Archive for the ‘Standards’ Category

How do I develop my organization’s management system?

August 5, 2013

As Quality Manager recognize that your organization already operates according to its management system. Recognize that quality is primarily the responsibility of the people doing the value adding work. Also recognize that an individual’s performance is largely determined by the system in which that individual works.

Understand the organization as a system. Define the scope of the system. Assess its strengths, weaknesses, opportunities and threats. Determine system objectives. Analyze what the organization does with its suppliers and customers to turn customer needs into cash in the bank. Determine the cross-functional key processes from the core process and as necessary to sustain and direct the core process. Assign and brief the process owners.

Analyze or design the key processes and their interactions. Obtain feedback (reality check or feasibility check) from the process teams. Incorporate feedback in the process descriptions (procedures). Correct minor nonconformities within two weeks (and issue corrective action requests for any remaining nonconformity). Train process teams in their new processes and in any new controls for existing processes.

Train leaders to run the management system awareness sessions so employees can see they are committed to requirements coming from customers, regulators and their management system. Have them promise management system performance reports.

Facilitate improvements of the system, its processes and products. Audit the management system for how well it helps employees to determine and meet requirements. Facilitate reviews of management system performance with top management so they initiate the changes necessary for their management system to improve the organization’s efficiency and effectiveness.

Monitor top management’s engagement of employees in the use and improvement of their process-based management system to fulfill the organization’s purpose or mission.

Are management system standards really standards?

October 13, 2012

We expect a standard to be definitive. Products that conform to standards for electrical safety, for example, are safe. But management system standards specify general requirements for parts of the system without guaranteeing the performance of all management systems that conform to the standard. Some say this is because standards for management systems generate widely differing interpretations according to the circumstances of use.

So, is a management system standard like ISO 9001 really a standard?

To answer this we first need to examine the relationship between products, processes and systems. Products depend on their processes. Processes depend on their system. The organization is the system that nurtures or disrupts its processes.

By focusing on product standards, we can verify products for conformity and reject those products that do not conform. But an inspection-led approach to quality increases costs for customers. Some processes result in products that would be too expensive to verify fully. Consequently, for processes that could result in products with hidden defects, we had to have process standards too. These special processes include sampling, testing, brazing, auditing and anodizing.

Then we realized that if standards work for special processes, why not capture a model of how the best organizations actually deliver quality assurance?

This led to the first quality system standards that customers could specify in their contracts. Adherence to these early system standards enabled their contractors to focus their time and effort on prevention to reduce the cost of poor quality. Contractors now paid costs of poor quality so they invested more in the prevention of nonconformity. Customers (and contractors) saw quality improve and their costs reduce. A win for all parties involved.

Customers pre-qualified new contractors by auditing their quality systems. Contractors, having to entertain a customer audit every month or so, found this very expensive. Customers had to reduce the number of second party audits. In 1979, the UK issued BS 5750 as a civilian model for quality systems. In 1987, this standard became ISO 9001. LRQA (Lloyd Register Quality Assurance) was the first registrar accredited in 1985 to certify quality systems resulting in one certificate that was recognized everywhere.

Guidelines like ISO 9004 are not standards because they recommend rather than specify acceptance criteria. Documents that specify requirements for management systems are standards but they need a real customer’s requirements and a real system to be fully useful as standards. When combined with the contractor’s management system the standard’s requirements are usually sufficient to determine conformity or cite evidence of nonconformity for corrective action.

Using ISO 9001 with real external requirements driving use and improvement of the management system we see that it becomes an effective standard. It is possible for a well-trained thinking auditor to gather and evaluate evidence to verify conformity of that system to the standard.

Avoid “ISO Implementations”

December 12, 2010

Organizations should use the ISO 9000 family (particularly ISO 9001) of system standards to develop and improve their management systems so they are process-based to assure mission accomplishment.

Instead, many if not most organizations implement ISO 9001 to end up with another layer of documents competing for management attention with the management system that runs the organization.

Any organization that has applied our methodology (first published for all to use free of charge in 1986) will have developed the management system that actually runs the organization.

The biggest reason for poor usage of the standard is organizations feeling they are made to obtain certification.

Reluctant conformity leads to many dismal organizations.

Instead of selling certification, we want to know what our clients want to achieve with, and as result of developing, their process-based management systems.

Most of our larger clients do not bother with certification (although many do with their mission management systems).

These days we spend more time replacing sets of burdensome documents with process-based management systems.

Special License

July 28, 2010


License Plate - blog

What is difference between ISO 9000 and Six sigma as quality standards?

June 30, 2010

On being asked to summarize the differences between two quality standards, ISO 9000 and Six sigma, this is how I replied:

A. ISO 9001 is a management system standard.
B. Six-sigma is a statistical description of process performance.

A. ISO 9001 focuses organizations on their management system that governs the processes that yield products. At the system level ISO 9001 is inviting organizations to address common (system level) causes of process variation. The process-based management systems specified by ISO 9001 can be used to assure product quality and manage continual improvement (to add value faster and prevent loss sooner).

B. Six-sigma is a continual improvement methodology. Most organizations run at two or three sigma.  Six-sigma focuses on designing products so they can be made with fewer defects and on running projects to progressively remove the most costly assignable causes of process variation. Many organizations mistakenly focus their six-sigma efforts on manufacturing before product design. Six-sigma literally means 3.4 defects per one million products. I understand that US airlines with the FAA run their safety processes at about 7-sigma.

So, A and B are designed to work together. Most text books do not mention the 10 to 20 year investment that Motorola, Allied Signal and other six sigma leaders made in developing their management systems before investing in six-sigma. Consequently, perhaps, many organizations using these books have neglected their systems and waste money on their six-sigma efforts because they are let down by inadequate management systems.

To summarize, ISO 9001 specifies a process-based management system which could include its six sigma improvement process.  So, both are compatible and many would say that you should first put in place the organization’s process-based management before investing in six sigma training to turbo-charge the system’s improvement process.

In conclusion, develop your process-based management system first. Run it to assure quality and prevent pollution for a few years. Then invest in six sigma to supercharge your continual improvement process to yield even more cost savings from design, production and delivery.

Please note that certification is not necessary for this but may provide marketing benefits.