Operational Excellence & Quality

Operational Excellence

Operational excellence in a corporate culture enhances the way an organization provides patients with products and services. Operational excellence requires a strong commitment and a culture of continuous improvement to solve current delivery problems such as cost and efficiency.

Operational excellence is a philosophy of leadership, teamwork and problem solving that results in continuous improvement throughout the organization by focusing on the needs of the patient, empowering employees, and streamlining existing activities in the process.

Continuous improvement applies not only to improving the quality of human resources, but also to improving processes and standards. Improvement starts by setting and correctly measuring the key process indicators (KPI), using the right documentation, controlling results, and defining preventive and corrective actions. That’s the way to achieve continuous improvement in a company's performance.

Implementation of operational excellence and continuous improvement processes will lead to reduced waste and operational costs, shortened cycle time and reduced cost of the product/service.

Over the years Tefen accompanied dozens of companies in implementing processes of continuous improvement and operational excellence with professional multidisciplinary teams and a shared commitment to improve business results.

Organization Design

The trend for changing organizational culture and design to improve customer focus and effectiveness of the value chain is still on-going across the Life Sciences industry. Meanwhile, organizations are still trying to figure out how to create this desired “Lean” culture across their sites and determine which organization design would suit their needs best. At Tefen, the notion of organizational structure and culture are two of the most important pillars of our business excellence solutions, along with operational improvement, transformation capability and strategy of operations for the Life Sciences industry.

Our Approach

With help from the deep and broad knowledge of our industry experts and close partner engagements, we provide our clients with a fresh perspective as well as both hard and soft benchmark data from more than 80 Life Sciences sites worldwide. Using our proven diagnostic methodologies and best practice data we not only aid our clients with understanding the attributes of different structures and finding the best one for them, but also run focused projects to implement cultural and organizational change and drive tangible performance improvements straight from the shop floor.

PCO – Process-Centric Organization

One of Tefen’s most common recommendations for Life Sciences sites is the implementation of a PCO – Process-Centric Organization. Our industry experience shows that a traditional functional organization is a root cause of poor on-time delivery, confusion and low morale.  A PCO is split along the value streams (by product or product group) with value stream leaders being accountable for end-to-end delivery to the customer and with access (where possible through line reporting) to all resources required to achieve the delivery. At the same time, activities detached from day-to-day activities sit in functional centers of excellence (such as Finance, Procurement and others).

Expected Benefits

A PCO structure allows the site benefit from the following: 1) streamlined processes eliminating duplication and waste; 2) organizational alignment with the customer, enabling consistent on-time delivery; 3) empowered employees making decisions at the closest level to the actual operation, resulting in quicker problem solving; and, finally 4) improved flexibility thanks to value stream leaders owning end-to-end resources, ensuring they meet ever changing customer needs. Therefore, a Process-Centric Organization serves customers better, adds more value, increases employee satisfaction, and reduces costs.

Manufacturing Effectiveness

Manufacturing effectiveness is of significant importance in the Life Sciences sector because it fundamentally dictates both quality and delivery performance. The term embodies a vast scope of methodologies, which are primarily designed to streamline processes that add value to the customer and remove processes that lack customer value. The importance of this subject matter is heighted as internal drivers and competition increase the pressure for improved performance. Subsequently, industry-wide, manufacturing effectiveness is always a subject for improvement.

Our Approach

The advancement of manufacturing effectiveness requires a comprehensive understanding of the current state performance, as well as a tangible vehicle to deliver the needed change. High performance requires the removal of complexities and the clarification of  root causes of issues and the subsequent design of focused change solutions. Specificity is what facilitates perpetual manufacturing effectiveness, because the most significant process inhibitors are not always apparent. These inhibitors may be the subject for improvement for immediate benefit.  

Methodologies

Given our depth of experience in this field, Tefen has established a proven success record in providing services such as:

  • Lean Six Sigma – a philosophy which amalgamates principles from Lean and 6 Sigma, drawing on the notion of reducing waste and variability to reduce the time between customer order and shipment (cycle time). Change sought at the global or local levels leads to a competitive advantage. This initiative is delivered using tools such as:
    • KANBAN – inventory control using visual records.
    • KAIZEN – Continuous improvement through incremental change.
    • SMED – techniques to reduce tool setup and change over down-time. 
    • POKA YOKE – practices to detect or remove defect occurrences.
  • OEE (Overall Equipment Effectiveness) - a methodology to drive equipment performance improvement and build data capture and reporting systems that are integrated within a company's management routines to ensure a decrease in losses from breakdowns and support sustainable improvement initiatives.
  • TPM (Total Productive Maintenance) – methodology in which maintenance is executed in-line with production where continuous tool upkeep prevents tool deterioration, eliminating unscheduled downtime.

Benefits

Alongside decades of experience within the Life Science sector, our Tefen experts may draw upon a bank of additional methodologies to advise clients on how to gain increased customer value, greater flexibility for growth, cost reduction or better operational reliability.

At the same time, Tefen recognizes that at its pinnacle, manufacturing effectiveness ought to be a self- driven mechanism, where improvement may be recognized and leveraged at any level within an enterprise. When change for self-improvement is instigated both at a physical and cultural level, true manufacturing effectiveness is achieved.  Our methodologies facilitate this end by implementing a paradigm shift so that all available resources are aligned to deliver a manufacturing excellence focused on adding sustained customer value. 

Quality Control

A common hurdle in the Life Sciences industry is the optimization of laboratory processes. One misconception is that it is impossible to gain the same benefits from applying Lean approaches in lab environments as in manufacturing environments. QC departments in labs are often perceived as having numerous steps along their value streams and acting like a brake; whereas in manufacturing QC is seen as the accelerator. This QC perception in labs makes it difficult to achieve the balance between reducing lead-times and boosting reliability and product quality.

