Meeting the New Forensic ISO Standard: ISO 18385

Sue Wigdal, Senior Quality Assurance Scientist at Promega, explains why there was a need for an international standard governing how forensic kits are manufactured, how this standard was created, and what this means for the forensic community.






My name is Sue Wigdal. I work at Promega Corporation as a Quality Assurance Senior Scientist. My training is in science. I have a PhD in Cellular and Molecular Biology, but what drew me to this job is the fact that I get to help people. I feel like I can contribute. I sit on new product teams, so I get to be one of the team members who helps to make sure that the products are designed – that they’re going to be high quality products, they’re going to be effective products.

That’s the new product side of things, but then on the operations side of things, part of our job is to review the batch records to make sure that the products pass the quality control specifications that were designed to make sure that every time they are manufactured, they still meet those high quality standards.

My poster is talking about the new ISO standard, ISO 18385. It’s a standard specifically for forensic manufacturers with the goal of minimizing human DNA contamination during manufacturing.


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So, over about the past 7 years or so, the STR kits have become more and more sensitive, which is really great. What that means is that forensic DNA labs can analyze trace amounts of DNA from crime scenes, and that increases the body of evidence, and therefore (hopefully) the accuracy with which the criminal justice system can solve crimes. But, increased sensitivity also means that trace amounts of accidental DNA contamination during manufacturing can now be detected.

So, how that impacts our customers is if that contamination is seen during a negative control sample, it invalidates their run, so then they have to do repeat testing, it increases their turnaround time, or it could potentially even result in the loss of a valuable sample. Maybe they only had enough to run the sample once, not twice.

Or, if the contamination is observed when they are analyzing a casework sample, they may not even recognize it as contamination. So, that profile then gets used for further investigation, and that results in wasted police time and efforts.

So, the forensic leaders recognized this problem, and they also recognized that it wasn’t going to go away. And they knew that no existing international standard met the specific needs of minimizing human DNA contamination during manufacturing. So, their goal was to develop a new ISO standard to meet this specific need.

The ISO standard was published in February of this year, and it really wouldn’t be possible without the dedication and hard work of all of the ISO committee members. The members consisted of forensic leaders and manufacturers worldwide, there was 13 participating countries. In the United States, the key forensic leaders were Kermit Channel, who is the Executive Director of the Arkansas Crime Lab. He also was the chair of the US Technical Advisory Group, and Soraya McClung, who is the Scientific Training Director at the Houston Forensic Science Center.

This was actually a really amazing opportunity for me, to get to work with our customers, and to learn what is critical to their success, and then help them achieve that success through the development of the standard.

What we as manufacturers were able to contribute is to help translate their end goal into a set of guidelines that were able to work with manufacturing processes and workflows.

I’ll start by saying that Promega has been manufacturing products for the forensic market for over 20 years, and as a manufacturer of STR kits, we know and have controlled for accidental human contamination over the course of those 20 years. But what this standard provides is the assurance to the customers that forensic manufacturers worldwide are all working to the same set of guidelines that was laid forth by the community itself. And, ultimately, this doesn’t just help the forensic labs, it doesn’t just help the forensic manufacturers, but it really helps the entire criminal justice system.


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