process approach
TRANSCRIPT
Process Approach to Quality Management System
Process Approach to Quality Management System
[Rashid Mahmood]
Neutro Pharma (Pvt.) Limited Lahore, Pakistan
ObjectiveObjective
Understanding the concept of
“Process Approach” &
techniques/skills to
implement this approach.
Key IssueKey Issue
Exceptionally, If your organization has struggled to show measurable and sustainable improvements in performance for your customers or toward top-priority management goals, then ISO may be thought to be in "maintenance mode" within your organization, rather than a vital tool to address today's critical business needs.
Key Issue (Continued)Key Issue (Continued)
Common symptoms of the situation are:– The same corrective actions come up again and
again.– Audit reports identifying seemingly "petty" issues.– Management review meetings "going through
the motions" and often poorly attended.– Improvements made in the past don't show
sustained results today.– There is a "burn out" factor within your internal
auditor team.
But, WHY does this occur?
Key Issue (Continued)Key Issue (Continued)
These indications point to a quality
management system (QMS) that has
generally LOST ITS FOCUS.
Key Issue (Continued)Key Issue (Continued)
Having an effective process management
process may be a "missing link" in your
current QMS and this gap may be a key
reason your system (ISO) has lost its luster.
To simplify
“Process Approach is missing”
What is a “Process”?What is a “Process”?
“Set of interrelated or interacting activities, which transforms inputs into outputs”
(ISO 9001:2008)
These activities require allocation of resources such as people and materials
A Generic ProcessA Generic Process A desired result is achieved more
efficiently when activities & related resources are managed as “Process”
InputRequirements
Specified(Includes Resources)
OutputRequirements
Satisfied(Result of a process)
Interrelated or interacting activities &
control methods
EFFECTIVENESS OF
PROCESS = Ability to achieve desired results
EFFICIENCY OF
PROCESS = Results
achieved Vs resources
used
Monitoring & Measurement
A Generic Process (continued)A Generic Process (continued)
Inputs and intended outputs may be tangible (equipment, materials or components) or intangible (energy or information). Outputs can also be unintended, such as waste or pollution.
Each process has customers and other interested parties (either internal or external to the organization), with needs and expectations about the process, who define the required outputs of the process.
A Generic Process (continued)A Generic Process (continued)
A system should be used to gather data to provide information about process performance, which should then be analyzed to determine if there is any need for corrective action or improvement.
All processes should be aligned with the objectives, scope and complexity of the organization, and should be designed to add value to the organization.
A Generic Process (continued)A Generic Process (continued)
Process effectiveness and efficiency can be assessed through internal or external review processes.
What is “Process Approach”?What is “Process Approach”?
“The application of a system of processes
within an organization, together with the
identification and interactions of these
processes, and their management to
produce the desired outcome, can be
referred to as the “process approach“.(ISO
9001:2008)
Function-based Management(A Traditional, Prevailing Style)
Function-based Management(A Traditional, Prevailing Style)
Organizations are often structured into a hierarchy of functional units. Organizations are usually managed vertically, with responsibility divided among functional units.
The end customer or other interested party is not always visible to all involved.
Function-based Management (continued) (A Traditional, Prevailing Style)
Function-based Management (continued) (A Traditional, Prevailing Style)
Consequences are– A series of “Complex Chains” or interactions
between departments or divisions;
Function-based Management (continued) (A Traditional, Prevailing Style)
Function-based Management (continued) (A Traditional, Prevailing Style)
– Unclear relationship between INPUTS, RESOURCES & Outputs;
Function-based Management (continued) (A Traditional, Prevailing Style)
Function-based Management (continued) (A Traditional, Prevailing Style)
– People competing (fighting) for resources;
Function-based Management (continued)
Function-based Management (continued)
Functional……..Complicated Processes
Function-based Management (continued) (A Traditional, Prevailing Style)
Function-based Management (continued) (A Traditional, Prevailing Style)
– Non-value adding (inefficiency adding) activates exist (process interfaces poorly managed)
– No responsibility for the whole range of the process (departmental mentality)
– Inspection & firefighting (Not preventive)– Stability seeking (Doesn’t trigger
improvement)
Function-based Management (continued)
Function-based Management (continued)
Organizational Structure defined based on functional units.. (complicated & hierarchical)
Function-based Management (continued)
Function-based Management (continued)
Functional………..As Marketing Requested It
Function-based Management (continued)
Function-based Management (continued)
Functional………..As Sales ordered it
Function-based Management (continued)
Function-based Management (continued)
Functional………..As Engineering designed it
Function-based Management (continued)
Function-based Management (continued)
Functional………..As Production Manufactured it
Function-based Management (continued)
Function-based Management (continued)
Functional………..As Plant installed it
Function-based Management (continued)
Function-based Management (continued)
Functional………..
