Implementing and recording changes in methods and procedures needed to correct and prevent

identified quality problems

Ensuring that information related to quality problems or nonconforming product is disseminated to

those directly responsible for assuring the quality of such product or the prevention of such problems

Submitting relevant information on identified quality problems, as well as CAPA for management review

Ultimately, there are many reasons to put a priority on a strong CAPA system. FDA inspectors will look there first
and often use that first impression of your operation to influence the rest of the inspection. Perhaps even more
importantly, CAPA presents firms with an exciting opportunity to prevent recalls, improve operational efficiency,
and boost the bottom-line.

Conclusion

The trend of inspectors using CAPA as a bellwether for the strength of a companys overall operations and
compliance is clear. Getting CAPA just right isnt easy. But getting it wrong, or ignoring weaknesses in the
system can be even harder on your company. The FDA doesnt show any sign of letting up on CAPA. Wise drug
and device makers shouldnt either.

Additional Resources
From the FDA:

Good Manufacturing Practice/Quality Systems: www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm
QSIT Guide: www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.pdf
21 CFR Part 11: www.fda.gov/ora/compliance_ref/part11

Case Studies:

Available in electronic format at www.assurx.com/customer-case-studies.htm, or to request printed copies,

please call 408-778-1376, ext,. 705
Bausch & Lomb: Implementing a Global 21 CFR Part 11 CAPA System
Guidant / Boston Scientific: Going Electronic with Enterprise-wide CAPA
Galderma R & D: A New Streamlined Approach for QA Audits & CAPA Processes
Alcon Labs: A New Vision of Quality Assurance

To find out how AssurX can help with your compliance needs, please call 1-888-9-ASSURX.

WHITEPAPER

An FDA Look at CAPA & Quality Systems

Inspectors are Demanding Stronger Programs.
What They Look For & Why

If an FDA inspector comes to your facility, he or she will want to see how you have configured your
Corrective and Preventive Action (CAPA) program. Bet on it.
FDA Warning Letters continue to show a heavy inspector focus on getting CAPA right. In 2010, CAPA
accounted for the second and fourth most cited issues in FDA observations. In 2011, CAPA related
citations were ranked first and third. In 2011, medical device firms were issued 175 Warning Letters,
FDA officials say. Of those, 85% had CAPA citations, and 80% had purchase control citations.
That trend continues with no sign of changing soon. But the challenge for industry goes beyond
understanding that the FDA cares deeply about CAPA. It becomes obvious from delving into Warning
Letters that the problem usually isnt a lack of a CAPA program, but that the program in place is weak.

Why CAPA Matters

There are two reasons for this intense focus on CAPA; one official and the other unofficial. Officially, the FDA
always includes an inspection of a CAPA system in its rounds. A level 1 abbreviated quality system inspection
technique (QSIT) inspection will include a look at CAPA and one of three other areas: management controls,
design controls or production and process controls. A level 2 QSIT inspection will look at all four areas.
But the unofficial reason may be more important: FDA inspectors have told many company officials and
consultants off the record that they view a firms CAPA capabilities as an indicator of how well or how poorly a
firm has a handle on its overall operations.
FDA inspections often focus on deviations, including what was done to investigate the causes, how the
deviations were resolved, and what was done to prevent future similar issues, points out John Vadnais, Vice
President at RCM Technologies. The FDA particularly looks at the companys investigations process (see the
hallmark Barr decision on investigations), and at the CAPA record which often is made in response to a deviation,
he adds. CAPAs offer the benefit of formal tracking which empowers the company to ensure that all items are
resolved. It offers the FDA a view into the companys compliance process and, through its openness, may serve to
reassure the FDA.The deviation, and the accompanying CAPA record, if used, is a frequent focus for FDA review.

