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  • 1.  Complaints vs Feature Requests

    Posted 05-Feb-2016 11:27

    Greetings to all.

     I would like some guidance/suggestions on handling customer feedback on a class 1 medical device in the EN ISO 13485 environment. Specifically relating to Complaints and requests for features not in the device.

      

    Background: In 21 CFR 820.3(b) a Complaint is defined as:

    • Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution

    .I was not able to find any reference to feature requests other than as input to design.  :

    Some large companies log all customer interactions (complaints, feature requests etc) into a database and then that data can be analyzed for trends, feeding into CAPA or VOC for the next product upgrade.

    Smaller companies tend to use spreadsheets for entering/tracking complaints, but other customer interactions may not be documented.

    My questions are:

    1. If a customer ‘alleges’ that my device should do ‘X’ but ‘X’ is not a feature in the device, is it a complaint or feature request?
    2. If we get a lot of feedback about the device not doing ‘X’, at what point, if ever, does it become a complaint?
    3. What is best practice for differentiating between feature requests and complaints?  Is there a guidance document I missed?

      

    Comments and suggestions invited.

    ------------------------------
    Jim Watkins
    DIrector of Quality
    Lebanon PA
    United States
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  • 2.  RE: Complaints vs Feature Requests

    Posted 06-Feb-2016 10:24

    The first issue is the context of your question. You start with the context of a class 1 medical device in the EN ISO 13485 environment, but then shift to the definition from FDA.

    I infer the context is EN ISO 13485:2012. The definition of a complaint and the requirements to handle complaints are not the same in FDA QSR and in ISO 13485:2012. You say this is a class 1 device, but you don’t say where. The devices classes are not the same in the US, the EU, or Canada.

    Because you raised an EN ISO 13485 environment, I’ll infer the question concerns the EU. Presumably, you apply the CE Mark without a Notified Body.

    A customer complaint, in EN ISO 13485:2012, is an allegation of a deficiency related to at least one of the enumerated characteristics. The first question is whether the customer complaint concerns one of those characteristics. For example, an allegation of a late delivery would not qualify as a customer complaint. In your case, if a customer alleges the device should do “X” but doesn’t, the characteristic is probably performance. Unfortunately, neither EN ISO 13485:2012 nor ISO 9000:2005 defines performance.

    In Clause 7.3.2.a design inputs include “functional, performance and safety requirements, according to the intended use”.

    A simple classification would determine if the communication concerns required performance that is deficient. Required performance could come from the MDD Annex I, some standard you followed (in your technical documentation), customary requirements for this type of device, or some characteristic that your company decided to include. If the communication is not of this flavor, then it is not a customer complaint.

    If it were a customer complaint, then Clause 8.5.1 would require records of investigation and either corrective action, preventive action, or a record of why neither was conducted. In other words, there is an assumption that the complaint is a nonconformance.

    I would recommend that your company track feature requests because they provide useful information for product updates. EN ISO 13485:2012 takes the position that customer satisfaction is not an appropriate regulatory objective of medical devices. However, your company’s long term viability may depend on effective collection and use of this information.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States



  • 3.  RE: Complaints vs Feature Requests

    Posted 06-Feb-2016 20:45
    Jim,

    I would recommend you seriously consider what I am suggesting below.

    As for a "feature" suggested by a customer, you should analyze as follows.

    Based on intended use/indications for use (user needs/user requirements), design control starts with development/approval of design inputs (design input requirements).  
    Information leading to design input requirements should be based on VOC, basic standards (horizontal), product standards (vertical), other standards and products on the market, etc.  

    In EU, under MDD, there are harmonized standards conferring "Presumption of Conformity" if complied. 

    It is generally acceptable that role of international consensus standards as a tool is to assure the safety, performance and quality of medical devices. 
    In the US, Quality is defined under 21 CFR 820.3(s).  
    In conclusion, 

    If the feature (per your customer) should have been included as part of "User Needs/Requirements" per the standards (basic and product standards and/or VOC) and if the same feature should have been reasonably expected to be available for your device's performance by customers, your customer is in fact complaining about your device's quality.

    The term "Quality" is quite often misconstrued by many firms/professionals. If you interpret the feature as part of the quality per 21 CFR 830.3(s) (in PDF) in view of complaint under 21 CFR 820.198 in connection with MDR, your customer's request/feedback should be treated as a complaint (for example, poor quality).  

    I provide training seminars on complaint/MDR, medical device control, 510(k), PMACE mark, etc.  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 4.  RE: Complaints vs Feature Requests

    Posted 08-Feb-2016 11:29

    Hi Jim,

    A great deal depends on the nature of the communication from the user. If the comment is along the lines of "I wish it worked a little differently" or "it's longer than I need for my application" or some such, it's a suggestion for improvement rather than a complaint. On the other hand, if the user comments that the device is missing a feature that is necessary for safe or effective use, then it's clearly a complaint.

    If you get a number of comments about the "missing" feature, even if they are not considered complaints you might consider opening a corrective action request, as it could suggest that improvements could be made to the process of validating that the design meets are user and patient needs for the intended use.

    Parsing what is and is not a complaint is often challenging.

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    Michael Parmenter
    Director, Reg. Affairs & Quality Assurance
    Endoshape, Inc.
    Boulder CO
    United States



  • 5.  RE: Complaints vs Feature Requests

    Posted 09-Feb-2016 10:22

    Hello Jim,

    Beauty  is in the eyes of the beholder...  since you are Class 1 device manufacturer, I would keep it simple. I would not try to classify the communication from the customer as  Complaints or Feature Requests on the front-end. If you take that approach, you will formalize [w/o an investigation] a conclusion that a Complaints is a Feature Requests or Feature Requests is a complaints. Your Complaint Handling SOP should have a CAPA requirements. The CAPA process will determine what is the issue, who is involved, what happen, root cause, corrective action and/or preventive action. Keep in mind that your customer may not be using the product as intended. This would raise other concerns. Likewise, your customer may  be using the product as intended, but.... This would also raise other concerns, as well.

    I hope this helps...

    Regards,

    Ray

       

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    Ray Witherspoon
    Manager Regulatory Affairs and Quality
    ray.witherspoon@mckesson.coMemphis TN 38119