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?

Clause 0.2

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]

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Why are internal audits conducted?

Obtain factual input for management decisions? ---or--Produce data needed to receive certification? Improve documentation? Enforce conformity?

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The Old-Fashioned Way of Auditing

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

Good quality = satisfied the needs Bad quality = failed to meet the needs

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The Old-Fashioned Way of Auditing

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

Auditor looked to see if documents had been reviewed and approved by authorized person Did Auditor look for:

Competency of approver? Why change was made? Did change improve performance?

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More Effective Methodology Needed

Focuses on performance, not just conformity Management needs to know:

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

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?

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

Based on processes that achieve organizations objectives Requires auditor to know what the processes are prior to conducting audit

ISO/IEC 17021 (Stage 1 and Stage 2) Code of Practice for Registrars

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Process Approach to Audit Plans

Common processes, for example:

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

Does not require detailed checklist Auditor can be guided by their understanding of the Standard

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Process Audit Worksheet #

Company: Process: Documents Reviewed Location: Standard Clauses: Audit Notes (addl pages as required)

Verify exclusions (if applicable)

Date: Auditor Name: Personnel Interviewed (incl. Qualifications)

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 for Improvement

Major Nonconformities

Minor Nonconformities

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Process Approach to Audit

Start with top management and business management processes Continue with resource management processes, establishing linkages

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

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 20 Orion Registrar, Inc. improving nonconformities related to

The Process Approach requires a change in attitude across the organization!

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What the Process Auditing Approach Provides

Process Auditing provides:

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 22 Orion Registrar, Inc. effective and more efficient

Five Basic Questions

Basic questions can apply even though the specific questions will be different:

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 its the best way of doing it? How do you know its the right thing to do?
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Five Basic Questions at Three Levels

Business Level Audit results should make the auditor confident that the organization:

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

Managerial Level Audit results should make the auditor confident that management:

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

Operational Level Audit results should make the auditor confident that individuals:

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

Internal auditing using process approach

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 27 Orion Registrar, Inc.

Orion Registrar, Inc.

7850 Vance Dr., Ste. 210 Arvada, CO 80003 303-456-6010 www.orion4value.com Westminster, MD 410-857-1748 kgilson@orion4value.com 410-884-9165
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