Interna Audit

8/7/2019 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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Generating audit findingsEither conformity or non-conformity

Sort out isolated or systemic

deficienciesIsolated deficiency:

ends to ha pp en r ando m ly; no m eanin g fu lp atte r n; r a r ely ha pp ens

Syste m ic deficiency:C o u ld be connected to a p a r tic u la r pr ocess,pr od u ct, m ate r ial, p e r son o r o rg anisation; showsp atte r n; ha pp ens m o r e than once

AUDITING ACTIVITIES (2)


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ISOLATED VERSUS SYSTEMIC DEFICIENCY

N N C N RM ANCE DE ICIENCIE S

I SOL ATED SYST EMIC

Handling the product without putting gloves & masks

SOP/WI contains an error

Wrong expiration date written on areagent bottle

Batch production record is poorlywritten so instruction can be confusing

Operator spills a bulk Area management does not reinforcerequirement to continually recordinformation properly

Liquid filling machines motor burnsout

Preventive maintenance program doesnot include liquid filling machine motor


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The audit finding can be classified into 2 groups:1. ComplIQAnce :

a. Satisfactory /Adequateb. Outstanding

2. Non-complIQAnce :

a. Critical deficiencyb. Major deficiencyc. Minor deficiency

AUDIT MONITORING


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Objectives Audit scope Identification of audit team leader and

members Date and place where the on-site audit

activities were conducted Audit criteria and findings Conclusions

AUDIT REPORT


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Various formats can be used depending on auditee(vendors, management or auditee)Usually include name and location of auditee, date

of audit, audit plan, audit observations,classification of non-compliances, recommendationsor expectationsShould write against a standardFocus on deficient conditions and not peopleInclude any positive observationsKeep the audit report simple and clear

AUDIT REPORT


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No STD.Ref indings of IQA Grading Location Auditee Auditor

1. .2. Available records

are not in line withstandard SOP

Minor Human

Resources

SB AKT

2. 7. . Monitoring of temperature in awarehouse

Minor Warehouse ST AKT

.2.2 Process runningwith out anysupervisor

Major Production GKP AKT

AUDIT REPORT: AN EXAMPLE


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CLOSUREFollow-up and closing of loop:

Receive a satisfactory response from auditee and

their commitment to correct for any deficiency,record the same on the CAR format.

Ensures CAPA identify the root cause and they aresatisfactory, accomplished and documented

Timeframe for CAPA is being followed Verify and track CAPA by scheduling a follow-upaudit and/or requesting for an updated SOP


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Initiator : _______________________ Dept. __________________Issued to :____________________ Dept. __________________

Date : _______________ CAR No .: _______________

R eason for CAR/PAR:Customer Complaints (__________________)Process Non Conformance (______________)

Internal Audit (____________________)External Audit (____________________)

Final Release QA (_______________)Other Specify (_________________)

Nature of NC:

Major Minor ObservationDetails of Non C onformities /P otential Non C onformities *

___________________________________________________________________________

Initiator : _____________________________________ Date : _________________________

For Q A Dept.

Investigation required : Yes No Reason : ___________________________________________________ Comment (If any ) : ___________________________________________________________________________________________

M anagement R epresentative : _____________ Date : _________ Q A M anager : __________ Date : _____________

C ause of P roblem : * ___________________________________________________________________________

R oot C ause of P roblem : * ___________________________________________________________________________

C orrection Taken :T o eliminate the non conformities:

_______________________________________________ _______________________________________________ _______________________________________________

C orrective /P reventive A ction Taken :T o eliminate the cause of non conformities/potential non conformities inorder to prevent their occurrence:

___________________________________________

___________________________________________ P erson R esponsible : __________________ Date : ___________ Section Owner : _____________ Date : __________

Verification for C lose out :Yes : Reason __________________________________________________________________________________

No : Reason __________________________________________________________________________________ Further Corrective Action Required : CAR No. or other References _______________________________

____

No Possible Corrective Action Taken : Reason __________________________________________________________ Q A M anager _________________ Date : ____________

CORRECT IVE / RE VENT IVE CT ION REQUEST


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CONCLUSIONS

Nobody li to be d ited..

It i eans to ave on tinuous i r ovemen t

Documents

Interna Audit