infographic: the guiding principles of a quality management system
TRANSCRIPT
The goal is to design a system that maintains compliance, drivescontinual improvement and supports efficient and flexible processes
The Guiding Principles of a QualityManagement System
Improve
Plan
Execute
Monitor
Quality By Design
Continuous Improvement
Risk Management
First Pass Quality
Take actions tocontinually improveprocess performance
Monitor and measureexecution againstdefined objectives
Establish objectives andprocesses necessary to
deliver results
Execute processes according todefined objectives
Management & StaffResponsibility
QMS Documentation
The Personal Quality CommitmentIndividual Accountability is Essential for a Successful Global System
Demonstrate a Culture of Quality
Ensure Competency to Do Work Correctly
Identify and Assess Risks
Follow and Enforce Procedures and Standards
Report and Investigate Abnormal events
I will strive to be a role model and will demonstrate leadership in my Quality behaviors
I will welcome identification of opportunities for continuous improvement of activities related toensuring Quality results
I will ensure adequate training and understanding of Quality requirements and standards related tothe execution of my work and/or that of my staff
I will actively ensure that quality risks are identified, and assessed
I will take action to recognize and prevent behaviors that could result in non-compliance oradverse Quality impact
I will follow GMP/GDP procedures, standards and requirements
I will notify my manager prior to proceeding if the requirement or procedure cannot be met aswritten or intended
I will report and thoroughly investigate all abnormal incidents and near misses
I will implement and assure effectiveness of CAPA’s; and share results with other applicable staffand functions
I will actively do, and ensure others do, the following, when performing tasks and activities,especially when governed by Good Manufacturing/Distribution Practices
"Standard Operating Procedures" not "Stacks Of Paper"Developing the documentation side of a QMS with the user in mind is essential to its success.
SOPs should
Only be written for processes that benefit from them
Help standardize processes where required
Drive adoption of best practices that improve the qualityand robustness of the process or outcome
Be written for the operator in consultation with experts
Be clear and easy to follow
Require a periodic review and be updated on a regular basis
- Policies- Operating Standards
- SOPs
- Management Review
- Quality Plan
The Management ReviewA Robust System Requires Constant Monitoring by Senior Management
The Management Review is an action-oriented cross functional review of the business by seniormanagement with the goal of providing safe and effective products to patients.
Drive continuous improvement and Operational Excellence
Enable effective corrective and preventive action
Mitigate riskAnalyze key metrics, reverse unfavorable trendsFocus on accountabilityAssess resource allocationConstructive and solution oriented, not punitive
The Management Review Maturity Model (DIKW)
Conte
xt
Understanding
Data = raw observationsand measurementInformation = analyzedrelationships of dataKnowledge = usinginformation for actionWisdom = “why”and“when”related to actions
Researching Absorbing Doing Interacting Reflecting
Joining ofwholes
Formationof a whole
Connection ofParts
Gathering ofParts Data
Information
Knowledge
Wisdom
Take Home Messages for a Successful Global Quality SystemManagement’s role in the system should be to be seen to lead in Quality and provide clear Qualityexpectations yet empower individuals
Individuals must know why Quality is important and be recognized for achieving it
Design the system with the user in mind
Include only essential elements that add real value –the system should facilitate Quality and notdrive work-arounds–Simple and Robust
Manufacturing technology advances and QbD control strategies can realize a reduction of Qualityrequirements (e.g. cleaning validation, lot release and stability testing etc.)
This infographic was created from the information presented by Tony Mire-Sluis, Vice President, North America, Abingdon, Singapore,Contract and Product Quality, Amgen Inc., at the American Biomanufacturing Summit 2015 in San Diego. The information herein is for
broad informational purposes only and while Generis strives to ensure the information is up to date and correct, we make norepresentations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability of theinformation for any purpose. Any reliance you place on such information is strictly at your own risk. In no event will Generis be liable for
any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arisingfrom loss of data or profits arising out of, or in connection with, the use of this infographic.This document may not be duplicated or
altered without the express permission of Generis.
Hear First-Hand Case Studies and Best Practices to Create a QualityFocused Culture Within Biomanufacturing Facilities
American BiomanufacturingSummit 2016May 10 - 11, San Diego, CA
WWW.BIOMANAMERICA.COM