QUALITY SYSTEM PROCEDURE Doc.
No :- FSI :QSP:03
Rev. No. : 07
Rev. Date : 05.02.2023
INITIAL PRODUCTION CONTROL Page No:- 1/5
1. Purpose: To establish a procedure for Initial Production Control and to ensure that the controls required
for Initial supplies in the case of New Product, change in existing product and process are established,
implemented and maintained at our end and as well as supplier end.
2. Scope:
This procedure is applicable for Below Mention
AA Absolutely new component; no experience of production so far
A Part happens to be similar to that had been produced
B ECN/PCN
C Tool Supplied by Customer
D Raw material Change
E Plant Location Chang/Layout Change or shift to another plant
F BOP Supplier Change or supplier Develop
G Suddenly Volume Increase in Regular Production Part (i.e. 30% Hike)
H Restart of parts after long duration 1 Years
3. Responsibility: QA Head.
4. Definition& Abbreviations: -
IPC INITIAL PRODUCTION CONTROL
SOP START OF PRODUCTION
CFT CROSS FUNCTION TEAM
DEV. DEVELOPMENT
SPC STATISTICAL PROCESS CONTROL STUDY
MSA MEASURMENT SYSTEM ANALYSIS
MOM MINUTES OF MEETING
PDCA PLAN DO CHECK A
ECN ENGG.CHANGE NOTE
PPM PARTS PER MILLION
5.Reference CFT:-
CREATE CROSS FUNCTIONAL TEAM for IPC (FSI:F:DEV:01)
6. Systems:
SN Activity Input Output Responsibility
Prepared By Checked By Approved By
QUALITY SYSTEM PROCEDURE Doc. No :- FSI :QSP:03
Rev. No. : 07
Rev. Date : 05.02.2023
INITIAL PRODUCTION CONTROL Page No:- 2/5
1 After pilot lots, IPC shall start from In-house SOP up to IPC Announce IPC Log Book QA Head
3 months/5000 Pcs/3 Lots or suggested by customer Alert FSI:F:DEV:18
Whichever Later SOP at Customer end.
Inform to all departments for announcement of IPC MOM & Sign QA Head
2 IPC Initiation
through IPC initiation sheet QA Head authorize the sheet
start & Termination of IPC and ensure the all FSI: F:DEV:15
required special control to be done during IPC
period
3 Department Head will provide On Job training to List Of Employee
operators and concerned person for the different On The Job QA/Prd. Head
FSI: L:HR:01 Training
stages of operation and record to be maintained
FSI: F:HR:09
4 Readiness of IPC:- Before Commencing
IPC Period endure readiness of all production
related point & share the report to concern
department
Ensure readiness of production equipment
(tool/Gauge/Fixture etc)
Availability of Critical Spare Part if any
Readiness of Testing Equipment
(Vernier/Micrometer/Height gauge Etc )
Working of Poka-Yoke if any
Availability of Limit samples IPC Readiness IPC Readiness QA Head/Prd
Readiness of IPC Documents Check sheet Report Head
Display of OPS/WI/Inspection Standards FSI:F:DEV:23 FSI:F:DEV:23
Use of PPE (Safety)
Availability of IPC Communicating bard
Availability of Inspection table
Availability of Fixed IFM inspector
Availability of Fixed PDI Inspector
Training to operator/Inspector for New
Part
Availability of Identification IPC Tag
Ensure Storage available for IPC Material
Availability of Bins & Trolley
Certified SPC/MSA person
Note:-
Control items will be either defined by customer or FSI CFT
In case of customer-initiated IPC /Customer format of IPC used, Identification Tag will be used as per
customer requirement
5. Special Control to be Monitoring at the time of Initial Supply:-
Prepared By Checked By Approved By
