The Quality
The Quality
Auditing
Auditing
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or Qu
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Auditors]
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
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
AUDITING
AUDITING
The Background and
The Background and
Basics
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"
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
toard a quality standard.
toard a quality standard.
!hat is
#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.
$irst party audit or self%audit or internal audit:
#arried out by people of the organization or on behalf of
the organization itself to examine its on quality system.
&econd party audit or audit by customer or external audit:
#arried out by the customer on the organization or by
organization on the suppliers to examine the quality of
suppliers.
Third party audit or independent agency audit or external
audit:
#arried out by an external independent agency to assess
compliance usually for the purpose of certification. '$or
example: (&$DA,)*+A,*- )/ "&- etc.0
"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.
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.
AUDITOR
Conduct and Necessary
Skills
$irst, the auditor must have a certain amount of
exposure to c)/s.
&econd, the auditor must have some understanding of
the manufacturing, 6A, and 6# environments and
requirements.
Third, the candidate must ant to become a c)/
auditor, A 4Draftee5 generally does not perform too ell.
−
ood oral and ritten communication s!ills
−$act finding
−(nbiased
−*onest
−Tactful
−Attentive
−/atient
−
/olite and /rofessional
A VERY Important Trait
Undesirable Traits of a %(P Auditor
/oor #ommunications s!ills
Arrogant
3egligent
7iased
8ague
7laming
"mpatient
"mpolite
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
isten to the ansers 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 alloance 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 reard competence
and expertise hen2here appropriate.
<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>.
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.
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 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
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.
QUALITY AUDIT
Audit /lanning
#ommunicate the Audit /lan
&election of Auditors
/reparing for Audit
/re%audit "nformation
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.
&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.
*oever convenience of the auditee is essential and
their readiness and concurrence should be determined
before proceeding on an audit.
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.
=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.
7ased on educational qualification, industrial experience,
in%house 2 outside trainings and technical !noledge 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 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.
/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!lists 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.
Activities performed by auditee
&ite master file
6uality )anual
+evie the layouts
(nderstand the men material flo
Performing the Quality
Audit
#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.
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.
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.
<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
differentlyB
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
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
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
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.
*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
issues.
#an be time consuming.
;ou need to !no hen to stop.
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.
"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
analysis.
+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, alays revie the
related documentation.
+ecord all of the details as accurately as possible,
including :
−
hat
−
here
−
hen
−ho
-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.
#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 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 question.
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
#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.
+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.
Critical, -aor, -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 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.
-'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
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.
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.
#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.