Nonconforming product at customer detected by a routine inspection by field service

[Thomas Dorner]

Hi,

I would like to pick your brains to a topic I struggle with:

We have an internal discussion about, whether a nonconforming part from the field (detected by a routine inspection by field service) should be send back to our facility for further evaluation or not. Concerns that were brought up not to have them back at the factory are like; Shipping costs, Labor, taxes/duties etc.

In the event of a failed part, wouldn't it be useful to investigate further and set appropriate measures for prevention in place (e.g. Design Change, further discussion with Supplier for replacement etc.)?

I am eager to hear your opinions and how you are handle such situations in your company. Do you have rules established that determine when a nonconforming part has to send back to the factory and if not what should happen?

Thank you in advance for your inputs,
Thomas

 

[Edward Reesor]

Our products are disposable, inexpensive medical devices that are very cost sensitive, yet perform a vital role in critical care. Therefore, costs involving shipping back and forth can end up being far more that the original cost of the device itself. Whenever we experience an issue with the device, we insist that the device be returned in the original packaging at all times. Preferably, we like to receive pictures of the device and label as soon as possible so we can trace all devices with the same lot and model number and try to determine what immediate action is required. It can take weeks to have a device returned, at times longer than the timelines we set as a goal to resolve such cases.

Once it is returned, marked and quarantined away from the other devices, it undergoes immediate inspection and testing. More often than not, there are signs from the original packaging that the device has been manipulated in some way (parts destroyed, augmented or missing). To be honest, more often than not the non-conformance can be traced back to user failure in some way, shape or form.

Regardless of the cause, all non-conforming products are reassessed for changes, whether its to the IFU, labeling or design changes to the device itself. Proper failure analysis would direct you to the resolution and follow-up surveillance would verify the effectiveness.

 

[blackholequasar]

Are you able to have a field tech access the product that failed and provide feedback? Places I've worked in the past sent international items that were very large - it was too expensive and too high of a risk to have them returned to the facility so we would send field techs (or roaming techs who we could hire to evaluate the product).

All feedback is valuable, and the best way to really get to the guts of the issue is to have the product returned in like-condition. @Edward Reesor makes some very good points as well - assessment is definitely key!

 

[Mike S.]

It depends.....

You have given us no idea of what your nonconforming part is.

Over a 30 year career my "parts" have been anywhere from the size of an aspirin tablet to several cubic feet and hundreds of pounds in size; from a value of a dollar each to tens of thousands of dollars each. No one policy would cover all those products.

 

[Sidney Vianna]

Do you have rules established that determine when a nonconforming part has to send back to the factory and if not what should happen?

Thank you in advance for your inputs,
Thomas

What is the context of the product and the failure? Are we talking about a medical device or a non critical consumer good? Did the failure result in an inconvenience for the user or was it a catastrophic breakdown? Without context is impossible to consider risks. And, in the end of the day, this should be a risk based decision.

 

[Cari Spears]

Also, can the evaluation happen on-site - via pictures, web-ex, etc?

 

[Thomas Dorner]

Thank you for all the replies....

Our products are used in laboratories but doesn't fall under the medical device standard. Usually all products are be able to get put on a standard table. This means nonconforming parts can vary from a small valve up to a more complex sub-assembly. Shipping in mind shouldn't be the big issue, because of the size and low weight (in most cases).

I agree if there is a breakdown at the customer site, all hands on deck and evaluate right away, either by phone, Skype etc. or if possible by the techs at the customer site. Pictures certainly help as well.

Our field-techs have the capability to "fix" the unit, but can't analyze or further investigate the issue (either they are not experienced enough or no engineers). Most of the time, they simply have no time to do so.

Thank you,
Thomas

 

[normzone]

When you say " simply have no time to do so " what I hear is " nobody ever made it clear that it is a part of the job ", or " can't be arsed ".

It may not be something they want to do unless they get paid for it.

But somebody has to do it, and somebody has to pay for it.

It just depends on if you want to pay the tech, or take the cost in customer dissatisfaction, or send some poor soul out there to do it.

 

[Sidney Vianna]

When you say " simply have no time to do so " what I hear is " nobody ever made it clear that it is a part of the job ", or " can't be arsed ".

It may not be something they want to do unless they get paid for it.

But somebody has to do it, and somebody has to pay for it.

It just depends on if you want to pay the tech, or take the cost in customer dissatisfaction, or send some poor soul out there to do it.

Failure analysis is something that may take time, knowledge and resources that a field technician simply does not have, for the most part.

 

[Tagin]

In the event of a failed part, wouldn't it be useful to investigate further and set appropriate measures for prevention in place (e.g. Design Change, further discussion with Supplier for replacement etc.)?

The degree of opportunity ('useful'-ness) is the unknown in this case. If your company cannot formulate a theoretical cost/benefit relationship to this opportunity, then perhaps it may be practical to implement a pilot program to bring back failed parts for analysis, etc. for a given period (3mo?, 6mo?, 1 yr?) or for x quantity of parts (0.5% of sold? 1% of sold?, etc.) in order to ascertain the general cost/benefit relationship. If there is no worthwhile benefit realized, then the pilot program ends, and that's that.

On the other hand, the pilot program may show that this practice is useful. But even if there are benefits that exceed "costs", you may ascertain that its only useful for certain categories of parts and not for others. So, a permanent policy could be implemented to henceforth return parts, but only if they belong to certain categories. This could help defray costs and focus attention on where improvements can best be made.

In short, it seems like it may be an opportunity that can be "chunked down" to smaller commitments.