Effective Use of CAPA in Remediating Quality Management Systems

Effective Use of CAPA in
Remediating Quality
Management Systems
February 25, 2016

The Role of CAPA in Quality Remediation 4
Building a CAPA Culture within Your Organization 10
What to Do When Your CAPA System Needs a CAPA 13
Lessons Learned and Next Steps if Your CAPA Fails 17
Presentation Topics
2©2016 Maetrics. All Rights Reserved.

Presentation Topics

©2016 Maetrics. All Rights Reserved.
4
The Role of CAPA in Quality Remediation
 Definition
 The correction of something bad or defective, reversal or stopping of damage
 Righting a wrong, correcting a fault
 Common aspects of Quality remediation
 Revision/establishment of requirements
 Historical review of previous records to check for non-conformances
 Correction of non-conforming records
 Confirmation of adherence to new standard
What is Remediation?

5
 CAPA is a methodology and vehicle for change
 Provides the framework to conduct all aspects of remediation
 Establishes timelines
 Defines ownership and accountability
 Allows for documentation using objective evidence
 Visibility and accessibility of information regarding the problem and solution
 Traceability for historical context
Use of CAPA in Remediation

6
 Identify and investigate product and quality problems
 Collect and analyze information
 Develop corrective/preventive actions (CAPA)
 Verify actions
 Communicate actions
 Management review
 Documentation
Purpose of CAPA
CAPA builds the business
case for change

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 Ensure compliance to standards and regulations
 Identify issues
 Correct issues
 Address and contain issues before they become
widespread problems
 Prevent recurrence of issues
Intent of the CAPA Program and the Associated Quality System
Problems are bad…
CAPAs are good

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 Implementation of systemic solutions
 Development and revision of procedures
 Additional training
 Retrospective review to close identified gaps
 Continuous improvement
Result of Remediation

What to Do when Your CAPA System Needs a CAPA 13
Presentation Topics

10
Building a CAPA Culture within Your Organization
 Focus on the patient and the solution
 Requires support by all levels of the organization
 Drive solutions
 Involve appropriate skill sets
‒ Education and mentoring
 Promote honesty and transparency
 Encourage problem solving and innovation
 Teamwork
 Appropriate tools available
Effective Remediation is Dependent on a Healthy CAPA Culture

11
 Thorough independent investigation
 Objectivity
 Proper application of tools
 (Example: 5 why, ishikawa, 6M analysis, 3x5 why, 8D, is/is not, DMAIC)
 Honest and accurate problem statements
 Systemic evaluation and solutions
 Appropriate understanding of containment, bounding, impact to product
 Effective interim controls and corrective actions
 Involvement of appropriate owners and stakeholders
 Management support of CAPA and remediation efforts
Essential Elements of CAPA Culture

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 Ensures consistency of the process
 Provides an independent objective viewpoint and perspective for investigation and root
cause analysis
 Creates a quality mentoring atmosphere
 Leads to an environment of continuous CAPA process improvement
 Allows for escalation when needed
Importance of Quality Oversight of the CAPA Process

Presentation Topics

14
What to Do When Your CAPA System Needs a CAPA
 CAPA is one of the most frequently requested documents during an
FDA inspection
 Any FDA QSIT audit (Inspection level 1 or 2, abbreviated or
comprehensive) will include the CAPA subsystem
 A significant number of FDA inspection findings are related to CAPA*
 In 2014 FDA issued 121 warning letters to medical device manufacturers,
109 (90%) included citations for the CAPA subsystem
‒ 21 CFR 820.100(a) was the most frequently cited (77 total)
 In 2014 FDA issued 1,106 Form 483s (from 2,213 QSIT audits), out of the
3,740 observations for QSR deficiencies, 1,148 (31%) were CAPA
subsystem
‒ 21 CFR 820.100(a) was the most frequently cited (376 total)
Statistics – You are Not Alone
*Data from CDRH, Office of Compliance

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 Using CAPA to remediate the CAPA systems can cause greater issues for the whole
remediation
 Critical when remediation efforts include multiple QMS elements in parallel
 Important not to have CAPA issues lead to failure of the remediation effort
 Prioritization should allow for up front CAPA work if necessary so that the tool used for
remediation will be effective
Challenges to Remediation in a Broken CAPA System

