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(1)

The Quality

The Quality

Auditing

Auditing

[T

[T

raini

raini

ng f

ng f

or Qu

or Qu

ality

ality

Auditors]

(2)
(3)

Course Syllabus

Course Syllabus

and Agend

and Agend

a

a

The Background and Basics

The Background and Basics

 Auditor Conduct and Ne

 Auditor Conduct and Ne

cessary Skills

cessary Skills

 Audit Preparation and Pl

 Audit Preparation and Pl

anning 

anning 

Performing the

Performing the

Audit 

Audit 

(4)
(5)

Course Syllabus

Course Syllabus

and Agend

and Agend

a

a

The Background and Basics

The Background and Basics

 Auditor Conduct and Ne

 Auditor Conduct and Ne

cessary Skills

cessary Skills

 Audit Preparation and Pl

 Audit Preparation and Pl

anning 

anning 

Performing the

Performing the

Audit 

Audit 

(6)
(7)

AUDITING

AUDITING

The Background and

The Background and

Basics

(8)
(9)

Definition:

Definition:

A

A

quality

quality

audit

audit

is

is

a

a

systematic

systematic

,

,

independent

independent

and

and

documented process of examining any activity of an

documented process of examining any activity of an

organization based on objective evidence, to determine

organization based on objective evidence, to determine

a.

a.

The

The

extent

extent

to

to

hich

hich

quality

quality

activities

activities

and

and

related

related

results

results

comply ith the planned arrangements

comply ith the planned arrangements

b.

b.

The

The

extent

extent

to

to

hich

hich

these

these

arrangements

arrangements

have

have

been

been

implement

implement

ed effectively, and

ed effectively, and

c.

c.

hether

hether

these

these

arrangem

arrangem

ents

ents

are

are

suitable

suitable

to

to

achieve

achieve

the

the

quality objectives.

quality objectives.

!hat is an Audit" 

(10)
(11)

 An independent a

 An independent a

nd systematic examination

nd systematic examination

to

to

establish hether quality activities and related

establish hether quality activities and related

results comply

results comply

ith planned

ith planned

arrangements. A

arrangements. A

quality audit needs to loo!

quality audit needs to loo!

at effective

at effective

implementation of quality arrangements and

implementation of quality arrangements and

hether they are suitable for the achievement of

hether they are suitable for the achievement of

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

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

toard a quality standard.

toard a quality standard.

!hat is

(12)
(13)

#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.

(14)
(15)

$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 on 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

suppliers.

Third party audit or independent agency audit or external

audit:

#arried out by an external independent agency to assess

compliance usually for the purpose of certification. '$or

example: (&$DA,)*+A,*- )/ "&- etc.0

(16)
(17)

"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 plant2quality

management system.

(18)
(19)

3ormally an audit should have positive approach ith

the objective of 4finding facts rather than faults5.

*oever 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.

(20)
(21)

AUDITOR

Conduct and Necessary

Skills

(22)
(23)

$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

requirements.

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

auditor, A 4Draftee5 generally does not perform too ell.

(24)
(25)

ood oral and ritten communication s!ills

$act finding

(nbiased

*onest

Tactful

 Attentive

/atient

/olite and /rofessional

(26)
(27)

 A VERY Important Trait 

(28)
(29)

Undesirable Traits of a %(P Auditor 

/oor #ommunications s!ills

 Arrogant

3egligent

7iased

8ague

7laming

"mpatient

"mpolite

(30)
(31)

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

environment.

7e professional 9 you represent your department and

#ompany.

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

defensive move, ill disengage from the audit and

(32)
(33)

isten to the ansers and sho interest. #larify here

needed.

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

you need. Then you may provide a balanced decision or

opinion.

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

poor judgment % ma!e alloance for the 4fear factor5.

)aintain focus on your goals and agenda. ;our duty is to

complete 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 reard competence

and expertise hen2here appropriate.

(34)
(35)

<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>.

(36)
(37)

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 beteen 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.

(38)
(39)

 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

receive.

− 7e illing to re%phrase a question.

−  As! the auditee to expand upon their anser. − +epeat the question hen necessary.

 Language barriers can require even greater tolerance.

− 7e aare of potential misunderstandings, and be patient.

