Receiving Inspection - One drum leaks - Should entire lot be rejected?

A

alanchencn

#1
Dear all,
I came across one issue in our plant. We received 160drums of Raw material with the same batch. During inspection to this incoming material, we observed one drum with material leaking. We tested to the other drums (according to sampling procedure)to get satisfactory result.

I understand that we need to conduct investigation to the root cause of material leakage and perform risk assessment to use other drums of material but My question is that if we can not get definite root cause or just suspection (e.g. shipping damage), should we reject all drums or just reject the one with leakage? Is there any guidance to support/describe this kind of case (not for failure of incoming material testing, but just for failure of visual check)?

Thanks for any input!
 
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S

SilverHawk

#2
Re: Receiving inspection. One drum leaks, should entire lot be rejected?

Out of 160 drums, you should have collected a sampling based on your sampling plan. For example if the lot size is 160 and the sample size is 25, randomly open the cap of teh drum and collect the sample to test the raw material. If found to be within the spec, accept the lot.

BUT, now most organization is practicing a Zero Acceptance Inspection! In other words, if one drum is found not to be meeting the acceptance criteria, then the whole lot is rejected.

Perhaps, you should investigate whether the leaking drum is due to the logistic problem or is it that the packaging is not meeting any UN packaging requirements. If the leaking is due to poor packaging and not meeting the packaging requirements, it is necessary to reject the whole lot.
 

qusys

Trusted Information Resource
#3
Re: Receiving inspection. One drum leaks, should entire lot be rejected?

Dear all,
I came across one issue in our plant. We received 160drums of Raw material with the same batch. During inspection to this incoming material, we observed one drum with material leaking. We tested to the other drums (according to sampling procedure)to get satisfactory result.

I understand that we need to conduct investigation to the root cause of material leakage and perform risk assessment to use other drums of material but My question is that if we can not get definite root cause or just suspection (e.g. shipping damage), should we reject all drums or just reject the one with leakage? Is there any guidance to support/describe this kind of case (not for failure of incoming material testing, but just for failure of visual check)?

Thanks for any input!
Which are the incoming procedure that you have agreed with your supplier for this case? WHich are the agreement in place for this kind of material shipping?
I think that you could meet with the control of non conforming product and you shall follow the related procedure.
We should need more details to have a better understanding of the issue:bigwave:
 

somashekar

Staff member
Super Moderator
#4
Re: Receiving inspection. One drum leaks, should entire lot be rejected?

Dear all,
I came across one issue in our plant. We received 160drums of Raw material with the same batch. During inspection to this incoming material, we observed one drum with material leaking. We tested to the other drums (according to sampling procedure)to get satisfactory result.

I understand that we need to conduct investigation to the root cause of material leakage and perform risk assessment to use other drums of material but My question is that if we can not get definite root cause or just suspection (e.g. shipping damage), should we reject all drums or just reject the one with leakage? Is there any guidance to support/describe this kind of case (not for failure of incoming material testing, but just for failure of visual check)?

Thanks for any input!
Welcome to the cove alanchencn ...
If I were to be in your place I would reject just that one leaking drum, and set the others in further process after 100% inspection for the leakage aspect, same time try and find out what could have caused leakage of just that one drum, and how much it is due to our own handling, transporters handling, manufacturers handling, etc by a better study of the type and extent of leakage to find out what further needs to be strengthened. I would communicate to all concerned in the supply chain to find out potentially what could have been the cause of such a leakage, take pictures and share and build awareness about handling and transportation etc. I would also look at how to claim insurance of the damaged drum.
 

harry

Super Moderator
#5
..............................Is there any guidance to support/describe this kind of case (not for failure of incoming material testing, but just for failure of visual check)? ..........................
The principle of 'mutually beneficial supplier relationships' should be used in trying to reach a decision in this case. First, it has nothing to do with product quality (so outright rejection is unfair) - it is a secondary issue on packaging. Is this an isolated case or had there been similar issues previously?

What one can also do is to have a physical examination of the drum for signs of external damage. If there is, it is usually something to do with handling, transport/logistics. If not and if there were previous issues, you may want to invoke your CAPA mechanism with the hope of putting an end to it.
 
A

alanchencn

#6
Thanks to all your valuable inputs!

We have one checklist for incoming material physical check such as package status etc.

Only passed primary check, can we receive the incoming material to our warehouse, and then QC conduct sampling&test.

To my understanding, during primary check stage, if some pieces are found out damage, is may not possible to conduct investigation prior to making decision to receive or not.

Also I understand that we need to do risk assessment/find out root cause, but for quick decision of receipt or not, I just wonder if it is proper to reject the damaged pieces and accept other piece? Is there any guidance to reflect this kind of procedure?
 
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