TC001320A

Teleconference Course Materials

You may duplicate this for each person attending the conference.

Implementing an Effective CAPA System:

What You Need to Know
by a Panel of Experts from FDA & Industry

Date: Thursday, March 6, 2008

Time: 1:00pm – 2:30pm Eastern Standard Time (GMT –5 hours)
12:00pm – 1:30pm Central Time
11:00am – 12:30pm Mountain Time
10:00am – 11:30am Pacific Time

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you can also calll in on +1-212-457-9857.

At the conclusion of the conference, an audio CD will be made available

for order. Attendees receive a special reduced price of $225.
To order go to www.foiservices.com/capa0408 or call 301-975-9400.

Important Notice
The information provided in this course by the instructor is his/her personal opinion and does not necessarily
represent the opinions of FOI, Inc. or its staff. Companies relying on the information do so at their own risk
and assume the risk and any subsequent liability that results from relying on the information.
The information provided does not constitute legal advice.

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 Faculty Biographies & Contact Information

Richard DeRisio is Vice President, Global Regulatory Affairs for Advanced Medical
Optics, Inc. (AMO). Previously, at Kinetic Concepts, Inc., Johnson & Johnson, and
Pfizer, Dick held positions in clinical research, regulatory affairs, quality assurance and
compliance During a ten-year career with FDA, Dick worked in the Division of Field
Operations, the Foreign Inspection Branch, and the Office of Compliance in the Center
for Devices and Radiological Health. He can be contacted at Richard.DeRisio@amo-
inc.com
Linda Lovett is the Director of Quality for Medtronic Spinal & Biologics Business.
In this capacity she directs all aspects of the Quality Assurance organization to assure
compliance with (CDRH) Quality System Regulations, MDD, ISO 13485:2003, ISO
14971, and CMDR for Class I (Sterile), Class II, and Class III products. Previously,
Linda was a manager of Product Quality/Operations and a senior QA/ Quality Systems
engineer at Abbott Laboratories. Linda can be contacted at linda.l.lovett@medtronic.com

Dan Olivier is President, Certified Compliance Solutions and an acknowledged expert in

the field of medical system validation and safety risk management. He has supported over
two hundred medical device and pharmaceutical companies in addressing regulatory
issues and process improvement. Dan has been engaged by FDA to provide contract
training for field investigators and to prepare inputs for FDA validation guidance
documents. He is an ISO 9001 RAB certified lead auditor and has been a reviewer for
ISO WG10 defining software process assessment standards. He can be contacted at
dolivier@certifiedcompliance.com

Nancy Singer is President of Compliance-Alliance, LLC, a firm that specializes in

professional development for those employed within the medical device industry.
Previously, Nancy served as AdvaMed’s Special Counsel for FDA compliance and
enforcement matters. Her food and drug career began as an attorney at the Department of
Justice where she did litigation for FDA. Subsequently she was a partner at the law firm
of Kleinfeld, Kaplan and Becker. Nancy can be contacted at nancy_singer@juno.com

Jan Welch is a Quality System/IVD Expert in FDA’s Center for Devices and
Radiological Health. She serves as a Quality System expert for medical device legal
actions and other medical device issues involving complex, controversial, and precedent-
setting regulatory actions involving GMP requirements. Jan identifies and recommends
new policy and administrative or regulatory approaches in highly intricate situations in
specialty areas where no policy or precedent exist. She also reviews enforcement actions
proposed by FDA’s field offices, and decides when regulatory action (based on
adherence to the Quality System regulation) is appropriate. Jan can be contacted at
jan.welch@fda.hhs.gov
Implementing An Effective CAPA System:
What You Need to Know

Nancy Singer, Compliance-Alliance

Richard DeRisio, Advanced Medical Optics, Inc

Jan Welch, Office of Compliance, CDRH

Linda L. S. Lovett, Medtronic Spinal and Biologics
Daniel P. Olivier, Certified Compliance Solutions, Inc
1
 Agenda
• Overview
– Compliance-Alliance Survey
– FDA Quality System Regulation Requirements
– Key Definitions
– ISO 13485:2003 Requirements
• View From the FDA
– FDA 483 Observations
– Warning Letters
• Practical Examples of CAPA Implementation
• Pitfalls

