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C ti and d Preventive P ti Corrective Actions

(CAPA)

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Corrective Actions
The

process of reacting to an existing product problem, p , customer complaint or other nonconformity f it and d fixing fi i it it.

Preventive Actions
A

process for detecting potential t ti l problems bl or nonconformances nonconformance s and eliminating them.

Why CAPA?

Regulatory Requirements

Both FDA and ISO require an active CAPA program as an essential ti l element l t of f a quality lit system. t

Customer Satisfaction

The ability Th bilit t to correct t existing i ti problems bl or i implement l t controls to prevent potential problems is essential for continued customer satisfaction

Good Business Practice

Quality problems can have a significant financial i impact t on a company.

CAPA Procedures

Implementing I l i an effective ff i and df fully ll compliant Corrective / Preventive action program is a seven step process process. Each step must be thoroughly documented!

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 and ISO.

CAPA Procedures
Seven Steps
1. 2. 3. 4 4. 5. 6. 7.

Identification clearly define the problem Evaluation appraise pp the magnitude g and impact p Investigation make a plan to research the problem Analysis perform a thorough assessment Action Plan create a list of required tasks I l Implementation t ti execute the action plan Follow Up verify and assess the effectiveness

CAPA Procedures
Seven Steps
1. 2. 3. 4 4. 5. 6. 7.

Identification clearly define the problem Evaluation appraise pp the magnitude g and impact p Investigation make a plan to research the problem Analysis perform a thorough assessment Action Plan create a list of required tasks I l Implementation t ti execute the action plan Follow Up verify and assess the effectiveness

1. Identification

The initial step in the process is to clearly define the problem or potential problem. This should include: the source of the information, a detailed explanation of the problem problem, Documentation of the available e idence that a problem exists. evidence e ists

1. Identification

Source of the Information


The specific source of the information is documented. There are many possible sources:
Service requests Internal quality audits Trend data Process monitoring

Customer complaints Staff observations QA inspections Risk analysis

This information is important for the investigation and d action ti plan, l b but t also l useful f lf for effectiveness ff ti evaluation and communicating the resolution of p the problem.

1. Identification

Explanation of the Problem

A description of the problem is p written that is concise - but complete. The description must contain enough information so that the specific problem can be easily understood.

1. Identification
Evidence

List the specific information, , or data available that documents, demonstrates that the problem does exist.

This information will be very important


during the investigation into the problem.

CAPA Procedures
1. 2. 3. 4. 5 5. 6. 7 7.

Identification clearly define the problem 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 required tasks Implementation execute the action plan Follow Up verify if and d assess th the effectiveness ff ti

2. Evaluation

The situation must be evaluated to determine both the need for action and then the level of action required then, required. An evaluation should include: Potential P t ti l I Impact t of f the th problem. bl Risk to the company or its customers Remedial Action that may be required

2. Evaluation
Potential Impact

Determine and document specifically why the problem is a concern and what the impact to the company y and/or customers may y be.

Concerns may y include costs, , function, ,


product quality, safety, reliability, and/or customer satisfaction.

2. Evaluation
Risk

Based on the result of the impact evaluation, the seriousness of the problem is assessed. The level of risk that is associated with the problem will affect the actions that are taken and the priority assigned to the situation.

2. Evaluation
Remedial Action

The potential impact and risk assessment may 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, l d after ft documenting d ti th the rationale ti l f for this decision and completing appropriate follow up up.

CAPA Procedures
1. 2. 3. 4. 5 5. 6. 7 7.

Identification clearly define the problem 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 required tasks Implementation execute the action plan Follow Up verify if and d assess th the effectiveness ff ti

3. Investigation

A written procedure for doing an investigation into the problem is created. This procedure should include: The objectives for the action An investigation strategy Assignment A i t of f responsibility ibilit and d required resources

3 Investigation 3.
Objective

The objective is a statement of the desired outcome(s) of the corrective or preventive action. The action will be complete when all aspects of the objective have been met and verified.

3 Investigation 3.
Strategy

A set of specific instructions for determining the contributing and root causes of the problem bl i is written. itt This procedure directs a comprehensive review of all circumstances related to the problem and must consider:
- equipment q p - personnel - design - software - materials - procedures - training - external factors

3 Investigation 3.

Assign Responsibility and Resources

It is important to assign someone the responsibility for each aspect of the investigation. Any additional resources (financial (financial, equipment, etc) should be identified and documented.

