4M Change &
Abnormal Handling
Procedure
Agenda
○ Purpose & Definitions
○ What is 4M
○ What is Process
○ 4M Change Category
○ 4M Change Process Flow
○ 4M Change Examples
○ 4M Change Handling Procedure
○ 4M Change Monitoring Criteria
○ 4M Change Communication System
○ 4M Change & Abnormal Conditions Management System
○ 4M Change Monitoring Sheet
○ 4M Change PDCA Cycle
○ Thanks Note
Purpose & Definition
Purpose
The Organization shall monitor
the effect of change in 4M (Man
, Machine, Material , Method )
Condition & Control the
situation which affecting the
finished product
Definition
Any Addition , Updation
or Deletion from pre-
Approved procedure is
called 4M Change.
4M (आदमी, मशीन, सामग्री, विधि) स्थिति में
परिवर्तन के प्रभाव की निगरानी करना और उस
स्थिति को नियंत्रित करना जो तैयार उत्पाद को
प्रभावित कर रहा है !
पूर्व-अनुमोदित प्रक्रिया में कोई भी जोड़,
अद्यतनीकरण या हटाना 4M परिवर्तन
कहलाता है !
Objective & Definition
Definition
A Condition that occurs in
a Process system When
an Operating Variable
(Flow , Temperature,
Pressure etc.) ranges
outside of its Normal
Operating Limits.
Objective
The Objective of
Abnormal Situation
Management is to Return
The Process to Normal
before Safety System and
Defects are Engaged
असामान्य स्थिति प्रबंधन का उद्देश्य
सुरक्षा प्रणाली और दोष उत्पन्न होने से
पहले प्रक्रिया को सामान्य स्थिति में
लौटाना है !
एक ऐसी स्थिति जो एक प्रक्रिया
प्रणाली में तब घटित होती
है जब एक ऑपरेटिंग वेरिएबल
(प्रवाह, तापमान, दबाव आदि)
अपनी सामान्य ऑपरेटिंग सीमाओं से
बाहर होता है
01
02
03
04
Man
Who works in a process to manufacture a Use full
Product
Machine
By Which a Product is being manufactured.
Material
Raw Material which is being used for
manufacture the Product
Method
The Method by which A product is being
produced.
What is 4M
These are the resources which is used to convert Input Material into Output Material.
What is Process
Process
A process of Activity which converts input material in output
material with the utilization of Available Resources.
These available Resources are called 4M. Man , Machine , Material
, Method
एक प्रक्रिया गतिविधि का एक समूह है जो उपलब्ध संसाधनों के
उपयोग के साथ इनपुट सामग्री को आउटपुट सामग्री में परिवर्तित
करती है।
इन उपलब्ध संसाधनों को 4M कहा जाता है।
Process (As per ISO 9001 :2015)
Process (GB Enterprises Pvt. Ltd.)
MotherCoil Slitting RollForming
Packing
FG Product
Dispatch
SlittingCoil
4M Change Category - Definition
Planned Change
When We have
information about
any change within
The Organization ,
It is called Planned
Change.
Unplanned
Change
When We do not
have information
about any change
within the
organization , It
is called
Unplanned
Change
Abnormal
Condition
When any
Undesired
condition occurs
against defined
Procedure , It is
called Abnormal
Condition.
असामान्य स्थिति –
जब कोई अवांछित
स्थिति निर्धारित प्रक्रिया
के विपरीत उत्पन्न होती
है तो उसे असामान्य
स्थिति कहा जाता है।
अनियोजित परिवर्तन -
जब हमें किसी परिवर्तन
के बारे में कोई
जानकारी नहीं होती
तो उसे अनियोजित
परिवर्तन कहा जाता है।
नियोजित परिवर्तन –
जब हमारे पास किसी
परिवर्तन की जानकारी
होती है तो उसे नियोजित
परिवर्तन कहा जाता है
4M Change Process Flow
Set Up Approval
Category
Planned Change
Unplanned Planned
Change
Abnormal Change
4M Change
Start Production
Set Up Approval
Start Production
Retro-Active
Checking
Set Up Approval
Start Production
Identify Suspected
Lot
Method Material
Man Machine
4M
Example
4M Change Examples
Are the Work Standard Adequate
Is the Work Standard Adequate
Is it a Safe Method
Is it a Method that ensures a Good Product
Is it an efficient method
Is the Sequence of work adequate
Is the set up adequate
Are the temperature and humidity adequate
Are the lighting and ventilation adequate
Is there adequate contact with the previous
and next processes
Does he follow standard.