2
 Overview

Richard DeRisio, Advanced Medical Optics, Inc

&
Nancy Singer, Compliance-Alliance

3
 Compliance-Alliance Survey
January 2008
• 374 respondents
• Small, medium and large firms
• 262 individual comments regarding survey questions
• The 24 survey questions included:
– Sources of quality data inputs
– Use of risk management tools
– Use of statistical methods for CAPA management
– Criteria for opening and closing CAPAs
– Metrics for measuring CAPA effectiveness
– Techniques for managing the CAPA program
– Review of CAPA data during management reviews
– CAPA Challenges 4
 Quality System Regulation
21 CFR 820.100
• Establish a CAPA Procedure
• Analyze (with statistical methodology)
sources of quality data to identify sources
of quality problems

5
 Sources of Quality Data

• Customer complaints 91%

• Internal audits 89%
• Incoming components/Materials 86%
• Inspection/test data “final” 80%
• Inspection/test data “in process” 79%
• Record/document issues 77%
• Rework and nonconforming material 77%
• Supplier nonconformances 76%
• Management review 75%
• 3rd party audits 75%
• Process control data 74%
• FDA observations 73%
• Supplier audits 73%
• Validation issues 73%
• Facility control/environmental issues 73%
• Training records 72%
6
 Sources of Quality Data (continued)

• Device history records 70%

• Field actions (corrections and removals) 68%
• Equipment data 67%
• Change control records 65%
• Scrap/rework/yield data 64%
• Temperature monitoring/control 63%
• Design control data 61%
• Returned goods 61%
• MedWatch/MDR/Vigilance reports 61%
• Handling/storage of product data 61%
• Field service reports 44%
• Clinical data 34%
• Employee complaints 29%
• Product warranty 24%
• Clinical literature and journal articles 21%
• Legal claims 21%

7
Establish a CAPA Procedure (continued)
• Investigate causes of nonconformities
– Most firms (73%) use risk management to determine
whether to open a failure investigation
• FMEA 84%
• Hazard Analysis 43%
• Fault Tree Analysis 38%

8
Establish a CAPA Procedure (continued)
– Criteria used to open failure investigation
• Severity 85%
• Frequency 78%
• Impact 68%

– Effective CAPA Management Reduces Risk

• Safety
• Business interruption
• Product liability
• Regulatory compliance
• Loss of customer goodwill

9
 Establish a CAPA Procedure (continued)

• Identify actions needed to correct and prevent

recurrence
• Verify or validate effectiveness
• Implement and record changes in records and
procedures
• Disseminate information to affected personnel
• Submit information about problems and corrective/
preventive action for management review
• Document activities

10
 Information Examined During
Management Reviews
• Volume and Aging Report 77%
• CAPA Quality System Effectiveness Report 47%
• Analytical statistics from quality data sources 47%
• CAPA Effectiveness Report 46%
• Comparison across all quality data sources 35%
• Scrap/Yield Report 35%
• Comparison to other product lines 21%
• Use “As Is” Report 19%
• Risk Impact Report 19%
• Change Control Impact Record 12%

11
 QSIT
• 1997-1999 FDA reengineered Quality System Inspections
http://www.fda.gov/cdrh/comp/qsitpage.html
• QSIT training provided definitions

12
 Definitions From FDA QSIT Slides
• Correction refers to repair, rework, or adjustment and
relates to the disposition of the existing nonconformity

• Corrective action refers to action taken to eliminate the

causes of an existing non-conformity, defect or other
undesirable situation in order to prevent it recurrence

• Preventive action refers to action taken to eliminate the

cause of the potential non-conformity, defect or other
undesirable situation in order to prevent occurrence

13
 ISO 9000:2005
• Nonconformity: non-fulfillment of a requirement (3.1.2)

• Correction: action to eliminate a detected nonconformity

(3.6.2)

• Corrective action: action to eliminate the cause of a

detected nonconformity (3.6.2) or other undesirable
situation

• Preventive action: action to eliminate the cause of a

potential nonconformity (3.6.2) or other undesirable
potential situation
14
 Examples from QSIT Training
• Correction: Devices returned because out-of-box failures
are repaired and put back into inventory

• Corrective action: Defective components damaged by

ESD during assembly caused out-of-box failures. ESD
controls instituted; operators are trained in ESD controls.

