8 replies to this topic

[matthewcc]

Hello all, I have a question that I have never seen on the forums. We package and label bottles of capsules and liquids, and the bottle neck seal has a perforation. That is, it has a perforation when the machine applying the plastic neck seal (that is heat-shrunk onto the bottle) is working as it should. It does tend to work intermittently, quite well usually, but with occasional glitches.

 

Our specifications are set up such that the perforation is not a critical step or required, but rather we have in our SOPs and master manufacturing record instructions that we apply a neck seal with a perforation. The perforation on the neck seal is for convenience to make it easier for the consumer to open the bottle.

 

My question is this: During a packaging run, if we find that the perforation has not been done properly, do we have to go back and rework all the bottles that have neck seals without perforation, or is it OK to just let those go since it is not a specification and does not affect food safety?

 

I was on the fence about this because it appears to allow us to have inconsistent product quality if we cannot always say that the bottles we produce will have a perforation on the neck seal.

 

We manufacture dietary supplements in the United States and have SQF food safety and NSF GMP certifications.

 

Thank you,
Matthew

[TimG]

" is it OK to just let those go since it is not a specification and does not affect food safety?" My thoughts on this are that it would be an NCP that you (or someone 'responsible') would inspect, and after inspecting if you determined it was truly not affected food safety nor was it required by spec, you could sign off and release it. 

The issue will be if this happens often enough that you are constantly writing NCP's, you will either want to take measures to lower the occurrence, or put together a risk analysis which shows why this common occurrence issue is cosmetic only and not required for product release.

 

All of that is assuming your customers don't have a problem with the perforations..

[Tony-C]

Hi matthewcc,

 

Your post leads me to a couple of questions:

 

Is quality included in your certification or customer requirements?

 

Do you get complaints regarding people not being able to open the bottles?

 

Kind regards,

 

Tony

[matthewcc]

No, quality is not included in our certification. I think we have received one complaint before from a customer having a hard time opening a bottle, but it has been several years since that.

 

Hi matthewcc,

 

Your post leads me to a couple of questions:

 

Is quality included in your certification or customer requirements?

 

Do you get complaints regarding people not being able to open the bottles?

 

Kind regards,

 

Tony

[Scampi]

I think you should still be investigating the process to find out why it is consistently inconsistent

 

As for rework, I wouldn't waste any time on that, the seal is there after all

[GMO]

If the perforation doesn't work properly, could it lead to a food defence risk, i.e. the cap could be removed in the entirety without the seal breaking so someone could tamper with it undetected?

[matthewcc]

I don't think so, because we still have a seal that is inside the lid. I should have mentioned that earlier.

 

If the perforation doesn't work properly, could it lead to a food defence risk, i.e. the cap could be removed in the entirety without the seal breaking so someone could tamper with it undetected?

[jfrey123]

So the hardest audit I ever sat through, still giving me nightmares to this day, was a customer visit.  She kept marking down various findings, and I was struggling to figure out what standard she was working to, so I finally asked and she simply and plainly stated, "I'm marking findings against your own SOP's."

 

It was a gut shot.  I was new at the time, but still, being called out for failure to enforce your own rules was a punch right in the man-bits.  One example: Did we make auditors and visitors wash their hands?  Boss man said no, because they're not getting close to production, and we "don't want to offend them" (seriously something he said to me).  But our SOP clearly stated, correctly, that all persons entering production must wash hands.  So she wasn't calling out some citation for a standard we were unaware of, she was calling out our own danged SOP.  To this day, it's the audit that haunts me the worst.

So to your question OP:  I don't think there's any hazard here and absolutely not a recall issue, but if your own SOP calls for the shrink wrap to be perforated, then dag-nabbit, your shrink should be perforated.  From a QA standpoint, you've written this into policy somewhere, so it deserves some effort to fix.  From a consumer standpoint, it surely will hurt sales when the little old folks can't easily open your bottles and they remember that when choosing a different brand.

[acarver]

 "From a consumer standpoint, it surely will hurt sales when the little old folks can't easily open your bottles and they remember that when choosing a different brand."

 

I'm "that" little old folk...it makes me crazy when I cannot find the best way to open the bottle and end up with a knife or other dangerous object in hand to do so! And, yes, I will remember and shop different brands next time.