IQA HAND OUT

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INTERNAL QUALITY AUDIT TRAINING

1. QUALITY AUDITS

1. Introduction

AUDIT is the function of independent verification of selected activities by collecting

facts and on scrutinizing evidence by an employee or outsider not connected with the

actual activity under verification.

It calls for a systematic, independent and documented process for obtaining evidence and

evaluating it objectively to determine the extent to which audit criteria are fulfilled. The

audit criteria means set of policies, procedures, and requirements against which collected

audit evidence is compared.

2. What is Quality Audit?

The definition of the term Quality Audit as given in the International Standards, ISO-

8402 and ISO-10011, is as follows:

A systematic and independent examination to determine whether quality activities

and related results comply with planned arrangements and whether these

arrangements are implemented effectively and are suitable to achieve objectives.

The term independent is critical to the concept of audit and is used in the sense that the

reviewer called the Auditor is neither the person responsible for the performance under

review nor is he the immediate supervisor of that person.

The other important aspect of Quality Audit is that it aims to collect facts or objective

evidence during the course of audit.

Quality audits are conducted in accordance with documented procedures and they provide

assurance that the implementation and maintenance of the total quality system is in line

with the stipulated quality policies, objectives, plans and procedures.

Typically, a quality audit is a verification tool that identifies system weaknesses and their

potential and, in so doing, providing avenues for corrective action and system

improvement. A quality system audit offers wide range of benefits as it:

helps to develop an effective Total Quality System

assesses conformance of specified requirements

improves the overall management decision-making process

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AIB-VINOTTE ACADEMY, OMAN


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assists in the optimal allocation of resources

helps avoid potential problems

allows timely corrective action

reduces overhead and liability costs

reduces overhead and liability costs

improves profitability, customer satisfaction and marketability

3. Quality Audits and ISO - 9000 Certification

Quality auditing is an essential and integral part of ISO-9000 certification process. There

are three types of Quality Audits:

i) Internal Audits - First Party Audits

ii) External Audits - Second Party Audits

iii) Extrinsic Audits - Third Party Audits

i) Internal Quality Audit - First Party Audits

In this Audit, a unit looks at its own system, procedures and activities in order to

ascertain whether they are adequate and being complied with it. The audit is

carried out by the employees of the unit itself, but essentially they are not

responsible for the activity being audited.

Companies seeking ISO-9000 certification have to develop their own internal

quality audit schedule and procedures.

ii) External Quality Audits - Second Party Audits

This is an audit performed by an agency other than the one producing a product orrendering a service. Generally this is an audit of a supplier by a customer to assess

their capabilities in meeting specified requirements (Britanias Audit on the

Contract Packers is an example).

iii) Extrinsic Audit -Third Party Audit

a. This is reciprocal of External Audit. A third party audit is one, which is

conducted by an independent Certification Body or Registrar to assess the

capabilities of the organization to meet the requirements of the applicable

Quality System Standard.

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b. Such a body issues a certificate, indicating acceptance of the organization as a

company of Assessed Capability. This bears worldwide testimony that the

assessed organization complies with all the requirements of the particular

Quality System Standard (ISO 9001).

4. Phases of Third Party Audits

There are three phases of any audit scenario:

a) Adequacy Audit

b) Compliance Audit

c) Surveillance Audit

a) The Adequacy Audit:

This is also known as a system audit, a documentation audit or management audit

and is normally an office exercise which determines the extent to which the

document system represented by the quality manual and the associated procedures

adequately meets the requirements of the applicable standard. In short this is to

verify, what has been outlined in the manual is adequate to meet the requirements

of applicable standard. Adequacy audit could be done by sitting in ones own

office as it involves the examination of quality manual only.

b) A Compliance Audit

i) This is the audit, which seeks to establish the extent to which the documentedsystem is implemented, and observed by the workforce, i.e. are the people

complying with the system?

ii) This part of audit is done in actual activity field, wherein auditors go round the

different departments/sections of the unit. This audit seeks to establish the extent

to which documented quality system is being implemented and observed in a unit

by its employees or how far what has been outlined in the Quality Manual of the

unit is being complied within the unit is being ascertained.

iii) The salient features of Compliance Audit are:

Ensure that the entire scope is covered

Ensure that clear and precise Non-Conformance Reports are completed and

initiated

Seek proof by objective evidence

Control and run the assessment to a plan

Check samples of Documents / Records

Check follow-ups of corrective actions

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c) Surveillance Audit:

After the initial certification of a company, the certification bodies carry out

surveillance audit of the Quality Systems normally twice a year to ensure that the

Auditee organization is continuing to maintain the Quality System in accordance

with terms of certification. The corrective actions taken on the Non-conformances raised on the previous audits are verified and closed out during the

surveillance audit.

