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TÜV SÜD TÜV SÜD
Best Practices –Implementing an Effective CAPA System
Presented by Edna R. Falkenberg
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TÜV SÜDTÜV SÜD
TÜV SÜD in numbers: Growing from strength to strength
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1 One-stop technical solution provider
800 locations worldwide
employees worldwide 20,200
million Euro in sales revenue 20131,900
150 years of experience
TÜV SÜD
Global expertise. Local experience.
Global Headquarters: Munich, Germany
INTERNATIONAL
Euro 750 mio9,800 staff
GERMANY
Euro 1,190 mio10,400 staff
Legend:
Countries with TÜV SÜD offices
Regional headquarters
Note: Figures have been rounded off.
14-05-12 Slide 3
TÜV SÜD
TÜV SÜD America Inc.
• TÜV SÜD America Inc., founded in 1987, is the North American subsidiary of TÜV SÜD AG.
• TÜV SÜD America Inc. provides complete services through its divisions:– Product Service– Management Service– Industry Service– Chemical, Oil and Gas – Global Risk Consultants
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• Regulatory Requirements– Both FDA and ISO require an active CAPA program as an
essential element of a quality system.• Good Business Practice
– Quality problems can have a significant financial impact on a company.
– CAPAs can increase visibility into areas of potential risk• Customer Satisfaction
– The ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction
Why CAPA?
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CFR: 21 CFR 820.100 (Medical Device) “(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action
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CAPA Requirements – CFR: 21 CFR 820.100
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ISO 13485:2003, 8.5.2 Corrective Action
•The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the non-conformities encountered.
•A documented procedure shall be established to define requirements for:
a) reviewing nonconformities (including customer complaints)
b) determine the cause of nonconformities,
CAPA Requirements – ISO 13485
Analyze DataInvestigate
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ISO 13485:2003, 8.5.2 Corrective Action (cont.)
c) evaluating the need for action to ensure that the nonconformities do not recur,
d) determining and implement action needed, including, if appropriate, updating documentation
e) recording the results of any investigation and of action taken, and
f) reviewing the corrective action taken for its effectiveness
Actions Needed?
Plan/Implement Changes
CAPA Requirements – ISO 13485
Document
Are Actions Taken Effective?
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• FDA and ISO requirements are similar •Process Steps are the similar, see below simplified the requirements out of the regulation and standard translated and simplified
Analyze Data from Inputs
Investigate
Issue CAPA
Plan Actions to be Taken
Root Cause Analysis,
Implement Changes
Verify Changes –Are they
Effective?
Documentand Close Loop
CAPA Requirements - Summary
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1. Not considering input from other quality system elements and external sources
2. Complex CAPA process
3. Documentation
4. Focus on single rather than on systemic issues
5. Resources
6. CAPA Software
7. Multiple Sites / Global Companies
Key Challenges for Medical Device Companies
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Internal Feeder into the CAPA system
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External Feeder into the CAPA system
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• A process too complex often interferes with the ability to act appropriately and in a timely manner, e.g. multiple approvals, signature requirements, decentralized functions
• Process is software-driven, but both (SW and process) are not aligned
• This often results in aging of CAPAs and delays in improvement activities
• Multiple CAPA systems in place - Risks not considered, difficult to detect similar issues, early detection difficult (not used as „early warning system“)
Complex CAPA process
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Documentation
Main problems:• CAPA documentation not up-to-date, paper-based• Documentation does not reflect all initiated and performed
actions properly• CAPAs overdue, extentions filed, but not justified
Documentation should contain as a minimum:• Well-defined problem statement• Correction or containment measure• Data review• Investigation / root cause analysis• Action Plan• Forward – backward traceability
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Resources
• CAPA is „Quality“, so it is not my job
• Often conflicting and/or changing priorities
• CAPA often is a „Competition“ for resources
• Alignment of CAPAs with quality and business objectives can prevent resource issues
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Software
• There are many Software tools for supporting a CAPA process on the market
• First, define your process, then automate it with the appropriate tool
• Software used to drive the process is a Tool, NOT a solution
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Global Companies / Multiple Sites
Companies with multi-sites (and potentially different systems) must overcome the concerns that are different
– Methods– Culture– Terminology – Businesses and– Processes
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An Effective CAPA System?
A systematic approach which
• considers all relevant inputs from internal and external feedersfor processes, products, and quality systems
• identifies existing and/or potential causes of nonconformities (product/process/system-related)
• investigates for root cause(s) consistent with the associated risk(s)
• identifies actions needed to correct the nonconformity and prevent recurrence
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An Effective CAPA System?
A systematic approach which
• verifies the effectiveness of initiated and performed actions
• is monitored and reported to management
• Contains a feedback loop
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Example CAPA Process - Simplified
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CAPA Procedures - Seven Steps
1. Identification – clearly define the problem2. Evaluation – appraise the magnitude and impact3. Investigation – make a plan to research the problem4. Analysis – perform a thorough assessment5. Action Plan – create a list of required tasks6. Implementation – execute the action plan7. Verification for Effectiveness– verify and assess the
effectiveness
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1. Identification
• The initial step in the process is to clearly define the problem or potential problem.
• This should include:– the source of the information, – a detailed explanation of the problem, – Documentation of the available evidence that a problem exists.
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• The situation must be evaluated to determine both the need for action and then, the level of action required.
