4M Change Management

1
Agenda:
1. Explanation of a 4M Change
2. Why is 4M Change Management Necessary
3. 4M Change Management System
4. Benefits of 4M Change Management
5. Nissan’s Minimum Requirements

2
What is a 4M Change?
A 4M Change is as any change (planned or unexpected) in:
MAN MACHINE
People who transport, Equipment that
build, assemble, or manufactures goods
inspect goods

MATERIAL METHOD
Raw goods or parts The way the parts are
used to manufacture manufactured,
products inspected, or handled

3
Examples of MAN changes

Planned
1. New Hire
2. Adding a new shift
3. New Team Leader
4. Adding/Removing an operator to improve cycle
time or cost/pc

Unplanned
1. New, untrained, or unfamiliar operator/team
leader due to:
1. Absenteeism
2. Illness
3. Injury
4. Unplanned termination
5. Vacation
2. Adding an operator / running process short
handed to time to make a shipment

4
Examples of MACHINE changes

Planned
1. New equipment, dies, jigs, etc.
2. Introduction of a Poke-yoke
3. Equipment lay-out (location) change
4. PM
5. Parameter Adjustment

Unplanned
1. Tool Break
2. Die crash
3. Poke-Yoke bypass
4. Equipment down time
i.e. Sensor replacement
5. Parameter adjustment
1. Within or out side of a set range

5
Examples of MATERIAL changes

Planned
1. New Tier N Supplier
2. Tier N supplier location change
3. Design change
4. Initial run of newly PPAP’ed parts
5. Packaging / Shipping change

Unplanned
1. Lot to lot variation
1. Visually
2. Dimensionally
2. Re-work
3. Inventory shortage
4. Packaging shortage

6
Examples of METHOD changes

Planned
1. Kaizen process flow change to improve cycle time /
throughput
2. New/Revised work instruction, SOS, Inspection
criteria, etc.
3. Permanent change in operator tool (Air -> Battery)
4. Reduced/Added inspection
Unplanned
1. Temporary switch from auto to manual
2. Temporary change in operator tools
3. Additional inspection criteria due to quality
issue/1-point lesson
4. Temporary change in the process flow

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Why is a 4M management system
necessary?

If people making the 4M change do not understand the

quality impact of the change, then the quality of the finished
product can not be ensured.

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Example１
What’s missing for this process change?

Failure：Defect happened at a new operator’s station

 Defect received ：Part was assembled wrong

 Causative change ：New operator

 Reason for change? ：New operator placed on the line after orientation

 What’s missing？ ：Inspection at the next process was not conducted and
operation observation not conducted.

Ok, it seems I didn’t know that

easy. I can it could be
handle it. assembled wrong
You can start
with this
machine
because it’s a
simple I thought it looked
Leader process. New
ok, no one told me
Operator that it was wrong…
Example１（Answer example）
What’s missing for this process change?
Failure：Defect happened at new operator’s station
 Defect received ：Part was assembled wrong

 Causative change ：New operator

 Reason for ：New operator placed on the line after orientation
change?
：Inspection at the next process was not conducted
 What’s missing？ and operation observation not conducted.

＜Key point＞
Prod.：Higher frequency of operation observation is required after new operator training.
Prod.・QA：Sharing of new operator placement information is required.
Prod.：Extra inspection is needed at the next process.
QA： Special inspection at final inspection process is required. Operation process
is OK! Product
handling is good!

<Info sharing by 4M board>

New Operator in xx line
Prod. :Training & Observation
QA ：Special inspection

I understand!

4M control board Training & Observation

Example２
What’s missing for this process change?

Failure：Missing nut defect due to the Poke-Yoke equipment in bypass

 Defect received ：Missing welding nut

 Causative change ：Poke-Yoke was put in bypass by maintenance during a repair

 Reason for ：Sensor was broke during repair and maintenance couldn’t cycle m/c
change?
：？
 What’s missing？
Part presence sensor There is Poke-Yoke for
OK！ missing nuts, we don’t
have to check for it !

