TUV INDIA TRAINING ACADEMY

Questioning Technique - Examples

Open ended & closed ended questions

Have you been trained for the task you perform ? (Closed Ended)
How have you been trained for the task you perform ? (Open Ended)

Do you record the complaint in the register ? (Closed Ended)

How do you record the complaint ? (Open Ended)

Is the material inspected to verify conformity to specifications ? (Closed Ended)

How is the material inspected to verify conformity to specifications ? (Open Ended)

Leading questions

I think you some times take outside help for testing critical parameters. Am I right ?
The intention behind such question is leading to an answer which an auditor wants.

This should be avoided.

Questions to elicit maximum information

Where do you keep batch manufacturing records ?

Likely answer is “in the box file” It gives information that auditee knows there is one & its location
as well.

What do you do once inspection is complete ?

Provides information on flow of documents & sequence of activities

More Questions

1. Brief me about your activities

2. Show me what you do ?
3. How is it carried out ?
4. Where is that kept ?
5. What happens once this is complete ?
6. When is this done ?
7. Who will do that ?

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7.3 AUDIT PERFORMANCE & REVIEW

Under this heading we shall cover,

 Opening meeting

 Audit Objective

 Communication during audit

 Collecting & Verifying information.

 Identifying audit finding

 Preparation for audit conclusion

 Closing meeting

Opening Meeting

 To be held with auditee’s Purpose

management, and
 To establish good communication & co-
 Where appropriate, it may be held
operation,
with those responsible for the
 To confirm the audit plan,
functions or processes to be
 To introduce audit team
audited.
 To provide short summary of audit
 Depending on the size & culture
process,
of organization, it may be formal
 To provide an opportunity for auditee to
and elaborate or informal and
ask questions,
quick.
 To ensure that planned activities can be
performed.

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Communication during audit

Within Audit Team With Auditee

 To exchange information,  To communicate progress & any concerns,

 To asses audit progress,  Audit findings specifically when it is a non-
 To reassign the work conformity,
between audit team  Any concerns about issues outside the
members. scope of audit,
 Changes to audit plan if any,

Collecting & Verifying Information

What Information ?

 To establish good communication & co-operation,

 To confirm the audit plan,
 To introduce audit team
 To provide short summary of audit process,
 To provide an opportunity for auditee to ask questions,
 To ensure that planned activities can be performed.

An Overview of collecting & verifying information

Sources of information Collecting by means of appropriate sampling

Audit Evidence Evaluating against audit criteria Audit Finding
Reviewing Audit Conclusion.

Methods to collect information

 Interviews,
 Observation of activities,
 Review of documents and/or records

Sources of information

 Interviews with employees

 Observation of activities & surrounding work environment & conditions (machines, materials,
methods etc.)
 Documents (Policies, objectives, plans, procedures, instructions, licenses & permits,
specifications, drawings, contracts, orders etc),
 Records (Inspection records, MOM, registers, audit reports, results of measurements etc.)
 Data summaries & performance indicators,
 Reports from other sources (customer feedback, supplier rating)
 Data bases & web sites
 Simulation & modeling

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Conducting Interviews

 Meet HOD under audit  Speak Clearly, correctly & politely,

 Talk to those responsible for  Listen patiently,
performing the activities at all  Explain reason for interview & note
levels. taking,
 During normal working hours  Ask to describe their work,
 At normal work place  Summarize interview results,
 Put interviewee at ease prior to &  Thank interviewed person.
during interview.

Sampling

 Adopted when it is not practical or cost effective

 Objective of sampling is to have confidence that the audit objectives can be achieved.
 Risk is that the sample may not the representative of the population from which they are
selected due to which the audit conclusion may be biased.
 Sampling methods :
 Judgement based sampling
 Statistical Sampling

Can be applied to :

 Documented information
 Processes & equipments,
 People,
 Products,
 Records
E

Examination of Evidence

What Evidence ? Why Examine ?

 Documented information  Availability,

 Interviews,  Completeness of information,
 Facts witnessed  Designated authorization,
 Data generation time & date,
 Practiced Consistently

Taking Notes

Auditors need to develop habit of taking notes during the audit.

What is to be noted ?