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Process Audit

First Party Audit

(Internal Audit)

Second Party Audit

(External Audit)

Third Party Audit

(Extrinsic Audit)

For ISO 9000 Certification Process

Adequacy Audit

Product Audit

Compliance Audit Surveillance Audit

QUALITY AUDIT


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5. Audit Roles & Responsibilities

Roles and Responsibilities

i) Management Representative

a) If an audit is to be done by a team responsible for the audit program there will be

one person to be the leader of the team, and he can be Management Representative.

b) The Management Representative is ultimately responsible for all phases of the

audit. The Management Representative should have management capabilities and

experience and should be given authority to make final decisions regarding the

conduct of the audit observations.

ii) Auditor

A person who has been trained to conduct a quality audit. Auditors are responsible

for:

- complying with the applicable audit requirements;

- communicating and clarifying audit requirements;

- planning and carrying out assigned responsibilities effectively and efficiently;

- documenting the observations;

- reporting the audit results;

- verifying the effectiveness of corrective actions taken as a result of the audit (if

requested by the client);

- retraining and safeguarding documents pertaining to the audit;

submitting such documents as required

ensuring such documents remain confidential

treating privileged information with discretion

iii) Audit Team

Whether an audit is carried out by a team or an individual, a leader should be

placed in overall charge. Typically, the Management Representative can be the

leader of the Audit team.

iv) Auditee:

An organization to be audited.

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v) Observation:

A statement of fact made during an audit and substantiated by objective evidence.

vi) Objective Evidence:

An qualitative or quantitative information, records or statements of fact relating to

the quality of a product or service or to the existence and implementation of a

quality system element, which is based on observation, measurement or test that

can be verified.

vii) Non-conformity:

The non-fulfillment of specified requirements.

viii) Independence of the Auditor:

Auditors should be free from bias and influences that could affect objectivity. All

persons and organizations involved with an audit should respect and support the

independence and integrity of the auditors.

6. Internal Auditing Teams

The Internal Auditing may include selected persons preferably of various strata of the

organization including executives and tops to make it a possible opportunity to get intouch with the employees of grass root level and know the status and progress on ground.

This audit also serves as a motivating force for the employees as they get the opportunities

to directly interact with their top boss.

7. Selection of Audit Members

a) Personal attributes of members

Communication, monitoring and follow-up

The auditor should have the ability to communicate with the auditee without being

offensive, rude or abrasive. He should be able to collect the factual position.

Having collected the facts, he should be able to present them effectively. Auditor

has to present his findings to the Head of the department which he audited and

discusses the subject. As such, successful auditing calls for oral and written

communication skills. Having communicated effectively, he should monitor the

progress in regard, to the corrective action. By close monitoring, he should follow

up the matter with the concerned so that the deficiencies pointed out are remedied.

b) Selection

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Factors to be taken into account is the number of functions to be assessed, the

planned direction of the assessment. Team selection will depend on;

i) the type of quality system standard against which the audit is to be conducted (for

example, manufacturing, computer software or service standards)

ii) the type of service or product and its associated regulatory requirements (for

example, health care, food, insurance, computers, instrumentation, nuclear devices)

iii) the need for professional qualifications or technical expertise in a particular

discipline

iv) the size and composition of the audit team

v) the need for skill in managing the team

vi) the ability to make effective use of the skills of the various audit team members

vii) the personal skills needed to deal with a particular Auditee

viii) the required language skills

ix) the absence of my real or perceived conflict of interest

x) other relevant factors

The Auditor should be able to apply these attributes in order to:

- obtain and assess objective evidence fairly

- remain true to the purpose of the audit without fear or favor

- evaluate constantly the effects of audit observations and personal interactions

during an audit

- treat concerned personnel in a way that will best achieve the audit purpose;

- perform the audit process without deviating due to distractions;

- commit full attention and support to the audit process;

- arrive at generally acceptable conclusions based on audit observations;

- remain true to a conclusion despite pressure to change that is not based on

evidence.

