Vitalo Plastics Solutions India Private Ltd.

DDN - Document Distribution / Retrieval Notice

DOC REF : QSA.PA-03/FM-01 Rev.3 Date: 30.06.10

Copy Holder Distribution Points

Category Sub Category Doc. ref. Level Document Title

10 - OPER

14 - PACK

15 - PLAN
11 - WHK
3 -LOGIS

7 - PRDN

8 - MAIN

13 - PUR
Revision

5 - KAM
1 - QAS

9 - ACC

12 - QI
2 - SM

6 - AA
4 - CS
HRM Master List HRM.PA-01/LS-01 IV List of Trainees 1 Φ Φ
MAN Master List MAN.PA-03/LS-01 IV Tooling list VPIN 1 Φ Φ
MAN Master List MAN.PA-07/LS-01 IV Spareparts list (Addison) 1 Φ Φ
PUR Master List PUR.PA-01/LS-01 IV List of suppliers 1 Φ
SCS Master List SCS.PA-01/LS-01 IV List of customers 1 Φ Φ Φ Φ Φ

Distribution list of documents VPIN.xls Page 1 of 10

QAS Master List QAS.PA-05/LS-01 IV Calibration list 1 Φ Φ
QAS Master List QAS.PA-05/LS-02 IV List of instruments 1 Φ Φ
QAS Master List QAS.PA-07/LS-01 IV List of drawings 1 Φ Φ
QAS Master List QAS.PA-07/LS-02 IV List of customerspecifications 1 Φ Φ

Distribution list of documents VPIN.xls Page 2 of 10

 Vitalo Plastics Solutions India Private Ltd.
DDN - Document Distribution / Retrieval Notice
DOC REF : QSA.PA-03/FM-01 Rev.3 Date: 30.06.10

Copy Holder Distribution Points

Category Sub Category Doc. ref. Level Document Title

10 - OPER

14 - PACK

15 - PLAN
11 - WHK
3 -LOGIS

7 - PRDN

8 - MAIN

13 - PUR
Revision

5 - KAM
1 - QAS

9 - ACC

12 - QI
2 - SM

6 - AA
4 - CS
HRM Form HRM.PA-01/FM-01 IV Training Requistion Form 1
HRM Form HRM.PA-01/FM-03 IV Training plan 1
HRM Form HRM.PA-01/FM-04 IV Training record 1
HRM Form HRM.PA-01/FM-05 IV Jobdescription: Production Planner 1
HRM Form HRM.PA-01/FM-06 IV Jobdescription: Production Supervisor 1
HRM Form HRM.PA-01/FM-07 IV Jobdescription: Warehousekeeper 1
HRM Form HRM.PA-01/FM-08 IV Jobdescription: Maintenance Technician 1
HRM Form HRM.PA-01/FM-09 IV Jobdescription: Account Manager 1
HRM Form HRM.PA-01/FM-10 IV Jobdescription: Operator 1
HRM Form HRM.PA-01/FM-11 IV Jobdescription: Administrative Assistant 1
HRM Form HRM.PA-01/FM-12 IV Jobdescription: Accounts Administration and Logistics Manager 1
HRM Form HRM.PA-01/FM-13 IV Jobdescription: Accounts Assistant 1
HRM Form HRM.PA-01/FM-14 IV Jobdescription: QC Inspector 1
HRM Form HRM.PA-01/FM-15 IV Jobdescription: Packer 1
HRM Form HRM.PA-01/FM-16 IV Jobdescription: Quality Assurance supervisor 1
HRM Form HRM.PA-01/FM-17 IV Jobdescription: Site Manager 1
HRM Form HRM.PA-01/FM-18 IV Jobdescription: Purchase and Taxes coordinator 1
HRM Form HRM.PA-01/FM-19 IV Jobdescription: Maintenance Supervisor 1
HRM Form HRM.PA-01/FM-20 IV Jobdescription: Customer Service (Internal Sales) 1
HRM Form HRM.PA-01/FM-22 IV Skill Matrix 1
HRM Form HRM.PA-01/FM-23 IV Training Need Identification Form 1
HRM Form HRM.PA-01/FM-24 IV Training Feedback & Effectiveness Form 1
HRM Form HRM.PA-01/FM-25 IV Employee Feedback 1
HRM Form HRM.PA-02/FM-01 IV Performance Evaluation 1
HRM Form HRM.PA-02/FM-02 IV Performance & Development Review 1
HRM Form HRM.PA-03/FM-01 IV Attendance sheet Vitalo Personnel 1
HRM Form HRM.PA-03/FM-02 IV Visitors report 1
HRM Form HRM.PA-03/FM-03 IV CCTV Weekly Survillence Form 1
MAN Form MAN.PA-01/FM-01 IV Production order 1
MAN Form MAN.PA-01/FM-02 IV Production logfile 2
MAN Form MAN.PA-01/FM-03 IV Centerlining paper Addison 2
MAN Form MAN.PA-01/FM-04 IV Logfile corrective actions (production) 2
MAN Form MAN.PA-02/FM-01 IV Daily Production Plan 1
MAN Form MAN.PA-03/FM-01 IV Toolcontrol form 1
MAN Form MAN.PA-03/FM-02 IV Tooling acceptance form 2
MAN Form MAN.PA-05/FM-01 IV Pick-up request document 1
MAN Form MAN.PA-05/FM-02 IV Delivery overview 1
MAN Form MAN.PA-07/FM-01 IV Master schedule preventive maintenance 1
MAN Form MAN.PA-07/FM-02 IV Registration preventive maintenance 1
MAN Form MAN.PA-07/FM-03 IV Maintenance /repair form 1
PUR Form PUR.PA-02/FM-01 IV Supplier Self Assessment Questionnaire 1
PUR Form PUR.PA-02/FM-02 IV Supplier Evaluation Form 1
SCS Form SCS.PA-01/FM-01 IV Quotation 1
SCS Form SCS.PA-01/FM-02 IV WorkForm New Project & Invoicing 1
SCS Form SCS.PA-01/FM-03 IV Communication Matrix 1
SCS Form SCS.PA-02/FM-01 IV Customer satisfaction survey 2
QAS Form QAS.PA-01/FM-01 IV On hold tag 1
QAS Form QAS.PA-01/FM-02 IV Material evaluation and disposition form 1
QAS Form QAS.PA-01/FM-03 IV NCPT - form raw materials 1
QAS Form QAS.PA-01/FM-04 IV Request for concession or deviation 1
QAS Form QAS.PA-01/FM-05 IV NCPT - form finished products 1

