Packaging Issues Resulted CAR by customer

We are a small manufacturing company that makes plastic tubing for medical devices. We are not the finished product and we hold our cert ISO13485.We received 2 customer complaints that the 2nd outer bag was not there. 2 different employees, and 2 different shifts. The employee missed 6bags that are required by the customer double bagging. I have been here very short time. I notice that they really never address there complaints with solutions just making excuses and leaving the door open for re-occurrence. All final packaging is done in a CLEAN ROOM area but really isn't but its cut off from the production areas. We do order clean room plastic tubing bags that come on rolls and we cut to what ever length of tubing needs packaging. Mind you customer requires the inner bag to be labeled. Then when you get the 2nd bag on sometimes its hard to tell that its there without man handle some of the more sensitive tubing. My question is I am looking for some suggestions on how to mistake proof this besides going to each employee and reminding them to do this. I will also say I cant change the color of the bags either. I am racking my brain out to come of with a simple solution where I'm not adding another step where it still could be missed. Oh yeah I also looked into having the company logo on the outer bag but its not going to work because we cut to desire length.


Thanks for any and all feed back. I really need help with this.

Good day love02eat,

Can you stage the bagging process to clarify the two steps of 1st bag, then second bag?

In order to see if two bags are used, is it possible to have the inner bag a different color? I do not know if approved bags are available in color.

I am at least as concerned about not having clean room conditions if they are required, but that is a separate issue from the bagging.

Good idea. In addition to staging, would it be possible to pre-cut the bags and have available only the amount needed to fill the order? If you get to the end and have bags left, you know you've missed some.

This also might be an opportunity to examine the effectiveness of your inspection process.

The process starts with the double bagging in the actual production area. Work Orders will tell the operator to double bag or single bag the product but it doesn't get the final label. Then the product is sent to QC dept. were they do a final inspection and create the shippable label. I have watched many times in the QC area that when they have there orders they are pre cutting already. we sell our plastic tubing to medical companies so we are limited to using only clear bags. Also the reason why we need to cut is because all our tubes vary in size.

If you can't vary the bags themselves, can you vary how the bags are sealed so they are clearly different and evident?

You mentioned some only require one bag; (although it goes against lean principals) could you put all customers products in two bags to minimize the liklihood of confusion and mistakes?

David

If the inside bag has been cut off a roll and sealed, is it possible to notch off a corner past the seal so that's viewable from the outside of the second bag?

If the issue is taking place in QC we might look there for the need to apply clearly identified staging and the discipline to support it.

I assume you get the packaging bags as flat tubing in roll form
You will know the size and length to cut from the packing tubing for a given item to pack.
The inner bag is smaller than the outer in width and length.
Preparation:
1. Cut to length the inner bag from the tubing. Seal one end.
2. Apply the label.
3. Cut to length the outer bag from the tubing. Seal one end. (Both sealing is validated)
4. Insert inner bag into outer bag.
Packaging:
5. Insert the plastic tube to be packed into the inner bag
6. Seal the inner and outer bag in one go (This sealing is validated)
You may like to mark on the packaging the place to open the packaging for the customer.

David-D said:

If you can't vary the bags themselves, can you vary how the bags are sealed so they are clearly different and evident?

You mentioned some only require one bag; (although it goes against lean principals) could you put all customers products in two bags to minimize the liklihood of confusion and mistakes?

David

Click to expand...

Unfortunately we packaged to there customer requirements. I need something that can stand out but not create another step that may cause another error.

somashekar said:

I assume you get the packaging bags as flat tubing in roll form
You will know the size and length to cut from the packing tubing for a given item to pack.
The inner bag is smaller than the outer in width and length.
Preparation:
1. Cut to length the inner bag from the tubing. Seal one end.
2. Apply the label.
3. Cut to length the outer bag from the tubing. Seal one end. (Both sealing is validated)
4. Insert inner bag into outer bag.
Packaging:
5. Insert the plastic tube to be packed into the inner bag
6. Seal the inner and outer bag in one go (This sealing is validated)
You may like to mark on the packaging the place to open the packaging for the customer.

Click to expand...

yes all bags are cut to certain lengths. and inner is smaller and the outer is bigger not by much. I really need something that would stand out and be noticeable if the 2nd bag got missed. As in said to another person. We cant change the color and the label has to go in the middle.

love02eat said:

I need something that can stand out but not create another step that may cause another error.

Click to expand...

Well, sometimes that extra step is exactly what can prevent more errors. If your operator is trying to do too many things in one step, they may not be able to adequately focus on each task. By separating them, you allow the operator to apply more attention to that particular task, without it getting lost in the shuffle of all the other tasks. Plus, by separating it, you've noted the importance of that step, which some evidently do not see in the current process.