15
 Examples from QSIT Training
• Preventive action: SPC chart indicated process is
drifting toward the upper limit for diameter of injection
molded part. Investigation determines cause of drift is
wear to mold. Replace mold, and verify/validate that
process yields parts meeting specs.

16
 ISO 13485:2003

Corrective and Preventive Action

Requirements of the Standard

17
 8.5.1 – Improvement: General
• Organization shall:
– Identify and implement changes to ensure suitability and
effectiveness of the quality management system
• Quality Policy
• Quality Objectives
• Audit Results
• Analysis of Data
• Corrective and Preventive Action
• Management Review
– Establish documented procedures for the issuances of advisory
notices
– Review customer complaints and provide information if necessary to
other organizations involved
– If complaint not followed by CAPA, document the reason
– Establish procedures for reporting adverse events 18
 8.5.2 – Corrective Action
• Organization shall take action to eliminate the cause of
nonconformities to prevent recurrence;
• The corrective action shall be appropriate to the level of the
effects of the nonconformance
• Documented procedure shall include:
– Reviewing nonconformities including complaints
– Determining the cause of nonconformities
– Evaluating the need for action to prevent recurrence
– Determining and implementing action needed
– Updating documentation, as appropriate
– Recording the results of any investigation and action
– Reviewing the corrective action taken and effectiveness
19
 8.5.3 – Preventive Action
• Organization shall determine action necessary to eliminate
the cause of potential nonconformities to prevent occurrence
• The preventive action shall be appropriate to the effects of
the potential problem
• A documented procedure shall define how to:
– Determine potential nonconformities and their causes
– Evaluate the need for prevent nonconformities
– Determine and implement the action needed
– Record the results of an investigation and action taken
– Review preventive action and its effectiveness

20
 CAPA System Practices:
From the FDA Perspective

Jan Welch
Quality System Expert
Office of Compliance, CDRH
Food and Drug Administration
21
 CAPA System Advice

► “CAPA system” is not just the formal, tracking

mechanism for elevated, opened investigations
► More than the paper files or databases established for
these functions
► A true and robust CAPA system encompasses all of the
mechanisms and data sources that a sound quality
system uses to monitor the quality of people, processes,
product, and problems
► This includes complaint handling, nonconforming product
mechanisms, medical device reporting, corrections,
removals, and recalls

22
 75(c)
70
“BIG C”

30(i) 820.100 CAPA

820.22 Internal audits
820.90 Non-Conformances
80 198 820.198 Complaints
820.75(c) Process Changes
820.70 Production
22 820.30(i) Design Changes
820.80 Acceptance
90 820.20 Management
820.200 Service
100 820.50 Purchasing
20 CAPAs/CARs 820.170 Installation
820.72 Calibration
“little c” 820.40(b) Document Changes
806 Corr/Removals
806 803 803 MDRs

200
40(b)
50

170 72 23
 CAPA System Advice

► A robust CAPA system will constantly be supplied with

data from many sources within the QMS, and from
several external to the QMS
► Feed the CAPA system! Don’t be afraid!
► Management often afraid to have numerous CAPAs;
perception that this is a bad thing and reflects poor
control of the QMS
► Au contraire!
► Must have appropriate mechanisms in place to
determine when a situation merits a formal CAPA

24
 CAPA System Advice

►FDA’s focus is not on numbers of CAPAs

►FDA wants to see how the QMS handles the
data flow
►Is the CAPA system doing what it needs to?
►Not every situation can be a code red, priority
one, major fire…really!
►So what to do about that?
►Use risk management tools to prioritize CAPA
work
25
 CAPA System Advice

