denise dion, vp ra/qa services eduquest, and former fda expert
TRANSCRIPT
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Operating in a State of Control;
A Risk-Based Approach to Quality
EduQuest EDUcation: QUality Engineering, Science, & Technology
Denise D. Dion
Vice President Regulatory and Quality Services
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Design Controls
Material
Controls Records,
Documents, and
Change Controls
Equipment and
Facility Controls
Production and
Process Controls
Corrective and
Preventive
Actions
Management
Controls2
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FDA Focus
• Management oversight
• Product life-cycle concept (cradle-to-grave)
• Conformance evidence – documentation
• Change Management
• Audits – overall quality system/design controls
• Corrective and Preventive Action system
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FDA Product Lifecycle
Draft Requirements
Prelim. Risk Assessment
Approved Requirements
510(k), PMA, PMA
supplement,
IDE, HDE, IRB
P1, early P2
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Pre-Market: Design
• Concept and Feasibility
– This is the time to determine the requirements of the
device
– Design starts once your initial requirements are
approvable
– Preliminary risk analysis (top-down) should be done
concurrent with determining your requirements
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The Yin/Yang of Design/CAPA
• Design is the beginning
• Risk Analysis – (product and process) begins with
Design
• Production and Post-Production Planning feeds the
CAPA system
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Cradle-to-Grave Concept
Design Controls
CAPA
Product
Monitoring
Complaints
Risk Management
Audits
Service Reports
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The Yin/Yang of Design/CAPA
• Production and Post-Production data is used to
– Assure our original risk assessments were correct
– Assist us in proper evaluation and investigation of
nonconformances (product, process, system)
– Identify needed actions to improve our product design,
processes and systems
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The Yin/Yang of Design/CAPA
• In deciding on requirements for design changes or new
designs
– Marketing data
– Voice of the Customer
– Human Factors
– Regulatory/Standards
– Production/Post-production data from similar designs
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Use of Trace Matrices
• Use trace matrices
– To help identify affected parts of design when changes
are made
– To Identify tests to be repeated on changed design
• To understand where you may be introducing new risks
or failure modes or affecting existing mitigations
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Design Input Requirements
• Initial Design Input Requirements include:
– User needs
– Intended uses
– Safety attributes
– Performance features or usability (Human
Factors)
– Technical compatibility, Standards
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Design Inputs – Sources
• Human Factors
• Regulations
• Standards
• Guidance
• Preliminary Risk Assessment activities
• Failure Investigations of Complaints, MDRs,
CAPAs, Recalls (Yours and Others)
• Marketing and Clinical studies and surveys
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Design Input and Outputs
• Initial Design Input Requirements
– What we design to
• Final Design Output Specifications – the
Device Master Record
– What we build to
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Design and Usability Goals
• Design for the most common users and tasks
– 80% of users and tasks
– Users, not engineers
• Make information easily obtainable (intuitive)
– Memory is fallible
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Design and Usability Goals
• Provide obvious error control
– Prevent errors
– Make errors recognizable
– Enable immediate error recovery
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Consequences of Poor Usability
• Use Error – complaints, recalls
• Increased technical support costs
• Increased training requirements
• Revision of User Manual
(possible FDA submission)
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Why Design Input is Important
• Garbage In – Garbage Out (GIGO)
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Consequences of
Inadequate Design Input
• Device not fit for its intended use
– Not effective
– Not safe
• Complaints, MDRs, Recalls
• Changes – design, manufacturing process
• FDA Regulatory Action
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Design and Risk Management
• Perform initial (top-down) risk assessment during the
creation of the initial design input requirements.
• Perform final risk assessment (bottom-up) to help finalize
your design output specifications contained in the device
master record.
• For pre-market knowing frequency of occurrence of harm
may be enough;
• For post-market you will also need frequency of
occurrence of the event or failure mode.
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Post-Market: CAPA
• An effective CAPA system uses mechanisms to monitor
the quality of people, processes, product, and quality
system
• This includes complaint handling, nonconforming
product mechanisms, adverse event reporting,
corrections, removals, and recalls
• Need to understand product and process risk to make
appropriate decisions
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Purpose of a CAPA System
• To collect and analyze quality information - feedback
• Identify and investigate product and quality problems
• Take appropriate and effective corrective and preventive
actions to prevent their occurrence
or recurrence
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CAPA Data Sources – Quality Data
• Customer complaints
• Incoming components
/Materials
• Inspection/test data
“final”
• Inspection/test data
“in process”
• Calibration
• Record/document issues
• Nonconforming material
or product
• Supplier audits
• Management review
• 3rd party audits
• Internal audits
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CAPA Data Sources – Quality Data
• Process control data
• FDA observations
• Process Validation issues
• Facility control
• Training records
• Design Verification
/Validation
• Device history records
• Field actions (corrections
and removals)
• Equipment maintenance
• Change control records
• Scrap/rework/yield data
• Environmental
monitoring/control
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CAPA Data Sources – Quality Data
• Returned goods
• Medwatch/MDR/
Vigilance reports
• Handling/storage of
product data
• Field service reports
• Clinical data
• Employee complaints
• Product warranty
• Clinical literature and
journal articles
• Legal claims
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CAPA Procedures
• Procedures that discuss how any nonconformance
or complaint is initially evaluated for validity,
extent and impact
• Procedures that state when a root cause
investigation is required for all data sources as
well as for trends – criteria for escalation
• Procedures to describe how root cause
investigations are to be conducted and documented
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General Flow for a CAPA System
Nonconformance
Product Process or System
Potential or Actual
Potential NC Report
Process or Quality NC Report
Non-complaint
NCMR
Level 2 FI?
