Featured Video
This Week in Quality Digest Live
Operations Features
Jesse Lyn Stoner
Seven tips to say it quick and make it stick
Ryan E. Day
The FARO Cobalt Array Imager helps VRSI and Dynacraft get it done
Jason Furness
Managers, heed these dangers while en route to a Black Belt
Fred Schenkelberg
Can I use it instead of MTBF?
Kevin McCardle
It boils down to knowing your own speed

More Features

Operations News
125 strategies to achieve maximum confidence, clarity, certainty, and creativity
More effective and less expensive than heavy-zinc galvanize
Earn continuing education units
$79 device delivers dedicated neural network processing to a range of host devices
Features faster measurement speed, onscreen averaging, and auto-rotating display
If you want to understand a system, try and change it
Components will be designed from the onset to inhabit multiple configurations during service
How to engage, retain, and develop talent for maximum performance

More News

Chad Kymal

Operations

From Percent Rejects to Parts Per Billion: Moving Toward Zero Defects

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

Published: Monday, October 16, 2017 - 11:03

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. See figure 1:


Figure 1: Requirements manager/flow down and risk analysis (Click here for larger image)

 

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

Figure 2 shows the links between process flow, PFMEA, control plans, and work instructions. Similar to the links between DFMEA and test plans is the link between PFMEA and control plans. An important element when doing the DFMEA and PFMEA is to look at the scrap and rework data, and ensure that the FMEAs are populated by the “things actually going wrong.”

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.

 
Fig. 2: Links between process flow, PFMEA, control plans, and work instructions (Click here for larger image)

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.

Join me and Quality Digest’s editor in chief Dirk Dusharme on Tues. Oct. 17, 2017, for an exciting webinar: “From Percent Rejects to Parts per Billion.” Find out how the links between requirements, DFMEA, PFMEA, and the shop floors can be made using software. Also, learn how organizing the products and processes by part family and collecting PPM data while using analytics allows companies to benefit from design and process reuse. Register here.

 

Discuss

About The Author

Chad Kymal’s picture

Chad Kymal

Chad Kymal is the CTO and founder of Omnex Inc. Kymal developed and teaches auditor training for ISO 9001, ISO 14001, ISO 45001, and OHSAS 18001. Kymal also founded the registrar organization, AQSR, that provided integrated audits of quality, environmental, and occupational health and safety management systems. Kymal has authored seven books and more than 100 papers, several on integrated management systems. He served on the Malcolm Baldrige Board of Examiners and has received numerous quality achievement awards. Kymal has an MBA and a master’s degree in industrial and operations engineering from the University of Michigan.

Omnex has been working in the Automotive industry for 30 years and Omnex principals been active in writing different automotive standards including QS 9000, ISO/TS 16949, Semiconductor Supplement, APQP, FMEA and Core Tools. Kymal conducted the first worldwide witness audit for QS 9000 a predecessor to IATF 16949.

He is currently working on books for ISO 14001 and IATF 16949.