2 replies to this topic

[SamIam]

SQF Edition 9 Code 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. We use Hygenia Insite Snap Swabs that get put directly into an incubator and looked at after 48 hours.  For any presumptive positive hits, we send to an outside accredited lab for verification/validation of the presumptive positives. We are not doing actual pathogen testing, just an indicator test looking for pathogens. In other areas of our facility, we also send out swabs directly to an outside accredited lab. We do hands on retraining of our program yearly.  We also dispose of the Insite Snap swabs properly.  Are we technically still considered a laboratory?  We do hands on retraining for the staff yearly, so does this cover the annual proficiency testing for staff? 

[Charles.C]

SQJ Edition 9 Code 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.

We use Hygenia Insite Snap Swabs that get put directly into an incubator and looked at after 48 hours.  For any presumptive positive hits, we send to an outside accredited lab for verification/validation of the presumptive positives. We are not doing actual pathogen testing, just an indicator test looking for pathogens. In other areas of our facility, we also send out swabs directly to an outside accredited lab. We do hands on retraining of our program yearly.  We also dispose of the Insite Snap swabs properly.  Are we technically still considered a laboratory?  We do hands on retraining for the staff yearly, so does this cover the annual proficiency testing for staff? 

 

Hi Samlam,

 

^^^(red) - Based on numerous previous SQF threads, this seems to be a very frequently misunderstood terminology.

 

Can try this  -

 

https://www.campdenb...ncy-schemes.php

 

As to the definition of laboratory, google has -
 

 

a room or building equipped for scientific experiments, research, or teaching, or for the manufacture of drugs or chemicals.

 

So I guess having an incubator might "just" "partially" qualify.

(One might argue that a laboratory should be a room totally dedicated to analytical work which in present case should probably be  automatically complied with since microbial pathogens are potentially being "handled")

[Mulan1010]

  You should go to the SQF Website and listen to their short webinar on Laboratories.  That might help.  From what I have heard listening to the Ed 9 updates I would tend to say you should lean towards being considered an Internal Laboratory.  You may not be confirming your positives but you are testing in your lab and reading the results of the tests; you are only sending out the tests you are saying are reading positive for confirmation. You might consider writing a risk assessment explaining why you do not consider your laboratory to qualify as an Internal Laboratory under SQF Qualifications.  

  From listening to auditors in the past, training is not the same as proficiency testing.  Ideally proficiency testing is some type of test against a known standard but the employee you are testing does not know the end result just the tester does.  That is hard to do for some types of testing so sometimes you have to observe the employee performing test and verify he/she is proficient that way.  Written tests can be considered a form of proficiency testing in some cases if you are testing over a written protocol.

  SQF has been offering some Ask us Anything Web Meetings on the new code.  You could sign up for one and ask your question there; although listening in they were pretty generic in their answers.  There are also some consultants that will answer your questions over the phone and not charge you an arm and a leg.  You might call around and ask for fees.