PHARMLIFE MEDICALS
RISK MANAGEMENT PLAN
INTRODUCTION
PURPOSE AND OBJECTIVES
A risk is an event or condition that, if it occurs, could have a positive or negative effect on a
project’s objectives. Risk Management is the process of identifying, assessing, responding to,
monitoring, and reporting risks. This Risk Management Plan defines how risks associated with
the Pharmlife Medical project will be identified, analyzed, and managed. It outlines how risk
management activities will be performed, recorded, and monitored throughout the lifecycle of the
project and provides templates and practices for recording and prioritizing risks.
PROBABILITY OF OCCURRENCE
Table 1 - Risk Probability of Occurrence
PROBABILITY CONSEQUENCES
OF OF
OCCURRENCE OCCURRENCE
Very Low Low Moderate High Very High
Unlikely to occur
May occur about
half of the time
Probably will
occur
Very unlikely to
occur
Very likely to
occur
■ Low Risk ■ Moderate Risk ■ High Risk
IDENTIFIED RISKS AND POSSIBLE CONSEQUENCES/EFFECTS
A. NATURAL DISASTERS
The Pharmlife Medicals identified the likelihood of occurrence of calamity disasters such as:
● Floods
● Earthquakes
● Typhoons
● Tsunamis
Consequences/Effects: Natural disasters are naturally occurring events and it can cause a lot
of damage in manufacturing settings. One can impairment of any pharmaceutical supplies. It can
also delay the delivery of the products. Another is the facility or the building will be damaged and
there will be a shortage of the supplies.
B. FIRES
Fire is a common hazard that is usually a problem for most people. It is a chemical reaction
between oxygen and heat and other chemical substances which produce flame.
Consequences/Effects: Fire can cause a lot of damage in a certain area or place. It can burn
stocks, any important materials, documents, etc. Fire can also harm employees and can be a
cause of death.
C. REJECTION AND RECALL
This happens usually when a certain product is returned for a certain defect but it depends on
what type of issues is seen in the product.
Consequences/Effects: This can cause a loss of costumer’s trust. It also can decrease the
sales of the company and even lose a lot of customers.
D. HEALTH RISKS OF EMPLOYEE
Employees are considered to be the backbone of a company. Thus, the likelihood that something
can harm or affect their health is also included. These incidents involved as:
● Exposure to chemical
● Injury on site
Consequences/Effects: This can cause a delay of the production and can cause the delay of
supplies.
E. ENVIRONMENTAL HAZARDS
This involves physical hazards including activities or natural substances in a work environment
that can lead to health risks.
● Chemical leaks
● Garbage disposal
Consequences/Effects: Environmental hazards can cause a lot of problems not just in the
environment but also to people. The toxicity of the chemicals that are spreading can harm living
things and can cause a lot of health problems to humans.
F. FINANCIAL ISSUES
One of the concerning problems in the company that can bring a great problem to everyone.
Consequences/Effects: Financial issues can lead to a crisis in the company. This can also
decrease or lower the supplies of the product.
G. MACHINERY BREAKDOWN AND EQUIPMENT MONITORING AND CALIBRATION
This is a common problem that usually happens to the manufacturing setting. It is when an
equipment is under maintenance or unavailable to use.
Consequences/Effects: This can slow the manufacturing process and cause the delay of
supply.
H. ENSURING COMPLIANCE WITH GOVERNMENT AND INTERNATIONAL
REGULATIONS
Compliance with federal and international regulations is another highlighted risk, such as
adhering to a set of established rules that create standards in areas such as correct processes.
Consequences/Effects: Failure to do so might result in a loss of reputation and loss of
customers.
I. INADEQUATE QUALITY OF RAW MATERIALS
Raw materials are the input commodities or inventories that a company requires to manufacture
its products.
Consequences/Effects: The consequences of poor raw material quality include not only the
costs associated with product defects, but also the costs associated with company processes,
policies, or operations that cause defects and errors. Poor quality may also lead to a company’s
reputation being ruined, as well as client loss and financial loss.
J. INADEQUATE QUALITY OF PACKAGING MATERIALS
The danger of having inadequate or low quality packing materials such as misprinting,
discolouration, and breakage.
Consequences/Effects: It can result in customer loss, reputation loss, business loss, and
product damage
K. CONTAMINATION
The major problem in manufacturing is contamination. Usually this is most likely to occur when a
product is starting to produce. This is caused by the materials that are used or that product itself
is contaminated already.
