CONTEXT OF THE ORGANISATION

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

UPDATION DATE: 07-07-2024

Sl. Risk Rating Risk

No. Issue Expected result Uncertainty Conseque Likely level Opportunities
Score
nce hood
Availability of Reliable, Errors, mistakes, un planned To prepare Competency matrix of all
1 Qualified and Staff are competent activities may happen due to 3 2 6 L operators and improve the competency
Competent Staff in competent persons levels

Absentees am, Un acceptable quality of work due to Provide motivational trainings , Create Good
2 Staff shortage
Work force is motivated
staff shortage
3 2 6 L
working atmosphere

Work force remain with

Work force retention Work force leaving for better
3 Loyalty
the organisation for
payment
3 2 6 L Review of Salary structure
their working life

Conducive work
Suffocation due to Exhaust system Proper preventive maintenance of Exhaust
4 Work environment environment , so that
not working
4 2 8 M
System
operators should freely

Work force not

Work force should
following Dress code, Contamination of products during Continuous motivation of operators to use
5 aprons, masks, head
follow GMP /SOP
the process
4 2 8 M
Dress code,
instructions
covers
Safety of
Safety instructions not Safety Awareness to be created. HIRA
4 followed
employees ,without any Incidents 2 2 4 L
assessment carried out
incidents

Training not conducted, skill level

5 Trainings as per plans Trainings as per plans
not improved 2 2 4 L

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

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

UPDATION DATE: 01-07-2024 PROCESS: DEVELOPMENT

Risk Rating
Risk
Issue Expected result Uncertainty Opportunities
Sl. Conseq Likely level
Score
No. uence hood
- To create Designing verticals for
Developing product as
Competency in Design Product not meeting customer different types of products.
1 and development
per customer
application requirement
4 2 8 M
- Recruit Multi Skilled Development
application requirement
team
Usage of banned drugs
product legal
2 requirement
Compliance Product not meeting the legal 5 1 5 L -
requirements

Product development Delay in development process leads

- Meticulous planning of
3 Delay in development should be completed to more development cost , as well 5 2 10 M
development
within planned time as loosing market

End product not meeting Development product Developed product not meeting
4 the Application should meet expected Expected result leads to huge loss of 5 2 10 M
- Review of each state of
requirement/Specification results money, man hours, and market share
development to ensure the
development is going in right
Less yield of Developed Yield should be Less yield , leads to high production direction
5 product minimum 98% cost
5 2 1 0

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

UPDATION DATE: 07-07-24 PROCESS: QUALITY ASSURANCE

 CONTEXT OF THE ORGANISATION

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

Risk Rating
Risk
Issue Expected result Uncertainty Opportunities
Sl. Conseq Likely level
Score
No. uence hood
May lead to reworks/rejections in
Errors in Batch process
1 Records
Error free BPR production and may lead to customer 4 1 5 L
complaints

Obsolete BPR available in process

2 BPR Control Issue of Latest BPR
leads to Reworks , rejections 5 1 5 L

PROCESS: PURCHASE

Sl. Risk Rating Risk

Issue Expected result Uncertainty Opportunities
No. level
Conseque Likely
Score
nce hood
Purchasing material as
Delay in material Delay in purchase leads to Delay in
1 purchase
per plan to ensure no
delivery and customer dissatisfaction
2 3 6 L
stoppage of production
New supplier , not supplying
Supplier selection and
2 evaluation
Dependable supplier materials committed, material quality 3 3 9 M
not good , Delay in supplies
Purchasing cost as per
Estimated cost not matching ,
3 Purchase cost estimation
purchasing cost
3 3 9 L
/Development
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

UPDATION DATE: 07-07-124 PROCESS: PRODUCTION


Document No;
Sl.
No Issue
.
1 Skill of operators
Required Tools/Special
2 tools/Machinery
3 Planned production
4 Space Constraint
5 Power interruptions
PREPARED 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
UPDATION DATE: 07-07-24
CONTEXT OF THE ORGANISATION
INTERNAL ISSUES
RISKS AND OPPROTUNITES: RISK REGISTER
SPL/QMS-IIR
Risk Rating
Risk
Expected result Uncertainty Opportunities
level
Conseque
Likely hood Score
nce
Skilled operators to To prepare Competency matrix of all
carry out all the If Not skilled, may lead to reworks, Delays 3 1 3 L operators and improve the competency
activities of production levels
Suitable tools Tools,
In adequate tools/Machinery leads to
and machinery for
reworks, delays, in completion of Batch
4 1 4 L
production
Un expected delays,
Meeting production plan Not meeting production plan leads to 4 2 8 M
despatch delay and customer dissatisfaction
Adequate space to
store and process the Leads to mix, up and handling problems 3 1 3 L
batch
Un interrupted Risk is acceptable, it is eliminated with as
production
Delay in production 3 2 6 M
Generator is provided
APPROVED BY
PROCESS: MAINTENANCE
 CONTEXT OF THE ORGANISATION

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

Sl. Risk Rating

No Issue Expected result Uncertainty Risk level Opportunities
Consequence Likely hood Score
.
No stoppage of Production stoppage,
1 Breakdowns production due to Delay in production 4 2 8 M
breakdowns Effect on product quality
Preventive Compliance with Production stoppage, Preventive maintenance
2 maintenance not done Preventive maintenance Delay in production 4 2 8 M Plans .Critical list of
as per plan Schedule Effect on product quality spares to be pread and
made available
Repairs to be done within
Non availability of
3 spares for repair
acceptable time to ensure Delay in repairs and production 4 2 8 M
no stoppage of production
Recruit person , who has
competency of repairs,
Competency in Competent person to
4 repairing repair
Delay in repairs and production 4 2 8 M develop the skills of
employees to attend the
breakdowns

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

UPDATION DATE: 07-07-24 PROCESS: QUALITY

Sl. Issue Expected result Uncertainty Risk Rating Risk Opportunities

 CONTEXT OF THE ORGANISATION

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

No Consequenc
e
Likely hood Score level
.
To prepare
Competency matrix of
Inspection ,Analysis Adequate inspection skills Skills not sufficient lead to measurement,
1 skills, Test methods for quality staff Uncertaininity.
4 2 8 M all operators and
improve the
competency levels
Instruments n Instruments calibration as
2 calibration per plan
Un certainty in measurement 4 1 4 L

All BPR are reviewed

for completion of
activites , analysis as
Deviations in the batch Deviation free batch of
3 of product released products
Customer complaints 5 2 10 M per spec , after
satisfaction only
products re
despatched
Test methods, Leads to error in results,
Compliance with Test
4 inspection methods not
methods
Batches getting rejected/or Poor Quality 5 1 5 L
followed properly batches release to market

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

UPDATION DATE: 07-07-24 PROCESS: MARKETING

 CONTEXT OF THE ORGANISATION

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

Sl. Risk Rating Risk

Issue Expected result Uncertainty Opportunities
No. Consequence Likely hood Score level
Opportunity to meet
new customers and
Growth as predicted 10%
Competition in the Not getting the orders due to export Add more
every year, New customer
1 market. Falling
identification one in a
competition, Low price in the market. 4 2 8
M
customers.
behind competitors Opportunity to build
month
confidence in
customers
Submitting Quotes Submitting Quote within Delay in Submitting quote may lead to
2 on time 24 hours loss of order
4 1 4 L

Excess orders/Qty
Orders as per plant Not able to meet customer delivery
3 requirement from
capacity requirements 5 1 5 L
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

UPDATION DATE: 07-07-24 PROCESS: WARE HOUSE

 CONTEXT OF THE ORGANISATION

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

Sl. Risk Rating Risk

Issue Expected result Uncertainty Opportunities
No. Consequence Likely hood Score level
Material to be used within
1 SHELFT LIFE
shelf life
Usage validity expired material 4 1 1
L
Preservation,
maintaining Storage Material to be preserved Material losing its properties due to bad
2 conditions, as per MSDS storage conditions
4 1 1
L
temperature

Orders as per plant Not able to manufacture as per customer

3 Stock out of material
capacity delivery requirements 5 1 1 L

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

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

INTERNAL ISSUES: HR UPDATION DATE: 07-07-2024

S.No Expected Risk Rating

Description of Result opportunity
. Uncetaininity Risk involved Risk level
issue Consequenc
Likely hood Score
e
Adequate and Skill matrix to be prepared
Availability of competent staff for each employees
should be Errors, mistakes, un planned activities may Skill levels of operators to
1 Reliable, Qualified
available happen due to 4 2 8 Medium
and Competent in competent persons be improved at least 10
Staff operators in a year

2 Absentees am, Staff should Un acceptable quality of work due to staff Leave policy
3 2 6 Low
Staff shortage attend regularly shortage
Work force Risk under control
3
retention Should work for Work force leaving for better payment 4 2 8 Medium --
Loyalty long time
Training on Operational
4 Safety instructions Should follow Incidents 4 2 8 -- controls related to Safety
not followed safety
instruction
 CONTEXT OF THE ORGANISATION

INTERNAL ISSUES

RISKS AND OPPROTUNITES: RISK REGISTER

Document No; SPL/QMS-IIR

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