Name: Date:

Course & Year: Score:

Activity
Section D: Risk Communication
5.4

Information about risks and risk management that is shared between decision-makers and other parties
is known as risk communication. At any point during the risk management procedure, parties can
communicate. Communication and documentation of the output/result of the quality risk management
process must be done correctly. Information about risks to quality may be included that relates to their
existence, nature, form, probability, severity, acceptability, control, treatment, detectability, or other
aspects. It is not necessary to communicate for every risk that is accepted.

To make sure that risks are properly communicated (1) internally, (2) to the FDA, (3) to healthcare
professionals and consumers, and/or (4) to other stakeholders (DOH, LGU), the drug manufacturer
should set up a communication system. The circumstances and requirements under which risk
communication is required, as well as the channels of communication, must be made explicit in the
system.

Activity 4.4
This activity will be performed and submitted INDIVIDUALLY. You will make section D or risk
communication.

To create the risk communication protocol:

1. Identify criteria (events) that will warrant risk communication.

2. For each criterion, describe the content of the communication and the medium as to how the
content will be communicated.
3. Tabulate the information as shown in the sample (Annex B)
Naming Convention Criteria Communication Content Medium

Storage Risk Continuous Power Inform the personnel in charge Phone or Email
Failure of operations and warehouse
management about the risks to
quality and how to prepare for
them.

For assistance, get in touch with

power supply and plant support
services.

Unsatisfactory Share information with the Phone

 storage conditions appropriate management staff
resulted in a decline in about the threats to the
product quality. materials and product quality.

Make inquiries with the Phone

materials and warehouse
departments to investigate any
deviations from standard
storage conditions and find a
solution.

Notify the quality control Letter of request

division that products whose written and via
quality has decreased as a email
result of the incident require
testing.

Mix-ups with rejected, Employees should be informed Phone

expired, returned, and about the hazards to the
recalled products. product's identity and quality
through communication.

To perform a product inspection Phone

and appropriately separate the
products, get in touch with the
materials and warehouse
departments.

Premises Risk Unintentional release Inform management and Phone

of a toxic material that maintenance staff about
got into the ventilation potential threats to the
system manufactured product quality
through communication.

For assistance and suitable Phone

remediation, get in touch with
the plant support services
department.

Inform and communicate with Phone

An inadequate staff members about the threats
ventilation system to the manufactured goods'
quality.

For assistance and suitable Phone

remediation, get in touch with
the plant support services
department.
Production Risk In-process Inform management and Phone
mismatches in maintenance staff about the
materials quality, performance, and
formulation of in-process
materials as well as the risks
associated with them.

Request in writing for Letter of request

verification of the identity and written and via
purity of materials used in email
process from the quality control
department.

Equipment Risk equipment rusting, Inform and educate the Phone

which caused maintenance staff about the
contamination. associated risk to the product's
quality.

Notify the quality control Letter of request

division that products made with written and via
the aforementioned equipment email
require inspection and testing.

Product on Inform and discuss potential Phone

inadequately cleaned threats to the manufactured
equipment that may product quality with the
have been maintenance and operation
contaminated by a department.
foreign substance
a letter to the quality control Letter of request
department regarding the written and via
possibility of equipment email
contamination jeopardizing the
manufactured goods' quality.

injuries and delays in Inform and educate Phone, Verbal

operations brought on maintenance staff about the communication
by broken equipment. associated risk to on site visitation
manufacturing operations and
worker safety.

If you need help, get in touch Phone

with plant support services, and
they can send someone to fix
the equipment.

Speak with a medical team to Phone

help injured employees.

P a g e | 21 Pharmaceutical Manufacturing Laboratory Manual