7 steps of CAPA for Medical Device Manufacturing

Implementing an effective corrective or preventive action which is capable of satisfying quality

assurance and regulatory documentation requirements is accomplished in seven basic
procedures:
a) Identification – Clearly define and describe the scope of the problem
b) Evaluation – Appraise the magnitude and potential impact
c) Investigation – Make a plan to research the problem
d) Analysis – Perform a thorough assessment with the right documentation
e) Action plan – Create a list of required task
f) Implementation - Execute the action
g) Follow up – Verify and assess the effectiveness

Purpose and scope of CAPA

The purpose of a CAPA subsystem is to collect and analyze information, identify and investigate
product and quality problems, and take appropriate and effective corrective and preventive action
to prevent their recurrence.

CAPA should be viewed as an umbrella system which allows a company to assess and evaluate
its entire program. The scope of any corrective and preventive action , CAPA system must
include the verification of corrective and preventive actions.

Additional elements include the communicating corrective and preventive action activities to
those responsible, providing relevant information for management review and documenting
those activities. These activities are essential in dealing effectively with product and quality
problems, preventing their recurrence and preventing or minimizing device failures.

Under the CAPA umbrella, the organization should include all activities and processes taken to
eliminate the causes of potential nonconforming products, processes and conditions within its
documented quality system.

Problem Statement

There is a company by the name of Gagah Healthcare Berhad which have been receiving a
number of complaints lately. The complaints were related to the poor manufacturing of the
medical devices for public usage. The medical devices that they distribute to certain hospitals
were not satisfied by the medical staffs as the devices were too dangerous to be handled. So, the
company should improvise its manufacturing policy to amend to its poor medical devices.
For most manufacturers of medical devices, these activities include their methods for:

 Complaint handing (21 CFR 820.198).

 Medical device reporting (21 CFR 803).
 Reports of corrections and removals (21 CFR 806).
 Product recalls (21 CFR 810).
 Postmarket surveillance (for companies assessed under the Medical Device Directive
93/42/EEC from the European Economic Community).
 Quality audits (21 CFR 820.22).
 Nonconforming products, processes and conditions (21 CFR 820.90 for nonconforming
products).
 Device tracking, as appropriate (21 CFR 821).

1 - Identification - Clearly define the problem

The medical devices were not properly inspected resulting in huge loss to the manufacturing
company financially. The devices are also not safe to be used by the hospitals.

• The source of the information - The specific source of the information is documented.
Some of the possible sources:
Service requests, Internal Quality Audit, Customer complaints, Internal quality audits, Staff
inspection, Trend data, QA inspections, Process monitoring, Risk analysis, Process performance
evaluation, Management analysis, and Failure mode validation. This information is important for
the investigation and action plan, but also useful for effectiveness evaluation and communicating
the resolution of the problem.

• Detailed explanation of the problem

Received a number of complaints regarding the medical devices manufactured whereby the
devices posed formidable risks and challenges during surgery or other medical operations. The
devices did not meet the safety standards as the forceps and the scissors were not properly
examined and inpected.

• Documentation of the available evidence that a problem exists.

Collect and compile the specific documents or data available which demonstrates the existing
problem . The informations gathered would be very important and helpful during the
investigation of the problem. For instance, there would be higher service requests or the product
will be returned if there is evidence that the product has drawbacks or flaws. This may arouse the
rise in the problem of the product in the longterm and hamper the manufacturers growth.

• Corrective/Preventive Action Request form

A sample form known as“Corrective/Preventive Action Request” that can be used to initiate a
CAPA action and collect the initial information.

3- Evaluation – Appraise the Magnitude and the potential impact

The problem of having medical devices that are defective is a concern to the manufacturer
him/herself, the customers and the public. Manufacturing such devices would be impactful from
the company’s point of view as well as the customers and the public in a way that

a) The company’s profit margin or financial part of it would be in stake

b) The consumers would be in risky scenario
c) Surgery and any medical operations or procedures would be miserably affected
d) The medical devices may lead to complications and would cause fatality
e) The manufacturing company would face serious blacklash from the crowd and it might
be even sued.
f) Country’s health sector would be in danger

3 - Investigation - Make a plan to research the problem

A written procedure for doing an investigation into the problem is created. A written plan helps
assure that the investigation is complete and nothing is missed.

This procedure should include:

• The objectives for the action

To observe the workers and technicians involved in manufacturing of the medical devices

• An investigation strategy
A set of specific instructions and guidelines for discovering the contributor and root causes of
the problem. This procedure provides a comprehensive review of all the circumstances related to
the problem and must consider factors like where were the medical devices were kept,
environment , material in contact with and the people who handle those devices.

• Investigation Procedure form

A sample “Investigation Procedure” form is included. This is a written plan of action for the
investigation into the problem. It should include the overall objective and the instructions for
conducting the investigation. The person or persons responsible for the investigation and an
expected completion date should also be entered
•
Assignment of responsibility and required resources

(Responsibilities and authorities )

Assignment of responsibilities and authorities for the corrective and preventive action system
will vary among companies, primarily as a result of organizational structure. In a hypothetical
organization, let's make the following assignments to department management, quality
department personnel and everyone else in the company.