The Bellwether

Former FDAer Ken Miles agrees that CAPA represents something of a bellwether for overall compliance work in
the eyes of the agency. Many of us, myself included, felt in our inspection that if the firm was strong in CAPA,
they were likely to be in good shape elsewhere. Likewise, if they had CAPA problems with us at the outset, we
suspected we were in for a long, tough inspection. Miles was inspector in the agencys Oakland, CA Office.
Even a quick reading of the FDAs hundreds of 483 Warning Letters issued in the past few years shows that
the agency is serious about enforcing firm-wide CAPA compliance. Here are just a few examples from actual
Warning Letters:

Copyright 2012, AssurX, Inc. All rights reserved.

AssurX, Inc. Tel 888.927.7879 Fax 408.776.1267 info@assurx.com www.assurx.com

2012

Failure to adequately verify or validate the corrective and preventive action to ensure that this action is
effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example,
the reports for CAPA 2012-2-14 and CAPA 2012-1-05 do not contain evidence to indicate that the corrective
actions taken were verified or validated as effective and did not adversely affect the finished device.
Does not include the requirements for implementing and recording changes in methods and procedures
needed to correct and prevent identified quality problems.
Procedures for implementing corrective and preventive actions were not implementedin your firms
handling of two quality assurance problems that led to recalls.
Significant deviations include, but are not limited to the following: Failure to adequately establish and
maintain procedures for implementing corrective and preventative action, which include requirements
for analyzing processes, work operations, concessions, quality audit reports, service records, complaints,
returned product, and other sources of quality data to identify existing and potential causes of
nonconforming product or other quality problems.
CAPA activities have not been documented, including investigations of causes of nonconformities.
It is no surprise that these and other CAPA violations appear on the first page of these Warning Letters just a
few lines under the Dear Firm salutation, notes Michael Causey, former editor of the industry newsletter Part 11
Compliance Report and now an independent consultant. FDAers expect firms to have strong CAPA capabilities
in every aspect of their operation.
In public presentations, FDAers including Jan Welch in the Office of Compliance at an industry conference have
stressed that CAPA compliance remains critical even with the agencys shift to emphasize a risk-based approach
to current good manufacturing practice (GMPs) inspections. [See Quality System chart below]

Corrective
Corrective &
Preventive
Preventive
Actions
Actions
Production
Production &
Process
Process
Controls
Controls

Design
Design
Controls
Controlls
Management
Management

Equipment
Equipment &
Facility
Facility
Controls
Controls

Material
Material
Controls
Controlls
Records
Records
Documents
Documents &
Change
Change Controls
Controls

When the agency has a problem with a firms CAPA program, theyre going to look to the top for answers,
Causey notes. He points out that the FDA inspectors manual carries these instructions for the conclusion of an
inspection:
Evaluate whether management with executive responsibility ensures that an adequate and effective
quality system has been established and maintained.

CAPA Given Short-Shrift?

