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Looking for corrective action of violation of product lab test results

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carine

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Posted 24 April 2014 - 04:12 AM

Hi all, i'm wondering anyone of u got example of corrective action for violation product lab test results. Thanks in advance.    



fgjuadi

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Posted 24 April 2014 - 12:05 PM

It really depends on the violation


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Charles.C

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Posted 24 April 2014 - 04:59 PM

And maybe -

 

(1) the product

 

(2) the lab

 

(3) the test

 

(4) the results

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


carine

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Posted 25 April 2014 - 03:15 AM

the test results of product out of limit. Should we request re-sampling? Stop production? What is the corrective action should we do? 



fgjuadi

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Posted 25 April 2014 - 11:32 AM

It depends on what the test was, what your product is, and what the limit is.

If you make baby formula and you found pathogen in your finished product, that is different than if you make cardboard packaging and found high APC. 


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cazyncymru

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Posted 25 April 2014 - 12:39 PM

If the test result is outside of your agreed parameters, the of course you must repeat the test.

 

Depending on what the test was, then it may be prudent to stop production (if the test is measuring a CCP), or place product on hold. If production is stopped, then you will need to place everything since the LAST GOOD CHECK on hold.

 

You would then need to establish a testing regime for the product you have on hold.

 

I'm astonished you don't already have this documented.

 

Caz



BhardwajSneha

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Posted 26 April 2014 - 04:16 AM

Hey

 

It really depends on a no. of factors like

1 what product (Finished or raw)

2 what parameter did it fail on (Total plate count or any pathogen)

3 what is the critical limit for the test

 

For the corrective action..Say for example, if it is a finished product and say it failed on TPC then u can consider reveiwing the shelflife of raw materials used, and keeping conditions of your products.

 

Or, if it is a finised product showing high pathogenic load, then there is definitely some handling problem which has led to contamination of the product at some point in the production line.

 

These are just examples... and may not apply in your case. Just remember that analysing Microbiological results for charting the Corrective action plan depends on various factors. You'll have to analyse acordingly.

 

Good Luck

 

Sneha



Charles.C

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Posted 26 April 2014 - 08:51 AM

Dear carine,

 

Actually the terminology in yr OP did sound quite serious in which case it may be appropriate to assume a worst case, crisis-type, FS scenario. Especially if you have internal reasons to believe the reported serious defect.

 

As per previous posts, most companies already have a documented response for such cases which is ready to implement. Usually involves a mixed Management Responsibility ( > Correction / Damage Limitation).

 

I assume the defect is believed to be ongoing.

 

Corrective action minimally involves stopping production / segregation processed material and considering a recall of any related shipped material.

 

Simultaneously verify the validity of the failure report.

 

Rgds / Charles.C

 

PS- of course, if you are responsible for QA and yr alert as above turns out to be a case of  "cry wolf", better have some rock-solid, validated explanations at hand ! :smile:


Kind Regards,

 

Charles.C




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