Internal Quality Audit - Training for Auditors

8/12/2019 Internal Quality Audit - Training for Auditors

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The QualityAuditing

[Training for QualityAuditors]


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Course Syllabus and Agenda

The Background and Basics

Auditor Conduct and Necessary Skills

Audit Preparation and Planning

Performing the Audit

Audit Report and Followup


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AUDITING

The Background andBasics


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Definition:

A quality audit is a systematic, independent anddocumented process of examining any activity of an

organization based on objective evidence, to determine

a. The extent to hich quality activities and related resultscomply ith the planned arrangements

b. The extent to hich these arrangements have beenimplemented effectively, and

c. hether these arrangements are suitable to achieve thequality objectives.

!hat is an Audit"


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An independent and systematic examination to

establish hether quality activities and related

results comply ith planned arrangements. Aquality audit needs to loo! at effective

implementation of quality arrangements and

hether they are suitable for the achievement of

objectives. "t is an integral part of or!ing

toard a quality standard.

!hat is an Audit" Continued#


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#ompliance audit:

The process of chec!ing hether the organization hasimplemented hat they have stated and hether the

people are doing, the documents had as!ed them to do.

!hat is an Audit" Continued#


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$irst party audit or self%audit or internal audit:

#arried out by people of the organization or on behalf ofthe organization itself to examine its on quality system.

&econd party audit or audit by customer or external audit:#arried out by the customer on the organization or byorganization on the suppliers to examine the quality ofsuppliers.

Third party audit or independent agency audit or external

audit:

#arried out by an external independent agency to assesscompliance usually for the purpose of certification. '$orexample: (&$DA,)*+A,*- )/,"&- etc.0

Types of Audits


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"nternal audit:

"nternal audit acts as the organizations eyes and ears to

gather feedbac! for correction and improvement.

The purpose of internal audit is

1 to identify possible product2process improvements.

1 to identify deficiencies in products or in the plant2qualitymanagement system.

$nternal Audit


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3ormally an audit should have positive approach iththe objective of 4finding facts rather than faults5.

*oever in case of internal audit by the organization

here the primary goal is 4correction and improvement5the more faults found the more the corrections andgreater the compliance.

These audits must be conducted regularly inaccordance ith the audit plan.

3ormally audits must be carried out as per plan andschedules prepared each time for the audit.

$nternal Audit Continued#


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AUDITOR

Conduct and NecessarySkills


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$irst, the auditor must have a certain amount ofexposure to c)/s.

&econd, the auditor must have some understanding ofthe manufacturing, 6A, and 6# environments andrequirements.

Third, the candidate must ant to become a c)/auditor, A 4Draftee5 generally does not perform too ell.

A %ood Auditor should ha&e''


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ood oral and ritten communication s!ills

$act finding

(nbiased

*onest

Tactful

Attentive /atient

/olite and /rofessional

Traits of a %ood %(P Auditor


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A VERY Important Trait

Common Sense !


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UndesirableTraits of a %(P Auditor

/oor #ommunications s!ills

Arrogant

3egligent

7iased

8ague

7laming

"mpatient

"mpolite


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Dress in business clothing, appropriate to the climateand the business principles of your auditee.

7e punctual. The auditee is also a very busy person,and his2her time is equally as valuable as yours.

7e courteous, considerate and respectful 9 goodmanners cost nothing and ill promote an open, honestenvironment.

7e professional 9 you represent your department and

#ompany.

Do not be rude or too aggressive 9 the auditee, in adefensive move, ill disengage from the audit andverbally shut don.

Auditors Beha&ior


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isten to the ansers and sho interest. #larify hereneeded.

7e open and non%judgmental until you have all the factsyou need. Then you may provide a balanced decision or

opinion. 3ervous people ma!e errors, miss%statements, or exercise

poor judgment % ma!e alloance for the 4fear factor5.

)aintain focus on your goals and agenda. ;our duty is tocomplete the audit and provide a balanced c)/assessment.

ive praise here it is due and recognize good or!.)aintain a sense of self esteem and reard competenceand expertise hen2here appropriate.

Auditors Beha&ior Continued#


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Don?t lose your temper 7e confident of your facts by using standards to bac! you up.


