Packaging Instruction and BOM Control - Manufacturer of a medical device

S

sardonyx

#1
Hi All

Can someone help me on our issue? We are a manufacturer of a medical device and we have a contract manufacturer to assemble our finish product and our office is just an R&D. We are buying a front cover sub-assembly from a different plastic manufacturer and they are shipping that sub-assembly to our contract manufacturer (CM). The issue is they are asking us to provide them the Bill of Materials of the packaging of the front cover assembly and the packaging instructions but initally they were the one who shipped and packed the parts to our CM. Do we have control of their packaging instructions and BOM? My thinking is they can have their own procedure on how to ship our parts to our CM since we will not have a direct contact with them only with our CM. Am I right? I don't know why they are asking the BOM and instructions which we don't know in the first place on how they were doing the packaging. And now, we have to ask them the information and create the BOM for them? It's a waste of time! Why can't they just create their own BOM and we approved it? Is this possible? I'm confused? :bonk:
 
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CarolX

Super Moderator
Super Moderator
#2
Well, I will try not to get too harsh here. Your plastic shop and CM are job shops. They are producing parts to your design. Why do you think design ends with the part? Your suppliers do not have design authority, you do. Obviously, there is some issue related to packaging and the plastic shop is looking for some instructions from the design owner…in other words…You. This is your responsibility.

I have a customer who puts this note on their drawings “PACKAGING SHALL PROVIDE PROTECTION DURING SHIPMENT, HANDLING AND STORAGE. PART SEPARATION IS REQUIRED WHEN SHIFTING OR RUBBING COULD CAUSE DAMAGE TO PART.” I have request more specific instructions from our customer because a) we use their specified shipper – what are the shippers handling procedures? b) what are the storage conditions – outside in the elements or a controlled environment. Unfortunately, our customer was unresponsive to our requests – and now we reject all claims against us for “damage”.
 
S

sardonyx

#3
Thanks Carol

Maybe I misunderstood the process, :yes: now I understand it....do you have any sample procedure for packaging that involves job shops as you mentioned? Or maybe can someone send a similar sample on the packaging procedure or instruction? :frust:
 
S

sardonyx

#4
More question regarding packaging, the job shop or our plastic CM is using ziploc bags, and they are using these to prevent contamination from cardboard residue due to static. Is this acceptable? I'm suggesting ESD bag but our director of engineering & manufacturing said it is ok to use ziploc, I do not agree with them. Am I right? If they are trying to prevent static why don't they use ESD bag, for me this is more safe than ziploc. :confused:
 

Al Rosen

Staff member
Super Moderator
#5
sardonyx said:
More question regarding packaging, the job shop or our plastic CM is using ziploc bags, and they are using these to prevent contamination from cardboard residue due to static. Is this acceptable? I'm suggesting ESD bag but our director of engineering & manufacturing said it is ok to use ziploc, I do not agree with them. Am I right? If they are trying to prevent static why don't they use ESD bag, for me this is more safe than ziploc. :confused:
There are basically two types of ESD safe bags. One type minimizes the generation of charge and one dissipates a charge. The former is used for hardware and the latter for storing electronic components.

What Type of ESD Bag Is Best for You?
 

CarolX

Super Moderator
Super Moderator
#6
sardonyx said:
If they are trying to prevent static why don't they use ESD bag, for me this is more safe than ziploc.
I am no expert on ESD - but it sounds like you are trying to keep the parts clean, not prevent damage from static discharge. If that is the case, ziploc bags should be fine.

I will look for some sample instructions for you. I don't have access to them today.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#8
sardonyx said:
More question regarding packaging, the job shop or our plastic CM is using ziploc bags, and they are using these to prevent contamination from cardboard residue due to static. Is this acceptable? I'm suggesting ESD bag but our director of engineering & manufacturing said it is ok to use ziploc, I do not agree with them. Am I right? If they are trying to prevent static why don't they use ESD bag, for me this is more safe than ziploc. :confused:
If the issue is to prevent contamination from the cardboard cartons a ziploc type baggie should be fine.
I worked for a plastic injection and blow molder that makes pharmaceutical containers and we never used ESD bags - just plastic bags to keep dirt and cardboard particulate out of the parts.
In my current company we make parts that are cleaned for Oxygen service and we use heat sealed bags.
If static is a concern perhaps you can ask if your plastic shop can blow the parts off with a ionizing air gun before packaging?
 

Manoj Mathur

Quite Involved in Discussions
#9
I am attaching a few of my SOPs for packaging.
That is how we do packing for our Foil Products. For Alloy wheels pacakaging is sometimes specified by OEMs which I canj not attach due to OEMs restrictions.

Regards,

Manoj Mathur
 
S

sardonyx

#10
Thanks for all your inputs.
Here's what the jobshop emailed to us,
"10 X 13 2MIL Ziploc Bags - Bags are used to prevent contamination from cardboard residue due to static"

Does it mean we don't need an ESD bag? :confused:

BTW, Manoj where is your attachment? I can't find it here.
 
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