The Top 5 Automotive Quality Management Failures of All Time

According to J. D. Powers and Associates, the initial quality of new vehicles improved five percent in 2012 over last year’s numbers. But that doesn’t mean that quality issues are a thing of the past for automakers.

You only need look no further back than the recent woes of Toyota to realize that although overall automotive industry quality continues to improve, internal failures of automotive quality management systems within an organization can still drastically affect a brand’s reputation and thus its sales.

The industry has been plagued over the years with quality management system shortfalls that have lead to the deaths of hundreds of people and the recall of millions of vehicles for safety-related issued. In many cases, profits have been the driver behind quality failures in the industry.

Since quality is a driver of safety, it stands to reason then that in order to improve safety and reduce the number of recalls mandated by the NHTSA and thus the reputation of the industry, auto industry leaders must re-evaluate their commitment to quality, and look back at the industry to find similar failures and avoid repeating them.

The Top 5 Automotive Quality Management System Failures

1. Ford Pinto and Mercury Bobcat (Model Years 1971 to 1976)

In order to compete with burgeoning Japanese imports, Ford Motor Company mandated the production of a car that would cost no more than $2000 and weigh no more than 2000 pounds. The result was the Ford Pinto and its cousin the Mercury Bobcat. As the car neared production, engineers discovered that it failed rear end collision tests miserably due to the location of its fuel tank between the rear bumper and rear axle. Despite being made aware of the problem, Ford management decided to leave the car as is, electing to bear the cost of any lawsuits versus spend the $11 per car to fix the problem. In 1978, after over 100 deaths caused by fuel tank fires were reported due to rear end collisions, the NHTSA recalled 1.4 million Pintos and Bobcats to modify the fuel tank. Ford’s reputation suffered terribly, being seen as the company that put profit ahead of safety, and drove even more buyers to imported cars, the purpose for creating the Pinto from the start.

2. Various General Motors Models (Model Years 1997 to 2003)

Although it had been producing and heavily utilizing its 3.8L V-6 engine for decades, General Motors was forced to recall 1.5 million vehicles due to engine fires that could ignite when oil dripped onto the exhaust manifold during hard braking conditions. An oil leak in the engine could catch fire when exposed to the hot manifold, melting a plastic spark plug wire retainer located directly overhead. The plastic can ignite, resulting in a full-blown engine compartment fire. The NHTSA issued the recall in 2009, six years after the last model was produced. Ironically, General Motors is recently recalled almost half a million Chevrolet Cruze’s for a very similar problem.

3. Ford Explorer (Model Years 1991 to 2001)

Ford owed much of its profitability in the 1990s to the popularity of it’s SUV icon, the Ford Explorer. But it was quickly discovered that the Explorer was top-heavy, tending to roll over during emergency handling maneuvers. The problem was not enough of an issue in and of itself to cause Ford to re-evaluate the Explorer. However, many were outfitted with Firestone tires, which had their own tread separation issues. When combined, the unstable vehicle and faulty tires lead to the deaths of over 200 people. Ford recalled Explorers in 2001 to replace more than 6.5 million faulty tires. Despite the fact that the Explorer was redesigned in 2002, it never regained its dominance in the SUV marketplace.

4. Ford Various Models (1988 to 1993)

In 2002, Ford was court-ordered to recall 7.9 million cars and trucks due to a faulty ignition module. The module’s location on top of the distributor would cause it to overheat and fail, causing cars to stall and lose control of steering and braking. Ford was aware of the problem, but rather than relocating the module to a cooler location at the urging of their engineers, they chose instead to beef up the module to make it last just long enough to exceed the warranty period, forcing owners to bear the cost of replacement. The module had been installed on over 22 million Ford cars and trucks, but by the time the recall was issued, only about one-third of them remained.

5. Toyota Various Models (2005 to 2010)

Removable floor mats were identified as the cause of Toyota’s recall of 9 million cars in the U.S. The floor mats were found to move and wedge the accelerator in position, causing it to stick and lead to a potential crash. When the recall was announced, 52 deaths had been attributed to the issue. Despite proactively cancelling the sales and production of the recalled models, Toyota’s reputation as a quality leader was damaged.

There have been many other image-damaging recalls over the years that did not make the list but deserve some notation.

The Runner Ups

General Motors’ X-cars were recalled 13 different times over the course of their short two year life for a variety of safety and mechanical issues.

The Plymouth Volare / Dodge Aspen were recalled a total of 8 times, and were notorious for premature body rusting and mechanical failures.

And the Audi 5000, despite much lower total recall numbers, suffered the same flaw as Toyota with a faulty floor mat causing the accelerator to stick. The drop in sales due to bad press from the “unexpected acceleration issue” almost caused Audi to close its doors.