Department management is responsible for:

 Maintaining overall responsibility for management of corrective and preventive action

activities in areas of responsibility.
  Responding to identified nonconforming conditions within defined time periods and with
complete information to describe the planned (and actual) corrective actions taken.
 Assigning appropriate personnel and other resources to develop and implement corrective
and preventive action plans.
 Ensuring implemented corrective and preventive actions are completed, effective and
documented.
 Notifying quality department personnel of the corrective and preventive action
resolutions.

Quality department personnel are responsible for:

 Maintaining a listing or database of nonconformance reports and the identified corrective

actions.
 Maintaining a listing or database of identified preventive actions.
 Performing periodic statistical analyses (for example, trend analyses) of identified
nonconforming conditions.
 Reviewing corrective and preventive action documentation for timeliness.
 Coordinating verification of corrective and preventive actions by the assigned personnel.

Company personnel are responsible for reviewing and implementing corrective and preventive
action procedures and changes that influence their positions.

5 - Action Plans

When the corrective and preventive action system is assessed during a QSIT inspection,
investigators focus on the following 10 key activities:

1. Verify the CAPA system procedures that address the requirements of the quality system
regulation have been defined and documented.

2. Learn whether appropriate sources of product and quality issues have been identified and
confirm data from those sources are analyzed to identify existing product and quality issues that
may require corrective action.

3. Determine whether sources of product and quality information that may show unfavorable
trends have been identified and confirm data from those sources are analyzed to identify
potential product and quality issues that may require preventive action.

4. Challenge the quality data information system and verify the data received by the CAPA
system are complete, accurate and timely.

5. Verify appropriate statistical methods are employed where necessary to detect recurring
quality issues and determine whether results of analyses are compared across different data
sources to identify and develop the extent of product and quality problems.
6. Using sampling tables, determine if failure investigation procedures are followed and that the
degree to which a quality issue or nonconforming product is investigated is commensurate with
the significance and risk of the nonconformity. Investigators will also determine if failure
investigations are conducted to determine root cause, where possible, and verify there is control
for preventing distribution of nonconforming product.

7. Using sampling tables, determine whether appropriate actions have been taken for significant
product and quality issues identified from data sources.

8. Determine whether corrective and preventive actions were effective and verified or validated
prior to implementation and confirm corrective and preventive actions do not adversely affect the
finished device.

9. Using sampling tables, verify that corrective and preventive actions for product and quality
issues were implemented and documented.

10. Determine whether information concerning nonconforming medical devices, quality issues
and corrective and preventive actions has been properly disseminated (this includes distribution
for management review).

Sources of data

Data to be included in a CAPA system come from a variety of sources, both internal and
external. Some sources of internal data include:

 In-process and final inspection and test data.

 Scrap and yield data.
 Process control data.
 Incoming component testing and inspection test data.
 Equipment data (preventive maintenance, calibration).
 Internal audits.
 Device history records.
 Training records.
 Change control records.
 Rework and reprocessing.
 Nonconforming materials reports.
Some sources of external data include:
 Complaints--customers, employees, MedWatch (the FDA's medical products reporting
program), field service reports, journal articles, information from the FDA and other
regulatory bodies.
 Warranty reports.
 Legal claims.
 Study reports.
 Third-party audits.

Corrective action procedures

Documentation of the identified nonconforming product, process or condition should be
performed according to the organization's documented procedures. After being informed of the
identified nonconformance, responsible personnel then assign appropriate personnel to
investigate the nonconformance and identify its root causes. Representatives from other
functions may be used.

Once the investigation is completed, appropriate meetings, discussions and training sessions are
held with department personnel and other groups whose activities may be impacted by the
investigation and corrective action implementation.

The identification of the root causes (established, in part, by failure analysis, when appropriate)
is indicated on the company's appropriate documents. The documents are completed, returned to
the individuals who identified the nonconformance and then reviewed according to the process
described in documented procedures.

Once the corrective action has been verified as implemented, the documents are forwarded to
quality department personnel, who enter the corrective action information into the database for
future statistical analysis.

Preventive action procedures

As a result of identified nonconformances (for example, identified through trending) and

effective corrective actions, an individual may decide to implement a similar action to prevent
the occurrence of a nonconforming condition.

If department management identifies and approves a preventive action plan, it should also initiate
documentation. The preventive action plan and associated documentation are described on the
report form. Once the preventive action plan is accepted, the initiator verifies implementation
and effectiveness.

Documentation of preventive action is forwarded to quality department personnel for entry into
the database and possible subsequent statistical analysis.

Finally, records of corrective and preventive actions are maintained in accordance with the
company's defined process for control of quality records

6- Implementation
The action plan that have been developed are executed an all identified tasks and activities are
completed

7- Follow- up
The actions implemented are verified and assessed for effectiveness an it as the result the
medical devices are safer to use. Thus action plan generated are highly effective.