OK！
Example２（Answer form）
What’s missing for this process change?
Failure：Missing nut defect due to the Poke-Yoke equipment in bypass

 Defect received ：Missing welding nut

 Causative change ：Poke-Yoke was put in bypass by maintenance during a repair

 Reason for change? ：Sensor was broke during repair and maintenance couldn’t cycle
m/c
 What’s missing？
：

＜Action of related department＞

：
：
：
：
：
Example２（Answer example）
What’s missing for this process change?

Failure：Missing nut defect due to the Poke-Yoke equipment in bypass

 Defect received ：Missing welding nut

 Causative change ：Poke-Yoke was put in bypass by maintenance during a repair

 Reason for change?：Sensor was broke and maintenance couldn’t cycle machine

 What’s missing？ ：No Poke-Yoke verification or added inspection after machine repair

＜Key point＞
Prod. ：Conduct start-up check for missing nut with OK/NG sample (Red Rabbit) after repair
Eng., QA：Stop a line until repair is completed on NG sensor
QA：Quarantine parts back to last know good parts and verify NG part flow out to customer or next
process
Prod., QA：Add 100% inspection when parts have to be made in bypass
In case of production when
Sensor detected in bypass: Look!
missing nut.
Conduct 100% Missing nut!
Sensor is OK!
inspection until
repair is
completed

NG！
OK/NG Sample
Red rabbit
Start-up check 100% inspection
NG Sample
Example３
What’s missing for this process change?

Failure：NG part created after adjusting a welding jig

 Defect received ：Dimensionally NG parts received

 Causative change ：Welding jig improvement (Adjusted the clearance between the parts and jig to
improve the part insertion）

 Reason for ：Improvement to the loading process

change?
：
？
 What’s missing？ I have a
It’s hard grinder.
Lets fix Parts are not
to put
parts in it! secure and can move
this jig… because of the
adjustment…

At Shop floor After improvement

Example３（Answer form）
What’s missing for this process change?
Failure：NG part created after adjusting a welding jig

 Defect received ：Dimensionally NG parts received

 Causative change ：Welding jig improvement (Adjusted the clearance between the parts and jig to
improve the part insertion）

 Reason for change?：Improvement to the loading process

 What’s missing？ :

＜Action of related department＞

：
：
：
：
：
Example３（Answer example）
What’s lack for this process change?
Failure：Occurred dimension defect when conducted improvement
of Jigs
 Defect received ：Dimensionally NG parts received

 Causative change ：Welding jig improvement (Adjusted the clearance between the parts and jig to
improve the part insertion）

 Reason for change?：Improvement to the loading process

 What’s missing？ ：Parts were not compared before and after the change

＜Key point＞
Eng. : Confirm workability
Eng. ：Inspect jig after improvement
Prod.：Production trial with Engineering and Quality dept.
QA ：Inspect parts to confirm if parts are the same before and after the change
:Inspect for appearance – Is there a Scratch or Crack (all potential side effects）
※Inspect before and after change parts whether same quality level

It’s important to
compare parts
Comparison before and after
Spec change
Parts after
change
Before change
Inspection for jig Comparison
Parts inspection
Why is 4M Change Management Necessary?

Key Points:
- Reduced impact to Nissan by supplier changes from suppliers with known plant
wide 4M change management system

- All supplier’s PIRs for Q3 and Q4 - 40% caused by 4M change

- 4M plant wide supplier’s PIRs for Q3 and Q4 - 13% caused by 4M change
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What is the benefit of a 4M change
management system?

1. Quality
2. Cost
3. Meet the requirement for TS16949
4. Meet the requirement for ANPQP (Alliance New Product Quality
Procedure)

Answer: All of the above

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1. Quality

First three suppliers who implemented 4M

change management systems saw a significant
reduction in PPM (~63%)

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2. Cost
Average cost of a PIR is $10,000
This includes:
1. Administrative fee - $1000
2. Sorting at Nissan - $80/ hour until certified RANs received
3. Sorting at Supplier – Varies

Potential additional costs:

1. 3rd party sorting if SSC required - $30~50/hour (30 day minimum)
2. Repair costs if parts are assembled to vehicle's - $$$$$

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3. Requirement for TS16949
7.1.4 Change control
The organization shall have a process to control and react to changes that impact
product realization. The effects of any change, including those changes caused by any supplier,
shall be assessed, and verification and validation activities shall be defined, to ensure
compliance with customer requirements. Changes shall be validated before implementation.
For proprietary designs, impact on form, fit and function (including performance
and/or durability) shall be reviewed with the customer so that all effects can be properly
evaluated.
When required by the customer, additional verification/identification requirements,
such as those required for new product introduction, shall be met.
NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from,
the customer.
NOTE 2 The above requirement applies to product and manufacturing process changes.

8.2.3.1 Monitoring and measurement of manufacturing processes

The organization shall maintain records of effective dates of process changes

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4. ANPQP Change Management Requirements

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What is a 4M change management
system?
A 4M change management system has:

1. A way to identify and track all 4M changes

2. A defined verification plan for each change or type of change
• This should include an escalation policy based on the severity of
the change
• The responsible reviewers/approvers need to be identified
• Containment and cancelation requirements/ procedures should
also be included
3. A set way to communicate the changes
• Should include management and those affected by the change
4. A way to track and analyze the changes
5. A person responsible for managing and auditing to ensure
compliance
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Nissan 4M Change Management
Minimum Supplier Requirements

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 Minimum Requirements for Suppliers

1. Visual Management System

2. Escalation and validation plans for ALL changes
3. Quick containment of NG parts caused by change
4. Change data needs to be collected, stored, and analyzed
5. 4M discussed daily during QRQC
6. Designated 4M change control champion
7. Audit schedule (Internal and Tier N)

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Visual Management System

1. Each production area/department should have “Visible”

identification for all 4M changes
2. Each change should be communicated and the record
should be displayed and easily identifiable
A. Typically posted on a lineside communication and tracking
board
3. All 4M changes, planned and unplanned, should be
communicated
4. Benchmark level for visual management is to have a
visual cue at each cell/machine/station that raises
awareness of a change taking place

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Visual Management Example #1

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Visual Management Example #2

Common Themes:
• Dry erase boards used to show real time changes taking place.
• Boards displayed in QRQC areas and discussed by management daily.
• Instructions on how to manage sudden changes posted on the board.
• Classifications to associate risk with different sudden changes posted.

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Visual Management Example #3 -
Electronic 4M board

1. All changes are recorded lineside electronically

• No paper to lose
• Confirmations are also entered
2. Data is backed up on the server and viewable
from anywhere
• Easy to review all changes
• Confirmation of changes can be reviewed
by management
3. Since the information is already entered
electronically it can be easily be mined and
analyzed
Visual Management Example #3 -
Electronic 4M board
 Escalation and Validation Procedures

1. Changes need to be defined and grouped in order

of risk / severity
2. Unplanned changes need to be escalated
immediately to the appropriate management level
based on type of change
3. All changes need their validation procedure
communicated and discussed
4. All changes need their additional quality /
containment actions communicated and discussed
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Example 1: Escalation and Validation
Ranking / Items to When to Required to Specification / Standard to Record of
Category Definition of Change Evaluation Method
Classification Check / Validate Check / Validate Check / Validate Check / Validate To Check / Validation
1)Weekly 4M Meeting 1)4M Sheet
Permanent Addition / Subtraction of standard Planning Stage Thru
Per 4M Sheet 2)Daily / Weekly Soshin Management Team 4M Change Notice 2)PPAP
manpower staffing to process Implementation
3)Safe Launch 3)Safe Launch Data