 Name of the department, function or the process audited,

 Name of the HOD, process owner or the person interviewed,
 Evidence i.e. record, document verified,
 Important facts seen or heard of

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AUDITING COMPLIANCE WITH MANAGEMENT SYSTEM

The audit team should consider if the auditee has effective processes for:
 identifying its statutory and regulatory requirements
 managing its activities, products and services to achieve compliance with these requirements
 evaluating its compliance status.
Additionally, the audit team must also consider if the
auditee :
 has an effective process for identifying changes in compliance requirements
 has competent people to manage its compliance processes
 maintains and provides documented information on its compliance status
 includes compliance requirements in its internal audit programme
 addresses any instances of non-compliance
 considers compliance performance in its management reviews

AUDITING CONTEXT

Standard requires to determine its context, including the needs and expectations of relevant
interested parties and external and internal issues.
Hence, auditors to consider objective evidence related to:
 the processes or methods used
 the suitability and competence of the people contributing to the processes
 the results of the processes
 the application of the results to determine management system scope and development
 periodic reviews of context.

Auditors need to be competent to judge the effectiveness of process used to

determine context – sector specific knowledge essential.

AUDITING LEADERSHIP & COMMITMENT

 Auditors to obtain evidence of the top management’s involvement in decision-making

 Interview top management to confirm their understanding of the discipline-specific issues
relevant to their management system
 Auditors, not only to focus on leadership at the top management level but should also audit
leadership and commitment at other levels of management

Audit Finding

 Evaluate audit evidence against audit criteria to determine audit finding,

 Generate audit finding
 Audit findings to be reviewed
 Audit finding may be :
 a conformity and good practice,
 a non-conformity,
 an opportunity for improvement,
 any recommendation to the auditee

Non-conformity
Conformity& good practice  To be supported by audit evidence,
 To be reviewed, acknowledged &
should be summarized along with their understood by the auditee,
supporting evidences.  May be graded,
Non-conformity  Concerns if any, may be
appropriately resolved.

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ISO 9000:2015 defines nonconformity as : “Non-fulfillment of a requirement”

Requirement may be :

 specified by ISO 9001

 specified by a contract
 specified by QMS documentation
 specified by regulation
 implied

These are normally classified in to following groups :

1. Major

A Significant non-conformity with a (Quality) Management System Requirement

OR
A failure of , or complete omission of a (Quality) Management System Requirement
OR
A significant number of minor non-conformities concerning the same (Quality) Management System
Requirement
OR
A failure to comply with applicable statutory and/or regulatory requirement

2. Minor

An isolated incident of a failure to comply with a procedure or (Quality) Management System

Requirement.

(?) Observation (?)

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

Non-conformity

To be written in a way that it is : Checklist :

 Complete,  What was found ?,

 Clear in meaning,  Where was it found ?,
 Simple in language,  Why is it a non-conformity ?
 Easy to understand.

Non conformity – an Example

How to write a non-conformity statement (Example)

Inspection of Box Assembly SF0376 was observed being performed in the inspection area of production
unit B by inspector using issue 03 of drawing. Production planning document PR35 indicates that issue
04 drawing should be used.

 WHAT? Inspector undertaking inspection of Box Assembly

(SF0376) using Issue 03 of drawing.

 WHERE? Inspection area of production unit B.

 WHY? Production planning document PR35 requires Issue 04.

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Audit Conclusion

Debriefing : Conclusion can address issues such as :

 Review audit findings  The extent of conformity including

 Agree on audit conclusion effectiveness of QMS in
(Conformities, non-conformities & achievement of objectives ,
OFI’s)  Effective implementation,
 Prepare recommendations for maintenance & improvement of
improvements or future auditing QMS,
activities  Capability of M. Review process
 Discuss audit follow-up, as to ensure continuing suitability,
applicable. adequacy, effectiveness &
improvement of QMS,
 Root cause of findings,
 Similar findings made in different
areas that were audited for
identifying trends.

Closing meeting :

 Informal,
 Constructive,
 For communication of audit findings & conclusions,
 It is formal in case of 2nd party audits where :

 the MOM are recorded,

 attendance of participant’s is recorded.

Following to be explained in Closing Meeting

 Advising that audit evidences collected were based on sample of information available,
 The method of reporting,
 The process of handling of non-conformity,
 Present the audit findings in such a way that they are acknowledged & understood by the
auditee’s management,
 Post audit activities.