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Pay attention to body language both theirs and yours. &uperiority, hostility, contempt, concern, anger, boredom,

fatigue, confusion, apathy, fear and nervousness, can all bevisually communicated ithout ords. 7ut, be careful>>>

Sometimes it may be necessary to clarify the response youreceive. 7e illing to re%phrase a question. As! the auditee to expand upon their anser. +epeat the question hen necessary.

Language barriers can require even greater tolerance. 7e aare of potential misunderstandings, and be patient.

Be clear in your message. &trive for clarity and simplicity ith every question.

Communications


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Communications

Be aare of cultural differences.

+especting these differences builds bridges beteen people.

LS"#$ to hat the auditee is saying !!!!

Don?t formulate your next question hile listening to an anser. %ocus on one topic& one conversation& at a time.

'void distractions& hich can include (

Thin!ing ahead to the next question.

istening to side conversations. 8erbal overload from the auditee may dilute the true response.

)ou have * ears and + mouth use them in that ratio.


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QUALITY AUDIT

Preparation and Planning


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Audit /lanning

#ommunicate the Audit /lan &election of Auditors

/reparing for Audit

/re%audit "nformation

Planning and Preparation


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&chedule:

The audit schedule is a document that gives details ofthe area, process and department to be audited duringthe scheduled audit. "t also specifies dates of audit,

names of auditor and corresponding auditee area,process or department.

Timing:

The best time to audit is hen people are at their busiest

and tempted to ta!e short cuts or ma!e mista!es.*oever convenience of the auditee is essential andtheir readiness and concurrence should be determinedbefore proceeding on an audit.

Audit Planning Continued#


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Audit $requency

7ased on criticality of area 2 process to be audited.

7ased on quality history of the area to be audited.

eneral self inspection program at defined frequency.

#an be influenced by upcoming regulatory events 'e.g., audits,complaints2recall, follo%up, compliance etc.0

Do not agree to frequent requests for postponements or cancellations.

=mergency audits probably be added to your schedule at short notice.Do not over schedule yourself, otherise emergencies ill destroyyour carefully crafted schedule.

$acility 2 area upgrade 2 shutdons ill impact your schedule 9previe upcoming maintenance plans and or! around them.

Audit Planning Continued#


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=nsure that the schedule is communicated to all sitepersonnel, especially those hose areas ill be audited.

#learly list the areas 2 systems 2 products to be auditedand list specific dates for each of the audits.

+ealistically establish and agree each audit?s duration.

Adhere to the schedule 9 don?t ris! loosing credibility by

postponing audits.

Communicate the Audit Plan


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7ased on educational qualification, industrial experience,in%house 2 outside trainings and technical !noledge of theindividual.

/eople ithin the organization ho have been trained to

conduct audits. This training can be done by theorganization it self if expertise exists ithin and there canbe one auditor per department.

"mportant precaution to be ta!en is to ensure that people

do not audit their on area. 'because that ould ma!ethem biased0.

Auditors must treat audit as a fact finding exercise and soshould do a professional job.

Selection of Auditors


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/repare and send detailed agenda, objective and scopeof the audit.


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Activities performed by auditee

&ite master file 6uality )anual

+evie the layouts

(nderstand the men material flo

Preaudit $nformation


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Need Brea!


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Performing the QualityAudit


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#ontents

The opening )eeting

The site 2 Area tour

7eginning the #onference +oom audit

Auditing Techniques

6uestioning Techniques

The Daily rap up

#lassification of Audit -bservations

The close%out meeting.

Performing The *uality Audit


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This is your first point of face%to%face contact ith auditee.

3eedless to say, 7e on time.

=xchange business cards 'recommended for outside audits0

=ach side introduces the attendees

% =ach auditor introduces him2her self.

%=nsure that you clearly understand roles and responsibilities ofauditees

Try to remember names for use during the audit 9 /eople li!e tohave their names remembered.

+e%confirm the agenda. )odifications 2 changes if agreed by boththe sides.

&ite 2 departmental presentation. )a!e note of importantinformation.

(se brief presentation to brief yourself 'recommended for outsideaudits0

The +pening (eeting


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The Site , Area Tour

A very critical part of audit.

+espect dress codes of the areas to be visited.

As! for help 2 clarification for your gon.

Alays vie the or!ers goning area. Do not be afraid to as! to visit controlled areas.

Allo one auditor to spea! at a time.

