1. 2014 ISPE Annual Meeting
Bringing pragmatism to
crisis management
Presented by: Mark Stevens,
Formpipe GxP
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2. 2014 ISPE Annual Meeting
Approach
• Perspective of the Project Manager
• Anecdotal - my views and opinions
• Encourage the exchange of ideas and
experience
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3. 2014 ISPE Annual Meeting
Definition: Crisis
“A time of intense difficulty or danger”
“A time when a difficult or important
decision must be made”
Source: Oxford Dictionaries
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4. 2014 ISPE Annual Meeting
Introduction
• Crisis avoidance!
• Methodology for significant, non-routine
issues - consistency and efficiency
• …and Pragmatism!
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5. 2014 ISPE Annual Meeting
Introducing the speaker
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• Mark Stevens
• Chemical Engineer
• Pharma / Biotech / Food
• Design, construction,
validation, CSV, clinical,
QMS, demolition…
• Lots of remediation and
improvement projects

6. 2014 ISPE Annual Meeting
Experience - examples
• QC Analytical Operations – data integrity
• GMP Manufacturing – batch record
falsification
• Patient Information Leaflet (PIL) compliance
• Serious issues from regulatory audit –
e.g. voluntary license suspension
• GMP-critical business systems out of
compliance
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7. 2014 ISPE Annual Meeting
Experience - observations
• Consultant – things already in progress
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Lots of very busy people
Lots of commitments to
leadership, regulators,
customers
Different views and
understanding of scope
High demands on
Leadership Team at
tactical level
Lots of data
Lots of consultants being
drafted in

8. 2014 ISPE Annual Meeting
Experience - observations
• The problems and frustrations I encounter:
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Unclear scope definition
Unrealistic resource
demands between
remediation and ‘day job’
Confusion and conflict on
reporting lines
Progress limitations – key
individuals and / or work
processes
A desire to be too
optimistic on target dates
and resources
Duplication of effort:
meetings / reports /
actions

9. 2014 ISPE Annual Meeting
Experience - observations
• The good stuff:
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Clear communication to
the business
Recognised project team
Proper planning
Engagement and
ownership
The right people being
involved
True cooperation

10. 2014 ISPE Annual Meeting
How do we end up in this position?
Market and
Regulations
Type of
problem
Scope
Impact
People
Org.
Structure
Origin of
problem
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Every ‘crisis’ is
unique!
So each project
needs to be
treated uniquely

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Remediation planning
• Consistent process and methodology that suits your
business
• Acknowledgement that this is not a ‘side project’ and
requires real commitment and resource to succeed
• Sponsorship by senior Leadership
• Dedicated and empowered team able to lead and
make decisions
• A project manager to facilitate and drive the whole
thing
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12. 2014 ISPE Annual Meeting
Balance of activities
• Your day jobs do not disappear
• Situation dependent:
– Operations suspended
– Reduced capacity
– In-fill of routine operations (internal capacity?)
– Out-source (competitor?)
• Best use of your resources – routine operations
or remediation?
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13. 2014 ISPE Annual Meeting
Project Definition
• Problem Statement
• Scope, boundaries and success factors – what does it
need to achieve?
• Remediation vs. ongoing improvement
• Structure of project
• Communication
– Leadership team – What is it we need to do? Why? How
much? How long? Risks?
– Organisation – What is actually going on and how does this
affect me?
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14. 2014 ISPE Annual Meeting
Project Management
• Identify rate-limiting elements (people and
process). Improvements? Change?
• Not everyone needs to be involved with every
decision or every meeting
• Keep meetings brief with clear agenda on
decisions that need to be made
• Encourage a culture of compromise. Risk-based
and pragmatism
• Challenge the proposals. What is Plan B?
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15. 2014 ISPE Annual Meeting
Communication
• Simple metrics are great. Are we still good?
• Not everyone needs the same information or
level of detail
• What is it for? Keep me informed? Do I need
to make a decision?
• Speaking and meeting face-to-face are worth
many, many emails…
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16. 2014 ISPE Annual Meeting
Close-out
• Remediation is only part of an ongoing
process of continuous improvement
• How can the next remediation project be
delivered better?
• How can we identify and mitigate similar
issues in the future
• How do we transfer back to ‘business as
usual’?
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17. 2014 ISPE Annual Meeting
Conclusion
• No two projects are ever the same
• Mobilization process for your organization
• Support, commitment and resource needed for
success
• Clearly defined scope and communication
• Drive decisions, facilitate compromise and drive
to completion using a risk-based approach
• Remediation is only part of an ongoing process of
continuous improvement
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