Would you have laboratory personnel help release product?
Hi there ~
I didn't see this topic posted anywhere, but does your company have laboratory personnel help with final ingredient/product evaluation and release product? Would there need to be separation between 1) folks who perform laboratory testing and 2) those who determine whether specifications are met and release the product? What are your thoughts on how many "eyes" on the ingredient/product are enough?
We currently have two persons evaluate each ingredient and product to determine whether specifications are met and release product. Those workers are almost always entirely separate and independent from those who perform the laboratory testing. Is that separation necessary?
We manufacture dietary supplements in the United States under 21 CFR Part 111 and 117.
Thank you,
Matthew
Hi there ~
I didn't see this topic posted anywhere, but does your company have laboratory personnel help with final ingredient/product evaluation and release product? Would there need to be separation between 1) folks who perform laboratory testing and 2) those who determine whether specifications are met and release the product? What are your thoughts on how many "eyes" on the ingredient/product are enough?
We currently have two persons evaluate each ingredient and product to determine whether specifications are met and release product. Those workers are almost always entirely separate and independent from those who perform the laboratory testing. Is that separation necessary?
We manufacture dietary supplements in the United States under 21 CFR Part 111 and 117.
Thank you,
Matthew
Hi matthew,
It sounds like the Company Policy is "Trust Nobody".
Is there some background context / specific Security issues / previous event(s) which have promulgated this "need to know" type arrangement, eg perhaps a Coca-Cola like Product or record of Industrial espionage ?.
@Charles.C -
Thanks. No, it's not company policy, and there are no background issues or previous events such as corporate espionage. It's only the viewpoint of certain laboratory personnel who think they shouldn't be involved in the material final evaluation and release because they think there should be "more eyes" on the paperwork. The cynical side of me says that they want to get out of doing more work. However, I think the reality is more like they don't trust themselves to catch mistakes and don't necessarily have the time or feel like doing what they don't see as their core duties.
Well, smaller companies certainly have these shared duties, after all, there aren't enough people around to separate the duties even if you wanted to.
I don't see a conflict between someone performing a test and releasing the product. What you're really doing there is having someone who has the requisite expertise to review those test results actually make the call, and hopefully your lab staff don't have any sort of conflict of interest in place that would encourage them to report false results (such as a negative "postiive result" culture).
At my last plant all of the food safety end-item testing was performed and reported/approved by the micro peeps. But we did have a second reviewer simply to compare the spec to the numbers and make sure there were no alarming typos. A great example would be commonly people would forget to type the "<" before a value, and suddenly there was E. coli found in the product per the paperwork. A small typo, but a meaningful one that happened when you see the same paperwork day in-day out.
TL;DR, I don't see a particular conflict from them releasing the product, but I also see the value in having a second set of eyes make sure that your CoA's make sense and that no one becomes blind to their own errors.
Depends on the process, the organizational setup with levels of responsibility.
FWIW...in our facility the QA techs generally release the products. My QA Supervisor and myself rarely release any product. We are organized where the QA techs are doing all the testing and once that testing is complete and passed (in the limits) then they release the product. If outside of the QA test limits then they communicate the findings to my Supervisor and/or myself and we make a decision.