Consequences/Effects: It will cause a lot of damage to the product that is going to be
manufactured and can cause health problems to the employees.
RISK RATING
We must rate the risk once we have identified the hazards in our company . The rating will determine
whether it is safe to continue working or whether we need to implement additional Control Measures to
further reduce or eliminate the risk.
The rating is based on the likelihood of an event occurring (from minimal to extreme) as well as the
severity of the injuries that could occur if it does (from insignificant to severe injuries).
The terms are defined as follows:
Minimal risk- Maintain Existing Measures
Low risk- Review Existing Measures
Medium risk- Improve Control Measures
High risk- Consider suspending activity
Extreme risk- Do Not Proceed
Table 2 - Risk Rating
Severity of
Consequence
Probability Insignificant (1) Minor Moderate Major Severe
(3) (5) (7) (10)
Very likely to 5 15 25 35 50
occur (5)
Likely(has 4 12 20 28 40
before, will
again)(4)
Feasible(3) 3 9 15 21 30
Slight(rarely 2 6 10 14 20
occur)(2)
Very unlikely to 1 3 5 7 10
occur(1)
Risk Rating: Minimal Low Medium High Extreme
Likelihood = 1-10 11-20 21-30 31-40 41-50
Severity
PROACTIVE QUALITY RISK MANAGEMENT
Identified Risks Proactive QRM
Natural Disasters
● Flood
● Typhoons
● Earthquake
● Tsunamis
Fires
Rejection and Recall ● Procedures should be developed to track
all products sold, either by lot number or
by production time. Product registration
cards, which consumers fill out and return
with identifying information such as the
model number, style number, and special
characteristics of the product purchased,
should be considered by manufacturers.
● Having a good quality control system
which has a qualified quality control
department, auditing , and attending
seminars .
● Organization wide culture of product
safety including product management
(manufacturing and sales), design, quality,
use and testing, and literature
● Document response process if one or
more of these errors occur and
necessitate a product recall.
Health Risk of Employees
(Chemical Exposure, injury on-site, etc.)
Environmental Hazards .
Financial loss/Bankruptcy
Financial Issues
Machinery breakdown and equipment and ● Employees should always ensure that
monitoring calibration equipment maintenance and calibration
are performed on scheduled time.
● Employees should always report
equipment which requires maintenance
and calibration freely
● Maintenance programs should ensure
equipment performs consistently
● A log book should be placed in a place
where it can easily be found and should
include aspects such as equipment to
serve records, changes and problems.
● All users and technical manuals
associated with the calibration programs
should be kept in a central location.
Ensuring compliance with government ● Stay on track with changing laws and
and international regulations regulations. Compliance is not something
your organization just is, it is a continuous
process of scanning for changing laws
and regulation, identifying the areas in
which it impacts your organization,
changes in policy and the implementation
of policy change, and monitoring.
● There should be specialists, especially to
some small and growing organizations
that may unintentionally break laws. To
prevent the breaking of laws, ensure that
the organization is transparent in its
operations.
● Always ensure that employees follow
procedures especially the changing in
policy that may not always be adapted by
the workforce with ease, and employees
may be reluctant to change practices in
their everyday workflows.
● Schedule regular internal audits, it is a
great tool to uncover inadequate and
ineffective procedures that lead to not
being compliant.
● Use the right software, using good
compliance software can be a great help
in built-in tools for organizing documents
and automatically generates audit trails to
easily prove compliance.
Inadequate quality of raw materials .Verify that you have the necessary raw materials
on hand.
you should know how much raw material
is on hand and whether it can be
substituted with another type if there is a
shortage.
● you must determine if there is sufficient
knowledge and research to support how
safe the substance is for consumption—
for example, whether carcinogens
(cancer-causing compounds) are present.
● guarantee the materials given by the
provider are of the most ideal quality
whenever you've ensured the item
configuration is all set. For instance, you
can find out about the provider's standing
and history to find out about how
dependable they are probably going to be.
You can likewise associate straightforwardly
with the provider, and test the materials in
advance for quality affirmation.
● There ought to be a cooperative connection
between the provider and maker to help
recognize and address gives sooner if and
when they emerge. You'll learn in your
quality control program how to guarantee
the security of materials and medications
with the goal that you can assist with
protecting unrefined substances.
● If any progressions are to be made to the
cycle or materials, all such adjustments
should be imparted between the drug
producer and provider. This can be
incorporated in case the material's essential
bundling has been adjusted, which could
contrarily affect the item's quality
Inadequate quality of packaging materials ● Verify that you have the necessary raw
materials on hand. you should know how
much raw material is on hand and
whether it can be substituted with another
type if there is a shortage.
● you must determine if there is sufficient
knowledge and research to support how
safe the substance is for consumption—
for example, whether carcinogens
(cancer- causing compounds) are present.
● guarantee the materials given by the
provider are of the most ideal quality
whenever you've ensured the item
configuration is all set. For instance, you
can find out about the provider's standing
and history to find out about how
dependable they are probably going to be.
You can likewise associate
straightforwardly with the provider, and
test the materials in advance for quality
affirmation.
● There ought to be a cooperative
connection between the provider and
maker to help recognize and address
gives sooner if and when they emerge.
You'll learn in your quality control program
how to guarantee the security of materials
and medications with the goal that you
can assist with protecting unrefined
substances.
● If any progressions are to be made to the
cycle or materials, all such adjustments
should be imparted between the drug
producer and provider. This can be
incorporated in case the material's
essential bundling has been adjusted,
which could contrarily affect the item's
quality.
Contamination ● Wash hands before hold any equipments
inside the laboratory.
RETROSPECTIVE QUALITY RISK MANAGEMENT
Identified Risks Retrospective QRM
Natural Disasters
● Flood
● Typhoons
● Earthquake
● Tsunamis
Fires
Rejection and Recall ● A designated person with power to
conduct recalls in compliance with the
procedures must be appointed. The
designated person could be the
authorized person in charge of quality
control. If such is not the case, that QC
person must be kept up to date on any
recalls. The authorized person must have
enough staff to be able to conduct recalls
in a timely, effective, and efficient
manner. The appointed individual should
be independent of the sales and
marketing divisions, and they should have
the necessary standing and power to
carry out the procedure.
● A defined procedure defining the
situations in which a recall of an
intermediate or API might be considered
should be in place.
● The recall protocol should include who
should be involved in reviewing the data,
how a recall should be initiated, who
should be notified, and how the recalled
material should be handled.
● Check the material for status labels and
move the rejected material to the
rejected material storage area once you
receive the material rejection note.
● If the material gets rejected, QC will raise
the material rejection note and send it to
the commercial department with a copy
to the store.
Health Risk of Employees
(Chemical Exposure, injury on-site etc.)
Environmental Hazards .
Financial loss/Bankruptcy
Financial Issues
Machinery breakdown and equipment and ● Recognizing the problem or knowing the
monitoring calibration problem of the machine/equipment is an
important part for it not to be used while
it's broken
● Contacting the machine operator should
be the first step that should be done since
the machine operator is the one who
knows the main problem of the
machine/equipment.
● Troubleshooter should observe the
machine/equipment so that they will get
the first-hand impression or know what is
the problem
● The troubleshooter should also note all
the abnormalities, observations,
examination of the equipment and
documentation.
Ensuring compliance with government ● As an auditor, there should be
and international regulations communication involved with the group
but the communication should also show
respect to each other and the auditor
should also consider their responsibilities
to report instances of non-compliance or
any suspected non-compliance to the
group.
● Determining whether further action is
needed in order to assess the
appropriateness and effectiveness of the
response of management
● It is highly important to make a decision
whether to disclose the non compliance or
suspected non- compliance to an
appropriate authority or to change it.
● Documentation is needed in order to
record and note the changes.
Inadequate quality of raw materials ● Utilize hourly creation cautions to
recognize issues rapidly
● Utilize extra dashboards and reports to
distinguish the time and reason for scrap
● Swap out raw material to eliminate the
problem and resume production
● Recognize material part and solicitation a
discount from the provider
Inadequate quality of packaging materials .
Contamination
Required Resources:
Resource name Quantity
Fire Extinguisher 5
First Aid Kit 6
Personal Protective Equipment
Respiratory Protective Equipment
Online budgeting tool
ORGANIZATION
Roles and Responsibilities
Team manager:
The overall coordinator of the Risk Management
Plan
QRM Team:
Responsible for identifying, monitoring, and
managing risks
Subject Matter experts (SMEs):
Responsible for implementing risk management
tasks for this plan
End users