Distribution list of documents VPIN.xls Page 3 of 10

QAS Form QAS.PA-01/FM-06 IV Rework Register 1
QAS Form QAS.PA-02/FM-01 IV Incoming inspection report 2
QAS Form QAS.PA-02/FM-02 IV Sampleplan for foils 1
QAS Form QAS.PA-08/FM-01 IV Control plan for transport trays 2
QAS Form QAS.PA-08/FM-02 IV Measuring record: symmetry and measurement of cutting edge 2
QAS Form QAS.PA-08/FM-03 IV Measuring record: ESD 1
QAS Form QAS.PA-08/FM-04 IV Sample Report 1
QAS Form QAS.PA-08/FM-05 IV Certificate of conformity 1
QAS Form QAS.PA - 08 - B - FM - 01 IV Control Plan For Blister Trays 1
QAS Form QAS.PA - 08 - B - FM - 02 IV Measuring record: symmetry and measurement of cutting edge 1
QAS Form QAS.PA - 08 - B - FM - 03 IV Sample Report 1
QAS Form QAS.PA - 08 - B - FM - 04 IV Certificate of Compliance Report 1
QSA Form QSA.PA-02/FM-01 IV Internal Audit Planning 1
QSA Form QSA.PA-02/FM-02 IV Internal Audit Report 1
QSA Form QSA.PA-02/FM-03 IV Non Conformity Report 1
QSA Form QSA.PA-03/FM-01 IV DDN - Document distribution/retrieval notice 1
QSA Form QSA.PA-03/FM-02 IV Request for document revision/creation 1
QSA Form QSA.PA-05/FM-01 IV Registration form production results 2
QSA Form QSA.PA-05/FM-02 IV Operational Results 1
QSA Form QSA.PA-05/FM-03 IV BBS - Key performance indicators.xls 1
QSA Form QSA.PA-05/FM-07 IV Key Performance Indicator 1
QSA Form QSA.PA-06/FM-01 IV SCAR - Supplier Corrective Action Request 2
QSA Form QSA.PA-06/FM-02 IV CAR - Corrective Action Report 2
QSA Form QSA.PA-08/FM-01 IV Annual quality improvement plan 1
QSA Form QSA.PA-08/FM-02 IV Quality improvement project 1

Distribution list of documents VPIN.xls Page 4 of 10

 BEMPU HEALTH PVT LTD., DOC REF : BHPL-QSP-QA-01/F01
rev.

Effective
DDN - Document Distribution / Retrieval Notice date
1/1/2020

Copy Holder Distribution Points

DESIGN & DEVELOPMENT

PRODUCTION PLANNING
Folder File No

CUST SERVICE MGR

File

PRODUCTION MGR

PURCHASING MGR
2 - MGR- QUALITY
No in in Category Doc. ref. Level Document Title

ISSUE:1
S.No
System System

HR MANAGER

R.M/F.GW.H

DISPLAY
Revision

1 - CEO
1.0 1 1 Manual JMI-QM-01 I Quality Manual 0
2.0 1 1 System Procedure II 0
2 System Procedure II 0
3 System Procedure II 0
4 System Procedure II 0
5 System Procedure II 0
6 System Procedure II 0
7 System Procedure II 0
8 System Procedure II 0
9 System Procedure II 0
10 System Procedure II 0
11 System Procedure II 0
12 System Procedure II 0
13 System Procedure II 0
14 System Procedure II 0
15 System Procedure II 0
16 System Procedure II 0
17 System Procedure II 0
18 System Procedure II 0
19 System Procedure II 0
20 System Procedure II 0
21 System Procedure II 0
22 System Procedure II 0
23 System Procedure II 0
24 System Procedure II 0
25 System Procedure II 0
26 System Procedure II 0
27 System Procedure II 0
28 System Procedure II 0
29 System Procedure II 0
 BEMPU HEALTH PVT LTD., DOC REF
DDN - Document Distribution / Retrieval Notice rev.