Is his work efficiency acceptable
Is he problem conscious
Is he responsible / accountable
Is he qualified
Is he experienced
Is he assigned to the right job
Is he willing to improve
Does He maintain Good Human Relations
Is he fit & Healthy
Does it meet production requirements.
Does it meet process capabilities.
Si the lubrication adequate
Is the inspection adequate
Is operation Interrupted due to machine trouble.
Does It meet precision requirements.
Does it make any unusual noises
Is the layout Adequate
Are there enough machines / facilities
Is everything in Good Working order
Are there any mistakes in Volume.
Are there any mistakes in Grade
Are there any mistakes in brand Name
Are there impurities mixed in
Is the Inventory Level Adequate
Is there any waste in material
Is the Storage Layout Adequate
Is the Quality Standard Adequate
4M Change Handling Procedure
4M Change Handling Procedure
4M Change Monitoring Criteria
Set Up Approval to be done
Planned Changes
100% Visual Inspection
Move to Next Operation
Set Up Approval to be done
Unplanned Change
100% Retroactive
Inspection to be done
100%Visual Inspection to
be done of Suspected Lot
Move to next Operation
4M Change Escalation (Information) Flow
Monitoring Criteria
Inform To Concern
Supervisor (Operator)
Planned Change
Concern Supervisor takes
approval from concern
Head
Fill the 4M Change Request
Form
Production Sup. Inform to
QA Head by 4M Change
Req. Form
Verify the change by Set Up
Approval
100% Visual Inspection
Inform To Concern
Supervisor (Operator)
Unplanned Change
Concern Supervisor takes
approval from concern
Head
Fill the 4M Change Request
Form
Production Sup. Inform to
QA Head by 4M Change
Req. Form
Verify the change by Set Up
Approval
100% Visual Inspection of
Suspected Lot
Start of Production
by Quality Sup.
100% Retroactive
Inspection
4M Change & Abnormal Situation Management
4M Change & Abnormal Situation Management
4M Change & Abnormal Situation Management
4M Change & Abnormal Situation Management
4M Change Monitoring Sheet
ACT CHECK
PLAN DO
4M
PDCA
Cycle
Plan-Do-Check-Act for 4M Change
Take Preventive
Actions as required
Define the 4M Change
Monitoring Procedure
Implement the 4M
Procedure
Monitor 4M Conditions &
Check Effectiveness
Thanks!
Any questions?

4M CHANGE & ABNORMAL CONDITION TRAINING final.pptx

  • 1.
    4M Change & AbnormalHandling Procedure
  • 2.
    Agenda ○ Purpose &Definitions ○ What is 4M ○ What is Process ○ 4M Change Category ○ 4M Change Process Flow ○ 4M Change Examples ○ 4M Change Handling Procedure ○ 4M Change Monitoring Criteria ○ 4M Change Communication System ○ 4M Change & Abnormal Conditions Management System ○ 4M Change Monitoring Sheet ○ 4M Change PDCA Cycle ○ Thanks Note
  • 3.
    Purpose & Definition Purpose TheOrganization shall monitor the effect of change in 4M (Man , Machine, Material , Method ) Condition & Control the situation which affecting the finished product Definition Any Addition , Updation or Deletion from pre- Approved procedure is called 4M Change. 4M (आदमी, मशीन, सामग्री, विधि) स्थिति में परिवर्तन के प्रभाव की निगरानी करना और उस स्थिति को नियंत्रित करना जो तैयार उत्पाद को प्रभावित कर रहा है ! पूर्व-अनुमोदित प्रक्रिया में कोई भी जोड़, अद्यतनीकरण या हटाना 4M परिवर्तन कहलाता है !
  • 4.
    Objective & Definition Definition ACondition that occurs in a Process system When an Operating Variable (Flow , Temperature, Pressure etc.) ranges outside of its Normal Operating Limits. Objective The Objective of Abnormal Situation Management is to Return The Process to Normal before Safety System and Defects are Engaged असामान्य स्थिति प्रबंधन का उद्देश्य सुरक्षा प्रणाली और दोष उत्पन्न होने से पहले प्रक्रिया को सामान्य स्थिति में लौटाना है ! एक ऐसी स्थिति जो एक प्रक्रिया प्रणाली में तब घटित होती है जब एक ऑपरेटिंग वेरिएबल (प्रवाह, तापमान, दबाव आदि) अपनी सामान्य ऑपरेटिंग सीमाओं से बाहर होता है
  • 5.
    01 02 03 04 Man Who works ina process to manufacture a Use full Product Machine By Which a Product is being manufactured. Material Raw Material which is being used for manufacture the Product Method The Method by which A product is being produced. What is 4M These are the resources which is used to convert Input Material into Output Material.
  • 6.
    What is Process Process Aprocess of Activity which converts input material in output material with the utilization of Available Resources. These available Resources are called 4M. Man , Machine , Material , Method एक प्रक्रिया गतिविधि का एक समूह है जो उपलब्ध संसाधनों के उपयोग के साथ इनपुट सामग्री को आउटपुट सामग्री में परिवर्तित करती है। इन उपलब्ध संसाधनों को 4M कहा जाता है।
  • 7.
    Process (As perISO 9001 :2015)
  • 8.
    Process (GB EnterprisesPvt. Ltd.) MotherCoil Slitting RollForming Packing FG Product Dispatch SlittingCoil
  • 9.
    4M Change Category- Definition Planned Change When We have information about any change within The Organization , It is called Planned Change. Unplanned Change When We do not have information about any change within the organization , It is called Unplanned Change Abnormal Condition When any Undesired condition occurs against defined Procedure , It is called Abnormal Condition. असामान्य स्थिति – जब कोई अवांछित स्थिति निर्धारित प्रक्रिया के विपरीत उत्पन्न होती है तो उसे असामान्य स्थिति कहा जाता है। अनियोजित परिवर्तन - जब हमें किसी परिवर्तन के बारे में कोई जानकारी नहीं होती तो उसे अनियोजित परिवर्तन कहा जाता है। नियोजित परिवर्तन – जब हमारे पास किसी परिवर्तन की जानकारी होती है तो उसे नियोजित परिवर्तन कहा जाता है
  • 10.
    4M Change ProcessFlow Set Up Approval Category Planned Change Unplanned Planned Change Abnormal Change 4M Change Start Production Set Up Approval Start Production Retro-Active Checking Set Up Approval Start Production Identify Suspected Lot
  • 11.
    Method Material Man Machine 4M Example 4MChange Examples Are the Work Standard Adequate Is the Work Standard Adequate Is it a Safe Method Is it a Method that ensures a Good Product Is it an efficient method Is the Sequence of work adequate Is the set up adequate Are the temperature and humidity adequate Are the lighting and ventilation adequate Is there adequate contact with the previous and next processes Does he follow standard. Is his work efficiency acceptable Is he problem conscious Is he responsible / accountable Is he qualified Is he experienced Is he assigned to the right job Is he willing to improve Does He maintain Good Human Relations Is he fit & Healthy Does it meet production requirements. Does it meet process capabilities. Si the lubrication adequate Is the inspection adequate Is operation Interrupted due to machine trouble. Does It meet precision requirements. Does it make any unusual noises Is the layout Adequate Are there enough machines / facilities Is everything in Good Working order Are there any mistakes in Volume. Are there any mistakes in Grade Are there any mistakes in brand Name Are there impurities mixed in Is the Inventory Level Adequate Is there any waste in material Is the Storage Layout Adequate Is the Quality Standard Adequate
  • 12.
  • 13.
  • 14.
    4M Change MonitoringCriteria Set Up Approval to be done Planned Changes 100% Visual Inspection Move to Next Operation Set Up Approval to be done Unplanned Change 100% Retroactive Inspection to be done 100%Visual Inspection to be done of Suspected Lot Move to next Operation
  • 15.
    4M Change Escalation(Information) Flow Monitoring Criteria Inform To Concern Supervisor (Operator) Planned Change Concern Supervisor takes approval from concern Head Fill the 4M Change Request Form Production Sup. Inform to QA Head by 4M Change Req. Form Verify the change by Set Up Approval 100% Visual Inspection Inform To Concern Supervisor (Operator) Unplanned Change Concern Supervisor takes approval from concern Head Fill the 4M Change Request Form Production Sup. Inform to QA Head by 4M Change Req. Form Verify the change by Set Up Approval 100% Visual Inspection of Suspected Lot Start of Production by Quality Sup. 100% Retroactive Inspection
  • 16.
    4M Change &Abnormal Situation Management
  • 17.
    4M Change &Abnormal Situation Management
  • 18.
    4M Change &Abnormal Situation Management
  • 19.
    4M Change &Abnormal Situation Management
  • 20.
  • 21.
    ACT CHECK PLAN DO 4M PDCA Cycle Plan-Do-Check-Actfor 4M Change Take Preventive Actions as required Define the 4M Change Monitoring Procedure Implement the 4M Procedure Monitor 4M Conditions & Check Effectiveness
  • 22.