Setting Up A Complaint Handling System. Presented by Sue Jacobs Principal Consultant, QMS Consulting, Inc. Complaint Systems

Transcription

1 Setting Up A Complaint Handling System Presented by Sue Jacobs Principal Consultant, QMS Consulting, Inc. January 2008 ~ Orlando, Florida QMS Consulting, Inc Complaint Systems Written Procedures Designated Complaint Handling Unit Training Records Service Reports CAPA QMS Consulting, Inc sue@qmsconsultant.com 1

2 What Makes the System Effective Consistency in handling information Trained personnel Process that enables prompt response to customer needs Accurate and accessible records QMS Consulting, Inc Points to Consider The size of your company Single vs. multiple locations Domestic / foreign locations Organization & corporate structure Company culture QMS Consulting, Inc sue@qmsconsultant.com 2

3 Points to Consider Type of product multiple product lines, consumer vs. professional Risks consequences with product failure Servicing potential complaints / MDRs QMS Consulting, Inc Written Procedures How many procedures? Complaint Handling MDR Failure Investigation What s effective for one company may not be for another QMS Consulting, Inc sue@qmsconsultant.com 3

4 Written Procedures Assignment of responsibility Identify designated complaint handling unit Instructions for documenting complaint information Process for evaluating complaints Process for investigating complaints Identify and process MDR s How to process customer returns Records Trend analysis Complaint closure QMS Consulting, Inc Written Procedures Define the formal system to classify and document information distinguish valid complaints from invalid complaints QMS Consulting, Inc sue@qmsconsultant.com 4

5 Designated Complaint Handing Unit QMS Consulting, Inc Designated Complaint Handling Unit What department should have primary responsibility for the complaint management system? Regulatory Affairs Quality Assurance Manufacturing Marketing Legal Engineering Sales Others?? QMS Consulting, Inc sue@qmsconsultant.com 5

6 Preamble #191 Industry comment more than one "formally designated unit" FDA response there should be only one formally designated complaint handling unit for each product type or establishment QMS Consulting, Inc Preamble #191 (cont.) If a corporation chooses to operate with different complaint handling units for products and/or establishments, Clearly describe and define its corporate complaint handling procedure Ensure consistency throughout the different complaint handling units Each manufacturer should establish in its procedures which one group or unit is ultimately responsible for coordinating all complaint handling functions QMS Consulting, Inc sue@qmsconsultant.com 6

7 Considerations for Multiple Facilities Establish one group with ultimate responsibility Complaint Handling Units by product or by location Clearly describe Corporate Structure Consistency QMS Consulting, Inc Cross Functional Support QMS Consulting, Inc

8 Responsibilities of Other Departments Reporting complaints Complaint evaluation Complaint investigation Data collection Trending CAPA QMS Consulting, Inc Cross Functional Support Ensure information is received and processed in a timely manner Regulatory Quality Engineering Manufacturing Service Technical Support Marketing Sales others as necessary QMS Consulting, Inc sue@qmsconsultant.com 8

9 Ensure Consistency Preamble #191 A system that allows multiple interpretations in handling, evaluation, categorizing, investigation and followup is not acceptable QMS Consulting, Inc Ensure Consistency Flow Diagrams Written procedure, single or multi-facility, training aid Decision Charts MDR decisions, CAPA decisions, Management Review QMS Consulting, Inc sue@qmsconsultant.com 9

10 Ensure Consistency Checklists evaluation valid complaint investigation new - existing closure Correspondence Logs due diligence QMS Consulting, Inc TRAINING QMS Consulting, Inc sue@qmsconsultant.com 10

11 Training Trained staff able to recognize complaints and process information Internal Regulatory, Quality, Engineering, Operations, Marketing, Customer Service, others External Sales, Service, Technical Support others QMS Consulting, Inc Training Requirements ALL Customer Contact Personnel should receive Complaint Management Training Specific training will vary depending on level of involvement in the process Define and document training needs by function QMS Consulting, Inc

