Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA

Sources of complaints may arise from anywhere. As long as they meet the definition of a complaint (See FDA definitions) they can and do come from social media.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 27-Jun-2021 03:02
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA

Hi TIA,

I agree with Ed. You need to treat complaints from social media like any other input into your complaint system. The difference here may be that the complainants are not as responsive when you try to reach them - however, in generall any information that may report a nonconformance of your product needs to be documented and evaluated in your complaint management system and based on the information you have, you may also need to reach out to get more information.
Hope that helps.

All the Best

Markus

------------------------------
Markus Lantermann
Head of Q&R Region International
Mannheim
Germany
------------------------------

Original Message:
Sent: 27-Jun-2021 03:02
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA

In addition to what others have mentioned, I have found it best to NOT engage with a complainant on any social media platform.  The end result is never a good one.  Best practices I have seen are to try and get that conversation offline through posts or direct replies requesting they contact your internal help line or other contact point.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chairman, RAPS Board of Directors
United States
------------------------------

Original Message:
Sent: 27-Jun-2021 03:02
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA

This message was posted by a user wishing to remain anonymous

I have a question for the group.  I understand that any expression of dissatisfaction from whatever source should be classified as a complaint.  My question is how diligent (i.e., how much resource) should a firm be in searching out issues on social media?  What with the primary movers such as Facebook and Twitter being predominant, but there are literally thousands of other platforms ranging from lesser known social interfaces to blogs, chat rooms, etc.  My thinking is that trying to monitor everything could be a significant consumption of resources with very little real return, and per Glenn Byrd's post, should probably not be further engaged on the SM platform.

Thanks for your thoughts.
Original Message:
Sent: 29-Jun-2021 10:20
From: Glenn Byrd
Subject: Responding to Complaints on Social Media

In addition to what others have mentioned, I have found it best to NOT engage with a complainant on any social media platform.  The end result is never a good one.  Best practices I have seen are to try and get that conversation offline through posts or direct replies requesting they contact your internal help line or other contact point.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chairman, RAPS Board of Directors
United States

Original Message:
Sent: 27-Jun-2021 03:02
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA

The amount of time a company spends scouring media sources, including social platforms is unique to each company.  Some companies actively engage in social media as part of the corporate communications strategy and thus will see posts regarding company products.  Set up your procedures to suit your company's needs - business and legal needs.  Then at least you are following a process rather than a hit or miss random sampling.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chairman, RAPS Board of Directors
United States
------------------------------

Original Message:
Sent: 30-Jun-2021 07:12
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

I have a question for the group.  I understand that any expression of dissatisfaction from whatever source should be classified as a complaint.  My question is how diligent (i.e., how much resource) should a firm be in searching out issues on social media?  What with the primary movers such as Facebook and Twitter being predominant, but there are literally thousands of other platforms ranging from lesser known social interfaces to blogs, chat rooms, etc.  My thinking is that trying to monitor everything could be a significant consumption of resources with very little real return, and per Glenn Byrd's post, should probably not be further engaged on the SM platform.

Thanks for your thoughts.
Original Message:
Sent: 29-Jun-2021 10:20
From: Glenn Byrd
Subject: Responding to Complaints on Social Media

In addition to what others have mentioned, I have found it best to NOT engage with a complainant on any social media platform.  The end result is never a good one.  Best practices I have seen are to try and get that conversation offline through posts or direct replies requesting they contact your internal help line or other contact point.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chairman, RAPS Board of Directors
United States

Original Message:
Sent: 27-Jun-2021 03:02
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA

You say, "I understand that any expression of dissatisfaction from whatever source should be classified as a complaint". Your understanding is not correct.

There is a very interesting Warning Letter to Philips Medical in Cleveland. They used the definition you suggest, expression of dissatisfaction, as a reason to classify information as not a complaint. If there was not an explicit statement of customer dissatisfaction, they did not consider it a complaint.

Instead, you should be looking at the definition of a complaint in QSR and ISO 13485:2016. It is an allegation of a deficiency in one of the -ilities.

In my course, I used to distinguish between customer satisfaction complaints and regulatory complaints. For example, if the shipment arrived one week late it is a satisfaction complaint but not a regulatory complaint. Late delivery is not one of the -ilities.

If it arrived on time but label and content didn't match (size 2 on the label and size 12 in the box), the complaint is both satisfaction and regulatory.

