Doc. No.

SVST/WI-4M

Org. Date 02.01.2018

4M CHANGE MANAGEMENT AND ABNORMAL SITUATION CONTROL STANDARD
Rev. No./Date 02/ 03.08.2018

Expected Change UnExpected Change

Abnormal Situation Activities To Be Conducted
(Planned Change) (UnPlanned Change)
4M Change Description

Proactive Inspection/ Suspected Lot

ACTION TAKEN Set Up Approval Retroactive Inspection
Containment Action
Customer Approval
Identification
Reporting method

Inprocess Inspection report,

Inpropcess Inspection Containment Action will be
No No Not Required Proactive report & 4M change
report taken on all lots
request
Operator of same skill
Operator On Leave deputed
With Information
1. Identify lot with 4M Tag Inprocess Inspection report,
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts Proactive report, 4M change
No No
report taken on all lots in 4M Area request & Abnormal situation
Operator of under skill 3. Record Outward DC No. Record
deputed

Inprocess Inspection report,

Inpropcess Inspection Containment Action will be
No No Not Required Proactive report & 4M change
report taken on all lots
request
Operator On Leave Operator of same skill
Without deputed
Information
Inprocess Inspection report,
Inpropcess Inspection Containment Action will be Proactive report, 4M change
No No Not Required
report taken on all lots request & Abnormal situation
Operator of under skill Record
deputed

1. Identify lot with 4M Tag

Retroactive inspection Inprocess Inspection report ,Retro
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts
will be taken on the all No active report , Proactive report &
report taken on all lots in 4M Area & Record
lots 4M change request
Operator suddenly Operator of same skill Outward DC No.
leave work place deputed
due to
MAN accident/illness
1. Identify lot with 4M Tag Inprocess Inspection report ,Retro
Retroactive inspection
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts active report , Proactive report,
will be taken on the all No
report taken on all lots in 4M Area & Record 4M change request & Abnormal
lots
Outward DC No. Situation
Operator of under skill
deputed

1. Identify lot with 4M Tag

Inprocess Inspection report ,Retro
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts
New Operator report
No
taken on all lots
No
in 4M Area & Record
active report , Proactive report,
4M change request
Outward DC No.
Operator under
survillance

Inprocess Inspection report,

Inpropcess Inspection Containment Action will be
No No Not Required Proactive report & 4M change
report taken on all lots
request
Operator of same skill
Interchange of deputed
Operator in Other
Line
1. Identify lot with 4M Tag Inprocess Inspection report,
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts Proactive report, 4M change
No No
report taken on all lots in 4M Area & Record request & Abnormal situation
Operator of under skill Outward DC No. Record
deputed

Operator working 1. Identify lot with 4M Tag

Inprocess Inspection report ,Retro
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts
after greater than 30 report
No
taken on all lots
No
in 4M Area & Record
active report , Proactive report,
days leave Outward DC No.
4M change request
Operator under
survillance

Containment Action will be Inprocess Inspection report,

Inpropcess Inspection
No taken for lots after No Not Required Proactive report & 4M change
Production shifted to report
1 Hour request
same capacity
Machine/Bath under Machine / Bath
preventive
maintenance
Inprocess Inspection report,
Containment Action will be
Inpropcess Inspection Proactive report, 4M change
No taken for lots after No Not Required
report request & Abnormal situation
Production shifted to 1 Hour
Record
higher/lower capacity
Machine /Bath

1. Identify lot with 4M Tag

Retroactive inspection Containment Action will be Inprocess Inspection report ,Retro
Inpropcess Inspection 2. 100% Inspect the parts
will be taken for lots taken for lots after No active report , Proactive report &
report in 4M Area & Record
before 1 Hour 1 Hour 4M change request
Outward DC No.
Machine/Bath under Production done in
breakdown same Machine / Bath

1. Identify lot with 4M Tag Inprocess Inspection report ,Retro

Retroactive inspection Containment Action will be
Inpropcess Inspection 2. 100% Inspect the parts active report , Proactive report,
will be taken for lots taken for lots after Yes
report in 4M Area & Record 4M change request & Abnormal
Production shifted to before 1 Hour 1 Hour
Outward DC No. Situation
higher/lower capacity
Machine /Bath

MACHINE
1. Identify lot with 4M Tag
Power Failure with Inpropcess Inspection
Retroactive inspection Containment Action will be
2. 100% Inspect the parts
Inprocess Inspection report,
DG breakdown will be taken for lots taken for lots after Yes Proactive report & 4M change
report in 4M Area & Record
Production stopped before 1 Hour 1 Hour request
Outward DC No.
and starts with
temporary rently DG

Containment Action will be Inprocess Inspection report,

Inpropcess Inspection
New Machine report
No taken on the lots in the No Not Required Proactive report & 4M change
bath request
Production done with
New Machine

Jig/Fly bar under Inpropcess Inspection

Containment Action will be Inprocess Inspection report,
preventive report
No taken for all lots on that No Not Required Proactive report & 4M change
maintenance Production done with Jig request
Spare of
Jig/ Fly bar