1)Job Observation
1)Operator knowledge Management 1)Standard Operating Procedure (SOP) 1)Tepro Orientation Form / 3 Step
Temporary Addition / Subtraction of standard 2)Process Audit / Increased Inspection Frequency or
2)Product Quality At a change (Quality / Engineering / 2)Technical/Quality Standards 2)Product Audit Sheets
manpower staffing number (New Hire or Transfer) Secondary Inspection Results review
3)Line Efficiency Production) 3)Hourly Output Board / DPR 3)DPR
3)Performance Review
MAN
1)Job Observation
1)Operator knowledge 1)Standard Operating Procedure (SOP) 1)Tepro Orientation Form / 3 Step
2)Process Audit / Increased Inspection Frequency or
2)Product Quality New Operator / New Hire At a change Engineering / Quality 2)Technical/Quality Standards 2)Product Audit Sheets
Secondary Inspection Results review
3)Operator Efficiency 3)Hourly Output Board / DPR 3)DPR
3)Performance Review

1)Operator knowledge 1)Job Observation 1)Standard Operating Procedure (SOP) 1)3 Step
1)Operator transfer from another department
2)Product Quality 2)First Off Verification / Product Audit At a change Supervisor 2)Technical/Quality Standards / PPDC 2)PPDC Sheets / Supervisor Product Audit
2)Support staff changes or training
3)Operator Efficiency 3)Performance Review 3)Hourly Output Board / DPR 3)DPR

1)Weekly 4M Meeting 1)4M Sheet

Planning Stage Thru
Per 4M Sheet New / Additional Tool 2)Daily / Weekly Soshin Management Team 4M Change Notice 2)PPAP
Implementation
3)Safe Launch 3)Safe Launch Data

1)Process Parameter Adjustments (Outside of

1)Job Observation 1)Standard Operating Procedure (SOP) /
1)Operator knowledge Specifications) 1)Job Observation / One Point Lesson
2)Process Audit / Increased Inspection Frequency or Management Quality Alert / One Point Lesson
2)Product Quality 2)Poke Yokes not working 2)Product Audit Sheets / Quality Alert
Secondary Inspection Results review At a change (Quality / Engineering / 2)Technical/Quality Standards
3)Line Efficiency 3)Changes to Quality Confirmation Equipment (Outside 3)DPR
3)Performance Review Production) 3)Hourly Output Board / DPR
4)Operator Safety of Parameters) 4)Safety Audit / Safety Alert
4)Safety Risk Assessment 4)OSHA Safety Standards
MACHINE 4)Safety Device /Guarding Repair/Replacement
1)New Gauges / Check Fixtures
1)Job Observation 1)Standard Operating Procedure (SOP) / 1)Job Observation / One Point Lesson
1)Operator knowledge 2)Quality Confirmation Equipment repair (Poke Yoke)
2)Process Audit / Increased Inspection Frequency or Quality Alert / One Point Lesson 2)Product Audit Sheets / Quality Alert
2)Product Quality 3)Equipment adjustments affecting quality of part At a change Engineering / Quality
Secondary Inspection Results review 2)Technical/Quality Standards 3)DPR
3)Line Efficiency 4)Tooling / Assembly or Check Fixture repairs
3)Performance Review 3)Hourly Output Board / DPR 4)Safety Audit / Safety Alert
5)Critical equipment repairs

1)Minor equipment repairs

1)Product Quality 1)First Off Verification / Product Audit 1)Technical/Quality Standards / PPDC 1)PPDC Sheets / Supervisor Product Audit
2)PM activities At a change Supervisor
2)Line Efficiency 2)Performance Review 2)Hourly Output Board / DPR 2)DPR
3)Part / Tooling changeover

1)Weekly 4M Meeting 1)4M Sheet

1)Material change Planning Stage Thru
Per 4M Sheet 2)Daily / Weekly Soshin Management Team 4M Change Notice 2)PPAP
2)Component change Implementation
3)Safe Launch 3)Safe Launch Data

