CAPA due to Consumer not following Maintenance Instructions...

Hello,

My company has an open Corrective action. The non-conformance was: End User/Consumer failed to follow the battery charging instructions in the operating instructions and Maintenance Manual. I need to complete/close this CA and would like to know how you have handled similar instances. As a company what can you do when an end user does not follow the maintenance instructions?

FYI - I am new to this website, this is my very first post/question. Any help will be greatly appreciated!

Is this a Corrective Action assigned to you by a customer, or is it an internal Corrective Action generated by someone in your company?

The description

" End User/Consumer failed to follow the battery charging instructions in the operating instructions and Maintenance Manual "

sounds like a trigger incident dressed up and trying to pass as a root cause.

It is an internal corrective action assigned by someone in my company.

Welcome to the Cove:

My guess is the non-conformance is stating the root cause to a different NC. Something like "Batteries failed to operate for expected battery life per [insert standard here]". Like Normzone said, it sounds like the NC is written up to be a root cause.

I would ask the original author.

I think Normzone is correct. I'm not sure you can force an end user to follow instructions.

You could try to protect the company with legal language ("by engaging in the use of this product the user agrees to abide by the maintenance instructions...") or some more formal contract if it is a direct customer/not off- the-shelf or over-the-counter. Legal counsel could give information about liability, etc.

If this involves something like a battery that explodes or a part that causes damage then it's probably time to go back to engineering or legal and review safety and design requirements.

I don't have similar experience. But I will think about end consumer training or double check the IFU whether the instruction for battery change is noticeable.

Maira O. said:

As a company what can you do when an end user does not follow the maintenance instructions?

Click to expand...

Welcome to The Cove, Maira.

One has to realize that not all customer complaints/customer negative feedback has necessarily to trigger a corrective action. There is only so much one can do to "educate" end users and consumers about the necessary care of the device.

One thing you can do is to investigate if the instructions and warning in the manual are clear enough for the typical end users. Is the manual provided in the languages that end users are familiar with?
You can also consider some conspicuous labels on the device itself to ensure certain critical aspects of the device are observed by the users.

But, at the end of the day, we must realize that you can not control how end users will behave. For example, some people never check the oil level in the engine of their cars. When the engine ceases due to lack of lubrication, they can't simply blame the car maker for the problem.

Your system SHOULD allow the investigation to end up with NO CORRECTIVE ACTION NECESSARY, if that is the case.

Maira
What do you have to comply with in your product?
The reason to rise the CA it is because you didnt comply the requirements of product?
Remember, normally a CA is risen when a no conformance appears, although sometimes is solved by a correction.
On the other, hand someone in your company, may rise an OFI if it detects an Opportunity for improvement of the product.
When developing the OFI, you may need to find the root cause, by using fishbone , sw or other methods.
The CA is risen when it is needed to correct something that according to the customer's specs or needs or your requirements was not met.

Hope this helps.

Normzone, is correct the NC stated on the corrective action really is the root cause. The CA was warranted in order to remain "Vigilant". After discussion the staff realized there really is not much we can do as a company to prevent the user from following instructions. The manual has clear instructions, there is no gap in that area. The user simply did not follow them, and that is what brought me here. Was wondering what other companies have done in these situations. We are considering writing a justification document and performing a risk assessment in order to close this CA.

Maira O. said:

Was wondering what other companies have done in these situations. We are considering writing a justification document and performing a risk assessment in order to close this CA.

Click to expand...

It sounds like a customer complaint.

As pointed out above, it did not need to rise to the level of Corrective Action...especially if the corrective action is to take no action to correct it.

Complaint leads to evaluation.
Evaluation leads to determination of NC or not (in this case, there seems to be no NC)
No NC...nothing to correct...followed by risk assessment for doing nothing.
Document the choice to do nothing...and go back to real stuff.
If you choose to act based on the risk assessment...it sounds more like a PA to me.

I've seen these handled as an OFI/PA, and I've seen these filed under "we did it right and the customer broke it" depending on the risk assessment.