Send the link below via email or IMCopy
Present to your audienceStart remote presentation
- Invited audience members will follow you as you navigate and present
- People invited to a presentation do not need a Prezi account
- This link expires 10 minutes after you close the presentation
- A maximum of 30 users can follow your presentation
- Learn more about this feature in our knowledge base article
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