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Quality Systems and Risk Management
Transcript of Quality Systems and Risk Management
Internal Audit Findings
Quality Systems and
1. The attendees will become familiar with the
basic foundations of a successful quality system.
2. The attendees will obtain an understanding of the different approaches to risk management that have historically been used in various industries.
ISO 31000 – General Risk Management
ISO 14971 – Medical Devices Risk Management
FMEA - aerospace/automotive
HACCP – FDA Food Safety
Operational Risk Management – US Military and FDA Food Safety
Risk Reduction Plans – Workplace policies & procedures
Comparison to common serious risks (e.g. car accident)
Risk Management Standards/Approaches
Quality Management Standards/Approaches
ISO 9001 - General
ISO/TS 16949 – Automotive
AS9100 – Aerospace
ISO 13485/FDA QSR - Medical Device
Corrective and Preventive Actions
Data Collection & Record Keeping
Strong Foundation of Current Practices
Costs of Quality
Essential for fact-based decision making
Manual or automated
Paper or electronic
The risk of fatality is definitely increased if infection is allowed to infiltrate major organs of the body.
The risk o
atality is de
initely increased i
ection is allowed to in
iltrate major organs o
Chance to Improve
According to SAP, the volume of data created
by US companies could fill _______ Libraries of Congress.
According to Google, we create as much information
every two days
as was created from the year ____ to the year 2003.
Data is being created everywhere!
Initiate CAPAs and other