Transcript Slide 1

Process Auditing
Why do people think that this is
something new?
Presented by
Kevin Gilson, Orion Registrar, Inc.
For the ASQ ISO Users Group
October 8, 2008
So where in ISO is Process?
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Clause 0.2
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This International Standard promotes the adoption
of a process approach when developing,
implementing and improving the effectiveness of a
quality management system…. [ISO 9001:2000
page v]
Orion Registrar, Inc.
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Why are internal audits conducted?
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Obtain factual input for management decisions?
---or--Produce data needed to receive certification?
Improve documentation?
Enforce conformity?
Orion Registrar, Inc.
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The Old-Fashioned Way of Auditing
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Quality audits focused on procedures and not on
quality
Auditors did not examine costs
“Quality” was how well an outcome met the needs
of those for whom it was provided
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Good quality = satisfied the needs
Bad quality = failed to meet the needs
Orion Registrar, Inc.
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The Old-Fashioned Way of Auditing
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Companies ignored outcomes and customer
satisfaction when auditing
Auditors were looking to “check the box” leaving
performance ignored and unchallenged
Conformity auditing looking to establish if specific
requirement had been met
Requirement may have focused on a task, not
performance result or output
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Document Review and Approval
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Auditor looked to see if documents had been
reviewed and approved by authorized person
Did Auditor look for:
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Competency of approver?
Why change was made?
Did change improve performance?
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More Effective Methodology Needed
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Focuses on performance, not just conformity
Management needs to know:
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Does performance meet targets?
Are there opportunities for improving performance?
Are there processes that do not support the workers?
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As an Auditor…
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If I invent your process then I am auditing my
version of your company… and that version
may NOT exist.
Conflict of Interest!!!
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Process Approach to
Internal Auditing
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Process Input-Output Model
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Performance Process
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Performance Process Audit Plan
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What does you Quality Manual look
like?
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1. Introduction
2. Scope and Exclusions
3. Definitions and Acronyms
4. Quality Management System Requirements
5. Management Responsibility
6. Human Resources
7. Product Realization
8. Measurement, Analysis and Improvement
Appendix -- process maps or outlines
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Process Approach to Audit Plans
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Based on processes that achieve organization’s
objectives
Requires auditor to know what the processes are
prior to conducting audit
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ISO/IEC 17021 (Stage 1 and Stage 2)
Code of Practice for Registrars
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Process Approach to Audit Plans
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Common processes, for example:
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Business management
Marketing and sales
Resource management
Purchasing
Product / service realization processes are different
for each organization
Plan shows audit trail through business processes
and across department boundaries
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Process Approach to Checklists
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Does not require detailed checklist
Auditor can be guided by their understanding of
the Standard
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Process Audit Worksheet #
Verify exclusions (if applicable)
Company:
Location:
Date:
Process:
Standard Clauses:
Auditor Name:
Documents Reviewed
Audit Notes (addÕlpages as required)
Personnel Interviewed (incl. Q ualifications)
Inputs and Linkages from Other Processes
Outputs (incl. Records Generated)
Evidence of Measurements Related to Strategic or
Process Objectives (as applicable)
Resource Requirements (incl. Equipment
Requiring Maintenance and/or Calibration)
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Customer and/or Regulatory Requirements
Nonconforming Product Control (incl.
Corrective Actions)
Strengths
Opportunities forImprovement
Major Nonconformities
Minor Nonconformities
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Process Approach to Audit
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Start with top management and business
management processes
Continue with resource management processes,
establishing linkages
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Effective resource management processes will provide
competent employees and capable equipment to other
processes
Continue with other processes from marketing to
delivery
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Value of the Process Approach
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Focuses on results, not procedures
Determines effectiveness of the management system
Evaluates the results the system delivers
Tests linkages between departments and processes
Follows flow of work throughout organization
Determines if operations are under control and controls are
effective
Allows judgment on significance of findings
Helps determine depth of problems across organization
Focuses on benefits of correcting nonconformities related
to improving organizational effectiveness
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The Process Approach requires a
change in attitude across the
organization!
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What the Process Auditing Approach
Provides
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Process Auditing provides:
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Data for managerial decisions on growth, technology,
staff development, products / processes based on
current performance, not just current conformity
Information on whether performance meets targets
Information on opportunities for improving
performance through better control of processes
Information on making processes more effective and
more efficient
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Five Basic Questions
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Basic questions can apply even though the “specific
questions” will be different:
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What are you trying to do?
How do you make it happen?
How do you know you are doing it right?
How do you know it’s the best way of doing it?
How do you know it’s the right thing to do?
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Five Basic Questions at Three Levels
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Business Level – Audit results should make the
auditor confident that the organization:
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Knows what it is trying to do
Knows how to make it happen
Knows that it is doing the right things
Knows that it is doing it in the best possible way
Is managing performance
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Five Basic Questions at Three Levels
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Managerial Level – Audit results should make the
auditor confident that management:
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Knows what the process aims to achieve
Knows how to design and cause processes to achieve
results
Knows that it is doing the right things
Knows that it is doing it in the best possible way
Is regulating performance
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Five Basic Questions at Three Levels
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Operational Level – Audit results should make the
auditor confident that individuals:
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Know what they are supposed to do
Know they are doing the right things
Know they are doing them in the best possible way
Are regulating their own performance
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Summary
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Internal auditing using process approach
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Can take internal audit team from mission statement to
employee contributions
Identifies clear linkages between interconnected
processes
Ensures requirements of the Standard fit with processes
Eliminates weaknesses of other approaches
Enables internal audit team to establish that the
organization is managing processes effectively
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Orion Registrar, Inc.
7850 Vance Dr., Ste. 210
Arvada, CO 80003
303-456-6010
www.orion4value.com
Westminster, MD
410-857-1748
[email protected]
410-884-9165
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