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)

0

200

400

600

800

1000

1200

1400

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?

6

“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?

7

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.

1

2

3

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

1

2

Complaints Start particles

in Glut

3

CAPA Opened as

“Glut Crystals in

Jar”

4

Jar re-designed to prevent Glut

crystals from forming in the jar

4

Complaints continue

5

“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

6

7

More valves in the Glut dispensing

system are replaced

8

Complaints INCREASE

9

CAPA Team centers investigation on needle

manufacturer and finding alternative needles

10

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

11

12

Problem valves are removed from

dispensing system

13

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?