3 replies to this topic

[r.bub]

We had worked with an SQF consultant about 2 years ago and were told that because our in-house QA lab was not ISO 17025 certified, we would have to send product shelf life trials (when deemed necessary for SQF 2.3.1 - Product Development and Realization) to an outside accredited lab.  Is this the case, or is it more of a recommendation than a requirement?

 

I was looking at the SQF Code and could not find anything in 2.3.1 that specifically states shelf life testing must be done by an ISO 17025 accredited lab.  I found reference to ISO 17025 in section 2.5.4:

 

2.5.4.1 The methods, responsibility and criteria for sampling, inspecting and/or analyzing raw materials, finished

product and work in progress shall be documented and implemented. The methods applied shall ensure:

i. Inspections and analyses are completed at regular intervals as required and to agreed specification and

legal requirements;

ii. Inspections are conducted to ensure raw materials, work in process and finished products comply with the

relevant specification, regulatory requirements and are true to label; and

iii. All analyses are conducted to nationally recognized methods or alternative methods which are validated as

equivalent to the nationally recognized methods.

2.5.4.2 On-site personnel that conduct environmental or product testing shall participate in an applicable

proficiency testing program at least annually to ensure accuracy of results.

2.5.4.3 Where external laboratories are utilized to conduct input or product analysis, the laboratories shall be

accredited to ISO 17025 or an equivalent national standard, and shall be included on the site's contract service

specifications register (refer to 2.3.3.1).

2.5.4.4 Records of all inspections and analyses shall be maintained.

 

Our QA lab uses BAM/AOAC approved methods for our in-house micro testing and participates in annual proficiency testing through NSI Labs (they are accredited to ISO 17043 and 17025).

 

Any input would be appreciated.

 

Becky

[Sarah_E_W]

Hi Becky, 

 

although I'm in the UK and work to BRC v8 standards, any validation needs to be carried out by a UKAS acreditted lab. For instance allergen validation can be carried out with rapid swabs used in house, however the finished product would need to be sent to an acredditted lab the verfiry the effectiveness of the rapid swabs if that makes sense.

 

I would pull a schedule together to 'double up' to validate your in house lab versus the accredited one you mention  to cover all bases

[SQFconsultant]

It is pretty clear. If your own techs are not profiency tested then you need to use a lab that is.

[Charles.C]

 

We had worked with an SQF consultant about 2 years ago and were told that because our in-house QA lab was not ISO 17025 certified, we would have to send product shelf life trials (when deemed necessary for SQF 2.3.1 - Product Development and Realization) to an outside accredited lab.  Is this the case, or is it more of a recommendation than a requirement?

 

I was looking at the SQF Code and could not find anything in 2.3.1 that specifically states shelf life testing must be done by an ISO 17025 accredited lab.  I found reference to ISO 17025 in section 2.5.4:

 

2.5.4.1 The methods, responsibility and criteria for sampling, inspecting and/or analyzing raw materials, finished

product and work in progress shall be documented and implemented. The methods applied shall ensure:

i. Inspections and analyses are completed at regular intervals as required and to agreed specification and

legal requirements;

ii. Inspections are conducted to ensure raw materials, work in process and finished products comply with the

relevant specification, regulatory requirements and are true to label; and

iii. All analyses are conducted to nationally recognized methods or alternative methods which are validated as

equivalent to the nationally recognized methods.

2.5.4.2 On-site personnel that conduct environmental or product testing shall participate in an applicable

proficiency testing program at least annually to ensure accuracy of results.

2.5.4.3 Where external laboratories are utilized to conduct input or product analysis, the laboratories shall be

accredited to ISO 17025 or an equivalent national standard, and shall be included on the site's contract service

specifications register (refer to 2.3.3.1).

2.5.4.4 Records of all inspections and analyses shall be maintained.

 

Our QA lab uses BAM/AOAC approved methods for our in-house micro testing and participates in annual proficiency testing through NSI Labs (they are accredited to ISO 17043 and 17025).

 

Any input would be appreciated.

 

Becky

 

Hi Becky,

 

From Guidance sqf 8.1, section 2.5.4 -

 

If  an  internal  or  company  laboratory  is  used,  test  methods  should  be  checked  against  an  accredited  external laboratory at least once per year.

The  supplier  will  demonstrate  that  sampling  of  product  for  inspection  or  analysis  is  completed  using  recognized sampling methods.  

The supplier must ensure that staff is qualified, trained and competent to complete sampling inspection and analyses.  

Records must be maintained of all inspections, tests and analyses.

 

(I assume "supplier" means the Manufacturer in SQF English)

(I doubt that all test methods have to be checked)

 

Re-shelf life, it might depend on what you have to measure. I'm not an SQF user but it seems to me that if the measurements can be done in-house and above-quoted requirements are fulfilled, you are "good to go".

 

@Sarah, TBH it doesn't make sense to me. Surely the validation of a commercial test swab kit is done by their Manufacturer ?

PS - JFI, also see this post/thread regarding use of external labs -

 

https://www.ifsqn.co...on/#entry109437