CAPA Procedures
1. 2. 3. 4. 5 5. 6. 7 7.

Identification clearly define the problem 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 required tasks Implementation execute the action plan Follow Up verify if and d assess th the effectiveness ff ti

4. Analysis

The investigation procedure is used to conduct the investigation into the cause of the problem. Every possible cause is identified and appropriate data collected. The results of the data collection are documented and organized. Everything related to the problem must be id tifi d b identified, but t th the primary i goal l must tb be t to find fi d the root cause.

4. Analysis

Possible Causes / Data Collection

A list of all possible causes is created which then form the basis for collecting relevant information, test data, etc. The necessary y data and other information is collected that will be used to determine the primary cause of the problem.

Analysis
Results

Data may come f D from a variety i of f sources: testing i results and/or a review of records, processes, service information, design controls, operations, and any other information that may lead to a determination of the fundamental cause of the problem. The data collected is organized into a useable form form. The resulting documentation should 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.

4 Analysis 4.

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. symptoms Finding the primary cause is essential for determining appropriate corrective and/or preventive actions.

CAPA Procedures
1. 2. 3. 4. 5 5. 6. 7 7.

Identification clearly define the problem 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 required tasks Implementation execute the action plan Follow Up verify if and d assess th the effectiveness ff ti

5. Action Plan

Using the results from the analysis, the best method(s) for correcting the situation (or preventing a future occurrence) is determined determined. All of the tasks required to correct the problem and prevent a recurrence are identified and incorporated into an action plan. The plan includes changes that must be made and assigns responsibility for the tasks.

5 Action Plan 5.

Actions to be Completed

List all activities and tasks that must be accomplished to correct the existing problem or eliminate a potential problem, and prevent a recurrence. It is very important identify all actions necessary to address everything that contributed to or resulted from the situation.

5 Action Plan 5.
Changes

Needed changes to documents, processes, procedures, or other system modifications should be described. Enough g detail must be included so it is clearly understood what must be done and what the outcome of the changes should be.

5 Action Plan 5.
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 affected.

CAPA Procedures
1. 2. 3. 4. 5 5. 6. 7 7.

Identification clearly define the problem 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 required tasks Implementation execute the action plan Follow Up verify if and d assess th the effectiveness ff ti

6. Action Implementation!
The Action Plan that has been p is executed and all developed identified tasks and activities completed. The actions that were taken are summarized and all modifications to documents, processes, etc. are listed. listed

CAPA Procedures
1. 2. 3. 4. 5 5. 6. 7 7.

Identification clearly define the problem 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 required tasks Implementation execute the action plan Follow Up verify if and d assess th the effectiveness ff ti

7. Follow up

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 y verify y the successful completion of the identified tasks, but also assess the appropriateness and effectiveness of the actions taken.

7. Follow up
Key Questions

Have all of 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 g that understand the situation and the changes have been made? Has an investigation demonstrated that that the actions taken have not had any additional adverse effect on the product or service?

7 Follow up 7.
Verification Results

Make sure that appropriate information has been recorded that provides proof that all actions have been completed successfully.

7 Follow up 7.
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, Th actions The i taken k h had d no other h adverse d effects. ff Adequate monitoring of the situation is in place.

CAPA Procedures
Completion

When

the Follow Up has been finished the CAPA is complete finished, complete. It should be dated, and signed by appropriate, authorized personnel. personnel

Corrective / Preventive Actions Made Easy!

CAPA Facilitator
f from R. R M. M Baldwin, B ld i I Inc.
An integrated software system for implementing and documenting a fully compliant Corrective / Preventive Actions Program

Comprehensive management of corrective / preventive actions Simple step by step process Thorough documentation Encompasses all essential elements of a compliant system Create reports and summaries For information visit

www.rmbimedical.com

Corrective / Preventive Action

CAPA Guidelines
f from R. R M M. B Baldwin, ld i I Inc.
Written guidelines for developing and documenting a comprehensive Corrective / Preventive Actions Program

Describes all of the essential elements of a corrective / preventive action system Includes sample forms that can be used or modified.

Download CAPA Guidelines

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R. M. Baldwin, Inc

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Mechanical, electronic, biomedical design Software design and development Regulatory affairs Training Technical writing Email: rmbi@rmbimedical.com Website: www.rmbimedical.com Phone: 616-454-9639