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The Quality
[Training for Quality
Course Syllabus and Agenda

The Background and Basics

Auditor Conduct and Necessary Skills

Audit Preparation and Planning

Performing the Audit

Audit Report and Followup

The Background and

A quality audit is a systematic, independent and
documented process of examining any activity of an
organization based on objective evidence, to determine
a. The extent to hich quality activities and related results
comply ith the planned arrangements
b. The extent to hich these arrangements have been
implemented effectively, and
c. hether these arrangements are suitable to achieve the
quality objectives.
!hat is an Audit"

An independent and systematic examination to

establish hether quality activities and related
results comply ith planned arrangements. A
quality 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#

#ompliance audit:
The process of chec!ing hether the organization has
implemented hat they have stated and hether the
people are doing, the documents had as!ed them to do.
!hat is an Audit" Continued#

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

#arried out by people of the organization or on behalf of
the 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 by
organization on the suppliers to examine the quality of

Third party audit or independent agency audit or external

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

"nternal audit:
"nternal audit acts as the organizations eyes and ears to
gather feedbac! for correction and improvement.
The purpose of internal audit is
to identify possible product2process improvements.
to identify deficiencies in products or in the plant2quality
management system.
$nternal Audit

3ormally an audit should have positive approach ith

the objective of 4finding facts rather than faults5.

*oever in case of internal audit by the organization

here the primary goal is 4correction and improvement5
the more faults found the more the corrections and
greater the compliance.

These audits must be conducted regularly in

accordance ith the audit plan.

3ormally audits must be carried out as per plan and

schedules prepared each time for the audit.
$nternal Audit Continued#
Conduct and Necessary

$irst, the auditor must have a certain amount of

exposure to c.)/s.

&econd, the auditor must have some understanding of

the manufacturing, 6A, and 6# environments and

Third, the candidate must ant to become a c.)/

auditor, A 4Draftee5 generally does not perform too ell.
A %ood Auditor should ha&e''

.ood oral and ritten communication s!ills

$act finding






/olite and /rofessional

Traits of a %ood %(P Auditor
A VERY Important Trait
Common Sense !
Undesirable Traits of a %(P Auditor

/oor #ommunications s!ills








Dress in business clothing, appropriate to the climate

and 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 good

manners cost nothing and ill promote an open, honest

7e professional 9 you represent your department and


Do not be rude or too aggressive 9 the auditee, in a

defensive move, ill disengage from the audit and
verbally shut don.
Auditors Beha&ior

:isten to the ansers and sho interest. #larify here


7e open and non%judgmental until you have all the facts

you need. Then you may provide a balanced decision or

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 to

complete the audit and provide a balanced c.)/

.ive praise here it is due and recognize good or!.

)aintain a sense of self esteem and reard competence
and expertise hen2here appropriate.
Auditors Beha&ior Continued#

<eep an accurate record of events, findings, and facts.

Ta!e the time necessary to ta!e good notes.

=nsure audit objectives are maintained. 9 <eep one

eye on the cloc!, and the other on your agenda.

+espect #onfidentiality.
;ou ill be in possession of sensitive or confidential
information : do not discuss it outside of the audit>.
Auditors Responsibilities

Don?t lose your temper

7e confident of your facts by using standards to bac! you up.

<no your standards, and be illing to refer to them.

Do not argue at any time.

Auditees may argue, but auditors discuss.

&mile, brea! up the atmosphere, relax the auditee.

"t?s -< to have a sense of humor @ actually, it ill build bridges

beteen you and the auditees.

Time asting, unrelated side conversations long lunch times,

frequent brea! requests.

"dentify these diversions and politely address them. 9 This can be

a little difficult. Don?t ma!e it seem li!e an insult.

=vasive or indirect ansers.

)ifficult situations may arise

Pay attention to body language both theirs and yours.

&uperiority, hostility, contempt, concern, anger, boredom,

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

Sometimes it may be necessary to clarify the response you


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.


Be aare of cultural differences.

+especting these differences builds bridges beteen people.

L!S"#$ 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.

Preparation and Planning

Audit /lanning

#ommunicate the Audit /lan

&election of Auditors

/reparing for Audit

/re%audit "nformation
Planning and Preparation
Audit /lan
The audit plan is a formal document, hich covers every
area, process and department for the audit activity.
"t specifies :

The area, process or department to be audited.

The frequency of the audit, preferably the month in

hich the area, process or department ill be audited.

Audit Planning
The audit schedule is a document that gives details of
the area, process and department to be audited during
the scheduled audit. "t also specifies dates of audit,
names of auditor and corresponding auditee area,
process or department.
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 and
their readiness and concurrence should be determined
before proceeding on an audit.
Audit Planning Continued#
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 destroy
your carefully crafted schedule.

$acility 2 area upgrade 2 shutdons ill impact your schedule 9

previe upcoming maintenance plans and or! around them.
Audit Planning Continued#

=nsure that the schedule is communicated to all site

personnel, especially those hose areas ill be audited.

#learly list the areas 2 systems 2 products to be audited

and 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

7ased on educational qualification, industrial experience,

in%house 2 outside trainings and technical !noledge of the

/eople ithin the organization ho have been trained to

conduct audits. This training can be done by the
organization it self if expertise exists ithin and there can
be 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!e
them biased0.

