OmniActive Health Technologies Limited Document No.

D / QA / 03
566 – A1 & A2, KIADB Industrial area, Revision No 0
HN Pura Road, Hassan, Karnataka - 573201. Issue No. 1
Risk and Opportunity Register Issue Date 15.02.2022

Department: Leadership and Business Planning

RISK
RISK / INTERNAL Effectiveness
Sl. No. ISSUES SEVERITY OCCURRENCE FACTOR/VA LEVEL Mitigation Risk Assessment Plan
Opportunities /EXTERNAL Verification
LUE
Every MRM Business Plan and will be allotted , In
Failed to plan Monthly Financial Planning will be done by Finance Head Weekly
1 Financial Shortage INTERNAL 4 3 12 Emergency fund will be arranged as Cash By Finance
Financially and Petty Cash System will be Followed meeting
Head

All Government rules and regulation are followed by

Communication for better relationship, Friendly Monthly the MR and document maintained, if any issue are
2 Political Problem Legal actions EXTERNAL 3 4 12
environment is followed with the Government Officials meeting raised regarding the Statutory requirements then MR
will take the respective action to solve the problem.

Affecting business Industry will be closed at the time of issue to reduce the Training Given to all Employee for Emergency
3 Natural Calamity EXTERNAL 3 4 12 Every MRM
continuity severity Situation and how to tackle them

Monthly Turnover is monitored and fund flow maintained by Monthly New customer will be developed to achieve the
4 Banker not Support Financial demands EXTERNAL 2 3 6
Finance Head meeting business target on monthly basis

Quality of product , on time delivery as per customer

requirements and monthly monitor customer schedule vs.
Inadequate Customer Customer dis Monthly Every MRM review the competitor analysis and take
5 EXTERNAL 3 4 12 actual, Customer will be called frequently about the quality
Focus satisfaction meeting necessary action and implemented
and sales of the product and with the help of it the analyses
will be made for the improvement

Inadequate Employee Wherever changes required the MR revised the roles

In effective FSSC Target based incentives and the appraisal will be given to
6 Roles and INTERNAL 3 4 12 Every MRM and responsibility and authority and communicated to
implementation the employee.
Responsibility defined concern person.

Yearly once Performance awarded for best performance

Inadequate Employee In effective FSSC Target based incentives and the appraisal will be given to
7 INTERNAL 4 4 16 Every MRM and 100% Attendance award with the appraisal for that
motivation implementation the employee.
particular employee
The selling of the product without the proper bill is
Selling product Half yearly physical audit will be conducted by the
8 No traceability INTERNAL 4 4 16 By Auditing restricted and the person try to ask that sort of thing will
without Bill Accounts / Internal Statutory auditor.
dealt with the legal issue.
 OmniActive Health Technologies Limited Document No. D / QA / 03
566 – A1 & A2, KIADB Industrial area, Revision No 0
HN Pura Road, Hassan, Karnataka - 573201. Issue No. 1
Risk and Opportunity Register Issue Date 15.02.2022

Department: FSTL

RISK
RISK / INTERNAL OCCURRE Effectiveness
Sl. No. ISSUES SEVERITY FACTOR/V Mitigation Risk assessment plan
Opportunities /EXTERNAL NCE Verification
ALUE

Inadequate FSSC Loss in document External Qualified lead auditor as consultant implemented and conduct the internal
1 INTERNAL 2 3 6 Every MRM Manager is appointed by the MD and implement as perFSSC requirements
Implementation integrity audit as per plan to identify the gap and implement on regular Basis

Loss in document
2 Inadequate Document Control INTERNAL 3 4 12
integrity

Unawareness of FSSC
3 System Failure INTERNAL 3 3 9 MD will give detailed training about the requirements of FSSC Every MRM FSSC Awareness Training Provided to all employee.
Requirements to employee
Customer Requirements not Loss in Document Based on customer requirements manual and procedure are revised and
4 EXTERNAL 3 2 6 all customer specified requirements are included in process wise procedure updated Every MRM
included in FSSC Integrity approved by MD

inadequate Purchase and Loss of Control

All Purchase and Outsource requirements are included in process wise procedure Based on Purchase Requirements manual and procedure are revised and
5 Outsource process control in over the EXTERNAL 4 3 12 Every MRM
updated approved by MD
FSSC outsourcing

System Failure due to Internal

6 audit Not Planned and Not System Failure INTERNAL 2 2 4 Internal audit Plan Prepared and displayed in notice Board as per procedure Every MRM Internal Audit Process are Outsourced with Qualified Lead auditor as perFSSC
Conducted

Process wise not cover the Internal Audit Schedule Prepared and approved by MD and after circulate the plan to
7 System Failure INTERNAL 3 3 9 Every MRM Internal Audit Process are Outsourced with Qualified Lead auditor as perFSSC
Internal Audit all process owners

In adequate Internal Audit NC Effectiveness of MD to verify the route cause analysis and corrective implementation plan and
8 INTERNAL 2 2 4 Every MRM FSSC Awareness Training Provided to all employee
corrective action not taken FSSC not verified approve each non conformance
MRM Circular as per Standard requirements Prepared all the points included
As per MRM Plan not carried Fail to review The
9 INTERNAL 3 3 9 MRM Plan Prepared and display in office Every MRM and approved by MD for each MRM based on agenda points reviewed and
out System
maintained the documented information
Inadequate MRM Data
Effectiveness of Data Collection Training Provided to all Department Head and Every month data As per Agenda points checked by MD and approved the minutes of review
10 Collection and Analysis and INTERNAL 3 3 9 Every MRM
FSSC not verifies collection done and record maintained meeting record
action plan
 OmniActive Health Technologies Limited Document No. D / QA / 03
566 – A1 & A2, KIADB Industrial area, Revision No 0
HN Pura Road, Hassan, Karnataka - 573201. Issue No. 1
Risk and Opportunity Register Issue Date 15.02.2022

Department: Quality

RISK
INTERNAL EFFECTIVENESS
Sl. No. ISSUES RISK/OPPORTUNITIES SEVERITY OCCURRENCE FACTOR/VAL MITIGATION RISK ASSESSMENT PLAN
/EXTERNAL VERIFICATION High Priority moved to in house, Purchase order clearly
UE
mentioned delivery date, and follow action taken,
Supplier and sub contractor does not meet delivery alternate source developed .delivery Rating Done on
1
deadline
Production Delay INTERNAL 1 2 2 Supplier and sub contractor are Prioritized so highest priority items received first EVERY MRM
Monthly Basis.
Purchase Executive along with the Stores Head will Check the Quantity and Grade and EVERY MRM
inform to Customer /Supplier in case of Shortage of Wrong Grade of Material All Supplier Purchase order clearly mentioned for material
Wrong Material Grade or specification despatched by
2 Usage of Standard Material EXTERNAL 3 4 12 Technical specification and incoming inspection all material
supplier or sub contractor Received ,The immediate change over or the corrective action will be taken for the verified as per PO
particular material EVERY MRM

In process Inspection not carried out as per Control Low Quality Products
Training Given to Quality Team for Process and Product Knowledge and inspection Based on control Plan inspect the product by Quality Team
3 INTERNAL 3 3 9
plan by Quality Team frequency EVERY MRM and approved by Quality Head

Delay Delivery of Products

Monthly In house Rejection Register is followed by the Quality Head and the analysis are EVERY MRM Failure related training given to operators and the operator to
4 Above target the In-house rejection or failure INTERNAL 3 2 6
made out on that carry out the process

Incoming , In process Inspection and final inspection frequency increased based on type EVERY MRM Before Delivery product to customer pre delivery inspection
5 Rejection Product despatch to customer Customer dis-satisfaction INTERNAL 3 3 9
of Rejection done as per control plan and record maintained
EVERY MRM
Low Quality Products
Calibration done for the equipment prior to the due date ,calibration plan is available Calibration done well within due date and stock maintained
6 Monitoring and Measuring Equipment Failure INTERNAL 2 2 4
based on the calibration plan the calibration for the equipment is done EVERY MRM for equipments

Marchandising Manager verify the route cause analysis and corrective action, The root cause and the corrective action is discussed by the
In adequate Customer compliant corrective action not
7 Re-Occurrence of the problem INTERNAL 2 2 4 EVERY MRM Merchandising Manager in the meeting after analysis of the
taken implementation plan and approve each non conformance root cause
 OmniActive Health Technologies Limited Document No. D / QA / 03
566 – A1 & A2, KIADB Industrial area, Revision No 0
HN Pura Road, Hassan, Karnataka - 573201. Issue No. 1
Risk and Opportunity Register Issue Date 15.02.2022
Department: HR & Training

Effectiven
RISK / INTERNAL OCCURRENC ess
Sl. No. ISSUES SEVERITY RISK FACTOR/VALUE Mitigation Risk assessment plan
OPPORTUNITIES /EXTERNAL E Verificatio
n

Multi Skill for Employees will be done to

Employee Motivation for Incentives,
Frequent Leave of Facilitate inter Departmental Working. UN Every
1 Production Delay INTERNAL 2 1 2 Awarded for best performance .Multi Skill
Production employee Skilled Personnel gave On Job Training to get MRM
Training Provided and Records Maintained.
Additional Skilled Man power availability.

Competency matrix prepared for qualification

Skill Assessed for all employee based on skill and Experience, Skill required level selected
unavailability of Skilled Production Delay / Every
2 INTERNAL 1 1 1 assessment training provided to competent work and based on competency matrix select
employee Low Quality Products MRM
person for work and interview the employees and induction
training provided to new joiners

Competency matrix prepared for qualification

Skill Assessed for all employee based on skill
and Experience, Skill required level selected
Skill Assessment not done Improper Knowledge / assessment training provided to competent Every
3 INTERNAL 2 2 4 work and based on competency matrix select
for employee Outdated Technology person for work, Quality Head will evaluate the MRM
and interview the employees and induction
employee to check the job consistency
training provided to new joiners
 OmniActive Health Technologies Limited Document No. D / QA / 03

566 – A1 & A2, KIADB Industrial area, Revision No 0

HN Pura Road, Hassan, Karnataka - 573201. Issue No. 1

Risk and Opportunity Register Issue Date 15.02.2022

Department: Purchase

INTERNAL Effectiveness/
Sl. No. ISSUE RISK / OPPORTUNITIES SEVERITY OCCURRENCE RISK FACTOR/VALUE Mitigation Risk assessment plan
/EXTERNAL Verification

PO will clearly specify the Material Details with Model# , Item# and Quantity
Wrong Material Taken for Ordering will be done based on PO given by requesting Department and will Weekly
1 Production Delay INTERNAL 3 3 9 if required, Incoming verification will be followed By the MR with the help of
Ordering check the Po during the arrival of the product meeting
the QUALITY Manager

Supplier Assessment and rating is done on the supplier and selected as per
Choosing of Wrong Supplier Assessment form and the rating Done By Purchase Executives with
2 Loss in Quality INTERNAL 3 4 12 requirement. If the Rating gets down Then the supplier will be changed with the Every MRM
Supplier the approval of the of the MR
one with the trail and the Error method.

Inadequate Details
3 Provided to Supplier in
Purchase Order.
Purchase Order given To the supplier by the MD as per the requirement given by Purchase order clearly mentioning Grade, Quantity delivery date, and Delivery
Loss in Quality INTERNAL 3 3 9 Every MRM
the Quality Head Requirement and Provision of Test Documents.

Material in adequacy Stock will be checked daily by the Quality Head and the report will be given to
4 during the requirement in Loss in Quality EXTERNAL 3 3 9 Quality Manager for the purse of the product ,Then the Purchase Executive will Daily meeting Keep Minimum Stock for Emergency and maintain the stock register.
the stock make the Purchase order for the required product
Wrong Material Grade or
all Supplier Purchase order clearly mentioned for material Technical
specification despatched All Incoming Material inspected as per purchase order and record maintained for
5 Loss in Quality EXTERNAL 2 2 4 Every MRM specification and incoming inspection all material Verified as per PO by the
by supplier or sub Incoming verification and returns back the wrong Supply.
Purchase Manager
contractor
Less quantity material All Incoming Material inspected as per purchase order for Quantity and Intimate
6 Material Shortage EXTERNAL 3 3 9 Every MRM Incoming inspection done , supplier follow up by the Purchase Executive
supplied by supplier Supplier on Shortage.

Any New supplier and sub Contractor identified by the Purchase Executives
evaluate the supplier based on supplier Assessment form by the Purchase
Supplier Evaluation not Purchasing of Substandard
7 EXTERNAL 3 3 9 Manager, The Emergency purchase supplier will not be added in the supplier Every MRM Every supplier and Sub Contractor Evaluated and verified
done materials
assessment form until he is approved by the top management ( Sourcing Head) by
the Trial and error method

Supplier Performance not

8 Monitoring for quality and Low Quality Products EXTERNAL 2 4 8 Purchase Register maintained for all purchase items for quality and delivery monitoring Every MRM Every Six month once Supplier Performance Rating done and approved by Sourcing Head
Delivery
 OmniActive Health Technologies Limited Document No. D / QA / 03

566 – A1 & A2, KIADB Industrial area, Revision No

0

HN Pura Road, Hassan, Karnataka - 573201. Issue No.

1

Risk and Opportunity Register Issue Date 15.02.2022

Department: Stores
RISK
RISK / INTERNAL / OCCURREN Effectiveness
Sl. No. ISSUE SEVERITY FACTOR/VALU MITIGATION RISK ASSESSMENT PLAN
OPPORTUNITIES EXTERNAL CE Verification
E
Inward Register and Seal provided in Store area once the material enters into the
Inward Material not noted Difficult to trace the Weekly Incoming verification is followed for the Material Received as
1 INTERNAL 3 3 9 concern then it will be Checked by the Incoming Inspector and the seal will be
down material meeting per Delivery Challan and Actual.
provided at the Invoice.

Stores Head along with the Incoming Inspector will Check the Quantity and
Material Shortage/Model #
model number # and inform to Customer /Supplier in case of Shortage of wrong Weekly Incoming Inspection seal is followed and third party inspection
2 not as Per Delivery Challan Production Delay INTERNAL 2 4 8
model of material received ,The immediate change over or the corrective action Meeting is carried out
and P.O
will be taken for the particular material

Identification tag implemented and all stages of product status and maintained in All Incoming , In process product status identified and store
Difficulties in
3 Material Mixed up INTERNAL 3 4 12 the stores and also in the production area, The raw material will have the name Every MRM consumable proper identification done and stock entry done
Traceability
written in the Outer of the raw material. by Stores team

Separate area is allotted for the particular product with the

Material will be stored Safely as per requirement of the respective Materials in the Identification for the particular product ,Work Instruction and
Difficulty in Weekly
4 Material Storage Improper EXTERNAL 2 2 4 allotted places, the particular space is allotted for the particular product so that it the procedures are formed and placed in the working
Traceability Meeting
will not get collapsed in the material handling area, area ,Stock Register is Available for identification of the
mismatch of the material

All Incoming , In process product status identified and store

Material mix-up/ Separate identification number is given for the separate product with the supplier
Material Status Identification Weekly consumable proper identification done and stock management
5 Difficulty in INTERNAL 2 4 8 name and With the identification tag on it so that the traceability is maintained on
and tractability not followed Meeting is maintained by the Stores Head only no other person is alloy
Traceability the respective material
abuse except the Sourcing Head

Material Stock not Stock Register Entry done on day to day basis and Stores Head will check the Physical Stock Taking Done Every 6 Months once to verify
6 Material Shortage INTERNAL 3 3 9 Every MRM
Maintained properly stock register on daily basis, Based on it the order will be placed. the deviations of material and improve stock accuracy.

Packing Will be done as Per Customer Requirement and the Incoming Inspector /
7 Poor packing Material Damage INTERNAL 2 2 4 Every MRM Packing Procedure/ GTD SOP will be followed.
Quality Head will make sure about the packaging before the dispatch.
 OmniActive Health Technologies Limited Document No. D / QA / 03

566 – A1 & A2, KIADB Industrial area, 0

Revision No
HN Pura Road, Hassan, Karnataka - 573201. Issue No. 1

Risk and Opportunity Register 15.02.2022

Issue Date

Department: Maintenance

RISK / RISK
INTERNAL OCCURRE Effectiveness
Sl. No. ISSUE OPPORTUNITIE SEVERITY FACTOR/VAL Mitigation Risk assessment plan
/EXTERNAL NCE Verification
S UE

Preventive Maintenance parameters are planned for daily, weekly, monthly

Preventive maintenance as per plan done for all
Machine Delay in required by machines which is carried out by the Machine operator in the case
1 INTERNAL 2 3 6 Every MRM machines, with the daily checklist to prevent
Breakdown production of breakdown, If it is impossible to cure it then by using the supplier
breakdown
assessment form, the subcontractors will be called for the repair.

Spares not
available in the Delay in Critical Spares minimum stock maintained and
2 EXTERNAL 3 4 12 Minimum Stock Maintained for critical spares Every MRM
market for production alternate source developed
machines

Each Machine the preventive maintenance schedule plan displayed and Work
Preventive Weekly once Maintenance Head verified the
Unexpected Instruction given to all operators every day morning 15 minutes for Daily
3 Maintenance not INTERNAL 4 3 12 Preventive maintenance record and as per plan
Breakdown maintenance activity ,Floor supervisor will make the checking at the end of meeting
carried out carried out by operator
the day

Electrical Failure
Production down Separate Maintenance persons are available for Electrical and other Monthly Once Factory Electrical connection
4 for work INTERNAL 2 2 4 Every MRM
time increases Maintenance activity. Checking in all areas
environment

Calibrations not Calibration plan is available for the all the measuring equipment with the due Calibrations done through the Calibration Agency
Wrong
5 Done on machine EXTERNAL 2 4 8 date on it , Quality Head/ Maintenance Head will verify the Calibration due Every MRM Certified by NABL. Preventive maintenance Done
Measurements
parameters date and make the necessary action to renewal it as per the plan for all the machines as per the plan
 OmniActive Health Technologies Limited Document No. D / QA / 03

566 – A1 & A2, KIADB Industrial area, Revision No 0

HN Pura Road, Hassan, Karnataka - 573201. Issue No. 1

Risk and Opportunity Register Issue Date 15.02.2022

Department: Production

RISK /
INTERNAL RISK Effectiveness
Sl. No. ISSUES OPPORTUNITIE SEVERITY OCCURRENCE Mitigation Risk assessment plan
/EXTERNAL FACTOR/VALUE Verification
S

Production plan will be made based upon the customer order it will be monitored by
Delay in Material Customer Dis - General
1 INTERNAL 3 3 9 the Production Manager and verified by the GM to make sure that the plan meets Product plan vs. production actual report
Despatch to customer satisfaction meeting
the order

Production Not Done as Delay in

2 INTERNAL 2 4 8 Material and Preparations done as per the plan to achieve production as per priority. Every MRM Production report
Per PLAN Dispatch
Machine not used Production
3 INTERNAL 3 4 12 Machine Efficiency Monitored On Daily Basis Every MRM Daily status Sent to CEO and Chairman
Efficiently Delay

Frequent Leave of Production In Case of Leave by Employees, Production is Balanced by another employee Employee Motivation for Incentives , Awarded for best
4 INTERNAL 3 3 9 Every MRM
Production employee Delay ( Core Team)/Running some other model by the low Skilled Employees. performance

Competency matrix prepared for qualification and

Unavailability of Skilled Production Skill Assessed for all employee based on skill assessment training provided to Experience, Skill required level selected work and based
5 INTERNAL 2 4 8 Every MRM
employee Delay competent person for work on competency matrix select and interview the employees
and induction training provided to new joiners

Select the professional Transporter and evaluate the supplier and approved by
Delay in Alternate Transportation developed and own vehicle plan
6 Transportation Problem External 3 4 12 Admin Head , in case of any issue alternate transporters will be available for the Every MRM
dispatch in future
operation

Inadequate Work Production All Process Work Environment of lighting and ventilation, Proper Safety aspects
7 INTERNAL 4 2 8 Every MRM Based on Industrial Requirements are implemented
Environment process Delay provided to employee

Waiting for Machines and Production Proper Planning done by Top Management availability of material ,machine and
8 INTERNAL 3 4 12 Every MRM Resource Planning are reviewed in every MRM
Instruments ,Operator Delay employee

Exposure of Instruments Incidents and Employee are provided with the proper gloves and mask to protect them from them Weekly HR Head will check the properly to wearing of the safety
9 INTERNAL 4 4 16
to employee Accidents to overexposure with the environment meeting equipments.