ASQ Orange Empire – The Global Voice of Quality - Corrective … · 2019-10-21 · The intent of...
Transcript of ASQ Orange Empire – The Global Voice of Quality - Corrective … · 2019-10-21 · The intent of...
Corrective Action Preventative Action (CAPA)
CAPA Culture AcademyCreate Success Through Leadership
FDA Audits tend to focus on CAPA
as a “pulse check” on Organizational
Quality System Health
FDA Inspectional Observations (2004 – 2015)
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2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
P&PC CAPA DES MGMT DOC
Why do so many medical device companies
struggle with CAPA?
1. Because companies don’t know what the FDA is looking for
2. Because companies fall prey to commonly identified mistakes for investigations of CAPAs.
What is the FDA is looking for?
“Your corrective and preventive action (CAPA) system (SOP XXXXX) requires CAPAs to be investigated and completed in a timely manner and requires verification of effectiveness of the actions to be conducted to ensure safety and functionality of the device. You failed to verify or validate corrective actions to ensure that each action is effective and does not adversely affect the finished device and you did not identify actions needed to correct the deficiency.”
What catches your eye?
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“Your corrective and preventive action (CAPA) system (SOP XXXXX) requires CAPAs to be investigated and completed in a timely manner and requires verification of effectiveness of the actions to be conducted to ensure safety and functionality of the device. You failed to verify or validate corrective actions to ensure that each action is effective and does not adversely affect the finished device and you did not identify actions needed to correct the deficiency.”
What catches your eye?
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Failure to establish and maintain adequate procedures for corrective and preventive actions, as required by 21 CFR 820.100(a). For example:
a. Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems (21 CFR 820.100(a)(3). Specifically:
Your firm has received multiple complaints regarding XXXX… Your firm did not implement appropriate corrective actions to control the XXXX process…
b. Failure to investigate the cause of nonconformities relating to product, processes, and the quality system (21 CFR 820.100(a)(2)). For example:
Your firm received 39 complaints for particulate contamination on various finished devices, including complaint XXXX… This complaint was also filed as a Medical Device Report (MDR) due to the potential harm to the patient. Twenty-one additional nonconformance reports were initiated for particulate contamination… You initiated CAPA which listed the “Proposed Root Cause” as “inspection is performed visually” and the corrective action was to add XXXX to the inspection process… Your firm did not investigate to determine the source of the particulate matter.
What catches your eye?
Failure to establish and maintain adequate procedures for corrective and preventive actions, as required by 21 CFR 820.100(a). For example:
a. Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems (21 CFR 820.100(a)(3). Specifically:
Your firm has received multiple complaints regarding XXXX… Your firm did not implement appropriate corrective actions to control the XXXX process…
b. Failure to investigate the cause of nonconformities relating to product, processes, and the quality system (21 CFR 820.100(a)(2)). For example:
Your firm received 39 complaints for particulate contamination on various finished devices, including complaint XXXX… This complaint was also filed as a Medical Device Report (MDR) due to the potential harm to the patient. Twenty-one additional nonconformance reports were initiated for particulate contamination… You initiated CAPA which listed the “Proposed Root Cause” as “inspection is performed visually” and the corrective action was to add XXXX to the inspection process… Your firm did not investigate to determine the source of the particulate matter.
What catches your eye?
FDA is looking for:
FDA is looking for:• Lack of documented investigation
• Incomplete investigation
• Corrective / Preventive actions not:
➢ Implemented
➢ Tracked
➢ Completed
• Effectiveness not verified
• Timelines not followed, not extended
A recent FDA report said
the third highest reason a 483, warning letter, or consent decree was issued
was because of discrepancies and/or failures in investigations due to:
1. Inadequate content
2. Timeliness
What are the
common CAPA
errors?
CAPA Errors
It's never good to begin anything with a closed mind
The true intent of any investigation is to
systematically evaluate an event to determine the problem
1 Close-Minded Investigations
CAPA Errors 1 Close-Minded Investigations
Close-Minded Investigations =
Confirmation Bias
CAPA Errors
"Incomplete" refers to documentation when it is missing
supporting data, objective evidence or references.
In other words, the document cannot stand on its own merit.
2 Incomplete Investigation
CAPA Errors
Remember from our examples:
You failed to verify or validate corrective actions…
You did not identify actions needed to correct the deficiency…
Failure to identify the action(s) needed to correct and prevent recurrence of
nonconforming product…
Your firm did not implement appropriate corrective actions…
3Failure to Identify and/or
Execute the Appropriate CAPA
CAPA Errors
Investigations need to be in depth enough to identify
and assign CAPA to root causes
Assign Corrective Actions and Preventative Actions (CAPA)
to root causes
3Failure to Identify and/or
Execute the Appropriate CAPA
CAPA Errors
Incomplete investigations can also lead to poorly written
investigations
Poorly written investigations often have a common theme:
Assuming that the reader understands or knows your
organizational Quality System
4 Poorly Written Investigations
CAPA Errors
This is sign of an investigation that may have challenges
5Inadequate Quality Impact
Assessment
CAPA Errors
The intent of a quality impact assessment is to evaluate:1. what happened against the batch/lot,
2. the line/room/equipment used,
3. the system/instructions/batch records,
4. the end use,
5. etc.
