12807857 audit terms and definitions iso 9001 2000
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IQA
TOI
SO90
00:2000
Audit Terms andAudit Terms and
DefinitionsDefinitions
Ref: ISO/CD.3 19011Ref: ISO/CD.3 19011
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Audit: systematic, independent and documented
process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit
criteria are fulfilled
Audit Criteria: set of policies, procedures or
requirements used as a reference
Audit Evidence: records, statements of fact or
other information, relevant to the audit criteria and
which are verifiable (can be quantitative or qualitative)
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Audit Finding(s): result(s) of the evaluation of
the collected audit evidence against audit criteria
Audit Conclusion(s): outcome of an audit,
reached by the audit team after consideration of the
audit objectives and all audit findings
Auditee: organization being audited
Auditor: person with the competence to conduct
an audit
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Audit Team: one or more auditors conducting an
audit (one being appointed as audit team leader)
Technical Expert: person who provides specificknowledge or expertise with respect to the subject
to be audited
Audit Program: set of one or more auditsplanned for a specific time frame and directed
toward a specific purpose
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Audit Plan: description of the on-site activities
and arrangements for an audit
Audit Scope: extent and boundaries of an audit(typically includes a description of physical
locations, organizational units, activities and
processes, as well as the time period covered
Competence: demonstrated capability to apply
knowledge and skills
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QA
TOI
SO90
00:2000
Competence of AuditorsCompetence of Auditors
Ref: ISO/CD.3 19011Ref: ISO/CD.3 19011
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Elements of Competence
Personal
Attributes
AuditExperience
Work
Experience
Auditor
Training
Education
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There should be an evaluation process that should
first be used for initial evaluation of a person who
wishes to become an auditor
Even in case where he/she doesnt, thedevelopment process of an auditor should be
clearly defined to ensure a sound and professional
function in the organization
Providing competent auditors is only the first steptowards ensuring the reliability of the audit process
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General Guidelines
EDUCATION: minimum high school, preferably
graduation
TOTAL WORK EXPERIENCE: minimum 5 years
TOTAL QUALITY EXPERIENCE: at least 2 years
from the 5 years general
AUDITOR TRAINING: two days for internal auditor,
5 days (Lead Auditor) for the External Auditors
AUDIT EXPERIENCE: 4 complete audits or 20
days of audit
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Auditors Personal Attributes
Mature
unbiased and fair
ethical
open minded
diplomatic
observant
decisive self-reliant
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QA
TOI
SO90
00:2000
Managing An AuditManaging An AuditProgramProgram
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What is being Audited ?
Machinery
Facilities Procedures
People
ProcessesProduct
?
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Why an organization is beingaudited?
it is an ISO 9000s requirement no trust on employees
check and balance is a human nature people tend to forget and/or neglect managers are not competent a sort of an external and internal
pressures to run systems or anything else
?
Ho t e e tent o an a t
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How t e extent o an au tvary?
Large TextileSpinning1000 persons4 processes
Dental Clinic3 person
Many ComplexTreatmentProcesses
AutomobilePlant400 person
3 5 processes
Scope ?Objective?Duration?Expertise?Frequency of Audit?
Complexity of Product and Processes?Legal Requirements?Standards?Audit Criteria?Social Environment?
Educational Environment?
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Can you identify companysProduct ?
Shoe company Pharmacy Hospital
Airline University Primary School Insurance Company
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What does it mean to Audit aProcess Model ?
to audit every process
to audit departments in a certain sequence
to audit people in a certain sequence
to audit QMS in a certain sequence and logic
D scuss on Exerc se Process
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D scuss on Exerc se - ProcessModel
You are auditing a purchase dept. that buys
material for the company. How would you apply the
QMS Process Model on the activities of the
department? Identify the sequence of your checkpoints / from the requirements of ISO 9000:2000.
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Audit Process
Initiating the Audit1 Definition of scope, objective andcriteria
Establish audit team and contacts
Document Review2 Review the documents of the QMS andestablish their completeness and correcness (relevance to their processes)
Site AuditPreparation3
.
Planning Team assignments Preparing working documents
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Audit Process (cont.)
Site Audit4.
Opening Meeting Verification Process (collecting andverifying information), audit findings,communicating findings, closing meeting
Audit Reporting5 audit report preparation report review, approval and distribution retention of documents
Audit Completion
6 confirmation of completion as per the
audit plan
Audit Follow-up7 Verification of Corrective, Preventiveand/or Improvement Action
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Key Points of the Audit Process
Audit Objectives, scope, and criteriaAudit Objectives, scope, and criteria
to be defined by the auditee
Objectives: compliance to all applicable ISO 9001 QMS
requirements, legal obligations (illegality) for productconformity, contractual obligations to clients, and
consumer protection (in general)
scope: boundaries of audit, I.e. location, organizational
units, activities and processes to be audited
criteria: applicable policies, procedures, standards, laws,QMS requirements, contractual requirements, industry
codes,
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Audit Teams Requirement
GENERAL
independence, process familiarity, mature personality,
good communicator and analyzer, motivated, physically fit,
socially disciplined, free from conflict of interest, honest,capable to write objective audit findings/reports, not
submissive, and interactive
APPROPRIATE COMPETENCE
relevant technical expertise or take assistance of technicalexperts with appropriate technical knowledge, skills and
experience.
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Auditees Right on acceptabilityof Auditors
Both the audit client and auditee have a right to
request the replacement of particular team
members on reasonable grounds, which should be
communicated to those responsible for managingthe audit program.
