Implementing ISO 9001:2008: Process Mapping to Support Process Management Process Management Presented to the ASQ Baltimore Section -- January 12, 2010 By Kevin Gilson Gilson Quality Services Inc January 12, 2010 Process Mapping 1 Gilson Quality Services, Inc.
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Implementing ISO 9001:2008: p gProcess Mapping to Support
Process ManagementProcess Management
Presented to the ASQ Baltimore Section -- January 12, 2010y
By Kevin GilsonGilson Quality Services Inc
January 12, 2010 Process Mapping 1
Gilson Quality Services, Inc.
AgendaI t d tiIntroductionRequirements of ISO 9001:2008 auditsBasics of Process Mapping
Symbology -- keep it simpleTop Level Process Map -- the basic organization and what it doesL L l P M th t fLower Level Process Maps -- the rest of the story
Link between process and strategyHelped Board look at the effectiveness of strategy implementation
Personal experiences in ISO auditsLinks between processes and the StandardDepiction of company’s processes
January 12, 2010 Process Mapping 3
What ISO 9001:2008What ISO 9001:2008 Requires
4.1 General requirementsThe 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 informationMonitor, 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 usingAn 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
January 12, 2010 Process Mapping 7
Other Standard Models
Standard software development modelEngineering development modelEngineering development modelWaterfall 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 processesp y ) p y pLink the key business processes to the Clauses in the StandardClauses in the StandardShow how the organization actually implements the Standardimplements the Standard
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Process and Auditing
Auditors are starting to:Analyze processes for problem areasAnalyze processes for problem areasAnalyze product/service delivery
Evaluate customer complaintspLook at effectiveness of countermeasures
Evaluate interface effectivenessEffect on variation
Assess risk to customers
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What do we Audit?
Worksheets include:Process being auditedProcess being auditedStandard Clauses for that processInputs/linkages from other processesInputs/linkages from other processesOutputsMeasures related to strategic or processMeasures related to strategic or process objectivesEffectiveness of the process audited
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Effectiveness of the process audited
Importance of Process inImportance of Process in Excellence Models
The two leading world models of operational excellence have Process as pkey measures of excellence:
Malcom Baldrige National Quality ProgramMalcom Baldrige National Quality ProgramCategory 6: Process Management
EFQM Quality Model 2009yCategory 5: Processes, Products and Services
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Malcom Baldrige NationalMalcom Baldrige National Quality Program
January 12, 2010 Process Mapping 13
European Quality Model 2009European Quality Model 2009 (EFQM)
January 12, 2010 Process Mapping 14
What is a Process Map?What is a Process Map?
Begin with the end in mind. S. CoveyS. Covey
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What’s Important AboutWhat s Important About Process?
Take a trip with me…Identify the destinationIdentify the mode of travelIdentify the constraintsIdentify the routeEstimate the timeLocate intermediate stops/places to stayMake 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, CustomerOutputs = product/service satisfying Customer requirements, needs and expectationsActivity = actions to transform inputs into outputs
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Steps in Process Mapping
Start with the Macro-ProcessDon’t be tempted to begin with the micro-Don t be tempted to begin with the microprocess or -processesUse the SIPOC diagramgExpect between 3 and 6 major ActivitiesGet 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 OutputWhat does the Customer require, need and expect?expect?
Define the InputSuppliers, resources, other inputsSuppliers, resources, other inputs
Create the 3 to 6 Activities needed to create the desired Output
List micro-processes for each ActivityDefine 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 TheOriel SIPOC Model from The Team Handbook
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Macro- Micro- Example
From: GoalQPCProject ManagementMemory Jogger
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The Activity: From Waking toThe Activity: From Waking to Arrival at Work
Steps:Set Macro-process boundariesSet Macro process boundariesUsing SIPOC:
Describe the Macro-process Outputs p pin customer terms
Describe the Macro-process InputsIdentify in flowchart form the Key Activities to transform the Inputs into the OutputsList 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 QMSMay need more than one to describe yourMay need more than one to describe your organization’s processesDepict the Activities of your companyp y p yDetermine the Micro-processes for each Macro-Activityy
Create Micro-SIPOC’s or procedures for eachFor each Micro-process Activity, show the
li bl ISO Cl
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applicable ISO Clauses
Conclusion
Process MapsHelp auditors understand how to structureHelp auditors understand how to structure an auditCan show the link between processes and pthe ISO 9001:2008 StandardProvide a starting point for continual gimprovement Form the basis for procedures
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References
Peter Scholtes et al., The Team Handbook, 3rd ed., OrielDi G ll M i W k PDiane Galloway, Mapping Work Processes, ASQ Quality Press, 1994Robert Boehringer et al The ProcessRobert Boehringer et al., The Process Management Memory Jogger, GOALQPC, 2008Dan Madison, Process Mapping, Process Improvement and Process Management, Paton Press 2005
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Paton Press, 2005
About the Speaker
Kevin GilsonPrincipal in Gilson Quality Services, Inc.Principal in Gilson Quality Services, Inc.ISO 9001:2008 Lead Auditor for Orion RegistrargConsultant with Theseus Professional Services, LLC35 years experience in Quality Management disciplines