We now fully understand the cost implications of reworking the bags and have identified a clear failure pattern that has only occurred in this current batch. Most of the failures are occurring in the same area where the seal is separating.I worked at more than one organization that ‘rebranded’ a manufacturer’s product - both our design and their design. If you rework the bags you are most likely legally responsible and you may even have shared liability for the non-reworked bags…but I am not product liability lawyer - this is not advice only sharing of my experience. You need to consult your own lawyer….
The seal of the bag is a critical to function characteristic. And the waste it is supposed to contain is a high risk thing - maybe not the highest risk (death) depending on its actual usage, but it’s high. Any rework should be validated and approved - there is no indication that you are truly capable of reworking these bags since you ‘subcontracted’ the work.
AQL sampling is substandard both statistically and practically. (First of all most people never understand that AQL stand for acceptable defect rate that will be shipped and then they select an incredibly high acceptable defect rate to keep the sample size low.There are plans that are statistically and practically viable but too few people understand them - including statistical reviewers at regulatory agencies). 100% inspection is the only inspection/test for these bags until you truly understand the process and all failure causes - but it too needs to be validated if it isn’t destruct. Both the inspection effectiveness and its potential harm to the bag seal. Even the process of non-destruct testing can weaken the bag if it isn’t properly designed and validated. And the process itself needs to be properly validated (rework or initial seal).
You should also be performing causal investigation to understand and rectify the causal mechanism. Is there any temporal (time based) pattern to the failures? Is there any pattern within the bag for the compromised seal on the bag? Is there any indication of contamination or lack of sealant or lack of properly applied seal method? Etc. someplace to start….
I’m sorry that you are in a small company but that doesn’t excuse you from the obligation to provide safe products and to take the type actions required to manufacture safe products.
…and yes get rid of that ‘subcontracted’ manufacturer.
Since the bags are heat-sealable, our investigation suggests that the sealing method is faulty. We have already reported this issue to our subcontractor and are currently awaiting the results of their internal investigation.
We recognize the importance of product safety and are proactively working to resolve this issue. Patient safety remains our top priority.
we are now in the process of finding a new subcontractor. Over the next 4–6 months, our focus will be on:
Reevaluating our testing process to improve defect detection.
Identifying a new, more reliable supplier with stronger quality control.
Strengthening our inspection process to ensure robust quality assurance moving forward.
Thank you so much
