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

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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

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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