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QUALITY SYSTEM PROCEDURE Doc. No.

: RI/QP-09
Rev. No. : 00
INITIAL SUPPLY CONTROL Date : 01.04.2015
Page: 1 of 3.

1.0 PURPOSE:
Special control needs to be exercised during the initial phase of mass production when one of the
above items occurs with the purpose of collection sufficient data on order to judge whether the
mass production can be continued using the existing process.

2.0 SCOPE:
This procedure is applicable to all groups of new development, products manufactured by the
Organization and any ECN change raised by customer.
This procedure is also applicable for new BOP part /change part at supplier end.

3.0 RESPONSIBILITY:
Dev Head is responsible for initiating and terminates the initial supply control activities.

4.0 Definition of Initial Product : The first piece /part or lot that Produced after NPD, ECN
or process change or major change in tool/die is consider as initial part.

4.1-Handling of Initial Product: Initial products handle with extra care during
manufacturing process

• Put identification tag on initial product bin/ trolley


• Prepare report for initial product
• Fix location for initial product in the shop floor
• Put initial product part on decided location
• Send initial part to customer with identification tag.

Initial Supply Control :-


“ Initial Supply Control is a process of monitoring & additional controls in the
process by taking precautionary & preventive actions during the initial period of
mass production of a new or changed part for a defined duration.”

4.2-Initial supply control covers :-


a) A new part is manufactured-New Product

Prepared By Approved By
QUALITY SYSTEM PROCEDURE Doc. No. : RI/QP-09
Rev. No. : 00
INITIAL SUPPLY CONTROL Date : 01.04.2015
Page: 1 of 3.

b) Similar to other part is manufactured -New Product


b) Existing part change as per specification change required by customer.-ECN (raise)
c) starting manufacturing after a long lay-off ( 12 months)-Process Change
d) R/M, Product design/process/Tool/ Die/ Machine/ Equipment change/minor change-
New Product/ECN/Process Change
e) Layout Change-Process Change
f) Relocated Plant Process Change
g) Supplier/vendor/Sub vendor Change-Process Change

5.0 Period of Initial Supply Control:-

3 Months / 3000 nos. whichever is later for new part.


1 Months / 1000 nos. Whichever is later for Design and process change.

5.1 Establishment of Initial Flow Control: Special activities

The following activities related to the part (for which initial flow control is being observed) shall
be carried out during this period:
In case of customer issue/complaint 100% inspection to be done for each lot qty.
Special inspection / Process controls that is higher than normal controls. These
could be either added inspection points or inspections at higher frequencies.
Please refer Pre-launch Control plan (FM/QA/16)
Process Capability check. It shall be carried out on special characteristics as
decided by SQA or defined by customer once in a month
Conduct MSA once in a month
Systematic observation and recording of problem and taking countermeasure.
Conduct process audit.

5.2 Information about Initial Supply Control:

For this information Initial Supply process Tag is used (FM/DEV/12)

4.4 For Termination

Prepared By Approved By
QUALITY SYSTEM PROCEDURE Doc. No. : RI/QP-09
Rev. No. : 00
INITIAL SUPPLY CONTROL Date : 01.04.2015
Page: 1 of 3.

S.No. Control Item UOM Specificat. Month-1 Month-2 Month-3 Remarks


No. of Customer Complaints
1 Numbers

Customer rej. PPM


2 PPM

Inprocess rejection
3 PPM

Incoming rejection/ Supplier Rej.


4 PPM
Cpk
5 > 1.33
MSA
6 GRR < 10

Results of C'measure taken against


Current VS
7 problem during production Effective
Previous
preparation
Results of C'measure taken against
Current VS
8 problem during initial supply Effective
Previous
control
Defect Rate for critical defect
9 %

Process Audt All NC's


10 No of NC's should
closed
a) Refer annexure -1 for target setting

b) If any of the criteria listed above are not meet continue three month, Initial Flow Control
period shall be extended till the time all criteria are met. Refer Annexure -2 for sign off
sheet.

6.0 RECORD:

6.1 Initial Supply Control Process Tag (FM/DEV/12)


6.2 Initial Supply Control Sign Off (FM/DEV/13)

Rev No Rev Date Amendment detail Prepared By Approved By

Prepared By Approved By

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