But former FDAer Timothy Wellsan FDA team leader for the QSIT program and now an independent
consultant worries that many firms arent giving CAPA work the time it deserves. When I visit pharmaceutical
companies I often find [a] lack of CAPA programs, no management review, and a poor audit program, he said.
Wells and others in the field argue that firms that dont have a strong CAPA program are ultimately hurting
themselves most. I believe that having those [CAPA] systems in place will also result in less recalls, less
investigations, less product loss and more profits for the industry.
Medical device firms generally lead the way in these compliance efforts, most experts agree. With standards in
place and arguably a better understanding of how compliance with CAPA and issues including 21 CFR Part 11s
electronic records provisions works, firms including Thermage, Bausch & Lomb, Guidant Corporation and Fischer
Imaging are pioneers in leveraging these compliance efforts into better business practices and operations.
For example, Thermage tapped AssurX, Inc. for their corporate-wide quality tracking system that includes
customer complaints, supplier quality, CAPAs, investigation reports and nonconformances. Thermage is a
medical device company that manufactures ThermaCool TC, an advanced radio frequency (RF) based device used
for the treatment of skin in dermatology and plastic surgery applications.
According to Richard Meader, Thermages Vice President of Clinical, Regulatory and Quality Affairs, We selected
AssurX because it was 21 CFR Part 11 compliant and we could easily configure the system to our existing
processes and workflows. And since AssurX is so flexible, we see potential applications outside of the quality
systems area as well.
Fischer Imaging, the United States oldest existing manufacturer of x-ray medical equipment, is utilizing
AssurX largely in its operations, quality regulatory group and engineering departments, but other departments
are brought in as required by job. Fischers operations group includes purchasing, receiving, inspection, and
production. It is truly a corporate wide usage, says Gary Turner, VP of Quality and Regulatory Affairs. The
products ease of use and flexibility makes it easy to add new users and find new ways to take advantage of its
capabilities, adds Frank Strupeck, Supplier Quality Engineer.
It is also worth noting that innovative firms outside the FDAs regulatory reach are embracing the value of
strong firm-wide CAPA capabilities. For example, Watlow selected AssurX for the firms corporate-wide corrective
action system to be rolled out at seven North American plants. Watlow, headquartered in St. Louis, MO, is a
provider of thermal components and solutions to a variety of industries including semiconductor, plastics
processing, foodservice equipment, life sciences, aerospace, and others.
Watlows Quality Process Leader Drew A. Dubray stated, Before we selected AssurX, all of our facilities were
using different systems. We needed to consolidate all of this information into a single, centralized, Web-based
system that everyone could use, and provide better visibility on a corporate-wide basis.

Source: FDA Overview of the Quality System Regulation for Medical Devices

An analysis of the FDAs 483 letters in recent years demonstrates clearly that CAPA is a big issue and that it will
remain so. In the pre-QSIT inspection world, CAPA was the number one item cited in 483s, appearing 50% of the
time. However, in the QSIT world, CAPA is now the number one and three item, cited 85% of the time.

c o m p l i a n c e

w h i t e p a p e r

Failure to adequately verify or validate the corrective and preventive action to ensure that this action is
effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example,
the reports for CAPA 2012-2-14 and CAPA 2012-1-05 do not contain evidence to indicate that the corrective
actions taken were verified or validated as effective and did not adversely affect the finished device.
Does not include the requirements for implementing and recording changes in methods and procedures
needed to correct and prevent identified quality problems.
Procedures for implementing corrective and preventive actions were not implementedin your firms
handling of two quality assurance problems that led to recalls.
Significant deviations include, but are not limited to the following: Failure to adequately establish and
maintain procedures for implementing corrective and preventative action, which include requirements
for analyzing processes, work operations, concessions, quality audit reports, service records, complaints,
returned product, and other sources of quality data to identify existing and potential causes of
nonconforming product or other quality problems.
CAPA activities have not been documented, including investigations of causes of nonconformities.
It is no surprise that these and other CAPA violations appear on the first page of these Warning Letters just a
few lines under the Dear Firm salutation, notes Michael Causey, former editor of the industry newsletter Part 11
Compliance Report and now an independent consultant. FDAers expect firms to have strong CAPA capabilities
in every aspect of their operation.
In public presentations, FDAers including Jan Welch in the Office of Compliance at an industry conference have
stressed that CAPA compliance remains critical even with the agencys shift to emphasize a risk-based approach
to current good manufacturing practice (GMPs) inspections. [See Quality System chart below]

Corrective
Corrective &
Preventive
Preventive
Actions
Actions
Production
Production &
Process
Process
Controls
Controls

Design
Design
Controls
Controlls
Management
Management

Equipment
Equipment &
Facility
Facility
Controls
Controls

Material
Material
Controls
Controlls
Records
Records
Documents
Documents &
Change
Change Controls
Controls

When the agency has a problem with a firms CAPA program, theyre going to look to the top for answers,
Causey notes. He points out that the FDA inspectors manual carries these instructions for the conclusion of an
inspection:
Evaluate whether management with executive responsibility ensures that an adequate and effective
quality system has been established and maintained.

CAPA Given Short-Shrift?