• An evaluation should include:– Potential Impact of the problem.– Risk to the company or its customers– Remedial Action that may be required
2. Evaluation
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Potential Impact
• Determine and document specifically why the problem is a concern and what the impact to the company and/or customers may be.– Concerns may include costs, function, product quality, safety,
reliability, and/or customer satisfaction.
2. Evaluation
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Determine what happened, how it happened, extent, identify true root cause(s)•Seven classic quality tools
– Flowchart– Check sheet– Cause/Effect diagram (Ishikawa, fishbone)– Pareto chart– Control chart– Histogram– Scatter Diagram
•More tools– 5-whys– Is/Is-not– Contradiction matrix
•Keep Records
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3. Investigation
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• The investigation procedure is used to conduct the investigation into the cause of the problem.
• Every possible cause is identified and appropriate data collected.
• The results of the data collection are documented and organized.
• Everything related to the problem must be identified, but the primary goal must be to find the root cause.
• A list of all possible causes is created which then form the basis for collecting relevant information, test data, etc.
• The necessary data and other information is collected that will be used to determine the primary cause of the problem.
4. Analysis
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• Using the results from the analysis, the best method(s) for correcting the situation (or preventing a future occurrence) is determined.
• All of the tasks required to correct the problem and prevent a recurrence are identified and incorporated into an action plan.
• The plan includes changes that must be made and assigns responsibility for the tasks.
• List all activities and tasks that must be accomplished to correct the existing problem or eliminate a potential problem, and prevent arecurrence.
• It is very important identify all actions necessary to address everything that contributed to or resulted from the situation.
5. Action Plan
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• Lists corrective and preventive actions (if applicable)
• Clearly addresses root causes
• Commensurate with the risk of the issue
• Where effectiveness checks are defined
• Identification of task owners and task due dates
• Implementation due date
• Keep records
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5. Action Plan
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Verification for Effectiveness
•Verification may be simple – Procedure change/implementation verified– Training completed, records verified– Document corrected, document verified
•Verification may be more complex– Monitor defect or complaint rates over a period of time– Monitor receipts of product from suppliers– Re-audit of the process
6 + 7. Implementation / Effectiveness Verification
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• When the Follow Up has been finished, the CAPA is complete.
• It should be dated, and signed by appropriate, authorized personnel.
CAPA Completion
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• If verification for effectiveness is not successful, a decision will need to be on how to close the loop– Need more time for verification– Revisit the CAPA– Issue new CAPA
• Once the corrective action is successfully verified, it can be closed!
CAPA Completion
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Reporting• CAPA is a required input to Management Review, per ISO 13485
and ISO 9001
• What data will be presented at Management Review?
• Examples may include:– CAPA aging– CAPA’s by site, department, quality system element– CAPA’s by supplier
CAPA Reporting
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What are the expectations, in terms of the process?
• Risk assessment• Plan to address:
– Root cause– Containment/Correction– Corrective Action
CAPA Process
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CAPA Process
• Implementing an effective and fully compliant Corrective / Preventive action program is a five / seven step process.
Each step must be thoroughly documented!– Properly documented actions provide important historical data
for a continuous quality improvement plan and are essential for any product that must meet the regulatory requirements demanded by FDA and ISO.
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Details for an Effective 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
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Details for an Effective CAPA Process
CAPA Assessment• Determine the need for a corrective and/or preventive action• Document Rationale
CAPA Identification and Implementation• CA: Actions necessary to eliminate the cause(s) of the
nonconformity and to prevent recurrence.• PA: Action necessary to eliminate the cause(s) of the potential
nonconformity to prevent occurrence.
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Details for an Effective CAPA Process
• Evaluation: The objective evidence that the root cause was appropriately corrected and/or the investigation has adequatelyaddressed 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– Monthly Nonconformance Control, CAPA Oversight, and
Business Metric Reviews – Trending Analysis– Management Reviews for suitability and effectiveness
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Summary: Best Practices
• Documented procedure– Simple and easily integreted throughout the company– Closed-loop program– Risk-based– Defined CAPA input sources (feeder)– Defined process flow with decision – Assure that there are linkages between products, processes, and
quality systems
• Resources– Drive for employee understanding and ownership
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Goals
• Meeting (global) regulatory requirements, e.g. ISO13485, QSR, CMDR, MDD, etc.
• Implement Data Analysis, Measurement Mechanism for process analyses
• Implement a comprehensive closed-loop CAPA system
• Simple, risk-based system implemented throughout the entire organization
• Archieve a consistently used process by utilizing training programs
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Benefits
• Decrease cost of quality (scrap, nonconforming products, complaints, field actions, process deviations)
• Decrease resource consumption
• Increase capacity and revenue
• Use CAPA as a business improvement tool
• Enhance communication
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• Required per FDA/ISO requirements
• A system that requires the support and understanding of Top Management
• A system that, if executed properly, will help the company document, correct/resolve issues and prevent recurrence
• A system that can be used to communicate to Top Management about issues and their resolutions
• Applicable to all functions within the organization
• Dependent on cross-functional cooperation
CAPA is…
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• Unnecessary documentation
• The sole responsibility of the quality organization
• A way to pass a problem onto someone else
• Needed to resolve every problem or issue
• A bad thing
CAPA is not…
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Contact us today
Thank you for attending!
EDNA FALKENBERGMANAGER, QUALITY AND R&D, LEAD AUDITOR,
ACTIVE MEDICAL DEVICESP: 978-573-2567
Please send inquiries to:[email protected]