What the customer wanted
Function-based Management (continued)
Function-based Management (continued)
What is Wrong………..????
Function-based Management (continued)
Function-based Management (continued)
This is the reason:– Process disconnection across departments in an
organization with functional orientation.
Function-based Management (continued) (A Traditional, Prevailing Style)
Function-based Management (continued) (A Traditional, Prevailing Style)
This leads to “LITTLE” or “NO” improvement as actions are usually
focused on the functions, rather than
overall benefit of to the organization
Process ApproachProcess Approach
The process approach in the contrary:
– introduces horizontal management, crossing the barriers between different functional units and unifying their focus to the main goals of the organization.
– It also improves the management of process interfaces
Process ApproachProcess Approach
A process approach is thus a powerful way of organizing and managing activities to create value for the customer and other interested parties.
Process ApproachProcess Approach
The processes are managed as a system defined by the network of the processes and their interactions, thus creating a better understanding of added value
Process ApproachProcess Approach
Often the outputs from one process can be the inputs into other processes and are interlinked into the overall network or system
PROCESS A
PROCESS C
PROCESS B PROCESS D
Inputs to A
Inputs to B Outputs from A
Inputs to C Outputs from C
Outputs from B Inputs to D
Outputs from D
Outputs from other processes Outputs from
other processes
Process ApproachProcess Approach
Process sequence & their interactions
Resource Processes
Product Design
Process Design
Project Planning
Production
Management Processes
Mea
surem
ent, A
nalysis, a
nd Im
provem
ent
OI
IO
I O
I O
I O
I O
I O
I O
Resource Processes
Product Design
Process Design
Project Planning
Production
Management Processes
Mea
surem
ent, A
nalysis, a
nd Im
provem
ent
OI
IO
IO
I OI O
I OI O
I OI O
I OI O
I OI O
I OI O
Process ApproachProcess Approach
Process linkage across departments in an organization with process orientation
Process Approach Vs Functional ApproachProcess Approach Vs Functional Approach
Difference at a glance
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Process Type?
Process Name?
Process Owner?
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Management Processes
– Planning (Strategic & Operational)
– Resource Management
– Management Review
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Product Realization Processes
– Contract Management
– Transportation
– Storage
– Product Design
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Resource Provision Processes
– Recruitment
– Training
– Maintenance
– Payment
– Document Control
– Information Management
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Monitoring & Measurement Processes
– Internal Audit
– Inspection
– Testing
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Monitoring & Measurement Processes
– Internal Audit
– Inspection
– Testing
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Name the Process
– Purchase Process
– Order Fulfillment Process
– Training & Development Process
How to implement “Process Approach”How to implement “Process Approach”
Identify Processes
Define the “Process Owner”
– Process owner is one who plays central role
in the process & has the basic responsibility
of implementing the process
– Everyone’s Responsibility is No One’s
Responsibility
How to implement “Process Approach”How to implement “Process Approach”
Define Processes Sequence & Interaction
Sequence
Order Fulfilment Process
How to implement “Process Approach”How to implement “Process Approach”
Define Processes Sequence & Interaction Interaction
Monitoring & Measurements
Finance HRPlanning
How to implement “Process Approach”How to implement “Process Approach”
Plan the Processes
Define the activities within process
Define monitoring & measurement requirements
Define the resources needed
Verify processes against planned objectives
How to implement “Process Approach”How to implement “Process Approach”
Implement & Measure the Processes
Analyze the Process
Take Corrective Actions to Improve Process
Process MappingProcess Mapping
What is Process Mapping?
–“Process mapping is a workflow diagram to bring forth a clearer understanding of a process or series of parallel processes.”
Process MappingProcess Mapping
Process mapping is the first step of process management. It uses tools that enable us to:– Document,– Analyze– Improve– Streamline, &– Redesign the way we do our works
Process Mapping TechniquesProcess Mapping Techniques
Make your goal to define three process states:
– “As Is”
–“To Be”
–“Could Be”
Process Mapping TechniquesProcess Mapping Techniques
““As Is”As Is” Process State
– It is how our process/work is currently being performed.
–In any journey, it is important to know “where we are”“where we are” before we head off in a new direction.
