From Percent Rejects to Parts Per Billion Moving Towards Zero Defects

As a strategy, product or process reuse can reduce launch costs

When Philip Crosby announced zero defects as a philosophy during the 1970s, it was met with incredulity. There were already many articles written on the fallacy of such a strategy and the enormous costs of moving toward zero defects. Fast forward 40+ years, and zero defects has become a reality.

The automotive and semiconductor/high-tech industries that we have worked with have achieved this strategy over a 30-year time period. The strategies to shift organizations that were at 20,000 to 50,000 defective parts per million (PPM) during the late 1980s to 1,000 PPM to 100 PPM and even parts per billion are now quite straightforward. Let us understand how this is done.

New-product development, defect prevention, and FMEA

Quality improvement and defect prevention start with a disciplined, new-product development process that includes phase gates. Most important, three tools are key to overall success:

1. Failure mode and effects analysis (FMEA) that is used with design and processes

2. Design for manufacturing (DFM) and design for assembly (DFA)

3. Upfront involvement of manufacturing in design

These are not the only tools, but they are the most important that contribute to overall success. This article will focus primarily on FMEA.

DFMEA

Our understanding of design failure mode and effect analysis (DFMEA) has grown over time. DFMEA looks at the functions of a product and its requirements and then works on the failure modes of that product. During the design phase, the causes of potential failure are focused on just design failures and not manufacturing failures. The fear is that instead of improving the design, the design team will assign all issues to manufacturing. DFMEA identifies both preventive and detective controls. Preventive controls can go into a preventive checklist, but the detective controls are linked directly to test plans.

DFMEA and test plans

At Omnex, DFMEA at the system level is called system FMEA. There is a link between system FMEA, subsystem FMEA, and component DFMEA. This link is defined by the functions and requirements of each of the design elements.

The link between DFMEA and test plans, as well as the links between DFMEAs are high-level topics only understood by best-in-class organizations. Furthermore, these links between DFMEAs and test plans are really only possible using software.

Critical and significant characteristics

The definition of critical and significant characteristics is an important part of the journey to zero defects. Both design and manufacturing need to define safety and key functional characteristics. These characteristics get defined during design, and this definition needs to populate manufacturing tools such as process flow, process failure modes and effects analysis (PFMEA), and control plans.

Process flow, PFMEA, and control plans

Omnex has made dramatic improvements in company quality simply by using a methodology that we call Process Review. The Process Review is conducted by cross-functional shop-floor teams created around families of products or processes. Process flow, PFMEA, and control plans are conducted from the viewpoint of overall improvement using historical data. Most important, the updated FMEAs need to become “lessons learned” for future new-product launches.

Disciplined problem solving—corrective action

When a product is launched, no matter how good the team is, problems or issues are going to occur both internally and at the customer. These problems are solved using a disciplined problem solving process, typically the 8D process. While the 8D methodology deserves great credit, this article focuses on the preventive nature of taking the problem, its root causes, and the corrective action, and populating both design and process FMEAs. In this way, all known problems are taken into the FMEA and used in the next product design.

Design and process reuse

This then brings us to the topics of design and process reuse. At a high level, this topic is about reusing design and processes that are known to work. What if an organization has data that shows the PPM levels of each process or product—not just the product itself, but to its functions? When product or process reuse is taken as a strategy, organizations can launch products with little to no risk. Very easily, the areas of risk can be pinpointed. In many ways, this is the next generation of the zero defects philosophy, using design and process reuse to reduce new-product launch costs.

Speaker

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.