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2. THE ART OF QUESTIONING IN QUALITY AUDITS

1. Think Before Questioning

i) A common error generally committed is not thinking before questioning. If the

Auditor puts forth a question that may be perceived by the Auditee as some piece

of nonsense that has nothing to do with the subject at hand, then the

communication bond has been broken. Once this bond is broken, the entire

process of questioning and answering is jeopardized.

ii) An assessment cannot be made of the verbal exchange, evidence must be examined

to confirm or otherwise that what has been said is in fact true and borne out by

evidence, i.e. examine drawings, orders, calculations, specifications etc.

iii) The Auditee would also have a comfortable feeling of having dealt with a fair and

competent professional and thus will welcome the Auditor with open arms the next

time around.

2. Audit Questioning

The auditor learns how to ask questions. The auditor should never frame the questions in

such a way that mono-syllable answers can be given by the Auditee is YES or NO

Eg: Are you doing in such and such manner?Or

Whether he is entrusted with that responsibility?

The Auditor should use open ended questions to avoid answer YES or NO.

Eg: How this activity -----------

Or

Explain me how this is ------------

Or

Show how this is addressed ---------- etc.,

The auditor should think in the like of 8 Ws & 1 H made.

i. Who?

ii. Whom?

iii. Whose?

iv. Which?

v. What?

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vi. When?

vii. Where?

viii. Why? and

ix. How?

Among these the auditor should be very careful where the question why is asked. Since

such a question should never sound like criticism or disapproval of what is in vogue.

The auditor should not start the questions as soon as he meets the auditee. After the

personal introduction pleasantries have to be exchanged and a general discussion has to be

done before the subject is branched.

Only one question should be asked at a time and proceed with the next question after the

first question is answered.

Any elucidation is to be given for any question the same should be done taking into carethe basic tenet is not disturbed even to the minutest degrees.

Auditor should record his finding then and there so as not to forget what has been

gathered. They are not supposed to use a tape recorder.

The Auditee has to be told in advance that there will be a note prepared after completion

of the audit.

Art of deciphering the body language that is capable of achieving good part of

communication should be effectively made use of by the auditor.

Eg: Picking up an item, looking at it, raising the eyebrows perhaps scratching of the

back of the head are some of the body languages which can be had with the auditor.

This phase of the audit is to fully make use of the unasked question.

The Auditor should cultivate a habit for listening and he should keep his eyes into the eyes

of the auditee and speak overcoming the known barriers to communication.

Effective time management is of prime importance and the Auditor has to do planning in

advance. The auditor should develop the capacity to deal with persons who have theknock of beating about bush or divert the attentions to trivial aspects and engage auditors

in unproductive and peripheral activities and areas.

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3. PLANNING AND STRUCTURING OF AUDIT

1. Introduction

This is very important and the scope has to be clearly decided whether to cover the

Procedures, Instructions, and Quality System in total or only procedure specific. As for

the Certification, the scope has to be defined to cover the entire range of activities.

2. Preparation and Planning

a) The preparation and planning phase of any assessment is critical to the overall

success of the exercise.

b) Inadequate preparation & planning leads to:

- a devaluation of the result from the assessment.

- a loss of credibility in the overall assessment function.

- a waste of both assessors and assesses time.

- the creation of a false sense of security in that the poorly prepared

assessment does not probe deeply enough to highlight fundamental problems and

casts aspersions on both the assessor and his parent organization.

c) A good rule of thumb is to spend 40% of total man hours estimated for the

assessment in preparation activities. A further 40% should be allowed to conducting

the assessment, with the remaining 20% devoted to reporting and follow-up actions.

Depending upon the dates arranged for the assessment, notice shall be sent to all team

members about the details of the logistics, audit scope, objective and methods.

The structuring of Audit programme has to be done carefully by reaching an agreement on

the rules, purposes and mode by establishing proper collaboration among the following

groups.i. Heads of auditee departments

ii. Head of the audit group

iii. Upper management which presides over the two groups

The collective agreement is an important ingredient for the success of an audit

programme, the generally found failure areas being:

i. The abrasive relationship between auditors and line Manager.

ii. Failure of line Managers to keep the audit reports.

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3. Legitimacy of Audit:

The questions of legitimacy for audit arise in areas:

i. Subject matter of audit

ii. Should auditor be accompanied during his/her visitiii. When the auditor may interview

The legitimacy in totality should be covered by a Charter approved by Upper

Management.

4. Objectivity:

The auditor should be guided by objective approach and should not make any subjective

judgment to compare things with the standards, which leads to a situation where there areminimum chances for difference of opinion.

5. Non Personalization:

Auditors comments and observations should be devoid of personal favour. The audit in

no way is directed against the Head of Department or his employees.

