2013 ohsug - facilitating pharmacovigilance globalization with process reengineering
DESCRIPTION
Facilitating Pharmacovigilance Globalization with Process ReengineeringTRANSCRIPT
PREVIOUS NEXT PREVIOUS NEXT
Streamlining a Global Life Sciences Company's Pharmacovigilance Operations
Facilitating Globalization with a standard approach to process reengineering
July 18, 2012
Rodney Lemery, MPH, PhD Vice President, Safety and Pharmacovigilance
BioPharm Systems, Inc.
PREVIOUS NEXT
Agenda
• Summary of Situation • Project Overview
• Review of Current State
• Description of Methods Used • Origin of Methodology
• Techniques Used
• Results of Methods
• Lessons Learned
• What This Means for You
PREVIOUS NEXT
Summary of Situation
Project Overview • A leading U.S.-based pharmaceutical company founded in the early 1980s
issued a RFP asking for assistance in the globalization of their current Argus Safety system
• The company would be integrating three separate non-Argus safety applications into their central Argus database
• To accommodate this, procedures and work instructions not currently representing a global environment required analysis and updates to prepare the company for the use of the application in this new paradigm
PREVIOUS NEXT
Summary of Situation
Process Overview • Company’s acquisition of a global generics company resulted in the need
to incorporate international case management, local labeling and other globalization aspects of process into their existing drug safety quality system
0 Policies 10 Procedures 4 Work Instructions
PREVIOUS NEXT
Summary of Situation
Current State
PREVIOUS NEXT
Summary of Situation
Client Needs
• Update of global procedures governing non-Argus systems into Argus specific documents
• Consolidation of all country specific procedures and work instructions into a more global process
PREVIOUS NEXT
Methods Used
PREVIOUS NEXT
Methods Used
Origin of Methods
• Process re-engineering methods are diverse and range from the simple to the complex
• Recent research has shown that the use of the Strengths, Opportunities, Weaknesses and Threats (SWOT) analysis is a powerful tool in strategic planning and process initiatives (Helms and Nixon, 2010)
• Well entrenched in peer-reviewed journals
• Used beyond strategic planning
• Time tested
PREVIOUS NEXT
Methods Used
Origin of Methods • In order to facilitate accountability in the process improvement
initiative, BioPharm use a tool referred to as a RACI Diagram (Costello, 2012) • Responsible
• Accountable/Approve
• Consulted
• Informed
• BioPharm has also determined that the SWOT report can easily be transformed into a gap analysis summary
• In turn the gap analysis provides traceability to a strategic mitigation plan (road map) for the identified gaps
PREVIOUS NEXT
Methods Used
PREVIOUS NEXT
Techniques Used
RACI Table Produced
•Project management literature (Costello, 2012) describes the importance of clearly documenting and communicating the expectations around deliverables for a given project •BioPharm has found that using a tool referred to as a RACI table, to be an effective tool facilitating agreement of scope and responsibility
• Identification of business unit resources and responsibilities
• Identify all anticipated deliverables
• Meeting to cover scope of process re-engineering tasks and agree on both scope and responsibility
PREVIOUS NEXT
Techniques Used
Preliminary RACI for Anticipated Work
PREVIOUS NEXT
Techniques Used
PREVIOUS NEXT
Techniques Used
Desired Quality System
•Determine Standard Quality System •BioPharm used our understanding of the global regulatory reporting environment and the Argus application to identify a set of quality standards needed to operate the Argus application in this context.