QUALITY SYSTEM PROCEDURE Doc. No :- FSI :QSP:03
Rev. No. : 07
Rev. Date : 05.02.2023
INITIAL PRODUCTION CONTROL Page No:- 3/5
SN CONTROL ITEMS REGULAR PRODUCTION IPC
1 Raw Material 5 Strip/lot 10 Strip/Lot
2 Setup approval 5pcs checked/1 pc records 5pcs checked/5 pc records
3 In process inspection 3pcs/4 hours 5pcs/2 hours
200% inspection by two different
4 Visual 100% or as specified by customer
inspector
5 Inspection method Both Variable & attributes Only variable instrument used
6 PDI Inspector Skilled Level L-3 Inspector will check Only L-4 Inspector will check
1st lot of every month Till IPC
7 Process capability study Once in a Year
Period
1st lot of every month Till IPC
8 MSA study Once in a Year
Period
1st lot of every month Till IPC
9 Process audit Once in a Year
Period
10 In-house rej.target As per present target set 50%of current rejection target
11 Complaint resolving Complaint (7working days) Same day
12 Defect Rate Monitoring - 50% Less to current
1st lot of every month Till IPC
13 Coherence Check Once in a Year
Period
6. If the given targets are not met during IPC Period, in that case the termination period will be extended
as per the guidelines given below:-
MINIMUM PRODUCTION CONTROL
CATEGORY MINIMUM EXTENDED PERIOD
PERIOD
AA 3 months/5000 Pcs/3 Lots 3 months/5000 Pcs/3 Lots
A 3 months/5000 Pcs/3 Lots 3 months/5000 Pcs/3 Lots
B 2 months/3000 Pcs/2 Lots 2 months/3000 Pcs/2 Lots
C 3 months/5000 Pcs/3 Lots 3 months/5000 Pcs/3 Lots
D 2 months/3000 Pcs/2 Lots 2 months/3000 Pcs/2 Lots
E 3 months/5000 Pcs/3 Lots 3 months/5000 Pcs/3 Lots
F 3 months/5000 Pcs/3 Lots 3 months/5000 Pcs/3 Lots
G 1 Month/3000 Pcs/1 Lots 1 Month/3000 Pcs/1 Lots
H 2 months/3000 Pcs/2 Lots 2 months/3000 Pcs/2 Lots
SN Activity Input Output Responsibility
Prepared By Checked By Approved By
QUALITY SYSTEM PROCEDURE Doc. No :- FSI :QSP:03
Rev. No. : 07
Rev. Date : 05.02.2023
INITIAL PRODUCTION CONTROL Page No:- 4/5
7 INSPECTION FRQ.AS PER IPC CONTROL IPC Control Plan Inspection QA Head
PLAN FSI:D:QA:03 Reports
Stricter control, like Increase In-process sample FSI:F:QA:05
size and frequency. 200 % visual inspection by two
different PDI Inspector and Dimensionally by QA
inspector as per IPC Inspection matrix
IDENTIFICATION TRACEBILITY:- IPC Parts IPC Tag
8 PRD/QA Head
All process under IPC to be identified by separated
area like bin, trolley, machine etc with
identification tag
MSA Plan MSA Reports QA Head
9 MEASUREMENT SYSTEM ANALYSIS(MSA)
FSI:F:QA:11 FSI:F:QA:12
Conduct MSA for 1st lot of every month
10 STATISTICAL PROCESS CONTROL (SPC)
IPC Plan SPC Reports QA Head
SPC Study done for 1st lot of every month. Target
FSI:F:QA:08 FSI:F:QA:09
Value of Cp>=1.33
NOTE:- Conduct MSA Before SPC
Note During IPC 125 minimum readings
to be taken for calculate the SPC value
SPC will be conducted by Only Certify
person
CUSTOMER COMPLAINT
11 QA Head
If Any customer complaint during IPC. it is Mail/Phone PDCA Sheet
analyzed immediately and take countermeasure Verbal Etc FSI:F:QA:13
without delay
& communicated it from top management to
operators immediately
PROCESS AUDIT DURING IPC Process Audit QA Head/Dev
12 Process Audit
To verify whether IPC control plan requirement Reports Head
Plan
are followed or not. Process Audit is done in first,
Mid and at the end of IPC
DEFECT RATE MONITORING
