Professional Documents
Culture Documents
1. QUALITY AUDITS
1. Introduction
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.
The definition of the term “Quality Audit” as given in the International Standards, ISO-
8402 and ISO-10011, is as follows:
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:
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AIB-VINÇOTTE ACADEMY, OMAN
INTERNAL QUALITY AUDIT TRAINING
Quality auditing is an essential and integral part of ISO-9000 certification process. There
are three types of Quality 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.
This is an audit performed by an agency other than the one producing a product or
rendering a service. Generally this is an audit of a supplier by a customer to assess
their capabilities in meeting specified requirements (Britania’s Audit on the
Contract Packers is an example).
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a) Adequacy Audit
b) Compliance Audit
c) Surveillance Audit
b) A Compliance Audit
i) This is the audit, which seeks to establish the extent to which the documented
system 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.
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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-
conformance’s raised on the previous audits are verified and closed out during the
surveillance audit.
QUALITY AUDIT
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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.
ii) Auditor
A person who has been trained to conduct a quality audit. Auditors are responsible
for:
- verifying the effectiveness of corrective actions taken as a result of the audit (if
requested by the client);
iv) Auditee:
An organization to be audited.
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v) Observation:
vii) Non-conformity:
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.
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 in
touch 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.
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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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)
vi) the ability to make effective use of the skills of the various audit team members
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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
The Auditor should use open ended questions to avoid answer YES or NO.
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 care
the 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 the
knock 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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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.
a) The preparation and planning phase of any assessment is critical to the overall
success of the exercise.
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.
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3. Legitimacy of Audit:
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 are
minimum 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.
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 of
implementation of Quality Systems.
a) Horizontal Auditing
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.
b) Vertical Auditing
Used for contractual audit activities when a contract placing authority wishes to
verify that an organisation in applying a contractually agreed Quality System to all
activities 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
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.
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.
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.
- 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.
- the format of the closing meeting, e.g. where, when, who will attend etc.
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 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.
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 Assessor’s
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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d) Programs may be distributed to the Management. Each team member should also
be provided with a copy. The team leader should identify team member’s
responsibilities at this stage.
6. Examination
iii) These formal records constitute the output from the audit and should be recorded
as official paperwork.
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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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
b) Minor Non-Conformity
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 organization
the 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.
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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.
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 specific
requirements 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.
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.
• Present the overall findings of the audits in an objective and factual manner
against the scope of assessment.
a) Sampling
b) 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.
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.
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:
- details of the audit plan, the identification of audit team members and auditee’s
representative, audit dates, and identification of the specific organization
audited;
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- observations of non-conformities;
- audit team’s judgment of the extent of the auditee’s compliance with the
applicable quality system standard and related documentation;
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
e) Audit Completion
The audit is completed upon submission of the audit report to the Management.
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.
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.
NON-CONFORMANCE REPORT
NON CONFORMITY
CORRECTIVE ACTION
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