Tal! to or!ers during site tour.

=nsure that you understand the ansers.

"f not as! the same question again.

As! for clarification if required.


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The Site , Area Tour Continued#

Are supervisors 4supervisingB5

#hec! the condition of the building's0 9 are surfaces

appropriateB #leanliness of the areas, equipments and materials

transported. Are goning regimes appropriate and honoredB

Are doors shut hen not in useB

Are pressure differentials monitored and compliantB

Are rooms, products and containers clearly labeledB Are &-/s available for operatorB

"s appropriate pest control in placeB

Are logboo!s maintainedB


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Beginning the -Conference Room. Audit

Don?t concern about number of people in the room

9 but, limit attendance to only those people

necessary.

Try to relax yourself and everyone else.

&et a good, efficient or! pace.

Allo reasonable brea!s.

&tand up from time to time, stretch, get a drin! andrestart. 7rea! the monotony>>


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Conference Room Audit

;ou can open conference room audit in one of thefolloing ay:

The first item on your agenda.

;our list of documents requested during tour. The c)/ violations seen during tour.

7y as!ing questions relating to the documents youanalyzed before the audit began.

/roduction 2 process record revie. '7atch record,supporting &-/s, /ersonnel training etc.0

-r just start at the beginning of the process flo.


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eneral Techniques

*orizontal 9 just s!imming the surface>

8ertical 9 in depth, be sure on ho far

do you digB

#ombination of the to, stepise

digging here necessary to return againto the surface.

Auditing Techni/ues


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*orizontal Auditing $ollos a process from goods receipt through to finished

product release and distribution.

A good ay to get a 4feel5 of the site and its problems.

Auditing Techni/ues Continued#

8ertical auditing

ood to help identify the severity of a specificissues.

#an be time consuming.

;ou need to !no hen to stop.

$ocuses deeper and deeper into a specific area,product, or problem.


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The "deal #ombination

"deally a c)/ audit should include mostly horizontal

auditing ith occasional vertical auditing hen possible

issues are noted or something does not 4feel5 right.



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"he Beginning to #nd technique ( &tart at the beginning of the process, and follo the

or!2process through to the very end.

/rovides the auditor ith a progressive, detailed vie of

the process and requirements. 7atch records simplify this approach.

)ost common approach to process auditing.

"he #nd to Beginning technique (

ood for assessing complaints, lab failures, reor!s, etc. 7egin ith a !non problem and trace it bac! to its origin.

enerally a focused approach leading to root causeanalysis.



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+andom sampling 9 good hen limited time, gives a4feel5 and flexibility 'good notes are needed for laterdescription0.

7ut regardless of hich audit you do, alays revie the

related documentation.

+ecord all of the details as accurately as possible,including : hat

here hen ho hy 'if any issue0



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-pen questions :

*o do you perform this processB

#an you describe site?s )/ training programB

hat is your program for *=/A filter certificationB

-pen questions require a factual, detailed response by the auditee.

The ansers to your open ended questions ill tell you if theauditee understood the questions.

#reates a dialog beteen the auditor and the auditee.

The auditee begins to understand hat it is you ill be as!ingfor, and becomes better prepared to provide it C a great timesaving device.

enerally, one open ended question ill lead to anotherthrough the dialog process.

*uestioning Techni/ues


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#losed questions : Are products manufactured using batch recordsB

Are the operators responsible for entering process data into therecordB

Are the operators also responsible for recognizing and

recording deviationsB

#losed questions require a simple 4yes5 or 4no5 from the auditee.

The anser does not allo you to judge if the question as fullyunderstood 'or miss understood0 by the auditee.

Does not promote a dialog beteen the auditor and the auditee.;ou must engage the auditee in order to realize the full benefitsof the audit.

+equires that the auditor follo up ith a second or thirdquestion.

$orces the auditor to do all of the or!.

*uestioning Techni/ues Continued#


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As! a combination of open and closed questions :

6 :Do you have a system for recording and addressing deviationsB

A :yes, e do.

6 :=xcellent. ould you please describe ho the system or!sB

6 :ho is responsible for registering deviations that occur duringthe manufacturing processesB

A :The operators are responsible for recording any deviations.

