Juhani Anttila
Venture Knowledgist Quality Integration
Helsinki, Finland




Considering quality in product development it should be based on a modern Quality Management (QM) philosophy and practices. Essential issues are to understand the principles, have effective tools and innovative organizational management environments. QM is always a company-dedicated implementation. Product development has highest impact on product quality and customer satisfaction. Quality issues of product development should be originated from the business management decisions and practices.

Quality in product development as a part of company's QM approach

There is a broad variety of diffrerent responsibilities and activities needed for creating appropriate new products to the market-place covering:
- Discovery and intention
- Orientation and substantiation
- Product development
- Engineering and production

Scientific and societal research are foundations for the product development. That makes possible that product development should concentrate effectively in its task and not to extend to the research area.

Prerequisites for a successful and comprehensive quality approach establishing a profound domain of action consist of:
- Guiding ideas
- Theory, methods, and tools
- Innovations in leadership infrastructure

The leading world-wide recognized quality related management approach today is called Quality Management (QM), which is aiming at business performance excellence and emphasizing leadership and all stakeholders' satisfaction. Acording to ISO 9000 standard QM is defined as quality of management.

These general QM key issues should be applied in product development, too. Product development is the business area with the highest impact on product quality and the only area where one can influence up-to-date attributes - which means customer orientation. Especially specification phase of product development is crucial from quality (ie. customer satisfaction) point of view.

Major sources of management reference models for the world class quality (QM) are:
1. ISO 9000 family of standard for quality management and quality assurance,
2. Performance excellence models (quality award criteria)
3. Successful company references (benchmarks and best practices)
4. Great teachers (gurus) of quality management
In practice today all these have the same general principles and substance of contents.

QM is often seen as a distinct mangement doctrine. I addition to the the quality related approaches there are also a lot of other management doctrines and schools compeating with each other. Most well-known examples are:
- Activity Based Management
- Business Process Reengineering
- Time Based Management
- Organizational Learning
- Lean Management
- Time Based Management
- Knowledge Management
- Environmental Management.

In fact, all these different schools are based on the very similar basic principles of QM, particularly including customer focus, top management commitment, and process approach. Within an organization the above mentioned 'isms' may cause difficulties through collisions both on strategic level (CEO, president) and on operational level (business processes). To avoid this kind of development a company must always base its development on its own existing business management system and understand QM as quality of management. These different doctrines should only be considered as tools but never as requirements.

Professional QM approaches are based on generally recognized guiding principles. Good examples are the quality management principles of ISO 9000 standards. These principles could be applied also within product development.

Producer's business processes, included product development, may be extended by outsourcing. This means that quality aspects of product development may depend also on sub-contractors' capabilities

Complexity of product concept

General consideration of product development is difficult because there are many very different kinds of products including:
- Simple commodities
- Hardware products
- Software products
- Complicated system products
- Processed materials
- Pure services
- Services with goods (materials)

All products include intended elements and also unintended elements. All products also include services. In fact there never may be any product without service-elements. Therefore unintended elements and service elements should always taken into account in product development because they may have important effect on customer satisfaction.

For procuct development it is crucial to understand, what the product is. From conceptual point of view the standard definition (ISO 9000) of product is recommended. Product is defined as result of activities or processes. Product may include service, hardware, processes materials, software or combination thereof (ie. a system). Especially service means result generated by activities at the interface between the supplier and the customer and by supplier internal activities. Product is in fact the linking item between supplier and customer.

Product development discipline

Product development should cover the whole life cycle of the product including:
- Specification phase
- Development phase
- Manufacturing phase
- Operation phase
- Disposal phase

Configuration management is a specialized discipline and methodology to take into account necessary design related activities during the whole product life cycle.

Product performance (based on product characteristics) is one of the key issues in product development. All the products have numerous characteristics. All those characteriscics can be considered and grouped in a systematic way. Customer satisfaction (product quality) is originated in product caharacteristics. The most recognized methodology for product development to consider customer needs and expectations relating to customer satisfaction is developed by Prof. Noriaki Kano.

Essential issue for product development is to know how a buyer chooses a product. According to Dr. Rinne's negation principle:
1. Buyers like to choose a product without any risks. They do that on emotional basis. As a general, they don't use logical or systematic advantageousness comparisons.
2. They don't have any wide preference scale, e.g. considering and comparing 9 to 10 product characteristics.
3. One can recognize separately at most 10 caharacteristics.

A product to be chosen must not include any of the major negations recognized by the buyer, and it should have at least one clearly good feature.

The most advanced modern methodology for customer-oriented product development is QFD (Quality Function Deployment).

Products are developed, produced, delivered, and marketed through business processes. All those processes should be taken into consideration in product development, too. All companies have their own system for key business processes, support processes and management processes. However as a rule, product development should be considered as one of the key business processes. The major outputs of the product development are product specification as well as production and delivery process specification. For a succesful product development it is important to recognize the possible information gaps within the company process structure and between different key processes.

Product development management includes two different management disciplines:
- Management of development process
- Mangement of development projects

The both must be considered by the management. They differ from each other due to:
- Nature, target
- Responsibility
- Measures and indicators

Product development-project evaluation demands:
1. How much will the project cost
2. How valuable are the results of development to the company
3. How likely is it that the project will succeed within the predetermined time (ie. time-to-market)
4. How valuable are the product charateristics to the customer

In competitive business environments, very essential questions of practical product development are:
- How can we provide ever earlier development decisions with high impact to the product and high confidence?
- How can we frontload the development in order to early detect and solve potential problems and reduce engineering rework?

Normal process management principles and practices should be used also in product development. That means that:
- The system of interlinkaged key processes (the business system of key process network or map) are managed, ie. the whole business is managed from the process point of view.
- The individual key processes, including product development, are managed using process plan, process control and quality assurance, and continual process improvement.