Effective

Copy Holder Distribution Points

15-PRODUCTION PLANNING
10 - R.M/F.GW.H MANAGER
File S.No

7-CUST SERVICE MGR

Folder File No

2 - Sr. MGR- QUALITY

5-PRODUCTION MGR

6-PURCHASING MGR
No in in Category Doc. ref. Level Document Title
System System

4-QC MANAGER

HR MANAGER

17 - DISPLAY
Revision

1 - QAM
1 Work Instructions MP1001 III Top Casing Sub Assembly B Φ Φ
2 Work Instructions MP1001 III Sensor Cup Sub Assembly B
3 Work Instructions MP1001 III Bottom casing Sub Assy with PCBA Assy B
4 Work Instructions MP1001 III Battery Sub Assy with spring & pull swith B
5 Work Instructions MP1001 III Final Assy & Packing B
6 Work Instructions MP1002 III Secondary Packaging A
7 Work Instructions MP1003 III Transparent Primary Package A
8 Work Instructions MP1004 III Transparent Secondary Package A
9 Work Instructions QIP001 III Quality Instruction Pocedure of PCBA B
10 Work Instructions QIP002 III Quality Instruction Pocedure for Accuracy test B
Final Quality Instruction procedure of Bempu Hypotermia alert
11 Work Instructions QIP003 III B
device
12 Work Instructions MP1001 III PSLHR for Hypothermia alert device B
Distinguish for different states & Visibility of auidability alarm
13 Work Instructions STM001 III A
indication
14 Work Instructions STM002 III To run the device in stimulated test condition for 30 days
15 Work Instructions STM003 III Pull swich activation test
16 Work Instructions STM004 III Device drop test
17 Work Instructions STM005 III Battery short test
18 Work Instructions STM006 III Temperature Response time test
19 Work Instructions STM007 III Environmental operatin condition
20 Work Instructions STM008 III Durability of pad printed text after cleaning
21 Work Instructions STM009 III Device end off life ( 30 days ) indication test
22 Work Instructions STM010 III Temperatue stress on packaging box
23 Work Instructions STM011 III Temperature storage condition test
24 Work Instructions STM012 III Coin battery drop test
Effect in the ( db Level ) volume due to putting
25 Work Instructions STM013 III
the top casing & silicon band
26 Work Instructions STM014 III Minimum audible volume(db level ) of the device
27 Work Instructions STM015 III Hypohermia alarm verification test
28 Work Instructions STM016 III Measurement repeatability & stability
29 Work Instructions STM017 III Band off condition test
30 Work Instructions STM018 III Thermistor short / open test
31 Work Instructions STM019 III Sanitation test on medical grade band
32 Work Instructions DHD006 III Product Desin Validation Plan A
33 Checklist QIP001-F03 III Test Data Sheet for Accuracy test B
34 Checklist QIP001-F02 III Test Data Collection Sheet for PCBA A
35 Checklist QIP003-F03 III Test Data Collection Sheet FQT B
36 Checklist MP1001-F02 III Serial Number Tracker A
37 System Procedure MP1001 III Final Packing of Device with small box B
 Issued By

Received By

Date
 BEMPU HEALTH PVT LTD., DOC REF : BHPL-QSP-QA-01/F01
rev. 0

Effective
DDN - Document Distribution / Retrieval Notice date
1/1/2020

Copy Holder Distribution Points

DESIGN & DEVELOPMENT

PRODUCTION PLANNING
Folder File No

CUST SERVICE MGR

File

PRODUCTION MGR

PURCHASING MGR
2 - MGR- QUALITY
No in in Category Doc. ref. Level Document Title

ISSUE:1
S.No
System System

HR MANAGER

R.M/F.GW.H

DISPLAY
Revision

1 - CEO
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
 BEMPU HEALTH PVT LTD., DOC REF
DDN - Document Distribution / Retrieval Notice rev.

Effective

Copy Holder Distribution Points

15-PRODUCTION PLANNING
10 - R.M/F.GW.H MANAGER
File S.No

7-CUST SERVICE MGR

Folder File No

2 - Sr. MGR- QUALITY

5-PRODUCTION MGR

6-PURCHASING MGR
No in in Category Doc. ref. Level Document Title
System System

4-QC MANAGER

HR MANAGER

17 - DISPLAY
Revision

1 - QAM
Issued By

Received By
Date