Where quality systems, microbiology, and data-driven thinking meet – translating complexity into clear, actionable outcomes.
Over the last several months I’ve been developing a personal project called Quality OS where I have been building the Quality Management System I have always wanted.
It started as a way to explore better document control and change management for regulated manufacturing environments. Since then it has grown into a self-hosted Quality Management platform designed around practical quality system workflows rather than generic document storage.
Current capabilities include: Continue reading
Over the last few weeks I’ve been building a demonstration quality platform using self-hosted, open-source software.
What started as a simple Quality Management System (QMS) quickly evolved into a broader question:
Could a small or medium manufacturer operate an integrated quality ecosystem without relying on multiple disconnected platforms and duplicate data entry?
Areas I’m currently exploring include: Continue reading
Recently I’ve been involved in moving a training matrix from a spreadsheet-based system into Rapid Global.
It’s been an interesting process because the platform itself had already been selected and implemented before I became involved, so rather than writing a URS and evaluating systems beforehand, the focus became understanding the capabilities of the existing platform and adapting the training framework around it. Continue reading
One of the most overlooked indicators of a company’s internal systems is how it handles recruitment.
What stands out to me is the consistency of communication during the process, or rather the lack of it.
Over the past decade, I’ve kept a fairly consistent log of recruiter interactions. One pattern stands out: communication is strong at the beginning of the process with the position discussed, candidate alignment established and engagement is positive. Continue reading
In any cleaning validation program, two common sample methods usually used.
One is rinse sampling and the other is swab sampling.
For swab sampling, some companies choose to use a 25 cm² swab area, others are using a 100 cm².
As per my limited info, no regulation ask to use a specific swab area.
But since you choose to use one of them, there must be a scientific rational/ justification, right ?
is it because, the larger is your swab area, the greater residues you can swab and recover ?
practically, some factors affect and effected by determining a swab surface area, Like ; recovery, the swabbed equipment part, residue limit..etc.
so, what is yours ?
Having worked in sterile production environments where contamination control was vital, there were zero exceptions to following the established procedures. Exceptions would invariably lead to unacceptable outcomes. With regards to lock-down and quarantine in relation to SARS-COV-2, there are many exceptions and deviations from the requirements. That will only lead to….you guessed it, an unacceptable outcome. With this in mind, I present to you a brief article on contamination control in sterile production environments. Continue reading
The Question posed directly:
“Hi. I have a cleanroom question. When collecting an air sample with an air sampler device can you put the impactor head down when changing the plate. Can you put the lid of the plate down when you change the plate. What do you do with the two lids when changing the plate as I thought you could not put them down.
Thanks“
I wrote the first version of this article in 2014 based on training I developed in 2006. I have updated and reviewed the content to ensure it remains relevant in 2020.
When testing non sterile products, as well as allowed numbers of microbes, there are certain types of microbes that are specified in the regulations as not allowed and still others that can de deemed to be objectionable.
If you work as a microbiologist where you test total microbial aerobic counts (TMAC), total yeast and mould counts (TMYC) and for specific microbes or conduct investigations into the nature of microbes and what impact they may have on the product and the end user, this presentation will benefit you. I will teach you the the following:
