This document details the procedure of Corrective Action & Preventive Action. It is the policy of Pharmaceuticals Limited that a written procedure shall be followed to provide a guideline for identification, evaluation & implementation of the corrective Action & Preventive Actions for reacting to an existing product, problem, customer complaint, or other non-conformity and fixing it.
This
procedure is to be applied at the time for identification, assessment, and
implementation of the Corrective Action & Preventive action for detecting
potential problems or non-conformances and eliminating them to prevent
recurrences.
RESPONSIBILITY
Persons
along with their responsibilities are given below:
5.0 DEFINITION
5.0.1 Corrective Action: The process of reacting to an existing product,
problem, customer, complaint, or other nonconformity and fixing it.
5.0.2 Preventive
Action: A Process for detecting potential problems or
non-conformance and eliminating them.
5.1 CAPA Procedure
5.1.1 DOCUMENTATION OF THE CAPA
Properly
documented actions provide important historical data for a continuous quality
improvement plan and are essential for any product that must meet the
regulatory requirements demanded by FDA & ISO.
5.1.2 CAPA PROCEDURE
Seven
steps shall be followed to implement the corrective & preventive actions.
Identification:
Clearly define the Problems.
Evaluation:
Appraise the magnitude and impact.
Investigation:
Make a plan to research the problem.
Analysis:
Perform a thorough assessment.
Action
plan:
Create a list of the required tasks.
Implementation:
Execute the action plan
Follow-up:
Verify and assess the effectiveness.
5.1.3 Identification of CAPA
The
initial step in the process is to clearly define the problem or potential
problem.
This shall include. The source of the information, A detailed explanation of the problem, and documentation of the available evidence that a problem exists. The Source of the information: the specific source of the information shall be documented; there may be possible sources.
Service
requests
Trend
Data
Process
monitoring
Customer
complaints
Staff
observations
QA
inspections
Risk
analysis
This
information is important for the investigation and action plan, but also useful
for effectiveness evaluation and communicating the resolution of the problem.
Explanation
of the Problems: A description of the problem is written that is
concise but complete. The Description must contain enough information so that
the specific problem can be easily understood.
Evidence:
- List the specific information, documents, or data available that demonstrates
that the problem does exist. This information will be very
important during the investigation into the problem.
5.14
Evaluation: Appraise the magnitude and impact
The
situation shall be evaluated to determine both the need for action and then,
the level of action required.
An
evaluation shall include:
The
potential impact of the problem.
Risk
to the company or customers.
Remedial
action that may be required.
Evaluation (Potential Impact)
Shall
be determined and documented specifically why the problem is a concern and what
the impact to the company and our customers may be. Concerns may include costs,
function product Quality, safety, reliability, and/ or customer satisfaction.
Evaluation (Risk)
Based
on the result of the impact evaluation, the seriousness of the problem is
assessed. The level of the risk that is associated with the problem will
affect the actions that are taken and the priority assigned to the situation.
Evaluation (Remedial Actions)
The
potential impact and risk assessment shall indicate a need for some immediate
action to remedy the situation until a permanent solution can be implemented. In
some cases, the remedial action may be adequate. If so, the CAPA can then be
closed, after documenting the rationale for this decision and completing an appropriate follow-up.
5.15 Investigation:- A plan shall be made to research the problem.
A
written procedure for doing an investigation into the problem shall be created.
This
procedure shall include:
The
objectives for the action
An
investigation strategy
Assignment
of responsibility and required resources
Investigation (Objective)
The
objective is a statement of the desired outcome (s) of the corrective or
preventive action. The action shall be complete when all aspects of the objects
have been met and verified.
Investigation (Strategy)
A
set of specific instructions for determining the contributing and root causes
of the problem shall be written. This procedure directs a comprehensive review
of all circumstances related to the problem and must be considered.
Equipment - Materials
Personnel - Procedures
Design - Training
Software - External factors.
Investigation
(Assign Responsibility and Resources)- It is important to assign someone
the responsibility for each aspect of the investigation. Any additional
resources (Financial, equipment, etc) shall be identified and documented.