But former FDAer Timothy Wellsan FDA team leader for the QSIT program and now an independent
consultant worries that many firms arent giving CAPA work the time it deserves. When I visit pharmaceutical
companies I often find [a] lack of CAPA programs, no management review, and a poor audit program, he said.
Wells and others in the field argue that firms that dont have a strong CAPA program are ultimately hurting
themselves most. I believe that having those [CAPA] systems in place will also result in less recalls, less
investigations, less product loss and more profits for the industry.
Medical device firms generally lead the way in these compliance efforts, most experts agree. With standards in
place and arguably a better understanding of how compliance with CAPA and issues including 21 CFR Part 11s
electronic records provisions works, firms including Thermage, Bausch & Lomb, Guidant Corporation and Fischer
Imaging are pioneers in leveraging these compliance efforts into better business practices and operations.
For example, Thermage tapped AssurX, Inc. for their corporate-wide quality tracking system that includes
customer complaints, supplier quality, CAPAs, investigation reports and nonconformances. Thermage is a
medical device company that manufactures ThermaCool TC, an advanced radio frequency (RF) based device used
for the treatment of skin in dermatology and plastic surgery applications.
According to Richard Meader, Thermages Vice President of Clinical, Regulatory and Quality Affairs, We selected
AssurX because it was 21 CFR Part 11 compliant and we could easily configure the system to our existing
processes and workflows. And since AssurX is so flexible, we see potential applications outside of the quality
systems area as well.
Fischer Imaging, the United States oldest existing manufacturer of x-ray medical equipment, is utilizing
AssurX largely in its operations, quality regulatory group and engineering departments, but other departments
are brought in as required by job. Fischers operations group includes purchasing, receiving, inspection, and
production. It is truly a corporate wide usage, says Gary Turner, VP of Quality and Regulatory Affairs. The
products ease of use and flexibility makes it easy to add new users and find new ways to take advantage of its
capabilities, adds Frank Strupeck, Supplier Quality Engineer.
It is also worth noting that innovative firms outside the FDAs regulatory reach are embracing the value of
strong firm-wide CAPA capabilities. For example, Watlow selected AssurX for the firms corporate-wide corrective
action system to be rolled out at seven North American plants. Watlow, headquartered in St. Louis, MO, is a
provider of thermal components and solutions to a variety of industries including semiconductor, plastics
processing, foodservice equipment, life sciences, aerospace, and others.
Watlows Quality Process Leader Drew A. Dubray stated, Before we selected AssurX, all of our facilities were
using different systems. We needed to consolidate all of this information into a single, centralized, Web-based
system that everyone could use, and provide better visibility on a corporate-wide basis.

Source: FDA Overview of the Quality System Regulation for Medical Devices

An analysis of the FDAs 483 letters in recent years demonstrates clearly that CAPA is a big issue and that it will
remain so. In the pre-QSIT inspection world, CAPA was the number one item cited in 483s, appearing 50% of the
time. However, in the QSIT world, CAPA is now the number one and three item, cited 85% of the time.

c o m p l i a n c e

w h i t e p a p e r

A Healthy CAPA

According to the FDAs Welch, Healthy CAPA subsystem procedures include provisions to:
1.

Identify and correct existing nonconforming product or other quality problems

2.

Identify and eliminate the causes of existing nonconforming product and other quality problems

3.

Identify and eliminate the causes of potential nonconforming product and other quality problems

A common mistake made by drug and device firms is to believe that CAPA is only a factory floor issue, notes
Causey. The FDA doesnt look at it that way, and neither should a firm that wants to be operating efficiently.
Firm-wide risk management is key to a successful CAPA program, Causey noted. For example, FDA risk
management and assessment concept papers suggest a firm perform an error prevention analysis to minimize
medication errors. The four main components of that program should be to:

Recording the results of any investigation and of action taken

Reviewing the corrective action taken and its effectiveness

ISO 13485 also calls for the organization to determine action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Those preventive actions should:

Determine potential nonconformities and their causes

Evaluate the need for action to prevent the occurrence of nonconformities

Determine and implement any action needed

Record the results of any investigations and actions taken

Review preventative actions taken and their effectiveness

1.