12 Basic Training Definition of complaint MDR reporting time frames Written procedure and forms Process for reporting information to the designated complaint handling unit How to differentiate between Customer Inquiry and Customer Complaint Complaint and MDR QMS Consulting, Inc Complaint Management Training Customer Call Center Responsibilities explain their role in the process General understanding of complaint definition Expression of dissatisfaction with product or service Differentiate between customer call and customer complaint Provide specific examples using your products and types of calls Communicate importance for timely processing of information Possible MDR reportability QMS Consulting, Inc

13 Sales Complaint?? What kind of complaints would the FDA expect to see from sales personnel? Sales people are trained to overcome objections QMS Consulting, Inc Complaint Management Training Sales Responsibilities explain their role in the process Knowledgeable of FDA definition, reporting timeframes, complaint process Provide actual examples that relate to Sales How to recognize a potential complaint during the sales process New customers, existing customers Trade shows QMS Consulting, Inc sue@qmsconsultant.com 13

14 Complaint Management Training Service Knowledgeable of Complaint definition, complaint process, MDR reporting timeframes Requirement to analyze service reports [ ] Communicate importance for timely processing of information Provide actual examples that relate to servicing Service occurs more frequently than planned Problems beyond service call QMS Consulting, Inc Service & Repair Requirements Review documented service and repair reports for potential complaints or MDR s What to look for: Unscheduled service or repair Problems beyond initial scope or service call Trends, spare parts replacements, frequency Reports which represent a complaint must be processed through the Complaint Management System QMS Consulting, Inc sue@qmsconsultant.com 14

15 Timely Reporting of Service and Sales Complaints How do you motivate your Service and Sales personnel to report complaints? Training and knowledge to increase awareness Reward complete and on-time documented service reports Involve Sales and Service in the solution K-I-S-S QMS Consulting, Inc RECORDS QMS Consulting, Inc

16 Records The manufacturing site is responsible for maintaining complaint files Manufacturer outside the US Reasonably accessible in the U.S. where records are regularly kept, or at the Initial Distributor Manufacturer should have access complaint evaluations and investigations QMS Consulting, Inc Records Complaint and MDR files must demonstrate due diligence to obtain required information Define record retention policy Equivalent to design and expected life of the device In no case, less than 2 years from the date of release for commercial distribution Facilitate corrective and preventive action QMS Consulting, Inc sue@qmsconsultant.com 16

17 CAPA QMS Consulting, Inc Relationship to CAPA CAPA data source Not all complaints will require CAPA Correction vs. Corrective Action Complaint procedure should clearly define criteria for CAPA When CAPA criteria are reached - initiate CAPA process QMS Consulting, Inc sue@qmsconsultant.com 17

18 Relationship to CAPA CAPA provides the link to Management Review Number of Complaints by product, by facility, duration, risk Trends by product, by facility similar complaints across different product lines Relationship to internal data sources nonconforming product, installation QMS Consulting, Inc Summary Effective complaint management Timely processing of information Consistency Training Procedure Facilitate continuous improvement QMS Consulting, Inc

19 Thank You! Sue Jacobs QMS Consulting, Inc. Hoffman Estates, Illinois QMS Consulting, Inc QMS Consulting, Inc. Provides worldwide consulting services to medical device manufacturers seeking to establish, implement, or improve Quality System and Regulatory Compliance to US FDA Regulations, ISO/EN Standards, and European Medical Device Directives. Services provided include: Perform Quality System assessments for compliance to US FDA regulation requirements, ISO/EN Standards, and European Medical Device Directives Assist firms in resolving US FDA Regulatory Enforcement Action; FDA Form 483 Observations, Warning Letters, Certification Audits In-house training US FDA Medical Device Quality System Regulation, US FDA Inspection Readiness Training (QSIT), CAPA, Complaint Management, Quality Auditing, and ISO13485:2003 Provide hands-on assistance in developing and implementing effective CAPA systems Conduct Management Organizational Assessments to identify opportunities for improved operating efficiency Outsourcing alternative for medical device manufacturers: Short-term Management Staffing, Supplier Audits, Internal Quality System Audits, Procedure Development and Implementation QMS Consulting, Inc