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Quality Risk Management Training
Quality Risk Management Training
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Pricing
Indicative pricing is A$500 per person or A$4500 per day, with discounts available when more
than 10 people attend the same course.
What you will learn
Upon completion of this course participants will be able to;
understand Risk Based compliance, risk based decisions and be able to focus efforts on
the greatest risks to patient safety and product quality
do basic Risk modelling
devise risk reduction and mitigation strategies that actually achieve their purpose
understand how knowledge of your product and processes can lead to profitability
Course materials
Participants will receive a copy of the presentation(s), relevant notes and workshop materials.
A certificate of completion will be issued to participants who successfully complete the
assessment.
Assessment
A written assessment is conducted at the end of the course.
Course Format
The course is a combination of lecture-style learning and active workshops with participants
working in small groups on assigned tasks.
Who should attend?
Validation personnel
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1. Check sheet
The check sheet is a form (document) used to collect data
in real time at the location where the data is generated.
The data it captures can be quantitative or qualitative.
When the information is quantitative, the check sheet is
sometimes called a tally sheet.
The defining characteristic of a check sheet is that data
are recorded by making marks ("checks") on it. A typical
check sheet is divided into regions, and marks made in
different regions have different significance. Data are
read by observing the location and number of marks on
the sheet.
Check sheets typically employ a heading that answers the
Five Ws:
2. Control chart
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