Process plan includes definition of:
- Process owner (identification, responsibility)
- Process entity (purpose, outputs, inputs, work flows, external/internal links, activities and tasks, resources, restrictions)
- Measures and indicators (external, internal, targets and requirements, measurements, recording)

Measures and indicators for product development should be defined on company level, on process level, and on project level. A modern way to consider in the strategic measures, indicators, and targets company-widely is balanced startegy card (BSC) methodology. It should also cover the needs of product development.

Successful innovative product development means that the results of the development should also generate real sales of new products on the market-place. It is a strategic product development issue of a company how big portion of the sales are generated by new products.

Rather often questions have been presented in relation with the productivity of product development: How big portion of product development projects should be successful/unsuccessful? Where are the limits to take risks in product development? There are no doupts that also product development should be a productive activity (process). However product development should not be mixed up with research activity where uncertainty may much higher. Uncertainty of development decisions should be managed by:
- Assessing credibility of both technical and commercial success, and
- Using appropriate analytical risk management methodology.

Product development in the framework of company-wide quality management (QM)

Consistent and integrated elements for quality of product development are also included in general quality management frameworks:
- ISO 9000 standards for quality management and quality assurance
- Performance excellence models (quality award criteria), e.g. Malcolm Baldrige criteria mainly for business performance self- assessment

In fact, all modern product development means, tools, and methods can also be considered in a systematic way in these frameworks of ISO 9000 or Malcolm Baldrige.

Issues of ISO 9004:1994 which are related to quality management and quality assurance of design and development of new products include:
- Design and development planning
- Organizational and technical interfaces
- Specifications
- Design process
- Design input
- Design data
- Design output,
- Testing and measurement
- Design reviews
- Design changes and change impact
- Qualification and validation
- Production release
- Identification and traceability
- Product safety

The most important instruments of quality management and quality assurance in product development are design review, verification and validation. However, in practice very often their meanings are not clear. Therefore is recommended to use their standardized definitions (ISO 9000):
- Design review: documented, comprehensive and systematic examination of a design to evaluate its capability to fulfil the requirements, identify problems, if any, and propose the development of solutions
- Verification: confirmation by examination and provision of objective evidence that specified requirements have been fulfilled
- Validation: confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled

Realization of QM in organizations and their functions is not any on/off issue. In fact, QM always exists in all organizations. Therefore QM has always a certain level of maturity, and it can and should always be improved. Thus QM is a fuzzy concept, it is a matter of degree. Therefore it is important to have means to assess the real QM situation in companies in order to carry out effective measures for improvements. Continual improvement is one of the key issues of quality management. All that is relevant also for product development. Recognized comprehensive means for self-assessments within a company are quality award criteria (e.g. Malcolm Baldrige criteria which is the best of different quality award criteria), auditing and benchmarking. In a company the methods should be applied in their own systematic way.

Quality award criteria include assessment area also for product development process. E.g. Malcolm Baldrige criteria are asking: " How products are designed, implemented, and improved? How production/delivery processes are designed, implemented, managed and improved?" With these questions and evidence from the real business operations one can critically judge the existing situation and to find strengths and weaknesses and also score the situation. That is a profound basis for continual business performance improvements.

Internal auditing is best applied to business processes. Auditing means a systematic and independent examination to determine whether activities and related results of a business process comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives (ISO 10019). Examination items in process auditing, which are very relevant also for product development, may include questions of:
- Customer interface
- Process flow as a whole
- People issues
- Tools, methods, etc
- Supplier issues
- Environmental responsibility
- Process management

Quality assurance for confidence among customers

Quality assurance is an important activity for the customer relationship. It means all the planned and systematic activities implemented within the quality management system, and demonstrated as needed, to provide adequate confidence to the customers or others that a product fulfils requirements (ISO 9000). Unless requirements fully reflect the needs of the user, quality assurance may not provide adequate confidence. Product development issues for quality assurance must based on quality management activities of the product development process, including e.g. reviews, verification, validation, audits, analyses, measires and indicators, etc.

In practice there are many different and alternative means for quality assurance including:
- Bilateral quality assurance plans and agreements
- First, second, or third party auditings and certifications, as appropriate

General standardized tools which can be used for quality assurance are:
- Quality assurance plans (ISO 10005)
- Quality assurance models (ISO 9001)

Quality as a never-ending challenge

QM practices must always be company-dedicated and they must be based on clear comprehension and practical/flexible framework of the company. Thus important issues are:
- Corporate shared values and business needs
- Own QM infrastructure (QM model) integrated with business management
- Consistent methodology as well as competent and sufficient facilitator resources

The aim of company-dedicated QM approach should be business performance excellence in a unic way. Modern QM approach does not mean any particular and separate quality system. In fact, this kind of system may even be harmful from quality point of view.

QM is always also a national movement. E.g. European Union supports modern QM approach. Therefore the Commission launched Quality Promotion Policy and is carrying out special actions to reinforce the realization of the policy. By these actions innovative company activities for QM are emphasized because particularly in Europe wrong quality strategies have hindered suitable development of the competitiveness of European organizations. E.g. an over-emphasis on certification at the expense of continuous improvements could mean that the European businesses have been behind its competitors in terms of quality.

Quality management development in organizations is always business culture related. If the culture is introvert oriented and based on to comply mechanically with the rules there are big difficulties to apply modern quality thinking and practices. Therefore in order to start seriously with modern quality management initiatives a cultural change is needed. In fact, there are always opportunities for improvements in quality. That means a never ending business strategy.

[This text was presented as an ACCESS seminar paper in Helsinki, in 1998]