5Inadequate Quality Impact
Assessment
Avoid common mistakes
Five commonly identified mistakes for investigations are:
1. Close-minded investigations
2. Failure to identify and/or execute the appropriate CAPA
3. Incomplete investigations
4. Poorly written investigations
5. Inadequate quality impact assessment.
Adopt Great CAPA Habits - The Fabulous 5
Five commonly identified mistakes for investigations are:
1. Close-minded investigations
2. Failure to identify and/or execute the appropriate CAPA
3. Incomplete investigations
4. Poorly written investigations
5. Inadequate quality impact assessment.
Five CAPA Habits to adopt:
1. Keep an open mind
2. Identify and execute the appropriate CAPA
3. Complete the investigation
4. Document clearly
5. Perform the appropriate quality impact assessment
Adopt Great CAPA Habits - The Fabulous 5
Five CAPA Habits to adopt:
1. Keep an open mind
2. Identify and execute the appropriate CAPA
3. Complete the investigation
4. Document clearly
5. Perform the appropriate quality impact assessment
Ineffective corrective
actions and lack of preventive
actions
Recurrent issues and new problems never
avoided
Inadequate investigations without root
cause analysis
The Vicious Cycle
When you know better you can do better
BREAK THE CYCLE!
Keepers & AH-HA’S
The third highest cause of an action from FDA is due poor investigations
and inadequate follow-up.
It is critical to perform and document thorough investigations.
CAPA is a “pulse check” for FDA on how well a firm’s Quality System is operating.
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What are YOUR Keepers & AH-HA’S?
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
CAPA Culture Academy: Essential Elements
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
CAPA Culture Academy: Essential Elements
1. START QUICKLY2. ASSIGN AN OWNER3. DEFINE THE PROBLEM4. PERFORM:
1. Containment 2. Interim Actions
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
CAPA Culture Academy: Essential Elements
1. FORM the CAPA Team2. RISK ANALYSIS3. ROOT CAUSE ANALYSIS4. DETERMINE:
1. Corrections2. Corrective Actions3. Preventative Actions
CAPA Culture Academy: Essential Elements
1. BEFORE Implantation, Perform Verification and Validation of Corrections, Corrective Actions and Preventative Actions
2. Provide Objective Evidence of Completion:1. Corrections2. Corrective Actions3. Preventative Actions
3. Determine Method and Interval for Effectiveness Monitoring
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
CAPA Culture Academy: Essential Elements
1. Assess Whether the Actions Taken Prevented Recurrence Over Time
Effectiveness Monitoring = Pass SUCCESSFUL CAPA
Effectiveness Monitoring = Fail UNSUCCESSFUL CAPA
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
CAPA Culture Academy: Essential Elements
1. Complete Report2. Close CAPA
Requirements
AnalysisDesign Development Testing Maintenance
CAPA Culture Academy: 10X Analogy
Software Development Life Cycle
10X 10X 10X 10X
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
Requirements
AnalysisDesign Development Testing Maintenance
CAPA Culture Academy: 10X Analogy
Software Development Life Cycle
10X 10X 10X 10X
Initiation Investigation ImplementationEffectiveness Monitoring
Closure
Cautionary Tale
Valves replaced in Glut
dispensing system
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Complaints Start particles
in Glut
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CAPA Opened as
“Glut Crystals in
Jar”
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Jar re-designed to prevent Glut
crystals from forming in the jar
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Complaints continue
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“Glut Crystals” are sent for analysis
Results show the particles are metallic not organic
CAPA Team indicates that suturing needles are the culprit and needles
could be breaking
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More valves in the Glut dispensing
system are replaced
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Complaints INCREASE
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CAPA Team centers investigation on needle
manufacturer and finding alternative needles
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Second analysis shows that particles don’t have the same composition as
the needles
CAPA Team tests all sources that contact solution with metallic components – ball bearings in valves of dispensing system
are found to have the same composition as the particles found in the jar
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Problem valves are removed from
dispensing system
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Problem and complaints
STOP
Medical Device companies tend focus on the CAPA procedure (technical change)
and miss the opportunity for greater improvement with their culture (adaptive change)
- C. Knierim -
CAPA Culture Academy: Mindset
Get excited when you are tasked to be a CAPA owner
Begin with the End in
Mind
- Stephen Covey -
“The Seven Habits of
Highly Effective People”
CAPA OWNER(Primary Investigator)
ASK, ASK, ASK
Become an Askhole
CAPA Culture Academy: Vision
CAPA Culture Academy: Vision
Quality Vision
….is a company where every employee believes and
behaves according to the principle “I am responsible for the quality and value of
MY work.”
What is YOUR Vision?
CAPA Culture Academy:
Empowered You
Empowerment is key to you
and your Teams Success
Take 100% responsibility for your life and your
results.
E+R=OEVENT
+ RESPONSE
OUTCOME
E+R=OEVENT
+ RESPONSE
OUTCOME
BLAME THE EVENT!
E+R=OEVENT
+ RESPONSE
OUTCOME
Leaders focus
on their Response
“Excellence is an art won by
training and habituation.”
“We do not act rightly because
we have virtue or excellence,
but we rather have those
because we have acted rightly.”
“We are what we repeatedly do.
Excellence, then, is not an act
but a habit.”
– Aristotle (384 BC – 322BC)
CAPA Culture Academy:
High Performance Habits
Build your habitsBuild your team
What are YOUR Habits?
What new Habits would YOU
like to develop?
Adopt Great CAPA Habits - The Fabulous 5
Five CAPA Habits to adopt:
1. Keep an open mind
2. Identify and execute the appropriate CAPA
3. Complete the investigation
4. Document clearly
5. Perform the appropriate quality impact assessment
- Jim Rohn
Work harder
- Jim Rohn
Work harder
on yourself than
you do on your job
If I were to take just 5% more responsibility for my CAPA effectiveness I would…
I would appreciate
your feedback
I would
appreciate
your
feedback
Reference
Top 40 Publicly
Traded Best
Companies
to Work for
in N. America
Average Annual
Return 16.39%
S&P 500
Average Annual
Return 4.12%
Why Create a Great CAPA Culture in Your Company?