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Program At-A-Glance
Format
This 2 day course provides
intensive coverage of integrating risk
management practices and principles
into a medical device manufacturer's
quality system. This highly
interactive format includes relevant
examples from a broad product
spectrum that demonstrate current
industry practices of risk
management. In addition, interactive
exercises will allow participants to
practice applying risk management
concepts, principles, and tools
throughout the product lifecycle.
DAY 1
Risk Mgmnt. throughout Product Life
8:00 AM- Cycle
5:00 PM
Basic Terms and Concepts
ANSI/AAMI/ISO 14971 Overview
Management Responsibilities
Risk Management at CDRH
Design Input
DAY 2
Design Input (cont)
8:00 AM- Design Output
5:00 PM Software Risk Management
DAY 3
Design Transfer
8:00 AM12:00 PM Overall Residual Risk
Course Materials
1. Check sheet
2. Control chart
Control charts, also known as Shewhart charts
(after Walter A. Shewhart) or process-behavior
charts, in statistical process control are tools used
to determine if a manufacturing or business
process is in a state of statistical control.
If analysis of the control chart indicates that the
process is currently under control (i.e., is stable,
with variation only coming from sources common
to the process), then no corrections or changes to
process control parameters are needed or desired.
3. Pareto chart
5.Ishikawa diagram
Ishikawa diagrams (also called fishbone diagrams,
herringbone diagrams, cause-and-effect diagrams, or
Fishikawa) are causal diagrams created by Kaoru
Ishikawa (1968) that show the causes of a specific event.
[1][2] Common uses of the Ishikawa diagram are product
design and quality defect prevention, to identify potential
factors causing an overall effect. Each cause or reason for
imperfection is a source of variation. Causes are usually
grouped into major categories to identify these sources of
variation. The categories typically include
People: Anyone involved with the process
Methods: How the process is performed and the
specific requirements for doing it, such as policies,
procedures, rules, regulations and laws
Machines: Any equipment, computers, tools, etc.
required to accomplish the job
Materials: Raw materials, parts, pens, paper, etc.
used to produce the final product
Measurements: Data generated from the process
that are used to evaluate its quality
Environment: The conditions, such as location,
time, temperature, and culture in which the process
operates
6. Histogram method