The document discusses implementing a process approach to quality management. It begins by explaining that adopting a process approach can help organizations regain focus on continuous improvement if their quality management system has lost effectiveness over time. Key points include: - Identifying the organization's processes, process owners, and how processes interact and flow. - Planning processes, defining activities and requirements, and verifying against objectives. - Implementing and measuring processes, analyzing results, and taking corrective actions to improve. - Process mapping techniques like documenting the "as is", "to be", and "could be" states of processes can aid analysis and redesign.

1. Process Approach to Quality
Management System
[Rashid Mahmood]
Neutro Pharma (Pvt.) Limited
Lahore, Pakistan

2. Objective
Understanding the concept of
“Process Approach” &
techniques/skills to
implement this approach.

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. 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. But, WHYdoes this occur?
Key Issue (Continued)
 These indications point to a quality
management system (QMS) that has
generally LOST ITS FOCUS.

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. 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. 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. 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. 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. A Generic Process (continued)
 Process effectiveness and efficiency can be
assessed through internal or external review
processes.

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. 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. Function-based Management (continued)
(A Traditional, Prevailing Style)
 Consequences are
– A series of “Complex Chains” or interactions
between departments or divisions;

15. Function-based Management (continued)
(A Traditional, Prevailing Style)
–Unclear relationship between
INPUTS, RESOURCES & Outputs;

16. Function-based Management (continued)
(A Traditional, Prevailing Style)
–People competing (fighting) for
resources;

17. Function-based Management (continued)
 Functional……..Complicated Processes

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. Function-based Management (continued)
 Organizational Structure defined based on
functional units.. (complicated & hierarchical)

20. Function-based Management (continued)
 Functional………..
As Marketing Requested It

21. Function-based Management (continued)
 Functional………..
As Sales ordered it

22. Function-based Management (continued)
 Functional………..
As Engineering designed it

23. Function-based Management (continued)
 Functional………..
As Production Manufactured it

24. Function-based Management (continued)
 Functional………..
As Plant installed it

25. Function-based Management (continued)
 Functional………..
What the customer wanted

26. Function-based Management (continued)
What is Wrong………..????

27. Function-based Management (continued)
 This is the reason:
– Process disconnection across departments in an
organization with functional orientation.

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. 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. 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. 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. 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. 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. Process Approach
Process linkage across departments in an
organization with process orientation

35. Process Approach Vs Functional Approach
Difference at a glance

36. How to implement “Process Approach”
 Identify Processes
 Process Type?
 Process Name?
 Process Owner?

37. How to implement “Process Approach”
 Identify Processes
 Management Processes
– Planning (Strategic & Operational)
– Resource Management
– Management Review

38. How to implement “Process Approach”
 Identify Processes
 Product Realization Processes
– Contract Management
– Transportation
– Storage
– Product Design

39. How to implement “Process Approach”
 Identify Processes
 Resource Provision Processes
– Recruitment
– Training
– Maintenance
– Payment
– Document Control
– Information Management

40. How to implement “Process Approach”
Identify Processes
 Monitoring & Measurement Processes
– Internal Audit
– Inspection
– Testing

41. How to implement “Process Approach”
Identify Processes
 Monitoring & Measurement Processes
– Internal Audit
– Inspection
– Testing

42. How to implement “Process Approach”
Identify Processes
 Name the Process
– Purchase Process
– Order Fulfillment Process
– Training & Development Process

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. How to implement “Process Approach”
Define Processes Sequence &
Interaction
 Sequence
Order Fulfilment Process

45. How to implement “Process Approach”
 Define Processes Sequence & Interaction
 Interaction
Monitoring & Measurements
Finance HRPlanning

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. How to implement “Process Approach”
 Implement & Measure the Processes
 Analyze the Process
 Take Corrective Actions to Improve
Process

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. 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. Process Mapping Techniques
Make your goal to define three
process states:
– “As Is”
–“To Be”
–“Could Be”

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. 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. 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. 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. Process Mapping Techniques
 Hierarchical Process MappingHierarchical Process Mapping
Macro/organization Level Process Mapping
Micro/activity Level Process Mapping
Middle Process Mapping

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Constructing Process Flow Charts
 Sample of Flow ChartSample of Flow Chart
Process Start
Activity
Decision?
Activity Process Start
FeedBackarrow

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. 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. Keys Elements in Process Mapping
 Select PeopleSelect People
 Define ProcessDefine Process
 Gather DataGather Data
 Construct MapsConstruct Maps
 Analyze MapsAnalyze Maps
 Issue RecommendationsIssue Recommendations

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. 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. 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. 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. 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. Questions/Feedback-Most Welcome
 rashidpharmacist@yahoo.comrashidpharmacist@yahoo.com