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MASTERWORKS Training
PracticeWorks Quality System Overview
CHRa1.100.RC1.2
Objectives
After completing this class you should be able to:
Objectives
After completing this class you should be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
Objectives
After completing this class you should be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
• Define a Quality System
Objectives
After completing this class you should be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
• Define a Quality System
• Locate the Quality Policy on the intranet site
Objectives
After completing this class you should be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
• Define a Quality System
• Locate the Quality Policy on the intranet site
• Understand your role in maintaining an effective system for
Quality
Overview of Quality
What is Quality?
Quality
Overview of Quality
What is Quality?
Quality
Sales
Support
Retirement
Overview of Quality
What is Quality?
Value
Quality
Overview of Quality
What is Quality?
Value
Delivery
Quality
Overview of Quality
What is Quality?
Value
Delivery
Quality
Support
Overview of Quality
What is Quality?
Value
Delivery
Quality
Reliability
Support
Overview of Quality
What is Quality?
Value
Safety
Delivery
Quality
Reliability
Support
PracticeWorks and the FDA
PracticeWorks and the FDA
FDA Responsibilities
White House
Department of Health and Human Services
Food & Drug
Administration
Food
Drugs
Medical/Dental Devices
Biologics
Cosmetics
Radiation Emitting Devices
PracticeWorks and the FDA
Government Requirements
Regulated facilities must:
• Comply with Federal Law – Quality System Regulation
(QSR)
• Clear medical and dental devices through the FDA before
bringing them to market
• Maintain the safety and effectiveness of our products
PracticeWorks and the FDA
FDA Mandates
Quality Policy
• Outline quality goals
PracticeWorks and the FDA
FDA Mandates
Quality Policy
• Outline quality goals
Quality System
• Attain quality goals
• Manage quality issues
• Measure quality
• Ensure public safety
PracticeWorks and the FDA
FDA Mandates
Quality Policy
• Outline quality goals
Quality System
• Attain quality goals
• Manage quality issues
• Measure quality
• Ensure public safety
Quality System Documentation
• Maintain quality records
PracticeWorks and the FDA
FDA Inspections
• Inspections are used to police adherence to the QSR
• Inspectors must have access to the facility and to certain
records
• PracticeWorks has been regularly inspected
• Inspectors look for non-compliance
PracticeWorks and the FDA
FDA Inspections
• Inspections are used to police adherence to the QSR
• Inspectors must have access to the facility and to certain
records
• Inspectors look for non-compliance
• Failure to comply could result in:
– FDA warning letters
– Product recalls
– Federal injunctions
– Federal charges against
company individuals
PracticeWorks and the FDA
FDA Care About . . .
Business processes
• Impact safety and effectiveness of products
Business activities or procedures
• Impact product quality
PracticeWorks and the FDA
The FDA Care About . . .
Warehouses
PracticeWorks and the FDA
The FDA Care About . . .
Warehouses
Customer Service departments
PracticeWorks and the FDA
The FDA Care About . . .
Warehouses
Customer Service departments
Purchasing procedures
PracticeWorks and the FDA
The FDA Care About . . .
Warehouses
Customer Service departments
Purchasing procedures
Sales personnel
Consider this …
Why does the FDA care about our technical support
calls?
Answer
Why does the FDA care about our technical support
calls?
Technical support call representatives must
professionally handle and document customer
complaints and address potential problems that place
patients at risk in a timely and responsible manner.