5.16
Analysis: The investigation procedure is used to conduct the investigation into
the cause of the problem. Every possible cause shall be identified and
appropriate data collected. The results of the data collection shall be
documented and organized. Everything related to the problem must be identified,
but the primary goal must be to find the root cause.
Possible causes/Data collection
An
A-list of all possible causes shall be created which then form the basis for
collecting relevant information, test data, etc. The necessary data and
other information shall be collected that will be used to determine the primary
cause of the problem.
5.17
Results:- Data may come from a variety of sources, testing results, and/ or a
review of records, processes, and service information, design controls,
operations, and other information that may lead to a determination of the
fundamental cause of the problem.
The Data collected shall be organized into a usable form.
The
resulting documentation shall address all of the possible causes previously
determined. This information is used to determine the root cause of the
problem. The effectiveness of the analysis will depend on the Quality and
thoroughness of the information
available.
5.18 Root cause analysis:- Use the data to complete a Root cause analysis. This involves finding the actual cause of the problem rather than simply dealing with the symptoms. Finding the primary cause is essential for determining appropriate corrective and or/ preventive actions.
5.19 Action Plan: A list of required tasks shall be prepared Using the results
from the analysis, the best method (S) for correcting the situation
(or preventing a future occurrence) shall be determined. All of the
tasks required to correct the problem and prevent a recurrence shall identify
and incorporated into an action plan. The plan includes changes that must be
made and assigns responsibility for the tasks.
5.20 Actions to be completed: all activities and tasks shall be listed that
must be accomplished to correct the existing problem eliminate potential
problems and prevent a recurrence. It is very important to identify all actions
necessary to address everything that contributed to or resulted from the
situation.
5.21 Changes: Needed changes to documents, processes, procedures or other system modifications shall be described. Enough detail must be included so it is clearly understood what must be done and what the outcome of the changes should be.
5.22 Training: Employee training is an essential part of any change that is made and
should be made part of the action plan. To be effective, all modifications and
changes made must be communicated to all persons, departments, suppliers, etc.
that were or will be effective.
5.23 Implementation: Execute the action plan. The Action plan that has been developed shall be executed and all identified tasks and activities completed. The actions that were taken are summarized and all modifications to documents, processes, etc. shall be listed.
5.24 Follow-up: verify and assess the effectiveness. One of the most fundamental steps in the CAPA process is completing an evaluation of the actions that were taken. This evaluation must not only verify the successful completion of the identified tasks but also assess the appropriateness and effectiveness of the action taken.
5.25 Verification Results: Have all the objectives been met? (Did the actions correct or prevent the problem with assurances that the same situation will not happen again?)
Have
all recommended changes been completed and verified?
Has
training and appropriate communications been implemented to assure that all
relevant employees understand the situation and the changes that have been
made?
Has
an investigation demonstrated the actions were taken?
Has
an investigation demonstrated that the actions taken have not had any additional
adverse effect on the product or service?
Make
sure that appropriate information has been recorded that provides proof that
all actions have been completed successfully.
5.26
Validation Results: A validation of the action is done. This must document that
The
root cause of the problem has been solved,
Any
resulting secondary situations have been corrected,
Proper
controls have been established to prevent a future occurrence,
The
actions taken had no other adverse effects.
Adequate
monitoring of the situation is in place.
5.27 CAPA
Completion: When the follow-up has been finished, the CAPA is complete. It
shall be dated and signed by appropriate, authorized personnel (Production,
Quality Control, Regulatory Affairs, Process & Development &
Quality Assurance)
ANNEXURE
-I
CORRECTIVE
& PREVENTIVE ACTION REQUEST
1.0
Date of Request:
2.0
Name of Department:
3.0
CAPA PROCEDURE:
ANNEXURE-II
Corrective &
Preventive Action Remedial action required
Date:
Name
of Department:
3.0
Root causes:
4.0
Action Plan:
5.0
Follow-up:
Approved
by
Quality
Assurance Manager
ANNEXURE -III
Corrective
& Preventive Action Investigation Procedure
Date:
2.0
Investigation Objective:
3.0
Investigation Strategy:
4.0
Investigation was done by:
5.0
Investigation Analysis mentioning:
Possible causes/ Data collection
6.0
Result of Investigation: