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Process approach

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Process Approach to Quality Management is a key to success in developing company culture of building quality in the product

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Process approach

  1. 1. Process Approach to Quality Management System [Rashid Mahmood] Neutro Pharma (Pvt.) Limited Lahore, Pakistan
  2. 2. Objective Understanding the concept of “Process Approach” & techniques/skills to implement this approach.
  3. 3. Key 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.
  4. 4. 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.
  5. 5. But, WHYdoes this occur? Key Issue (Continued)  These indications point to a quality management system (QMS) that has generally LOST ITS FOCUS.
  6. 6. 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”
  7. 7. 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
  8. 8. A Generic Process  A desired result is achieved more efficiently when activities & related resources are managed as “Process” Input Requirements Specified (Includes Resources) Output Requirements Satisfied (Result of a process) Interrelated or interacting activities & control methods EFFECTIVE NESS OF PROCESS = Ability to achieve desired results EFFICIENCY OF PROCESS = Results achieved Vs resources used Monitoring & Measurement
  9. 9. 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.
  10. 10. 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.
  11. 11. A Generic Process (continued)  Process effectiveness and efficiency can be assessed through internal or external review processes.
  12. 12. 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)
  13. 13. 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.
  14. 14. Function-based Management (continued) (A Traditional, Prevailing Style)  Consequences are – A series of “Complex Chains” or interactions between departments or divisions;
  15. 15. Function-based Management (continued) (A Traditional, Prevailing Style) –Unclear relationship between INPUTS, RESOURCES & Outputs;
  16. 16. Function-based Management (continued) (A Traditional, Prevailing Style) –People competing (fighting) for resources;
  17. 17. Function-based Management (continued)  Functional……..Complicated Processes
  18. 18. 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)
  19. 19. Function-based Management (continued)  Organizational Structure defined based on functional units.. (complicated & hierarchical)
  20. 20. Function-based Management (continued)  Functional……….. As Marketing Requested It
  21. 21. Function-based Management (continued)  Functional……….. As Sales ordered it
  22. 22. Function-based Management (continued)  Functional……….. As Engineering designed it
  23. 23. Function-based Management (continued)  Functional……….. As Production Manufactured it
  24. 24. Function-based Management (continued)  Functional……….. As Plant installed it
  25. 25. Function-based Management (continued)  Functional……….. What the customer wanted
  26. 26. Function-based Management (continued) What is Wrong………..????
  27. 27. Function-based Management (continued)  This is the reason: – Process disconnection across departments in an organization with functional orientation.
  28. 28. 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
  29. 29. Process 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
  30. 30. Process Approach  A process approach is thus a powerful way of organizing and managing activities to create value for the customer and other interested parties.
  31. 31. Process 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
  32. 32. Process 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
  33. 33. Process Approach  Process sequence & their interactions Resource Processes Product Design Process Design Project Planning Production Management Processes Measurement,Analysis,andImprovement 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 Measurement,Analysis,andImprovement OI IOIO I OI O I OI O I OI O I OI O I OI O I OI O
  34. 34. Process Approach Process linkage across departments in an organization with process orientation
  35. 35. Process Approach Vs Functional Approach Difference at a glance
  36. 36. How to implement “Process Approach”  Identify Processes  Process Type?  Process Name?  Process Owner?
  37. 37. How to implement “Process Approach”  Identify Processes  Management Processes – Planning (Strategic & Operational) – Resource Management – Management Review
  38. 38. How to implement “Process Approach”  Identify Processes  Product Realization Processes – Contract Management – Transportation – Storage – Product Design
  39. 39. How to implement “Process Approach”  Identify Processes  Resource Provision Processes – Recruitment – Training – Maintenance – Payment – Document Control – Information Management
  40. 40. How to implement “Process Approach” Identify Processes  Monitoring & Measurement Processes – Internal Audit – Inspection – Testing
  41. 41. How to implement “Process Approach” Identify Processes  Monitoring & Measurement Processes – Internal Audit – Inspection – Testing
  42. 42. How to implement “Process Approach” Identify Processes  Name the Process – Purchase Process – Order Fulfillment Process – Training & Development Process
  43. 43. 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
  44. 44. How to implement “Process Approach” Define Processes Sequence & Interaction  Sequence Order Fulfilment Process
  45. 45. How to implement “Process Approach”  Define Processes Sequence & Interaction  Interaction Monitoring & Measurements Finance HRPlanning
  46. 46. 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
  47. 47. How to implement “Process Approach”  Implement & Measure the Processes  Analyze the Process  Take Corrective Actions to Improve Process
  48. 48. Process 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.”
  49. 49. Process 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
  50. 50. Process Mapping Techniques Make your goal to define three process states: – “As Is” –“To Be” –“Could Be”
  51. 51. Process 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.
  52. 52. Process 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.
  53. 53. Process 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.
  54. 54. Process 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.
  55. 55. Process Mapping Techniques  Hierarchical Process MappingHierarchical Process Mapping Macro/organization Level Process Mapping Micro/activity Level Process Mapping Middle Process Mapping
  56. 56. Process Mapping Techniques  Macro/organization Level Process MapMacro/organization Level Process Map – Mapping process commences fromMapping process commences from organizational level maps or macroorganizational level maps or macro level & hierarchically moves to thelevel & hierarchically moves to the detail or micro level of system.detail or micro level of system.
