Interna Audit

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    Tuesday, April 26,2011

    Prepared By: A.K. Tiwari 1

    IQA (Importance, conductingand reporting)

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    INTRODUCTION

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    OBJECTIVES FOR THIS SESSION

    " To learn how to plan, perform and monitor &report IQA

    " To define the activities and requirements of IQA

    " To identify the roles and benefits of IQA in aquality management system

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    DEFINITION$ Internal Audit" is an independent examination of

    a quality system$ It measures the effectiveness of an organisation's

    quality management system.$ It is a documented and systematic tool$ It should be done periodically by independent and

    qualified people$

    Audit" itself is a checking system , NOT aquality assessment

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    ROLES OF IQA As a powerful tool to measure the effectivenessof quality management system

    Evaluates manufacturer s compliance with QMSin all aspects related to production and qualitycontrol

    Detects any shortcomings in the implementationof QMS

    Recommend the necessary corrective andpreventive actions

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    SCOPE OF IQA (1)

    $ Ensures quality in obtaining and responding to thefeedbacks from customers, consumers, employers,employees, government authority and otherrelevant institutions

    $ Ensures quality in design, approval,monitoring and evaluation of products shouldcomply GMP requirements

    $ Ensures quality in GMP implementation and itsstrategies

    $ Ensures quality in appointment, development and performance of staff and key personnel

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    SCOPE OF IQA (2)

    Includes all written QMS documents,instructions and records

    Covering all elements of QMS including resultsof previous internal quality audit and anycorrective and preventive actions (CAPA)taken

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    BENEFITS OF IQA$ Tells you the health of a quality system$ Identify the root of a problem and plan for

    corrective and preventive actions with timeline$ Achieve better allocation of resources$ Able to avoid potentially big problems$ Learn what an auditors look for$ Continuous improvement

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    Strategies in conducting audit: Ask with the basic audit questions about the qualitysystem in placeStart with what, why, how, who, where, when

    KEY PRINCIPLES OF IQA Approaches towards IQA:

    Independent Evidence-based approach

    All activities related to IQA should:be reviewed by an independent partybe a self-appraisal systemhave a sampling plan and tracking systembe open, constructive and effective

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    PRINCIPLE OF AN AUDITOR

    Ethical

    Professional

    Fair

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    GUIDANCE WHEN CONDUCTING AN AUDIT

    Auditing should be seen as a positive process not afault finding

    Audits need to be documented

    Prior to the audit date, an auditor needs to reviewthe quality system documentation, corrective andpreventive actions, and past audit findings anddevelop a checklist

    During an audit, an auditor need to see evidencesthat the processes are being done in accordance toprocedures and policies

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    GUIDANCE FOR AUDITEE

    When being audited:

    Volunt eer i nformation Report de fici enci es and difficulti es if you know of any B e h on es t, op en and coop erativ eEnsur e that und erlying caus es ar e id entifi ed

    Ask th e auditor if you r e not sur e

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    MANAGING IQA

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    FLOW CHART OF IQA

    Improving the auditprogramme

    competence andevaluation of

    auditors

    Authority for the a uditprogramme

    A udit ac tivitiesAct

    Plan

    Check

    Impleme nting internal a udit programscheduling audits

    evaluating auditorsselecting audit team

    directing audit activiriesmaintaining records

    Establishingthe internal audit program

    obectivesresponsibilitties

    resourcesprocedure and guidance

    Monitoring & reviewingthe internal audit program

    monitoring & reviewingidentifying needs for corrective

    identifying needs for prevention actionsidentifying opportunities for improvement

    Do

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    RESOURCES FOR IQA

    Considerations should be given to the following:

    Resour c es

    Audit te c hniquesProc esses to a c hieve and m aintain thec omp eten cy of auditors and to i mp rove theirp erfor m an c eComp eten cy and availabilit y of auditor

    Available ti m e for auditing

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    The planning of IQA consists of :

    IQA PLANNING

    Establishing IQA program

    O bje ctiv es

    R esponsi bility Proc edur e and guidanc e

    Aut hority f or ad minist ering t he IQAprogra m

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    The implementation of IQA program

    consists of :

    IQA IMPLEMENTATION

    S ch eduling audit Impl em entation of audit program Audit r ecord and r eport

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    Implementation of audit program should bemonitored at appropriate intervals and reviewedto assess whether its objectives have been met and identified opportunities for improvement.

    IQA MONITORING

    Auditing findings should be reported to themanagement.

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    AUDI TING AC TIVI TIE S

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    OVERVIEW OF AUDIT ACTIVITES

    Planning and sche duling audit

    Conducting docum e nt rev i ew

    Conducting audit

    Pr ep ar e audit r ep ort

    Conducting follo w- up

    Pr e paring for on -s it e activiti es

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    Forming an audit team and assign roles andresponsibility and agreed on the scope

    Conducting document review

    Preparing for the on-site audit activities

    R eview documents ( SO Ps, audit findings ,

    corrective action/preventive action , etc.) , chec k the integrity of the quality systemand various controls are effective

    Preparing audit plan

    Assigning wor k to the audit teamPreparing wor k documents(eg. audit chec k lists , sampling plans , forms forrecording information; questionnaires)

    AUDIT ACTIVITIES

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    AUDIT DOCUMENTATION

    Audit report is an

    off ic ial doc um ent to report t h e audit f inding s

    Audit p l ansh ou l d be sent to auditee prior to audit ac tiv it y f inding s f rom t h e l ast audit s h ou l d be a l so

    m entioned Audit note s h ou l d in cl ude

    an audit questionnairea ll rec ords and c omm ents durin g t h e audit

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    EXAMPLE OF AN AUDIT

    CHECKLISTGeneral format for an audit checklist

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    IN TE NA AUDI T QUEST I NAI E S

    Area audited : ______________________ Date: __________________

    Question (Q SR- G Reference) Response

    1. Does the company have a work instruction tooperate the machine?

    2. How is the machine being cleaned andmaintained?

    . Are personnel trained to use the machine?

    .How often is the equipment being calibratedand cleaned?

    . When is the last breakdown of the machine? Are there any product being affected?

    IQA MONITORING

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    AUDITING ACTIVITIES (1)

    Conducting on -site audit activities

    Int ervi ews with diff er ent p ersonn e l Carry out both horizontal and v ertical audits .

    Focus on saf e ty and quality of product .Us e Trac e-b ack m e thod

    Conduct op enin g m ee tin g

    Good communication durin g th e audit

    St eps in conductin g on sit e audit :

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