►When CAPAs are open for longer periods

of time, include status information and
milestones in the record
►It is not good when a CAPA is open for a
long period of time, with no indication of
activity
►Document decision-making rationale in
the CAPA record

26
 CAPA System Advice

►If corrective action is made to only some devices

and not all devices, this decision-making
process needs to be thoroughly explained
►FDA certainly focuses on this
►See this in software “fixes,” “upgrades,”
“corrections”
►Corrective action made on new models, returned
devices, but not made to all devices in use;
document why!

27
 2007 CAPA Data
► Analysis of data from FDA’s Turbo EIR
database.

► Time frame 1/1/2007 to 12/31/2007

► 3332 observations were cited on the FDA-

483s for 21 CFR 820 deficiencies

28
 2007 CAPA Data
► 200 observations were cited for 21 CFR
803 deficiencies (MDR Reporting)

► 38 observations were cited for 21 CFR

806 deficiencies (Corrections/Removals)

► 1 observation was cited for 21 CFR 821

deficiency (Tracking)
29
FDA-483 Observations (n=3332)
1/1/2007 to 12/31/2007

3332
3500

3000

2500

2000
1219
1500 964
609
1000 423

500 117

0
TOTAL CAPA PPC MGMT DESIGN DOC

30
Observations by Subsystem
1/1/07 to 12/31/07

Management
P&PC 18%
36% Document
4%

Design
13%
CAPA
29%
31
 Number of CAPA Subsystem
Observations by CFR Cite -2007

Tracking (821) 1

Corrections & Removals (806) 38

Nonconforming (820.90) 127

MDR's (803) 200

Complaints (820.198) 363

Corrective & Preventive Actions (820.100) 474

Total 1203

0 200 400 600 800 1000 1200 1400

32
21 CFR 820.100 Data
820.100(a) 104
820.100(a)(1) 79
820.100(a)(2) 36
820.100(a)(3) 45
820.100(a)(4) 27
820.100(a)(5) 25
820.100(a)(6) 4
820.100(a)(7) 10
820.100(b) 144

Total 474
33
 Warning Letters with
CAPA System Cites 2007
• January – December 2007
• FDA issued 74 Warning Letters
to medical device firms for
QS/GMP deficiencies
• 62/74 or 84% contained cites
for CAPA system deficiencies
• 21 CFR 820.90, 820.100, or
820.198 cites

34
 Warning Letters
CAPA Data
Year # WLs # w/ %
CAPA cite
2007 74 62 84
2006 79 69 87.3

2005 97 85 88
2004 113 89 79
2003 69 61 88
35
2007 Warning Letter Example

“Specifically, your complaint files are

incomplete, investigations are incomplete
and in some cases not performed at all,
and some complaints have no
documentation of activity for 5 or 6 months
after receipt. [21 CFR § 820.198]”

36
2007 Warning Letter Example

“Management reviews at your …. facility did not

include non-conformances and quality data
analysis from all sources, in that re-works, re-
sterilizations, preventive maintenance corrective
actions and returned goods (sources of quality
problems) were not addressed in management
reviews.”

37
 Warning Letter Database

¾ Go to FDA’s web site and use this link:

http://www.fda.gov/foi/warning.htm

¾ These WLs redacted for FOI purposes;

trade secret, proprietary info blacked
out
38
Implementing an Effective CAPA System:
What you need to Know

Presented by:
Linda L. S. Lovett
Quality Systems Director

Medtronic
Spinal and Biologics
39
 Key Challenges:
CAPA in Medical Device Industry
Companies are struggling with some of the same fundamental challenges….

• More companies are under increased scrutiny by regulatory agencies and authorities
– Enforcement Actions taken (Form 483 Observations, Warning Letters, Consent Decrees,
Injunctions, Product Seizures, etc.)