6. Verification of Facts:

The HODs and Faculty members are to be made an active part of the program by bringing

them into review of any deficiencies located during the audit. Any factual deficiency

should be agreed upon before any item is entered in the report sent to upper management.

7. Cause Analysis:

In normal course, the auditors make recommendation for investigation and analysis of the

causes for deficiencies and the organization units are expected to do the same. However,in some major cases of non-conformities auditor is expected to investigate major

deficiencies to determine their causes.

8. Recommendations and Remedies:

With a view to reduce deficiencies and improve performance the units itself make the

recommendation based on audit findings except in some major cases where auditors make

the cause analysis and recommendations for remedial measures to correct the non-

conformities.

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However, the auditors are asked to follow up the recommendations to assure that effective

action is taken.

9. Methods of Audit

These fall into three main categories, each of which may be used to good effect depending

upon what we are trying to achieve from the audit. However, some require more

experience on the part of the auditor.

a) Horizontal Auditing

b) Vertical Auditing

c) Random Auditing

Each of these methods may be combined with the techniques of forward or backward

tracing and trail following to provide powerful mechanisms for verifying adequacy ofimplementation of Quality Systems.

a) Horizontal Auditing

Examining each functional area of an organisation to verify adequacy and

implementation of Quality System requirements.

Used for Internal System Auditing and for Second and Third Party

Assessments when it is necessary to establish if a basic quality management system

has been installed and is being implemented and maintained.

Each functional area is checked of conformance with Quality System

requirements applicable to that area.

b) Vertical Auditing

Examining functional area of an organisation that are actively contributing to a

specific work package or contractual requirement.

Used for contractual audit activities when a contract placing authority wishes to

verify that an organisation in applying a contractually agreed Quality System to allactivities undertaken in support of that contract.

Functional areas of the organisation and interfaces with the contract placer are

examined to verify conformance with contractually agreed Quality System

requirements, which may be detailed in a contract specific Quality Plan or

Program.

The audit team usually work through the logical sequence of events undertaken

following contract negotiation and pass through those functional areas contributing

to the contract as the logical sequence is followed.

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c) Random Auditing

Examining aspects of an organizations operation as determined by the auditor and

as demanded by the need to closely examine a particular activity or generallyprobe the system in a random manner.

10. Forward and Backward Tracing

The auditor follows a logical sequence of process steps either starting at the input to the

series and progressing to the output or working from the output and progressing back to

the input.

11. Trail Following

During the course of an audit the auditor uncovers something that is worthy of further

investigation, however this now leads away from the original plan of action and may even

involve progressing the audit into other areas of the organisation not originally intended

for audit or areas that have been/are to be audited at some other time.

We should always be prepared to follow trails

However, sometimes it is better to take notes and follow the trail at a more convenient time or when

the audit moves to the area where the trail leads.

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4. PROCESS OF AUDIT

1. Introduction

The main purpose of the audit is to examine the Quality System documents and to assess

whether work practices are as laid down in the documented System.

2. Opening Meeting

The last stage of preparation is also the opening phase of the Audit Investigation or

assessment.

An opening meeting is held with the Management, is chaired by the Management

Representative, and is held in the presence of senior management and those responsible

for the function concerned. The purpose of Opening Meeting is:

- introduction of auditing team.

- reiteration of the assessment purpose and objectives i.e. the department and activities

to be included, details and depth of audit to be expected, with reference to Quality

Systems including all the relevant standards as applicable.

- review of the assessment program and identification of the functions of teammembers. Any queries regarding the program should be resolved.

- the format of the closing meeting, e.g. where, when, who will attend etc.

- clarification regarding minor/major non conformance and observations.

The opening meeting should be brief and conducted in a businesslike and professional

manner. Names and positions of personnel attending should be noted and the points

covered recorded. The sequence of audit opening meeting would be as under:

3. Check List

Checklists of questions should be prepared for each area to be covered by the assessment

team. Checklists perform a number of functions:

- they provide a useful aide-memoir to the assess or

- they form a record of the assessment, provided that responses to questions are

recorded.

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- they ensure that all major points are covered, provided the checklists are followed

- they help to save time in note taking during the assessment, and

- they assist the preparation for the closing meeting and the subsequent written report.

Checklists can be compiled in two ways.

Firstly, they can be designed to reflect the criteria of the Quality Assurance Standard.

Secondly, they can be prepared on a departmental basis, reflecting the activities for which

each particular area is responsible. The latter method is the most commonly used and is

the easier of the two methods to use.

