Implementing ISO 9001:2008: p g Process Mapping to Support - - PowerPoint PPT Presentation

Implementing ISO 9001:2008: p g Process Mapping to Support Process Management Process Management

Presented to the ASQ Baltimore Section -- January 12, 2010 y By Kevin Gilson Gilson Quality Services Inc

January 12, 2010 Process Mapping 1

Gilson Quality Services, Inc.

Agenda

I t

d ti

Introduction Requirements of ISO 9001:2008 audits Basics of Process Mapping

Symbology -- keep it simple Top Level Process Map -- the basic

• rganization and what it does

L L l P M th t f Lower Level Process Maps -- the rest of the story

Summary

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Summary

Introduction

Why this topic?

June 13, 2009, Board Retreat June 13, 2009, Board Retreat

Link between process and strategy Helped Board look at the effectiveness of strategy implementation

Personal experiences in ISO audits

Links between processes and the Standard Depiction of company’s processes

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What ISO 9001:2008 What ISO 9001:2008 Requires

4.1 General requirements

The organization shall: The organization shall:

Determine the processes needed for the QMS.. Determine the sequence and interaction…. Determine criteria and methods needed…. Ensure availability of resources and information Monitor, measure, analyze these processes… Implement actions to achieve planned results and continual improvement of these processes

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and continual improvement of these processes

ISO 9001:2008 Principles

0.2 Process approach

…promotes the adoption of a process …promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system… “For an organization to function effectively, it has to determine and manage numerous linked activities.”

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ISO 9001:2008 Principles

0.4 Process approach

“An activity or set of activities using An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.”

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ISO 9001:2008 Model

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Other Standard Models

Standard software development model Engineering development model Engineering development model Waterfall model of development …right out of the textbook But

what is THEIR process???

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But…what is THEIR process???

Purpose of the Model

Introduce the auditor (and customers or

employees) to the company’s processes p y ) p y p

Link the key business processes to the

Clauses in the Standard Clauses in the Standard

Show how the organization actually

implements the Standard implements the Standard

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Process and Auditing

Auditors are starting to:

Analyze processes for problem areas Analyze processes for problem areas Analyze product/service delivery

Evaluate customer complaints p Look at effectiveness of countermeasures

Evaluate interface effectiveness

Effect on variation

Assess risk to customers

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What do we Audit?

Worksheets include:

Process being audited Process being audited Standard Clauses for that process Inputs/linkages from other processes Inputs/linkages from other processes Outputs Measures related to strategic or process Measures related to strategic or process

• bjectives

Effectiveness of the process audited

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Effectiveness of the process audited

Importance of Process in Importance of Process in Excellence Models

The two leading world models of

• perational excellence have Process as

p key measures of excellence:

Malcom Baldrige National Quality Program Malcom Baldrige National Quality Program

Category 6: Process Management

EFQM Quality Model 2009 y

Category 5: Processes, Products and Services

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Malcom Baldrige National Malcom Baldrige National Quality Program

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European Quality Model 2009 European Quality Model 2009 (EFQM)

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What is a Process Map? What is a Process Map?

Begin with the end in mind.

• S. Covey
• S. Covey

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What’s Important About What s Important About Process?

Take a trip with me…

Identify the destination Identify the mode of travel Identify the constraints Identify the route Estimate the time Locate intermediate stops/places to stay Make appropriate arrangements

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What is a Process?

Remember the ISO 9001:2008 definition:

“An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.” process. Key Ideas:

Inputs = Supplies, Resources, Customer Outputs = product/service satisfying Customer requirements, needs and expectations Activity = actions to transform inputs into outputs

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Steps in Process Mapping

Start with the Macro-Process

Don’t be tempted to begin with the micro- Don t be tempted to begin with the micro process or -processes Use the SIPOC diagram g Expect between 3 and 6 major Activities Get agreement on the depiction! Get agreement on the depiction! List Micro-processes below Macro-process activities on the diagram

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g

Steps in Process Mapping

Define the Output

What does the Customer require, need and expect? expect?

Define the Input

Suppliers, resources, other inputs Suppliers, resources, other inputs

Create the 3 to 6 Activities needed to create

the desired Output

List micro-processes for each Activity

Define the Feedback mechanism

C ti l i t d P ti A ti

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Continual improvement and Preventive Action

Oriel SIPOC Model from The Oriel SIPOC Model from The Team Handbook

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Macro- Micro- Example

From: GoalQPC Project Management Memory Jogger January 12, 2010 Process Mapping 21

The Activity: From Waking to The Activity: From Waking to Arrival at Work

Steps:

Set Macro-process boundaries Set Macro process boundaries Using SIPOC:

Describe the Macro-process Outputs p p

in customer terms

Describe the Macro-process Inputs Identify in flowchart form the Key Activities to transform the Inputs into the Outputs List some of the Micro-processes

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List some of the Micro-processes

Relating SIPOC to ISO

Create the Macro-SIPOC for your QMS

May need more than one to describe your May need more than one to describe your

• rganization’s processes

Depict the Activities of your company p y p y Determine the Micro-processes for each Macro-Activity

Create Micro-SIPOC’s or procedures for each For each Micro-process Activity, show the li bl ISO Cl

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applicable ISO Clauses

Conclusion

Process Maps

Help auditors understand how to structure Help auditors understand how to structure an audit Can show the link between processes and p the ISO 9001:2008 Standard Provide a starting point for continual g improvement Form the basis for procedures

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References

Peter Scholtes et al., The Team Handbook,

3rd ed., Oriel

Di

G ll M i W k P

Diane Galloway, Mapping Work Processes,

ASQ Quality Press, 1994

Robert Boehringer et al

The Process

Robert Boehringer et al., The Process

Management Memory Jogger, GOALQPC, 2008

Dan Madison, Process Mapping, Process

Improvement and Process Management, Paton Press 2005

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Paton Press, 2005

About the Speaker

Kevin Gilson

Principal in Gilson Quality Services, Inc. Principal in Gilson Quality Services, Inc. ISO 9001:2008 Lead Auditor for Orion Registrar g Consultant with Theseus Professional Services, LLC 35 years experience in Quality Management disciplines

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