Doc. No.

QP/NPD/07
Issue No. 01
INTEGRATED SYSTEM Revision Date 05.07.2019
PROCEDURES Page 1 of 3

CHANGE MANAGEMENT

1. Purpose: To establish a process for Change Management

2. Scope: This process covers all activities for new product/ Current Production Run.

3. Process Owner: Head –NPD/Head–Engg. & R&D

A cross functional team is involved for establishing detailed outputs mentioned in these processes.

4. Abbreviations & Definitions:

4M – Man /Machine/Method/Material
PPAP – Product Part Approval Process
CFT—Cross Functional Team
BOP- Bought Out Parts
PFMEA – Potential Failure Mode & Effect Analysis
CP-Control Plan
Top Management Team – Team comprising Managing Director, Director Manufacturing, Director Sales and Director
Technical.

5. Procedure:

Sr. No. Activity Responsibility References

A Change Inputs: Customer

5.1 Change Inputs are raised by customer through new drawing release/Emails NPD Engg. &
Received from customer. Review should be completed within 10 working R&D Head
days of receipt of notification of Engineering standards/specifications
changes.

The need for design changes is determined on the basis of

5.2  Customer Requirements (Change Note, complaint, failure) F/ NPD / 16,
 Design verification /validation. Customer
NPD Head
ECN,
 Change in Legal, regulatory / statutory requirements

5.3 The Changes are Incorporated in the relevant Documents as per the
procedure for product and process changes. NPD Head F/NPD/037

5.4 During the development change History Sheet is uploaded along with the
changed document. NPD Head F/ NPD /14

5.5 Once the product is in the regular production the Changes are incorporated NPD Head F/ NPD /15
through ECR and ECN. F/ NPD /16

Prepared By Approved By
 Doc. No. QP/NPD/07
Issue No. 01
INTEGRATED SYSTEM Revision Date 05.07.2019
PROCEDURES Page 2 of 3

CHANGE MANAGEMENT

Before releasing the Changed Document appropriate verification /Validation

is performed, it is ensured that if any other document is affected as the result NPD Head F/ NPD /13
5.6 of the change in one document, the affected document is also updated.

Customer
In case a Customer Specifies, the approval on the changes is obtained from
5.7 NPD Head approved
the customer before introducing the change in the product.
documents
F/ NPD/16
The date on which changes is implemented is recorded on the ECN & ECN
5.8 NPD Head F/NPD/16A
list Summary sheet to be updated and ECN communicated to concerned
F/NPD/40
personnel.
5.9 Any Change required from the supplier end should be communicated to NPD Head F/NPD/16
concern supplier & same is communicated to customer Purchase Head

5.10 Risk Assessment to be updated when any change NPD Head

5.11 During New Product development any change required updated the timing NPD Head
plan as per changes

B Changes due to in house Developments

5.10 Change consists any change in 4M NPD Head QP/PRD/6A

Man, Machine, Method, Material are raised in 4M change tracking sheet,4M F/PRD/25
Change management standard & abnormal situation to be handling as per
procedure QP/PRD/6A.

5.12 Changes in Man, Machine, Method, and Material are applicable whenever F/NPD/037
any customer demand/Customer Complaints /Location Change NPD Head
/improvement project to increase productivity/quality improvement/Alternate
Supplier Introduced. Any Machine change /Material Change/or Process
(Method Change)/Mistake proofing implementation etc.

5.13 Information has to be given to customer in case of any deviations in product Head Marketing Deviation Form
& process or any changes and If there is any impact on Fit, Form and F/SYS/25 or
Function of Product including performance and/or durability of the product or Customer
whenever customer demands or in-house changes/requirement. approved
Deviated Product or material identified with job card & deviation form documents,
attached till dispatch. Job Card
’F/PRD/01”
NPD Head F/NPD/18
5.14 Process Validation is required in case of any Change or Location Change. Head- F/NPD/18A
Process validation & process capability required at the time of machine Production F/NPD/18B
installation or process change. F/NPD/18C,
F/NPD/019,
F/NPD/12,12A
F/QCD/20

Prepared By Approved By
 Doc. No. QP/NPD/07
Issue No. 01
INTEGRATED SYSTEM Revision Date 05.07.2019
PROCEDURES Page 3 of 3

CHANGE MANAGEMENT

5.15 All Key documents like PFMEA/CP/PFD Sample Inspection Report need to NPD Head F/NPD/26,
submit to customer (If Customer demand) F/NPD/27,
F/NPD/28
5.16 Re-PPAP submission is required if customer ask for it or retain all NPD Head
documents at MASU

5.17 After change a “Change Management check sheet “to be filled to covered all NPD Head F/NPD/037
requirements

5.18 Any Change required from the supplier end should be communicated to NPD Head F/NPD/036
concern supplier & same is communicated to customer. /Purchase Head

6. Monitoring & Measurement

Description Measurable Frequency

Process Validation Process Validation Sheet Each Change

7. References

S No Document Number Document Description

1 F/NPD /013 Design Verification & Validation Plan
2 F/NPD /014 Product Design Change History Sheet
3 F/NPD/015 Engineering Change Request
4 F/NPD/016 Engineering Change Note
5 F/NPD/018 Moulding Process Validation
6 F/NPD/018A Heat treatment Process Validation
7 F/NPD/018B Finishing Process Validation
8 F/NPD/018C Powder coating process validation
9 F/NPD/036 Change Management Sheet
10 F/NPD/037 Change Management Check Sheet
11 F/QCD/20 SPC
12 F/NPD/12 Software Validation Record
13 F/NPD/26 PFD
14 F/NPD/27 CONTROL PLAN
15 F/NPD/28 PFMEA
16 F/PRD/01 JOB CARD
17 F/SYS/25 Deviation Form
18 F/NPD/16A MASTER LIST OF ECN
19 QP/PRD/6A 4M Change management standard & abnormal situation
20 F/PRD/25 4M Change Tracking sheet
21 F/NPD/16A Master List of ECN
22 F/NPD/40 ECN Communication matrix

Prepared By Approved By