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Quality Systems and Risk Management

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by

Matt Mortensen

on 19 June 2014

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Transcript of Quality Systems and Risk Management

Data Trends
Risk Management
Internal Audit Findings
Quality Systems and
Risk Management

CAPA Results
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.

Learning Objectives
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
TQM
Baldrige Criteria
ISO 9001 - General
ISO/TS 16949 – Automotive
AS9100 – Aerospace
ISO 13485/FDA QSR - Medical Device
Corrective and Preventive Actions
Current Practices
Data Collection & Record Keeping
Risk Management
CAPA
Management Review
Strong Foundation of Current Practices
Costs of Quality
Prevention
Planning
Training
Appraisal
Inspecting
Auditing
Failure
Recalling
Treating Infections
Internal Auditing
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.
7!
The risk o
f

f
atality is de
f
initely increased i
f
in
f
ection is allowed to in
f
iltrate major organs o
f
the body.
Periodic Checks
Against
written
requirements
Chance to Improve
Identify
Assess
Mitigate
Management Representative
According to SAP, the volume of data created
every year
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
improvement activities
Full transcript