Lean RA

The Trouble with Dedicated Resources: Leveling the Workload

Adrian Fegan — Thu, 17 Jan 2019 21:36:24 +0000

Published by Adrian Fegan in Lean Laboratory, Lean QA, Lean R&D, Lean RA on January 17, 2019

Dedication of resources may seem like a good way to have “Subject Matter Experts” (SMEs) get through work quickly, but it gives rise to a costly productivity penalty. The antidote is to level the workload across the team (without compromising the important role of the SME!).

Within all areas of business it is common to find specific activities being assigned to dedicated people. Tasks of all types and frequency can be found with dedicated resources, e.g. daily tasks: ‘We have two people every day testing sterility’, or less frequent tasks: ‘I am in charge of reviewing all the incoming raw material data’.

In some cases the work is assigned to single people, e.g. ‘I do all the incoming raw material sampling and he reviews all the printed materials’, or to small groups of people, e.g. ‘My team does the testing for all the new products with X API’. Or, more generally, dedicating individuals to specific work streams as “Subject Matter Experts” (SMEs) is often used as a strategy to get work done efficiently, especially if tasks are seen as highly specialized.

At BSM, assessments have shown time and time again that work streams in QC and R&D labs, QA groups, and Regulatory Affairs (RA) groups, rarely have a steady enough flow of work to be suitable for the use of dedicated resources. However, despite this day-to-day or weekly workload volatility, for several reasons (such as the “SME argument”), we find dedicated resources, and the ensuing symptoms of backlogs, stress, and a costly productivity penalty.

The graph is an example of product testing workload for three dedicated QC testing groups in an R&D lab. Each group had a fixed resource, and was dedicated to specific products. The aim had been for the products to be divided between groups, so that each group could specialize, and also have about the same workload, to match their resources.

However, what seemed like an even distribution of work over the long term, proved to be very volatile in the shorter interval (daily and weekly). For example, the weekly number of test runs for one group varies between 4 and 33 (excluding weeks with holidays).

Bucketing the workload into specific teams caused the members of each team to have a volatile workload and hence increased stress in the work environment: when one team had very little testing to do (a cause of stress in its own right!), another team was working late evenings and weekends to meet deadlines.

But when the combined workload for the whole lab is considered the variation is significantly less: between 35 and 76. This can be seen visually in the graph above. So clearly the lab would get the benefits of repeatability and predictability that would come with levelling the workload across the groups.

As part of a Lean lab, Lean QA or Lean RA project we help develop tools and put in place mechanisms which allow for the easy redistribution of work among team members. This is not to suggest that there is not a place in organizations for SMEs. It is still possible to level workloads, and respect the need for having specialists deal with certain tasks. In fact, most Real Lean implementations free up the time of specialists to do their specialized work!

The role of SME is very important; however, it’s worth noting that it can become the case that SMEs become experts in a particular test or work stream at the expense of other people being trained in these skills. Leveling the workload also requires (& encourages) more cross training within teams. This in turn can lead to personal development opportunities for people and a great satisfaction in the work place as people become able to work on new things. Another benefit of distribution of work is that it can encourage greater communication between previously isolated people and resources. This leads to greater knowledge sharing and the opportunity for other improvements when tasks are being undertaken by a ‘fresh set of eyes’.

While it feels comfortable to have tasks assigned to specific people or groups there is a significant productivity penalty to the business, coupled with higher stress for the employees. This loss can be recovered by leveling the work load and distributing the work among the team, leading to a more predictable work environment for everyone.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.

Labelling Updates in Regulatory Affairs: Is product specific dedication of resources a good idea?

Gary Ryan — Wed, 11 Apr 2018 16:20:24 +0000

Published by Gary Ryan in Lean RA on April 11, 2018

Managing changes to the content and format of product labelling is a key function within any Regulatory Affairs Organisation. Such functions are typically structured by therapeutic area, where each provides support for a reasonably small group of specific products.

This may sound like a good idea as it provides each therapeutic area with a fixed point of contact and the opportunity to work with people who have some knowledge of the labelling content and previous updates for specific compounds. However, organising in this manner carries a significant cost.

Figure 1. The impact of dedicated groups with volatile workloads

The graphs show the number of updates which each of the dedicated groups must manage on a weekly basis. The coefficient of variance (CoV – a normalized measure of volatility) for each is 0.5. If lead-times are to be maintained these groups would individually need to manage up to 12 updates per week (a total of 36 for the three groups). This could be achieved by either over-resourcing each group to the maximum capacity or by over-burdening people in busy weeks requiring them to work overtime.

If we look at the alternative where the three have been combined into one group the CoV has been dramatically reduced to just 0.1, and the peak number of updates has dropped to 24 (a 33% reduction).

We have observed that in managing labelling updates, process knowledge (being able to navigate the different types of updates and the various IT systems involved) is much more critical than any knowledge relating to specific compounds. Organising resources based on process allows us to operate in the manner outlined on the right of Figure 1, where different work-streams have been combined.

Lean tools for Regulatory Affairs

In order to enable us to implement this approach to “Lean Labelling” a number of tools / lean practices must first be put in place.

Structured queuing

All projects are entered in a centralised tracker, their work content estimated, and each placed in a queue according to order of priority.

Level loading

On a daily / weekly basis individuals in the group are assigned a fixed amount of work according to the level demand.

Flexible outsourcing

Despite our best efforts spikes in regulatory workload may still be inevitable and having a flexible outsourcing partner to act as a release valve during the busy periods is an important additional levelling tool.

Standard work

A standard and repeatable set of activities is documented for each task.

Performance management

KPIs for process and people are developed which allow for proactive identification and resolution of issues / opportunities for continuous improvement.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.

Lean in Regulatory Operations

Alan Maloney — Thu, 25 Jul 2013 15:10:12 +0000

Published by Alan Maloney in Lean RA on July 25, 2013

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;

Unanticipated moving of submission dates
Unlevel loading of new product launches
Rework (caused by lack of built in quality)
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:

Visualize the workload using queues.
Move to a “task experts” model (as opposed to a “product expert” model).
Level-load through workload sharing.
Isolate routine tasks and introduce Flow.
Utilize flexible capacity (outsourcing).
Hold frequent workload management meetings or “huddles”.
Implement Data Collection As Standard (DCAS) and design appropriate metrics.
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.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.