Process approach

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?


These indications point to a quality

management system (QMS) that has

generally LOST ITS FOCUS.


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 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.


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)


Consequences are– A series of “Complex Chains” or interactions

between departments or divisions;



– Unclear relationship between INPUTS, RESOURCES & Outputs;



– People competing (fighting) for resources;

Function-based Management (continued)


Functional……..Complicated Processes



– 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)



Organizational Structure defined based on functional units.. (complicated & hierarchical)



Functional………..As Marketing Requested It



Functional………..As Sales ordered it



Functional………..As Engineering designed it



Functional………..As Production Manufactured it



Functional………..As Plant installed it



Functional………..

What the customer wanted



What is Wrong………..????



This is the reason:– Process disconnection across departments in an

organization with functional orientation.



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


A process approach is thus a powerful way of organizing and managing activities to create value for the customer and other interested parties.


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


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 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


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 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?


Identify Processes


– Planning (Strategic & Operational)

– Resource Management

– Management Review


Identify Processes

Product Realization Processes

– Contract Management

– Transportation

– Storage

– Product Design


Identify Processes

Resource Provision Processes

– Recruitment

– Training

– Maintenance

– Payment

– Document Control

– Information Management


Identify Processes

Monitoring & Measurement Processes

– Internal Audit

– Inspection

– Testing


Identify Processes

Name the Process

– Purchase Process

– Order Fulfillment Process

– Training & Development Process


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


Define Processes Sequence & Interaction

Sequence

Order Fulfilment Process


Define Processes Sequence & Interaction Interaction

Monitoring & Measurements

Finance HRPlanning


Plan the Processes

Define the activities within process

Define monitoring & measurement requirements

Define the resources needed

Verify processes against planned objectives


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”


““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.


““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.


““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.


““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.


Hierarchical Process MappingHierarchical Process Mapping

Macro/organization Level Process Mapping

Micro/activity Level Process Mapping

Middle Process Mapping


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.


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


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


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


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)





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



–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



–ArrowArrowShows process Shows process “Direction” “Direction” of of

flow.flow.Process directs fromProcess directs from “Tail”“Tail” to

“Head”“Head”

Activity A Activity B



–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



–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


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.


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.


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.


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.


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


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


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


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.


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


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


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

[email protected]@yahoo.com

Process approach

Health & Medicine

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