CAPA reports for medical device companies

1. Prepared by Connie Dello Buono 8/10/2011
Corrective and Preventive Action Plan/Report (CAPA) is used to improve the organization even when your
supplier defines your failure rate or customer complaints. CAPA helps in finding the core issues and
specifics of actions that lead to improvement programs.
You can assist your supplier in defining the problem, performing the investigations and finding comparisons
and clues and likely causes of the problem and testing the solution to the problem. Training is an important
quality element in the effort of collaborating with suppliers in CAPA documentation.
Use root cause analysis to point to the right direction, the specific target by which action plans can be
implemented to solve the problem or product failure.
Root Cause Analysis , RCA, is finding clues that suits your organization:
 2 clues: Process and Method
 4M: material, manpower, machinery, method
 Ms: mother nature, management, measurement
 Service: surroundings, supplier, system, skills
 6P: People, process, policy, plant, program, product
The end result of RCA is identifying the unnecessary constraints, unrecognized hazards, broken or missing
barriers and inadequate controls. What are examples of inadequate controls in process and methods:
1. Incomplete inspection criteria and specifications
2. Incomplete test specifications
3. Inadequate training
4. Inadequate testing in incoming, in-process and final test
5. Inadequate process of sub-contractor selection and qualifying
6. Incomplete method of assembly

2. At the end, we identify the causal factors such as equipment problem or human error but we did not take into
account management system weakness such as lack of systems/controls: Procedures, Policies, Training,
Communication, Supervision, Equipment Design Process, Manufacturing Process and Practices
What are important data sources to measure and analyze?

3. Other References (gopathwise.com):
A CAPA system includes
 CAPA System Management – The requirements to manage the CAPA System as a business process.
 CAPA Projects Review – The requirements for review and management of CAPA projects.
 CAPA System Review – The process of analyzing the CAPA System Metrics and escalation to
Management Review.
 CAPA Escalation Decision – The process of analyzing the severity of a non-conformance issue and
documenting the outcome. This is the linkage between a QS sub-system that produces non-conformances
and the CAPA System.
 CAPA Process – The requirements to execute and document the six phases of a CAPA project:
1. Initiation – Phase where the identified issue is scoped and documented and becomes
a CAPA Project.
2. Investigation – Phase where the issue is investigated and the root cause is
determined.
3. Action Plan – Phase where the results of the investigation are turned into a plan of
action for correction and/or prevention.
4. Implementation – Phase where the execution of the action plan occurs.
5. Verification of Effectiveness – Phase where the corrective or preventive actions are
verified to be effective.

4. 6. Closure – Phase where the documented activity necessary to gain closure of the
CAPA occurs.
 NC and CAPA Trending – The requirements to analyze and trend nonconformance quality data and CAPA
project effectiveness.
The instructions for executing CAPA project work and the various additional elements of a CAPA System are unique
and separate. The separate system components should be individually defined within a system of documents that
work together to accomplish the effective execution of all CAPA activity within the organization. In their entirety, these
documents then comprise the organization’s CAPA System.
Efficient CAPA System
A properly constructed CAPA System should consist of streamlined work processes that provide an organization with
some significant benefits:
 In using appropriate escalation rules, the organization is less likely to become overwhelmed with the trivial
many and can properly address the significant few non-conformance issues that arise from the QS sub-
systems.
 By enabling a separate focus on the execution of the distinct phases of a CAPA project, the work output is
capable of being efficiently completed within each individual phase resulting in a more successful CAPA
project in aggregate.
 By enabling a distinct phases of a CAPA project work, with different required skill sets required for
execution, CAPA project work is capable of being assigned by phase and in accordance with individual
skills.
 Appropriate trending process will identify the “common cause” variation for non-conformance reduction
improvement initiatives that can provide significant return in the investment of a CAPA project.
CAPA Documentation
For each failure or defective components:
Details of Corrections and CAPA Plans (Please complete)
The following are major areas that need to be addressed in your detailed
investigation for each failure:
1. An in-depth Root Cause Analysis (RCA); Analyze failure for root cause
(RC)
2. Identification of appropriate actions (Lists of tasks, who, when, what data or
analysis results will make the defect go away) ; Correction CO or Corrective
Action CA or Preventive Action PA
3. Verification of identified actions ; Check CK (Proof)
4. Implementation of actions ; Do IA (Plan, results, mgt review)
5. Effectiveness Check of Implemented actions ; Determine effectiveness of
actions/validate DE (example: Field data gathered after 3-6months

5. indicating the absence of similar failure, monitor data, audit process,
compare before and after implementation data, etc.)
Preventive
Action – action
Product Failure taken to
eliminate the
Interim Action cause of
Remedial
Corrective action taken potential
Action – action
Correction Action (CA) until the root problem from
taken on
- action taken cause occurring in
already
Quick Fix to eliminate investigation is another area,
released
Root cause complete & CA product or
product
is ID facility
(independent
of whether a
CA has been
ID)
Failure A ; Example: Example: Example: Parts Change
Replacement 1. Tighter in- 1. 100% replacement supplier
of parts (from coming incoming
Audit
a different inspection with inspection
vendor, higher revised 2. 100% final Monitor
quality) sampling plan inspection Compare _ to _
or inspection 3.
criteria
2. Training
3. Supplier
approval
criteria
implemented
4. Others