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Risk Management Unveiled:

ACreative Exploration of
ISO 14971
Ch Mohammed Gamal
.
 Introduction
Welcome to Risk Management
Unveiled: A Creative Exploration of
ISO 14971. In this presentation, we will
explore the fundamentals of risk
management and how it relates to ISO
14971. We will also discuss creative
approaches to risk management.
 Documents may be used to guide the journey
· The Therapeutic Goods Administration’s risk management approach to
the regulation of therapeutic goods

· Draft international standard ISO/DIS 13022 ‘Medical products containing

viable human cells – application of risk management and requirements for
processing practices’

· ISO 14971 ‘Risk assessment for medical devices’

· ISO 22442 ‘Part 1 Medical devices utilizing animal tissues and their
derivatives - Part 1: Application of risk management’

· ICH Q9 “Quality Risk Management”

· EMEA ‘Guideline of Human cell-based medicinal products’

· EMEA ‘Guideline on safety and efficacy following-up-Risk management of

advance therapy medicinal products’

· AS/NZS ISO 31000:2009 Risk management, Principles and Guidelines.

What is Risk Management?
Risk management is the process of
identifying, assessing, and controlling
risks that could potentially impact a
project or product. It involves evaluating
the likelihood and severity of risks and
taking action to minimize or eliminate
them.
Risk Management Definitions You Need To Understand

risk management—systematic application of management policies,

procedures, and practices to the tasks of analyzing, evaluating,
controlling, and monitoring risk

risk—combination of the probability of occurrence of harm and the

severity of that harm

hazard—potential source of harm

hazardous situation—circumstance in which people, property, or

the environment are exposed to one or more hazard(s)

harm—physical injury or damage to the health of people, or

damage to property or the environment

severity—measure of the possible consequences of a hazard

risk analysis—systematic use of available information to identify

hazards and to estimate the risk

risk estimation—process used to assign values to the probability of

occurrence of harm and the severity of that harm
Risk Management Definitions You Need To Understand

risk evaluation—process of comparing the estimated risk against

given risk criteria to determine the acceptability of the risk

risk assessment—overall process comprising a risk analysis and a

risk evaluation

risk control—process in which decisions are made and measures

implemented by which risks are reduced to, or maintained within,
specified levels

residual risk—risk remaining after risk control measures have been

taken

Risk Assessment = Risk Analysis +Risk Evaluation

ISO 14971Overview

ISO 14971 is an international standard that

provides a framework for managing risks
associated with medical devices. It
outlines a process for identifying,
evaluating, and controlling risks
throughout the lifecycle of a device.
Design Controls & Risk Management

Design Controls are intended to demonstrate that a medical device has

been:
1. Designed to address the needs of users and patients.
2. Designed to meet inputs and requirements.
3. Proven to meet applicable standards.
4. Meets performance criteria.
• In fact, using Risk Management as a real tool will help you with Design
Verification and Design Validation planning.
 Risk Management Plan

• A Risk Management Plan is a product-level document.

• The Risk Management Plan should identify the risk management activities
you anticipate and plan throughout the product’s life cycle.
• The Risk Management Plan is dynamic and should be revisited and
updated often.
• This is not a “one and done” activity.
 Risk Management Plan criteria
• Scope of the Risk Management activities. Define the product included. It is possible to have
multiple products described within a single Risk Management Plan.
• •Describe the intended use of the product(s).
• Identify all Risk Management activities planned throughout the product life cycle.
• Define roles and responsibilities. Identify the Risk Management team that will be reviewing
and approving risk documentation.
• Criteria for the product’s risk acceptability. (Note, that oftentimes this is likely to be defined
within your Risk Management Procedure.)
• Specify methods to verify Risk Control measures are implemented and reduce risks to the
pre-established acceptable levels.
• Define how post-production information will be captured and fed into Risk Management
activities for the product.
 Risk Identification

The first step in risk management is

identifying potential risks. This can be
done through brainstorming, analyzing
past experiences, and consulting with
experts. It's important to consider all
possible risks, including those that may
seem unlikely.

A good technique for identifying hazards is to go

through all the steps required for your product to be
used. At each step, identify if there are any potential
sources of harm.
 Risk Assessment

Once risks have been identified, they

must be assessed to determine their
likelihood and severity. This involves
analyzing the probability of a risk
occurring and the potential impact it
could have. Risks are typically
categorized as low, medium, or high.
Risk Control
After risks have been identified and assessed, measures
must be taken to control them. The goal is to reduce the
likelihood and severity of risks.
You should consider Risk Control options according to
the following priority:
• Inherent safety by design
• Protective measures in the actual medical device
and/or manufacturing process
• Information for safety, such as labeling and
instructions for use
 Risk Acceptance

In some cases, it may not be possible to

completely eliminate a risk. In these
situations, the risk may be accepted if its
likelihood and severity are deemed
acceptable. This decision should be made
by a team of experts and documented in
a risk management plan.
Risk Communication

Effective communication is essential in

risk management. It's important to
communicate risks to stakeholders,
including users, regulatory agencies, and
internal teams. This can be done through
labeling, instructions for use, and other
forms of documentation.
Creative Risk Management
While risk management can be a complex
process, there are creative approaches that can
be taken to make it more effective. These
include involving users in the risk management
process, using storytelling to communicate
risks, and leveraging technology to automate
risk management tasks.
Risk Management and Compliance

Compliance with regulatory

requirements is an important aspect of
risk management. ISO 14971 provides a
framework for managing risks
associated with medical devices, and
compliance with this standard is
required by regulatory agencies in many
countries. It's important to understand
and comply with all relevant regulations.
Risk Management and Quality

Effective risk management is essential

for ensuring the quality of a product or
project. By identifying and controlling
risks, quality can be improved and
potential issues can be avoided. Risk
management should be integrated into
all aspects of a project or product's
lifecycle.
Case Studies

Case studies can provide valuable insights into effective

risk management practices. We will review several case
studies that illustrate the importance of risk
management and the creative approaches that can be
taken to manage risks.
Studies
Best Practices
In summary, effective risk management involves
identifying, assessing, and controlling risks associated
with a project or product. It's important to
communicate risks to stakeholders and comply with
relevant regulations.
Creative approaches can be taken to make risk
management more effective.
 Thanks!
Do you have any
questions?
mohammed.alkhelaly@gmail.com

+201276079449