Quality & QbD

Quality by Design (QbD) is an industry keyword these days – spoken equally with reverence and frustration by those trying to understand how to implement it. QbD is a system of tools that assures quality is built into the design throughout the process, rather than inspecting it in, testing it in, or bearing costly changes to get it right after the fact.

Guidance publications have provided descriptions of QbD tools that can be used to move from a traditional, empirical development approach to an enhanced QbD approach, but many companies are overwhelmed by a sense of complexity of doing so. While it is the discretion of each company to chose which approach they use, clearly the focus is on QbD – and the benefits of doing so are immense.

Benefits of QbD

“In the last 15 years, some companies in the automotive sector have moved from 5 digit outgoing PPM levels to double or single digits using QbD tools. It doesn’t happen overnight, but initial gains can be made quickly and they continue to gain momentum as usage matures,” Wilson states, based on her own experience as an International Quality Director.

“The QbD tools being recommended are the same tools that have been used in many industries in their Product Development Process (PDP). By embedding the QbD tools into their PDP framework, Gate Reviews and procedures, they have become standard practice throughout their organisations.”

QbD offers the possibility of some very attractive advantages in Pharmaceutical :

• Flexibility and Cost Savings – Exhibiting an enhanced knowledge of product performance over a range of material attributes, manufacturing options and process parameters yields an expanded design space. This enables continual improvement of the manufacturing process within that design space without further regulatory review, increasing quality and productivity without additional cost.

• Risk Management & Knowledge Management – Tools like FMEA define potential risks and assign risk priority numbers to focus attention on resolving highest risks and preventing design or process defects from occurring. Besides preventing possible failures, this builds a knowledge base for future similar products, allowing faster designs and better results.

• Defect Prevention – Control strategies including Real Time Release Testing ensure quality of in-process or final product based on real time data – preventing production defects before they occur, improving quality, minimizing waste and saving money.

• Re-engineering of Current Products – Knowing where to step back into the process allows usage of a selection of tools to quickly and easily improve the current design, and utilizing the knowledge base means they can be designed faster, with more certainty and with the potential of less regulatory testing.

Challenges of QbD Implementation

Unfortunately, many companies are unfamiliar with the QbD tools described, struggle to define how QbD fits with their current PDP, or are unsure how to implement QbD in a way that will satisfy their internal quality representatives and regulatory authorities.

QbD is a ‘system’ of tools that interlink and flow, progressively building on knowledge gained to produce the best design, process and control strategy to achieve the Quality Target Product Profile (QTPP) and performance intent. Therefore, training is essential for company’s multi-functional personnel so that the philosophy, usage and application are congruent and understood.

QbD fits best within a well-defined PDP. At a minimum, an organisation needs an established PDP that meets the following – or the PDP should also be revised or improved.
• A clearly defined, common and disciplined approach to design and deliver product – from concept through commercialization – that begins with customer and business objectives.
• A multi-functional approach that assures involvement at the right time on the right activities, and facilitates simultaneous tasks via concurrent engineering.
• Gate Reviews to assure the right deliverables and quality are met and agreed before exiting to the next stage.
• A process that is flexible and scalable, enabling the same effectiveness for re-engineered current product as for new products.
• A means of capturing knowledge for reuse in other similar projects – enabling speed, certainty and quality.

Finally, often, people just can’t “see” how QbD fits with the PDP. The guidance documents are descriptive, but not pictorial or visual.

Make QbD Visual and Integrated into Your PDP

“A lesson learned from other industries is that to be embraced effectively, QbD must be made easier to understand – that is, visual – in order to make the complex more manageable,” she states.

What is needed is an approach that clearly and simply communicates when to use QbD tools in the PDP, how tools interrelate and what happens next.

This requires:
1. A high level PDP, indicating key phases of work in a time progression across the top, and function or activity bands along the side specifying major activities to be completed in each stage. Second level definition specifies tasks required per activity, and a third level defines the procedure of how to do each task.
2. Understanding of the QbD tools and their linkages from concept through commercialization
3. Defining and visualizing where QbD tools are used within the phases of the PDP
4. Defining the Standard Work, Standard Management & Visual Management to sustain the permanent culture change you desire.

Understanding the QbD tools and linkages are shown in Figure 1: The Requirements Flow-down Matrix (RFM). The RFM depicts how development tools flow through a PDP. Elements of QbD are integrated into each phase of the RFM. Tools are executed left to right using rolling wave planning. However, timing planning and analysis occur from right to left to verify the integration and linkages.

An example of placing the QbD tools within a PDP is shown in Figure 2: QbD in PDP. Every company has their own PDP with their own defined phases. This is a high level view of how it might be organized.

Benefits are Worth the Effort

QbD is not simple. But implementing it, understanding it and making it part of your normal operating process does become easier and faster if you make QbD visual and embed it within a clearly defined and structured PDP.

While integrating QbD into your PDP initially takes time to develop and implement, and evolves in effectiveness as used, the benefits are immense and quickly apparent. Within a short time, it transforms your way of doing business, and after the metamorphosis, no one in the organization could imagine doing business any other way.

Cindi Wilson is Director of Quality Transformation, Supply Development & Customer Satisfaction at Total Flow Limited. Her career has included being an International Director of Quality and Customer Satisfaction within the automotive industry, and Vice President Global Supplier Quality within consumer electronics.

Taking the UK as a ‘below average’ performer there is some simple maths to emphasise the task:

• 26million existing homes (99.9% leaking heat and wasting energy)
• A shortage of 2million homes
• Current build rate of <100thousand per year.
• Maximum ever U.K. build rate of 400k in 1948
• Design life of 200 years (optimistic).
• So just to get housing stability we need to:
• Replace 26,000,000/200 = 130,000 homes per year
• End the shortage, 10yrs  = 200,000 homes per year
• Assuming all these are built to high standard (not the minimum building regulations private developers create today) there will be:
• 7.2M Energy efficient homes in the UK by 2050
• To meet the CO2 reduction agenda by 2050 we need to either:
• Refurbish the balance: 21.8M in 40yrs = 550,000/ yr.

Dilapidated house

(A real challenge from a standing start).

Or

Knock down and build new: 730,000/yr on average over 40yrs.

This is nearly double what we have ever built before.

The answer will be some combination of the two and the key challenge is to make both refurbishment and new-build more affordable.