Amit Lunia

QMS India Limited

www.qmsil.co.in

PFD, FMEA and Control Plan

Amit Lunia
QMS India Limited
1
 Quality of Events.

• For all 23 elements, quality expectations are

defined in the guideline
• Out of these 23 elements, the following 8 elements
are considered as focus elements;
Design FMEA Process FMEA
Design Verification Plan Pre-Launch Control Plan
Prototype Build Control Plan Operator Process Instructions
Manufacturing Process Flow Chart Production Control Plan

• These elements when completed with ‘Quality’ and

“On Time” lay a foundation for Programme success

Amit Lunia 2
QMS India Limited
 What is a Flowchart?

• A Flowchart is a diagram that uses graphic symbols

to depict the nature and flow of the steps in a
process. Another name for this tool is "flow
diagram.“
• A Process Flow Chart / Map is a graphical means to
reduce complex processes into bite-sized and
understandable elements to perform analysis
(PFMEA , Simulation, and Continuous
Improvement).
Amit Lunia
QMS India Limited
 FLOW CHARTS

What is a Flow chart ?

 Graphical representations of a process.
 Sequential flow of processes & sub-process.
 Process steps shown with symbolic shapes.
 Process flow indicated by arrows & symbols.
To determine how a process currently functions.

 To determine how a process could ideally function.

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QMS India Limited 4
 7 QC TOOLS

The 7 QC Tools;

 Flow chart

 Check sheet

Q
 Histogram

 Pareto Diagram

 Cause & Effect

 Scatter diagram

 Control charts and . . . .

Amit Lunia
QMS India Limited
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 When to use Flow chart
• At the beginning of the process improvement efforts, an
as-is Flowchart helps the team and others involved in
the process to understand how it currently works.
• The team may find it helpful to compare this as-is
Flowchart with a diagram of the way the process is
supposed to work.
• Later, the team will develop a Flowchart of the modified
process—again, to record how it actually functions.
• At some point, the team may want to create an ideal
Flowchart to show how it would ultimately like the
process to be performed.
Amit Lunia
QMS India Limited
FLOW CHARTS - SYMBOLS

Operation

Inspection

Transportation

Delay

Storage

Amit Lunia
QMS India Limited 7
 Defining Flow Chart Symbols

PROCESS DOCUMENT Off Page

INPUT/ OUTPUT DECISION CONNECTOR

Amit Lunia
QMS India Limited
 How To
• Identify the right people to develop the chart.
• Determine what you expect to get from the
Flowchart.
• Identify who will use it and how.
• Define the level of detail you need.
• Establish the boundaries of the process to be
improved

Amit Lunia
QMS India Limited
 How To
• Start with the big picture
• Observe the current process
• Record process steps
• Arrange the sequence of steps
• Draw the Flowchart

Amit Lunia
QMS India Limited
 Inputs for Process Flow Chart

• Customer prints or CAD transmission

• In-process prints
• Plant layout
• Problem reports and logs
• System and Design FMEA
• Process FMEA from a similar product or
process

Amit Lunia
QMS India Limited 11
 Process Flow Chart - Other Documents

• Other documents that could be partially or

fully completed at the same time are,
– Floor Plan
– Characteristics Matrix (Optional)
– List of Special Product & Process Characteristics
– A baseline knowledge of each operation

BACK
Amit Lunia
QMS India Limited 12
 Why?

It is useful in,
– Showing the Process Operation Graphically
– Determine what outcomes are desirable from each step
– analysing sources of variations
– of machines , materials, methods and manpower
– from beginning to the end
– Helps in analysing total process than individual
steps

BACK
Amit Lunia
QMS India Limited 13
 Preparing a Process Flow Chart

• Process Flow Chart must be detailed enough that people

outside the Team can use it like a map to walk through the
process
• PFC Format includes :
– Operation No.
– Operation Description
– Operation Symbols
– Product Characteristic
– Process Characteristic
– Characteristics
– Open Issue

Amit Lunia
QMS India Limited 14
 Benefits of using Flowcharts

• Promote understanding of complex processes

and the functional interfaces, station to
station.
• Define Ownership of process
• Provide a tool for training employees.
• Identify problem areas and opportunities for
process improvement.
• Depict customer-supplier relationships
Amit Lunia
QMS India Limited
 Benefits of a process flow

It can be used as tool in many contexts :

• Bottleneck analysis.
• As foundation for remaining process review documents
– PFMEA -Control Plan
• It also meet selected TS requirements like, 4.2.3, PPAP
• Create Visual map of process.

• To identify time lags & NVA steps.

• Determine major & minor inputs in the process

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QMS India Limited 16
 Continuous Improvements
• Process Flow Chart gives an excellent
opportunity to look for weaknesses/
improvement
• Quality
– Is current process capable
• Cost
– Any non-value added steps
• Ergonomics
– Any ways of reducing operator fatigue

BACK
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QMS India Limited 17
 Sample Flow Charts
• Flow Chart of Ball bearing
• PFD as per TS requirements

Amit Lunia
QMS India Limited 18