Care should be exercised when preparing checklists so that it is not to be too detailed,which can lead to a too rigid approach. Checklists are essentially an aide-memoir and

departure from them can be done when a more promising line of enquiry presents itself.

Checklists should also be compiled in logical sequence; often low-charting the procedure

under scrutiny can help in this respect. Questions should be structured so as to gain

detailed answers, rather than yes/no type answers, and care should also be exercised not to

structure questions so that their applicability is not dependent on a specific answer to the

previous question.

4. Team Briefing

a) The team leader should hold a briefing session for his team prior to the assessment

at which he will ensure that preparations are complete and that all team members

are aware of their roles.

b) The team leader should conduct interim team briefing during the audit

investigation and any relevant information should be shared and potential

difficulties or problem discussed and resolved as necessary.

5. Assessment Program

a) Knowing the total time available for the assessment investigation, the Audit leader

must decide how much time to allocate to investigating the quality assurance

management system in each department or work area. The Lead Assessors

decision on this will eventually be documented as the PROGRAM for the audit.

b) There are a number of approaches, which can be used when compiling a program

for a full systems assessment. Most commonly used are the TRACE FORWARD

and TRACK BACK methods.

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c) The Audit Program should include:

- The date(s) when the assessment will be performed.- The starting time for the Opening Meeting

- For each audit sub-team, the anticipated times at which they will be in each

area/department to be visited.

- The starting time for the Closing Meeting.

d) Programs may be distributed to the Management. Each team member should also

be provided with a copy. The team leader should identify team members

responsibilities at this stage.

6. Examination

Collecting Evidence and Recording the findings

i) As an auditor conducts interviews, passes through the various departments of an

organisation and generally observe working practices, there will be of necessity

that many aspects of operations or comments made by Auditee that need to be

recorded for further reference.

ii) However, as a minimum the following should be recorded in a formal manner

Instances of non-conformance to the Quality System Standard.Instances of non-conformance to documented working practices.

Aspects to operations that are leading towards non-conformance to either of

the above.

iii) These formal records constitute the output from the audit and should be recorded

as official paperwork.

iv) Such formal records will inevitably be termed Deficiencies or Non-

Conformances. The actual term used may vary depending upon the auditing

organisation.

v) The important point to remember is that the auditor must detail clearly and

concisely what has been observed and why it is a concern. The Auditee needs to

know what the problem is before it can be satisfactorily corrected.

vi) However, auditors must remember that they should report only agreed findings

based on factual evidence. It is good practice to gain the signature of the Auditee

(or auditees representative) on the audit Deficiency report.

vii) It is important that the facts findings are agreed before the auditors move on to

another area.

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viii) The Deficiency statement needs to be worded so that it is understandable to those

who were present at the time of audit and also those who were not and who may be

involved in implementing corrective actions.

ix) Thus the need to record facts.

What was found?

Where was it found?

Why is it a Deficiency?

Who was present?

x) Statements should be clear, concise and meaningful to enable the Auditee to fully

understand the problem and correct it. Remember that such statements need to be

written at the time of audit and so should be short, sharp and to the point.

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7. Non-conformity

a) Major Non-Conformity

A Significant Non-Compliance with a Quality System Requirement.

orA Failure of, or complete omission of a Quality System requirement.

or

A Significant Number of Minor Non-Conformities Concerning the Same Quality

System Requirement.

b) Minor Non-Conformity

As isolated incident of a failure to comply with a procedure or Quality System

requirement.

It is important for an auditor to differentiate between things that are of a serious

nature and those that may be less so.

But in many instances an auditor may be given information or make an observation

that whilst not a non-conformance as such, indicates that potentially one may exist

and so further questioning or observation of working practices is necessary.

8. Importance of Taking Notes

i) These snippets of informations should be recorded in an informal manner as theauditors notes.

ii) The human short-term memory is not particularly adept at retaining large amounts

of data when such data is being rapidly received. In an audit situation, we are in a

completely new and possible strange environment, it is easy to become

overwhelmed by what we see and hear. In this situation, it is often difficult to

remember all of those interesting things that need to be investigated further at

some later time or in another section of the organisation. Hence, it is advisable and

indeed good practice for an auditor to record this type of data in working notes.

iii) Also, notes should be made of who has been interviewed where in the organizationthe audit has been conducted and what procedures or documented working

practices or drawings etc., have been examined.

