NIDEC PRECISION PHILIPPINES CORPORATION Doc.

Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

REVISION HISTORY

Iss. Rev Effectivity

No. No. Description Originator Checked Approved Date

05 00 Major Revision Jane Uy Hilda Lopez Kyohei Shinike 08/05/2011

05 01 Minor Revision Jane Uy Hilda Lopez Kyohei Shinike 10/25/2011

Dolor Yoshikazu
06 00 Major Revision Ivy Lazo 10/29/2012
Dimaunahan Tanaka

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Nidec Precision Philippines Corp

1.0 PURPOSE

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
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 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

To established proper review, control and provide records for any changes subject to be
made in the manufacturing process for improvement and prevent recurrence of
nonconformity.

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2.0 SCOPE Nidec Precision Philippines Corp

2.1 NPFL Manufacturing Process & Supplier

 When there are changes in the location of production plant and physical lay-out of
the existing line.
 When there are changes or additional process and machine.
 When there are changes in the Production and QA equipment (including
measuring equipment), jigs or fixture that will affect the quality of the product.
 When there are changes or additional inspection & method.
 When there are changes in the indirect materials and raw materials of the parts
supplied.
 When there are new models from supplier or new process made by supplier.

3.0 DEFINITION / ABBREVIATION

3.1 4M - Refers to man, method, machine & material

3.2 DCC - Document Control Center
3.3 QE - Quality Engineering
3.4 SQE - Supplier Quality Engineering
3.5 CQE - Customer Quality Engineering
3.6 PCN - Process Change Notice
3.7 SPCR - Suppliers Process Change Request (customer)

4.0 RESPONSIBILITIES AND AUTHORITIES

4.1 Initiating department – is responsible to initiate 4M Change Application whenever there

is a change in manufacturing process.

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
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 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

 Quality Control is responsible to initiate 4M Change Application in case of

parameter relaxation after data Cpk review and tight internal control due to quality
issues.
 Supplier Quality Engineering is responsible to initiate 4M Change Application
concerning changes on the operation of the supplier.
 Measuring Instrument Control group is responsible to initiate 4M Change
Application for new measuring instruments before it was officially use at
production and/or inspection area.
 Engineering (Equipment, Plant or Machinery) is responsible to initiate 4M Change
Application for internal design change, new production lines, new machines, new
tools, washing machines and automation processes.
 Production is responsible to initiate 4M Change Application when there are
changes on the existing process for the purpose of productivity and quality
improvement. Including cycle time reduction, standard tool life setting and tool
movement.
 Production Control is responsible to initiate 4M Change Application for changes
related to raw material, supplier, and consumables like chemicals, packaging and
other indirect materials.

4.2 DCC – is responsible to control and safekeeping of the approved 4M Change

Application.
4.3 CQE – coordinates all 4M Change to customer for items that needs customer approval.

5.0 PROCEDURAL STEPS MASTER COPY

Nidec Precision Philippines Corp

5.1 Process Change Notice

5.1.1 Process Change Notice (PCN) shall be made and initiated by any department
when any of the following conditions stated on 2.1.
Note:
If changes concerning by the supplier, SQE is responsible to initiate PCN in
coordination with the supplier.
5.1.2 The purpose of the PCN is to have initial information to all concerned
departments for the new activities to be studied and evaluated prior
application of 4M Change.

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
MASTER COPY stamp symbolizes that it undergoes document control procedure
 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

5.1.3 Weekly review shall be initiated by the concerned departments & Quality
Engineering to determine the status of on-going evaluation.
5.1.4 Using PCN, QE shall indicate if changes are in need of customer approval.
QE will refer to Evaluation table for 4M change given by CT/L to determine
the Grade of changes. When changes need to be approved by the customer,
CQE will send their updated PCN to customer.
5.1.5 CQE shall issue 4M Change Review Checklist to initiator. This serves as
reference for requirements needed prior and during evaluation.
5.16 Once evaluation is completed and final result is ACCEPTED, initiating
department shall apply 4M Change Application.

5.2 Initiation of 4M Change Application

5.2.1 Initiating Department shall secure 4M Change Application form via Intranet
System.
5.2.2 Minutes of the Meeting of previous discussion and Technical Report
specifying the objectives, evaluation results and statistical studies shall be
included on the 4M Change Application.
NOTE:
For the introduction of new chemicals, Initiating Department shall secure
“Application of New Chemicals” with MSDS duly signed by PCO & Safety
Officer attached to the 4M Change Application.
5.2.3 4M Change Application shall need initial review & approval by the
Department Manager &/or Technical Adviser.
5.2.4 Initiating Department shall circulate 4M Change Application to concerned
departments for their review and comments regarding the nature and extent
of the changes.
5.2.5 If justification for change is insufficient or if it can cause problems regarding
product quality, 4M change will be rejected. For supplier 4M Change
Application, SQE shall feedback the result to concern vendor.

5.3 Distribution & Control of 4M Change Application

5.3.1 Submit 4M Change Application to DCC with appropriate attachments.
Advance information to all concerned department shall be done through e-
mail messages.