Identify known and potential medication error modalities

2.

Identify potential and actual causes of each error

FDA DEFINED: Correction vs. Corrective Action & Preventive Action

3.

Prioritize the errors according to the expected outcome, especially in terms of risk of harm to patient

Remember to approach your CAPA system with a clear understanding of the difference between correction and
corrective action:

4. Minimize the potential for an error through corrective action including renaming, relabeling or
repackaging
Even the strongest CAPA program can lose its value if a firm cannot measure and demonstrate system
performance for an FDA inspector, Causey said. That also means senior management must be able to articulate
the CAPA program and its metrics in a way that is clear to the FDA.

Audit Trails Critical

FDAers are fond of saying if you cant show it, it didnt happen, Causey said. That means even an otherwise
strong CAPA program wont do a firm much good during an inspection unless they can utilize clear audit trails
to detail your CAPA program and how it identifies potential problems and notifies relevant personnel.
Whether developing a program in-house or working with a vendor with a strong track record like AssurX, Causey
stresses that the audit trail capability is crucial. If your system cannot quickly and accurately produce audit
trails in human readable form, you are simply not ready for prime time from an inspectors point of view.
Another key to developing a strong CAPA program is starting with a definition of the sometimes-elusive
concept; two underlying definitions provide potentially helpful foundations for your own interpretation: ISO
13485 and 21 CFR 820.100(a).

ISO 13485

Under this definition, corrective actions shall be appropriate to the effects of the nonconformities encountered.
ISO 13485 calls for a documented procedure to be established to define requirements for:

Reviewing nonconformities (including customer complaints)

Determining the cause of nonconformities

Evaluating the need for action to ensure nonconformities do not recur

Determining and implementing action needed, including, if appropriate, updating documentation

c o m p l i a n c e

Corrective action is defined by the FDA as an

action taken to eliminate the causes of an existing
non-conformity, defect or other undesirable
situation in order to prevent recurrence. An example
of a correction action is when defective components
damaged during assembly cause out-of-box failures.
Controls to fix it are instituted and operators are
trained in them.

Preventive action is defined by the FDA as an

action taken to eliminate the cause of a potential
non-conformity, defect, or other undesirable
situation in order to prevent occurrence. An
example is when SPC charts indicate a process is
drifting toward upper limit for diameter of injection
molded part. Investigation determines the cause of
the drift is wear to the mold. You replace the mold,
and verify/validate that the process yields parts
meeting specifications.

Correction refers to repair, rework, or adjustment

and relates to the disposition of an existing
nonconformity. An example of a correction is when
devices are returned because of out-of-box failures
are repaired and put back into inventory.

21 CFR 820

Sub-part J of the rule says each manufacturer should establish and maintain the following procedures for
implementing CAPA:

Analyzing processes, work operations, concessions, quality audit reports, quality records, service
records, complaints, returned products, and other sources of quality data to identify existing and
potential causes of nonconforming product, or other quality problems

Investigating the cause of nonconformities relating to product, processes and the quality system

Identifying the actions needed to correct and prevent recurrence of nonconforming product and other
quality problems

Verifying or validating the CAPA

w h i t e p a p e r

A Healthy CAPA

According to the FDAs Welch, Healthy CAPA subsystem procedures include provisions to:
1.

Identify and correct existing nonconforming product or other quality problems

2.

Identify and eliminate the causes of existing nonconforming product and other quality problems

3.

Identify and eliminate the causes of potential nonconforming product and other quality problems

A common mistake made by drug and device firms is to believe that CAPA is only a factory floor issue, notes
Causey. The FDA doesnt look at it that way, and neither should a firm that wants to be operating efficiently.
Firm-wide risk management is key to a successful CAPA program, Causey noted. For example, FDA risk
management and assessment concept papers suggest a firm perform an error prevention analysis to minimize
medication errors. The four main components of that program should be to:

Recording the results of any investigation and of action taken

Reviewing the corrective action taken and its effectiveness

ISO 13485 also calls for the organization to determine action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Those preventive actions should:

Determine potential nonconformities and their causes

Evaluate the need for action to prevent the occurrence of nonconformities

Determine and implement any action needed

Record the results of any investigations and actions taken

Review preventative actions taken and their effectiveness

1.

