t understand it. He has a hammer and your ESD status is his nail. We went through the exact same thing. Validation testing data, historical field data (service AND instrument fault data), and had a world expert in ESD state that we had the appropriate design to not require ESD protection and we lost.

There are really good auditors out there and there are really bad ones.
 
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Al Rosen

Staff member
Super Moderator
#12
The auditor will have a finding against 7.5.11
7.5.11 Preservation of product
The organization shall document procedures for preserving the conformity of product to requirements
during processing, storage, handling, and distribution. Preservation shall apply to the constituent parts
of a medical device.

The organization shall protect product from alteration, contamination or damage when exposed to
expected conditions and hazards during processing, storage, handling, and distribution by:
a) designing and constructing suitable packaging and shipping containers;
b) documenting requirements for special conditions needed if packaging alone cannot provide
preservation.
If special conditions are required, they shall be controlled and recorded (see 4.2.5).
There is always the issue of latent defects which go undetected until after delivery and all electronic components are susceptible at some level.

Your supplier should also have esd controls in place as well.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#13
Al Rosen made the point I was about to make. :agree: You can have a part tested, but ESD damage can take time to form. Think of it as a sort of internal corrosion, which is what its appearance resembled when I looked at an example with x-ray imaging. Over time the corrosion worsens to the point where signal will be lost or interrupted.

But not every sort of component is susceptible. You were right to ask an engineering firm to evaluate. This is an excellent way to show you have assessed risk. This is also good for the audit, but more importantly it's good for business.
 

Tidge

Trusted Information Resource
#14
I went back to check some of my notes, including a review of ESD S20.20-2014. I'll quote the opening paragraph of that standard for reference:
ANSI/ESD S20.20-2014 said:
This standard covers the requirements necessary to design, establish, implement and maintain an Electrostatic Discharge (ESD) Control Program for activities that manufacture, process, assemble, install, package, label, service, test, inspect or otherwise handle electrical or electronic parts, assemblies and equipment susceptible to damage by electrostatic discharges greater than or equal to 100 volts Human Body Model (HBM) and 200 volts Charged Device Model (CDM). The CDM voltage level as used in this document is based on managing process essential insulators to mitigate field induced voltages on devices that could lead to damage.
When I was involved with review and establishment of the ESD control program, IIRC the most ESD sensitive components and assemblies were somewhere around 150 -200 volts in the HBM (with presumably higher limits for CDM).

I agree that the 'ask' for ESD controls can seem onerous (as opposed to valuable) especially if you believe this to be a non-factor in device performance/reliability.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#16
He accepted no ESD with a letter from a PhD in EE stating he reviewed our ESD testing report.

If testing ESD per IEC standards and it passes then what is the purpose of a passing report?

Our only OFI was "Your MR minutes were not in the order of your slides." I explained that a question on another slide prompted us to move ahead to another slide out of order; I said if we were going to talk about other slides lets just talk about it at that time. No point going back and forth.
 
Last edited:

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#17
An OFI about the MR minutes not being in the order of the slides is non-value added. Auditors need to learn to be more flexible; some are having a hard time with it. I am glad he accepted the ESD letter.

I wonder if I understand your question correctly. A letter saying a report has been reviewed is not a record of a test. It's a record of a person's review. As such it's very nice but provides no information that could be researched for engineering learnings later.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#19
The auditor's objection was that although we tested the device to various IEC standards it doesn't speak directly to whether we needed ESD in place in line. The Ph.D. reviewed the reports and our work instructions for production and made an attestation that based upon his expertise adding ESD protection with a non-Metal Oxide Semiconductor material he concluded that ESD use would result in negligible effect.
 
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