Internal Quality Audit - Training for Auditors
Short Description
Internal Quality Audit...
Description
The Quality Auditing
[Traini [T raining ng for f or Quality Quality Auditors]
Course Syllabus and Agenda Agenda
The Background and Basics
Auditor Conduct and Necessary Necessary Skills
Audit Preparation and Planning Planning
Performing the Audit Audit Report and Followup Followup
Course Syllabus and Agenda Agenda
The Background and Basics
Auditor Conduct and Necessary Necessary Skills
Audit Preparation and Planning Planning
Performing the Audit Audit Report and Followup Followup
AUDITING The Background and Basics
!hat is an Audit"
Definition: A quality audit is a systematic 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 The extent to hich these arrangements have been implemented implement ed effectively, and hether these arrangem arrangements ents are suitable to achieve the quality objectives.
b. c.
!hat is an Audit" Audit"
Continued#
An independent and 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.
Types of Audits
$irst party audit or self%audit or internal audit: #arried out by people of the organization or on behalf of the organization itself to examine its on quality system. &econd party audit or audit by customer or external audit: #arried out by the customer on the organization or by organization on the suppliers to examine the quality of suppliers. Third party audit or independent agency audit or external audit: #arried out by an external independent agency to assess compliance usually for the purpose of certification. '$or example: (&$DA,)*+A,*- )/ "&- etc.0
$nternal Audit
"nternal audit: "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.
$nternal Audit
Continued#
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
A %ood Auditor should ha&e''
$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.
Traits of a %ood %(P Auditor −
ood oral and ritten communication s!ills
−
$act finding
−
(nbiased
−
*onest
−
Tactful
−
Attentive
−
/atient
−
/olite and /rofessional
A VERY Important Trait
Common Sense !
Undesirable Traits of a %(P Auditor
/oor #ommunications s!ills
Arrogant
3egligent
7iased
8ague
7laming
"mpatient
"mpolite
Auditors Beha&ior
Dress in business clothing, appropriate to the climate and the business principles of your auditee.
7e punctual. The auditee is also a very busy person, and his2her time is equally as valuable as yours.
7e courteous, considerate and respectful 9 good manners cost nothing and ill promote an open, honest environment.
7e professional 9 you represent your department and #ompany.
Do not be rude or too aggressive 9 the auditee, in a defensive move, ill disengage from the audit and
Auditors Beha&ior
Continued#
isten to the ansers and sho interest. #larify here needed.
7e open and non%judgmental until you have all the facts you need. Then you may provide a balanced decision or opinion.
3ervous people ma!e errors, miss%statements, or exercise poor judgment % ma!e alloance for the 4fear factor5.
)aintain focus on your goals and agenda. ;our duty is to complete the audit and provide a balanced c)/ assessment.
ive praise here it is due and recognize good or!. )aintain a sense of self esteem and reard competence and expertise hen2here appropriate.
Auditors Responsibilities
>
Sometimes it may be necessary to clarify the response you receive. − 7e illing to re%phrase a question. − As! the auditee to expand upon their anser. − +epeat the question hen necessary.
Language barriers can require even greater tolerance. − 7e aare of potential misunderstandings, and be patient.
Be clear in your message. − &trive for clarity and simplicity ith every question.
Communications
Be aare of cultural differences. − +especting these differences builds bridges beteen people.
LS"#$ 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.
)ou have * ears and + mouth – use them in that ratio.
QUALITY AUDIT Preparation and Planning
Planning and Preparation
Audit /lanning
#ommunicate the Audit /lan
&election of Auditors
/reparing for Audit
/re%audit "nformation
Audit Planning 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
Continued#
&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 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.
Communicate the Audit Plan
=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.
Selection of Auditors
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.
Preparing for Audit
/repare and send detailed agenda, objective and scope of the audit.
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