Identify known and potential medication error modalities

2.

Identify potential and actual causes of each error

FDA DEFINED: Correction vs. Corrective Action & Preventive Action

3.

Prioritize the errors according to the expected outcome, especially in terms of risk of harm to patient

Remember to approach your CAPA system with a clear understanding of the difference between correction and
corrective action:

4. Minimize the potential for an error through corrective action including renaming, relabeling or
repackaging
Even the strongest CAPA program can lose its value if a firm cannot measure and demonstrate system
performance for an FDA inspector, Causey said. That also means senior management must be able to articulate
the CAPA program and its metrics in a way that is clear to the FDA.

Audit Trails Critical

FDAers are fond of saying if you cant show it, it didnt happen, Causey said. That means even an otherwise
strong CAPA program wont do a firm much good during an inspection unless they can utilize clear audit trails
to detail your CAPA program and how it identifies potential problems and notifies relevant personnel.
Whether developing a program in-house or working with a vendor with a strong track record like AssurX, Causey
stresses that the audit trail capability is crucial. If your system cannot quickly and accurately produce audit
trails in human readable form, you are simply not ready for prime time from an inspectors point of view.
Another key to developing a strong CAPA program is starting with a definition of the sometimes-elusive
concept; two underlying definitions provide potentially helpful foundations for your own interpretation: ISO
13485 and 21 CFR 820.100(a).

ISO 13485

Under this definition, corrective actions shall be appropriate to the effects of the nonconformities encountered.
ISO 13485 calls for a documented procedure to be established to define requirements for:

Reviewing nonconformities (including customer complaints)

Determining the cause of nonconformities

Evaluating the need for action to ensure nonconformities do not recur

Determining and implementing action needed, including, if appropriate, updating documentation

c o m p l i a n c e

Corrective action is defined by the FDA as an

action taken to eliminate the causes of an existing
non-conformity, defect or other undesirable
situation in order to prevent recurrence. An example
of a correction action is when defective components
damaged during assembly cause out-of-box failures.
Controls to fix it are instituted and operators are
trained in them.

Preventive action is defined by the FDA as an

action taken to eliminate the cause of a potential
non-conformity, defect, or other undesirable
situation in order to prevent occurrence. An
example is when SPC charts indicate a process is
drifting toward upper limit for diameter of injection
molded part. Investigation determines the cause of
the drift is wear to the mold. You replace the mold,
and verify/validate that the process yields parts
meeting specifications.

Correction refers to repair, rework, or adjustment

and relates to the disposition of an existing
nonconformity. An example of a correction is when
devices are returned because of out-of-box failures
are repaired and put back into inventory.

21 CFR 820

Sub-part J of the rule says each manufacturer should establish and maintain the following procedures for
implementing CAPA:

Analyzing processes, work operations, concessions, quality audit reports, quality records, service
records, complaints, returned products, and other sources of quality data to identify existing and
potential causes of nonconforming product, or other quality problems

Investigating the cause of nonconformities relating to product, processes and the quality system

Identifying the actions needed to correct and prevent recurrence of nonconforming product and other
quality problems

Verifying or validating the CAPA

w h i t e p a p e r

Implementing and recording changes in methods and procedures needed to correct and prevent
identified quality problems

Ensuring that information related to quality problems or nonconforming product is disseminated to

those directly responsible for assuring the quality of such product or the prevention of such problems

Submitting relevant information on identified quality problems, as well as CAPA for management review

Ultimately, there are many reasons to put a priority on a strong CAPA system. FDA inspectors will look there first
and often use that first impression of your operation to influence the rest of the inspection. Perhaps even more
importantly, CAPA presents firms with an exciting opportunity to prevent recalls, improve operational efficiency,
and boost the bottom-line.

