Complete Cycle for Complaint Process - Idea Searching

[20130523]

I am looking for ideas, a procedure, or comments if you are willing to share. (Class I Medical Device ISO 13485)

How do you handle the life cycle of the complaint with the feedback to the customer, and do you have different process for the customer type? (An end user, a distributor, or a broker for example)

I am not concerned with Continuous Improvement or Customer satisfaction; I am not 9001 registered, so I do not have to prove either, and I am not looking for recall or vigilance. Just all around good business practices.

For example, If you sell let's say 220k - 250k units per month, and you receive 40-60 complaints per month, and of those 40-60 complaints per month, on average 2 are verified to need further action, while the rest are found to be not verified or no further action required, how are you managing the intake of that complaint, the return of the goods, the review, the feedback to customer(s) and the closure of the incident.

Do you manage that in 5 processes? One? How do you measure it? Any particular KPI you use to consider the process sufficient? What do you use to consider the complaint closed, particularly if it was an item that upon research was either user error or not verified? How do you equip your team to manage the complaints?

Thanks for your input!

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[20130523]

I get the feeling I have asked quite the loaded question.

I think this may be an area that many people need to make improvements on!

 

[yodon]

Indeed, a pretty loaded question and difficult to answer in a general sense. So much has to do with the type of product, the nature of the complaint, etc. I'll throw out a couple of thoughts to maybe get the ball rolling.

First off, I don't think you could or should completely uncouple continuous improvement or customer satisfaction from this. It should all be well integrated. Now I'll poke a little at each point.

I don't know what you mean by "manage intake" of complaints. Since you have a medical device, you're obligated to record the complaint and have a process for processing the complaints. That *should* cover intake - so you'll probably need to be more specific on the issues there. I typically have a "complaint form" filled out for ALL complaints to systematically walk through the process.

Nor do I understand what you mean by (managing the) return of goods. If material is returned, you need to first and foremost have controls in place to ensure it's not re-introduced into the distribution chain. I typically recommend that, for each article returned, there's some kind of documentation associated with it that provides a final disposition. This documentation can be used to facilitate the review you mention. If the material can be re-introduced in the distribution chain, it needs to be first confirmed to still meet specifications. You may need documented procedures and records for this.

As far as feedback to the customer goes, you obviously need to first do what's required. Complaints can range from do nothing to recall. If it's important to communicate back to the customer, you should do so! If it impacts safety, you're required to.

Closure goes back to the process you have for managing the complaint. And it depends on the nature of the complaint. This also can range from do nothing to (confirmation of the effectiveness / completeness of) recall.

You'll also want to watch for trends in the complaints. Pareto analysis can help. If trends indicate a systemic issue, you may want to take Corrective Actions. This is where things like business decisions / customer satisfaction / regulatory all merge.

 

[20130523]

Thanks!
I currently have all processes in place, including th continuous improvement and the customer satisfaction. My systems work, but I was hoping some would have suggestions or processes they were willing to share.

I am looking for different ways people handle the communication to customers. My only KPIs are number of complaints surveyed in a variety of ways and dpm and customer surveys. All those numbers indicate things are going well, and internal audits would support that as well, and so would 3 ISO audits back to back with zero nonconfomance identified. BUT I know it needs improvement.

Some customers want a certain response, a letter, a CAPA, some want just a replacement, some distributors want to be involved, some don't, some internal sales reps want to know more than others, big accounts need more attention when there is more business at risk, etc. How are the customer needs being identified and delivered? How do you measure the success of the process in place to meet that? How do you identify customer needs? When you are logging 40-60 complaints per month, it is not always possibe to thoroughly understand the need of the customer, and with automated processes around complaints, sometimes the "special circumstance" is overlooked, and I know it is an opportunity we are missing to look stellar to the customer.

Thank you for your comments!

 

[yodon]

BUT I know it needs improvement.

I don't mean to sound snarky, but what do you base this on? You can't make 100% of the people happy 100% of the time. And you have to balance attempting to do so with the business concern. Spending a million $$ to make a small % of the users happy (happier) just may not make business sense.

Without a detailed understanding of your products, the complaint types, and your processes, I doubt anyone will be able to offer any advice.

It sounds like you feel that the 40 - 60 complaints / month is burdensome to coordinate / correlate. Maybe look at that process to see if there's a way to simplify / clarify / classify the complaints.

I would suggest that in a forum like this, the more specific your question, the more likely to get meaningful responses. Maybe start breaking your problem down into specific concerns and re-post individually?

 

[20130523]

"I don't mean to sound snarky..."

Fail.

Because you did.



Does it make you feel better to critique someon'e honest and genuine question? Were you hoping to make me feel an inch big with your response? Because it worked. So, thanks, I suppose.

I am looking for different ways people handle the communication to customers. That is it. I suppose I'll withdraw my question.

Have a good day.

 

[yodon]

Sorry if I offended, wasn't intended. My only point was that I thought you might be over analyzing.