13 Defect Rate Monitoring to be done for each lot Defect Rate QA Head/Dev
IPC Logbook
under initial production control period monitoring Head
FSI:F:DEV:19
Prepared By Checked By Approved By
QUALITY SYSTEM PROCEDURE Doc. No :- FSI :QSP:03
Rev. No. : 07
Rev. Date : 05.02.2023
INITIAL PRODUCTION CONTROL Page No:- 5/5
SN Activity Input Output Responsibility
12 IPC TERMINATION: -
Dev Head holds an IPC termination meeting and presents the data IPC Records MOM Dev Head
after reviewing current condition & target meeting condition QA
Head will Terminate the IPC Period If Target not Meet then QA
Head Extend the IPC period as per define Criteria
13 Initial Production Control Termination Criteria
SN Criteria IPC Target
Warranty Failure 0
Customer
A Line Rejection 0
Complaint
BOP Rejection 0
Supplier
B Rejection Defect/PPM 0
Rejection
C Delivery Should be on time as per schedule 100%
Produced
D No Line stoppage Plan Vs Actual
Qty
In-house Set Target Should be In Improving 20% Less to
E
Rejection Trend Current Target
Result of c'measure taken against
C’Measure Should be Initiations Initiation Plant
F problems during production
NPD effective
preparation Sheet and Head/Dev
Record line Problem on Daily basis FSI:F:DEV:15 Termination Head
Line Should be
G & all observation must be closed OR IPC
Problem Closed
during Initial Period Control
Sign off
Result of c'measure taken against FSI:F:DEV:15
C’Measure Should be
H problems during initial supply
IPC effective
control
Gauge R& Gauge R& R value should be in
I ≤10
R improving trend up to 3 months.
Process SPC value should be in improving
J CP≥1.33
Capability trend up to 3 months.
50% Less to
K Defect Rate Defect rate at PDI Station
Current Target
L Defect Rate Defect rate at IFM Station 0
Process
All NC should be closed & in Actual Vs
M Audit
Improving trend Closed
( NC Status)
Coherence
All NC should be closed & in Actual Vs
N Review
Improving trend Closed
(NC Status)
Part Part Accuracy should be in
O 100%
Accuracy Improving trend
Prepared By Checked By Approved By
QUALITY SYSTEM PROCEDURE Doc. No :- FSI :QSP:03
Rev. No. : 07
Rev. Date : 05.02.2023
INITIAL PRODUCTION CONTROL Page No:- 6/5
7.0 Reference Documents:-
S .N Documents Name Doc No Responsibility Retention Period
1 IPC Log Book FSI:F:DEV:18 QA Head Continuous
2 MSA Plan FSI:F:QA:11 QA Head 1 Year
3 MSA Report FSI:F:QA:12 QA head Product Life+11 yrs
4 SPC Plan FSI:F:QA:08 QA Head 1 Year
5 SPC Report FSI:F:QA:09 QA Head Product Life+11 yrs
6 IPC Inspection Matrix FSI:F:DEV:14 QA Head 3 Years
7 Initiation and Termination OR IPC Sign off FSI:F:DEV:15 NPD Head Product Life+11 yrs
8 IPC Readiness Checksheet FSI:F:DEV:23 QA Head Product Life+11 yrs
7 05.02.2023 IPC Termination & Extended Criteria Revise
Scope, Minimum Qty produced or Min extended qty special control monitoring revise &
6 01.12.2022
Min.125 Reading for SPC define
5 05.06.2021 Rules made of extended the termination criteria if the target not met
4 11.02.2021 E Scope added for sudden increase of Volume in regular production Part
3 03.01.2020 Quantity of Monitoring during IPC Revise 3000 Nos. to 5000 Nos.
2 27.04.2019 Initial Production Control Period:-& Extended Criteria Revise
1 01.06.2018 Change done as per Requirements
0 30.11.2017 Initial Release
Rev No. Rev. Date Details of Amendment
Prepared By Checked By Approved By
