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Case For Quality Company B: Risk Management

1) The document discusses creating a risk management system that is simple, systematic, integrated, sustainable, and compliant. 2) It defines risk according to ISO 31000 and ISO 14971 standards as the combination of the probability and severity of harm. 3) The medical device community is under scrutiny for overusing and misusing failure mode and effects analysis (FMEA) and not presenting a comprehensive risk management system.

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Rakesh
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77 views10 pages

Case For Quality Company B: Risk Management

1) The document discusses creating a risk management system that is simple, systematic, integrated, sustainable, and compliant. 2) It defines risk according to ISO 31000 and ISO 14971 standards as the combination of the probability and severity of harm. 3) The medical device community is under scrutiny for overusing and misusing failure mode and effects analysis (FMEA) and not presenting a comprehensive risk management system.

Uploaded by

Rakesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Case for Quality

Company B
Risk Management
Risk Management
Purpose
• Create a simple, systematic, integrated,
sustainable, and compliant Risk Management
System
Risk Management
What is Risk?

Standard Purpose Definition


ISO 31000 Enterprise Risk Effect of uncertainty on
objectives

ISO 14971 Medical Devices – Application Combination of the


of Risk Management to medical probability of occurrence
devices of harm and the severity
of that harm
Risk Management
Medical device community under scrutiny on the
overuse and misuse of FMEA’s for risk management

• "I can’t tell you how many manufacturers I


have seen that have tried to present their risk
management system by simply presenting a
FMEA. That is NOT a risk management
system.“
-Kim Trautman, former QSR expert at FDA, CDRH
http://www.prweb.com/releases/FDAnews/MDRiskMgmntChicago/prw
eb12107152.htm
Risk Management
Risk Management System
ISO 14971

• Focus is on Health and Safety


• Consistency, from design to process
• All hazards, hazardous situations and
harms must be addressed in the Risk
Trace Matrix
• Knowledge management repository
• Flexible use the right tools for input, not
just FMEA
Risk Management
Example of Risk Profile
Risk Management
Example of Risk Table
Hazardous Situation/ Potential Harms Severity Rationale
Foreseeable Sequence of Events

Device is not sterilized and Infection 5 Device must be sterile.


gets shipped to user as unsterile.

Materials used to manufacture Mild tissue abrasions 4 Minor medical condition that
device packaging, labels, do not resolves itself.
meet requirements for
compatibility with other
materials with which they come
into contact.

User gets dirt on device during No impact to health ≤3 Personal cleanliness for
handling. User may experience and safety device handling is contained
discomfort. in the package insert.
Risk Management
Example of Risk Matrix

Hazard Hazard Hazardous Risk Control Sev Prob of Risk Source Objective
Class Situation Method Harm Acc Document for Evidence
Risk Control

Chemical Non- User uses device Bio- ≤3 Low Biocompatibility Report


conforming with non- compatibility reports, device numbers and
limits of conforming of device is specifications, specification
process levels of process confirmed process numbers
aids in aids various issues validation
device reports
Risk Management
Master Product Health & Safety Risk
Identification Table

• Knowledge management center


• All known hazards, hazardous situations,
potential harms and severity ratings
• Internal Product Health & Safety standard list
• All references to severity determination are
traceable
Risk Management
Product Health & Safety Risk Trace Matrix
– Risk Management File

• Matrix containing all identified hazards,


hazardous situations, risks controls, applicable
product safety standards and references to
supporting documentation associated with
products
• Ensures that all identified risks have been
appropriately analyzed, evaluated, controlled,
and documented

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