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[email protected] Ted Wilson Hogan Lovells US LLP Keys to an Effective Complaint Handling System: How to Audit and Improve Yours July 18, 2018
Ted WilsonHogan Lovells US LLP
Keys to an Effective Complaint Handling System: How to Audit and Improve YoursJuly 18, 2018
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• Historically, most companies established a “one size fits all” complaint handling system, addressing process, timeliness, personnel, etc.– This meets regulatory requirements for QSR, ISO 13485 and other geography
specific requirements
– May be the easiest system to implement and maintain
– Appropriate for smaller companies or business units, company with limited number of devices or complaints
• Companies frequently face resource challenges with timely and effective complaint management
Complaint handling for a Total Product Life Cycle environment
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• In the current risk-based and resource constrained world, companies should consider establishment of a risk based complaint management system– For example, take into consideration the potential for patient or user harm in
determining timing and use of resources for complaint handling, while still meeting the baseline requirements of QSR, ISO 13485 and other geography specific requirements
Complaint handling for a Total Product Life Cycle environment
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• Understand the importance of updating TPLC information relative to complaint management– FDA is increasingly focusing on postmarket surveillance information in terms of
recall and product submission expectations
• But it is not just about satisfying regulators – Your complaint handling process is an opportunity to learn about how your
products are performing in the field and to make necessary improvements to enhance product quality and customer (physician and patient) satisfaction
Complaint handling for a Total Product Life Cycle environment
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• Use the risk information developed pre-market to establish priorities for complaint handling– Consider developing risk-based decision trees, using factors such as:
– Inherent risk of device
– Possible failure modes and severity of risk associated with each
– Rather than focusing just on actual death and serious injury, also prioritize malfunctions based on potential for serious injury or death
– Both safety and effectiveness must be considered in assigning risk
Complaint handling for a Total Product Life Cycle environment
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• Identify appropriate personnel to manage various types of complaints, based on risk– For example, many companies assign administrative processes involved in
complaint handling to resources who may have less background and experience
– The same can be done with lower risk complaints, freeing up personnel with more experience and background to deal with more serious/complex complaints, as well as post-market device updates
• If you change your process, it is important to assure process effectiveness both before implementation and on a periodic basis thereafter
Complaint handling for a Total Product Life Cycle environment
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• Whatever the process, assure there are sensible written procedures in place, that personnel are adequately skilled and trained to perform their roles, and that written procedures are followed
• Consider the use of tools to promote consistency in decision-making and collection of information (especially important to mitigate effects of turnover)
Complaint handling for a Total Product Life Cycle environment
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• We have seen companies successfully develop a tiered approach to their complaint handling systems– All complaints must meet the baseline regulatory requirements of applicable geographic
locations (Tier I requirements)*
– Higher risk complaints are subject to additional evaluation and investigation requirements (Tier II)*
*Postmarket surveillance information could change the Tier into which certain complaint types fall
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Use of Complaint Data
• Valuable source of information that feeds into TPLC information
• All appropriate functions should be aware of important complaint information and trends– One purpose of management review
– How do you assure adequate dissemination? Who should receive complaint information? How should it be used?
