ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
1
How to Harmonize and Simplify Quality Systems
Fredrik Asell, VP Quality Americas
Agenda
• Approaches to QMS integration
• A Case Study
• Business Process Management
• Q&A
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
2
Key considerations when approaching QMS integration:How globally standardized is my company? (not only QMS, but as an overall company) How mature is the new partner in ”business as usual” GMP supply?
3
Lo
ose
sit
e n
etw
ork
Glo
bal
pro
ced
ure
sJ
oin
t s
yste
ms
Start-up R&D going commercial Mature global pharma
Standardization & Centralization
Partner GMPmaturity
Phased integration
Quickly: Issues/complaints, communications etc
Can wait: Common doc mgmt system etc
Light touch
Quickly: Issues/complaints, communications etc
COMMON
Establish baselineAuditsManagement reviewEtc
Establish key staffhighly desirable
”Be careful” / ”Build”
Will require more ”hands on” thannormal parent company approach
Transfer as much as possible from most similar site in networkConsider consultants support
Heavy integration
”Copy/paste procedures” etc
Parachute in people
Recognize people and culture too!
As the Parent Company
Respect previous identity.
Look for win-win wheneveryou can
Leverage possible new best practice.
Common
Agree expectations early
Not everything is equally urgent: agree on priorities
As the Acquired Company
Come to terms: this will happen.
Look for the positives
Get engaged in networks quickly.
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
3
An Example QMS Project From the Plant Network
Background• Medimmune acquired by AZ in 2007.
• Operated for a number of years on existing SOP’s and systems (Light Touch approach).
• Focus on biologics pipeline.
• As products launched the focus shifted to commercial execution.
• Mid 2016 new management in many key positions at the site from top 5 firms start to ask questions.
• AstraZeneca overall had also shifted towards standardized global ways of working
This change control process is more complex and effort than I’m use?
It seems like the events and minor deviations are taking a lot of effort for
low risk issues?
It seems like controls could be enhanced to
ensure new GMP materials are controlled and risks reduced what
do you think?
It takes a week or more to get access to
document like an SOP to begin editing, I have a short term deadline!
Most of our processes are common across the AZ network; why don’t we leverage this more?
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
4
Governance Structure and Teams
Steering CommitteeProgram Management
Deviation & CAPA
Co‐Leads: Ops & Quality
Site Process Owner:
Document Processes
Co‐Leads: Ops & Quality
Site Process Owner:
Change Control
Co‐Leads: Ops & Quality
Site Process Owner:
Materials Control
Co‐ Leads: Ops & Quality
Site Process Owner:
• Establish governance and bi-weekly steering committee meetings
• Each QMS Team had a co-lead from Ops and Quality and the Site process owner and a few SME’s
• Standardize approach to site QMS redesign starting with AZ Policy and SOP
• Standard project dashboard and schedule expectations
Phased Integration of high priority QMS and begin Process Mgt (BPM)
QMS Redesign Schedule
Task / Week November December January February March April May June
Current State Assessment
Future State Design
Implementation / Communication Plan
Document Revisions and Approvals
Communication to key stakeholders
Training Materials Development
Training
High level of Implementation Support
Key Stakeholder Engagement / Feedback
Rapid Implementation of QMS redesign for 5 key systems. Go fast with a standard project approach and engaged governance.
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
5
Project Plan
Step 1 – Current State
- Establish steering team
- Teams populate current state template
- Complete charter and approval
Month 1
Step 2 – Future State
- Start with AZ corp QMS
-Benchmark industry good practices to help define site SOP
-Define future state targets and process and SOP
Month 2
Step 3 – Implementation Plan
-Create implementation plans
-Assess and mitigate implementation risks
- Develop communication and Change mgt. plans
Month 3
Step 4 – Implementation
- Document approvals & Training
-Retire old Medimmune Corp SOP’s
- Increased communication & support during implementation
Month 4-6
Simplify Quality Systems Program Status – Example
Current Status Previous Status Key Milestone /Deliverable Owner Due Date Latest Estimate Actual Comments
G Y Project VSCR and Tasks Week of 10Apr Complete Rec#163200, approved on 13Apr17.
G Y Site Communication Week of 10Apr Complete Distributed on 13Apr17.
G Y DMS Implementation 17Apr17 Complete VSCR Tasks for DMS Implementation are closed.
G Y Dev Mgt Implementation 17Apr17 Complete VSCR Tasks for Deviation Implementation are closed.
G G CAPA Implementation 28Apr17 Complete VSCR Task pending closure.
G G Change Control Implementation 31May17 On Track Documents (6) revision/creation in progress. Training materials development in progress.
G G MM Implementation 30Jun17 On Track Phased Implementation (iBuy and New Materials)Documents (10) revision/creation in progress. Training materials development in progress.
G Poster Session 03May17 On Track Posters ready for printing
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
6
The Challenges• Multiple PAI’s • Multiple audits• Project Time for the team leads and owners while doing current role• Alignment of Stakeholders on future state system• Changes to corporate systems like TrackWise at the same time• Meeting aggressive schedules for design and implementation
The Results • Established process ownership of each of the major QMS elements• Eliminated reference to old Medimmune procedures• Simplified procedures to AZ standard and industry best practice
– Improve effectiveness • Improved cycle time •Refocused to risk based approach
–Reduced level of effort on low risk areas–Increased focus on medium and high risks
• Improved clarity of roles and responsibility• Improved Consistency in QMS execution
–Reduce compliance risk
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
7
Operations PQS ‐ BPM Based with Foundation in ICHQ10
13 core elements
+ 15 sub-elements
= 28 BPOs
PC
Executive Process Owner
• Sets the strategic direction & targets for theprocess
• Holds a holistic overview to ensure alignment across related processes
• Sponsors the process and supports the BPO
EPO
Process Champion
• Champions the process in own site / region / function
• Represents their area in process design & improvement
• Trains & coaches local end user community
• Ensures adherence to process with users & local management
• Shares good practice & improvement ideas from own area
PE
Business Process Owner
• Operational leadership of the process
• Defines & owns the standard process
• Provides training & communications
• Monitors process adherence
• Monitors process performance & drives improvement
• Leads a cross-functional process network
• Manages links with related processes
• Manages any supporting systems / IT
BPO
LM
Line Manager
• Ensures adherence to the agreed process
• Ensures appropriate capability and succession planning for process users
• Supports BPO in process improvement
Process Expert
• Provides deep subject matter expertise in the process
• Supports BPO & process champions in training & coaching users
Operations BPM Roles
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
8
Quality Global BPM Model
Site
Users
Global
BPO
RPC
Function Users
Regional Process
Champion
Functional Process
Champion
Regional Process
Champion
Regional Process
Champion
Site Process
Champion
Site Process
Champion
Site Process
Champion
GlobalProcessNetwork
RegionalProcessNetwork
User User
UserUser
User
User
User
User
Networks & Forums3 41 2
BPM Maturity
Level
ISPE Annual Meeting29 October – 1 November 2017
San Diego, CA
9
Questions and Answer