Corrective and Preventive Action (CAPA) systems are important tools for addressing issues and preventing recurrences. However, CAPAs require careful planning and execution to be effective. Common pitfalls include opening CAPAs without stakeholder buy-in, failing to thoroughly investigate root causes, and establishing unrealistic timelines. Keys to success are gaining management support, using root cause analysis tools, defining specific action items, conducting effectiveness checks, and maintaining thorough documentation. The FDA scrutinizes CAPA systems and may issue observations for deficiencies.

1. Corrective and Preventive Action
Pitfalls and Keys to Success
Geoff Habiger, G Habiger Consulting, LLC

2. In FY2014, 21CFR211.192 was the 3rd
most cited
paragraph in 483 observations. (Source: FDA Inspectional Observation Summaries)
“There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a
batch or any of its components to meet any of its specifications] whether or not the
batch has been already distributed.”
Why are CAPAs important?
Section 211.192 says (in part):
All drug production and control records…shall be reviewed and approved by the quality control unit to
determine compliance with all established, approved written procedures before a batch is released or
distributed. Any unexplained discrepancy…or the failure of a batch or any of its components to meet
any of its specifications shall be thoroughly investigated, whether or not the batch has already been
distributed. The investigation shall extend to other batches of the same drug product and other
drug products that may have been associated with the specific failure or discrepancy. A written
record of the investigation shall be made and shall include the conclusions and followup.

3. Okay, so we know that CAPAs are
important, and we have a CAPA system in
place. Isn’t that enough?
Simply put – no. The FDA looks at CAPAs during their
inspections and will cite a company for CAPAs that do not
meet established procedures.
Why are CAPAs important?

4. FDA 483 Obs. Jan 2013:
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Specifically, 1. Your firm's long term CAPA two month minimum interim reporting requirement specified in
Step 9.4.15 of procedure SGPO16 Corrective Action and Preventive Action Program was not consistently
met as follows:
a. The first interim report issued for CAPA 12-011, initiated on 6/29/12, was not approved until 9/10/12.
b. The first interim report issued for CAPA 12-007, initiated on 6/13/12, was not approved until 9/10/12 .
c. The first interim report issued for CAPA 12-009, initiated on 6/21/12, was not approved until 9/10/12.
d. The first interim report issued for CAPA 12-001 and approved on 2/28/12 did not receive an approved
follow-up interim report until 5/15/12.
e. The first interim report issued for CAPA 12-013 and approved on 9/13/12 did not receive a follow-up
interim report until its final approved closure report on 1/9/13.
FDA 483 Obs. May 2011:
A 1/20/2010 CAPA, TRK #93875, was implemented to address execution of varied manual interventions
(redacted) (specifically defined interventions) performed during aseptic filling operations. However, not all
of the personnel that are currently engaged in the manufacture of finished products have completed the
CAPA’s requisite training.
Why are CAPAs important?

5. FDA 483 Obs July 2012:
b) According to the firm's Deviation and CAPA Management Procedure, status reports are required
every (redacted) calendar days and "any delays shall be promptly documented and justified in the
respective section/form" (See Section titled, "Overall Timing Requirements"). The status report #87754
states in the Section titled "Extension Request / Justification of Delay", "In addition, this Status Report
covers Status Report missed on May 2012" and gives no explanation as to why the status report was
"missed."
We know that the FDA will look at our quality systems,
including CAPA system. And your point is?
Why are CAPAs important?

6. Knowing the FDA will look at your CAPA system is the first
step to making that system robust.
How do you make it robust?
By avoiding common Pitfalls and making use of Keys to Success!
Why are CAPAs important?

7. Try not to be like Calvin and avoid these
CAPA pitfalls. We want to fix our problems,
not blame somebody else or the process.
© Bill Watterson
Why are CAPAs important?