• May be very helpful in identifying issues to be resolved prior to the issue becoming a crisis (“feedback is a gift”)
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Use of Complaint Data
• Complaint data and complaint trending is typically reviewed by regulators; it can be a starting point for an in-depth inspection
• Helpful in understanding safety and performance/effectiveness of device, as well as market place perception of device
• Nobody wants unsatisfied customers; view this process as an opportunity to improve, not as a burden
Complaint handling for a Total Product Life Cycle environment
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• Important to handle every complaint as if it were true
• Many companies trend both “as reported” and “as verified” complaints (or “confirmed” and “unconfirmed” complaints) to ensure that all reported complaints are factored into decisions as to whether a potential or actual signal exists
Complaint investigations
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• Failure to possess the device (retained or returned) is not a rationale for failure to investigate
• Documentation is required for decision not to investigate– A rationale for no investigation must also be documented and must be carefully
considered and sensible
Complaint investigations
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• Potential avenues of investigation include:– Review the Device History Record, Quality System Record
– Look beyond whether product met specifications
– Determine, for example, if product was released at high or low end of approved specification, environmental control ranges and process operating ranges
– Look for any deviations or changes; determine whether they could be related to cause of complaint
Complaint investigations
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• Potential avenues of investigation include:– Review of records / examine samples from other lots or serial numbers of the same
and similar device
– Review TPLC information for the device, including information for similar devices from other companies
– Review the Design History File
– Computer modeling or simulations
Complaint investigations
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• Complaint investigations are a subset of failure investigations
• Additional sources of failure information requiring investigation:– In-process and final device testing
– Bench studies
– Stability studies
– Clinical trials
– Literature
Failure investigations
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• If no failure investigation is determined to be appropriate, document the decision and provide a rationale. For example:– Already investigated or currently under investigation
– Root cause known
– Be careful that when you state the root cause is known, you can defend that the current complaint does in fact represent the same issue (has same root cause) as previously investigated issue(s)
Failure investigations
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• Written procedure required for process and records, to include:– Reasonable time for failure investigation (based on regulator, not company, view)
– Establishment of failure investigation plan with milestones/timelines
– Personnel to be involved
– Identification of actual or likely root cause
– Corrective and preventive actions
– Notification (internal or customer)
– Labeling
– Training
– Modification of device
– Re-design of device
– How to determine and monitor effectiveness of corrective and preventive actions
Failure investigations
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• Documentation– The more significant the failure (in terms of potential harm), the more thorough the
documentation needs to be
– Should tell the story of the investigation in a way that an uninvolved party can understand
– Rationale must be provided for all decisions
– All findings and conclusions must be supported by objective evidence in file. Avoid speculation, assumptions, hyperbole
– Should be considered and placed in full context of what is known about the device
– Close all open issues (e.g., if the plan called for four potential root causes to be investigated, be sure the documentations closes the loop for all four)
Failure investigations
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• QSR and ISO 13485 require periodic audits of quality system requirements, including complaint handling
• Tips for what to look for in the audit:– Review of written procedures to assure all regulatory requirements are met
– Adherence of assigned personnel to written procedures, work instructions and forms
– Does the file “tell a story” (are there gaps in the story that need to be addressed?)
– Whether the file demonstrates that multiple good faith attempts were made to obtain additional information
– Thoroughness of investigations and adequacy of documentation
Auditing your complaint handling system
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• Tips for what to look for in the audit :– Documentation of deviations; typically these are related to the time required to
close complaints
– Consistent decision making and documentation
– Review of responses to customers
– Complaint trending
Auditing your complaint handling system
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• Tips for what to look for in the audit :– Closure of prior quality audit observations and inspections/audits by third parties
– Is the system working under “stress” (during periods of high volumes of complaints, when retrospective reviews are undertaken, if there is a change to the SW system used, if there is high or frequent turnover, during inspections, etc.)
– Other required actions (typically, adverse event reports, CAPAs, recalls and product modifications)
Auditing your complaint handling system
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• Tips for what to look for in the audit :– Periodic review of other sources of information on device safety and performance
– Cumulative review of device-specific information
– Incorporation of complaint and associated information into risk management system
– Follow up actions taken as a result of TPLC information
– Input of updated risk management information into new device design and device modifications
• Ask your stakeholders what is working and not working and what suggestions they have for improvement
Auditing your complaint handling system
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• Common inspectional observations:– Failure to have adequate process and written procedure, lack of timeliness, lack of
evaluation for MDR, failure to file MDRs when deemed necessary by FDA
– Complaints involving possible failure of device, labeling, packaging must be reviewed, evaluated and investigated, unless investigated previously
– Inadequate record of investigation
– Decision to investigate and record of decision
– Handling of OUS complaints
Auditing your complaint handling system
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• Both QSR and ISO 13485 have requirements for electronic records and electronic signatures which must be followed to render records trustworthy, reliable, and generally equivalent to paper records and handwritten signatures
• These apply to any records required by regulation, including complaint procedures and records, audit procedures and records, complaint and failure investigations
• For electronic submissions to regulatory agencies, follow the specific rules in place at the time of submission
• Consider retaining an outside subject matter expert to audit this aspect of the complaint handling system
21 CFR Part 11 compliance
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