Lean in Regulatory Operations

BSM have been pioneering applied research into the utilization of Real Lean methodologies to solve problems and generate efficiencies in Regulatory Affairs Operations (Reg Ops) in large life science companies. Operations from a Regulatory perspective encompasses the standard activities that accompany the filing of Regulatory submissions such as Labelling, Publishing, Production, Archiving etc. “Real Lean” is the term used to describe BSM’s approach to implementing Lean in a wide variety of industrial settings. We use this term to distinguish our approach from generic Lean implementations which primarily focus on elimination of the seven wastes. “Real Lean” has at its core a commitment to incorporate the key principles of Levelling, Flow and Standard Work as a basic operating system.

BSM have demonstrated that the concepts of “Real Lean” are equally applicable and effective in Regulatory Affairs Operations and have developed a skill set capable of transforming Reg Ops groups into highly efficient, high quality, highly compliant and low cost operators.

Key challenges for Regulatory Operations

A. Process Harmonisation

Many large multinational life science companies have evolved as a result of multiple mergers and takeovers of smaller organizations. When a small company is assimilated into a larger organization, the Regulatory Affairs (RA) department will often remain in situ as a satellite office retaining the support function for the products that the parent once produced. This coupled with poor harmonization of processes can result in the same basic activities/functions being executed very differently within the same company, a potential compliance issue.

B. Workload Volatility

The submission profile for any large life science multinational is likely to be inherently volatile. This volatility is present at a number of levels, each causing difficulties from an operational perspective.

The causes of the volatility can be both internal and external. Examples of external volatility sources are ad hoc requests and directives from Health Authorities which can have a considerable impact on the overall workload, particularly if they coincide with a period of intense activity on large applications. There is nothing that can be done to “level” external sources of volatility as they are outside the control of the company.

Measures can readily be taken to address the internal sources of workload volatility and significant improvements can be made provided you have the support of all process stakeholders. The main sources of internal volatility are;

1. Unanticipated moving of submission dates
2. Unlevel loading of new product launches
3. Rework (caused by lack of built in quality)
4. Personnel dedication

In our experience, most Reg Ops departments are significantly over-resourced in order to cope with the volatility in their process. We term this the Volatility Penalty, and unless specific measures to reduce the impact of volatility are taken, the company will be shouldering this considerable cost burden for a very long time. 

C. Lack of Flow

Delays and inefficiencies (lack of Flow) throughout the R&D value stream and in the submission building process accumulate and manifest at the end of the Regulatory value stream (i.e. Reg Ops). A constant flow of urgent submissions leads to significant Work-Life Balance issues for employees as stress levels increase proportionally with the urgency level.

D. Lack of Appropriate Metrics

Reg Ops managers will be able to tell you how many submissions they process per year, but they are unlikely to have accurate data on Cycle Time, Lead Time, Touch Time, Number of Defects, First Pass Acceptance Rate etc. This is largely a cultural issue as historically there has been much focus on Compliance and little focus on Operational Excellence. Data collection is seen as a burdensome activity and to many the value of collecting information routinely is not clear.

Countermeasures

We have discussed the many issues that a Lean Project Team is likely to encounter in the Regulatory environment. Key elements of BSM’s “Real Lean” solution to address these issues are:

1. Visualize the workload using queues.
2. Move to a “task experts” model (as opposed to a “product expert” model).
3. Level-load through workload sharing.
4. Isolate routine tasks and introduce Flow.
5. Utilize flexible capacity (outsourcing).
6. Hold frequent workload management meetings or “huddles”.
7. Implement Data Collection As Standard (DCAS) and design appropriate metrics.
8. Develop effective project management and project planning capabilities.

Benefits of Lean in Reg Ops

The potential benefits of a Lean Implementation in Regulatory Operations include;

• Productivity - Improvements of 400% have recently been achieved
• Quality - >2 fold reduction in quality defects achieved
• Compliance- Improved project management and workload visibility can reduce audit observations (e.g.  implementation of safety updates in labelling (See recent blog post written by Gary Ryan 'Labelling Updates in RA')
• Speed – Introducing Flow and reducing Waste reduces task cycle times.
• Work Life Balance Improvements
• Continuous Improvement Opportunities become apparent
• Provision of additional services- Freed up resources can be used to provide new services according to the business needs.

Over the past few years, BSM have proven that the benefits of a “Real Lean” transformation in the Regulatory Environment are truly astonishing. To our mind it is no longer a question of whether or not Lean theory applies to RA, this has been proven beyond reasonable doubt. The only question is when are you going to use Lean to revitalize and reenergize your Regulatory Affairs Operations groups and gain the competitive advantage that Lean performance brings?

Download the free white paper on Lean in Regulatory Operations.