2014 ISPE Annual Meeting

Bringing pragmatism tocrisis management

Presented by: Mark Stevens, Formpipe GxP

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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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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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2014 ISPE Annual Meeting

Introduction

• Crisis avoidance!

• Methodology for significant, non-routine issues - consistency and efficiency

• …and Pragmatism!

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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

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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2014 ISPE Annual Meeting

Experience - observations

• Consultant – things already in progress

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Lots of very busy peopleLots of commitments to leadership, regulators,

customers

Different views and understanding of scope

High demands on Leadership Team at

tactical level

Lots of dataLots of consultants being

drafted in

2014 ISPE Annual Meeting

Experience - observations

• The problems and frustrations I encounter:

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Unclear scope definitionUnrealistic 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

2014 ISPE Annual Meeting

Experience - observations

• The good stuff:

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Clear communication to the business

Recognised project team

Proper planningEngagement and

ownership

The right people being involved

True cooperation

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

2014 ISPE Annual Meeting

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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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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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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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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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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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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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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