Interactive Session: Complaint Management Best Practices

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Tim Mohn

Industry Solution Director Sparta Systems, Inc.

Carl Ning

Senior Solutions Consultant Sparta Systems, Inc.

Collaborative approach to best practices

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Agenda



_{Complaint Handling Vision}



_{Key Challenges}

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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.

Complaint Handling Vision

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PLM and Doc Mgt Training

Typical complaint process

ECO Change request eMDV Paper eMDR Product

investigation Correction assessment Risk Root cause CAPA

Reportability

assessment Reportabilityassessment Reportabilityassessment Call capture CA Change request CRM Field Service Complaint Investigation

Regulatory Reportability Assessment

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Complaint Triage

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Broader complaint handling environment

‘Core’ complaint handling process

Quality evaluation Regulatory reporting

CAPA High-volume data

entry Triage (inquiry to complaint)

Retain testing Returned goods

authorization

Change control Design changes

Service records updates (field or

depot)

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Common complaint system landscape

Field Service

Call Center

CRM

Call Center Call Center

Field Service CRM

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How do you globally manage complaints with

so many disparate input systems?

Key challenge

Field Service

Call Center

CRM

Field Service CRM

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Answer: Global approach for complaint

handling

Field Service

Call Center

CRM

Field Service CRM

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Also allow direct complaint entry into

TrackWise system

Field Service

Call Center

CRM

Field Service CRM

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Common Complaint Handling Challenges

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 _{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 CRM 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

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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

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Customer Relationship Management (CRM)

definition

Marketing

Sales

Orders

Support

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

_{Very importantly, CRM 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 CRM strategy, typically driven by sales and marketing, to help them be more effective



_{Many companies have regional CRM 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

CRM co-existence

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

_{Very importantly, CRM 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 CRM strategy, typically driven by sales and marketing, to help them be more effective



_{Many companies have regional CRM 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

CRM co-existence

Marketing

Sales

Orders Support

Key question – how does a company efficiently and effectively

manage call resolution?

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

_{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 CRM and TW is critical in many scenarios

Call triage

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Sample CRM<->TW integration

Auto-create complaint investigation

Investigation status & info Up-to-date records &

cross reference Potential complaints

eMDR to FDA

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Interactive session – defining a “perfect”

system

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Scenario 1 – examination gloves

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Sell via distributors to hospitals, ambulances, doctors offices

Disposable

How does model change if sell directly to consumers?

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Scenario 2 – x-ray machine

Direct sales to hospitals and doctors offices

Field service

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Scenario 3 – arthroscopic surgical device

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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? How do you handle calls If the patient is literally ‘on the operating room table?’

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Scenario 4 – surgical equipment

Distributors Sterilized

How many times can equipment be sterilized? How do you keep track?

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Scenario 5 – drug coated stent

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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? Drug safety requirements?

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Thank you!

Tim Mohn

Industry Solution Director

Carl Ning

Senior Solutions Consultant