1)Job Observation
1)Operator knowledge Management 1)Deviation / Quality Alert 1)One Point Lesson
2)Process Audit / Increased Inspection Frequency or
2)Product Quality Temporary utilization of non-standard packaging At a change (Quality / Engineering / 2)Technical/Quality Standards / PPDC 2)PPDC Sheets / Supervisor Product Audit
Secondary Inspection Results review
3)Line Efficiency Production) 3)Hourly Output Board / DPR 3)DPR
3)Performance Review
MATERIAL
1)Job Observation
1)Operator knowledge 1)Deviation / Quality Alert 1)One Point Lesson
2)Process Audit / Increased Inspection Frequency or
2)Product Quality At a change Engineering / Quality 2)Technical/Quality Standards / PPDC 2)PPDC Sheets / Supervisor Product Audit
Secondary Inspection Results review
3)Operator Efficiency 3)Hourly Output Board / DPR 3)DPR
3)Performance Review

1)Product Quality 1)First Off Verification / Product Audit 1)Technical/Quality Standards / PPDC 1)PPDC Sheets / Supervisor Product Audit
Change of material lots At a change Supervisor
2)Operator Efficiency 2)Performance Review 2)Hourly Output Board / DPR 2)DPR

1)Process change (addition / subtraction of process 1)Weekly 4M Meeting 1)4M Sheet

Planning Stage Thru
Per 4M Sheet step) 2)Daily / Weekly Soshin Management Team 4M Change Notice 2)PPAP
Implementation
2)Facility Site Transfer 3)Safe Launch 3)Safe Launch Data

1)Line Rebalance
1)Job Observation
1)Operator knowledge 2)Change process to secondary machine or major Management 1)Deviation / Quality Alert 1)3 Step
2)Process Audit / Increased Inspection Frequency or
2)Product Quality refurbishment activity At a change (Quality / Engineering / 2)Technical/Quality Standards 2)PPDC Sheets / Supervisor Product Audit
Secondary Inspection Results review
3)Line Efficiency 3)Addition of Supplimental Process (Offline rework) Production) 3)Hourly Output Board / DPR 3)DPR
3)Performance Review
METHOD 4)Assembly Sequence Change

1)Job Observation
1)Operator knowledge 1)Deviation / Quality Alert 1)One Point Lesson
1)Additional inspection 2)Process Audit / Increased Inspection Frequency or
2)Product Quality At a change Engineering / Quality 2)Technical/Quality Standards 2)PPDC Sheets / Supervisor Product Audit
2)SOP (Standard Operating Procedure) changes Secondary Inspection Results review
3)Operator Efficiency 3)Hourly Output Board / DPR 3)DPR
3)Performance Review

1)Operator knowledge 1)Standard Operating Procedure (SOP) 1)One Point Lesson

1)First Off Verification
2)Product Quality At a change Supervisor 2)Technical/Quality Standards 2)PPDC Sheets / Supervisor Product Audit
2)Process / Product Audit
3)Operator Efficiency 3)Hourly Output Board / DPR 3)DPR
Example 1: Escalation and Validation
Ranking / Items to When to Required to Specification / Standard to Record of
Category Definition of Change Evaluation Method
Classification Check / Validate Check / Validate Check / Validate Check / Validate To Check / Validation
Permanent Addition / Subtraction of 1)Weekly 4M Meeting 1)4M Sheet
Planning Stage Thru
Per 4M Sheet standard manpower staffing to 2)Daily / Weekly Soshin Management Team 4M Change Notice 2)PPAP
Implementation
process 3)Safe Launch 3)Safe Launch Data
1)Job Observation
1)Operator knowledge Temporary Addition / Subtraction of 2)Process Audit/Increased Inspection Management 1)Standard Operating Procedure (SOP) 1)Tepro Orientation Form / 3 Step
2)Product Quality standard manpower staffing number Frequency or Secondary Inspection Results At a change (Quality / Engineering / 2)Technical/Quality Standards 2)Product Audit Sheets
3)Line Efficiency (New Hire or Transfer) review Production) 3)Hourly Output Board / DPR 3)DPR
MAN 3)Performance
1)Job Review
Observation
1)Operator knowledge 2)Process Audit/Increased Inspection 1)Standard Operating Procedure (SOP) 1)Tepro Orientation Form / 3 Step
2)Product Quality New Operator / New Hire Frequency or Secondary Inspection Results At a change Engineering / Quality 2)Technical/Quality Standards 2)Product Audit Sheets
3)Operator Efficiency review 3)Hourly Output Board / DPR 3)DPR
3)Performance Review 1)3 Step
1)Operator knowledge 1)Operator transfer from another 1)Job Observation 1)Standard Operating Procedure (SOP)
2)PPDC Sheets / Supervisor Product
2)Product Quality department 2)First Off Verification / Product Audit At a change Supervisor 2)Technical/Quality Standards / PPDC
Audit
3)Operator Efficiency 2)Support staff changes or training 3)Performance Review 3)Hourly Output Board / DPR
3)DPR

