Requirement to track and trend positive feedback from customers

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Our auditor claims we need to track and trend positive feedback from customers. Is that correct? To me positive feedback means "don't change anything"
 
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Golfman25

Trusted Information Resource
#2
I don't know about that. You may need to consider customer satisfaction but how you do it should be up to you.
 
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Marcelo

Inactive Registered Visitor
#4
You need to gather and monitor any information regarding the experience of the device. This include, for example:
- Feedback about patient clinical benefits​
- Feedback about indications for use​
- Knowledge of new performance trends​
- Knowledge of long-term performance, reliability and chronic complications​
- Knowledge of performance in different population of users​
- Feedback about use with other devices, accessories and substances​
- Confirmation (or not) of risk analysis​
- Knowledge of ways in which the product is incorretly applied​
- Information of incidents related to the products​
- Identification of surveillance reports​
- Feedback about instructions for Use​
- Feedback about necessary training for users​
These are all information that needs to be part of your post market surveillance system. This also has to be active (as the standard required the information to be gathered), instead of only reactive (as is the case of complaints).
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
Our auditor claimed we need to track feedback from Amazon.com on customer who Like vs Love our product and trend it. Literally graphs showing how many customer said they "loved" our product vs how many customer merely "liked" our product and showed trending to management. To me those adjectives are pointless. Sales revenue is how we track people who like/love our product and purchase it. Beyond that how would we change our behavior with only adjectives of liked or loved our product and no other information? If behavior doesn't change based on feedback the feedback is pointless.
 

Steve Prevette

Deming Disciple
Staff member
Super Moderator
#6
As with any sort of quality issue, if you only track the problems you miss half the issue. For example, there were bearing failures, and an oil contaminant was found in the failed bearings. They fixed the oil contamination problem, but since there was the same oil contamination in the "Good" bearing, no change in failure rates occurred.

So, if you are trying to use customer feedback to make decisions from, a feature or function one person may hate vehemently may be loved by a much larger number of customers. A good read on this is Why do things go right?.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
Agreed but the "good" data has to be actionable. Like and love are not actionable.
 

Golfman25

Trusted Information Resource
#8
Our auditor claimed we need to track feedback from Amazon.com on customer who Like vs Love our product and trend it. Literally graphs showing how many customer said they "loved" our product vs how many customer merely "liked" our product and showed trending to management. To me those adjectives are pointless. Sales revenue is how we track people who like/love our product and purchase it. Beyond that how would we change our behavior with only adjectives of liked or loved our product and no other information? If behavior doesn't change based on feedback the feedback is pointless.
Wow. Give me your product and I'll give you a bunch of "Loves" on Amazon. :)
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#9
And Golfman has hit on the specific issue with your auditor suggesting - let alone requiring - you to track the likes vs loves on Amazon. These 'surveys' are not statistically designed (the categories of choices are not mutually exclusive and exhaustive nor do they have solid operational definitions. The granularity is arbitrary and therefore meaningless. Making things worse, Amazon and other open social media forums are subject to trolls; both 'good' and bad feedback resulting in potentially very biased data. There is obviously some good information to glean from social media sites but only the information that is credible or actionable. 'data' or counts of things are not always equivalent to information
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#10
Social media is interesting in some regards. I did 820.30 for DARPA and the VA and Cleveland Clinic for IDE Chronic Implants. We consented 20 subjects to undergo surgery. One of the subject went non compliant after surgery and stopped communicating with the team. There was a forum with the FDA and we submitted an MDR event. We had no way of knowing if the subject had died or fled or what. We located him on social media and saw he was posting so we asked the FDA if we could use that as evidence he did not die. There was a bit of joking followed by the FDA has no guidance to use on social media posts to indicate health of a test subject.
 
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