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8/13/2019 Corrective and Preventive Actions [Compatibility Mode]
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orrec ve an reven veorrec ve an reven ve
c onsc ons
. .. .
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Corrective Actions
The process of reacting to
roblem customercomplaint or other
noncon orm y an x ng .
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Preventive Actions
A process for detectingpo en a pro ems or
eliminating them.
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Why CAPA?
Regulatory Requirements Both FDA and ISO require an active CAPA programas an essen a e emen o a qua y sys em.
Customer Satisfactione a y o correc ex s ng pro ems or mp emen
controls to prevent potential problems is essential for
continued customer satisfaction
Good Business Practice Quality problems can have a significant financial
mpac on a company.
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CAPA Procedures
Implementing an e ective and ullycompliant Corrective / Preventive action.
Each step must be thoroughly
Properly documented actions provide importanthistorical data for a continuous qualityim rovement lan and are essential for anproduct that must meet the regulatoryrequirements demanded by FDA and ISO.
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Seven Steps
1. Identification clearly define the problem2. Evaluation a raise the ma nitude and im act
3. Investigation make a plan to research the problem
.
5. Action Plan create a list of required tasks
6. mp emen a on execute the action plan
7. Follow Up verify and assess the effectiveness
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Seven Steps
1. Identification clearly define the problem2. Evaluation a raise the ma nitude and im act
3. Investigation make a plan to research the problem
.
5. Action Plan create a list of required tasks
6. mp emen a on execute the action plan
7. Follow Up verify and assess the effectiveness
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1. Identification
The initial step in the process is toclearly define the problem or potential
problem.
This should include:
the source of the information,
, Documentation of the availableev ence a a pro em ex s s.
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Source of the Information
documented. There are many possible sources:Service requests Customer complaints
Internal quality audits Staff observations
Trend data QA inspections
This information is important for the investigationProcess monitoring Risk analysis
an ac on p an, u a so use u or e ec venessevaluation and communicating the resolution ofthe roblem.
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Explanation of the Problem
A description of the problem iswritten that is concise - but com lete.
The description must contain enough
problem can be easily understood.
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Evidence
List the specific information,documents or data available that
demonstrates that the problem does
exist. This information will be very important
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CAPA Procedures
1. Identification clearly define the problem2. Evaluation appraise the magnitude and
impact
3. Investigation make a plan to research the
4. Analysis perform a thorough assessment
. 6. Implementation execute the action plan
. ver y an assess e e ec veness
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2. Evaluation
The situation must be evaluated todetermine both the need for action anden, e eve o ac on requ re .
An evaluation should include:otent a mpact o t e pro em.
Risk to the company or its customers
Remedial Action that may berequired
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Potential Impact
Determine and documentspecifically why the problem is aconcern and what the impact to the
company and/or customers maybe. Concerns ma include costs, function,
product quality, safety, reliability,and/or customer satisfaction.
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Risk
Based on the result of the impactevaluation, the seriousness of the
problem is assessed.
The level of risk that is associated withthe problem will affect the actions that
are taken and the priority assigned to the
situation.
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Remedial Action
The potential impact and risk assessmentmay 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
c ose , a ter ocument ng t e rat ona e orthis decision and completing appropriate
o ow up.
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CAPA Procedures
1. Identification clearly define the problem2. Evaluation appraise the magnitude and
impact
3. Investigation make a plan to research the
4. Analysis perform a thorough assessment
. 6. Implementation execute the action plan
. ver y an assess e e ec veness
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3. Investigation
A written procedure for doing aninvestigation into the problem is created.
This procedure should include:
An investigation strategy
ss gnmen o respons y anrequired resources
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.Objective
The objective is a statement of thedesired outcome s of the
corrective or preventive action.
e w e p e e w e
all aspects of the objective have
been met and verified.
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.Strategy
A set of specific instructions for determiningthe contributing and root causes of the
pro em s wr en.
This procedure directs a comprehensive
problem and must consider:- e ui ment - materials
- personnel - procedures
- design - training
- software - external factors
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.Assign Responsibility and Resources
It is important to assign someonethe res onsibilit for each as ect
of the investigation.
y e u e ,
equipment, etc) should be
identified and documented.
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CAPA Procedures
1. Identification clearly define the problem2. Evaluation appraise the magnitude and
impact
3. Investigation make a plan to research the
4. Analysis perform a thorough assessment
. 6. Implementation execute the action plan
. ver y an assess e e ec veness
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4. Analysis
The investigation procedure is used to conductthe investigation into the cause of the problem.
appropriate data collected.
The results of the data collection aredocumented and organized.
Everything related to the problem must be
en e , u e pr mary goa mus e o nthe root cause.
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Possible Causes / Data Collection
A list of all possible causes is createdwhich then form the basis for collecting
relevant information, test data, etc.