Process Mapping TechniquesProcess Mapping Techniques
““As Is”As Is” Process State– Many re-engineering efforts
fail because managers/consultants reach for dramatic breakthroughs without understanding how (or why) current processes operate.
Process Mapping TechniquesProcess Mapping Techniques
““To Be”To Be” Process State
– It consists of the optimal performance level of “as is”“as is” state.
– In other words, if we streamline the existing process & remove all reworks, delays, bottlenecks, and assignable causes of variation, we will achieve the “To Be”“To Be” state.
Process Mapping TechniquesProcess Mapping Techniques
““Could Be”Could Be” Process State
– It is a new level of performance that can be achieved via process re-design.
– This state requires “out of the box” “out of the box” thinking.
– This is the exact process re-engineering.
Process Mapping TechniquesProcess Mapping Techniques
Hierarchical Process MappingHierarchical Process Mapping
Macro/organization Level Process Mapping
Micro/activity Level Process Mapping
Middle Process Mapping
Process Mapping TechniquesProcess Mapping Techniques
Macro/organization Level Process MapMacro/organization Level Process Map
– Mapping process commences from Mapping process commences from organizational level maps or macro organizational level maps or macro level & hierarchically moves to the level & hierarchically moves to the detail or micro level of system.detail or micro level of system.
Process Mapping TechniquesProcess Mapping Techniques
Middle-Level Process MapMiddle-Level Process Map– We can map the processes or sub-We can map the processes or sub-
processes for some selected from processes for some selected from the organizational overview the organizational overview process maps into process level process maps into process level maps.maps.
– Purchase process map of a Purchase process map of a company is an example of middle-company is an example of middle-level process maplevel process map
Process Mapping TechniquesProcess Mapping Techniques
Activity/Detail Level or Map (Micro-Activity/Detail Level or Map (Micro-Level Process MapsLevel Process Maps
– Usually, activity or detail level Usually, activity or detail level process maps are constructed & process maps are constructed & analyzed preferably using flow analyzed preferably using flow charting method.charting method.
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 1: Step 1: Determine the Process Boundaries
– Where does a process begin?Where does a process begin?
– Where does a process end?Where does a process end?
– Describe the beginning step in an Describe the beginning step in an oval flowchart symboloval flowchart symbol
Start
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 2: Step 2: List the Process Steps
– Ask yourself “what happens next”?Ask yourself “what happens next”?
– List these steps & add each to the List these steps & add each to the flowchart as rectangleflowchart as rectangle
– Don’t put arrows until laterDon’t put arrows until later
Activity/Sub-process Activity/Sub-process
Activity/Sub-process Activity/Sub-process
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 3: Step 3: Sequence the Process Steps
– Determine the sequence of each Determine the sequence of each activity/sub-processactivity/sub-process
– Numbering of boxes is preferableNumbering of boxes is preferable
Activity/Sub-process(1)
Activity/Sub-process(2)
Activity/Sub-process(3)
Activity/Sub-process(4)
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 4: Step 4: Draw Appropriate Symbols
–OvalOvalIt acts as It acts as “Terminator”“Terminator”Shows input to Shows input to start start the process the process
or output at the or output at the endend of the of the process.process.
Start End
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 4: Step 4: Draw Appropriate Symbols
–Rectangle (“Box”)Rectangle (“Box”)Represents Represents “Process/Sub-“Process/Sub-
process”process”Show Show “Task”“Task” or or “Activity”“Activity”
performed in the processperformed in the process
Activities
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 4: Step 4: Draw Appropriate Symbols
–ArrowArrowShows process Shows process “Direction” “Direction” of of
flow.flow.Process directs fromProcess directs from “Tail”“Tail” to
“Head”“Head”
Activity A Activity B
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 4: Step 4: Draw Appropriate Symbols
–DiamondDiamondShows the point in process Shows the point in process
where where “YES/NO” “YES/NO” decision is decision is required.required.
Pass?No
Yes
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 4: Step 4: Draw Appropriate Symbols
–DiamondDiamondIf feed back Arrow is used make If feed back Arrow is used make
sure it joins the loop some wheresure it joins the loop some where
Pass?
Feed back arrow
No
Yes
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 5: Step 5: Use System Model Approach– Draw charts using Draw charts using “System Model “System Model
Approach”Approach”..InputInput - use information based upon - use information based upon
–PeoplePeople–MachinesMachines–MaterialMaterial–Method andMethod and–Environment.Environment.
