Regulatory Open Forum

I'd be interested in knowing how companies are approaching the requirement at clause 7.2.3 (c) of ISO 13485 to "determine and implement effective arrangements for communicating with customers in relation to customer feedback..." Not so much complaints but other kinds of feedback. How actively do you solicit feedback? Do you just make a feedback mechanism available (a form or a survey link on a web page?), or do you actively contact customers to gain their feedback? Or is it somewhere in between? Any practices you would care to share, in terms as general or specific as you feel comfortable with, would be much appreciated.

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

The Sales Department should call their customers on schedule.  It's their job; they like it :)



-------------------------------------------
Virginia Guest
Flagstaff AZ
United States
-------------------------------------------


Original Message:
Sent: 07-31-2014 13:33
From: Michael Parmenter
Subject: Customer Feedback

I'd be interested in knowing how companies are approaching the requirement at clause 7.2.3 (c) of ISO 13485 to "determine and implement effective arrangements for communicating with customers in relation to customer feedback..." Not so much complaints but other kinds of feedback. How actively do you solicit feedback? Do you just make a feedback mechanism available (a form or a survey link on a web page?), or do you actively contact customers to gain their feedback? Or is it somewhere in between? Any practices you would care to share, in terms as general or specific as you feel comfortable with, would be much appreciated.

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

We track any feedback given by the customer, we also ask them for feedback based on changes that have been made. We have also used responses from KOL at tradeshows. And as we grow we plan on using surveys.

-------------------------------------------
Keri Froese RAC
Quality Assurance Specialist
Ottawa ON
Canada
-------------------------------------------


Original Message:
Sent: 07-31-2014 13:33
From: Michael Parmenter
Subject: Customer Feedback

I'd be interested in knowing how companies are approaching the requirement at clause 7.2.3 (c) of ISO 13485 to "determine and implement effective arrangements for communicating with customers in relation to customer feedback..." Not so much complaints but other kinds of feedback. How actively do you solicit feedback? Do you just make a feedback mechanism available (a form or a survey link on a web page?), or do you actively contact customers to gain their feedback? Or is it somewhere in between? Any practices you would care to share, in terms as general or specific as you feel comfortable with, would be much appreciated.

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

I recommend to my clients that they use the methods in ISO 10004:2012 Quality Management - Customer Satisfaction - Guidelines for Monitoring and Measuring. The differences between ISO 9001:2000 and ISO 13485:2003 include a discussion of why customer satisfaction is not appropriate in 13485. That notwithstanding ISO 10004 gives good advice on how to obtain feedback and utilize it.

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


Original Message:
Sent: 08-01-2014 08:56
From: Keri Froese
Subject: Customer Feedback

We track any feedback given by the customer, we also ask them for feedback based on changes that have been made. We have also used responses from KOL at tradeshows. And as we grow we plan on using surveys.

-------------------------------------------
Keri Froese RAC
Quality Assurance Specialist
Ottawa ON
Canada
-------------------------------------------


Original Message:
Sent: 07-31-2014 13:33
From: Michael Parmenter
Subject: Customer Feedback

I'd be interested in knowing how companies are approaching the requirement at clause 7.2.3 (c) of ISO 13485 to "determine and implement effective arrangements for communicating with customers in relation to customer feedback..." Not so much complaints but other kinds of feedback. How actively do you solicit feedback? Do you just make a feedback mechanism available (a form or a survey link on a web page?), or do you actively contact customers to gain their feedback? Or is it somewhere in between? Any practices you would care to share, in terms as general or specific as you feel comfortable with, would be much appreciated.

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

Concerning "...ISO 13485...to determine and implement ....for communicating with customers....."

It should be adequately handled for "complaints," "customer feedback," "your response to customer's solicitation of information," or "your solicitation of customer's feedback."

Some firms generally develop an SOP for "Complaints and/or Customer Feedback."

For example, the SOP "for initiating, receiving, resolving and maintaining records of complaints relating to the quality of your work products, processes and services; and other customer feedback...."

Here is a template for your review as a reference (particularly related to ISO 13485) at http://www.regulatorydoctor.com/template-sop-for-complaint-and-customer-feedback-procedures/

FYI: There are some 41 FDA warning letters for citing inadequate handling of customer feedback and complaints...

I recently wrote an SOP for a firm who received FDA 483s.  In this firm, they have an automated system tracking all calls and communications (e.g., customer feedback, complaint, phone order, etc.).  Thus, I wrote the SOP to reflect their practice for complaints and customer feedback with criteria for MDR and CAPA, etc.  The firm's 483s have been addressed. 

As for solicitation, this may/can open a can of worms if not handled adequately, especially concerning intended uses/indications including off-label use, new use, extra-use or illegal use.  

Suggestions:

1. Develop your SOP for initiating, receiving, resolving and maintaining records of complaints AND/OR communication relating to the quality of your work products, processes and services; and other customer feedback.
2. Keep them as part of your QMS doc control either in paper or electronically or both.
3. Ensure you also describe an interface (an internal system per se) for complaint handling, risk management, CAPA, and MDR, to the extent, applicable.
4. Ensure your documentation is ADEQUATE.
5. Ensure your compliance is SUSTAINABLE.

-------------------------------------------
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------


Original Message:
Sent: 07-31-2014 13:33
From: Michael Parmenter
Subject: Customer Feedback

I'd be interested in knowing how companies are approaching the requirement at clause 7.2.3 (c) of ISO 13485 to "determine and implement effective arrangements for communicating with customers in relation to customer feedback..." Not so much complaints but other kinds of feedback. How actively do you solicit feedback? Do you just make a feedback mechanism available (a form or a survey link on a web page?), or do you actively contact customers to gain their feedback? Or is it somewhere in between? Any practices you would care to share, in terms as general or specific as you feel comfortable with, would be much appreciated.

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