Common QMS Myths

A recent Quality Insider column of Quality Digest identified the 10 most common myths about implementing a quality management system. An edited version is shown below.

The authors state that belief in these myths is the most common barrier to the use of management system standards and, in addition, the greatest cause of frustration and diminished benefits on the part of users. Understanding these myths can help organizations choose to adopt a management system and ultimately achieve the intended benefits embedded within all management system standards. Their paper was written to identify and debunk the most common myths.

1. Management systems require excessive documentation and paperwork

The most popular management system standard in the world, ISO 9001, requires only six documented procedures, enough to provide transparency, structure, and confidence to the organization, its customers, and its employees. Beyond this, the number of documented procedures depends upon the organization’s size, types of activities, and operational needs. Excessive documentation will, in fact, reduce the management system’s value to the organization and its customers and should be considered counterproductive.

2. Management systems don’t add value, but I have to have one because my customers want me to have one.

Management systems provide bottom-line cost savings and improved profitability and performance through embedded preventive practices. Organizations of any size performing activities of any kind that are considering adopting a management system standard can expect to see increased value to customers and greater return on investment through appropriate discipline and communication.

3. Management systems are a net cost to my organization

Studies have shown that preventing a problem is less expensive-and in many cases much less expensive-than dealing with the consequences after a problem occurs. If an organization implements a management system standard and its net cost increases, the organization needs to examine and reconsider its approach to implementing the management system,

4. Management system standards do not allow my organization to be flexible and innovative

During management system implementation, the organization will need to make decisions that allow it to remain flexible where flexibility is important, while at the same time providing enough structure to ensure good discipline where discipline is needed.

Management systems are written in a way that serves any organization. If an organization has an inflexible management system that ties the organizations hands, it is because the management system was created that way. Careful decisions are required to balance the need for discipline and structure on one hand and the need for flexibility on the other.

5. Management system certification is not required; therefore, my organization doesn’t need it

Management system standards contain a collection of best practices. They provide a pragmatic, systematic methodology for organizations, helping them achieve results for themselves and their customers. Certification of a management system by an internationally recognized accreditation body, such as the ANSI-ASQ National Accreditation Board (ANAB), will verify the successful adoption of the imbedded preventive practices and will foster confidence in customers and stakeholders.

6. Management systems don’t help my business; in fact, they distract my organization from its core activities

This myth will almost certainly come true for organizations that use a plug-and-play approach to implementing a management system, instead of making sure documents and practices fit their businesses.

Organizations can avoid this problem by adopting management system standards and implementing them in a manner that fulfills its needs and the needs of its customers and stakeholders. Organizations that recognize this and live by their management systems on a daily basis will achieve benefits that greatly exceed any cost or effort.

7. Management systems are a fad

Organizations have been using management system standards and their precursors in one form or another for more than 200 years. If management system standards had never been developed, organizations would need to follow preventive practices anyway. The preventive practices embedded in management systems standards will always make sense.

8. Management system standards do not guarantee product quality

Nothing can absolutely guarantee product quality. However, management systems can go a long way toward preventing problems from occurring in the first place, thus providing dramatic improvements in results while reducing costs.

9. My customer is already inspecting and auditing my organization and our products, so I shouldn’t need to adopt a management system and have it certified

Certification bodies are accredited to audit the full range of an organization’s activities. These audits are undertaken by personnel fully qualified to perform these audits, thus providing confidence to the organization, its stakeholders, and its customers. Your customer may be equally qualified to conduct these audits-or perhaps not.

Accredited certification bodies are themselves audited by an independent third party such as ANAB. This is unlikely to be true of your customer’s auditors.

10. I already have other certifications (FDA, UL, GLP, GMP), so I don’t need to adopt a management system and have it certified

None of these certifications represent full management systems that are verified by accredited certification bodies. In fact, many of these deal only with product attributes and inspections. They are often narrowly related to production and do not touch on the full range of preventive practices embedded in true management systems.

Avoiding Common Mistakes

Many of the myths discussed above result from mistakes commonly made during the implementation of the management system. The secret to successful implementation is to allow flexibility where flexibility is important and provide structure where structure is needed.

Mistakes in deciding how much flexibility will be allowed within the management system can dramatically reduce positive results and can inflict significant negative consequences for an organization that does not fully understand the customer satisfaction and cost benefits that can be achieved from successful implementation.

What your organization should not do

Your organization should not turn the project over to outside experts. Overuse of outside experts can dramatically reduce the organization’s ownership of the completed management system. It can result in top management and employees not understanding what is happening or why changes are being made. A knowledgeable external consultant may be able to provide valuable insight and can help streamline your project, but day-to-day ownership on the part of your organization is the single most important attribute of successful implementation.

Conclusion

Put simply, management systems prevent problems. They work efficiently and effectively whenever organizations can get past the myths addressed in this article. Use of management systems standards and the associated accredited certification process should reduce costs, improve results, and provide confidence to customers, stakeholders, and organizations.

The Quality Digest column was written by Mark Ames, president of AQS Management Systems; Reg Blake, vice president of corporate development and regulatory affairs for BSI Group America; Michael Caruso, vice president of certification for UL DQS; and Phil Heinle, owner of Quality Consulting.

To see the full column, and the additional Points to Consider for each myth, go to this Quality Digest web page.