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

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