 Be clear in your message.

− &trive for clarity and simplicity ith every question.

(40)
(41)

Communications

 Be aare of cultural differences.

− +especting these differences builds bridges beteen people.

 LS"#$ to hat the auditee is saying !!!!

− Don?t formulate your next question hile listening to an anser.

 %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.

(42)
(43)

QUALITY AUDIT

(44)
(45)

 Audit /lanning

#ommunicate the Audit /lan

&election of Auditors

/reparing for Audit

/re%audit "nformation

(46)
(47)

 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.

(48)
(49)

&chedule:

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.

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.

*oever convenience of the auditee is essential and

their readiness and concurrence should be determined

before proceeding on an audit.

(50)
(51)

 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, otherise emergencies ill destroy your carefully crafted schedule.

 $acility 2 area upgrade 2 shutdons ill impact your schedule 9

previe upcoming maintenance plans and or! around them.

(52)
(53)

=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.

(54)
(55)

7ased on educational qualification, industrial experience,

in%house 2 outside trainings and technical !noledge of the

individual.

/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 on area. 'because that ould ma!e

them biased0.

 Auditors must treat audit as a fact finding exercise and so

should do a professional job.

(56)
(57)

/repare and send detailed agenda, objective and scope

of the audit.

<no your standards.

=nsure that auditee is ell aare of the standards you

ill be using during the audit.

/repare a detailed chec!list.

%

#hec!lists are methodical ay of ensuring that all

necessary areas are audited and right question as!ed. A

chec!list is therefore useful tool.

%

*oever the auditors should adopt a flexible approach and

use their on judgment to deviate, if necessary.

(58)
(59)

 Activities performed by auditee

&ite master file

6uality )anual

+evie the layouts

(nderstand the men material flo

(60)
(61)
(62)
(63)

Performing the Quality

 Audit 

(64)
(65)

#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.

(66)
(67)

 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 auditees

 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

information.

(68)
(69)

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 gon.

 Alays vie the or!ers goning 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 ansers.

(70)
(71)

<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 toards the end of

the audit. *ave things changedB Are things being done

differentlyB

(72)
(73)

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 goning 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

(74)
(75)

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! and

(76)
(77)

Conference Room Audit 

;ou can open conference room audit in one of the

folloing 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

(78)
(79)

eneral Techniques

*orizontal 9 just s!imming the surface>

8ertical 9 in depth, be sure on ho far

do you digB

#ombination of the to, stepise

digging here necessary to return again

to the surface.

(80)
(81)

*orizontal Auditing

$ollos 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

issues.

#an be time consuming.

;ou need to !no hen to stop.

(82)
(83)

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.

(84)
(85)

"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, reor!s, etc.

7egin ith a !non problem and trace it bac! to its origin.

enerally a focused approach leading to root cause

analysis.

(86)
(87)

+andom sampling 9 good hen limited time, gives a

4feel5 and flexibility 'good notes are needed for later

description0.

7ut regardless of hich audit you do, alays revie the

related documentation.

+ecord all of the details as accurately as possible,

including :

hat

here

hen

ho

(88)
(89)

 -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 ansers to your open ended questions ill tell you if the auditee understood the questions.

− #reates a dialog beteen 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.

(90)
(91)

 #losed questions :

−  Are products manufactured using batch recordsB

−  Are the operators responsible for entering process data into the recordB

−  Are the operators also responsible for recognizing and recording deviationsB

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

− The anser does not allo you to judge if the question as fully understood 'or miss understood0 by the auditee.

− Does not promote a dialog beteen 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 question.

(92)
(93)

  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

(94)
(95)

#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

request.

− +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.

(96)
(97)

 +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 more of the same issues tomorro may ma!e the observation more severe.

− 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.

(98)
(99)

Critical, -aor, -inor,

C/"C'L

/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 folloing 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.

(100)
(101)

-'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!don in a system and therefore

(102)
(103)

Than! the auditees for their help and time.

ist the good things that you sa or found during the

audit.

/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.

(104)
(105)
(106)
(107)

 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.

(108)
(109)

 #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.

(110)
(111)

Remember22 

Performing the audit is the easiest part of the audit

 process' Successfully completing a timely and

thorough audit obser&ation followup 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 

(112)

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