• Focus is on product/ material issues rather than efforts to resolve systemic issues
– Companies tend to look at product/ material issues and correcting them and neglect to look beyond
into the processes and procedures (quality systems).
– Fast forward to the solution without identifying the “Root Cause”

• Developing, Implementing, and Maintaining a “Closed Loop” CAPA system that “Integrates
Compliance” into business practices and quality systems
– Not all inputs are identified
– Required process steps are not always completed
– Trending and data is not always analyzed and/ or visible to the appropriate level in the organization.
– Employees don’t always know or understand their responsibility or authority

• Using your CAPA system to “Improve Profitability by Decreasing the Cost of Quality”
– High cost of quality impacts the bottom line (rework, scrap, delays in product approval, resource
inefficiency, etc.)
– Data and risk driven – helps to determine where to focus actions and resources

• Many companies are still using manual paper based systems

– Difficult to manage
40
 What is an effective Nonconformance Control/ CAPA system?

Examples: A system that ……

• includes all nonconformance inputs from internal and
external sources for product, processes, and quality
Processes systems

• identifies existing or potential causes of

nonconforming products or other quality problems.

• evaluates/ investigates for root cause consistent with

Equipment Controls (Calibration/ the associated risk
Preventive Maintenance)
Production and Process Control • identifies actions needed to correct or prevent
Systems (Environmental Monitoring, recurrence
Handling, Storage, Distribution, Device
History Records) • verifies/ validates the CAPA for effectiveness and
assures that the actions do not adversely affect
finished product

• has a closed feedback loop – data that is collected,

Training reviewed, analyzed and further action is identified as
Product Complaints an output that becomes an input back into the
Facility Controls
Material Nonconformances process
Document Controls
(NCMR)
Records
Acceptance Activities
Supplier Controls • is measured, monitored, and reported to management

Products/
Quality Systems
Materials

41
Developing an Effective
Nonconformance Control and CAPA system

• Identify Team Resources, Champions,

Executive Sponsors
Mission Statement
• Determine the timeline and schedule

• Kick-Off Meeting
Scope
Goals • Provided CAPA System Training (QSR,
QSIT, ISO 13485:2003, MDD, etc.)

• Team Discussion – Benefits,

Opportunities, Experiences
Benefits
• Established the Project …
Communication – Mission Statement
– Scope
Plan – Goals
Opportunities – Communication Plan

42
 Developing an Effective
Nonconformance Control and CAPA system

Benefits Goals
• Increase Capacity and Revenue • Meet global requirements
(QSR/ISO/MDD/CMDR/etc.)
• Increase Company Credibility, Reputation, and • Design and implement a comprehensive
Good Will enhanced Closed loop CAPA system that
includes inputs from product, processes,
• Enhance Supplier Communication and materials, and Quality System nonconformances.
Relationships • System will be scalable, simple, risk based, and
easily integrated throughout the organization.
• Increase resources for Product Development
• Achieve Global employee understanding and
ownership (Accountability) without adding
• Increase Customer Base additional resources.

• Decrease Cost of Quality (Non conformances, Field • Achieve consistent and sustainable practices by
Actions, Complaints, Operational Scrap, Process utilizing tiered training programs, subject matter
experts/ trainers, and process owners.
Variability)
• Implement measurement, data analysis tools,
• Decrease Resource Consumption and processes for different levels of the
organization.
• Decrease Supplier Risk

• Prevent Regulatory Sanctions (Fines, Consent

Decree, Injunction, Product Seizure)

43
 Developed Gap Analysis - Example
– Identify all potential opportunities for non conformances for each key support system
– Determine current documentation practices
– Identify/ Classify potential nonconformance types – product/ material, process, or QS
– Develop the plan to eliminate gaps

Record or Form used to Nonconformance

Potential Nonconformance document the Type (Product,
Quality System Elements Opportunities Current Procedures nonconformance (Current) Process, QS)
Control of Inspection, Measuring and
Test Equipment New Equipment not Calibrated Calibration Management

Calibration record not reviewed

Calibration record/ form incomplete
Equipment not labeled as to
calibration status
Limited Calibration not appropriately
identified
Parameters not approved
Procedure Not Followed