8. Opening a CAPA without buy in from the
responsible lead or department that the CAPA
is necessary.
• Have clear ownership of the CAPA and clarity of roles.
(owner, lead, reviewer, approver, facilitator, etc.) – results
in accountability and empowerment.
• Have management engagement. QA shouldn’t be the only
driver.
• Start the CAPA process with a strategy meeting with key
personnel to discuss the event and make plans.
CAPA Initiation

9. CAPAs shouldn’t be a surprise that they are
coming. The responsible lead and stakeholders
should know about the CAPA before it is
opened. Discuss the need for the CAPA in
advance with all stakeholders to avoid opening
unnecessary or repeat CAPAs.
CAPA Initiation

10. • Opening without notifying stakeholders.
• Not notifying when project gates/CAPA stages are
met, next part is ready.
• Timely and accurate notification of all stakeholders
for all stages of the CAPA.
• Communication and removing silos are important
to keep all parties updated on the CAPA and to
allow for quick response in the event roadblocks or
problems are identified.
CAPA Notification

11. • Lack of/poor root cause. (Only identifying causal factors or
symptoms and not true cause.)
• Opening for immediate corrections. (Jumping to solutions.)
• Not identifying a preventive action, then having the issue
reoccur.
• Use root cause analysis (Brainstorming, 5-Why,
Fishbone, 6M, Process Mapping, Is/Is Not) consistently
to find true root cause.
• Have a well defined problem statement for the
event/cause.
Root Cause

12. Know the differences between a correction
(action taken immediately for containment),
corrective action (action taken to correct the
problem), and preventive action (action taken
to prevent recurrence on same or other
systems/process, etc.)
Root Cause

13. If you have many CAPAs for similar events
(not just the same event), then you are only
putting on Band-Aids and not fixing the
problem. You may need to re-evaluate the
original root cause.
Root Cause

14. Define the root cause method used in the
investigation so it is clear to a reader how you
reached the conclusion.
e.g. Chronology of Events, 5-Why Analysis, and 6M Analysis were used to determine the root
cause. These tools provide a comprehensive look at the event to be able to determine the root
cause. Cross-functional team members included Manufacturing Investigator (name),
Manufacturing Supervisor (name), and API Scientist (name).
Root Cause

15. • Action items are not specific.
• Changing/modifying action items without
notifying responsible person.
• Working on action items alone – within a silo.
• Well defined action plan with roles, due dates, and anticipated
effectiveness checks. Follow S.M.A.R.T process (Specific,
Manageable, Attainable, Realistic, Timely).
• Action items – even simple ones – will require input and
assistance from multiple people in different departments. It’s
critical to work together as a team to meet the CAPA goals.
Action Items

16. Action items should name the person who will do the
work (not just department), exactly what will be done,
due date for completion, and proposed effectiveness
check. Avoid generalities and vague statements. This
allows for ease of implementation and provides
accountability.
Action Items

17. Issue: Scale was set to the wrong units of measure.
CAPA ##### (Parent PR####) was previously initiated on 26Nov2012 to revise procedure (number)
Rev. (rev.) (effective date 20Dec2011) “(title)”. The revision will include instruction for performing a
daily weight check before initial daily use of the top loader balance and bench top scale in
manufacturing. The results of the weight check will be documented in a log book. The revision to the
procedure does not impact the validated state, regulatory filing, product quality, or product stability.
The revision will improve the process for using scales and balances in the manufacturing area,
alerting operators to potential issues with a scale or balance before use.
Responsible Person: Manufacturing Investigator (name): Due Date: 26Mar2014. This due date was
determined to be acceptable based on Status Report #### as allowing enough time to complete the
necessary tasks of revising the procedure and creating the logbooks.
An effectiveness check was identified in CAPA #####. The effectiveness check will be performed 30
days after the revision of (procedure) becomes effective and will ensure logbooks are present and
being used for each balance and scale.
Responsible Person: Manufacturing Investigator (name): Due Date: 26Apr2014
Examples

18. Issue: Foreign material found during packaging of product batch.
CAPA ###### was opened on 25Nov2013 to remove cardboard boxes from Processing Area XX (PA-
XX). Specifically, the box containing drum covers stored in a supply cabinet will be removed and
replaced with a plastic storage bin or tote. Other cardboard boxes, not including boxes used to hold
gloves or kimwipes, will be removed and replaced with a plastic storage bin or tote. For boxes
removed and replaced, place a label on the new container to identify the contents of the material
stored in the container. Perform an inspection of other Processing Areas at the facility for similar
cardboard boxes and replace them with plastic bins or totes as necessary, being sure to label the
container for the contents.
This CAPA will not impact product quality, product stability, regulatory filing, or the validated state.
Replacing the cardboard boxes is a preventive measure to improve the housekeeping in the
Processing Areas and reduce the risk of extraneous matter from cardboard sources.
Responsible Person: Manufacturing Supervisor (name): Due Date: 31Dec2013. This due date has
been determined to be appropriate based on the manufacturing schedule.
Examples

