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 Gilson Quality Services, Inc. January 12, 2010 Process Mapping 1
Agenda � Introduction � I t d ti � Requirements of ISO 9001:2008 audits � Basics of Process Mapping � Symbology -- keep it simple � Top Level Process Map -- the basic organization and what it does � Lower Level Process Maps -- the rest of � L L l P M th t f the story � Summary � Summary January 12, 2010 Process Mapping 2
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 January 12, 2010 Process Mapping 3
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 and continual improvement of these processes January 12, 2010 Process Mapping 4
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.” January 12, 2010 Process Mapping 5
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.” January 12, 2010 Process Mapping 6
ISO 9001:2008 Model January 12, 2010 Process Mapping 7
Other Standard Models � Standard software development model � Engineering development model � Engineering development model � Waterfall model of development � …right out of the textbook � But � But…what is THEIR process??? what is THEIR process??? January 12, 2010 Process Mapping 8
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 January 12, 2010 Process Mapping 9
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 January 12, 2010 Process Mapping 10
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 objectives � Effectiveness of the process audited � Effectiveness of the process audited January 12, 2010 Process Mapping 11
Importance of Process in Importance of Process in Excellence Models � The two leading world models of operational 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 January 12, 2010 Process Mapping 12
Malcom Baldrige National Malcom Baldrige National Quality Program January 12, 2010 Process Mapping 13
European Quality Model 2009 European 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. Covey S. Covey January 12, 2010 Process Mapping 15
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 January 12, 2010 Process Mapping 16
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 January 12, 2010 Process Mapping 17
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 g January 12, 2010 Process Mapping 18
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 � Continual improvement and Preventive Action � C ti l i t d P ti A ti January 12, 2010 Process Mapping 19
Oriel SIPOC Model from The Oriel SIPOC Model from The Team Handbook January 12, 2010 Process Mapping 20
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 � List some of the Micro-processes January 12, 2010 Process Mapping 22
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 organization’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 applicable ISO Clauses li bl ISO Cl January 12, 2010 Process Mapping 23
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 January 12, 2010 Process Mapping 24
References � Peter Scholtes et al., The Team Handbook, 3rd ed., Oriel � Di � Diane Galloway, Mapping Work Processes, G ll M i W k P 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 Paton Press, 2005 January 12, 2010 Process Mapping 25
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 January 12, 2010 Process Mapping 26
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