7 replies to this topic

[Alexxx]

Hi everyone,

As part of my procedures and schedule, I have to performed gluten tests on our products. Last month, we ran out of test kit and did not order in time to receive them before the end of the month. We only received them this month and did the tests ASAP. I would like to know if this needs a non-conformity with corrective action? This delay should have caused no increase risks since we are a gluten-free facility and have a very good supplier approval system to prevent any potential contaminations. We have also never tested positive for gluten tests.

 

Thanks.

[Scampi]

No, I don't believe you are ok with this

 

How frequently are you supposed to test and are your products labelled gluten free?

 

Assuming you receive a CoA for each lot of ingredients?

[Alexxx]

They are labeled and yes we do receive all CoA from our ingredients. 

And could you please elaborate why it is not okay if it was delayed by 2 weeks? It is not a test that we do every month.

[Scampi]

Ah, you didn't mention that part!

 

So you are in deviation of your frequency?  or not

[Alexxx]

Exactly. The test is usually schedule for January but was done this month (February), when we received the new test kit. We mentioned on the documents why the test was delayed by 2 weeks but I want to know if a corrective action is also needed.
Out of curiosity, what would have been the difference if the test is monthly and was missed? 

[Scampi]

I would simply write up a deviation or CAPA to state that you knew it was missed and why

 

the difficulty will be in the preventive action-------can you put your test kits on an auto fill order?

 

BTW I do feel it's odd that you label gluten free, but don't test more frequently, but that's just my opinion 

[GMO]

I agree.  If your risk assessment says you need to test by x date, write up the CAPA.  Then put in a auto reorder or Kanban system or visual management of some kind so you don't run out as a PA.

 

But if it's not concerning you that you were late, perhaps your risk assessment and test frequency needs review anyway?  But that's more of an opportunity than a preventive action.

 

As to whether your testing frequency is enough for GF, that's probably another question.

Edited by GMO, 01 March 2025 - 07:43 AM.

[jfrey123]

Exactly. The test is usually schedule for January but was done this month (February), when we received the new test kit. We mentioned on the documents why the test was delayed by 2 weeks but I want to know if a corrective action is also needed.
Out of curiosity, what would have been the difference if the test is monthly and was missed? 

 

The difference would be you're failing to follow your own program if you don't perform a test you've determined needs to be performed.  You're already kind of dismissed this as a non-issue by stating your whole facility is gluten-free and whatnot, but for whatever reason your existing HA dictates that you need gluten testing on your finished goods.  The tests are being done for a reason.

 

If your SOP currently doesn't specify what should be done when a test cannot be performed at its prescribed time, the SOP needs to be updated as part of this CAPA.