Customer Complaints - Categorization help requested

SGquality

Quite Involved in Discussions
#1
Hello,

I am writing a procedure our Customer Complaints and am stuck with categorizations for Critical, Major and Minor. Could some one help me with definitions and examples to support the defintions with respect to medical devices ?

Thank you
 
Elsmar Forum Sponsor
#2
We recently completed a similar exercise, revising our CAPA SOP to reflect a Risk level of Low, Medium or High to associate with various nonconformities. I recommend that you don't necessaily define an iron-clad risk or category to most of these. However, SAFETY, anything which can endanger the end user or patient, or something "reportable" under regulations such as the FDA part 803, should almost always be classified under the most severe category. Some of the other general categories we referenced include:
  • Prodcut Quality (functionality & reliability may be good subgroups here)
  • Performance such as on-time delivery or other Customer contactual requirements
  • Customer Satisfaction such as invoicing detail errors or poor response time, which aren't directly related to product quality
  • Internal cost issues with scrap, sub-optimal performance or similar items whose severity is commensurate with their monetary impact
  • Labeling and Packaging issues which can be quite severe especially when the regulatory impact is considered
  • Cosmetic issues with product, which can be subdivided into Cleanliness/ Contamination, finish issues, or other Customer expectations
  • Shipping (wrong address, quantity or product)
  • Invoicing errors or terms
  • other paperwork documentation not directly related to product quality or regulations...
:2cents:Hope this helps you get started,
Rob
 

SGquality

Quite Involved in Discussions
#3
Thanks Rob. Did you categorize these complaints as Critical, Major and Minor ?

Could you pls share the procedure ?

Thank you,
 
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