Keep satisfaction complaints separated from regulatory complaints. You have regulatory obligations that don't apply to satisfaction complaints.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 30-Jun-2021 07:12
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

I have a question for the group.  I understand that any expression of dissatisfaction from whatever source should be classified as a complaint.  My question is how diligent (i.e., how much resource) should a firm be in searching out issues on social media?  What with the primary movers such as Facebook and Twitter being predominant, but there are literally thousands of other platforms ranging from lesser known social interfaces to blogs, chat rooms, etc.  My thinking is that trying to monitor everything could be a significant consumption of resources with very little real return, and per Glenn Byrd's post, should probably not be further engaged on the SM platform.

Thanks for your thoughts.
Original Message:
Sent: 29-Jun-2021 10:20
From: Glenn Byrd
Subject: Responding to Complaints on Social Media

In addition to what others have mentioned, I have found it best to NOT engage with a complainant on any social media platform.  The end result is never a good one.  Best practices I have seen are to try and get that conversation offline through posts or direct replies requesting they contact your internal help line or other contact point.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chairman, RAPS Board of Directors
United States

Original Message:
Sent: 27-Jun-2021 03:02
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA

I work & live in Cleveland so Philips is well known. Hiring QARA persons follows a sine wave pattern there and we are constantly recruited to work there.

A complaint has a specific meaning and some feedback is not a complaint.

-Any written, electronic, or oral communication that alleges deficiencies related to the:

-Identity

-Quality

-Durability

-Reliability

-Safety

-Effectiveness

-Performance    

…of a device after it is released for distribution.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 30-Jun-2021 11:22
From: Dan O'Leary
Subject: Responding to Complaints on Social Media

You say, "I understand that any expression of dissatisfaction from whatever source should be classified as a complaint". Your understanding is not correct.

There is a very interesting Warning Letter to Philips Medical in Cleveland. They used the definition you suggest, expression of dissatisfaction, as a reason to classify information as not a complaint. If there was not an explicit statement of customer dissatisfaction, they did not consider it a complaint.

Instead, you should be looking at the definition of a complaint in QSR and ISO 13485:2016. It is an allegation of a deficiency in one of the -ilities.

In my course, I used to distinguish between customer satisfaction complaints and regulatory complaints. For example, if the shipment arrived one week late it is a satisfaction complaint but not a regulatory complaint. Late delivery is not one of the -ilities.

If it arrived on time but label and content didn't match (size 2 on the label and size 12 in the box), the complaint is both satisfaction and regulatory.

Keep satisfaction complaints separated from regulatory complaints. You have regulatory obligations that don't apply to satisfaction complaints.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 30-Jun-2021 07:12
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

I have a question for the group.  I understand that any expression of dissatisfaction from whatever source should be classified as a complaint.  My question is how diligent (i.e., how much resource) should a firm be in searching out issues on social media?  What with the primary movers such as Facebook and Twitter being predominant, but there are literally thousands of other platforms ranging from lesser known social interfaces to blogs, chat rooms, etc.  My thinking is that trying to monitor everything could be a significant consumption of resources with very little real return, and per Glenn Byrd's post, should probably not be further engaged on the SM platform.

Thanks for your thoughts.
Original Message:
Sent: 29-Jun-2021 10:20
From: Glenn Byrd
Subject: Responding to Complaints on Social Media

In addition to what others have mentioned, I have found it best to NOT engage with a complainant on any social media platform.  The end result is never a good one.  Best practices I have seen are to try and get that conversation offline through posts or direct replies requesting they contact your internal help line or other contact point.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
Chairman, RAPS Board of Directors
United States

Original Message:
Sent: 27-Jun-2021 03:02
From: Anonymous Member
Subject: Responding to Complaints on Social Media

This message was posted by a user wishing to remain anonymous

Hi,
How do companies respond to complaints discovered via social media, e.g., FG, Twitter, YouTube, LI? FDA guidance is strangely silent (or at least from what I see). We of course have a social media SOP and evaluate and trend those complaints like any other, as per Complaints SOP, but do companies 'engage' with said complainant? Request additional information? Offer advice? Until now, we've had a stock response sent to those we know of their contact information to contact their treating physician or to submit officially on our corporate website, which obviously requires providing mandatory personal health information and to which we reply to contact their physician.
Almost all complaints are within expected AE's and side effects noted in FDA-approved labeling, but some individuals use these platforms to loudly and continuously voice their displeasure.
TIA