Autoclave Log - Do we have to monitor the usage for every load?

K

kwikkid

#1
In order to be compliant with ISO 17025, I made an autoclave log to track the usage of each load. There are weekly maintenance checks that they are required to fill out. Lab techs are required to record the results of the autoclave tape, and the sterilization start/end times, as well as pressure along with the description of the load.

Now, being new to ISO 17025, do we have to monitor the usage for every load? Is this a requirement? Or is this information too much as I am getting complaints from the lab techs that the information is redundant.
 

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AnaMariaVR2

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#2
I say yes but I don't know your industry nor your product nor your regulations. My mindset is:
- as best practice, yes...if it is not written it never happened...just a rumor, not evidence. And when things go wrong, which in labs it is the bread & butter of every day, it would be more difficult to track down the root cause of it.
- if this is an accredited microbiology lab, absolutely a must.
- if this is part of assuring sterility, stability, cleanliness, prevent contamination, etc., such documentation will be critical.
- if the data generated is used to make business decisions or regulatory scrutiny depends on it---another yes to have an autoclave log.

Here is a good resource: Complying with ISO 17025:: A practical guidebook
for meeting the requirements of laboratory accreditation schemes based on ISO 17025:2005 or equivalent national standards
http://www.unido.org/fileadmin/user_media/Publications/Pub_free/Complying_with_ISO_17025_A_practical_guidebook.pdf

Good luck


PS: whatever it is decided, then have an SOP capturing that process so it is clear to everybody
 
K

kwikkid

#3
Thank you so much!

I totally agree, I guess the hardest part is to convince lab technicians the importance of documenting these events as proof of compliance to a standard.

We are a cannabis analytical lab and part of our testing involves screening for mold and yeast. We autoclave our agar, and water.
 
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