What is considered a "Critical" Raw Material? (Re: DNA Synthesis)


This was the closest forum to my question.

We a re a start up DNA synthesis company looking to get certified for ISO 9001:2015. I am seeking advice on what is considered a "critical" raw material. We track the raw materials we use, but we have no process of inspection before use. The raw material comes in, we use it in our process, track what we used, and thats it.... My past experience quality control had to test raw materials, or inspect C of A before release to production.

Any feedback is appreciated.


Sidney Vianna

Post Responsibly
Start-up organizations are always at a "disadvantage" because resources are scarce, but many fail to proceed to the next stage of maturity because they make fatal mistakes, exactly, due to the lack of resources.

The academic answer to your question is found in ISO 9001:2015, 8.4.2 d).

Your organization must decide on how such (critical) materials are verified to ensure they are in conformance with the required specs.

Like you inferred, previous versions of the ISO 9001 standard allowed for incoming inspection, source inspection, supplier's certification (CoC), third-party testing, etc... as means of verifying such conformance.

From a risk based thinking perspective, ordering critical raw materials and processing them without verifying their adequacy would violate the intent and requirements of ISO 9001, besides exposing the organization to a litany of liability cases.


Hi Sidney,

Thanks for the quick reply. Also, for pointing out the direct clause in ISO 9001:2015. It has been a struggle trying to explain why we need certain standards in place, when I cant navigate thought the new ISO 9001:2015, as I could in the 2008, lots of new verbiage...

I know what is required, and how we should probably be doing them, but getting everyone on board and understanding why id our first step.

My next step is to determine how we define "critical" raw materials. We use syringes, plates, reagents, enzymes, etc... To me"critical" would be any raw material used to make our product/services, as similarly stated in 8.4.1 (a).


Fully vaccinated are you?
Some people are pointing to using FMEAs to provide documentation that some things such as determining the criticality of the function/material/etc has, in fact, taken place. Of course the issue then becomes defining FMEA content (i.e.: what the potential failure modes are).

There is a lot out there about Risk Analysis - I did a G search and there are even software packages which claim to be proficient at risk analysis. I have no connection to the following, have never used it, but I do understand the essentials of what the software is essentially doing. https://www.mindtools.com/pages/article/newTMC_07.htm The page is an interesting read for some ideas.

When you posted I was a bit surprised. We don't get many people in DNA products here in the forums. I was glad you posted and happy Sidney replied.

My major in college (early 1970's) was biology. It's rather interesting knowing how limited the knowledge of DNA was when I was in college and what is known today. The advances in knowledge and technology over that time is simply amazing.
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