19. Effectiveness Check ##### has been opened to verify the effectiveness of CAPA ######. The
effectiveness check will perform a review 6 months after completion of CAPA ######. Perform a
(system) query for extraneous matter investigations where the material was identified or linked to
a cardboard source. There will be no investigations for cardboard being identified as the source
of an extraneous matter investigation in the manufacturing Processing Areas. If an event for
extraneous matter related to cardboard is identified conduct an investigation to determine the
source and cause.
Examples

20. • To short or “immediate”
• Not long enough based on processes and
procedures.
• Unrealistic – overpromising and underdelivering
• Timely completion.
• Setting realistic due dates based on sound reasoning
and accounting for variables such as production
schedule, procedures, vacations, holidays, etc.
Responsible Person: Manufacturing Supervisor (name): Due Date: 31Dec2013. This due
date has been determined to be appropriate based on the manufacturing schedule.
Due Dates

21. • Measurement not defined or vague
• Not timely (performed late, or not allowing enough
time to properly determine)
Creating and implementing continuous
monitoring into the system/process to measure
effectiveness.
e.g. continuous monitoring of equipment over the use of chart
recorders, continuous fill weight monitoring versus periodic fill
checks, etc.
Effectiveness Checks

22. • Lack of documentation
• Documents not up to date
• Documents sloppy and unclear.
• CAPA logs are not up to date
• Quantitative and Objective outcomes are fully documented.
• Include copies of all relevant documents and records. Should
be identified as attachments following documentation
procedures.
• CAPA log is updated in real-time when actions are completed.
Documentation

23. If you didn’t write it down, it didn’t happen!
Create your own CAPA file and put copies of all
documents there. This creates a backup and allows you
to have a record of everything you worked on. This
can have benefits outside of just CAPA or
Investigations, such as for performance evaluations.
(What did you work on the last quarter/year?)
Documentation

24. Treat your CAPA records like any other original
records. Are the final records controlled? Are they
stored like other records to be protected from fire
and/or water? What is the retention policy for
completed CAPAs?
Documentation

25. The FDA and other auditors will make judgements
about your entire Quality System based upon the
CAPA and Exception Event (investigation) logs used
to track these systems. If these logs are a mess, the
auditor will assume there are other problems in the
system.
Documentation

26. • Not containing the problem.
• Not documenting the containment.
• Not properly assessing risk – containing the wrong
thing or not enough containment.
Perform a thorough risk assessment
•Determine scope of impact (fence setting)
•Clearly documenting and performing the containment
for the duration of the CAPA.
•Assess risk to all systems – validation, regulatory,
product, stability.
Containment

27. Containment actions might involve using planned
deviations or temporary changes to document the
containment and rationale. It’s important to document
the containment and the justification why the
containment is acceptable. (How will this protect the
product/customer until the problem is fixed by the
CAPA?)
Containment

28. A proper risk assessment should happen as part of the
investigation. A separate risk assessment is not needed
for the CAPA, unless the CAPA is stand alone and not
tied to an investigation.
Containment

29. Not aligning a software system (tool) with the
CAPA process.
Not all investigations will require a CAPA,
and not all CAPAs must come from an
investigation!
CAPA Tools

30. Communication and education with staff on
the changes and the reason for them. This is
more than just training, but an understanding
of what the problem was and why the change
was implemented. This creates buy in with the
end users of the system/process.
Communication

31. Make your CAPA reports easy to read. Consider using
short sentences, small words, and avoid (or spell out)
acronyms – even if you think they are common. Use
headings and subheadings to break up the text and convey
information quickly. Write reports using an active voice.
“On 15Apr15, John Doe, manufacturing operator, reported that the
product method in batch record XXXXX did not match the method
stored in the Chromatography System.”
CAPA Reports

32. Create a CAPA Review Board (CRB)
• Meet periodically (monthly/quarterly) to discuss CAPAs.
• A formal process for updates to CAPAs, reviews, progress, issue
identification and mitigation.
• Monitors actions, supporting documentation, outputs, and metrics.
• An ongoing assessment of corrective actions and implementation of
preventive actions.
• Involve Quality Management (minimum) and other management as needed.
• Create metrics to monitor CAPA system (cycle time closure, CAPA type
(SOP/BR revision, training, equipment, etc.), department, missed gates/due
dates)
Review Board

33. Questions?