3 replies to this topic

[larissaj]

Hello, I dont have the typical lab. I own the hygenia incubator and listeria swabs and the salmonella swabs. We do a yearly GMP audit but will soon be doing SQF. With the GMP audit last year they said that with the incubator I am considered a lab because of the swabs we are doing. Is there an easy GLP program out there that I can see?  With that being said I took the advice from the auditor and I have a lock on my door and a sign, I just need the program but I dont know where to start because we only do those swab and we dispose of them with bleach like we are supposed to.  Any advise would be greatly appreciated. 

[FSQA]

Check Post # 2,

 

https://www.ifsqn.co...tory-practices/

 

Since you have an incubator in the lab, you will need to have better control and negative pressure should be maintained at all times.

[larissaj]

https://www.hygiena....ock-incubators/

 

The small block is what I have, everything is in the swabbing tube. Its just by heat from the incubator. So its not the same as the other incubators.

[kingstudruler1]

2.4.4.2   Product analyses shall be conducted to nationally recognized methods or company requirements, or alternative methods that are validated as equivalent to the nationally recognized methods. Where internal laboratories are used to conduct input, environmental, or product analyses, sampling and testing methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses.

 

you will need to meet the requirements of 17025 testing.   in particular proficiency testing,   I have pasted a link below and attached a checklist I found online.  it is my understanding that SQF auditiors are not being trained on 17025, so there might be a lot of subjectivity.  

 

I would review 17025 and make sure you have as much covered as possible.  (training, proficiency, subjectivity, calibration, approved methods, standards, controls, records etc.    maybe even create a lab  policy / procedure that covers how you address the requirements.  

 

 

http://www.nobelcert... 17025-2017.pdf

 

 

 

Attached Files

•  ISOIEC17025Cklist-2009-compatibleWord2003-2.doc   681.5KB   45 downloads