Doc. No.

ASP-NPD-04
ATOP SYSTEM PROCESS
Rev. No. 00
Effe Date 10.11.2017
APPL PRODUCT SAFETY
Page 01 of 03
1. PURPOSE

This process defines the method for product safety related products and manufacturing process

2. SCOPE
This is applicable for new & change in existing product.

3. RESPONSIBILITY
The overall responsibility for the effectiveness of this process lies with:
* HOD - PART DEVELOPMENT
* HOD - QA
* HOD - PRODUCTION

4. REFERENCE CLAUSE / SECTION

Clause / Section No. 4.4.1.2

5. DEFINITION

MDT - Multi disciplinary team---Consists of or organization’s design, manufacturing

engineering, quality, production, purchasing, supplier, maintenance and
customer, Machine manufacturer, technical expert

6. INPUT

Updation Rem
Sl. No. Description Source
Period ark
1 Customer drawing and specification Customer/Mkt As required
2 Customer specific requirement Customer/Mkt As required
3 Special characteristics Customer/Mkt As required
4 Target of cp, cpk for SC Customer/Mkt As required
5 Customer ECN/PCN Customer/Mkt As required
6 Legal & statutory requirement Customer/Mkt As required
7 Experience from previous development NPD As required

7. FLOW CHART:

Product safety Flow chart

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 DOC. NO ASP-NPD-04
ATOP SYSTEM PROCESS
REV NO 00
Effe Date 10.11.2017
APPL PRODUCT SAFETY
PAGE 02 of 04
Responsibility
(Ref Doc No)
1.
HOD NPD Recieve customer input data including statutory and regulatory
product safety requirement

2
Form CFT

CFT 3
FM-NPD-03 Review statutory and regulatory requirment
and product safety characterstics as
mentioned
in drawing through feasibility and risk
assessment

CFT
FM-NPD-03

no 4A
4 Discuss with customer for
CFT Feasible & Viable? necessary change
FM-QA-21
FM-QA-23
yes
5
Finalize special characteristics considering customer specified safety requirements after
design FMEA (only in case of product design responsible for that item and getting special
approval from customer) and process FMEA completion

CFT
FM-QA-22

6
Mention these all special
characteristic and require mistake
proofing in control plan with reaction
HOD NPD plan and escalation process, when
FM-QA-22 acceptance criteria not met
FM-QA-23

7A
7 Get Customer
no yes approval
Approval requred from
customer for process FMEA
and control plan?

no

A
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 DOC. NO ASP-NPD-04
ATOP SYSTEM PROCESS
REV NO 00
Effe Date 10.11.2017
APPL PRODUCT SAFETY
PAGE 03 of 04

Responsibility A
(Ref Doc No)
8
CFT Evaluate packing norms including applicable
statutory & regulatory requirements

HOD PROD./QA 9
Put mistake proofing facility, for not to generate safety charateristic
out of spec or automatic stop feature whenever produce out of the
spec.
HOD PROD.

10
Use highly skilled trained personnel on that
machine and maintain traceability

HOD PROD.

11
Monitor safety characteristics through control chart and
calculate Cp snd Cpk

HOD Marketing/ NPD

yes

12 12A
Change in product Follow ECN process
safety from customer
or intiated from no
HOD Purchase organization, approved
by customer

yes 13A
13 Ensure mistake prrofing, safety
Product safety allert, use of high skilled
characteristic operator through supplier audit.
HOD PROD./QA generated at supplier
end

No

11
Action plan when customer target not met for product safety
HOD PROD. characteristic and escalate process as it arises

14
Documents the lesson learned and keep as
organizational knowledge enhancement as well
as feedback for new product

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 Doc. No. ASP-NPD-04
ATOP SYSTEM PROCESS
Rev. No. 00
Effe Date 10.11.2017
APPL PRODUCT SAFETY
Page 04 of 04
8. OUTPUT
S.No. Discription Receiver Frequency Remarks
Beginning or
1 Product safety identified in PFMEA, Control Plan, HOD Engg.
change
Beginning or
2 Product safety identified in Standard operating process Process owner
change
Beginning or
3 Product safety identified in Work instruction Production
change

9. KEY PERFORMANCE INDICATOR (KPI)

Measurement Review
S.No. Indicators/Parameters
method with UOM Frequency
Responsibility

10. DOCUMENT REFERENCE

S.No. Document name Number Rev No. Rev Date
1

11. FORMAT/ RECORD

S.No. Fomat Name Number Retention period Method of storage

1 Process Flow Diagram FM-QA-21 1 Year Soft & Hard

2 PFMEA FM-QA-23 1 Year Soft & Hard
3 Control Plan FM-QA-22 1 Year Soft & Hard
4 Feasibility Study Sheet FM-NPD-03 1 Year Soft & Hard
5 Risk Assesment Sheet FM-NPD-14 1 Year Soft & Hard
6 ECN Report FM-NPD-02 1 Year Soft & Hard
7 TRG/TGW Report FM-NPD-05 1 Year Soft & Hard
8 Engineering Change Request FM-NPD-15 1 Year Soft & Hard

12. REVISION HISTORY

S.No. Nature of change/ description Revision Number Retention Date Remark

1 New requirment from TS 16949:2009 to IATF 16949:2016 0 11/10/2017

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