In all of these cases as well, the reputation of the manufacturer suffered, and it has taken them years to recover from their shortcomings.

 

Current Good Manufacturing Practices and CAPA

Take a walk around any Walgreens or CVS store and you’ll find hundreds, if not thousands, of cosmetics, medications, medicines, and pharmaceuticals available over the counter or from the pharmacy. If you watch television, listen to radio or browse the Internet, you are bombarded with advertisements for the latest cold remedy, hand lotion or shampoo to make you feel better, look better or cure some illness. These personal products and medications are intended to alter your look, mood or well-being, and therefore have the potential for good or harm.

In the pharmaceutical industries, quality refers to the identity, strength and purity of a product which relates to its safety and effectiveness. The public relies on the integrity and accuracy of pharmaceutical and cosmetics’ labeling and instructions to protect them from harm. Current Good Manufacturing Practices (CGMP) established quality standards within these industries to ensure products are safe and deliver the intended benefit or result. CAPAs, or Corrective and Preventive Actions, are processes used to investigate, identify and correct non-conformance as part of the CGMPs.

Regulations

The Food and Drug Administration regulates the manufacture, production and approval of these types of products. While it imposes strict guidelines, how a company regulates itself to adhere to the standards and its own internal processes leaves room for variation and error.

Industrial manufacturing and service industries can achieve ISO 9001:2008 quality system certification or some industry specific variation of the ISO 9001 standards in order to conform to globally accepted quality standards. In the United States, the FDA has established current Good Manufacturing Practices, or CGMPs, which outline quality system standards for food and drug manufacturers. CGMPs are not new or additional regulations for these industries. Rather, they establish standards for a quality system for these manufacturers similar to ISO 9001:2008.

The CGMPs are similar to ISO quality standards.

There are four major sections:

  1. Management Responsibilities — As with ISO 9001:2008, management has overall responsibility for the establishment and support of the quality management system. They provide the resources, leadership and support within the organization for the establishment and maintenance of the system. They also are responsible for management review.
  2. Resources – Management is responsible for providing the proper facilities and equipment to process and manufacture products according to specification and quality standards. The quality system also establishes guidelines to acquire and receive materials and for processing materials for use. It also provides for proper laboratory facilities and equipment to properly test and approve product samples and a system to document and affirm results. Qualified, trained personnel to perform all operations are another vital resource.
  3. Manufacturing Operations – Quality systems rely on the proper design, development and documentation of manufacturing operations systems, procedures and work instructions. Once established, there must be a process for controlling documentation, updating for quality improvement and ensuring documents and electronic systems are secure and controlled.
  4. Evaluation Activities – Corrective and Preventative Action (CAPA) is a well-established quality process that seeks to identify the root cause of deviations in quality process and product non-conformance to eliminate the cause and prevent further occurrence of the same or a similar situation. CAPA uses a closed-loop process to identify the source of a non-conformance and establish a plan of action for closure. Root cause analysis can involve customer complaints, end-users, vendors, workflow management, the training and experience of operators, reliability of documentation, quality of internal audits and the corrective and preventive action system itself.

Whether the CAPA system is electronic or manual, a reliable CAPA system is a vital component to CGMPs and ensuring the quality and integrity of manufacturing processes and products under FDA regulations.

Should a Small Business Invest in Document Control Software?

To properly control quality, an organization must be effective at controlling its quality documentation.

Document control and management are vital to achieving and maintaining compliance in regulated environments. Forms and procedures must be accessible to those requiring them at any time, while critical records, including non-conformance reports, test analyses, and audit results, must be strictly controlled to prevent unauthorized access and modification or deletion. In many cases, document control is a full-time job for one or more employees within a business.

To help streamline the document control system, many companies have developed document control software that allows an organization to maintain and control access to its documents. Whether or not a small business should invest in document control software depends to a large extent on the complexity of the quality management system in place, the number and relative availability of employees to perform the task, and the end product of the business. Document management software is not needed in every organization, but for most, it can be a helpful addition, if not a direct contributor to the bottom line of the business.

Document control software can be as simple as a stand-alone repository for a business’s policies, procedures, records, and documents, or as complex as a fully integrated application with notifications through email systems.

It can route documents for review and approval, send reminders of corrective actions overdue, assign new corrective actions, notify employees when training is required, and notify quality managers when equipment calibrations are due. The system can be housed completely internally on one PC workstation, or stored externally on a client-based web application or in a cloud environment.

