Is your company’s definition of “quality” getting the job done?

When you Google the word “quality,” the hits number nearly four billion. Clearly, quality management is a popular and much-discussed term, but it’s not an easy one to define. That is particularly true for those trying to make critical design decisions required in releasing product to market. It applies across industries, but especially so in fields like medical devices and aerospace, which directly impact our daily lives. It applies across the board in R&D as well as manufacturing. Today every part matters, even one as simple as the O-ring that tragically brought down the Space Shuttle Challenger. The problem is that there are no simple metrics for quality.

Component cost, for example, is an easy measure and simplifies the comparison among options, but that only applies once all risk factors have been considered. It can work perfectly for commodities, but few of today’s components or subsystems fit that description. Cost of the product itself can be a very small compared to the factors that make up total cost of ownership such as longevity, reliability, and cost of assembly of the finished product.

The (In)Significance of Certifications

Another option that may feel like a measure of quality is certifications like ISO9001. However, if quality procedures are not taken seriously when a company is not under audit, some certifications are more of a stand in for true measures of quality. A certification may look good framed in a corporate office, but possessing certifications could be considered the equivalent of “teaching to the test” in elementary and secondary education.

Their achievement is based on process rather than outcome, and while process can be important, as a buyer of components your success or failure depends on results. Using certification as the measure of quality is like the old story of the man searching for a lost contact lens under a street lamp because the light is better, rather than at the location down the block where he actually lost the lens. In short, when a product fails in the field, neither your customer (nor his or her customer) cares that the faulty component was manufactured in an ISO-certified facility.

Certification can, for example, enforce the establishment and adherence to a documentation system, and records of that system help ensure that the established process is being followed. But it is no “guarantee of goodness.” It can create the illusion that the job of ensuring quality is done. But when it comes to establishing and maintaining a quality management system, the organization has to ask whether it will lead to success for the customer or simply help pass an audit.

The 4 Functions That Drive Product Quality

If the importance and scope of quality can’t be understood simply in terms of Google searches and manufacturing certifications, how should it be viewed. Simply put, quality is like a balloon. The smallest failure can lead to a breakdown of the entire system. Effective quality management covers the entire product development process from concept to completion.

Design Definition

It begins in the definition of the product and its purpose. Quality in definition ensures that what you ultimately build will meet the expectations of the end user. Marketing must accurately assess the market’s and end users’ specific needs. R&D then considers component materials, and operations continues the process by considering factors like supply chain. In other words, the organization needs to accurately define the goals against which product success will be measured. These include function, ergonomics, appearance, cost, and others. Effective quality control of definition ensures that development will not produce a product that perfectly meets the wrong goals.

Definition of design is not limited to the fun engineering disciplines; this also includes assessments of regulatory requirements, patent issues, and customer needs. These topics are required to frame-up a proposed design. That design is balanced against material selections, material costs, and process capabilities. With documentation of these design inputs, a design requirements document is created.

Design Development

Product development takes place across multiple functional areas. R&D chooses materials and creates designs and processes to build a product that fully meets the defined market needs. This is an iterative process of moving ever closer to the initial product definition. It involves tradeoffs and decisions like “make or buy,” and identification of suppliers. Quality in development can also involve questions of “tolerance stack-up;” do parts that fall into an acceptable tolerance range still meet requirements as a group.

Once the design requirements are developed and design models are prototyped, product samples are tested in the lab and modified. Verification testing must assess the product “goodness” in a practical application. This process must be robust; it should include simple checklist measurements, market testing, and more.

Quality Assessment and Verification

Quality also means identifying and reducing design and manufacturing risks. For example, a product that meets every functional requirement will not succeed if it cannot be manufactured, if suppliers cannot meet required specs or deadlines, if it fails to meet durability requirements, or if costs are too high. Some of these gaps can be identified through prototyping, testing while others require specific risk management in areas like materials purchasing or regulatory.

On the verification side, quality assessment can identify a need to redesign or redevelop. This can be inconvenient and costly, but performing this assessment and making necessary changes here is far preferable to failing in the field, which is the most painful and expensive form of verification.

Process Transfer to Manufacturing

Finally, the defined, developed, verified product is moved to manufacturing. Manufacturing quality ensures that the production processes created follow through to the product that will actually enter the marketplace. The process that created the prototype and tested products requires a controlled transfer and scaled-up needs for manufacturing.

During this time, production processes must be documented and controlled. Staff must be trained to ensure that processes are followed to ensure the design remains the same. Over time, manufacturing processes must be consistent and monitored to identify unforeseen process changes that could negatively affect the finished product, yields, or cost.

By now, it should be clear that ensuring quality is an end-to-end process designed to create and produce products that meet defined market needs. Poorly monitored processes, insufficient training or confusion in the move to manufacturing will ensure quality shortfalls can occur along the way, cascading through to the end-product and ultimately impacting your success, reputation, and the bottom line.

If your company has experienced quality management issues as products move from development to manufacturing, your product review process may need an overhaul.

Tim Becker
Director of Quality Management