As companies serving the pharmaceutical industry look at the lessons of Lean Six Sigma methodology, contract testing laboratories providing biopharmaceutical analysis prove to be an early beneficiary.
For more than 20 years, Lean Six Sigma has been used for optimising and accelerating business processes in many different industries. A few years ago, the pharmaceutical sector took an interest and several large pharmaceutical companies implemented this methodology into their corporate culture (1).
The Lean principle involves the thorough investigation of processes to identify non-value steps and sources of waste. Meantime, the Six Sigma approach involves the use of data analysis and statistics for evaluating the robustness and efficiency of processes, with the objective to make the process more focused, less variable and less errorprone (see Figure 1). Combining Lean with Six Sigma there is an optimal toolbox for choosing the right performance-improving tool for any approach (2).
Lean Six Sigma for the Biotech Industry
Generally, Lean Six Sigma can be applied for various branches within many different industries. For the biotech industry, special benefits can be drawn from:
- Using tools for a thorough root cause analysis Ė since biopharmaceuticals are much more susceptible to contaminations, variations and assay failures than their chemical counterparts, this might be of special benefit
- Identifying critical factors of assay processes in order to avoid costly and time-consuming repeats of failed assays
- Using design of experiment (DoE) tools to effectively set factorial parameters during assay optimisation
- Using process capability analysis in order to understand the limits and variation of an assay process
- Using risk assessment tools that help to focus on the critical steps within a process and avoid sophisticated solutions
Identifying the Right Project
Project identification is an important step which should be thoroughly evaluated by management. The procedure for selecting a project should take into account the benefits and constraints of a potential project. In general, a project should be tied to the strategic goals of a company; the benefits for the customers as well as the estimated amount of hard and soft savings should be evaluated. How easy or difficult the implementation of a project might be should also be assessed, as well as factors such as supportiveness of leadership and availability of sufficient data and resources. All of these factors may be considered in a decision matrix approved by management in order to make sure that the right and most promising projects are identified.
Maximising Customerís Value
One basic strategy of the Lean/Six Sigma methodology is to listen to the voice of the customer. At the beginning of each project a thorough analysis of the customerís requirements should be performed in order to obtain a deep understanding of the exact needs.
Service providers should have a continuous focus on the customerís requirements and Lean Six Sigma provides support for improving this activity by analysing it from different perspectives. It is important that all departments involved in a service process contribute to this discussion. In terms of biopharmaceutical analysis services, input should come from the scientists, the quality assurance management representative, sales and client services in order to address all aspects which are critical to customer satisfaction. A common tool used in this phase of analysis is a CT tree, where the detail of level breakdown depends on the complexity of the product or service in focus (see Figure 2).
Lean Six Sigma in a Contract Testing Laboratory
A contract lab is a data-driven, process-oriented environment with a mathematical approach to testing, and therefore it is well suited for Lean Six Sigma applications. Methods applied in an analytical contract lab are often customised, especially if methods are applied on biopharmaceutical products. As a result, the general Lean approach to standardise is not always applicable for individual testing methods. Thus, it is a balancing act between standardising as many processes in the lab as possible, while maintaining enough fl exibility to meet the customerís special requirements.
Since Lean Six Sigma addresses a variety of processes, the focus is not only on the test methods themselves, but also on the general performance Ė either in the lab or in the general organisation and administration of the facility. Processes include reducing the hold time for samples until laboratory start, leaning the process of report writing by eliminating non-value steps in the review process and optimising waste management. These adjustments directly benefi t the business by either resulting in hard savings (such as the waste management project) or soft savings (for example, shortening cycle times and improving customer satisfaction).
In a contract laboratory, there are many different complex processes which intermesh and work in parallel. GMP and GLP regulation set distinct framework conditions regarding the performance. One of the pitfalls in developing the business is to overload systems with sophisticated solutions. Lean Six Sigma avoids this. The best solution for a Lean Six Sigma improvement is always simple, straightforward and easy to use. In this respect, Lean Six Sigma and GMP/ GLP go hand-in-hand, as both focus on quality as one of the main parameters for continuous and sustainable success.
One of the most important tools to manage the balance between increased regulatory demands and the need to be effi cient and effective is the use of risk assessments. Each evaluated process should be thoroughly investigated regarding its value for the company. Those processes that add value to the companyís business, by either fulfi lling corporate or regulatory requirements, should be made as effi cient as possible, while others could be minimised or even eliminated. Meanwhile, the risk assessment tool has become an important part of the regulatory guidelines (ICH Q9, Annex 20 EU Guidelines to Good Manufacturing Practice) (3).
Outsourcing to a Lean Six Sigma Partner
For a contract laboratory, the Lean Six Sigma tools can also be applied to client-specifi c projects, for example during setup and optimisation of new analytical methods for specifi c customer requirements. Applying Lean Six Sigma tools during method set-up may help identify critical factors of a process and design of experiments (DoE) can effectively investigate the optimal settings for those factors. Process limits and capabilities may also be examined, along with the variation of the method. The outcome of an investigation such as this is a very well-defi ned method that is fully understood and ready for validation or method transfer to the client.
A contract laboratory active in the fi eld of biopharmaceutical analysis on occasions can be faced with a situation where a tried and tested method suddenly shows problems. This is far more common for analysis performed in biopharmaceuticals than it is for work performed on chemicals. Lean Six Sigma tools can help to quickly addresses problems via root cause analysis. It has been proven effective to involve the study director, the lab team as well as the client in this kind of analysis, in order to get the complete picture and to brainstorm problems from the different points of view.
Lean Six Sigma has been proven to be an effective and helpful tool for a contract lab providing biopharmaceutical analysis. The Lean Six Sigma principle may be applied on general processes of the business as well as for specifi c method setup and optimisation. It also provides effective tools for root-cause analysis in situations where issues with long standing methods should arise. As an increasing number of large pharmaceutical companies have implemented Lean Six Sigma to improve their business, it is benefi cial for them to collaborate with an outsourcing partner that has experience of successfully installing a Lean Six Sigma corporate culture. Speaking the same language and using the same tools for process optimisation and evaluation helps to signifi cantly accelerate common projects.
- Pharmaceutical Technologyís QPEC Quality and Process Excellence Conference, VA, USA, July 2008
- Breyfogle FW III: Implementing Six Sigma: Smarter Solutions Using Statistical Methods, John Wiley & Sons, Inc
- Quality Risk Management, ICH Q9; EU GMP Guide, Annex 20