If adequate notes are not taken, it will be very difficult to recall what has been

observed.

iv) Do not trust your memory; write down information as you go.

v) Do not clutter your mind with trivial matters.

vi) Use your checklist and record on it if you wish.

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vii) Record what needs recording i.e.

Section / area audited

Person(s) interviewed

Document numbers and issue status

Equipment identificationProduct/material identification

General housekeeping conditions.

Make mental notes or jot down impressions gained of:

Workloads

Attitudes

Reactions

Organisation

Condition of equipment

Awareness and understanding of procedures.

Remember to listen to what is said and observe at all times, analyze and

record what is important.

9. Pre Closing Meeting

Prior to the final meeting the team leader should have the team assembled. The audit team

should then ensure that the observations are documented in a clear, concise manner and

are supported by evidence. Nonconformity should be identified in terms of the specificrequirements of the standard or other related documents against which the audit has been

conducted. The Management Representative should review observations with the member

of audit team. The member of the audit team should acknowledge all observations of non-

conformities.

10. Audit Closing Meeting

The main purpose of this meeting is to present audit observation to the Management in

such a manner so as to ensure that they clearly understand the result of the audit.

The main purpose of this meeting is:

Present the overall findings of the audits in an objective and factual manner

against the scope of assessment.

Present the non-conformance in a summarized manner placing emphasis on

those, which are significant to the quality of the end product or service

received by the customer.

Agree dates for the remedial action necessary.

The sequence of audit closing meeting would be, as under:

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Express thanks for co-operation of Auditee personnel.

Briefly state disclaimer clauses;

a) Samplingb) Negative Reporting

c) Not all the faults

Stress that particular negative data in audit team report does not amount to general

criticism of Auditees system.

Clarify that report is limited to audit team findings witnessed by Auditee

personnel.

Invite audit team members to present their report and recommendations.

Conclude audit team presentation with overall summary.

Invite questions/comments, direct discussion towards objectives. Avoid lengthy

argument.

Pursue agreement on follow-up action. Specify who is to act and within what time

scale action is to occur.

Closing the meeting after final brief comment from both sides.

11. Audit Documents

a) Audit report preparation

The audit report is prepared under the direction of the Management

Representative, who is responsible for its accuracy and completeness.

b) Report content

The audit report should faithfully reflect both the tone and content of the audit. It

should be dated and signed by the Management Representative. It should contain

the following items, as applicable:

- the scope and objectives of the audit;

- details of the audit plan, the identification of audit team members and auditees

representative, audit dates, and identification of the specific organizationaudited;

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- identification of the reference documents against which the audit was

conducted (quality system standard, auditees quality manual, etc.);

- observations of non-conformities;

- audit teams judgment of the extent of the auditees compliance with theapplicable quality system standard and related documentation;

- the systems ability to achieve defined quality objectives;

- the audit report distribution list;

Any communication made between the time of the closing meeting and the issue of

the report should be made by the Management Representative.

c) Report Distribution

The Management Representative shall give the audit report to the management.

The audit report should be issued as soon as possible. If it cannot be issued within

an agreed time period, the reasons for the delay should be given to the

Management with the revised issue date.

d) Record Retention

Audit documents should be retained for a considerable period of time.

e) Audit Completion

The audit is completed upon submission of the audit report to the Management.

f) Corrective Action Follow-up

The objective here is to ensure that effective corrective action has been taken in

every area of noncompliance. A follow-up procedure must be put in place to

verify the effectiveness of the corrective action. Experience has indicated that

companies who are able to develop self-correcting systems can effectively

establish a constancy of compliance and improvement.

Corrective action and subsequent follow-up audits should be completed within a

time period agreed to by the client and the Auditee in consultation with the

auditing organisation.

12. Management Review

All noncompliance including all reports on internal quality audits are to be reviewed at an

appropriate interval by the management to ensure the effectiveness & suitability of the

quality system.

5. SPECIMEN FOR NON-CONFORMITY REPORT

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NON-CONFORMANCE REPORT

QUALITY SYSTEM AUDIT

Audit Schedule No. __________________ NC. No. _________________

Auditee Dept. _______________________ Date ____________________

Auditor(s) __________________________ Auditee (s) _______________

__________________________ _______________

NON CONFORMITY

Standard ISO 9001: 2000Clause No.

Quality System DocumentsRef.

MajorMinor

Auditee Sign Auditor/s Sign Management Representative

CORRECTIVE ACTION

Responsible Person Proposed Completion Date Actual Completion Date

Clearance Report by Auditor/s with Date and Signature

Management Representative Signature with Date and Comments

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