Change #1: An operator transferred from another department

- Escalation (Required to approve): Supervisor
- Validation (What to check): Operator Knowledge, Product Quality, Operator Efficiency
- Verification (How to check): Job Observation, First off/Product Audit, Performance Review
Change #2: New Hire
- Escalation (Required to approve): Engineer / Quality
- Validation (What to check): Operator Knowledge, Product Quality, Operator Efficiency
- Verification (How to check): Job Observation, Increased inspection, Performance Review
Change #3: Permanent Addition/Subtraction of Standard Manpower
- Escalation (Required to approve): Management Team
- Validation (What to check): Per 4M sheet (existing process)
- Verification (How to check): Weekly 4M Meeting, Daily/Weekly Soshin, Safe Launch

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Example 2: Escalation and Validation

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Example 3: Escalation and Validation
Class 1 Class 2 Class 3 Class 4

Must be
documented on
4M change board

Must be reported
daily at QRQC

NNA PCR/FSTR
Approval Needed
NNA PQE
Notification Req’d

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Quick Containment of NG Parts

1. Confirmation of parts after change should be

completed before parts are shipped to the next
process or within 24 hrs after change took place
2. If parts are found to be NG after change, they should
be easily identified and contained
3. Typically suppliers use existing containment and
disposition processes

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 Change Data

1. Change data needs to be collected and retained

2. This data should be analyzed for trends and used to
improve internal processes
3. All planned changes need to be submitted to Nissan
1. DNotes, PCRs, FSTRs continue to be submitted on survey
and to Supplier Change Request email
4. Data should be available upon request by Nissan
1. Information will be used to study trends at suppliers and
reviewed to ensure compliance during genba reviews.

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Monthly Tracking – Totals
6 Plants
2 Class 1 Multiple
Commodities
32 Class 3
137 Class 135

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 Class and 4M Spikes
1
Plant 3 consistently has
highest Machine Change.
Due to amount of older
machines and assembly error
proofing

2
Reviewing Item
Classifications, Other facilities
may have repair items rated
Class 4 that should be Class 3

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Daily QRQC Meeting

1. Should occur daily at the beginning of the shift

2. 4M changes need to be discussed at the visual
1. Why change
management board(s)isoroccurring
lineside
2. Howchanges
3. Upcoming changeforwas validated
the day need to be
discussed,
3. Whatasadditional
well as unplanned changes
quality from
gates are
previous day. Management should be aware of:
1.
in place or are
Why change is occurring
needed to protect
2. customer
How change was validated
3. What additional quality gates are in place to protect customer

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 4M Change Management Champion

1. Change Management Champions need to be

designated, trained, and empowered
2. Will lead the development and initial implementation of
policy
3. Should collect, store, submit, and help analyze change
data
4. Will perform change management system audits both
in-house and at tier N suppliers
5. Train and push 4M change management policies at tier
N suppliers, and certify change control champions at
those suppliers

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4M Change Control Audits

1. Need to be performed at a set frequency

2. Will be done at Tier 1 and in the future at Tier N
suppliers
3. Scores should be tracked and reported to
management

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