Level 1 FI
Document Corrections for all existing and trend all
Trend Analysis Indicates Actual or Potential Non-conformance
Enter Into CAPA Database
Document and Track through Implementation and Effectiveness
Complaint
CAPA?
Level 1 FI
Level 2 FI?
Close
Trend Analysis Indicates Actual or Potential Non-conformance
Level 2 FI
Potential Actual
No
Yes
No Yes
Yes
No
Level 2 FI
Document and Trend
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CAPA System Advice
• Not every situation can be a code red
• Use risk management to prioritize Non-conformance and
CAPA work
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Key Phases of Investigations
• Three key phases (some companies break these out into
more than three)
– Investigation (to assess whether the observed result is
valid, extent and impact)
– Expanded investigation (to assess cause)
– Corrective action (to identify action(s) to correct the
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Key Objectives of Initial Evaluation
• To determine if the observed result is valid
• To determine its impact or significance
• To determine the extent of the problem
– Other lots or serial numbers of that product
– Related products and processes
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FDA Guidance
• “To be meaningful, the investigation should be
thorough, timely, unbiased, well-documented, and
scientifically defensible.”
– Note − this is an excellent starting checklist for
reviewing and challenging draft investigation reports
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SOAP
• S – Subjective data – at input, initial evaluation
• O – Objective data – initial evaluation and root
cause investigation
• A – Assessment – probable or actual cause
– Rule Out – what it definitely, maybe is not
• P – Plan – corrections, containment, corrective or
preventive actions, additional actions
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Corrective and Preventive Action
• Need to both –
– Treat the symptoms
• Design and implement corrective actions for
each cause
– Cure the related diseases
• Thorough and exhaustive root cause analysis
• Design and implement additional corrective or
preventive actions to ensure that the problem
cannot recur or occur
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Cradle-to-Grave Concept
Design Controls
CAPA
Product
Monitoring
Complaints
Risk Management
Audits
Service Reports
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EduQuestEDUcation: QUality Engineering, Science and Technology
• Global team of FDA compliance experts based near
Washington, DC
• Founded by former senior officials & investigators from
FDA’s Office of Regulatory Affairs (ORA)
Headquarters
• Advising medical device and bio-pharmaceutical
companies worldwide since 1995
• Focus on Audits and Training for Quality Systems, Risk
Management, Part 11, Validation, Inspection Readiness
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Denise DionVice President,
Regulatory & Quality Services
EduQuest
• 18 years of experience with the U.S. FDA Office of Regulatory
Affairs (ORA)
• Former FDA Medical Device Expert Investigator
• Developed many of FDA’s inspection guidance and training
materials
• Primary editor of the FDA Investigations Operations Manual
(IOM) – the “bible” for FDA inspectors
• Lead instructor for EduQuest CAPA, QSR Basics, and Design
Control classroom training courses (www.EduQuest.net)©2012 EduQuest, Inc.
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EduQuestEDUcation: QUality Engineering, Science and Technology
Additional Opportunity for Staff Training from EduQuest:
The CAPA Confidence Clinic:
Effective CAPA Systems, Failure Investigations & Complaint Management
• September 27-28, 2012 – Frederick, MD (near Baltimore and Washington, DC)
QSR Compliance Basics:
Complying with FDA’s Medical Device 21 CFR 820 Quality System Regulation
• October 16-17, 2012 – Frederick, MD (near Baltimore and Washington, DC)
Design Control for Medical Devices:
Meeting FDA’s 21 CFR 820.30 Rules for Quality Design and Manufacturing
• October 17-20, 2012 – Frederick, MD (near Baltimore and Washington, DC)
Details at www.EduQuest.net Or Email: [email protected]
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Questions
or Comments?
Contact: [email protected]; 240-449-5852
EduQuest, Inc.
1896 Urbana Pike, Suite 14
Hyattstown, MD 20871
+1 (301) 874-6031
www.EduQuest.net
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