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 5: Step 5: Use System Model Approach
– Draw charts using Draw charts using “System Model “System Model Approach”Approach”..ProcessProcess - use subsets of - use subsets of
processes inprocesses in
–Series or Series or
–Parallel.Parallel.
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 5: Step 5: Use System Model Approach– Draw charts using Draw charts using “System Model “System Model
Approach”Approach”..OutputOutput use outcomes or desired use outcomes or desired
results.results.Control Control use best in class use best in class
business rules.business rules.FeedbackFeedback use information from use information from
surveys or feedback.surveys or feedback.
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 6: Step 6: Check for Completeness
– Include pertinent chart informationInclude pertinent chart informationUsing title andUsing title andDate for easy reference.Date for easy reference.
Constructing Process Flow ChartsConstructing Process Flow Charts
Step 7: Step 7: Finalize the Flowchart– Ask the following Ask the following “questions”“questions” to to
yourselfyourselfIf this process is being run If this process is being run the way it the way it
should beshould be??Are people following the Are people following the process as process as
chartedcharted??Do we have a Do we have a consensusconsensus??What is What is redundantredundant??
– AddAdd what is what is missingmissing
Constructing Process Flow ChartsConstructing Process Flow Charts
Sample of Flow ChartSample of Flow Chart
Process Start
Activity
Decision?
Activity Process Start
Feed B
ack arrow
Keys to Successful FlowchartingKeys to Successful Flowcharting
Start with Big Picture:Start with Big Picture:– Draw a Draw a “Macro”“Macro” level flowchart first level flowchart first– Develop other diagrams for Develop other diagrams for “Detailed”“Detailed”
level process.level process. Observe the Current ProcessObserve the Current Process Record the Process Steps you observedRecord the Process Steps you observed Arrange sequence of steps & Draw Arrange sequence of steps & Draw
FlowchartFlowchart
Keys to Successful FlowchartingKeys to Successful Flowcharting
Draw the FlowchartDraw the Flowchart– Draw a Draw a “Macro”“Macro” level flowchart first level flowchart first– Develop other diagrams for Develop other diagrams for “Detailed”“Detailed”
level process.level process. Observe the Current ProcessObserve the Current Process Record the Process Steps you observedRecord the Process Steps you observed Arrange sequence of steps & draw Arrange sequence of steps & draw
flowchart.flowchart.
Keys Elements in Process MappingKeys Elements in Process Mapping
Select PeopleSelect People Define ProcessDefine Process Gather DataGather Data Construct MapsConstruct Maps Analyze MapsAnalyze Maps Issue RecommendationsIssue Recommendations
Keys Elements in Process MappingKeys Elements in Process Mapping
Select PeopleSelect People– Select right people to create map.Select right people to create map.– Include personnel who can provide Include personnel who can provide
cross-functional perspectives:cross-functional perspectives:Knowledgeable about processKnowledgeable about processInterested in improving processInterested in improving processAvailable & motivated to stay Available & motivated to stay
with the project until completionwith the project until completion
Keys Elements in Process MappingKeys Elements in Process Mapping
Define ProcessDefine Process– Decide which processes to map Decide which processes to map
first based on:first based on:Process impact on customer-Process impact on customer-
perceived valueperceived valueProcesses that most contribute Processes that most contribute
to customer-perceived value to to customer-perceived value to be world-class or at least be world-class or at least competitively superior.competitively superior.
Keys Elements in Process MappingKeys Elements in Process Mapping
Define ProcessDefine Process– Processes as part of core competencyProcesses as part of core competency– Cost reduction ProcessesCost reduction Processes– Cycle time reductionCycle time reduction– Defect reductionDefect reduction– Obsolete or changing technology Obsolete or changing technology
especially,especially,Information technology.Information technology.
– Competitive ReasonsCompetitive Reasons
Keys Elements in Process MappingKeys Elements in Process Mapping
Gather DataGather Data
– Three basic methods to collect the Three basic methods to collect the process information necessary to process information necessary to create a map:create a map:Self-generateSelf-generateOne-on-one interviewsOne-on-one interviewsGroup interviewsGroup interviews
Keys Elements in Process MappingKeys Elements in Process Mapping
Construct MapsConstruct Maps
– Start with the key elements of Start with the key elements of process/the widest possible process/the widest possible breadth of informationbreadth of information
– Then go back & fine-tune the map, Then go back & fine-tune the map, adding the required depth.adding the required depth.
Questions/Feedback-Most WelcomeQuestions/Feedback-Most Welcome
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