Denise Dion, VP RA/QA Services EduQuest, and Former

Operating in a State of Control;
A Risk-Based Approach to Quality
Denise D. Dion
Vice President Regulatory and Quality Services
EduQuest
EDUcation: QUality Engineering, Science, & Technology
Management
Production and
Process Controls
Design Controls
Material
Controls
Corrective and
Preventive
Actions
Records,
Documents, and
Change Controls
Equipment and
Facility Controls
Controls
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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
P1, early P2
Approved
Requirements
Draft Requirements
Prelim. Risk
Assessment
510(k), PMA, PMA
supplement,
IDE, HDE, IRB
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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
Risk Management
Product
Monitoring
Complaints
Service Reports
Audits
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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
• Clinical data
• Medwatch/MDR/
Vigilance reports
• Employee complaints
• Handling/storage of
product data
• Clinical literature and
journal articles
• Field service reports
• Legal claims
• Product warranty
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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
Process or
System
Product
Complaint
Potential or
Actual
Noncomplaint
Potential
Potential NC
Report
Level 1 FI
NCMR
Actual
Process or
Quality NC
Report
Level 2 FI?
Level 1 FI
No
Yes
Yes
Level 2 FI?
Close
No
Level 2 FI
Document
and Trend
Level 2 FI
No
Document
Corrections
for all
existing and
trend all
CAPA?
Yes
Trend
Analysis
Indicates
Actual or
Potential
Nonconformance
Enter Into
CAPA
Database
Trend Analysis
Indicates Actual or
Potential Nonconformance
Document and
Track through
Implementation
and Effectiveness
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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
cause of the problem and ensure the nonconformity
cannot recur)
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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
Risk Management
Product
Monitoring
Complaints
Service Reports
Audits
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EduQuest
EDUcation: 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 Dion
Vice 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)
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EduQuest
EDUcation: 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:
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Questions
or Comments?
Contact: denisedion@eduquest.net; 240-449-5852
EduQuest, Inc.
1896 Urbana Pike, Suite 14
Hyattstown, MD 20871
+1 (301) 874-6031
info@EduQuest.net
www.EduQuest.net
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