1. Identify lot with 4M Tag

Jig/ Fly bar under Inpropcess Inspection
Containment Action will be
2. 100% Inspect the parts
Inprocess Inspection report ,Retro
breakdown report
No taken for all lots on that No
in 4M Area & Record
active report , Proactive report &
Production done with Jig 4M change request
Outward DC No.
Spare of
Jig/ Fly bar

Material(Chemicals) Inprocess Inspection report,

received from Inpropcess Inspection
No
Containment Action will be
No Not Required Proactive report & 4M change
other approved source Start production report taken on the all lots
request
after set up
MATERIAL approval

Material(Chemicals) 1. Identify lot with 4M Tag

Inprocess Inspection report,
received from Start production
Inpropcess Inspection
No
Containment Action will be
Yes
2. 100% Inspect the parts
Proactive report & 4M change
Un-approved source / report taken on the all lots in 4M Area & Record
request
Rejected Chemicals after set up Outward DC No.
approval & Customer
approval

1. Identify lot with 4M Tag

Containment Action will be Inprocess Inspection report,
Program sequence Inpropcess Inspection
No taken for all lots on that Yes
2. 100% Inspect the parts
Proactive report & 4M change
Change report
program
in 4M Area & Record
request
Outward DC No.
Production done
with temporary altered
program sequence.

1. Identify lot with 4M Tag

Retroactive inspection Inprocess Inspection report,
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts
Inspection Instrument will be taken for all lots Yes Proactive report & 4M change
report taken for all lots in 4M Area & Record
failed /Malfunctioning before malfunctioning
Outward DC No.
request
Inspection done with
corrected and
recalibrated.

1. Identify lot with 4M Tag

Retroactive inspection Containment Action will be Inprocess Inspection report,
Inpropcess Inspection 2. 100% Inspect the parts
will be taken for lots taken for lots after No Proactive report & 4M change
Poka Yoke Not Working report
before 1 Hour 1 Hour
in 4M Area & Record
request
Outward DC No.
Production done with
corrected the Poka
Yoke.

1. Identify lot with 4M Tag

Retroactive inspection Containment Action will be Inprocess Inspection report,
Inpropcess Inspection 2. 100% Inspect the parts
will be taken for lots taken for lots after Yes Proactive report & 4M change
Lot Rejection report
before 1 Hour 1 Hour
in 4M Area & Record
request
Outward DC No.

Production done with

METHOD corrected the process.

1. Identify lot with 4M Tag

Part fallen down while Retroactive inspection Containment Action will be Inprocess Inspection report,
Inpropcess Inspection 2. 100% Inspect the parts
will be taken for lots taken for lots after Yes Proactive report & 4M change
handling happened in report
before 1 Hour 1 Hour
in 4M Area & Record
request
machine Outward DC No.

Production done with

corrected the machine.

Location /Layout /
1. Identify lot with 4M Tag
Re located Plant Inprocess Inspection report,
Inpropcess Inspection Containment Action will be 2. 100% Inspect the parts
No Yes Proactive report & 4M change
report taken for all Lots in 4M Area & Record
request
Outward DC No.

Production done with

altered location

Jigging method Change 1. Identify lot with 4M Tag

Containment Action will be Inprocess Inspection report,
Inpropcess Inspection 2. 100% Inspect the parts
No taken for all Lots in that Yes Proactive report & 4M change
report in 4M Area & Record
method request
Outward DC No.

Production done with

altered position of jig

Machine/ Bath Retroactive inspection Containment Action will be

1. Identify lot with 4M Tag Inprocess Inspection report ,Retro
parameters found out of Inpropcess Inspection 2. 100% Inspect the parts active report , Proactive report,
will be taken for lots taken for lots after Yes
spec. during routine report in 4M Area & Record 4M change request & Abnormal
Production done before 1 Hour 1 Hour
Outward DC No. Situation
checking with the corrected
condition

RESPONSIBILITY : PRODUCTION SUPERVISOR CHANGE APPROVAL AUTHORITY : QUALITY HEAD

Definition of Retroactive Inspection : The process of inspection carried out for the parts produced before the failure/change(Backward Process). Duration or Lot Size will be given detailed in the matrix.
Definition of Proactive Inspection: The process of inspection carried out for the parts produced after the failure/change(Forward Process). Duration or Lot Size will be given detailed in the matrix.
Definition of Containment Action: We Consider here proactive inspection itself has containment.

REMARKS :

Revision History
Rev No. Reason for Revision Rev Date Prepared By Verified By Approved By
00 New Release 02.01.2018 R.P.Dinakaran R. Murali Krishnan P.Suresh

01 Actions and Abnormal Situation included 20.03.2018 R.P.Dinakaran R. Murali Krishnan P.Suresh

02 Definition for Retroactive and Proactive/Containment action is added 03.08.2018 R.P.Dinakaran R. Murali Krishnan P.Suresh