Dataking Audit observation and correctiv

S.No. Obsevation Area

IQC inspection results found not recorded

1 properly, observed value mentioned as IQC
copy of specification.

Measuring Equipments(Vernier
2 Calliper,Micrometer) found not IQC
calibrated.
PVC(Tensile
Strength,Elongation,Hardness) measured
3 IQC
value mentioned as OK in place of
observed result.

4 FIFO not in system at W/H. W/H

No Identification of ACCEPT/REJECT
5 IQC
material

No separate area for IQC lot reject

6 IQC/WH
material

Reliability Test Report of each lot is not

7 IQC
available

Salt Spray Tester,Bending Tester,Thermal

8 Shock equipment not available; High IQC/OQC
Temp High humidity test not conducted.

Relaibility Test at Product level/Part

9 Reliability
Level(Connectors) is not conducted.

Validation of Function Tester used at line

10 is not found/Golden samples not Prod.
available

11 IMF samples verification not in practice. Prod.

 No any specified area for NG semi FG
12 Prod.
material at line.

Function Tester, Voltage Drop Tester not

13 OQC
available at OQC inspection.

Dedidicated manpower not available for

14 OQC
OQC Insepction.

Strenghteninng of OS&D feedback is

15 Prod.
lagging.

4M/ECN management need to implement

16 R&D
effectively

Quality Audit(Weekly/Monthly) not in

17 OQC
practice.

Equipment Parameters changed by

18 Operators without any information to Prod.
PQC/Equipment.
ation and corrective report & status
Detail Action Plan Target Date Evidence

IQC Checksheet formats are

changed and data is recorded 11/26/2016
as per standard requirement

All equipment is send

calibration by NABL 12/1/2016
approoved agengy

all observed numeric value is

11/28/2016
recorded in checksheets

FIFO system is implemented

and displayed in W/H and 11/29/2016
also applied in FG area

each and every raw

material ,WIP is identified by 11/26/2016
QC OK and NG stickers

Seprate area for IQC rejection

11/26/2016
area is identified

Reliabilty test report is

conducted for every incoming
11/29/2016
material and attached with
IQC report

salt spray tester,bending

tester ,pin insertion tester is
purchased and installed in
12/1/2016
factory rest thermal shock
tester will available in factory
on 1-12-2016

part level relaibility is started

12/1/2016
at part level

golden sample jig verification

is started and molding prod 11/29/2016
line

IMF sample verification is in

practice(process validation
11/29/2016
check sheet) and data is
recorded hourly basis in a day
all material trolly is divided in
two part for ok and ng
material and opertaors has 11/29/2016
statred to kept material as
per statndard

seprate function tester is

installed in oqc and voltaged
12/1/2016
drop tester is orderd and will
installed on 1 st december

dedicated engineer
mr.anubhav is appointed on 11/28/2016
oqc

rework report ,rework SOP

and os&d feedback by
11/28/2016
operator performance chart is
displayed on prod line

4M/ECN record is corrected

11/29/2016
and verified

Internal quality audit plan is

prepared and is conducted on 12/1/2016
1-12-2016

all operators and workers are

strictly prohibitted for change
of parameter ,prod supervisor
is authorised for change of 11/30/2016
machine parameter and will
generate a report on daily
basis