  57. 57. Process 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 fromprocesses for some selected from the organizational overviewthe organizational overview process maps into process levelprocess maps into process level maps.maps. – Purchase process map of aPurchase process map of a company is an example of middle-company is an example of middle- level process maplevel process map
  58. 58. Process Mapping Techniques  Activity/Detail Level or Map (Micro-Activity/Detail Level or Map (Micro- Level Process MapsLevel Process Maps – Usually, activity or detail levelUsually, activity or detail level process maps are constructed &process maps are constructed & analyzed preferably using flowanalyzed preferably using flow charting method.charting method.
  59. 59. Constructing 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 anDescribe the beginning step in an oval flowchart symboloval flowchart symbol Start
  60. 60. Constructing 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 theList 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
  61. 61. Constructing Process Flow Charts  Step 3:Step 3: Sequence the Process Steps – Determine the sequence of eachDetermine 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)
  62. 62. Constructing Process Flow Charts  Step 4:Step 4: Draw Appropriate Symbols –OvalOval It acts asIt acts as “Terminator”“Terminator” Shows input toShows input to startstart the processthe process or output at theor output at the endend of theof the process.process. Start End
  63. 63. Constructing Process Flow Charts  Step 4:Step 4: Draw Appropriate Symbols –Rectangle (“Box”)Rectangle (“Box”) RepresentsRepresents “Process/Sub-“Process/Sub- process”process” ShowShow “Task”“Task” oror “Activity”“Activity” performed in the processperformed in the process Activities
  64. 64. Constructing Process Flow Charts  Step 4:Step 4: Draw Appropriate Symbols –ArrowArrow Shows processShows process “Direction”“Direction” ofof flow.flow. Process directs fromProcess directs from “Tail”“Tail” to “Head”“Head” Activity A Activity B
  65. 65. Constructing Process Flow Charts  Step 4:Step 4: Draw Appropriate Symbols –DiamondDiamond Shows the point in processShows the point in process wherewhere “YES/NO”“YES/NO” decision isdecision is required.required. Pass? No Yes
  66. 66. Constructing Process Flow Charts  Step 4:Step 4: Draw Appropriate Symbols –DiamondDiamond If feed back Arrow is used makeIf 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
  67. 67. Constructing Process Flow Charts  Step 5:Step 5: Use System Model Approach – Draw charts usingDraw 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.
  68. 68. Constructing Process Flow Charts  Step 5:Step 5: Use System Model Approach – Draw charts usingDraw charts using “System Model“System Model Approach”Approach”.. ProcessProcess - use subsets of- use subsets of processes inprocesses in –Series orSeries or –Parallel.Parallel.
  69. 69. Constructing Process Flow Charts  Step 5:Step 5: Use System Model Approach – Draw charts usingDraw charts using “System Model“System Model Approach”Approach”.. OutputOutput use outcomes or desireduse outcomes or desired results.results. ControlControl use best in classuse best in class business rules.business rules. FeedbackFeedback use information fromuse information from surveys or feedback.surveys or feedback.
  70. 70. Constructing Process Flow Charts  Step 6:Step 6: Check for Completeness – Include pertinent chart informationInclude pertinent chart information Using title andUsing title and Date for easy reference.Date for easy reference.
  71. 71. Constructing Process Flow Charts  Step 7:Step 7: Finalize the Flowchart – Ask the followingAsk the following “questions”“questions” toto yourselfyourself If this process is being runIf this process is being run the way itthe way it should beshould be?? Are people following theAre people following the process asprocess as chartedcharted?? Do we have aDo we have a consensusconsensus?? What isWhat is redundantredundant?? – AddAdd what iswhat is missingmissing
  72. 72. Constructing Process Flow Charts  Sample of Flow ChartSample of Flow Chart Process Start Activity Decision? Activity Process Start FeedBackarrow
  73. 73. Keys to Successful Flowcharting  Start with Big Picture:Start with Big Picture: – Draw aDraw a “Macro”“Macro” level flowchart firstlevel flowchart first – Develop other diagrams forDevelop 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 & DrawArrange sequence of steps & Draw FlowchartFlowchart
  74. 74. Keys to Successful Flowcharting  Draw the FlowchartDraw the Flowchart – Draw aDraw a “Macro”“Macro” level flowchart firstlevel flowchart first – Develop other diagrams forDevelop 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 & drawArrange sequence of steps & draw flowchart.flowchart.
  75. 75. Keys Elements in Process Mapping  Select PeopleSelect People  Define ProcessDefine Process  Gather DataGather Data  Construct MapsConstruct Maps  Analyze MapsAnalyze Maps  Issue RecommendationsIssue Recommendations
  76. 76. Keys Elements in Process Mapping  Select PeopleSelect People – Select right people to create map.Select right people to create map. – Include personnel who can provideInclude personnel who can provide cross-functional perspectives:cross-functional perspectives: Knowledgeable about processKnowledgeable about process Interested in improving processInterested in improving process Available & motivated to stayAvailable & motivated to stay with the project until completionwith the project until completion
  77. 77. Keys Elements in Process Mapping  Define ProcessDefine Process – Decide which processes to mapDecide which processes to map first based on:first based on: Process impact on customer-Process impact on customer- perceived valueperceived value Processes that most contributeProcesses that most contribute to customer-perceived value toto customer-perceived value to be world-class or at leastbe world-class or at least competitively superior.competitively superior.
  78. 78. Keys 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 technologyObsolete or changing technology especially,especially, Information technology.Information technology. – Competitive ReasonsCompetitive Reasons
  79. 79. Keys Elements in Process Mapping  Gather DataGather Data – Three basic methods to collect theThree basic methods to collect the process information necessary toprocess information necessary to create a map:create a map: Self-generateSelf-generate One-on-one interviewsOne-on-one interviews Group interviewsGroup interviews
  80. 80. Keys Elements in Process Mapping  Construct MapsConstruct Maps – Start with the key elements ofStart with the key elements of process/the widest possibleprocess/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.
  81. 81. Questions/Feedback-Most Welcome  rashidpharmacist@yahoo.comrashidpharmacist@yahoo.com

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