SBS - The best value in QMS software

Is any dissatisfaction over a Medical Device considered as a complaint?

SGquality

Quite Involved in Discussions
#1
We have a customer satisfaction survey that in addition to feedback also resulted in certain dissatisfaction over the product - would this be considered a customer complaint? How do companies handle these situations - via Customer Complaint process or CAPA process or any other? Thank you!
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
What is the CONTEXT? What type of products? As mentioned numerous times here, in the FDA Medical Device regulated sector, ANY negative feedback, must be treated as a complaint and processed accordingly.

Without CONTEXT and ENVELOPE CONDITIONS, one can only guess....
 
#5
I work with a direct-to-consumer and retail Class II medical device manufacturer that gets literally several hundred "customer inquiries" a month. We cull them based upon a very, very simple concept of a "Complaint" by customer service reps. That definition of a "Complaint" is similar to the one shown above, but with more details added to product-specific situations. When it doubt, they get tagged. These culled out Complaints then get further analyzed for reportability by dedicated quality staff and investigated as necessary.
I disagree with Sidney that ANY "negative feedback" is a Complaint. For example, someone that straight-up buys the wrong product for their use ("my spoon doesn't make a good fork!"), or the wrong size--those aren't Complaints. The key is that the feedback must allege "deficiencies [...] of a device." Of course, when in doubt just call it a Complaint and handle according to your Complaint process, it's not a big deal.

Regarding CAPAs, your Complaint process should have very clear guidelines for when a Complaint must be escalated to a CAPA and I'd also recommend adding some guidelines for when it's recommended, such as:
  • The Complaint has a similar cause to any other Complaints within the last year​
  • There is no easy/specific correction.​
  • The device failure was severe/catastrophic.​
  • The cause is a design-level issue.​
  • The cause is a manufacturing issue.​
This is essentially verbatim from the slideshow Sydney posted from above, the entirety of it can be found here:
Search for "cdrh-industry-basics-workshop-nonconforming-product-and-complaint-files-november-7th-2017"

Hope this helps,
Josh
 
#7
What is the CONTEXT? What type of products? As mentioned numerous times here, in the FDA Medical Device regulated sector, ANY negative feedback, must be treated as a complaint and processed accordingly.

Without CONTEXT and ENVELOPE CONDITIONS, one can only guess....
Not all negative feedback constitutes a complaint. If a customer says that your product is too expensive, that would not be a complaint. If the customer says they don't like the color of the product, but the product's color as never specified in the order agreement, that is not a complaint.

The picture you posted with 820.3's definition of a complaint is the resource I would point to if someone is trying to determine whether or not negative feedback constitutes a complaint.
 
#8
In the modern era with so many streams of information, to me the definition of a Complaint is much less interesting (i.e., it's very clear-cut) than how you monitor the various streams through which Complaints can be communicated. I think this cuts to the core of the OP's original question.

At the end of the day, you should be routing Amazon reviews, Facebook responses to your marketing posts, etc. through your Complaint handling process, if the content meets the definition of a Complaint. This also means your social media/CX/brand management folks need to have documented training on what constitutes a Complaint and there needs to be a documented process for routing those types of communications to relevant quality personnel within the organization for analysis and investigation.

The main problem here is, e.g., with Amazon they own the customer so you cannot really engage in normal investigative practices. Make sure you copy and paste and/or screenshot the complaint itself because, e.g., with Facebook posts they very quickly get lost in a massive sea of other posts which makes finding the original content impossible even just a few weeks later when doing a more detailed investigation/evaluation of the Complaint.
 
#9
To clarify on my last post, I make a distinction between evaluating negative feedback as to whether or not it is a complaint, and handling it as a complaint. All negative feedback should be evaluated as to whether or not it is a complaint. Only negative feedback which meets 820.3's definition of a complaint is required to be handled and processed as a complaint.
 
Thread starter Similar threads Forum Replies Date
C Senior Management and Customer Dissatisfaction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Customer Satisfaction vs. Dissatisfaction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Customer Satisfaction and Dissatisfaction Measurement QS-9000 - American Automotive Manufacturers Standard 29
N Medical device name in different countries EU Medical Device Regulations 4
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 6
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0

Similar threads

Top Bottom