6 :"s that both production and pac!aging operatorsB

A :;es.6 :#ould please tell me ho you train your manufacturing

operators to recognize a deviationB



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#larification and #onfirmation

"f your question as not understood, you can +epeat the question. +e%phrase the question for clarity.

(se an example to further clarify the question. Dra a diagram 'don?t laugh > This really or!s>0. As! yourself, 4"s it time for a brea!5B

$ollo up selected questions ith a 4sho me the evidence5request.

+equest documentation for critical points. +equest documentation if you thin! that you may not be receiving

correct information. +equest documentation periodically throughout the audit, for both

4small5 and 4large5 points.



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+equire 2 +equest a daily rap%up meeting

"nclude the audit escorts and day?s participants at a minimum.

Do not categorize the issues 'as #ritical, )ajor minor0 9 moreof the same issues tomorro may ma!e the observation moresevere.

Discuss observations found during the day. ive the site achance to correct them or to provide more evidence to supporttheir defense.

Daily meetings promote understanding and prevent surprises atthe final rap%up.

#larify any follo%ups for tomorro and tomorro?s agenda.

The daily rap%up provides clarity and !eeps the auditeeengaged in the process.

The )aily !rapup 0For multiple day audits1


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Critical, -aor, -inor,

C/"C'L

/atient ris!, or no !ey system in place 'e.g. no deviation system0, ora condition hich may ma!e the product unfit for use, or acondition hich may be cited by regulatory authorities as criticalfolloing an inspection, or here previous major audit findingshad not been suitably addressed by the site.

A critical issue could require further operations to stop until correctiveactions have been implemented.

Classification of Audit +bser&ations


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-'01/ (

&ignificant problem in plant or systems hich lead to non lifethreatening conditions, or system not functioning properly ithseveral similar observations noted. These problems ill most li!elyresult in a citation by regulatory authorities.

/revious minor audit findings can be considered as major if they havenot been suitably addressed by the site.

-$1/ (

"solated problems that if not corrected, ould not cause harm to thepatient or product, but indicate minor breaches to )/. "f significantnumbers of remar!s are made in one system area, it could beindicative of the start of brea!don in a system and thereforeclassified as )ajor.

Classification of Audit +bser&ations Continued#


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Than! the auditees for their help and time.

ist the good things that you sa or found during theaudit.

/resent the #riticality of the observations highest first.$ocus on the #ritical and )ajor findings. Add minors ifthere are not too many findings in total.

/resent findings based on facts, and bac! the findings upith information contained in the standards, if questioned.

+espond to questions openly at end of the audit.

7e prepared to change your ordings or evenobservations based upon facts presented by auditee's0.

The Close+ut (eeting


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Audit Report and Followup


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2hy do e rite an audit report, As a record of site2departmental deficiencies. To provide the &ite )anagement Team ith an independent

report of deficiencies identified. To create the formal environment necessary for an active,

periodic follo up.

3o do e rite an audit report, "nclude positive points as ell as deficiencies identified. )anagement must have a balanced overvie of conditions

ithin the plant@ therefore, provide them information on areas ofstrength 'best practices0 and areas requiring improvement.

2hen do you rite an 'udit /eport, As soon as you possibly can after conclusion of the audit. 7efore you begin your next audit. 7efore you forget here you ere and hat you observed.

Reporting Audits


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#omplete the audit report.

#ommit to a time of delivery, and stic! to it.

#ompile the observations and add to the end of the report.

&end the audit report and observations ith a cover letter or a covere%mail to the auditee.

=nsure that you include firm instructions for reporting corrective andpreventive actions bac! to you.

/rovide the easiest and most convenient reporting format, such asord2=xcel table.

"f you require hard copy documentation to prove observation closeout, arrange for its proper transfer to your office.

=nsure that you have self notification process that can tell you hensomeone is overdue for reporting corrective actions.

$ollo%up ith late responses on a personal basis.

=levate non%response to observations to the next managementlevel.

After the Audit


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Remember22

Performing the audit is the easiest part of the audit

process' Successfully completing a timely andthorough audit obser&ation followup is the most

difficult and time consuming facet of the audit'

3nsure through your persistence4 tenacity4 a sense

of efficient organi5ation4 that you follow each

obser&ation through to its final4 c%(P compliant

conclusion' Ne&er gi&e up2


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THANK YOU

Documents

Internal Quality Audit - Training for Auditors