Doc No: FT-QA-37

HSOP Risk Register Issue:05/Rev:01

Process Step Potential Risk Impact of Failures Probability Impact Current Controls Recommended Actions Responsible Person
Back up Rub Resistance machine Identify outside agency for testing of
Testing of Material Equipment Breakdown Delay in testing Low High QC Incharge
provided at QC Lab material

Customer requirements
are not met w.r.to to
additional details to be Customer will hold Prepare a document stating the
Dispatch of Product submitted along with the batch for Medium High Nil number of samples required by QC Incharge
dispatched material such approval customer
as Uncut Sheets, Proof
samples, Shade Cards etc.

Lack of knowledge of Mistake while doing Periodic training on process

Inspection Activity Low High Nil Nil
process requirements inspection requirements for all QC personnel

Inadequate Operation Work Order will provide Prepare customer wise requirements,
information about Lack of fulfillment of Customer standard customer requirements. which are communicated via emails,
Low High QA Manager
customer customer requirements dissatisfaction But doesn't cover any new during customer meetings etc and are
requirements requirements not part of specification document

Delay in Production
Production Activity Equipment Breakdown leading to delay in Medium
dispatches
Key machinery is having AMC with Operators of trained effectively on
Medium Production Manager
Machine Suppliers preventive maintenance activities

Delay in Production Consider absenteeism of Manpower

Production Activity Personnel Absenteeism leading to delay in High Medium Nil by 2% in non-festival season and 5% in Production Manager
dispatches festival season and plan accordingly

Implement pre-defined checklist to

Personnel are trained on Line
Line Clearance Ineffective Line Clearance Mix-up of Products Low High guide personnel in line clearance QA Manager
Clearance activity
activity, wherever challenge is there

Frequent trainings to all QC/QA

Predefined checklist is prepared and
Online Inspection Improper Inspection Product rejection Medium Medium personnel to be provided on QA Manager
established at each process area
respective process areas
 Doc No: FT-QA-37
HSOP Risk Register Issue:05/Rev:01
Process Step Potential Risk Impact of Failures Probability Impact Current Controls Recommended Actions Responsible Person

Responsibility of trainings to be
Delay in Trainings or
Poor Skills of provided to respective department HR Manager and
Trainings Inability to conduct Medium Medium Nil
personnel managers / incharges which allows Respective Managers
trainings as per schedule
more trainings are conducted

Frequent trainings to all QC/QA

Predefined checklist is prepared and
FG Inspection Improper Inspection Product rejection Low High personnel to be provided on QA Manager
established at each process area
respective process areas

Install Fire extinguishers as per Fire

Material damage and Department suggestion. Training to employees to be provided
Safety Financial Loss Low High Admin Manager
Personnel Injury Provide First Aid Box accessible for on Fire Extinguisher handling
all personnel

Prepare a checklist for dispatch

Vehicle Fitness or
Material Dispatch Material damage Low High personnel for inspection of vehicle Nil Nil
Condition
before loading of material

Include formats inside each SOP alogn

with format number. Whenever
Formats are provided at the time of changes are done to formats, SOP
Training Activity Unavailability of format Ineffective training High Medium QA Manager
training should be amended as well.This will
ensure better traceability between
documents
 NEEDS and EXPECTATIONS
Interested Parties Needs/Expectations Current Status Gaps Action Plan Responsibility Target Date
Owners Needs Achieving the set targets
Needs Good Financial Condition
Expectations Surpassing the set targets
Expectations Effective Machine Utilization
Expectations Effective Manpower Utilization

Adherence to assured delivery dates isn't

Needs On time delivery effective. Data not available to understand
Customers the current state.
Needs Product quality meeting the specifications

Meeting quality standards such as GMP, GDP Personnel are trained on GMP and GDP
Needs etc. requirements
Needs Competetive Price
Needs Prompt Response to their queries

Priority to product delivery in emergency

Needs Based on customer urgencies priority is
situations
being provided for few product deliveries
Expectations Reduction in Product Prices

Expectations Shorter lead time No data available to measure current lead

time
Expectations Zero product quality complaints
Expectations Facilitating all products manufacturing

Expectations Upgrading machinery to their new

requirements
Employees Needs Career development
Needs Good & Safe Working environment
Needs Employment Security

Needs Timely Salary payment Salary is paid on 7th of every month.

Fulfilled the assurance
Needs Regular trainings on job responsibilities

Needs Adequate number of personnel to prevent

over loading

Expectations Less working hours / More Holidays Working on 2 Sundays in a month, Few
public holidays and extended hours on
normal working days to fulfill the deliveries
Expectations Training on New technologies No such plan in place
High Increments / Career growth
Expectations
opportunities
External Providers Needs Payment as per terms
 NEEDS and EXPECTATIONS
Needs Clear requirements
Needs Adequate Lead Time
Expectations More Orders / Increase in Orders YOY
Expectations No Negotiation in price
Renewal of Contract (Annually) / Increase in
Expectations price periodically
Expectations Quick unloading of material on receipt
 EXTERNAL AND INTERNAL ISSUES
Organization should particularly focus on factors and conditions that can affect your products, services, investments and interested parties
External Factors: Government regulations and changes in law, economic shifts in organization, competition, incidents that affects company's image, change in technology
Internal Factors: Regulatory requirements,
Factors External Issues Current State Gaps Action Plan Responsibility Target Date
New emerging suppliers are creating
Competition unjustified competition by quoting very less
price

Customer requires price reduction in

Customer products irrespective of increase in raw
material and operation expenses
Customer Delay in payments from customer
Customer loses major orders, resulting in
Customer
reduction / complete loss of orders

Increase in raw material prices affecting the

Market profit margin of the company, as customer is
not always willing to increase the product
price

Machine supplier made the equipment

Technology obsolete resulting in unavailability of
spares / technicians to handle maintenance

Environment End customer may shift to digital leaflets to

reduce usage of paper

Social Political strikes results in delay in dispatches

Power holidays due to lack of electricity

supply
Cultural

Factors Internal Issues Current State Gaps Action Plan Responsibility Target Date

Unavailability of backup for skilled personnel

Performance of
Organization in key process areas such as Printing,
Folding, Quality, Punching & Pasting

Inadequate skills for key personnel

Poor retention of executive & supervisory
level employees
Breakdown of machinery resulting in delays
in dispatches
Depedency on huge manpower in many
areas affecting the productivity

During festival season and exam season,

temporary workmen unavailability
 EXTERNAL AND INTERNAL ISSUES
Capacity planning is not done, resulting in
measuring the performance of machinery

No system to capture the process delays

Unavailability of spare parts results in delay

in rectification of machine issues
Workmen are not willing to adapt to changes
Culture
in process
Apathy of few workmen towards the
orgaization needs (such as targets and
quality requirements)

Unplanned leaves by workmen affecting

dispatches, as alternative operator is
unavailable in certain processes

Unauthorize use of mobile phones in

production areas affecting loss of
productivity
Workmen not aware of technology
Knowledge
advancement

Safety Fire accident may lead to loss of property

and personnel injuries
Inadequate safety practices may lead to
accidents

Inadequate infrastructure may lead to health

problems for personnel in certain areas (eg:
Suitable chairs for personnel working on
systems)

Improper environment conditions affect the

Environment machine operation, life of machinery, quality
of product and quality of raw material
 EXTERNAL AND INTERNAL ISSUES

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