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
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 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

5.3.2 DCC shall distribute copies of 4M Change Application to all concerned

department.
5.3.3 All concerned department shall implement such changes on the specified
effectivity date. Lot identification must be observed in order to distinguish old
lots with the fresh lots from implemented 4M Change Application.
5.3.4 Concerned department shall need to revise/ prepare related documentation
to support the 4M Change implementation.

5.4 Application of 4M Change approval to Customer

5.4.1 All 4M change summary will be presented on weekly basis during
management meeting for review and approval for Customer Submission.
5.4.2 CQE shall apply for customer approval using the provided customer form
(Supplier Process Change Request - SPCR) via Lotus Notes data base. The
assigned control number shall be noted on the 4M Change Application
(internal) to identify that request was submitted or made to concerned
customer.
5.4.2 CQE shall monitor status of applied customer SPCR using Process Change
Notice (data base monitoring) and require continuous monitoring and follow-
up until final status is being given.
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5.5 Disapproved 4M Change Application
5.5.1 CQE shall announce the disapproval of the SPCR including the reasons for
rejection.
5.5. 2 Updates the 4M Change Application then file for future reference.

6.0 APPLICABLE DOCUMENTS

6.1 NIPFRG-QAD004 - Machine Qualification

6.2 NIPFRG-SQE002 - Supplier Qualification
6.3 NIPFRG-SQE003 - Mold Qualification

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
MASTER COPY stamp symbolizes that it undergoes document control procedure
 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

7.0 RECORDS AND FORMS

7.1 NIPFFM-DCC003 - 4M Change Application Form

7.2 NIPFFM-CQE008 - 4M Change Review Checklist
7.3 PCN Form

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Nidec Precision Philippines Corp

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
MASTER COPY stamp symbolizes that it undergoes document control procedure
 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

FLOW CHART
8.0
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Nidec Precision Philippines Corp
8.1 Process Change Notice
Responsible Reference
Process Flow
Person(s) Document(s)

Start

Fill -up PCN form Concerned Department PCN

Sample evaluation
Concerned Department PCN

Weekly PCN updates

Concerned Department PCN
& Quality Engineering

Ne e d Yes Customer Quality PCN

Inform customer
c us to m e r Engineering
a ppro va l? using PCN

No
Concerned Department Evaluation results or
Issue 4M Change
PQC Technical Report
Review Checklist

Evaluation PCN

No Disregard or do
Ac c e pt?
improvement

Yes

4M Change Application

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
MASTER COPY stamp symbolizes that it undergoes document control procedure
 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

8.2 Internal and Customer 4M Change Application

Responsible Reference
Process Flow
Person(s) Document(s)

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Nidec Precision Philippines Corp
Initiating Department 4M Change
Application Form

Initiating Department 4M Change

Master List

Initiating Department 4M Change

Application

Initiating Department Technical Report/

Application for New
Chemicals

Initiating Department 4M Change

Application

Initiating Department 4M Change

Application

Initiating Department 4M Change

Application

DCC Customer SPCR

Revision on related
All concerns documentation

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
MASTER COPY stamp symbolizes that it undergoes document control procedure
 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

8.3 4M Change Application for customer approval

Responsible Reference
Process Flow
Person(s) Document(s)

CQE SPCR

Customer SPCR

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Nidec Precision Philippines Corp

CQE Rejected SPCR

4M Change
DCC Application

DCC 4M Change
Application

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
MASTER COPY stamp symbolizes that it undergoes document control procedure
 NIDEC PRECISION PHILIPPINES CORPORATION Doc. Code: NIPFRG-CQE002

Issue/Rev.: 05 / 01
REGULATION
Effectivity : Oct. 25, 2011
4M CHANGE APPLICATION Page No. : 1 of 10

9.0 DISTRIBUTION MASTER COPY

Nidec Precision Philippines Corp

This regulation including the referenced attachments shall be distributed as described in the
table below:

DISTRIBUTION & RETRIEVAL

COPY DATE COPY DATE

COPY HOLDER SIGN COPY HOLDER SIGN
NO. NO.
Issue Retrieval Issue Retrieval

01 Administration 11

02 Production Control 12

03 Production 13

04 14

05 15

06 16

07 17

08 18

09 19

10 20

10.0 DETAILS OF REVISION

Issue 05 Revision 00 – Major Revision (Incorporate PCR / PCN application / approval prior initiation of 4M change
application, Change document code from NPFRG-QAD010 to NIPFRG-CQE002).
Issue 05 Revision 01 – Minor Revision (5.2.2 inclusion of NOTE for the new chemical application)
Issue 06 Revision 00 – Major Revision (Detailed the scope of 4M Change applications, 5.1.5 Inclusion of 4M Change
Review Checklist form)

IMPORTANT: This document in PDF file is accessible thru INTRANET system and it does not require signature. The
MASTER COPY stamp symbolizes that it undergoes document control procedure