12807857 audit terms and definitions iso 9001 2000

8/14/2019 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

4


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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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8/46I

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

7


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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