QUALITY MANAGEMENT Annexure XII

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SYSTEM PROCESS DATE :01.12.2009
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GUIDELINES INITIAL
CONTROL
1. OBJECTIVE:
Special control needs to be exercised during the initial phase of mass production with purpose
of collecting sufficient data in order to judge whether the mass production can be continue using
the existing process to establish quality, quantity and delivery.

2. SCOPE:
This procedure covers the details of special control which will be exercised during the initial
phases of mass production when:
1. A new part is manufactured
2. Design Change
3. Process Change
a. Process parameter change
b. Tool/Die/machine/Equipment change
c. Layout change
d. Relocated plant
e. Supplier change
f. Operator change
g. Starting manufacturing after a long lay-off (12 month).

3. DEFINITION:
Initial Product – Initial product is the first piece/part or lot or samples from the first lot produced
during production trial, HVPT, after SOP of a new part or any change.

4. PROCESS OWNER:
Head Development / Q.A. has overall responsibility for implementation of this procedure.

5. INPUTS
 Drawings.
 Product samples.
 Product approval.
 Change in process flow.
 Change in special characteristics.
 Process flow diagram.
 Change in BOP’S/Vendors.
 Process and setup instructions (In house and Vendor end)

6. The following activities shall be carried out during initial flow period:-
6.1.1 The initial flow period must be fixed.
 3 months / 10000 nos. Whichever is later for new part Supplies.
 1 month / 5000 nos. whichever is later for Design & process change.
6.1.2 Extra Control during initial supply control.
1. Increased inspection parameters.
2. Increased frequency
3. Skilled operator.

PREPARED BY: APPROVED BY:

 QUALITY MANAGEMENT Annexure XII
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SYSTEM PROCESS DATE :01.12.2009
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GUIDELINES INITIAL
CONTROL
4. Added roles & responsibility of managers & Supervisors.
5. Reduced cycle time for problem solving.

6.2 Assembly parts should be checked 100 % and record to be maintain during initial
control.
6.2.1 Critical points should be checked in In-Process and Final inspection two times during
a day and record to be maintained during Initial Control.
6.2.2 Receipt inspection should be done double compared to regular check.

6.3 Initial Product will be tagged as follows:-

 Red- New product development.
 Blue- ECN in parts change.
 Orange- Process change.

6.4.1 During the initial supply / Product control, Tagging is required on the master packing of
parts at every stage like –Surface Treatment, Assembly dispatch
6.4.2 The process / machine producing initial product will be identified by a display tag on the
respective area during initial supply control period.1

6.5 If any non conformance found in product / process than it will be reviewed for the
entire product / process and specification of the design through analysis sheet.
6.5.1 Listing of problems related to all area of operation i.e.(Production, Quality, Purchase,
Dispatch, Logistics and Maintenance etc.)
6.5.2 Are problem noticed during initial solved.
6.5.3 Take appropriate action to solve all the problems.

6.6 Systematic observation and recording of problems and taking counter measures
and improvement actions.
6.6.1 Systematic conformation of effects of countermeasures for the Problems which were
observed during the production of FPP lot.

6.7 The initial flow control can be terminated, if at the end of the initial flow period, the
following conditions are satisfied:-
1. All Major problems (Related to Quality, Delivery, and Quantity etc.) has been solved
before SOP
2. If it is confirmed that the countermeasures taken for the problems occurred during the
production of FPP lot are effective.
3. If the countermeasures taken against problems observed during initial flow period
itself are found to be effective.
 During initial flow period NPD will be responsible for design related issues.
 Regular department like Q.C., manufacturing should be a part of initial flow to
gather know how about the product and process criticality.
 PPM Level for new product to be achieved as per PQCDDSM target for the
relevant year.

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 QUALITY MANAGEMENT Annexure XII
REV NO. : 00
SYSTEM PROCESS DATE :01.12.2009
Page : 3 of 3
GUIDELINES INITIAL
CONTROL
Note: - Similar system will be implemented at supplier end also.
 Head Div. is responsible for above activity for new manufactured part during the initial
flow period.
 Head QC is responsible for above activity for design and process change in existing
common parts during the initial flow period.

7. OUTPUTS
1. First off Inspection
2. Last of Inspection
3. Status of conformance/ non conformance
4. Corrective and preventive action planned/ taken
5. Change in documents. (Control plan)
6. Feed back from customer
7. Feedback from product processes for corrective action.
8. Action based on internal and external customer feedback.
9. Production part approval.
10. Product inspection and testing (performance test)

8. RESOURCES REQUIREMENTS

1. Competent personnel.
2. Checking aids (Drawings, MIS-P)
3. Approved Sample by internal or external Customer
4. Financial resources
5. Measuring and testing equipments.
9. MONITORING AND MEASUREMENT
1. First off approval before starting regular production on set up dominant
processes
2. Use of proper gauges and instruments
3. Use of appropriate documents
4. Department wise PPM trends
5. No. of customer complaints
6. Customer rejections
7. Warranty
10. PERFORMANCE CRITERIA
1. Department wise PPM trends
2. No. of customer complaints
3. Customer rejections
4. Warranty

11. REFERENCES
 Red tag for new product development
 Blue tag for ECN in part change
 Orange tag for Process Change

PREPARED BY: APPROVED BY: