CONTEXT OF THE ORGANISATION

EXTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-EIR

UPDATION DATE: 07-07-2024

Sl. Risk Rating Risk

Issue Expected result Uncertainty Opportunities
No. level
Conseque Likely
Score
nce hood

Compliance to Legal
1 Legal Compliance
requirements
Not meeting Legal requirements 5 1 5 L

Economics In sufficient funds to run the

2 Financial Security
Financial Security
organisation 5 1 5 L

More Customers, to
Depending on Few customer , leads
Depending on Few Ensure that there is no
to Not fully utilizing production Explore the market, we need to do
3 Customers breakup in production/
capacity
4 3 12 m
marketing after obtaining the Certifications
Full capacity production
should run

Non availability of raw Material availability for Delay in starting the production Keeping stock of material, /or developing
4 material in the market batch of production batch
3 3 9 M
usage method of alternate raw material

Fluctuation in the raw Constant price of raw

6 material price material
Material cost going high, less profits 3 2 6 L

All the intermediates

Ban of Unable to sale the produced batch to
7 Drugs/Intermediates
manufactured should be
Customer
5 2 10 M Only Manufacturing as Drug licence
supplied to customers

PREPARED BY APPROVED BY

Risk Score between 1 to 7 considered as low and Acceptable: between 8- to 15 Medium , we need to make action plan, Rating 16-25 high Risk
 CONTEXT OF THE ORGANISATION

EXTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-EIR

UPDATION DATE: 07-07-2024

Sl. Risk Rating Risk

Issue Expected result Uncertainty Conseque Likely Score Opportunities
No. nce hood
level
Follow CGMp praciices and
Public trust/Customer trust in
9 Reputation Risk
the brand
Undermine Trust 5 2 10 M getting cGMP Approvals.
Getting WHO Approvals

New formulation of
Abel to manufacture with new Loss of business due to new Develop new technologies, new
10 drugs/New
formulations drugs/technologies in the market
3 3 9 M
drugs with new formulations
technologies
Transport
delay/damages in
On time delivery without Damages to product leads to
11 transport during
damages customer dissatisfaction
4 2 8 M Transporters rating to be done
product despatch to
customer end

Access to internet Communication gap, non-

Proper communication with
12 Communication
Customers/Suppliers
receipt /issue of orders/ 3 3 9 M To have alternate Net connection
problem/Internet failure Drawings , specifications

Interaction with
Employees of SPARKVEE Training to be provided to sales
different levels of Communication gap between
should interact appropriately to staff on interpersonal skills,
13 customers/ different
different positions of customer
customers and SPARKVEE 2 3 6 L Communication and convincing
positions of customer employees
representatives skills
representatives

Interaction with Employees of SPARKVEE Communication gap between

14 different levels of should interact appropriately customers and SPARKVEE 2 3 6 L
suppliers. with representatives of suppliers employees

PREPARED BY APPROVED BY

Risk Score between 1 to 7 considered as low and Acceptable: between 8- to 15 Medium , we need to make action plan, Rating 16-25 high Risk
 CONTEXT OF THE ORGANISATION

EXTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-EIR

QUALITATIVE MEASURE OF LIKELIHOOD

SNO DESCRIPTOR DESCRIPTION
1 Rare Extremely unlikely, may only occur in exceptional circumstances. Has never occurred before.
2 Unlikely Unlikely to occur, but possible.occured less than once in 6 months.
3 Possible May occur/reoccur, but not definite. Has previously occurred once or twice in 3 months
4 Likely Will probably occur/reoccur. Has happened several times per month before
5 Very likely Continuous exposure to risk. Has happened before regularly and frequently
QUALITATIVE MEASURE OF CONSEQUENCE
SNO DESCRIPTOR

1 Minimal Little impact on Quality and Business, Interested parties not affected

2 Minor Slight impact on Business,

May affects Quality performance and business performance of the organisation the organisation. Minor affect
3 Moderate
on interested parties

4 Major Likely to affect Business performance of the organisation, Effect on interested parties,

5 Severe Likely to affect Business performance, Dissatisfaction of interested parties. Not meeting Compliance obligation