Examples of reasonable grounds can be conflict of
interest situation (formal employees, consultant),
unethical behavior, lacking appropriate professionalbackground of the audit team, non-professional
behavior (e.g. violating confidentiality), etc.
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Document Review
A necessary step before site audit
Should be reviewed in light of audit objectives,
scope and criteria
A preliminary on-site visit may be necessary to be
able to carry out the document review
Document Review should be done very carefully,
and is most effectively done with the support of
relevant records.
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Planning for On-Site Audit
Parameters of plan: auditor(s), departments /
sections, time (usually hours), applicable QMS
processes (clauses), applicable criteria (standards,
legal, contractual, etc.), locations / sites, logistics,language limitations, technical expertise (doctors,
computer specialists, pharmacists, architecture,
etc.)
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Working Documents
Audit procedure
audit checklist(s)
sampling plan
forms / papers for recording information and
supporting evidence
NCR forms
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On-Site Activities
Opening Meeting
Investigation
Observation
Interviews
confirmations
Communication
Audit Findings
Closing Meeting
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Opening Meeting
Establish an Audit Environment and
Communication links with the management
Inform about the audit plan and methodology
confirm the audit criteria (contractual, legal,
industrial, and companys obligations and
standards)
confirm the sampling plan (number of samples to
be used in the width and depth of audit)
confirmation of relevant work safety, emergency
and security procedures for the audit team
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Investigation
Main objectives:
what are the contractual and legal requirements
Does the company products meets the contractual and
legal requirements Is consistency ensured in the standards
Are company policies and procedures followed as a
routine activity
Is the company following the standards and procedures
genuinely
Is there any serious discrepancy between what is
produced and the test results
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(cont.)
Interviews:
relevant people must be interviewed directly at all levels
auditor should go to the relevant people to interview; they
should not be called to answer the auditor tone must be respectful and genuine
objective of interview must be clarified to the interviewee
Types of questions: Open-ended, Closed-ended, Leading-
questions, Personal -questions, Interrogative-questions,
taunting-questions. Certain types must be avoided.
The results from the interview should be summarized and
reviewed with the interviewed person
End must be with thanks
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(cont.)
Observations and Confirmations
actual products
actual processes (operators, skill levels, equipment,
material) actual operators
actual environment
actual records
external documents (customers, vendors, legal, and
referenced standards)
computerized data bases
effectiveness of procedures
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Audit Findings
Auditors should review all facts and the overallsituation
Conformities should be summarized to at least
indicate locations, functions, processes, or
requirements that were audited, where nononconformities were observed
Nonconformities should be recorded and supported
by audit evidence. It should be reviewed by the
auditee to ensure accuracy and understanding. Difference of opinions should be resolved before
finalizing
Nonconformity Statement
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Nonconformity Statement -a critical output of an Auditor
Few auditors write accurate, clear, and complete
statements of non-conformity
Example of a good non-conformity statement
One of the voltmeters, number 389000, used for
the testing of generators at the final test bench of
the main assembly shop was not calibrated, as
required by the Quality Procedure No.QSP4.11/2000. All test equipment which affect
product quality shall be calibrated to ensure
accuracy of results
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(cont.)
Poor way of writing NC statements:
Examples
quality objectives were not defined
test equipment was not calibrated
there were no training programs
identifications were missing
the procedure for SPC was wrong
Can you identify why the above statements are not good?
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(cont.)
Statements blaming to wrong people !
An operator was repairing the machine with wrong
method
OR
The operator was not properly trained to repair the
machines
who is to be blamed in the same incident above?
Prepar ng or t e os ng
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Prepar ng or t e os ngMeeting
Review the overall audit findings
Prepare the list of audit findings
reach consensus on the audit conclusions
agree on the roles and tasks for the closing
meetings (for more than one auditors)
prepare recommendations
discuss subsequent audit follow-up
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Closing Meeting
Present overall conclusion and findings. Address
your summary of Conformity and Non-conformity,
both.
Present non-conformities in order of priority (frommore important findings to less important)
Provide direction to management on Corrective,
Preventive and Improvement actions. It is auditee's
responsibility to identify C/A or P/A; however theynormally do not understand the difference.
Confirm follow-up audit
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Auditor-Auditee Roles
AuditAudit
ReportApprove
C/A
TakeC/A
Identify
Rootcause &Suggest
C/A
Verify
C/A
Improve-
ment
AUDITOR
AUDIT
EE
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Audit Report
Should provide a complete, accurate, concise and
clear record of the audit and should contain audit
conclusions on the following issues:
extent of conformance of the management system to theaudit criteria
effective implementation and maintenance of the
management system, and
the ability of management review process to ensure the
continuing suitability, adequacy, and effectiveness of themanagement system
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Contents of Audit Report
The second/third party reports are formal, whereas,
first party audit can be less comprehensive and
may include just nonconformance reporting.
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Audit Completion
An audit is completed when all activities in the audit
plan have been finalized and the approved audit
report has been distributed
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Normal Problems in Audits
Lack of Product Orientation
Lack of Process Orientation
Non-technical audits in technical areas
Incomplete audits depth
width
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Final Words ...
Audits driven by professional programs can be highly
valuable in improving the Quality of organizations. On
the other hand, if conducted unprofessionally, the same
can be damaging Auditors and audit programs should also be subject to
checking and improvements
Progressive development of auditors is generally
neglected, resulting in poor value Technical competence and personal attributes are both
important parts of the auditors
Announced audits can be mixed with unannounced ones
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