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7.4 AUDIT REPORTING

Under this heading we shall cover,

 Audit report - contents

 Approving & Distributing the Audit Report
 Completing the Audit

Audit Report Contents

Preferably, the audit report contains following information (ISO 19011 guidelines)

 Audit Objectives
 Audit Scope ( organizational & functional units or processes ),
 Names of the auditors & auditees,
 Audit date & place,
 Audit criteria (ref. of standard / document / procedure / WI etc.),
 Audit finding (conformities, non-conformities, OFI’s etc.),
 Audit conclusion,
 Summary of audit process including obstacles encountered,
 Areas not covered although within the audit scope,
 Unresolved diverging opinions between auditor & auditee,
 Recommendation for improvements,
 Agreed follow-up action plans,
 Distribution list for audit report.

Approving & Distributing the audit report

 To be issued within agreed time period,

 To be dated, reviewed & approved by a designated authority,

 Approved report to be distributed to the various recipients as per distribution list in the audit
report,

 Auditors & recipients to maintain confidentiality of report,

Completing the Audit

 Audit is completed when all activities in audit plan are carried out & approved audit report is
distributed,

 Documents pertaining to audit should be retained in accordance with applicable procedures,

statutory, regulatory & contractual requirements,

 Unless required, the audit team & those responsible for managing the audit shall not disclose
contents of documents, information obtained during the audit & audit report to any other party
without explicit approval of audit client (2 nd party audit)

 Lessons learnt from the audit to be entered in to continual improvement process of the
management system of the audited organization

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7.5 AUDIT FOLLOW-UP

Under this heading we shall cover,

 Non conformity raised

 Corrective action

 Close out

AUDITOR AUDITEE

Non-conformity Raised Understand It

Assign Responsibility

Analyze

Close Out
Determine Root Cause

Verify Effectiveness Propose Corrective Action

Evaluate It Implement It

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Chapter 8
Auditor Competence & Evaluation
Under this chapter we shall cover,

 Personal Behaviour,

 Concept of auditor competence,

 Generic knowledge & skills,

 Discipline & sector specific knowledge & skills of management systems,

 Auditor evaluation.

 Maintenance & improvement of competence,

Confidence & reliance in the audit process depends up on competence of those conducting the
audits. This competence is based on the demonstration of :

 The personal behaviour, and

 The ability to apply knowledge & skills gained through the education, work experience, auditor
training & audit experience,

The concept of auditor competence is illustrated in the following figure. Some of the knowledge & skills
are common to all management systems & auditors & some are specific to auditors of individual
discipline.

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Personal Behaviour – Desirable

• Ethical • Perceptive
• Open minded • Tenacious
• Diplomatic • Self reliant
• Decisive • Open to improvement
• Self disciplined • Culturally sensitive
• Versatile • Able to communicate
• Observant

Generic Knowledge & Skills

 Audit principles, procedures & techniques (Planning, preparation, questioning, interviewing,

listening, verifying & collecting evidence, reporting etc.),

 Management system & reference documents (interpretation, interaction, ref. standards),

 Organizational contexts (size, structure, functions, relationships, general business &

management concepts including planning, budgeting & managing personnel, cultural & social
aspects of auditee),

 Applicable laws, regulations & their governing agencies, basic legal terminologies, contracting
& liability etc.

Discipline & sector Specific Knowledge & Skills for QMS

 Quality related methods & techniques

 quality terminologies,
 quality management principles,
 quality tools e.g. statistical analysis, risk assessment (identification, analysis &
evaluation),

 Processes & products including services

 sector specific terminologies,

 sector specific processes & practices.

Auditor Evaluation

Auditor Evaluation Criteria should be :

 Qualitative (such as having demonstrated personal behaviour, knowledge or performance

skills in training or the work place)

 Quantitative (such as years of work experience and education, no. of audits conducted,
hours of audit training)

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Evaluation Method Examples

Review of records Records of education, training, employment,

professional credentials & audit experience

Feedback Surveys, questionnaires, personal reference,

testimonials, complaints, peer review,
performance evaluation.

Interview Personal interview

Observation Role playing, witnessing audits, on-the-job

performance

Testing Oral & written examinations, psychometric

testing

Post audit review Review of audit report, feedback from auditee

.

Maintenance & Improvement of Competence

CPD : Continual Professional Development Maintenance :

Can be achieved through : Can be achieved through :

 Regular participation of QMS

 Additional work experience, audits.
 Training,  CPD
 Private study,,
 Coaching.
 Attendance of seminars,
conferences etc.

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