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Seven Ways to Investigate Complaints When Devices Aren’t Returned


Continue learning from Rob Packard at OMTEC 2014

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An OEM may receive dozens or even hundreds of product quality complaints each year. During a recall, there may be hundreds of complaints per month. One of the greatest challenges in complaint handling is making sure that you have done enough when you are unable to verify the complaint. What do you do when you receive a complaint, but are unable to verify that the complaint actually involved a device malfunction?

A product quality complaint is any communication from a customer in which a real or perceived problem exists. These may relate to product efficacy, safety, purity, identity or any other form or function of the product.

Your complaint handling process must uniformly process each complaint in a timely manner, and you must perform an investigation when a product failure is alleged—even if the product is not returned. Users rarely make the effort to return defective product unless it can be repaired. Therefore, your complaint handling procedure should include a step-by-step investigation process that will be implemented even when product is not returned.

If you don’t have the product, what can you investigate?

There are seven things you can and should do to investigate product complaints—in addition to analyzing returned product.

Call the User
Email is a great productivity tool, but most busy professionals receive hundreds of emails a week. If someone you don’t know is asking for detailed information in an email, there are three possible outcomes: 1) delete, 2) spam and 3) ignore.

Try calling the user instead. Personally calling a surgeon will be perceived as a higher level of customer service and will allow your company to gauge the customer’s level of concern by the tone in his voice. When you call a user to follow up on a complaint, I recommend using a script. Ideally, you might include an example of this script as an appendix to your procedure. This would ensure that all the important information is addressed in the call, and if the person doesn’t answer, you can be confident that a standardized message will be left that includes all of the important information.

Send an Email Three Times
Even though emails are not the most effective way of requesting information from customers, emails do a great job of documenting when something was requested. Therefore, when you call a surgeon to collect information about a complaint, you should always follow up with an email, thanking the surgeon for her time and summarizing what she told you. This documents the call. If the surgeon did not answer and you left a message, then the email will document that you left a message.

Most companies will repeat this process three times. Why?

Because that’s the way it’s always been done.

Typically, the request will be made when the initial communication about the complaint is received in order to request return of product. The request will be repeated again at 30 and 60 days. If there is no response from the customer, the complaint will be closed at 90 days. Why is the frequency every 30 days?

Because email calendars can be easily set up to prompt you with a monthly reminder more easily than every 21 days.

Copies of each email should be printed and added to your complaint file or printed as a PDF and attached to your electronic complaint record. I haven’t seen any companies attach audio files recording phone messages, but I suspect a few companies with technical support call centers could do this. The recordings might even provide great training content for new employees.

Ask for a Photo
It wasn’t too long ago that companies had only one digital camera to share throughout the company and a surgeon might have one—but not at the hospital. Now my eight-year-old has a tablet and an iPod that can record digital videos and upload them to YouTube. You would have a hard time finding someone at a hospital without one or more camera phones. Therefore, train your sales representatives to remind users to snap and email a picture when there is a product complaint. This is a fantastic way to capture detailed information about a product failure and communicate that information with the manufacturer in seconds. Just a text with a picture communicated so much more than filling out a form—which nobody has time to do. Be sure you train the reps to ask for pictures of any product labeling or laser marking on the product and packaging as well.

Genchi Genbutsu
This is a phrase that lies at the core of the Toyota Production System. It means “Go to the source and see.” Instead of relying only upon emails and phone calls, sometimes you need to go to the surgeon and see how they are performing procedures. If a photo is worth 1,000 words, then a demonstration by a surgeon is worth a 1,000 photos.

The doctor may be freakishly tall, like me (6’6”/2.0m), or may be using a novel technique that he personally developed. These types of ergonomic and human factor considerations are hard to identify unless you can see what is happening in the surgical suite. Therefore, it is important to have sales reps and product managers who visit surgeons and know what issues may exist first-hand. This is also why it is important to have someone familiar with clinical use of product involved in the design team and risk management activities.


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