Auditors must treat audit as a fact finding exercise and so

should do a professional job.
Selection of Auditors

/repare and send detailed agenda, objective and scope

of the audit.

<no your standards.

=nsure that auditee is ell aare of the standards you

ill be using during the audit.

/repare a detailed chec!list.

%#hec!listAs are methodical ay of ensuring that all
necessary areas are audited and right question as!ed. A
chec!list is therefore useful tool.
%*oever the auditors should adopt a flexible approach and
use their on judgment to deviate, if necessary.
Preparing for Audit

Activities performed by auditee

&ite master file

6uality )anual

+evie the layouts

(nderstand the men material flo

Preaudit $nformation
Need Brea!
Performing the Quality


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

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 of

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

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

the sides.

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


(se brief presentation to brief yourself 'recommended for outside

The +pening (eeting
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.


<eep all senses open

&mell, &ight, *earing, Touch, Taste

&tay close to agreed plan of the tour

Try not to get distracted and lose time.

7e illing to stop and focus on an area of non%compliance

<eep a record of documents requested during tour.

:et your host !no that you are !eeping a record of all requests.

.o bac! into the .)/ areas again toards the end of

the audit. *ave things changedB Are things being done
The Site , Area Tour Continued#
The Site , Area Tour Continued#

Are supervisors 4supervisingB5

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


#leanliness of the areas, equipments and materials


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

Beginning the -Conference Room. Audit

Don?t concern about number of people in the room

9 but, limit attendance to only those people

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! and

restart. 7rea! the monotony>>
Conference Room Audit

;ou can open conference room audit in one of the

folloing 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 you

analyzed 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.


.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 again
to the surface.
Auditing Techni/ues
*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 specific


#an be time consuming.

;ou need to !no hen to stop.

$ocuses deeper and deeper into a specific area,

product, or problem.
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.
Auditing Techni/ues Continued#

"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 cause

Auditing Techni/ues Continued#

+andom sampling 9 good hen limited time, gives a

4feel5 and flexibility 'good notes are needed for later

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

related documentation.

+ecord all of the details as accurately as possible,

including :





,hy 'if any issue0

Auditing Techni/ues Continued#

-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 the
auditee understood the questions.

#reates a dialog beteen the auditor and the auditee.

The auditee begins to understand hat it is you ill be as!ing

for, and becomes better prepared to provide it C a great time
saving device.

.enerally, one open ended question ill lead to another

through the dialog process.
*uestioning Techni/ues

#losed questions :

Are products manufactured using batch recordsB

Are the operators responsible for entering process data into the

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 fully
understood '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 benefits
of the audit.

+equires that the auditor follo up ith a second or third


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

*uestioning Techni/ues Continued#

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 during
the 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
*uestioning Techni/ues Continued#
#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 evidence5


+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.
*uestioning Techni/ues Continued#

+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 D minor0 9 more

of the same issues tomorro may ma!e the observation more

Discuss observations found during the day. .ive the site a

chance to correct them or to provide more evidence to support
their defense.

Daily meetings promote understanding and prevent surprises at

the final rap%up.

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

The daily rap%up provides clarity and !eeps the auditee

engaged in the process.
The )aily !rapup 0For multiple day audits1
Critical, -a.or, -inor,
/atient ris!, or no !ey system in place 'e.g. no deviation system0, or
a condition hich may ma!e the product unfit for use, or a
condition hich may be cited by regulatory authorities as critical
folloing an inspection, or here previous major audit findings
had not been suitably addressed by the site.
A critical issue could require further operations to stop until corrective
actions have been implemented.
Classification of Audit +bser&ations
-'01/ (
&ignificant problem in plant or systems hich lead to non life
threatening conditions, or system not functioning properly ith
several similar observations noted. These problems ill most li!ely
result in a citation by regulatory authorities.
/revious minor audit findings can be considered as major if they have
not been suitably addressed by the site.
-!$1/ (
"solated problems that if not corrected, ould not cause harm to the
patient or product, but indicate minor breaches to .)/. "f significant
numbers of remar!s are made in one system area, it could be
indicative of the start of brea!don in a system and therefore
classified as )ajor.
Classification of Audit +bser&ations Continued#

Than! the auditees for their help and time.

:ist the good things that you sa or found during the


/resent the #riticality of the observations highest first.

$ocus on the #ritical and )ajor findings. Add minors if
there are not too many findings in total.

/resent findings based on facts, and bac! the findings up

ith information contained in the standards, if questioned.

+espond to questions openly at end of the audit.

7e prepared to change your ordings or even

observations based upon facts presented by auditee's0.
The Close+ut (eeting
Audit Report and Followup

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 of
strength '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

#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 cover
e%mail to the auditee.

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

/rovide the easiest and most convenient reporting format, such as

,ord2=xcel table.

"f you require hard copy documentation to prove observation close

out, arrange for its proper transfer to your office.

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

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

=levate non%response to observations to the next management

After the Audit
Performing the audit is the easiest part of the audit
process' Successfully completing a timely and
thorough 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