Quality Control is certainly vital in any Life-Sciences company in order to ensure that raw materials are suitable for use and the end product meets the highest quality standards required. QC typically is involved throughout the entire product life-cycle development process and focuses on testing products and materials to deliver results in the most efficient way in terms of cost and speed.

Our Approach

Our diagnostic benchmarking includes assessing a site’s priorities, practices and performance and allows for customized recommendations for the specific objectives and constraints of each company. In addition, Tefen has gathered detailed benchmark data from practices and performances in more than 60 labs (pharmaceuticals, biotech, biopharma, and more). The data covers 120 metrics that help drive performance improvements. This type of experience and data can be a valuable tool, not only in short-circuiting errors made by others, but also in building a viable, compelling and less risky case for change.

Tefen’s Lean quality programs utilize elements of Lean and Six Sigma to streamline processes within labs, e.g., resource planning and scheduling, layout design, and others. We help QC operations synchronize their organizations and operations with production; pull product right through the entire value chain; minimize setup times and process queues; eliminate waste through streamlined processes; and change layout. We also design organizational structures to encourage continuous improvement by developing standard management routines, clear accountability for improvement, visible leadership on the lab floor, and clear KPIs, etc.

All in all, the main objective is to optimize “flow” and “pull” to suit the needs of the organization by eliminating delays caused by bottlenecks, and to respond immediately to triggers from the subsequent process in order to produce results only when needed.

Expected Benefits

There are numerous benefits of Lean labs, such as improved productivity with reduced costs and lead times; minimized rework and unnecessary tests; a culture of continuous improvement to sustain business benefits and many others. All of these directly impact the bottom line and advance the joint efforts in quality, productivity, and effectiveness.

Quality Assurance

Strict regulatory requirements and the challenges of staying competitive in a fast-changing environment are not only raising the demands on sales, production and administrative functions, but also on Quality Assurance departments. QA teams are now expected to maintain control of quality, costs, reliability and speed, while also complying with regulations. In order to achieve this, Quality Assurance must become a proactive process that ensures product manufacturers adhere to specific standards and strive for continuous improvement and the elimination of errors. The goal is to create products that are “fit for purpose” and “right first time" through prompt and effective operational performance while still observing all statutory requirements.

In fact, many in the industry struggle with this challenge, because support functions, such as Quality Assurance, are increasingly tied up with administrative activities, which reduces the time spent on the shop floor to prevent issues and directly add value to the end customer. However, this trend also provides us with opportunities for optimizing and better organizing QA activities.

Perception of QA Excellence

Quality is now frequently included in Operational Excellence transformations. To ensure the sustainability of QA success, optimization of process reliability and efficiency is required. We advise our clients to acknowledge the need to streamline their operations to improve flow and operational speed, while minimizing unnecessary tasks that waste time and resources.

Organizations should structure themselves around key processes that add value to patients and users. Tefen’s methodology and experience of QA process optimization can create a quality culture across a Life Science organization and help overcome challenges. Tefen can show how Lean practices should be applied in an organization’s structure and introduce processes to encourage continuous improvement.

Our Approach

Tefen's holistic approach starts with a diagnostic benchmarking stage that assesses three key factors: a site’s strategic priorities, performance and practices. The results allow us to formulate customized recommendations for a company's specific objectives and constraints and give valuable insight into what other organizations with the same issues have done to improve their areas of low performance.

1 - Strategic Priorities

Before any structural changes are made, it is crucial to specify the priorities of each site. Conducting specially designed interviews gives us an understanding of the drivers, constraints and overall site philosophy, with its principles and trade-offs. This then enables us to define high-level targets for cost, quality and delivery metrics. Once site priorities have been set, a process/function matrix is used to prioritize the key business processes within the scope. Processes are then prioritized according to their impact on quality and drivers, such as workload per department, cost, lead-time, customer value, etc.


2 - Current State: Performance and Practices

An analysis of current practices at the site and their impact on performance is the foundation for any change and is crucial to the success of the program. Workshops are used to identify the process steps, inputs and outputs, and to clarify accountabilities. These processes are mapped, with the most critical QA processes as the focus. Customers, inputs, outputs, and suppliers are specified for each of the processes and subsequently, each of the process steps are categorized as either value adding, non-value adding or required for sustainable business. The aim of all this is to establish the impact of practices on quality and to quantify performance in terms of lead-time, FTEs or other costs. This allows for benchmarking performance levels with other sites in the industry. At this stage it is essential to invest time on site to uncover root causes and agree on action plans with the teams.

3 - Future State

For an organization to be successful it should have a clear vision designed to maximize customer value. At this stage, each of the mapped processes is analyzed, in close cooperation with the teams performing these activities. This analysis is used to determine the optimum measures for process streamlining and the removal of any waste and NVA activities.

Benchmarks and best practices are brought in, assessed and incorporated to improve QA activities. Once the processes have been streamlined, a structure can be designed to enhance their output. Roles, responsibilities, accountability and interfaces are redesigned while taking into account existing knowledge and skill levels. A training plan is designed to enable a speedy and effective transition. When the projected benefits of the improved processes have been quantified, new performance targets are set and KPIs are introduced to monitor and promote the effectiveness and reliability of each process.

4 - Implementation Roadmap

A roadmap will be designed to translate all these recommendations into a tangible and explicit work plan to enable a complete, timely and successful implementation. This includes detailed work streams, responsibilities, timescales, and resource requirements. The roadmap should clearly illustrate the exact route to be followed by the organization, in order to achieve the desired future state. It is imperative that the quality leadership and management teams agree and sign off on the roadmap to guarantee a successful implementation phase.

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