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.

Quality through the decades has been an adventurous evolution for those who’ve lived through it … not for the faint of heart, the action adverse or those afraid of culture and business change.  These changes have affected what we expect, what we buy, and even what we tell our friends, family and extended social networks.

Today’s global economy and technology explosion create even more challenges to be addressed: increased expectations, increasingly complex products, shorter timescales, while making the consequences of failure much more severe.  In addition, there are new challenges : labor/social laws, green/environmental sustainability, banned substance and counterfeit vigilance and reputations that can change in minutes due to Internet viral communication.

Let’s take a quick journey at the changes in Quality over the pivotal decades of the 1980’s to 2010:

(Note:  While some industries and some geographic locations were more advanced during this time, the following represents the journey of most industrial manufacturing segments outside of Japan.  Foundations of Lean and Six Sigma have been part of the Toyota Production System since the 1950’s.)

1980’s

“World Class Manufacturing” was the 1980’s keyword, and companies were attending workshops on the Toyota Production System (TPS) and Total Quality Management (TQM).  Just-in-time, waste reduction and process mapping had just begun.

While Deming’s SPC tools and Points for Management had been around since the 1950’s, they had largely been ignored.  However, with the success of his work in Japan and his book “Out of the Crisis” in 1982, companies were trying to implement Quality Circles, control charts and SPC.  Internal First Time Quality levels (FTQ) were either not measured or poorly measured, and external quality measures were usually 4 digits or more in Parts Per Million (PPM) or DPMO – (although normally measured in percent, as PPM was just too mind-boggling).  While Six Sigma was being initiated in Motorola, it would be another decade before it became a culture-changing tool in most other companies.

Manufacturing plants weren’t very good at knowing the real quality levels they were receiving from their suppliers, and long-term contracts made them slow to demand improvement and slower to remove business.

Consumer product quality was unreliable.  Frustrated consumers didn’t expect their products to last much beyond the warranty period, and producers weren’t very responsive in resolving problems even during the warranty period.  However, Consumer reporting agencies were beginning to compare and print failure rates, complaints and customer satisfaction … awakening consumer awareness and influencing purchase decisions.

1990’s

In the 1990’s, the keyword changed to “Lean Manufacturing”, with the introduction of Tom Womack’s book “The Machine That Changed the World.”  Likewise, Jack Welch brought Six Sigma into GE in 1995, and into mainstream thinking.

While new concepts were being implemented, change takes time – especially culture change – and real performance changed gradually.  External quality measures were usually still in 3 digit PPM, but companies were beginning to make the mental change from percent to PPM.

Manufacturing plants increased expectations for their suppliers, but their tolerance was still long, often giving a troublesome supplier a year or more to turn around results.  Consumer expectations were increasing and producers were beginning to feel the pressure of consumer report comparisons.

2000’s

In the 2000’s, Six Sigma was common terminology, enhanced by Jack Welch’s book “Jack: Straight from the Gut” in 2001.  Now companies struggled with a new dilemma – deciding whether to implement Lean or Six Sigma – mistaking them as mutually exclusive concepts.  By 2004, Mike George coined the term “Lean Six Sigma”, integrating the two tools.

In addition, Design for Six Sigma (DFSS) and Robust Engineering were being introduced as techniques to optimize the design during development, rather than improving after production.  Indeed, with the fast evolution of new electronics features, the first run might be the only run before the product changed again – and profitability could depend completely on initial quality with no possibility of later improvement.

Inspired companies were now producing in 2 digit or single digit PPM, with a growing focus on Cpk as a measure of process capability to prevent defects from occurring, and dedicated programs to move distributions from 1.33 (4 sigma) to 1.67 (5 sigma) to 2.0 (6 sigma).

Manufacturing plant tolerance of poor supplier quality had significantly decreased; with 6 month or 3 month improvement horizons before financial penalties or business re-sourcing were initiated.  In addition, annual price reductions and global outsourcing became the norm.

Consumers had enhanced expectations of their products working well beyond the legal warranty period, and companies who offered free extended warranties enjoyed a marketing advantage over their competition.