When a document control software solution is properly designed and implemented, it can provide a return on investment for a business. By carefully selecting and deploying components of such a system, administration of a document management system is drastically reduced, freeing employees formerly tasked with the responsibility to take on other responsibilities within the organization, thereby eliminating overhead. In some cases, it may be possible to reduce total organizational headcount.

Document searches can be completed quickly, saving time. Moreover, it improves the accuracy and reliability of the storage process, and can decentralize the system to allow users remote access to procedures and documents, improving the productivity of an organization.

Before any business, large or small, decides to invest in document control software, it should carefully assess its current document handling processes, and determine, in detail, exactly what it expects of a document control application, as well as its current electronic storage capabilities.

Small businesses will likely be successful with an existing off-the-shelf application and a single dedicated PC, while large companies may need to invest in customized software and a server, or contract for off-site data storage. It is critical for both simplicity and cost management to only purchase those portions of a system which are useful and add value to the organization. Investing in a large suite of document control modules that do not fit the needs of the business is wasteful, and overly complicates the software, training, and end use of the product.

Businesses investing in document control software should look for an application that is scalable with the business. Applications that can be integrated into an existing office suite are preferred for training and compatibility reasons, but are not necessary. Independent applications may afford the business with more capabilities, such as email reminders and automatic scheduling and approval routing. Regardless of the application chosen, it should have the ability to sign documents electronically, provide access control and password protection, and create an audit trail that can easily be followed for internal and third-party audits of the quality management system.

Small businesses will find that document control software applications exist in abundance that integrate easily with Microsoft Office and other business software suites. Some of the applications also exist as shareware or freeware, making their cost to the organization nil. In many cases, the same small business can use a stand-alone PC to house the application, and designate an individual within the organization to perform daily or weekly database back-ups to DVD for storage off-site or in a fireproof safe for records retention and business continuation purposes.

An independent PC with document control software also prevents hacking from outside intruders, and can be programmed for individual password access to specific documents and forms housed on the unit.

An investment in this type of hardware and software will be relatively small and affordable for the small business and will produce quick return on investment (ROI), yet will still enhance the quality management system requirements for document control and storage while at the same time allowing employees to be quickly trained to begin using the system.

What is ISO 9000?

ISO 9000 is a series of standards that has been deemed to represent good quality management practices by international consensus, consisting of a set of standards and guidelines related to quality management systems.

It is designed to help businesses ensure that they are meeting the needs of their customers and shareholders. The system is published by the International Organization of Standards (ISO), and deals with the fundamentals of quality management as well as the eight management principles on which they are based.

ISO 9000 was first published in 1987, although its roots go back to the MIL-Q-9858 United States Department of Defense standard that was published in 1959. ISO 9000 is based on the standards put forth by the British Standards Institution (BSI) that were presented to the ISO committee in 1979. MIL-Q-985 was revised into a NATO AQAP standard in 1969, which were then revised into the BS 5179 standard in 1974, which were once again revised to become the BS 5750 standard submitted to ISO to become ISO 9000.

The ISO 9000 series consists of the following standards: ISO 9000, ISO 9001, and ISO 9004. They are used when necessary with the ISO 10000 series of guidelines, as well as ISO 16949 and ISO 19011, specific guidelines for the automotive and environmental industries respectively. In its latest edition, ISO 9000 is ISO 9000:2005, and provides the fundamentals and establishes the vocabulary used in the remainder of the ISO 9000 series.

The main standard, ISO 9001:2008, lists the requirements for a QMS, and is the basis for all of the other ISO standards and guidelines in the 9000 and 10000 series. It is the only auditable standard in the series. ISO 9004:2000, the latest edition of that standard, provides guidelines for performance improvements in a wider spectrum than does ISO 9001 for sustained success in quality systems.

The ISO 9001:2008 standard consists of eight sections, with the last five being specific to the establishment of a quality management system that is sustainable and auditable. Specifically, they are:

  • Chapter 4: Overview of Systemic Requirements – This is a general introduction to the requirements of Chapters 5 through 8, and establishes the baseline for developing a quality management system based on ISO 9000:2008. This section requires a business to develop and maintain a quality manual, control quality documents, and maintain all records related to quality. It states that your procedures manual and documents must reflect what the business is doing and the manner in which it is to be accomplished.
  • Chapter 5: Overview of Management Requirements – This section defines the six sets of requirements that the management of a business must follow. It states that management must satisfy customers, support quality requirements, establish the policy for quality within an organization, perform periodic reviews, carry out the quality policy laid out, and control the quality system.
  • Chapter 6: Overview of Resource Requirements – Chapter 6 requires the recognition and establishment of quality resources within the business, including personnel, work environments, and infrastructure. Personnel placed in quality roles must be competent. Work environments must be fit to ensure a quality product is built. Infrastructure to fit the needs of the quality program must exist and maintained.
  • Chapter 7: Overview of Realization Requirements – This section of ISO 9001:2008 requires a business to recognize the processes that bring a product or service into being. A business must control customer processes, planning processes, and production processes. The quality aspects of the business’s product must be identified and controlled, and customer communication processes must be developed and controlled. Product design and development outputs must be controlled, and must be approved prior to implementation. These outputs must then be used to control product quality. Chapter 7 also establishes the need for validation, review, and design of a process, as well as the need to manage changes required of the product.
  • Chapter 8: Overview of Remedial Requirements – This final section requires that a business execute remedial actions as necessary based on a plan devised and provided by the organization. This includes the measurement and monitoring of processes used to demonstrate conformance with the ISO standard, and improve the quality of the processes and product. Chapter 8 sets forth requirements for the control of non-conforming products, including records establishment and maintenance, controlling their use, and verifying that the non-conformances have been corrected. This chapter also lays out the requirements of a continuous quality improvement process to prevent future non-conformities from occurring.

Presently, there are over 350,000 companies in over 100 different countries that are certified in the ISO 9000 process.

Organizations who invest the time and effort to become certified under the ISO 9000 process demonstrate to the business community that they are committed to creating their product based on a set of internationally-accepted standards.

Certification involves creating a QMS based on the criteria set forth in ISO 9001:2008, and then agreeing to commit to audits, both internal and external to the organization, to ensure that they are maintaining those standards.

ISO 9000 certification helps a business not only helps the organization develop and maintain an actionable QMS, but can also help it market that quality commitment to other businesses and consumers to expand its presence in its market niche.

 

The Automotive Industry’s Shift from QS-9000 to ISO/TS 16949:2009

Implementing a quality standard is no easy task.

Original Equipment Manufacturers (OEMs) in the automotive industry raced to comply with QS-9000, which was based on the ISO 9000:1999 quality management system. ISO/TS 16949:1999, the quality standard for the automotive industry, wasn’t considered significantly different from QS-9000 and conversion was slow.  As the ISO 9000 quality standard was revised, changes were made to the ISO/TS 16949 standard.  The ISO/TS 16949:2002 version put a greater emphasis on customer requirements.  OEMs felt changes were significant enough to give automotive industry suppliers a deadline to comply with the standard or be removed from the supplier list. Ford, GM and Chrysler required suppliers to certify to the new ISO/TS 1949:2002 standard by December, 2006.

One of the criticisms of the QS-9000 standard was the complicated implementation process. The International Automotive Task Force designed the revised standard with an improved implementation process.  It took a page from quality system design by incorporating input from suppliers, manufacturers and industry experts.

More than Just Compliance to the Standards

The revised ISO/TS 16949:2002 standard put more emphasis on customer requirements.  The revised standards aimed to improve effectiveness and efficiency of the entire process instead of a narrow focus on mere compliance with standards.  A company cannot continue to compete effectively with a quality system that is costly and inefficient.   The revision required employee training and a process to measure the effectiveness of employee training as part of the quality system audits.

The ISO/TS 16949:2009 revision is based on ISO 9001:2008.  It keeps the customer focus of the ISO/TS 16949:2002 version and requires building quality into the entire supply chain process.  It has the dual goal of improving quality and reducing costs—two business elements that can satisfy customer requirements and the bottom line.

Top Down Approach

A quality management system cannot succeed without management support.  The revised ISO/TS 16949:2009 version makes productivity, cost effectiveness and customer satisfaction equal goals that promote growth and the ability to compete in a global market.  These goals are easy for management to support and promote within the organization.

ISO/TS 16949:2009 goes beyond managing the quality process by making it proactive.  Instead of detecting non-conformance, errors and waste just through the audit process, it seeks to build in quality processes at every stage of the supply chain to eliminate the root cause of defects and non-conformance.  While customer feedback is important to the process, it doesn’t wait for customer complaints to analyze, revise and improve processes.

Each revision of the ISO/TS 16949 quality system requirements made it more critical for automotive industry suppliers to move away from the old QS-9000 standards.  A supplier has to comply with the new standards to stay in the game and continue to do business in the industry.

As part of the automotive industry supply chain, it must have a compatible quality management system to provide quality materials or supplies required by the OEMs.   A company with QS-9000 certification may meet all internal quality standards but lack the new requirements emphasizing customer focus, efficiency and cost effectiveness.   A company without ISO/TS 16946 quality system certification will be left on the sidelines while other certified suppliers continue to play and win the game.

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