CAPA—Common Pitfalls and

How to Avoid Them

ASQ Las Vegas section 705

February 21, 2007
Presented by Michelle M. Johnston, RAC
Advanced Quality System Solutions
 Sources of Potential Problems

 Root Cause Investigations

 Management oversight (or lack thereof)
 Procedural issues
 Timeliness
 What I’ve Encountered

 < 10% of CAPA systems are effective

 Most problems lie in implementation, not
within procedures
 Internal audits do not identify systemic
problems related to CAPA
 Timeliness is a common shortcoming
 Differences in CAPA Requirements
for Medical Device Manufacturers

 Prescriptive with regards to sources of data

• Traveler
• Complaints
• Nonconforming material
• Service reports
• Internal Audits
• Returned product
 FDA Enforcement

 Nonconformities are cited during

inspection, corrective action plan required.

 Warning Letter– more serious, available to

the public

 Fines, stop product shipment

Differences in CAPA Requirements
for Medical Device Manufacturers

• Use of statistical techniques to detect

quality problems
• Verification and validation to ensure that
device is not adversely affected by CAPA
• Dissemination of information regarding
quality problems to those responsible for
quality
 Root Cause Investigations

We can’t solve complex problems

using the same knowledge that
created them.”
-Albert Einstein
 Root Cause - Common Pitfalls

 Looking for a “Quick Fix”

 Everything under the sun is attributed to
employee training.
 Narrow focus—don’t consider similar
devices or processes
 Insufficient technical expertise – assign root
cause responsibility to CAPA Coordinator
 Lack of training in tools of investigation
 No reference to internal procedures or
methods
 Root Cause - Common Pitfalls

 Getting side tracked – extraneous data and

side issues.
 Lack of documentation or information
regarding root cause investigation (e.g.,
how did you get from point A to point B)
 No traceability to product or processes
 Assignment of blame
 Actions taken are not aligned with or
support results of investigation
 Recommended actions are not
implemented, no justification
 Root Cause Investigation

 Root cause is not always obvious, hence

the difficulties
 There can be more than 1 root cause
 Root cause is NOT restating the
nonconformity! (e.g., product packaging
did not include expiry date)
 Don’t rely on that next “epiphany”
 Root Cause Investigation

 Root Cause Investigations should be:

• Appropriate to the problem —
• commensurate with risk
• Determine cause, not fix symptoms
 Structured approach, problem solving
methods to correct and prevent
• What happened
• How it happened
• Why it happened
 Root Cause Analysis

 Root cause investigations should be a

formal and structured process and not just
thinking off the cuff
 Appropriate root cause analysis tools and
training
• FTA
• Pareto analysis
• Fishbone diagram
• 5 Whys
 Root Cause Investigation

 An inability to consistently determine root

cause may point to procedural or
investigative deficiencies.
 Repeat CAPAs indicate
• the root cause has not been identified …..
• Or a proper solution identified and implemented
CAPA Committees

Help or
Hindrance?
 CAPA Committees - Common Pitfalls

 CAPA seen as necessary evil

 Try to solve the problem in committee
 CAPA not a priority to management—
meetings are not held as required
 Members do not understand CAPA
requirements
 Difficulty in reaching consensus, hidden
agendas
 Insufficient documentation of meetings
 Decisions are not always conveyed to those
expected to carry them out.
 CAPA Committee - Considerations

 What exactly is their role?

• CAPA Committee is usually cross-functional
• Middle to upper management
• Meet at defined intervals
 Role of CAPA Committee

 Identify and initiate CAPA

 Assign priority
 Assign resources
 Review progress and address issues
 Monitor timeliness
 Verify effectiveness
 CAPA Committee –Summary

 CAPA committee only as good as the

system
 Not a requirement--if you have one, make it
value-added
Does it make a difference?

It depends.
CAPA Procedures
 CAPA Procedure - Common Pitfalls

 Responsibilities not clearly defined. Who

does what?
 Inputs not adequately defined. Are you
considering all sources of data?
 CAPA forms complex, not intuitive. If you
need to explain how to fill out the forms,
then they are likely too burdensome.
 One size fits all approach. No consideration
given to risk.
 CAPA Procedure - Common Pitfalls

 Decentralized CAPA system—local systems

don’t talk to each other
 Inadequate employee training. Many times,
employees are simply required to read the
procedure and depending upon their role,
this may not be sufficient
 Preventive action takes a back seat and is
rarely addressed
 CAPA Procedure - Common Pitfalls

 Supplier related CAPAs:

• Requirements not defined
• Not adequately monitored
• No evidence of internal review and acceptance
 CAPA Procedure - Common Pitfalls

 Verification of effectiveness is lacking or

confused with verification of
implementation.
• What is the method?
• What is the timeframe?
• Who is responsible?
 Considerations

 Clear,comprehensive, flexible procedure

 Easy to use documentation
 Closed loop system
 Clear lines of communication
 Considerations

 A robust CAPA system doesn’t exist in a

vacuum
 Appropriate linkages include:
• Management Review
• Risk Management
• Post Market Surveillance
• Internal Audit
Timeliness of CAPAs
 Common Pitfalls

 No aging data, timeliness not tracked

 Arbitrary deadlines – not linked to
complexity of the problem
 Requests for extension routinely granted
• Do you need this “contingency” clause?
• Should be the exception, not the rule
• Some requests are made after due date
 Allocation of resources—one person
responsible for multiple CAPAs
 Timeliness of CAPAs
Considerations

 Expected CAPA closure should be

commensurate with the nature and risk of
the problem
 Imposing arbitrary 30 day deadline may not
result in a comprehensive CAPA
investigation
 Demonstrate timely, forward progress
 Interim progress reports to keep due date
on target
 Summary

 Review your CAPA process to make sure

you avoid common pitfalls while ensuring
problems are identified and corrected.
• Properly investigating and identifying root cause
• Providing meaningful and effective oversight of
the CAPA process
• Ensuring the CAPA procedure is understood and
effective
• Closing CAPAs in a timely manner, appropriate
to the complexity of the problem
 CAPA—Common Pitfalls and
How to Avoid Them

For more information contact:

Michelle M. Johnston, RAC

T: 858.722.4471
E: mmjohnston@[Link]

Website (coming soon) [Link]