Let’s Review
PracticeWorks and the FDA
• Clear certain dental devices / dental software with the FDA
• Maintain a Quality System
– Quality policy
– Documentation
• FDA inspections
• FDA examines various business functions
Defining a Quality System
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Quality System Components
Quality System
Quality
Manual
Training &
Development
Tools &
Systems
Policies
Defining a Quality System
Purpose
Quality
System
Predictable
and
Verifiable
Outcomes
Defining a Quality System
Purpose
Quality
System
Predictable
and
Verifiable
Outcomes
Continuous
Improvement
Defining a Quality System
Purpose
Quality
System
Predictable
and
Verifiable
Outcomes
Reality
Matches
SOPs
Continuous
Improvement
Defining a Quality System
Quality Manual Elements
• Complaint Handling
• Corrective & Preventive
Action
• Design Controls
• Document Controls
• Handling, Storage,
Distribution & Installation
• Identification & Traceability
Defining a Quality System
Quality Manual Elements
• Complaint Handling
• Labeling & Packaging
• Corrective & Preventive
Action
• Management
• Design Controls
• Personnel & Training
• Document Controls
• Process Validation
• Handling, Storage,
Distribution & Installation
• Purchasing Controls
• Identification & Traceability
• Servicing
• Quality Records
Defining a Quality System
Quality Manual Elements
• Complaint Handling
• Labeling & Packaging
• Corrective & Preventive
• Management
Business
functions
affected:
Action
• Personnel & Training
• Design Controls
Distribution
• Process Validation
• Document Controls
Human Resources
Implementations• Purchasing Controls
• Handling, Storage,
Marketing • Quality Records
Distribution & Installation
Purchasing
• Identification & Traceability
• Servicing
Research & Development
Sales
Servicing
Support
Let’s Review
Defining a Quality System
Quality System
• Quality manual
• Training and development
• Business tools
• Policies
Quality System helps to prevent defects and errors
Locating the Quality Policy
Locating the Quality Policy
“PracticeWorks is committed to delivering high
quality products, services and solutions that meet our
customers’ needs and regulatory requirements. This
is accomplished through the maintenance of an
effective quality management system.”
Locating the Quality Policy
• Provide reliable, robust products and services that meet
customer needs.
• Effectively maintain and consistently execute our quality
system processes.
• Maintain regulatory compliance.
Locating the Quality Policy
PLACEHOLDER FOR GUIDED SIMULATION.
Let’s Review
Locating the Quality Policy
Understanding Your Role in Maintaining
an Effective System for Quality
Maintaining an Effective System for Quality
How Do We Achieve Our Quality Goals?
Quality
Assurance
Testing
High
Quality
Products &
Services
Quality
Procedures
Customer
Surveys
Maintaining an Effective System for Quality
What Does It Mean To Me?
Operating within a Quality System means:
• Employees utilize defined business processes and
procedures
Maintaining an Effective System for Quality
What Does It Mean To Me?
Operating within a Quality System means:
• Employees utilize defined business processes and
procedures
• Employees are responsible for improving quality and
eliminating errors or defects
Maintaining an Effective System for Quality
What Does It Mean To Me?
Operating within a Quality System means:
• Employees utilize defined business processes and
procedures
• Employees are responsible for improving quality and
eliminating errors or defects
• Employees receive training on standard operating
procedures
Maintaining an Effective System for Quality
What Does It Mean To Me?
Operating within a Quality System means:
• Employees utilize defined business processes and
procedures
• Employees are responsible for improving quality and
eliminating errors or defects
• Employees receive training on standard operating
procedures
• Everyone maintains records
Let’s Review
Maintaining and Effective System for Quality
The Quality System enables us to:
• Achieve our quality goals
• Comply with the FDA
• Enjoy the business benefits of a well-structured work
environment
Summary
You should now be able to:
Summary
You should now be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
Summary
You should now be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
• Define a Quality System
Summary
You should now be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
• Define a Quality System
• Locate the Quality Policy on the intranet site
Summary
You should now be able to:
• Explain how PracticeWorks is regulated by the Food and
Drug Administration (FDA)
• Define a Quality System
• Locate the Quality Policy on the intranet site
• Understand your role in maintaining an effective system for
Quality
[email protected]
The names of persons and the data reflected in this demonstration are fictitious and are not intended to
represent any real individual, event, or condition. Any resemblance or similarity of the names of persons or
data reflected in this demonstration to any actual person’s name, any event, or condition is purely
coincidental and unintended.
CHRa1.100.RC1.2
©PracticeWorks Systems, LLC. 2009.
MasterWorks is a trademark of Carestream Health, Inc.
The Kodak trademark and trade dress are used under license from Kodak.