Effective Use of CAPA in Remediating Quality Management Systems

Effective Use of CAPA in Remediating Quality Management SystemsFebruary 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?



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



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



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



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



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



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



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



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



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



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



Lessons Learned and Next Steps if your CAPA Fails

The CAPA Failed…Now What?



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?



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



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)



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




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




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



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



Questions

Thank You !

27

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.

©2016 Maetrics. All Rights Reserved.



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



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

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Effective Use of CAPA in Remediating Quality Management Systems

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