Training Inadequate training Training Procedure

Job performed before training

Not training to matrix requirements

Procedure Not Followed

Trained by an unqualified trainer

Training to incorrect revision

44
Nonconformance Control/ CAPA Process
• Identification, Evaluation/ Investigation
– Determine the nonconformance type and Risk
level
• Products/ Parts
• Process
• Quality System
– Isolate the issue (lot number, timeframe, etc)
– Identify root cause
• Correction
– Immediate fix of the issue
– Product or material disposition

• CAPA Assessment
– Determine the need for a corrective and/ or
preventive action
– Document Rationale
Risk
RiskManagement
Management
• CAPA Identification and Implementation
Principles
Principles – CA: Actions necessary to eliminate the cause(s)
(Risk Analysis, Health Hazard of the nonconformity and to prevent recurrence.
(Risk Analysis, Health Hazard
Evaluations, Product/ Material – PA: Action necessary to eliminate the cause(s) of
Evaluations, Product/ Material the potential nonconformity to prevent
Impact Assessment, Defect
Impact Assessment, Defect occurrence.
Recognition, FMEA, Fault Tree – EV: The objective evidence that the root cause
Recognition, FMEA, Fault Tree
Analysis, etc. was appropriately corrected and/ or the
Analysis, etc. investigation has adequately addressed the root
cause.
• Identify a measurable, statistically significant
objective
• Don’t rely only on post distribution data

• Trend and Data Analysis

– Day to day data collection and analysis (SPC,
NST, etc.)
– Monthly Nonconformance Control, CAPA
Oversight, and Business Metric Reviews –
Trending Analysis
– Management Reviews for suitability and
effectiveness

Implementing an Effective CAPA System: What you

need to Know
1
 CAPA Assessment – Thinking/ Talking Points
Questions to ask to determine the need for a CAPA……
Corrective Action: What needs to be done to prevent or stop the cause(s) of the
same nonconformity from happening again (prevent or stop recurrence)?
–Does the procedure need to be updated for gaps or clarification?
–Is the procedure missing?
–Do risk documents require an update? RESULTS
–Was training not adequate or missing?
–Are multiple corrective actions required?
–Are there other same products, different lot or serial numbers affected? Effectively and
Continuously
• If a corrective action is not performed, why? Improves
Products, Processes,
Preventive Action: What needs to be done to prevent or stop the cause(s) of a and Quality Systems!
similar nonconformity from happening within other parts of the quality system,
other products, or other processes (prevent/ eliminate occurrence)?
–Do other procedures need to be updated for gaps or clarification?
–Are other procedures missing?
–Do other product or process risk documents require an update?
–Are multiple preventive actions required?
–Are there other parts of the quality system, other products, or other processes affected?

• If a preventive action is not performed, why?

Effectiveness Verification: Evidence based to address the root cause of the issue.
–What will be measured and what is the acceptance criteria?
–How many records or products need to be reviewed, measured, trended, or tested to the
acceptance criteria? Statistically significant sampling plan.
–Who will perform the effectiveness check?
–When will the effectiveness be performed? How long after the CAPA implementation?
–Are multiple effectiveness checks required?

• Don’t rely only on post distribution data!

46
Closed Loop Monitoring, Trend Analysis, Effectiveness Reporting
• Determine frequency of data analysis and metric review and to
what extent.
• Determine risk based measurement, data analysis tools and Identification
processes for reviewing data Nonconformance
– Assure meaningful data is captured Management
Input
– Configure data such that problems can be identified Investigation
Review for
– Determine when and what actions should be taken Root Cause
Effectiveness
Correction
• Assure accurate and timely communication to management CA
PA
• Metric and Data Analysis and Review (Examples)
– Facility/ Equipment Control (Calibration/ Preventive
Maintenance)
– Training
Nonconformance
– Inspection Results (Incoming, Production/ Manufacturing) Control,
– Nonconformance Control/ CAPA Oversight CAPA Oversight,
– Complaint Handling/ Corrections/ Removals Business
– Business metrics (Technical Support, Cost, Strategic Data & Metric
Initiatives) Analysis & Actions
– Audit Results and responsiveness
– Cost of Quality

