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Quality & Environmental AuditingPanel Discussion

2008 Energy & Environmental Conference

Presented by:

Ben Marguglio

BW (Ben) Marguglio, LLC

PO Box 8Cold Spring, NY 10516

845-265-0123

ben@HighTechnologySeminars.com

www.HighTechnologySeminars.com

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Objectives

Planning options regarding:

Audit Objective

Audit Scope

Audit Data Collection

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Audit Objective

Compliance-basedEffectiveness-based

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Compliance-based

To determine whether or not the requirementsare being met

Effectiveness-based

To determine whether or not requirementshave value and are being met with safety,

reliability / consistency and efficiency

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Compliance-based

and

Effectiveness-based

are terms applicableonly to the

audit objective

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Audit Scope

Risk-basedNon risk-based

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Risk-based

The scope addresses activities

commensurate with their risk

Non-risk-based

The scope addresses activities

regardless of risk considerations

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Risk

Level of Adverse Effect of OccurrenceX

Probability of Re-occurrence

withConsideration for Possible

Mitigation of the Effect

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High Level Risks

Fatality

Hospitalization

Noncompliance with law

Reportability to outside entityDiscomfort with stakeholder

Loss of a pre-stipulated mission

Loss of $ above a pre-stipulated amount

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Risk Identification Methods

Probabilistic Risk (Safety) AnalysisOperating experience

Expert panels

Identification of the success factors

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Risk-based

and

Non-risk-based

are terms applicableonly to the

audit scope.

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Audit Data CollectionWHAT Data to Collect

Determine the success factors for the process

Determine the standards for the success factors

Determine the process steps that affect thesuccess factors

--------------------------------

Plan to collect data about these process steps

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Audit Data Collection

Program-based / System-basedPerformance-based

Results-based

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Program-based / System-based

Evaluate:

Policies

Administrative Procedures

Technical ProceduresProject Plans

Given a significant inadequacy of a

documented policy, procedure or plan, thevalue of auditing its implementation isquestionable

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Program-based / System-based(Contd)

This data collection method / source mustbe used to meet either the compliance-based oreffectiveness-based objective.

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For either objective, this can NOT be theonly data collection method / source used todemonstrate compliance or effectiveness.

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Performance-based

Real time, direct observation of procedureimplementation

OR

Analysis of absolute values and trends ofperformance indicators

(PIs speak for themselves)

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Performance-based (Contd)

Real-time, direct observation requires moreresources than records assessment.

Real-time, direct observation provides more

insight.

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Results-based

Analysis of absolute values and trends of

performance indicators (PIs)(PIs speak for themselves)

OR

Selection of an unacceptable event(s) andassessment of the action taken to:

Identify causal factors

Correct root and contributing causes