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Lab testing vs, on line measurments


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MEM

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Posted 22 November 2021 - 02:44 PM

We are a plastics packaging manufacturer and we do in process measurements of our plastic containers like Length, width, flanges, etc.

 

During an audit we were issued a non-conformance against clause 2.4.4.2 for not doing annual proficency testing on the operators ability to use these hand held instruments they use daily.  I don't consider this applicable as this isn't lab testing, but wanted some more opinons.

 

Product analyses shall be conducted to nationally recognized methods, 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 analysis, sampling and testing methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses.

External laboratories shall be accredited to ISO/IEC 17025 or equivalent international standard and included on the site’s contract service specifications list (refer to 2.3.2.7).

 

Thanks for your feedback

 

 

 



olenazh

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Posted 22 November 2021 - 02:47 PM

That requirement does not relate to measurements, but to the lab practices. Contact your CB to object the auditor's comment. I'd also mention lack of knowledge of the auditor...


Edited by olenazh, 22 November 2021 - 02:47 PM.


Scampi

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Posted 22 November 2021 - 03:06 PM

I agree with Olenzah

Online checks are not the same as offline evaluations

 

Assuming if an operator had a reading that didn't jive with the spec, that your QC would do offline evaluation?

 

Push back on this one


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Scampi

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Posted 22 November 2021 - 03:13 PM

the confusion will actually stem from because it mentions raw materials and WIP, but i still believe you should push back

2.4.4.1 The methods, responsibility, and criteria for sampling, inspecting, and/or analyzing raw materials, work-in-progress, and finished product shall be documented and implemented.

The methods applied shall ensure that inspections and analyses are completed at regular intervals as required and to agreed specifications and legal requirements.

Sampling and testing shall be representative of the process batch and ensure that
process controls are maintained to meet specification and formulation.

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kingstudruler1

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Posted 22 November 2021 - 05:14 PM

Are the measurements  "critical to food safety"?   It was my understanding that the clause was meant for only items that effect food safety.    I could be wrong.  

 

 

The guidance document can be found here:   https://www.sqfi.com...and-checklists/



Scotty_SQF

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Posted 23 November 2021 - 12:18 PM

I also agree that you should push back on the CB.  You are correct in your assessment.  The measurements you are conducting is not 'lab testing' and has nothing to do with food safety.






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