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 Managing the remediation effort while the CAPA system is changing will be vital to the
success of the project
 Understand and ensure completion of fundamental elements
 Engage stakeholders and establish a plan
 Manage to success
 Implementing solutions to stop the gaps
 Focus on the findings to ensure your interim process does not lead to repeat failures
 Understand the end goal of the changes to minimize rework
 Establishing well defined metrics
Challenges to Remediation in a Broken CAPA System

Presentation Topics

18
Lessons Learned and Next Steps if your CAPA Fails
The CAPA Failed…Now What?

19
 Start over with a clean slate and open a new CAPA
 If your CAPA was done poorly and there is nothing that you can salvage
 Need a new investigation and root cause analysis
 Ensure traceability
 Maintain current CAPA
 Add new actions (investigation, root cause, effectiveness monitoring)
 Only parts of the CAPA failed
 CAPA will withstand investigator scrutiny
 Always, always always…
 Consider options and use what is appropriate for situation providing traceability
The CAPA Failed…Now What?

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 Being too close to the process to do an objective CAPA investigation and root cause analysis
 Enlist an independent/quality viewpoint to support this effort
 Volumes of objective evidence added to CAPA with little or no value
 Include what evidence is and where it can be found, tell a story and allow the CAPA to stand alone
Common Pitfalls and Lessons Learned

21
 Documentation
 Remember – the records are all you will have when it comes to defending CAPAs
 Have a well defined problem statement (What , when , where, how much, who )
 Do a thorough RCA using appropriate tools
 One tool does not handle every problem
 Collect data as needed for before and after comparisons
 Make sure all records are stored appropriately
 Make sure objective evidence is easily found and properly labeled
 Provide a trace matrix on big problems (Cause – Action – Evidence)
Common Pitfalls and Lessons Learned (continued)

22
 Maintain the change
 Procedural changes made during remediation are not maintained with subsequent revisions
 Use the change control system and revision history to document the purpose of procedural
changes
 Pockets of improvement are made but not evident globally or systemically
 CAPAs should drive systemic thinking
 Stakeholders are not aware of changes made
 Communicate changes to all that are involved

23
 CAPA timelines are not met leading to a snowball effect for other related
CAPAs/actions
 Set realistic and reasonable timelines for remediation work
 Don’t determine when before you know what and how
 Global/systemic procedural changes are too high level to be meaningful
or value add
 Involve the appropriate process/system owners to get to a meaningful level
of detail
 Ignoring issues identified during the process because they are unrelated
to the identified issue
 Any additional issues identified during the process should be managed

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 Conducting training instead of implementing a compliant process where a gap was originally
identified
 Correct the process and train to that process
 Training and operator error are identified as the root cause - but most often are not
 Verifying that CAPA actions were completed instead of verifying that original findings have
been corrected
 Both should be verified because if the root cause was not properly identified the actions
implemented may not have corrected the problem
 Close the loop, ensure that effectiveness monitoring goes back to the original observation or issue

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Summary
 A compliant CAPA system can be an effective tool in quality remediation
 CAPA conscious cultures are an asset to any quality organization
 CAPA systems themselves may require remediation before further remediation work can
continue
 CAPA problems are common, avoid the pitfalls to drive success and continuous
improvement
Summary

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Questions

Thank You !
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The contents of this presentation are copyright ©2016 Maetrics. All rights reserved.
This presentation contains information in summary form and is intended for general
guidance only. It is not intended to be a substitute for detailed research or the
exercise of professional judgment. Maetrics LLC cannot accept responsibility for loss
occasioned to any person, firm, company or corporation acting or refraining from
action as a result of any material in this publication. On any specific matter, reference
should be made to the appropriate professional advisor.

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 Learn from past so as not to repeat it
 Consideration of regulators perspective of repeat findings
 Regardless of your role related to CAPA, accurate information is of utmost importance for
both identification of the problem as well as the correct solution
 Creator of data
 Reviewer/decision maker
 Potential product end user
Importance of a Fix not a Band-Aid Approach

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 Purpose of remediation effort
 Scope of work
 Remediation process
 Gap analysis
 Timelines and reporting
 Ownership and accountability
 Management and quality oversight
 Success criteria and closure
Establish a Remediation Plan

Effective Use of CAPA in Remediating Quality Management Systems

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