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.

Factors like market saturation, ageing and static populations, threat of low cost competition from emerging economies etc. are not completely new and their march has continued for the past several years. However, the crisis has brutally demolished any hopes of a gradual change and time to adjust to the new landscape.

Consumer and Govt spending is likely to remain under pressure for the foreseeable future and therefore demand for better value will be widespread and remain intense.

This situation can easily be seen to be mainly negative /threatening, but while undoubtedly painful for many consumers /businesses, it also presents opportunities for the innovative and the courageous. In Schumpeter’s words, today we see the perfect time for creative destruction / reconstruction in several industries.

In this series of short blogs, I will share some generic and a few industry specific thoughts on opportunities for creating profitable disruptive change.

There are many strong indicators pointing to an inconvenient truth – in many developed economies, waste or overconsumption in food and drink sectors is widespread. However, few established players, brand owners or retailers, seem to be willing to face up to the implications of dramatic reduction in volumes.

1. Between 30-50% of fresh / chilled food gets wasted in the UK. There are several factors, but a key one is offers like Buy One Get One Free.

2. The steadily increasing % of population that is overweight / obese in Europe and US.

3. An estimate from the recent Parliamentary committee report showed that the total alcohol sales in UK are 40% higher than the volume that can be consumed if all adults consumed the maximum weekly guideline quantities every week. This is not unique to UK and applies to several EU countries though the % varies.

4. Bottled water sales in W Europe have declined dramatically as consumers become aware of environmental consequences of packaging and transport involved in the sector (especially when compared to tap water).

So some of these sectors could see a significant portion of demand disappear for ever driven by stricter regulatory controls on promotions or shift in consumer attitudes. These challenges are as relevant for brand owners as they are for retailers.

I firmly believe that the implications are wide ranging, and product, pricing, promotions, supply chain all will be affected. Environmental and socio-economic implications of such waste / overconsumption are significant and the impact is not confined to corporate P&Ls.

The responses so far from both brand owners and retailers have largely been tentative. Brand owners have streamlined brand portfolios, e.g. Unilever selling many tail brands. Retailers have used Category Management to rationalise SKUs / offer more manageable choice on shelf.

But don’t you think the real opportunity lies in thinking more radically, e.g. ways of redesigning the entire value chain consumer back to fit in with the context today / in future rather than just tinkering with the models that evolved mainly during the 60s/70s/80s?

I believe it is possible to create a much better solution by applying fundamental principles of Lean thinking in combination with new technology and collaboarative networks of the key participants – consumers, retailers, brand owners and their suppliers.

Quite possibly, the spoils / benefits won’t be shared in the same way in the new system as they are today and therefore this requires the courage to free oneself from the vested interests and orthodoxy that naturally build up in industries and organisations.

Fortunately, responsible marketing is beginning to gather momentum. Different brands and businesses are correctly identifying aspects of responsibility most relevant to them and trying to do the right thing, e.g. Coke with water conservation, Unilever with Palm Oil, WalMart with carbon emissions etc.

What could we achieve if the envelope could be pushed much further to tackle the deep rooted challenges head on?