Conclusion

The trend of inspectors using CAPA as a bellwether for the strength of a companys overall operations and
compliance is clear. Getting CAPA just right isnt easy. But getting it wrong, or ignoring weaknesses in the
system can be even harder on your company. The FDA doesnt show any sign of letting up on CAPA. Wise drug
and device makers shouldnt either.

Additional Resources
From the FDA:

Good Manufacturing Practice/Quality Systems: www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm
QSIT Guide: www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.pdf
21 CFR Part 11:

Case Studies:

Available in electronic format at www.assurx.com/customer-case-studies.htm, or to request printed copies,

please call 408-778-1376, ext,. 705
Bausch & Lomb: Implementing a Global 21 CFR Part 11 CAPA System
Guidant / Boston Scientific: Going Electronic with Enterprise-wide CAPA
Galderma R & D: A New Streamlined Approach for QA Audits & CAPA Processes
Alcon Labs: A New Vision of Quality Assurance

To find out how AssurX can help with your compliance needs, please call 1-888-9-ASSURX.

WHITEPAPER

An FDA Look at CAPA & Quality Systems

Inspectors are Demanding Stronger Programs.
What They Look For & Why

If an FDA inspector comes to your facility, he or she will want to see how you have configured your
Corrective and Preventive Action (CAPA) program. Bet on it.
FDA Warning Letters continue to show a heavy inspector focus on getting CAPA right. In 2010, CAPA
accounted for the second and fourth most cited issues in FDA observations. In 2011, CAPA related
citations were ranked first and third. In 2011, medical device firms were issued 175 Warning Letters,
FDA officials say. Of those, 85% had CAPA citations, and 80% had purchase control citations.
That trend continues with no sign of changing soon. But the challenge for industry goes beyond
understanding that the FDA cares deeply about CAPA. It becomes obvious from delving into Warning
Letters that the problem usually isnt a lack of a CAPA program, but that the program in place is weak.

Why CAPA Matters

There are two reasons for this intense focus on CAPA; one official and the other unofficial. Officially, the FDA
always includes an inspection of a CAPA system in its rounds. A level 1 abbreviated quality system inspection
technique (QSIT) inspection will include a look at CAPA and one of three other areas: management controls,
design controls or production and process controls. A level 2 QSIT inspection will look at all four areas.
But the unofficial reason may be more important: FDA inspectors have told many company officials and
consultants off the record that they view a firms CAPA capabilities as an indicator of how well or how poorly a
firm has a handle on its overall operations.
FDA inspections often focus on deviations, including what was done to investigate the causes, how the
deviations were resolved, and what was done to prevent future similar issues, points out John Vadnais, Vice
President at RCM Technologies. The FDA particularly looks at the companys investigations process (see the
hallmark Barr decision on investigations), and at the CAPA record which often is made in response to a deviation,
he adds. CAPAs offer the benefit of formal tracking which empowers the company to ensure that all items are
resolved. It offers the FDA a view into the companys compliance process and, through its openness, may serve to
reassure the FDA.The deviation, and the accompanying CAPA record, if used, is a frequent focus for FDA review.

The Bellwether

Former FDAer Ken Miles agrees that CAPA represents something of a bellwether for overall compliance work in
the eyes of the agency. Many of us, myself included, felt in our inspection that if the firm was strong in CAPA,
they were likely to be in good shape elsewhere. Likewise, if they had CAPA problems with us at the outset, we
suspected we were in for a long, tough inspection. Miles was inspector in the agencys Oakland, CA Office.
Even a quick reading of the FDAs hundreds of 483 Warning Letters issued in the past few years shows that
the agency is serious about enforcing firm-wide CAPA compliance. Here are just a few examples from actual
Warning Letters:

Copyright 2012, AssurX, Inc. All rights reserved.

AssurX, Inc. Tel 888.927.7879 Fax 408.776.1267 info@assurx.com www.assurx.com

2012