Global service and customer satisfaction and environmental awareness were also expanding.  In 2000, ISO-9001 Quality Management System was revised to include customer satisfaction elements for both manufacturing and service industries, and became a universally accepted quality system certification.  Likewise, ISO-14001 was revised in 2004 to further define the standards of an Environment Management System to operate in an environmentally sustainable manner.

So Where does that Leave us Today?

We’ve come a long way … and hopefully you’ve kept pace with the changes.  However, in today’s competitive environment, it isn’t enough to just keep pace – you need to be remarkable:

• Manufactured quality needs to be at or near Six Sigma levels in order to remain cost competitive in a global economy.
• Lean principles should already be well implemented – because they not only reduce throughput time and eliminate waste – they also facilitate quality improvement and allow abnormal conditions to be easily detected.
• Not only do consumers expect perfect quality out of the box, they also expect it to last.  Extended warranties are assumed.  Design for Six Sigma and Robust Engineering applied at the development phase are critical to assuring the product will endure the stresses of use – under more and more varied conditions.
• Product users also want faster response and better service when there are issues, and on-line help and manuals.  Moreover, if they don’t get it, they are prepared to tell not just 10 friends, but also the entire world.
• Consumers also expect that even though products have more features, options and complexity, they should be user friendly and nearly intuitive in use.  In addition, Consumers expect that products can be modified or upgraded to new software versions or product generations.  Flexible, adaptable, expandable and serviceable are key words – as well as “common” for mating part interfaces.
• Extended supply chains cross continental borders.  As product complexity and cost pressures increase, product design, software creation, assembly tooling, test equipment and manufacturing may all occur in separate locations.  Program Management has never been so critical. Clear and agreed expectations, program milestones and performance requirements, and communication format and frequency are essential – as well as what will happen when they aren’t met.  Companies are responsible not just for Quality and durability, but also vigilance to:

–  Social and labor laws,
–  Environmental and recycling requirements,
–  No usage of banned substances, or counterfeit parts or materials, and
–  No infringement of intellectual property.

Any violation will be costly – in both damaged reputation and financial penalties.

The world is moving fast.  If you are left behind, it gets harder to catch up, is more costly to produce and leads to eventual loss of market as your competitors run faster.  If you aren’t where you want to be today … give us a call … we’ll get you back on the road.

For some it is a lands end to John O’ Groats bike marathon, to thers it meand looking at products from manufacture through to reatailer / point of sale.

True “end to end” for manufacturing companies is in my view much more than this. It has the same marathon elements mentioned above and means “getting visibility into supply, manufacture, distribution, retail and consumption”.

This is a  marathon in every way, and where do you start ? IFfyou start conventionally at supply and work through to consumption how can we judge what degree of flexibility is needed in manufacturing or material supply network ? So where do we start ?

Start with the customer! Lets do things correctly and work “right to left ”

With this approach true demand is seen and we can stop guessing. Does inventory profiling work ?and is what we call “supply chain management” just a way of managing warehouses ? When inventory and stock movements are analysed what do we see ? A mass of numbers with everyone using inventory to mask poor forecasting, inflexible operations, ineffective warehouse operations, logistics and retail aisle management.

Mapping right to left and analysing data properly gives us true damand. The output from this can be used to inform the organisation on how much inventory is needed and how an effective supply chain can be built. Moving upstream this informs on flexibility required in manufacturing together with how incoming material must be managed. Visibility an Pull are what is required, do you have them ?

I hav erecently done some work with a food manufacturer with hunderds of different products distributed to thousands of retail outlets. The picture was confused and chaotic  – until the process was mapped right to left and data through the supply chain was analysed. Then came the surprise ! The data does inform us on how many stock pockets are needed and where they should be, it also informs how frequently each product needs to be manufactured and in what quantities.

This gives us a true “end to end view” and align manufacturing to distribution and retail. Is it simpel ? No but it is possible and I recommend you take a look – now. The improvemnt possibilities are considerable, decreased stock, increased flexibility and customer satisfaction and of course profit !