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[Spnzy_obdz]

Greetings Everyone,

 

Hi FSQA MKE,

 

We have a little block incubator from Hygiena where we incubate the swabs. But we keep the block incubator in an entirely separate building (far away) from the products. I have also watched the training videos on how to use the incubator as well as how to dispose of the swabs properly, all of which I do in a separate building away from the product. I only swab the product zones with the InSite swab and then promptly walk the swabs over to the other (detached) building where the incubator sits and where I dispose of the swabs. 

 

We are planning to adapt this kind of set up in our facility. We have a separate building where we are planning to store samples for Incubation per the Standards of BRCGS but I still need the following Questions to be answered:

 

1) Do we need to apply for an ISO/IEC 17025 Certification?

2) Would it be ACCEPTABLE if we send Swab Samples to an external lab (Quarterly) or if there is a Presumptive Positive for Validation of Results.

 

We are also looking for several options but it looks like we are likely to use Hygiena InSite Listeria Glo/Listeria Sp/Salmonella Test Kits.

 

Thank you in advance,

SP

Edited by Charles.C, 27 May 2023 - 01:24 AM.
split from 41661

[Tony-C]

Hi Spnzy_obdz,

 

Setting up a laboratory can be done but does require some management and experience. IMO it is better to have the site laboratory certified to ISO/IEC 17025. I have posted relevant requirements for the BRCGS Global Standard for Food Safety Issue 9 below.

 

Clause 4.6.4 covers pathogen testing, it is acceptable to send to an external laboratory:

Pathogen testing (including pathogens tested as part of the site’s environmental monitoring programme) shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facility shall be fully segregated from the production and storage areas and have operating procedures to prevent any risk of contamination of products or production areas.

 

For your on-site laboratory, you will also need to comply with requirements of 4.6.5 - Design of laboratory facilities regarding laboratory operation including attention to:

- design and operation of drainage and ventilation systems

- access and security

- movement of laboratory personnel

- hygiene and protective clothing arrangements

- disposal of laboratory waste

 

Clause 4.6.6 covers ISO/IEC 17025 certification, it is advisable but not compulsory as long as the laboratory operates in accordance with ISO/IEC 17025:

 

Where the company undertakes or subcontracts analyses which are critical to product safety, authenticity or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO/IEC 17025, including proficiency testing where applicable. Documented justification shall be available where accredited methods are not undertaken.

 

Also note any external laboratory will need to be approved and monitored as per clause 3.5.3 Management of suppliers of services

 

Kind regards,

 

Tony