Interactive Session: Complaint Management Best Practices

Transcription

1 Interactive Session: Complaint Management Best Practices Collaborative approach to best practices Tim Mohn Industry Solution Director Sparta Systems, Inc. Carl Ning Senior Solutions Consultant Sparta Systems, Inc.

2 Agenda Complaint Handling Vision Key Challenges Interactive workshop defining a perfect system 2

3 Complaint Handling Vision

4 Complaint Handling Vision Thoughts? Consistent, compliant, and efficient global method of evaluating customer feedback so that potential health and safety issues, whether systemic or one-offs, are evaluated, triaged, and managed appropriately. These can lead to CAPAs, vigilance reports, product withdrawals, field actions, labeling changes, or product redesign. 4

5 Typical complaint process PLM and Doc Mgt Training Change request ECO Change request Complaint Investigation CA Call capture Product investigation Correction Risk assessment Root cause CAPA Triage Complaint Reportability assessment Reportability assessment Regulatory Reportability Assessment Reportability assessment emdr emdv Paper 5

6 Broader complaint handling environment High-volume data entry Triage (inquiry to complaint) Returned goods authorization Retain testing Core complaint handling process Quality evaluation Regulatory reporting CAPA Feedback to Service records updates (field or depot) Change control Design changes 6

7 Complaint Handling Challenges

8 Single biggest complaint handling challenge 8

9 Common complaint system landscape 9

10 Key challenge How do you globally manage complaints with so many disparate input systems? 10

11 Answer: Global approach for complaint handling 11

12 Also allow direct complaint entry into TrackWise system 12

13 Common Complaint Handling Challenges What organizations are involved? Roles and responsibilities? Technologies? Typically, companies have 3+ distinct groups involved in complaint handling process, each with different roles and responsibilities and technologies designed for their use alone Call entry -> triaging -> investigation -> service / returns / repair -> CAPA -> regulatory reporting There is no 1 central way to input complaints In many cases a customer service unit may take all calls, including re-orders, and may not have the skill set or priority to handle complaints Commonly, these different units have different IT systems entirely, in particular regional systems Types of products Single use vs. Re-usable Implantables Does the product evolve over time (modifications) Sterilized? How are repairs handled? Depot vs. field service Language Are all complaints documented in the same language? How track/trend? Read? 13

14 Complaint Handling Challenges con t How are modifications handled? Is there a need to modify device in the field? How is that tracked over life of the product? Service In what scenarios does a routine service event become a complaint? Triaging What criteria is used, and by whom, to determine what is escalated for further review? How is this maintained as expectations evolve for global reportability? Are all possible complaints forwarded to location as required by procedure? Sounds simple to do, but in reality isn t easy especially in remote parts of the world or companies that rely on resellers Distribution/servicing model Who physically sells the product? Resellers? Variation by region? What if you don t have enough information? Who, what product, when, where? Or ask for information and not provided? 14

15 Customer Relationship Management () definition Marketing Support Sales Orders 15

16 co-existence Very importantly, is a tool that drives commercial success Designed to help the sales organization sell and marketing team measure success of marketing campaigns Every successful organization has a strategy, typically driven by sales and marketing, to help them be more effective Many companies have regional systems to manage the global business What about customer complaints? Interesting challenge, as customers prefer to have 1 number for everything Ordering, customer service, complaints, service requests Marketing Support Sales Orders 16

17 co-existence Very importantly, is a tool that drives commercial success Designed to help the sales organization sell and marketing team measure success of marketing campaigns Every successful organization has a strategy, typically driven by sales and marketing, to help them be more effective Many companies have regional systems to manage the global business What about customer complaints? Interesting challenge, as customers prefer to have 1 number for everything Ordering, customer service, complaints, service requests Marketing Key question how does a company efficiently and Support effectively Sales manage call resolution? Orders 17

18 Call triage Call scripts to determine where the call should be routed Triage calls so that non-gxp issues are handled immediately and potential health and safety events are forwarded for quality/regulatory review Organizations rely on different strategies based on product type and risk Some companies have central hotline for all calls, others triage out quickly certain types of calls such as PH&S calls Many companies use one system for initial call triage and create records in the other system as appropriate Key: tight integrations between and TW is critical in many scenarios Marketing Support Sales Orders 18

19 Sample <->TW integration Potential complaints Up-to-date records & cross reference Auto-create complaint investigation Investigation status & info emdr to FDA 19

20 Interactive session defining a perfect system Describe considerations needed for each unique scenario based on product type

21 Scenario 1 examination gloves Sell via distributors to hospitals, ambulances, doctors offices Disposable How does model change if sell directly to consumers? 21

22 Scenario 2 x-ray machine Direct sales to hospitals and doctors offices Field service In what scenarios might routine maintenance become a complaint? 22

23 Scenario 3 arthroscopic surgical device Mix of direct and indirect sales Disposable parts + reusable power supply How do you know if issue is disposable part vs. capital equipment? How do you do return testing with potentially contaminated materials? 23 How do you handle calls If the patient is literally on the operating room table?

24 Scenario 4 surgical equipment Distributors Sterilized How many times can equipment be sterilized? How do you keep track? 24 What if hospital doesn t follow sterilization procedures?

25 Scenario 5 drug coated stent Direct sales Sterilized Follow drug and device regulations How many times can equipment be sterilized? How do you keep track? What if hospital doesn t follow sterilization procedures? 25 Drug safety requirements?

26 Thank you! Tim Mohn Industry Solution Director Carl Ning Senior Solutions Consultant