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1. 5 MOST COMMON Reasons
Behind CAPA Management
Problems (And, How to Deal with
them)

2. Maintaining discipline of processes, workflows, quality
management, and continuous improvement is difficult without
Corrective and Preventive Actions (CAPA) process especially if
you are associated with a highly regulated industry like Life
Science. The technology intervention has positively impacted
the effectiveness of CAPA with the introduction of CAPA
Management software systems.
For every organization having a quality management system
software, the Corrective and Preventive Actions (CAPA) process
is an inevitable part to ensure all the quality issues are
inspected, analyzed, and corrected thoroughly.

3. What is CAPA?
Before heading to the discussion of 5 MOST COMMON
Problems with CAPA Management, it would be
sensible to understand the concept of CAPA. It will
help you have a better understanding of every step.
CAPA refers to the improvements that any
organization makes to manage non-conformities and
eliminate its root-cause to prevent their reoccurrence.
It is basically a defined set of actions by the regulatory
authority that the organizations take to eliminate the
quality issues and their reoccurrences – be it for
manufacturing, procedures, documentation, or the
system itself.

4. CAPA comprises of two elements: Corrective Actions, and Preventive
Actions.
Corrective Actions
The actions that an organization takes to eliminate
nonconformities for preventing their reoccurrence.
Any corrective action shall be taken without any ado.
Also, the actions taken shall be effective enough over
the effects of the nonconformities identified.
Preventive Actions
The actions that an organization takes to eliminate
the possible causes of the potential nonconformities
to prevent problem occurrence well-in-advance. The
actions taken shall be effective enough to restrict the
effects of potential problems.

5. Now that you understand the concept of CAPA
in detail, it’s time to bring in the discussion
about the 5 MOST COMMON Reasons that
result in Problems with CAPA Management
along with the possible solutions.
• The five important reasons why there are
problems with CAPA implementation:
• No Cross-Functionality
• Being Reactive, Not Proactive
• Over usage vs Under usage
• Poor Root Cause Identification
• Poorly Defined CAPA Process

6. No Cross Functionality
CAPA is generally a process that medical device
companies own for their quality functions. Quality
is actually responsible to determine when exactly
CAPA is needed as it plays a vital role in the
implementation and effectiveness of the quality
management system.
Is it justified for a quality function to categorize
the nonconformities as CAPA without considering
all the aspects and inputs? Definitely not!
Do organizations collect data and information
from the resources to take decisions on
categorization? It is doubtful due to a lack of
transparency and commitment among the
departments.
In fact, most of the medical devices company
don’t have their trustworthy source of truth that
could enable them to make informed decisions.

7. Being Reactive, Not Proactive
In the majority of the nonconformity’s occurrences, there have been
reactions to resolve them rather than adopting any preventions to restrict
their occurrences by eliminating the possible causes. It is not the case
with medical device companies, it is, unfortunately, the case with every
other industry including automotive.
The reactive approach is not a long-term solution because organizations
are preparing for the nonconformities to happen while they should
identify the ways to prevent nonconformities from happening.
The medical device company doesn’t have easy access to all the data
sources, which keeps them at lagging position, not on leading.
There is a need for systems that can help identify issues before they
transform into bigger problems for end users as well as companies.

8. Over Usage Vs Under Usage
Over usage is yet another significant and systemic
problem that medical device companies encounter in
CAPA.
You can understand the concept of over usage with an
example. Let say, you receive a complaint in a product,
or you encountered a nonconformance. Will this much
of information be enough for declaring the event as
CAPA.
This is the most commonly observed issue with CAPA
management as medical device companies create a lot
of CAPAs over time to review and resolves while many
issues don’t even need much attention or
investigation.
It is an agreeable situation that under-usage or
ignoring the early signs of the problems can result in
bigger troubles. This indicates the need for an effective
CAPA Software that can perform complete data
analysis to identify the early signs backed with similar
cases that happened before.

9. Poor Root Cause Identification
An example here could be –for an error that caused a part to be made that did not
fit into the machine assembly:
• Why did the part not fit? – The part was too small.
• Why was the part too small? – The measurements were incorrect.
• Why were the measurements incorrect? – The mechanical engineer did
not take down the dimensions correctly.
• Why didn’t he take down right dimensions? – Because his tools were not
calibrated properly.
• Why his tools were not calibrated properly? – Because of his ignorance.
After the 5 Whys approach, a company needs to refer to cross-functional resources
to have confirmed information about the root cause(s).
Having great tools and CAPA management software improves the root cause
determination, which will result in an effective CAPA process in the longer run.
Make sure you don’t ignore the root cause aspect to keep all your quality
management effective.

10. Poorly Defined CAPA Process
Defining the CAPA process is often a
huge issue especially for the medical
device’s companies. Companies, in
fact, don’t have any idea about
managing the CAPA process effectively.
The root cause of ineffective CAPA
process lies in its poor-definition of the
resources and actions.
You must make sure that the CAPA
process is appropriately defined and
communicated to your employees or
the people involved so that right
action(s) can be taken at right time
through a well-structured workflow.

11. What is A Possible Solution?
Firstly, it is important for organizations to realize that CAPA is
something cross-functional in nature. Having a cross-functional
team to review and report the quality issues especially the ones
qualify for the CAPA process. Such a team is commonly referred
to as MRB i.e. Management Review Board that includes a
representative from every team including quality, operations,
manufacturing, and regulatory.
The MRB team can keep the frequency of their reviews as
weekly and closely review every issue – be it addressed through
customer complaints/feedback, internal audits, or
nonconformances reports.

12. • The goal of the MRB team is to review, assess, evaluate,
correct, prevent, and control quality issues while
documenting all the relevant information. However,
documenting all the details manually is not feasible. It is
sensible to go for CAPA Management software that
enables organizations to store as much as CAPA
information and documentation they want.
• Additionally, a CAPA software ensures a properly
defined process with optimum use of resources to
mitigate risks and possibilities of non-conformances.
• Wouldn’t you like to make your quality management
system and processes more effective? Integrate ISO
9001 quality management software like Qualityze in it
today!

13. Thank You