CAR is not good enough! Operator Error!

[Melissa]

Hello All,
I have a problem that I'm looking for some insight too or ideas...

Long story short we are a contract mfg. -- meaning we mfg. products that others have designed. We have been manufacturing a specific product for years with no complaints - recently we got a new employee on the machine, in the last 2 weeks i have gotten 2 complaints. Obviously my "customer" wants me to fix this. We determined it was operator error. (yes i opened a car) Well, the customer said retraining is ONLY PART of a corrective action for them. I understand that's my customer, but that's obviously not good enough for them. I guess I don't know what to tell them -- or some ideas i can do...

The best way to describe a product is (medical device) One time usage adhesive with no liner, and the liner was still on the adhesive.

I am improving the process by extended the line of sight to operator can see that liner has came off properly.

 

[Tagin]

I am improving the process by extended the line of sight to operator can see that liner has came off properly.

This is still relying on the same operator.

Ideally, you want to eliminate the possibility of recurrence. But if that's not possible due to materials/methods required, then detection controls (i.e., inspection) would make sense.

The customer would probably want to see a separate inspection process step performed by a second person, maybe with a signoff record.

 

[William55401]

Think about your CAPA in a more granular fashion. What was the root cause of how the defect was created? What are the actions to eliminate defect creation? What was the root cause of the failure of your firm to detect the issue prior to shipping to your customer? What are the actions to eliminate the gaps in defect detection?

Yes, the new operator has a role. However, your org must design a robust process (including inspections / verifications) that ensures quality product for your customer. Your current training reliant solution is not robust. What happens when the new person moves on? Do you have a complete end to end solution that ensure your customer is not aware of a new operator?

Hope this helps. Have fun. Enjoy the ride!

 

[Sidney Vianna]

Hello All,
I have a problem that I'm looking for some insight too or ideas...

Long story short we are a contract mfg. -- meaning we mfg. products that others have designed. We have been manufacturing a specific product for years with no complaints - recently we got a new employee on the machine, in the last 2 weeks i have gotten 2 complaints. Obviously my "customer" wants me to fix this. We determined it was operator error. (yes i opened a car) Well, the customer said retraining is ONLY PART of a corrective action for them. I understand that's my customer, but that's obviously not good enough for them. I guess I don't know what to tell them -- or some ideas i can do...

The best way to describe a product is (medical device) One time usage adhesive with no liner, and the liner was still on the adhesive.

I am improving the process by extended the line of sight to operator can see that liner has came off properly.

It seems that you are still posting about your previous enquiry @ Complaint about Adhesive and I am not sure why you would create another thread. In my estimation, Ninja's post #7 of that thread pretty much summed up what can be done. Yes, there are ways to get closer to 0 DPPM, but all of them will involve additional costs and/or increased lead time. There is no perfect, defect-free process in the world. You can play the corrective action game with your unreasonable customer and dream of mistake proofing the process even more, but are they willing to bear the additional costs?

 

[Danisa]

Hi,
My supplier always hire many temporary operators/ workers and we are facing many issues related.
I have to say that training is almost no many meanings and you can't assure the defect will not be escaped to customer in future.
Double checking, sampling checking by QA, periodic evaluation the operators and evaluating their skills by making the defective samples then input mass-production to see whether they can detect or not. Those actions I have applied and some cases they can help.
In addition, the most importance is you have to investigate exactly why this defect happened and you will find out the effective action.
Hopefully, this can help you,
Best regards!

 

[RoxaneB]

We determined it was operator error.

Who was involved in this "we?" Was the operator involved in this process where he ends up being the identified root cause?

...the customer said retraining is ONLY PART of a corrective action for them. I understand that's my customer, but that's obviously not good enough for them.

Retraining is a correction, in my opinion, not corrective action. It's like taking cough syrup to help a cold's cough go away and merely masks the symptoms - the cold remains. Corrective action is understanding why the cold was caught in the first place and taking steps to reduce the likelihood of catching a cold again.

I am improving the process by extended the line of sight to operator can see that liner has came off properly.

Why are you doing this? Is the WHY driving this action addressed as a root cause on your CAR?

 

[Melissa]

Operator was involved in the process of his error being the root cause.

Yes the WHY is driving this action -- the problem is the liner, the operator must be able to see -- and before was unable to see far enough which is what also caused the error, not looking down the web far enough and to make that happen we will be placing a mirror to reflect the part.

This is still relying on the same operator.

Ideally, you want to eliminate the possibility of recurrence. But if that's not possible due to materials/methods required, then detection controls (i.e., inspection) would make sense.

The customer would probably want to see a separate inspection process step performed by a second person, maybe with a signoff record.

There really is no way to double check it as the product ends in a roll and it would be more expensive to have someone babysit for 8 hours. We are unable to move this operator.

 

[Tagin]

There really is no way to double check it as the product ends in a roll and it would be more expensive to have someone babysit for 8 hours. We are unable to move this operator.

If that is the case, then per ISO 13485:

7.5.6 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

(italics added)

 

[blackholequasar]

IMHO if the operator is not able to perform the job function at a quality level, they should be moved from that operation. What is the cost going to be when you lose the customer due to quality issues? Your facility is either unable or unwilling; both of those situations need to be seriously weighed out. I know that I have had quality concerns with my vendors and when they refuse to make changes, I find a new vendor. And likewise, my customer can do the same to me.

I would have a serious conversation on how far your company really wants to take the issue because it sounds like you're chalking it up to "the operator sucks" and quite inflexible about a resolution.

It reminds me of a quote I have hanging at my desk: The bitterness of poor quality remains long after the sweetness of low price is forgotten

 

[Sidney Vianna]

What is the cost going to be when you lose the customer due to quality issues?

If a customer is willing to drop a supplier with a 2.5 DPPM and gamble on finding a better one, good luck to them. If corrective actions could lead to perfect, defect-free processes, we all would have reached utopia by now.