Key Support Metric ID Functional Frequency Description of the Metric Action Criteria
System Area Owner
Facility/ CAL 1 Quality Monthly *Number of items Scheduled for NST, 3 consecutive increases for late
Equipment calibration per month vs. Actual calibration

CAL 2 Quality Monthly *Number of Calibration Impact NST, 3 consecutive increases for OOT
Assessments with Out of Tolerance calibrations/Impact Assessments
(OOT) results and disposition
Training TRN 2 Quality Monthly Late Training Exceptions (Approved/ NST, decrease in overall or department
Unapproved) compliance

47
Nonconformance Control and Closed Loop CAPA Program
In Summary

• Make the Nonconformance Control/ CAPA system scalable, simple, risk based, and
easily integrated throughout the organization. Assure that sufficient mechanisms are
in place so that all steps are completed for each event.

• Have a Closed loop Nonconformance Control/ CAPA system throughout the entire
organization that includes external and internal inputs from product life cycle,
processes, and quality systems.

• Integrate risk management throughout product life cycle, processes, and quality
systems.

• Implement measurement, data analysis tools, and processes for different levels of the
organization. Configure data such that problems related to product, process, or
quality system can be identified. Results of the analysis and/ or any further decision
to take action are identified as an output of the CAPA system.

• Assure that there are linkages within between products, processes, quality systems,
and across multiple divisions and/ or facility locations.

• Drive for employee understanding and ownership (Accountability) by implementing

consistent and sustainable practices and tiered training program.
48
 Contact Information
Medtronic Linda L. S. Lovett
Spinal and Biologics Quality Systems Director

1221 Crossman Ave Direct: 408-548-5263

Sunnyvale, California 94089 Cell: 408-616-0361
408-548-6500 Main: 408-548-6500
Email: Linda.l.lovett@medtronic.com

49
QSR Complaint and
CAPA Compliance
Presented by:
Daniel P. Olivier
Certified Compliance Solutions, Inc.
16787 Bernardo Center Drive Suite A-1
San Diego, CA 92128
(858) 675-8200
dolivier@certifiedcompliance.com
50
 Achieving the Right Balance
• How much is enough
– Number of process steps
– Number of signatures
– Detail of CAPA forms
– Depth of investigations
– Follow-up required for closure
51
 Defining the Criteria for CAPAs
• The CAPA system should be significant
sources of quality problems, not:
– All complaints
– All safety complaints
– Variable based on proximity to next audit
– A means to get more attention to problems
that are overdue

52
 Failure Investigations
• These “root causes” suggest that the failure
investigation did not go far enough
– Training
– User error
– Operator error
– Testing
• Is a failure investigation always required?
53
 Effectiveness Checks
• 820.100(a)(4) Verifying or validating the … action to
ensure that such action is effective and does not
adversely affect the finished device
• ISO 13485:2003 8.5.2.e reviewing the … action
taken and its effectiveness
• Emphasis should be on finding the right fix, not on
monitoring
• Effectiveness for design should be V&V
• Monitoring should be in place for all processes, not
just CAPAs 54
Concealing CAPA Problems
• Extending the due date for late CAPAs
• Closing out several CAPAs to create a
new one(s) to reset due dates
• Evaluating CAPA completeness based on
report volume
• Defining training and SOP updates when
a substantive root cause can’t be found
• Relaxing closure criteria when deadlines
get close
55
 CAPA Process Solutions
• Resolving problems is key to achieving
significant quality improvements
• Escalating the right elements heightens
process effectiveness (risk based)
• Streamlining processes provides efficiency
• Measurement provides visibility

56
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 Training Evaluation Form TC001320A
Implementing an Effective CAPA System: What You Need to Know
March 6, 2008 — Presented by a Panel of Experts from FDA & Industry

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