•Agree upon standard •A meeting of all vested parties occurred to review the “standard” and agree
•Removal of policy creation/modification from scope
PREVIOUS NEXT
Techniques Used
Desired Quality System
PREVIOUS NEXT
Techniques Used
Current Quality System
•Deliver quality documents to BioPharm
•The documentation was organized into a typical quality system hierarchy
•Organize quality documentation •Each quality document was placed into the agreed upon “standard” quality framework
•Policy to Policy, SOP to SOP and WI to WI
PREVIOUS NEXT
Techniques Used
SWOT Analysis
•Conduct SWOT against Desired State •BioPharm conducted a standard Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis on the quality documents compared to the agreed upon “desired” framework
•Consensus Building •A meeting to review the SWOT analysis results will occur to gain consensus and understanding among the business units
•Extract the gaps from any Weaknesses or Threats
PREVIOUS NEXT
Techniques Used
SWOT Analysis Example
PREVIOUS NEXT
Techniques Used
Further Analysis (optional)
•Conduct Review of Inter-Unit Documents •Related business unit quality documents can also be compared to one another in tabular form and used to facilitate the discussion of “issues” among the quality documents that need to be harmonized
•Consensus Building •A meeting to review the analysis results will occur to gain consensus and understanding among the business units
•Extract the gaps from any Weaknesses or Threats
PREVIOUS NEXT
Techniques Used
Further Analysis Example
PREVIOUS NEXT
Techniques Used
Gap Analysis (Road Map Report) •Document gaps in quality documentation •Ensure that each existing Strength and appropriate Opportunities are represented and recognized in the resulting gap mitigation
PREVIOUS NEXT
Techniques Used
PREVIOUS NEXT
Techniques Used
RACI for Agreed Upon Work
PREVIOUS NEXT
Techniques Used
Quality Documentation Creation
•BioPharm created a number of updates to these documents
and facilitated numerous meetings to reach consensus on the
practices of the safety team
•Iterative and interactive meetings were scheduled using
WebEx to facilitate a spirit of collaboration
PREVIOUS NEXT
Results
Impact on Globalization
• Expanded the US-Centric WI into 8 Global WI appropriate to Argus
• Reduced 10 Procedures into 2
• Updated US-Centric procedures and WI to include comprehensive global language (strengths and opportunities were vital in this effort)
• Identified a number of Argus configurations required to meet global needs
PREVIOUS NEXT
Lessons Learned
• The collection of quality documentation is important and accurate, comprehensive and timely delivery for analysis was critical
• The use of the gap analysis report as a tool for project focus and effort is vital
• Iterative and interactive meetings aid in the fostering of ownership (of the quality documents ) to the appropriate department participants
• Global participation is often divergent and difficult; it is still crucial to ensure all vested parties are heard and their procedural needs are addressed
• MS Word comment fields were used to annotate these needs
PREVIOUS NEXT
Lessons Learned
• Even after all of the consolidation meetings occur, business procedures may differ too widely among the business units
• Consolidation should be a goal not a finite rule
• Possible that consolidation occurs only at the policy and procedure levels not at the departmental/work instruction level
• Local labeling work instructions, competent authority reporting etc.
• Procedural work often identifies system level configuration needs
PREVIOUS NEXT
Ways to Engage…
• For those ready • Proof of concept or scope discussions to see if this method would fit
your needs
• For those not quite ready • Schedule early engagement calls to provide guidance on similar projects
• For those in the midst of a process re-engineering • Refine your approach with guidance calls to review your approach and
evaluate if BioPharm’s methods might be useful to your organization
What this means for you?
PREVIOUS NEXT
• Helms, M. M., Nixon, J. (2010). Exploring SWOT analysis – where are we now?: A review of academic research from the last decade. Journal of Strategy and Management, 3(3) pp.215 – 251
• Costello, T. (2012). RACI; Getting Projects “Unstuck”. IT Professional, 14(2), pp. 62-64
References
PREVIOUS NEXT
Questions & Answers / Contact Information
Rodney Lemery, MPH, PhD Vice President, Safety and Pharmacovigilance +1 650 292 5310 (U.S.) [email protected] Rod Roderick Vice President of Business Development +1 877 654 0033 (U.S.) [email protected] Rudolf Coetzee Director of Business Development, EMEA +44 (0) 1865 910200 (U.K.) [email protected] For more information about our offerings, you can reach any team member above or
email [email protected].