The necessary data and otherinformation is collected that will be used
to determine the primary cause of the
problem.
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Results
ata may come rom a var ety o sources: test ng
results and/or a review of records, processes,service information, design controls, operations, and
determination of the fundamental cause of theproblem.
.
The resulting documentation should address all ofthe possible causes previously determined. This
the problem. The effectiveness of the analysis willdepend on the quality and thoroughness of theinformation available.
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.Root Cause Analysis
Use the data to complete a Root CauseAnalysis
This involves finding the actual cause of
the problem rather than simply dealing.
Finding the primary cause is essential for
and/or preventive actions.
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CAPA Procedures
1.
Identification clearly define the problem
2. Evaluation appraise the magnitude andimpact
3.
Investigation make a plan to research the
4. Analysis perform a thorough assessment
.
6. Implementation execute the action plan
. ver y an assess e e ec veness
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5. Action Plan
Using the results from the analysis, the best
method(s) for correcting the situation (or
.
All of the tasks required to correct the problem
incorporated into an action plan.
and assigns responsibility for the tasks.
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.Actions to be Completed
List all activities and tasks that must beaccomplished 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 thesituation.
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.Changes
Needed changes to documents,processes, procedures, or other system
modifications should be described.
Enough detail must be included so it isclearly understood what must be done
and what the outcome of the changes
should be.
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.Training
Employee training is an essential part ofany change that is made and should be
made part of the action plan.
To be effective, all modifications andchanges made must be communicated
to all persons, departments, suppliers,
etc. that were or will be affected.
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CAPA Procedures
1. Identification clearly define the problem
2. Evaluation appraise the magnitude andimpact
3. Investigation make a plan to research the
4. Analysis perform a thorough assessment
.
6. Implementation execute the action plan
. ver y an assess e e ec veness
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6. Action Implementation!
The Action Plan that has beendevelo ed is executed and all
identified tasks and activities
com leted. The actions that were taken are
documents, processes, etc. are
s e .
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CAPA Procedures
1. Identification clearly define the problem
2. Evaluation appraise the magnitude andimpact
3. Investigation make a plan to research the
4. Analysis perform a thorough assessment
.
6. Implementation execute the action plan
. ver y an assess e e ec veness
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7. Follow up
One of the most fundamental steps inthe CAPA process is completing an
evaluation of the actions that were taken.
This evaluation must not only verify thesuccessful completion of the identified
tasks, but also assess the
appropriateness and effectiveness of theactions taken.
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Key Questions
actions correct or prevent the problem withassurances that the same situation will not happen
Have all recommended changes been completed
and verified? Has training and appropriate communications been
implemented to assure that all relevant employeesunderstand the situation and the changes that
have been made? Has an investigation demonstrated that that the
effect on the product or service?
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.Verification Results
Make sure that appropriate informationhas been recorded that provides proof
that all actions have been completed
successfully.
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.Validation Results
A validation of the action is done. Thismust document that: The root cause of the problem has been solved, Any resulting secondary situations have been
Proper controls have been established toprevent a future occurrence,
e act ons ta en a no ot er a verse e ects. Adequate monitoring of the situation is in place.
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Completion
When the Follow Up has been, .
It should be dated, and signedby appropriate, authorized
.
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Corrective / Preventive Actions Made Easy!Corrective / Preventive Actions Made Easy!
CAPA FacilitatorCAPA Facilitatorrom . . a w n, nc.rom . . a w n, nc.
An integrated software system for implementingAn integrated software system for implementingand documenting a fully compliant Correctiveand documenting a fully compliant Corrective
Comprehensive management of corrective / preventiveComprehensive management of corrective / preventiveactionsactions
Thorough documentationThorough documentation
Encompasses all essential elements of a compliant systemEncompasses all essential elements of a compliant system
Create re orts and summariesCreate re orts and summaries
For information visitFor information visit
www.rmbimedical.comwww.rmbimedical.com
8/13/2019 Corrective and Preventive Actions [Compatibility Mode]
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Corrective / Preventive ActionCorrective / Preventive Action
CAPA GuidelinesCAPA Guidelinesrom . . a w n, nc.rom . . a w n, nc.
documenting a comprehensivedocumenting a comprehensive
Describes all of the essential elements of aDescribes all of the essential elements of a
corrective / preventive action systemcorrective / preventive action system
Includes sample forms that can be used or modified.Includes sample forms that can be used or modified.Download CAPA GuidelinesDownload CAPA Guidelines
www.rm me ca .comwww.rm me ca .com
8/13/2019 Corrective and Preventive Actions [Compatibility Mode]
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R. M. Baldwin, Inc
Multi-Disciplinary Engineering Services Mechanical, electronic, biomedical design
Software design and development
Regulatory affairs Training
Technical writing
Email: [email protected]: www.rmbimedical.com
Phone: 616-454-9639